The Spring 2023 issue of the DPHARM® newsletter gives a 360º view of innovative trial designs, from ideation to statistical design to operations, through five unique perspectives. Innovative trial designs, such as master protocols and adaptive designs, can increase efficiency and patient experience while reducing timelines and cost, but challenges remain in adoption, implementation and […]
Register Here
Lead Sponsor
Featured Executive Sponsor
Executive Sponsors
Associate Sponsors
Exhibitors
2022 Supporting Partner
2022 Media Partners
Event News
-
March 29, 2023
-
Spring 2023 DPHARM Newsletter
The Spring 2023 issue of the DPHARM® newsletter gives a 360º view of innovative trial designs, from ideation to statistical design to operations, through five unique perspectives.
Innovative trial designs, such as master protocols and adaptive designs, can increase efficiency and patient experience while reducing timelines and cost, but challenges remain in adoption, implementation and change management.
-
February 16, 2023
-
COUCH Health Releases a Report on Patient Engagement in Medical Technology
Patients have more knowledge than ever over their health, and have used digital health tools, such as mobile apps or wearable devices, to manage their health. To push forward innovations in medical technologies, including the patient voice in the development is necessary but complex. This paper from COUCH Health outlines how effective patient engagement provides […]
Patients have more knowledge than ever over their health, and have used digital health tools, such as mobile apps or wearable devices, to manage their health. To push forward innovations in medical technologies, including the patient voice in the development is necessary but complex.
This paper from COUCH Health outlines how effective patient engagement provides an opportunity to drive innovation in the medical technology industry, providing case examples, barriers to engagement and recommendations for overcoming those obstacles.
For more information, click this link to access the full article.
-
January 26, 2023
-
Diversity Action Plans for Clinical Trials Will Be Required, Per a New Law
Increasing diverse participation in clinical trials takes a big step forward with the recent passing of Public Law No: 117-328. The new law outlines that in any Phase III or, when appropriate, pivotal study, a diversity action plan must be submitted that includes the sponsor’s goals for enrollment, the rationale and plan for achieving such […]
Increasing diverse participation in clinical trials takes a big step forward with the recent passing of Public Law No: 117-328.
The new law outlines that in any Phase III or, when appropriate, pivotal study, a diversity action plan must be submitted that includes the sponsor’s goals for enrollment, the rationale and plan for achieving such enrollment.
For more information on the law, as well as future impacts, click the link to read the full article.
-
December 21, 2022
-
Podcast: Why Rare Disease Therapeutics Need Early Market Access Planning
About The Episode When developing and bringing a therapeutic for a rare disease to market, sponsors should think with the end in mind and plan for payer requirements early in protocol design. The economic and clinical value evidence required by payers for market access differs from the clinical efficacy and safety evidence demanded by regulators. […]
About The Episode
When developing and bringing a therapeutic for a rare disease to market, sponsors should think with the end in mind and plan for payer requirements early in protocol design. The economic and clinical value evidence required by payers for market access differs from the clinical efficacy and safety evidence demanded by regulators. Securing approval but lacking market access results in unrealized revenue and, most importantly, patients left untreated. But how do we price and how do we gain access on the promise of long-term value when we don’t have the long-term data?
Join Sangeeta Budhia, VP and Global Head, Pricing and Market Access, and Wyatt Gotbetter, Worldwide Head, Access Consulting, of Parexel, to discuss early market access planning, including inclusive data collection, payer models and the impact of new regulations and innovative trial design on data collection and ongoing evidence provision.
About the Speakers:
Sangeeta Budhia is VP and Global Head, Pricing and Market Access, at Parexel. Her role is to ensure that global strategies including pivotal clinical trials, long-term data collection studies, real world evidence generation plans and HEOR strategies are prepared for the reimbursement challenges that each product will face.
Wyatt Gotbetter is SVP & WW Head of Access Consulting, leading all facets of Parexel’s Access Consulting business with a focus on helping customers position products for market success. With more than 25 years of industry experience, he brings unique insights to guide Parexel’s strategy as we invest in this segment of the business to further our patients-first focus.
Sangeeta and Wyatt can be contacted at Sangeeta.Budhia@parexel.com & Wyatt.Gotbetter@parexel.com.
-
December 15, 2022
-
Expert Perspectives on What 2023 Will Bring for the Pharma Industry
The pharma drug development industry has faced, and will continue to face, massive upheaval from all sides: outside macro influences of geopolitics and recessions, internal pushes for diversity and competition for talent, and the domestic politicization of drug pricing. So what will 2023 bring? In this article from In Vivo, several industry experts, including the […]
The pharma drug development industry has faced, and will continue to face, massive upheaval from all sides: outside macro influences of geopolitics and recessions, internal pushes for diversity and competition for talent, and the domestic politicization of drug pricing. So what will 2023 bring?
In this article from In Vivo, several industry experts, including the R&D Leadership Summit’s chief advisor Fred Hassan, provide their thoughts on 2023.
For more information, click the link to read the full article here.
-
December 9, 2022
-
White House Seeks Input on Optimizing Clinical Trial Data Capture as Part of National Biodefense Strategy
The White House’s Office of Science & Technology Policy (OSTP) seeks input from clinical research stakeholders on how to optimize clinical data capture, and what technology to use, to support the White House’s National Biodefense Strategy. For more information on the new strategy, and to submit a formal comment, click the link to read the […]
The White House’s Office of Science & Technology Policy (OSTP) seeks input from clinical research stakeholders on how to optimize clinical data capture, and what technology to use, to support the White House’s National Biodefense Strategy.
For more information on the new strategy, and to submit a formal comment, click the link to read the full article: https://www.whitehouse.gov/ostp/news-updates/2022/10/31/ostp-in-partnership-with-onc-seeks-input-on-optimizing-data-capture-for-clinical-trials/
-
December 7, 2022
-
White House Seeks Input on How to Build Standing Trial Capacity to Address National Health Emergencies
The White House’s Office of Science & Technology Policy (OSTP) seeks input from clinical research stakeholders on what is needed to develop the clinical research capacity that can support coordinated, larger-scale studies in national health emergencies, as part of the White House’s larger National Biodefense Strategy. For more information on the new strategy, and to […]
The White House’s Office of Science & Technology Policy (OSTP) seeks input from clinical research stakeholders on what is needed to develop the clinical research capacity that can support coordinated, larger-scale studies in national health emergencies, as part of the White House’s larger National Biodefense Strategy.
For more information on the new strategy, and to submit a formal comment, click the link to read the full article: https://www.whitehouse.gov/ostp/news-updates/2022/10/25/ostp-and-nsc-seek-input-on-u-s-capacity-for-emergency-clinical-trials-research/
-
November 2, 2022
-
Podcast: How Sites Using Their Own Technology for Research Benefits All Stakeholders
About The Episode As technology advances in clinical research manage operational workflows, others arise as research sites juggle non-integrated technology systems deployed by sponsors and CROs, slowing operations and duplicating work. In this podcast, Stuart Cotter, VP of Product Strategy and Innovation at Advarra, will explain the work being done to allow sites to bring […]
About The Episode
As technology advances in clinical research manage operational workflows, others arise as research sites juggle non-integrated technology systems deployed by sponsors and CROs, slowing operations and duplicating work. In this podcast, Stuart Cotter, VP of Product Strategy and Innovation at Advarra, will explain the work being done to allow sites to bring their own tech to research studies when they are working with sponsors and CROs.
This episode addresses: sponsor concerns around site technology being fit-for-purpose; the pain points sites currently face on a daily basis; and Advarra’s Site-Sponsor Consortium that brings together stakeholders to brainstorm and problem-solve this issue.
About the Speaker:
Stuart Cotter, VP, Product Strategy and Innovation, Advarra
Stuart Cotter is the Vice President of Product Strategy and Innovation at Advarra. In this role, he collaborates with current customers and the research community to understand their challenges and translates those challenges into solution-based enhancements to our product offerings. Cotter also leads the Advarra Site-Sponsor Consortium, helping to seamlessly connect site and sponsor technology by addressing key data and process inefficiencies across the clinical research ecosystem. Prior to joining Advarra’s strategic team, Cotter worked as a Product Manager for Advarra eRegulatory Management System, and as Product Support Specialist on Allegro CTMS, where he worked alongside dozens of small- to mid-sized research sites to help them overcome their operational hurdles.
-
October 7, 2022
-
Podcast: Adjusting Your eCOA Strategy For Patient Centricity: Expert Advice
About The Episode As patient-centricity influences every part of the clinical trial process, sponsors may be surprised at how they impact eCOA strategy. On this episode, THREAD Research’s Chris Watson and Rebecca Tomalty share their expertise and experience, strategizing and developing patient-centric eCOAs to avoid surprise costs and delays. Listeners will learn: when to start thinking […]
About The Episode
As patient-centricity influences every part of the clinical trial process, sponsors may be surprised at how they impact eCOA strategy.
On this episode, THREAD Research’s Chris Watson and Rebecca Tomalty share their expertise and experience, strategizing and developing patient-centric eCOAs to avoid surprise costs and delays. Listeners will learn: when to start thinking about eCOA implementation, the unexpected hurdles that can pop up, the ways that patient-centricity has impacted future eCOA planning, and the questions to be asking of your eCOA partners.
About the Speakers:
Chris Watson, Director, Consulting, THREAD
Chris has over 27 years of experience in product and service development within regulated industries across multiple markets. The last 13+ years have focused on Clinical technologies, including tools and platforms to engage, educate and retain participants (and their families) in clinical studies. Chris is a recognised subject matter expert in eCOA and patient engagement, with a proven ability in the technical domain.
Rebecca Tomalty, Director of eCOA and Translations, THREAD
Rebecca has 20 years of industry experience, primarily in Operations. After several years of experience as a Project Manager, she moved to Clinical Outcome Assessment management in the form of scale management (eCOA Licensing and copyright management and Translations) and, most recently, eCOA design and oversight. As Director of eCOA and Translation Services, she has operational oversight for these two key areas of engagement.
-
September 30, 2022
-
Podcast: Sandoz’s Chief Operating Officer Discusses the New Initiative Act4Biosimilars
About This Episode: What is in the future for biosimilars? In this episode, Pierre Bourdage, Chief Operating Officer at Sandoz, lays out the promise and potential of biosimilars, and the important role they play in healthcare system sustainability. We also hear about the new initiative Act4Biosimilars which addresses the challenges of biosimilar approvability, accessibility, […]
About This Episode:
What is in the future for biosimilars?
In this episode, Pierre Bourdage, Chief Operating Officer at Sandoz, lays out the promise and potential of biosimilars, and the important role they play in healthcare system sustainability. We also hear about the new initiative Act4Biosimilars which addresses the challenges of biosimilar approvability, accessibility, acceptability and affordability, with the goal of increasing the global adoption of biosimilars by at least 30% in 30+ countries by 2030.
Key Takeaways:
How biosimilars can fuel competition, innovation and generate savings
The lasting impact on access for patients
How Act4Biosimilars works to support biosimilar adoption and accessAbout the Speaker:
Pierre Bourdage is the Chief Operating Officer of Sandoz, a division of Novartis, driving high quality off-patent medicine accessibility and affordability for millions of patients. He is a member of the Sandoz Executive Committee. His previous roles at Sandoz include Global Head, Biopharmaceuticals Business Unit and Global Head, Sandoz Biopharmaceuticals Strategy and Portfolio.
-
September 14, 2022
-
Acclinate Wins DPHARM Idol Disrupt 2022
The Conference Forum announced that Acclinate is the winner of DPHARM Idol Disrupt at the 12th annual DPHARM: Disruptive Innovations to Modernize Clinical Research 2022 event. Acclinate, represented by Del Smith, PhD, CEO and Co-Founder, specializes in accessing and engaging communities of color to enhance clinical trial diversity, helping pharmaceutical companies enhance diversity through access […]
The Conference Forum announced that Acclinate is the winner of DPHARM Idol Disrupt at the 12th annual DPHARM: Disruptive Innovations to Modernize Clinical Research 2022 event.
Acclinate, represented by Del Smith, PhD, CEO and Co-Founder, specializes in accessing and engaging communities of color to enhance clinical trial diversity, helping pharmaceutical companies enhance diversity through access to an already established online community, not through cold outreach to potential participants.
Acclinate had six minutes to present to DPHARM Idol Disrupt’s judges, followed by a rigorous Q&A.
“The core of what Acclinate is addressing is increasing trust, particularly with communities of color,” said Dr Smith. “It is about engaging with the individual before they become a patient, going further upstream in the process to do the work necessary to build trust.”
The DPHARM Idol Disrupt judges appreciated the combination of external community outreach and technology support, to develop a participation probability index through Acclinate’s community platform NOWINCLUDED and clinical trial management system e-DICT.
“The recent FDA draft guidances for diversity plans, as well as independent initiatives from pharmaceutical companies, makes Acclinate’s work both timely and relevant,” said Doug Schantz, SVP, Clinical Operations, Asklepios BioPharm and DPHARM Idol Disrupt Judge.
Acclinate had strong competition from the other DPHARM Idol Disrupt contenders:
- Autonomize – Represented by Ganesh Padmanabhan, MBA, CEO and Founder
- Captario – Represented by Matthew Kokkonen, MBA, Director, Strategic Account Management
- Cognivia – Represented by Dominique Demolle, CEO
- Seqster – Represented by Ardy Arianpour, CEO & Founder
- Trialbee – Represented by Matt Walz, CEO
“The focus at DPHARM Idol Disrupt is not just on the ‘wow factor’ but on picking a company that represents a disruption that has potential to soon make a meaningful difference for patients. Acclinate provides something that can be broadly implemented, accessible to most people and provides a high-value solution,” said Cindy Geoghegan, Patient Advocate and long-time Idol judge.
The judges included:
- David Apfel, Head, Data Science External Innovation, Janssen Research & Development LLC
- Cindy Geoghegan, Patient Advocate
- Yusuf Ghadiali, Executive Director, Head of Clinical Trial Operations, Daiichi Sankyo
- Andrea Jackson, Director, Northpond Ventures
- Hassan Kadhim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS
- Sarah Krüg, Executive Director, Cancer101/CEO, Health Collaboratory
- Matt W. Maddox, AVP, Eli Lilly and Company
- Judith Reece, PhD, VP, Digital Development, GSK
- Doug Schantz, SVP, Clinical Operations, Asklepios BioPharm
- Merle Schneider, Senior Director, Monitoring Excellence, Global Clinical Trials Operations, Merck & Co. Inc.
- Donna Usiskin, Chief Strategy Officer, New Enterprise Ventures
- Taylor Uttley, Head of Strategy and Operations, Data Strategy and Solutions, Vertex Pharmaceuticals
-
August 10, 2022
-
Video: What to Expect at the 12th Annual DPHARM Conference
DPHARM Directors, Valerie Bowling and Tracey Kimball, provide an overview of what to expect at the 12th annual DPHARM: Disruptive Innovations to Modernize Clinical Research in under 10 minutes. Watch below!
DPHARM Directors, Valerie Bowling and Tracey Kimball, provide an overview of what to expect at the 12th annual DPHARM: Disruptive Innovations to Modernize Clinical Research in under 10 minutes. Watch below!
-
July 21, 2022
-
In New Article, BMS Announces Launch of New Initiative to Ensure Patients With Disabilities Can Participate in Clinical Trials
Bristol Myers Squibb has launched the Disability Diversity in Clinical Trials initiative, to ensure that patients with disabilities have access to clinical trials, according to a new article in Endpoint News. Teaming up with the nonprofit Disability Solutions, the program will begin with a focus on creating recommendations for improving access, speed of enrollment and […]
Bristol Myers Squibb has launched the Disability Diversity in Clinical Trials initiative, to ensure that patients with disabilities have access to clinical trials, according to a new article in Endpoint News.
Teaming up with the nonprofit Disability Solutions, the program will begin with a focus on creating recommendations for improving access, speed of enrollment and participation of people with disabilities in trials. According to the CDC, roughly a quarter of US adults live with some type of disability.
We are pleased to share this article on the exciting work BMS is leading to increase the diversity of patient participants in clinical research. Click here to learn more about the work that BMS, and others, are doing to make research more equitable.
-
July 19, 2022
-
DPHARM Zeitgeist Speaker Dina Katabi, MIT, Recently Featured on Bringing Personalized Medicine Home
In this article, DPHARM 2022 Zeitgeist Speaker, Dina Katabi, PhD, MIT’s IT Center for Wireless Technology, explains how the touchless sensors she and her team are developing represent a move from wearables to “invisibles” in a new phase of remote health monitoring. We are pleased to share this article on the exciting work Dr Katabi […]
In this article, DPHARM 2022 Zeitgeist Speaker, Dina Katabi, PhD, MIT’s IT Center for Wireless Technology, explains how the touchless sensors she and her team are developing represent a move from wearables to “invisibles” in a new phase of remote health monitoring.
We are pleased to share this article on the exciting work Dr Katabi is pioneering in remote monitoring. At the upcoming DPHARM conference, Dr Katabi will be presenting on this and the power of machine learning and radio signals to monitor patient vitals and predict future diseases.
-
June 22, 2022
-
Adapting drug supply strategies to modern study models
As decentralized trials gain prevalence, clinical supply chains can flex to meet new needs Written by Parexel Decentralized trials (DCTs) make clinical research more accessible to diverse and geographically dispersed patient populations. By taking trials directly to the patient, barriers to enrollment can be eliminated and participation can be continued, which benefits patients and can […]
As decentralized trials gain prevalence, clinical supply chains can flex to meet new needs
Written by Parexel
Decentralized trials (DCTs) make clinical research more accessible to diverse and geographically dispersed patient populations. By taking trials directly to the patient, barriers to enrollment can be eliminated and participation can be continued, which benefits patients and can help accelerate the pace of drug development.
As DCTs are scaled, the industry also encounters unique challenges, particularly within pharmaceutical clinical supply chains. The success of any study hinges on effective supply chain management — getting the right drug to the right patient at the right time in the right condition. That’s complicated work. And it becomes more complicated for DCT management, which requires shipping to multiple coordinating sites and directly to patients’ homes.
So Parexel adapts our practices to fit direct-to-patient (DtP) models. And we’re working flexibly as regulators identify and address emerging DtP considerations. Through all of the change, however, our mission remains the same: supporting patients and their care teams through the consistent, convenient delivery of drugs and other trial supplies.
DtP drug shipments require layers of planning to maintain drug stability during transport. Providers also need ways to prevent unauthorized access, detect tampering, track temperature and dosing, and provide timely refills.
When facing such complexity, risk management becomes incredibly important. What happens if a patient isn’t home to accept a drug delivery? Or if a family member wants to sign for the shipment? If the temperature control system is compromised in transit, how will we know? How quickly can the compromised drugs be replaced? For every step of the process, we brainstorm possible obstacles and how to best handle them.
Some materials, like sample collection supplies or wearable devices, can be direct-shipped fairly easily. But there are situations in which alternatives to DtP deliveries are needed. For example, direct-shipping a drug that requires very strict temperature controls might create significant risk for product integrity. In such cases, to better serve patients, we’ve used depot-to-site shipping, with sites coordinating the final distribution.
Depot-to-site shipments are also a good option when clear regulatory guidance is lacking. For example, study medications may need to be distributed to patients in multiple states in the U.S. The FDA hasn’t clarified whether a trial-affiliated pharmacist is needed in each state to which the drug product is shipped — so if there’s a lack of pharmacists, it might be prudent in some cases to use site shipments, with clinical teams allocating drugs as appropriate.
There is precedent for regulatory approval on some DtP shipments. For example, when the COVID-19 pandemic forced the closure of clinical trial sites in Malaysia, Parexel was able to ship drugs directly to Malaysian patients from neighboring Singapore. Prior to this time, cross-border shipments were unusual, and our global trade compliance teams worked very closely with regulatory authorities in both countries. Ultimately, the work was a success. During the pandemic, many sponsors and CROs demonstrated the safe use of the DtP model, so we believe wider approval for domestic and international DtP shipments will come.
We’re also anticipating new industry technologies that will enhance the direct-ship patient experience. These include remote-access drug refrigerators that track patient access, caps that record and relay when a drug vial is opened, and over-encapsulation products that report when a patient has consumed a medication. While these innovations are still in the exploratory stage, they show our industry’s commitment to patient-focused, forward-thinking solutions.
And that commitment applies to patient-focused trial models as well. We expect the continued growth of hybrid trials, blending the benefits of virtual medicine with some site-based activities. This flexible model can serve a variety of patients and needs. So for patients with chronic but more easily managed conditions, like diabetes or asthma, the study team might design a hybrid trial with DtP medication shipments and visits that are mostly remote. In a hybrid trial for patients with more complex needs, however, the protocol could call for wearable technology and some in-home sample collection mixed with occasional in-person appointments at the study site.
When planning a protocol, we consider the unique needs of the patient population. In some cases, patients will welcome the convenience of remote appointments and at-home medications. There are also patients who see site-based appointments as a benefit of clinical research — a chance for in-person attention from experts in their therapeutic area. We weigh those wants as we design a study. Understanding patients helps determine our success.
Cost also factors into supply chain planning. Because DtP shipments must be delivered to many individuals, they are more expensive than depot-to-site shipments, which occur in bulk. The tradeoff, however, could be greater patient compliance and retention. Benefits and costs will be different for every trial and every medicine. In considering options, we’re looking for the best way to serve the patient while also managing risk and costs and ensuring data quality. That requires flexibility and a willingness to navigate complexity.
CROs can help manage that complexity, and there are many approaches. At Parexel, we streamline drug supply through our dedicated network of international depots, which gives us greater control over clinical trial supply and logistics. Using a hub-and-spoke strategy, our larger distribution centers serve many outlying regions with speed and efficiency. We also have a team of professionals whose approach to logistics is informed by a deep knowledge of GCP and GMP regulations.
And those experts know that, to be truly valuable, an innovation must solve a problem for the patient. In many situations, DtP shipments simplify trial participation and make it easier to stay compliant. They’re one of the many tools we use to solve problems — for patients and our partners.
Post sponsored by:
-
June 16, 2022
-
DPHARM 2022: Announcing first Line Up of Keynotes and Special Guests
The Conference Forum announced the launch of the 12th annual DPHARM: Disruptive Innovations to Advance Clinical Research conference, taking place September 13-14, 2022 at the Westin Copley Place in Boston, MA. DPHARM is the only conference dedicated to innovation in clinical trial operations. The 2022 theme is accelerating patient inclusivity, optionality and access. “We are […]
The Conference Forum announced the launch of the 12th annual DPHARM: Disruptive Innovations to Advance Clinical Research conference, taking place September 13-14, 2022 at the Westin Copley Place in Boston, MA.
DPHARM is the only conference dedicated to innovation in clinical trial operations. The 2022 theme is accelerating patient inclusivity, optionality and access.
“We are thrilled to present an exceptional speaking faculty comprised of renowned innovation thought leaders, best-selling authors, senior clinical operations executives, patient advocates and solution providers,” said Valerie Bowling, Executive Director, DPHARM.
DPHARM 2022 Keynotes and Featured Speakers include:
Scott Gottlieb, 23rd Commissioner, U.S. Food &Drug Administration addresses the future of medical innovation and the role clinical trial operations executives should be prepared for in modernizing clinical trials.
Malcolm Gladwell, renowned author of the “Tipping Point” shares his thinking on next-generation innovation and learning from the fringes.
Judy Sewards, Head of Clinical Trial Experience, Pfizer discusses leadership lessons needed to drive innovation.
Vijay Govindarajan, Coxe Distinguished Professor, Tuck School of Business, Dartmouth College and author of “Reverse Innovation” outlines how critical establishing a human-centric organization is to realizing a reverse innovation mindset.
Ezekiel J. Emanuel, MD, PhD, Vice Provost for Global Initiatives and the Diane v.S. Levy and Robert M. Levy University Professor, Co-Director of the Health Transformation Institute, University of Pennsylvania and Peter Ronco, Head of Global Development, Janssen R&D explore industry’s readiness to radically change informed consent to reduce patient burden and drive greater inclusivity.
Dina Katabi, PhD, Director, IT Center for Wireless Technology, MIT demonstrates exciting capabilities in remote data monitoring and its potential to help diagnose diseases prior to symptom onset.
David Lidsky, Deputy Editor, Fast Company comments on the 50 Most Innovative Companies of 2021 and their ability to make a meaningful impact.
This year’s agenda takes aim at how organizations can propel innovation by shifting organizational mindset and culture, enabling the implementation of new ideas and forging the right partners and collaborations. Presenting companies include:
- J&J
- Sanofi
- LEO Pharma
- Pfizer
- AstraZeneca
- BMS
- Regeneron
- Moderna
- AbbVie
- Gilead
- Amgen
- Merck
- And more
DPHARM expects over 700 attendees from the clinical trial operations community from both US and Europe.
-
May 19, 2022
-
Podcast: The Key Role of Strategy and Media in Improving Clinical Trial Enrollment Diversity
Summary: Join us for an important discussion about the necessity to adjust and adopt media and research strategies to ensure clinical trial recruitment of diverse populations. PharmaTalkRadio’s Valerie Bowling speaks with BBK Worldwide industry experts Justin Jones and Gaby Grekin who will share specific strategies and approaches to apply at the research and media […]
Summary:
Join us for an important discussion about the necessity to adjust and adopt media and research strategies to ensure clinical trial recruitment of diverse populations. PharmaTalkRadio’s Valerie Bowling speaks with BBK Worldwide industry experts Justin Jones and Gaby Grekin who will share specific strategies and approaches to apply at the research and media planning stage to achieve more balanced clinical trial representation. More specifically, our guests discuss:
- FDA expectations
- Strategic media approaches to create a more diverse and inclusive clinical trial environment
- What to do before initiating an enrollment or engagement campaign
- Key considerations for planning and executing an effective outreach campaign that engages and motivates diverse audiences
- What to prioritize?
This podcast will especially benefit study sponsors, site staff, PIs, CROs/CRAs, designers and planners of clinical studies, as well industry professionals who support these groups to aid in study recruitment and strategy.
Guests:
Justin Jones, Sr. Director Media and Content, BBK Worldwide
Justin leads BBK’s in-house media department and oversees media strategy, planning, buying, implementation, and reporting. He is responsible for the development of multinational creative platforms, which cross every traditional and social media channel. Justin is adept at transforming complex protocols into compelling, well-rounded advertising campaigns that command attention and motivate audiences to take action. His prowess in understanding the target audience and avenues for engagement have helped to enroll numerous clinical studies. In 2017, Justin was selected as one of the top 100 most inspiring and motivational people throughout the life-sciences industry by PharmaVOICE.
A fifteen-year veteran of BBK, Justin also leverages his expertise as a consultant to the creative team and advises on creative concepts and material development.
Gaby Grekin, Sr. Director of Global Strategy, BBK Worldwide
As Senior Director of Global Strategy, Gaby understands what it takes to achieve clinical trial enrollment success. She conducts in-depth analyses to understand the condition, patient and physician mindsets and motivations, the protocol, and the study landscape to set the strategic direction to guide campaign strategy, positioning, and messaging. She ensures that all internal specialists who will contribute to a campaign understand the target audience — who they are, what they value, the journey that has taken them to the point of interest in a clinical trial, the risks they face, as well as any barriers to their clinical trial participation. Her efforts help ensure that campaigns incorporate a thoughtfully identified strategy and the necessary tactics to ensure trials are inclusive and accessible to all. The imperative to fight for improved representation and diversity-related outcomes is a career-long passion for Gaby. Before transitioning to the healthcare industry, she spent over 20 years working for educational equity in both U.S. and international public schools. Gaby helped educational leaders make systemic changes to close achievement gaps, improve educational outcomes, and implement strategies to address longstanding challenges to diversity, equity, and inclusion. She began her career as a Teach For America corps member.
In her role, Gaby oversees patient and physician interviews, surveys, and focus groups.
Moderator:
Valerie Bowling, Executive Director, PharmaTalkRadio
For more information about patient involvement, engagement and centricity, click here.
-
May 11, 2022
-
Podcast: Is the End of SDTM in Sight?
About This Episode: Dr Derk Arts, Founder and CEO of Castor, lays out what he views as the next phase of data presentation to regulatory agencies, moving away from the standard SDTM (study data tabulation model) into something that more accurately represents the diverse streams of data that are being generated. Potential impacts include: […]
About This Episode:
Dr Derk Arts, Founder and CEO of Castor, lays out what he views as the next phase of data presentation to regulatory agencies, moving away from the standard SDTM (study data tabulation model) into something that more accurately represents the diverse streams of data that are being generated. Potential impacts include: drug approvals based on quality of life, a step forward into precision medicine, and overall increase in patient centricity.
Key Takeaways:
- How companies can prepare for a more data-friendly future
- Working groups at the FDA and their involvement in data submission
- What this direction means for precision medicine, remote monitoring and other innovations in clinical research
About the Speaker:
Derk Arts, MD, PhD, has over fifteen years of experience in medicine, research and technology. He founded Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus and impact of data. Castor enables sponsors worldwide to run patient-centric trials on a unified platform that helps them maximize the impact of research data on patient lives.
Dr Derk Arts believes the key to achieving lasting change in the industry is through scalability and standardization. Technology to run better trials and maximize the impact of data should be available to all researchers.
Over the past 12 months, Castor provided pro-bono support to over 300 COVID-19 trials, and provided the entire infrastructure for the World Health Organizations’ Solidarity Trials.
-
May 2, 2022
-
Spring 2022 Newsletter: Three Perspectives on Data Science
Read the latest issue of the DPHARM Newsletter including perspectives on data science with Janssen, Novartis, and Boehringer Ingelheim. Click here to read the issue.
Read the latest issue of the DPHARM Newsletter including perspectives on data science with Janssen, Novartis, and Boehringer Ingelheim.
-
April 26, 2022
-
Toward more inclusive studies: Reaching and retaining patients from underrepresented communities
Written by Parexel Across the clinical research community, we’re working toward creating more inclusive studies. By recruiting and supporting patients from underrepresented communities, we help ensure equitable access to clinical research opportunities. We also make our trials more comprehensive, giving us critical insight into a drug’s impact on a wider range of populations. As we […]
Written by Parexel
Across the clinical research community, we’re working toward creating more inclusive studies. By recruiting and supporting patients from underrepresented communities, we help ensure equitable access to clinical research opportunities. We also make our trials more comprehensive, giving us critical insight into a drug’s impact on a wider range of populations.
As we connect with underrepresented patients, we’re finding that past industry approaches aren’t always effective. If we want to reach a new mix of patients, we’ll need to communicate with and support them in new ways.
To encourage inclusion within our clinical studies, we ask ourselves a few questions as we plan and execute trials:
Is our study team diverse?
An inclusive study team helps make our organization more sensitive to and knowledgeable about the needs of diverse communities.
Are we culturally competent?
At Alcanza Clinical Research, an organization with a focus on inclusivity, team members participate in ongoing cultural competence training. “It’s important to learn about the customs, beliefs, and values of different communities,” said CEO Carlos Orantes. “When we understand and respect other cultures, we can communicate more effectively — with patients, but also with vendors and coworkers.”
Do we have ongoing organization-wide support?
“Making studies more inclusive is a whole-team effort,” said Rosamund Round, vice president of Parexel’s Patient Innovation Center. “To be effective, we need everyone invested.” At Parexel, we’ve created several groups to support inclusivity: our Patient Innovation Center, which champions patient-centered research practices, and our diversity, equity, and inclusion (DE&I) team, which addresses concerns for both patients and members of our own organization. We’ve also appointed a Chief Patient Officer who advocates for patients in all aspects of research — including equal representation.
Are we developing the protocol with inclusion in mind?
Study designs must account for the needs of underrepresented people. So what methods will we use to reach potential patients? What kinds of study environments will make them most comfortable? What technologies will feel familiar and be accessible to them? The protocol is the beginning of the patient experience.
What are the relevant cultural considerations?
Cultural norms and nuances can affect how communities respond to clinical research. In some groups, for example, certain illnesses carry stigmas. Another example: To reach communities that include people of Muslim faith, we must consider Ramadan. During the month-long observance, participants can’t take oral medications from dawn to sundown. As much as possible, we want to accommodate patients. We can do that through patient-centric protocol design and through the ways we choose to execute that protocol.
How can we build trust?
Minority groups have been harmed in the past by unethical conduct in medicine and clinical research. Understandably, these historical injustices have resulted in mistrust. But building relationships within underrepresented communities can help us work through wariness that might exist. We’ve had success in partnering with trusted local healthcare providers, community organizations, and patient advocacy groups. Through these partnerships, we’ve earned opportunities to explain the value and potential benefits of the studies we’re doing.
We also know patients value transparent communication. In recruitment materials, for example, we can explain the facts of a study in clear, concise language. And we can assure patients that clinical studies are reviewed and approved by independent regulatory authorities that prioritize participant safety.
How can we support enrolled patients?
Once patients have joined a study, we need ways to engage and assist them. At the outset, it’s helpful to discuss what participants can generally expect from the process.
Then, we like to talk with each patient about:
- Communication. Would this patient prefer to communicate by phone or text? Would he or she like to speak with the same person each time? Having a single point of contact, such as the clinical research coordinator, can increase patient comfort and connection to the study. And if that kind of consistency just isn’t possible, it helps to be clear about that from the start.
- Site visits. After reviewing what patients can likely expect during appointments at the research site, we ask if they plan to bring a friend or family member with them. If so, we want to include these support people in the process as much as possible.
- Transportation. Studies — and patients themselves — indicate that transportation difficulties can be a barrier to clinical trial participation, particularly for people in underrepresented communities. Asking patients how they will travel to the study site helps us assess and address potential problems. For instance, if patients need to walk a mile to a bus station or travel long distances by train, they may find it difficult to keep appointments. When we’re able to arrange more convenient transportation, patients are both appreciative and more adherent.
In addition to these questions, there’s one overarching question we like to keep in mind for all trial-related decisions: How could this help or hinder our efforts to include underrepresented people?
While the specific questions we’ve discussed above are very useful, we recognize that we could never create a comprehensive inclusive-research checklist. So we try to run all of our choices through this help-or-hurt filter, applying critical thinking to every aspect of our work. It leads to better outcomes and, just as importantly, helps us approach all patients with greater empathy and sensitivity.
Post sponsored by:
-
April 22, 2022
-
Podcast: How Listening Tech Disrupts Clinical Research to Create Patient-Centric Trials
About This Episode: Current efforts to source and disseminate patient insights in clinical trial planning are expensive and time-consuming. In this episode, Fabio Gratton, CEO and Co-Founder of InVibe, which was recently acquired by THREAD Research, discusses how patient voice listening technology is enhancing and disrupting clinical research by making it easier to collect […]
About This Episode:
Current efforts to source and disseminate patient insights in clinical trial planning are expensive and time-consuming.
In this episode, Fabio Gratton, CEO and Co-Founder of InVibe, which was recently acquired by THREAD Research, discusses how patient voice listening technology is enhancing and disrupting clinical research by making it easier to collect and use patient responses. The result could be more patient-centric trials informed by the actual patient voice.
Key Takeaways:
- How current listening technology can accurately capture and convey patient responses, emotion and perspective
- The difference from current methods of sourcing patient feedback
- Next steps in the journey of making trials more patient-centric
About the Speaker:
Fabio Gratton, Co-Founder and CEO of inVibe, part of THREAD Research, is a digital health entrepreneur. For over two decades he has adapted his early experience as a Hollywood scriptwriter with innate acumen in science and data to redefine how healthcare companies tell patient stories through technology. Of his many Fortune 5000 ventures, inVibe has transformed market research by enabling
brands to supplement their efforts with flexible, scalable, and impactful voice-driven insights.For more information about innovation in clinical research, click here. For more information about mobile technologies in clinical trials, click here.
-
April 19, 2022
-
Podcast: On-the-Ground Perspective on Putting Decentralized Strategies in Clinical Trials
About the Episode: In this podcast, Labcorp’s Linda Ross, Associate Director of Commercial Strategy, Decentralized Clinical Trials, brings an on-the-ground perspective to the benefit of incorporating decentralized strategies into your clinical trial approach. Having worked on multiple sides of clinical research, Ms Ross is using her experience running clinical trials via flexible approaches to […]
About the Episode:
In this podcast, Labcorp’s Linda Ross, Associate Director of Commercial Strategy, Decentralized Clinical Trials, brings an on-the-ground perspective to the benefit of incorporating decentralized strategies into your clinical trial approach.
Having worked on multiple sides of clinical research, Ms Ross is using her experience running clinical trials via flexible approaches to discuss how, after COVID, the industry can and should continue broader applications of flexible, decentralized clinical trials.
Key Takeaways:
- How to convey the value of consistent DCT planning to sponsors
- Understanding current attitudes and burdens around decentralization
- The next steps in wider adoption of flexible approaches
About the Speaker:
Linda Ross has over 20 years’ experience in the pharmaceutical industry and commenced work with Labcorp in Nov 2008 where she is currently employed as an Ass. Dir. Commercial Strategy, Decentralized Clinical Trials who is regionally based in Auckland, New Zealand. During this time, Linda has worked in a variety of leadership positions across different therapeutic areas that have involved multiple countries in Asia Pacific as well as Americas and Canada. She has developed extensive experience in developing decentralized clinical trials strategies on projects from pre-award, during set up, as well as leading new initiatives for ongoing studies which have been faced with challenging circumstances. Her current appointment includes a focus on developing DCT strategies within AsiaPac.
For more information about disruptive innovation in clinical research, click here.
-
March 15, 2022
-
DPHARM 2022 – Call for Topics is Open
If you are working on a new model, strategy, collaboration, process or new technology to truly modernize and advance an aspect of the clinical trial process, we want to hear from you! DPHARM 2022 is coming up September 13-14 in Boston, MA fully in-person. If you are interested in submitting a topic, please submit your […]
If you are working on a new model, strategy, collaboration, process or new technology to truly modernize and advance an aspect of the clinical trial process, we want to hear from you! DPHARM 2022 is coming up September 13-14 in Boston, MA fully in-person. If you are interested in submitting a topic, please submit your proposal through the form linked below.
-
February 8, 2022
-
New Study Highlights the Impact of Diverse Site Staff on Increasing Overall Patient Diversity in Clinical Research
A recent study from the Tufts Center for the Study of Drug Development (CSDD) has shown that sites with more diverse staff are highly correlated with enrolling more diverse patient populations. We are pleased to share the Tufts CSDD Impact report that underscores the need for more diverse site staff, in addition to efforts to […]
A recent study from the Tufts Center for the Study of Drug Development (CSDD) has shown that sites with more diverse staff are highly correlated with enrolling more diverse patient populations.
We are pleased to share the Tufts CSDD Impact report that underscores the need for more diverse site staff, in addition to efforts to gather feedback from representative groups of patients and optimizing site selection and management.
Click the image below to see the full report.
-
December 14, 2021
-
What COVID Taught Us About Focus, Innovation, and Leadership
By Ubavka Denoble, MD, Senior VP & Senior Medical Officer, Parexel Biotech Well before the COVID-19 pandemic struck in early 2020, drug developers were struggling to become more efficient. At industry conferences, executives, regulators, and investigators lauded new approaches, including decentralized trials (DCTs), patient centricity, adaptive study designs, and risk-based central monitoring. Still, uptake lagged. Then, in the space of months, the coronavirus crisis changed the clinical research landscape in three […]
By Ubavka Denoble, MD, Senior VP & Senior Medical Officer, Parexel Biotech
Well before the COVID-19 pandemic struck in early 2020, drug developers were struggling to become more efficient. At industry conferences, executives, regulators, and investigators lauded new approaches, including decentralized trials (DCTs), patient centricity, adaptive study designs, and risk-based central monitoring. Still, uptake lagged.
Then, in the space of months, the coronavirus crisis changed the clinical research landscape in three lasting ways:
- DCTs passed the Proof-of-Concept test.As researchers scrambled to keep trials going, they turned to DCT techniques. Telemedicine, home nursing, eConsent, centralized monitoring, and other tools aced their proof-of-concept testing in the COVID-19 crucible, proving quick and efficient. We’ll extend the use of these tools as we advance ways to take the studies to the patient to provide an improved patient experience and patient diversity.
- Patient-centricity went mainstream (finally).The pandemic proved that many clinical trials could deliver drugs directly to patients, collect streamlined data, and offer home- or local clinic-based visits. We can incorporate multiple options into trial protocols with flexible trial designs, reducing burdens on patients and sites and minimizing regulatory amendments.
- Biometrics and biostatistics got more important.Contactless trials required healthcare providers to communicate with patients via mobile devices, highlighting the need for advanced biometrics to authenticate interactions and safeguard patient data and privacy. And new data management platforms required more and better-trained biostatisticians. Any company running a trial will now need to prepare for these realities.
Working in this industry for decades, I’ve seen dramatic change. But I’ve never seen the intensity of transformation and innovation that I see today. How can sponsors and CROs survive and thrive? I have a few ideas.
Focus on change.
Efficient remote data collection, management, and interpretation require interoperable systems that don’t exist today. It takes an army of people to build new systems. It also takes investment. At Parexel, we have made a substantial investment in our clinical trial management systems so they can flag data signals more accurately and automatically.
It can be challenging to manage changes of this scope: it is necessary to review longstanding traditional systems and SOPs that may not currently be interoperable but have worked well. They won’t be adequate to handle the demands of remote, risk-based monitoring. Investing in data interoperability now will save money and time later.
Innovate first, then standardize.
But data interoperability doesn’t mean standardization. We’ve seen a heavy emphasis on “standardization” of data, systems, and approaches at industry gatherings and in journals. But I believe that most of the significant advances in drug development came from people and teams that did work that was not standard.
In a period of intense transformation, standardization should not be the goal. That’s a misconception. Setting rules based on what’s good today will not necessarily be good for tomorrow.
Now is the time to reward innovation. Let’s take the example of communicating with patients during studies. We know that we can boost recruitment and retention by engaging patients regularly and interactively during a trial. With new platforms and devices, we have the potential to share data with patients continuously. This is critical in cell and gene therapy trials or rare disease trials as there may be only a few hundred patients worldwide. But with technology and connectivity continually advancing, we will need to experiment extensively to refine how we do this well and in a compliant fashion. It’s too early to standardize any one approach.
Lead with courage.
Every company has its existing processes and loads of people who are comfortable with and knowledgeable about them. But the changes currently impacting drug development demand that people and companies go outside their comfort zone. That takes courage and leadership.
For example, for years, there has been a standard process for study start-up at sites, including a lengthy, face-to-face principal investigator (PI) training session. Now, we are conducting virtual training to clarify study designs and reach a consensus with PIs. This is proving to be much more efficient, as we can bring together all the stakeholders participating in the trial, regardless of location, facilitating decentralized data collection. Reimagining the study start-up process at sites may be unsettling, but it can lead to better solutions.
We can transform our industry and develop drugs faster and better with focus, innovation, and leadership — all qualities on display during the COVID-19 crisis.
-
November 15, 2021
-
DPHARM Pays Tribute to Glen de Vries, 1st Winner of DPHARM Idol
The DPHARM team would like to honor Glen de Vries, pioneering visionary clinical trial operations leader and co-founder of Medidata Solutions. Glen was the first winner of DPHARM Idol in 2013 at the DPHARM Disruptive Innovations to Advance Clinical Research conference. Glen won the competition for demonstrating how to empower patients to submit data samples […]
The DPHARM team would like to honor Glen de Vries, pioneering visionary clinical trial operations leader and co-founder of Medidata Solutions. Glen was the first winner of DPHARM Idol in 2013 at the DPHARM Disruptive Innovations to Advance Clinical Research conference. Glen won the competition for demonstrating how to empower patients to submit data samples directly into a cloud system.
“Glen was so ahead of the game when it came to visualizing decentralized capabilities in clinical research to reduce patient burden,” says Valerie Bowing, Executive Director of DPHARM. “Glen was the essence of DPHARM in that he never stopped challenging what’s possible in clinical trails.” Over the years, Glen and the Medidata team generously contributed to content ideas to help shape the event as it is today.
A graduate of Carnegie Mellon University, Glen had numerous accomplishments in business, academia and the non-profit world. He recently made international headlines as a Blue Origin Astronaut flying into space with actor William Shatner, Blue Origin vice president Audrey Powers and co-founder of Planet Labs Chris Boshuizen. Before co-founding Medidata Solutions, he worked as a scientist at Columbia Presbyterian in NYC where he identified problems that were ultimately resolved through the formation of Medidata Solutions.
In our last interview with Glen in 2020, he provided a look back at his DPHARM Idol win (click here).
Our deepest condolences go out to Glen’s family, friends, colleagues and the entire Medidata team.
-
November 4, 2021
-
Actigraphy Advances a Patient-First Approach
Reduce patient burden — and make the most of valuable data Nathan Noakes, Solutions Architect & Program Director, Scientific Data Organization, Parexel In a patient-centric clinical trial, we focus first on patient needs, finding ways to make participation simpler, more comfortable, and less invasive. To lessen patient burden, we need protocols that accommodate participants’ schedules, […]
Reduce patient burden — and make the most of valuable data
Nathan Noakes, Solutions Architect & Program Director, Scientific Data Organization, Parexel
In a patient-centric clinical trial, we focus first on patient needs, finding ways to make participation simpler, more comfortable, and less invasive.To lessen patient burden, we need protocols that accommodate participants’ schedules, locations, and preferences — and wearable technology can play a role in that effort. Wearables, such as actigraphy devices, let us measure quality of life while making data collection much easier for the patient.
Through accelerometers and optical sensors, actigraphy monitors track a user’s activity, heart rate, mobility, and sleep patterns during the course of a normal day. With continuous data collection, we see a broader view of a patient’s health, extending our knowledge far beyond what we capture during visits to site clinics. This gives study teams, sponsors, and CROs access to valuable insights not available through other avenues.
Thanks to actigraphy’s precision, we can detect even subtle shifts in patient behavior. Did participants become more active as the trial progressed? Sustain activity for longer periods? Were they sleeping longer? More deeply? By pairing actigraphy measurements with patient-reported outcomes (ePROs) and lab samples, sponsors can see the wider impact of a treatment, such as reductions in side effects or improved activity levels. Actigraphy-specific data allows sponsors to learn more deeply from their patient populations. Those findings can inform future drug development and research.
A recent survey of pharmaceutical companies found that 52% of respondents have used activity trackers in clinical trials. And 65% plan to use them in the future.[1] As these sponsors know, actigraphy data can be incredibly beneficial. But to fully capitalize on the technology, you need a detailed plan for how you’ll use it.
Choose the device that’s best for your trial
Actigraphy feels familiar to researchers and patients alike because of the many activity trackers available commercially, such as Apple watches and Fitbit bands. If you want to harness the power of actigraphy in a clinical trial, however, we always recommend using medical-grade devices.
While commercial devices may be easier or less expensive to source, they don’t meet the demands of clinical research. Instead of raw data, these devices provide step counts and sleep durations filtered through proprietary algorithms. This makes results less precise and less transparent, which will impact a regulatory authority’s confidence in your submission.
And while manufacturers support medical-grade devices for multi-year trials, commercial devices have shorter life cycles. A medical-grade device might use the same firmware for a decade to assure consistency in data collection. In the same timeframe, a commercial device may have introduced (and discontinued) several versions, so if patients join a study on a rolling basis, they might use different tracker models employing different data algorithms.
Determine your purpose
Actigraphy devices generate enormous amounts of data, none of which are human-readable. To maximize its value, you need to know exactly what you want to learn from it. Your plans for analysis will impact how your data is collected, reported, and delivered, with the device manufacturer customizing the platform for your purposes.
Every protocol should clearly define how actigraphy will support study endpoints. Specificity is critical, so this is the time to decide which measurements you’ll compare to actigraphy outputs.
For example, one home-based study[2] asked participants with arthritis to perform a sitting-to-standing test three times a week for four weeks. Participants were fitted with activity monitors and completed ePRO questionnaires after each test. By correlating ePROs to actigraphy data, researchers found that the time required to complete each test was significantly associated with the intensity of pain and stiffness reported by patients.
If you have questions about data and what they can do for you, consider enlisting a partner to help. A CRO offers access to additional expertise — statisticians, data management specialists, and others who can guide you through types of datasets and standards for reviewing them.
Consider the regulatory environment
While determining your purposes for data, you’ll also want to keep the evolving regulatory landscape in mind.
Because of the relative newness of the technology, regulatory agencies are still forming opinions on actigraphy in clinical research. Currently, several authorities have issued guidance but we are waiting for formal regulations.
We’re excited about the ways actigraphy could support primary endpoints but we’re not there yet. Based on available guidance, we recommend sponsors use actigraphy for secondary or exploratory endpoints. Our regulatory experts can advise sponsors from trial design forward, helping ensure that your data conforms to all available guidance.
Beyond its value in supporting endpoints, actigraphy data included in submissions will also compel regulatory agencies to issue broader regulations. If we want to fully use this valuable tool in clinical research, we can nudge regulators forward by submitting actigraphy-informed results and obliging regulators to rule on it. High-quality submissions will help demonstrate the reliability and usefulness of actigraphy.
An example of this is the European research project PROActive[3], in which a range of partners (including seven biopharma companies) developed tools to capture physical activity data in patients with COPD. Fitted with medical-grade actigraphy devices, all participants self-reported their experiences with physical activity and some received interventional coaching. Actigraphy data showed a meaningful increase in step counts for coached patients.
After submission, the European Medicines Agency (EMA) issued a qualification opinion regarding the use of PROactive tools in clinical trials. In addition to clarifying how the PROactive tools can be used in the future, this opinion expands the regulatory landscape and paves the way for future use of actigraphy in clinical research.
Bolster patient compliance
In order to deliver meaningful data, actigraphy devices must be worn continually. In the past, device designers have been primarily concerned with their scientific function, meaning comfort hasn’t been a top priority. That’s changing, however, and devices are becoming less noticeable, more comfortable, and more intuitive to use. We test and validate a range of devices — and comfort is always something we consider — so that our sensors team can point you to the sensors that will be most acceptable to your patient population.
A CRO partner can also create and carry out a plan to encourage compliance. At Parexel, we regularly monitor compliance to identify and address adherence issues. Our wrap-around services reduce the burden on patients and sites while guarding the integrity of data collection.
The future of actigraphy
During a clinical trial, investigation sites collect critical data. But data are only one window into a patient’s well-being. Going forward, we expect to see actigraphy devices used more often in clinical trials, and paired with other sensors: devices that measure heart rate, blood pressure, temperature, or blood glucose levels, for example. Collecting these data remotely will reduce the frequency of patient visits to clinics. will also give sponsors and care teams a fuller picture of a patient’s quality of life — insights researchers are eager for.
We also expect to see actigraphy expand into more therapeutic areas. Bulky actigraphy devices might not work for patients with dermatitis or cancer, for example. But as device forms improve and monitors become easier to wear, they will work for a wider range of patient groups.
A survey recently found that half of sponsors who use wearable devices in clinical trials introduced them in 2019 or later. And of those not currently employing wearables, more than 80 percent expect to begin using them within two years.[4] As technology continues to improve — and acceptance increases — we know actigraphy meters and other sensors will become increasingly important to clinical trials, including yours.
Ready to move forward with actigraphy or take its use further? Create a plan that considers all the angles: device selection, data use, regulation, adherence. And enlist experts when you need to. With the right approach and the right team, you can remove patient barriers and maximize actigraphy’s value.
[1] Commissioned research conducted by the Life Science Strategy Group, December 2020
[2] https://pubmed.ncbi.nlm.nih.gov/32095762/
[3] https://www.imi.europa.eu/sites/default/files/uploads/documents/reference-documents/IMI1_SocioEconomicImpactReport_2020.pdf
[4] Commissioned research conducted by the Life Science Strategy Group, December 2020
-
November 3, 2021
-
Applied Clinical Trials: Highlights from DPHARM 2021
Applied Clinical Trials‘s Moe Alsumidaie summarized some key takeaways from DPHARM 2021 in a recent article. He writes, “The pandemic has forced the clinical trials industry to adapt to new ways of thinking around patient-centricity; politicization seemed to have generated a renewed interest in clinical trial diversity inclusion, surging demand in decentralized technologies is transforming […]
Applied Clinical Trials‘s Moe Alsumidaie summarized some key takeaways from DPHARM 2021 in a recent article. He writes, “The pandemic has forced the clinical trials industry to adapt to new ways of thinking around patient-centricity; politicization seemed to have generated a renewed interest in clinical trial diversity inclusion, surging demand in decentralized technologies is transforming research, and advances in artificial intelligence (AI) and data access are allowing for new opportunities in RWE predictive research and early patient engagement. These were the main themes discussed at Disruptive Innovations to Advance Clinical Trials (DPHARM) 2021.”
-
October 14, 2021
-
DPHARM Conference Hits Year 11: Driven By COVID, It Delivers Its Proof Of Concept
Dan McDonald, VP, Business Development, Imperial Clinical Research Services wrote a great recap of some of the key takeaways at DPHARM 2021. Read below: Like many conferences in the COVID era, DPHARM, the annual conference based in Boston and focused on disruptive innovations in clinical trials, moved from in-person to a virtual setting this week, […]
Dan McDonald, VP, Business Development, Imperial Clinical Research Services wrote a great recap of some of the key takeaways at DPHARM 2021. Read below:
Like many conferences in the COVID era, DPHARM, the annual conference based in Boston and focused on disruptive innovations in clinical trials, moved from in-person to a virtual setting this week, due to local spikes of the Delta variant. To date, I’ve largely avoided these events because they lack the same authentic networking opportunities of live events. It’s becoming increasingly clear that the horizon for live events is unknown. So, I bit the bullet and attended the conference virtually. I was pleasantly surprised. The interface was clean, the sound and picture clarity good, and the interactivity solid. In fact, I even had one of my questions posted to the chat box read live and answered by the speaker. Cool!
-
September 29, 2021
-
Biofourmis Wins DPHARM Idol Disrupt 2021
The Conference Forum is pleased to announce that Biofourmis is the winner of DPHARM Idol Disrupt at the 11th annual DPHARM: Disruptive Innovations to Advance Clinical Research 2021 event. Biofourmis, represented by COO Jaydev Thakkar, offers solutions in virtual care and digital therapeutics that enable clinicians to deliver personalized predictive care, backed by artificial intelligence […]
The Conference Forum is pleased to announce that Biofourmis is the winner of DPHARM Idol Disrupt at the 11th annual DPHARM: Disruptive Innovations to Advance Clinical Research 2021 event.
Biofourmis, represented by COO Jaydev Thakkar, offers solutions in virtual care and digital therapeutics that enable clinicians to deliver personalized predictive care, backed by artificial intelligence and machine learning, to patients outside of a traditional hospital, clinic, or clinical research environment.
Biofourmis had five minutes to present their innovation and demonstrate how virtual care and digital therapeutics can disrupt clinical trials to DPHARM Idol Disrupt’s esteemed panel of judges, followed by a rigorous Q&A.
Biofourmis had strong competition from the other DPHARM Idol Disrupt presenters:
- Lifelink Systems – Justin Mardjuki, VP, Product Marketing
- Curebase – Tom Lemberg, Founder & CEO
- Pro-ficiency – David Hadden, President & Founder; Michael Raymer, Co-Founder
- Unlearn.ai – Charles Fisher, Founder & CEO
- Greenphire – Catherine Click, Director, Investigator Grants Payments
The judges included:
- Deirdre BeVard, R&D Strategic Operations, CSL Behring
- Esther Dyson, Executive Founder, Way to Wellville
- Cindy Geoghegan, Patient Advocate
- Jen Horonjeff, PhD, Founder and CEO, Savvy Cooperative
- Adama Ibrahim, eMBA, Director, Digital Solutions, Global Drug Development, Novartis
- Sarah Krüg, Executive Director, Cancer101, CEO, Health Collaboratory
- Doug Schantz, Vice President, Clinical Operations, Alexion Pharmaceuticals
- Mark Travers, PhD, MBA, Vice President, Head of GCTO Regions, Monitoring Excellence, Global Operations and eTMF, Merck
- Hassan Kadhim, Global Head of Clinical Trial Business Capabilities, Clinical Innovation, Industry Collaborations at Bristol-Myers Squibb
The DPHARM Idol judges were struck by the importance of more growth and leaders in the field to bring these digital measurements forward, and the responses Mr Thakkar provided to the judges questions regarding access and equity to bridge the digital divide.
-
September 21, 2021
-
A Patient-Centric Approach to Managing Clinical Trial Complexity
The average length of a clinical study cycle is on the rise and has been for decades. Look at any five-year period: cycles are seven to 10 percent longer than in the five years immediately prior. That’s according to Ken Getz, director of the Tufts Center for the Study of Drug Development (Tufts CSDD). When […]
The average length of a clinical study cycle is on the rise and has been for decades. Look at any five-year period: cycles are seven to 10 percent longer than in the five years immediately prior.
That’s according to Ken Getz, director of the Tufts Center for the Study of Drug Development (Tufts CSDD). When we had the opportunity to co-present at DIA 2021, Getz offered insights into three factors driving up average study duration: executional complexity, hyper-customization, and operating fragmentation.
Let’s look first at execution. Tufts CSDD found that on average from 2005 to 2020:
- Total sites per study grew from 40 to 104.
- Total procedures per study more than doubled.
- Total endpoints per study tripled.1
Perhaps most notably, total data points per study have increased sevenfold — up to 3.56 million per phase 3 protocol. And that’s an average. Some trials collect endpoints twice that number.2
We’re also seeing hyper-customization in trials, with data coming in from a diverse and steadily expanding range of sources. Getz expects a major increase over the next three years in the use of remote or virtual data collection solutions. This includes eSource data and EMRs, as well as data from smartphones and wearable devices, meaning that patients are increasingly directing the collection of their own data.
Add to complexity and customization the challenge of fragmentation. From 2000 to 2020 (projected), global R&D spending nearly tripled, with allocations for CROs and tech vendors seeing a significant increase. Numerous organizations support this growing development activity: approximately 4,200 sponsors, 3,300 CROs, 1,600 technology service providers, and 38,000 investigative sites.3 And these organizations must find ways to coordinate and integrate — which happens with varying degrees of success.
Complexity and customization aren’t inherently negative. With more sites, we can reach more patients. And more data points from a wider range of sources will lead to greater insights. But these conditions, along with fragmentation, certainly create challenges for sponsors, CROs, and their partners.
So how do we respond? It’s nearly impossible to reduce any of these factors. Complexity isn’t going anywhere, data sources are only increasing, and as research expands, so does the number of organizations that support it, which too easily leads to fragmentation.
Instead of reducing factors, let’s make better ways to manage them.
Within our own organizations, CROs and sponsors are efficient and rigorous. But much of our success depends on outside situations. Can sites recruit and retain patients? Will patients comply with protocols? Do technology providers offer and support the solutions we need?
If we find ways to apply internal standards and process controls to our external environment, CROs and sponsors will work more efficiently and more fully meet the needs of patients.
One place to start: Rather than running individual projects, let’s build comprehensive programs of studies that operate in consistent, patient-focused ways. At Parexel, we’re doing this through an operational delivery platform, which creates global networks of sites and partners dedicated to single therapeutic areas. Functioning as one team, each network adopts a shared operating agreement, creates common KPIs, and collaboratively supports protocol development.
By using data available to us, we also have the tools and expertise to create in-depth patient insights and patient personas, noting cultural, behavioral, and logistical challenges. By bringing this together with data specific to sites’ geographic region and clinical emphasis we are able to localize and customize patient engagement programs, which could include targeted patient materials, diversity and equity mapping, and outreach to local advocacy groups and social communities.
Within these specialty-specific networks, teams can also create technology stacks that fit their needs, choosing the best solutions for the studies they conduct. For example, consider a pediatric gene therapy study — a complex trial in which patients might spend months with their care teams. In this scenario, trial staff would need a consent tool with excellent video and animation capabilities and comprehension testing. But given the study’s level of in-person interaction, remote consent capabilities would be less important.
A study for a chronic ambulatory condition, however, would have different considerations. Because patients would have a less intense relationship with their study site, a tool with strong remote capabilities would be critical — but because the study would be relatively straightforward, video and animation wouldn’t be necessary.
By selecting its own go-to technology stack, each network ensures consistency for users. Users become familiar and comfortable with the tools, suppliers can offer continuous support, and study startup happens faster because the site selection, patient recruitment and engagement programs and tech platforms are already in place.
In clinical research, trial complexity threatens efficiency and progress. And while we can’t reduce complexity, we can create methods of managing it. Parexel has a patient-centric approach, and we believe that patient interests must be at the core of any successful effort. By optimizing the patient experience, sponsors and CROs improve overall patient engagement. This leads to faster recruitment and improved retention. Most importantly, it’s a solution that creates a higher quality experience — for patients, their care providers, and the entire clinical trial team.
1 Tufts Center for the Study of Drug Development.
2 Tufts Center for the Study of Drug Development.
3 EvaluatePharma; CenterWatch; William Blair & Wells Fargo Securities; TCSDD
-
September 14, 2021
-
Meet the 2021 DPHARM Idol Disrupt Companies
We are excited to announce the DPHARM Idol Disrupt 2021 presenting companies, who are shaking up the way clinical research is conducted by addressing a specific challenge with their technology. DPHARM Idol Disrupt is an annual live show taking place at the DPHARM: Disruptive Innovations conference, where representatives from startups and up-and-coming companies present and […]
We are excited to announce the DPHARM Idol Disrupt 2021 presenting companies, who are shaking up the way clinical research is conducted by addressing a specific challenge with their technology.
DPHARM Idol Disrupt is an annual live show taking place at the DPHARM: Disruptive Innovations conference, where representatives from startups and up-and-coming companies present and explain what they believe to be an innovative technology that positively disrupts an aspect of clinical research.
Before a judging panel of investors, biopharma veterans and patient advocates, each company has five minutes to prove why their technology can be disruptive in modernizing clinical research.
The six companies presenting this year are:
Biofourmis
Biofourmis offers solutions in virtual care and digital therapeutics that enable clinicians to deliver personalized predictive care to patients outside of a traditional hospital, clinic, or clinical research environment.
Curebase
Curebase leads decentralized clinical research using a eClinical software platform that manages all site/patient data capture, along with a fully virtual site that acts much like a traditional site, but with greater flexibility and reach. Curebase is also pioneering the Bring Your Own Physician (BYOP) model, allowing patients the comfort to make decisions with support from their trusted physician.
Lifelink Systems
Lifelink Systems is pioneering a new class of patient experience technology that’s mobile, conversational, and simple. Large hospitals and life sciences companies use Lifelink Systems chatbots to interact and communicate with large, diverse patient populations across a broad spectrum of care workflows.
Pro-ficiency
Pro-ficiency reduces the costs and complications of clinical training by using comprehensive analytics that enrich and protect clinical research with our simulation enabled, experiential learning platform that automates training compliance and focuses on improving the engagement rate of clinical professionals to transform clinical research training into a study tool.
Unlearn
Unlearn is using novel AI approaches to create disease progression models for clinical research to enable smaller, more efficient clinical trials. Unlearn’s technology has been published in conference abstracts and scientific journals, including Nature. Unlearn is partnering with the world’s leading pharma companies and is actively engaged with regulators, including FDA.
Greenphire
Greenphire is tackling clinical trial performance by streamlining payment processes from sponsors and CROs to sites and patients. Greenphire’s ClinCard and eClinicalGPS solutions deal with any type of trial design and complexity, resulting in more accurate and compliant payments globally for both sites and patients.
DPHARM Idol Disrupt 2021 will kick off with an update from the 2020 Winner, King-Devick Technologies, a SaaS model digital/telehealth company that offers a broad set of evidence-based products utilizing integrated technology to accurately and objectively assess eye movement (oculomotor) disorders.
The 2021 DPHARM Idol Disrupt judges are: Deirdre BeVard, R&D Strategic Operations, CSL Behring; Esther Dyson, Executive Founder, Way to Wellville; Cindy Geoghegan, Patient Advocate; Jen Horonjeff, PhD, Founder and CEO, Savvy Cooperative; Adama Ibrahim, eMBA, Director, Digital Solutions, Global Drug Development, Novartis; Sarah Krüg, CEO, Cancer101; Doug Schantz, Vice President, Clinical Operations, Alexion Pharmaceuticals; and Mark Travers, PhD, MBA, Vice President, Head of GCTO Regions, Monitoring Excellence, Global Operations and eTMF, Merck.
-
September 13, 2021
-
Improving Diversity and Inclusion in Clinical Trials
Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning about barriers to participation and strategies to overcome them. BBK has created a free, content-rich eBook that provides guidance for making clinical trials more diverse and inclusive. Features: Strategic guidance for study sponsors on creating a diverse and inclusive environment — […]
Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning about barriers to participation and strategies to overcome them. BBK has created a free, content-rich eBook that provides guidance for making clinical trials more diverse and inclusive.
Features:- Strategic guidance for study sponsors on creating a diverse and inclusive environment — from engaging locally to removing financial obstacles.
- Q&A with Michele Russell-Einhorn, chief compliance officer and institutional official at Advarra, providing an IRB’s perspective on improving diversity and inclusion in clinical trials.
-
August 27, 2021
-
DPHARM August 2021 Newsletter: How the Pandemic is Shaping Clinical Research
This issue features speakers from our upcoming DPHARM conference on the innovative work they’re leading and their thoughts on what innovations will persevere and shape clinical research because of the pandemic. Read the issue here. The 11th annual DPHARM: Disruptive Innovations conference is scheduled to take place September 28-29, 2021 and also has a virtual […]
This issue features speakers from our upcoming DPHARM conference on the innovative work they’re leading and their thoughts on what innovations will persevere and shape clinical research because of the pandemic.The 11th annual DPHARM: Disruptive Innovations conference is scheduled to take place September 28-29, 2021 and also has a virtual option. The conference features over 100 presenters who report on innovation that support the advancement of patient-centric clinical trials.
-
July 13, 2021
-
DPHARM in 10 Minutes with Director Valerie Bowling
In this podcast, DPHARM Executive Director, Valerie Bowling gives a 10 minute run down on what you can expect from DPHARM 2021. Learn more about the conference taking place September 28-29, 2021 at DPHARMconference.com.
In this podcast, DPHARM Executive Director, Valerie Bowling gives a 10 minute run down on what you can expect from DPHARM 2021.
Learn more about the conference taking place September 28-29, 2021 at DPHARMconference.com.
-
July 12, 2021
-
What Data Informatics Could Do For Your Clinical Research
Meredith Zozus, PhD, CCDM, is Professor and Division Chief, Clinical Operations; Director, Clinical Informatics at University of Texas Health San Antonio. Her active research program in Clinical Research Informatics focuses on methods to improve the design, conduct and reporting of clinical studies and especially in the area of data quality in healthcare and healthrelated research […]
Meredith Zozus, PhD, CCDM, Professor and Division Chief, Clinical Operations; Director, Clinical Informatics at University of Texas Health San Antonio
Meredith Zozus, PhD, CCDM, is Professor and Division Chief, Clinical Operations; Director, Clinical Informatics at University of Texas Health San Antonio. Her active research program in Clinical Research Informatics focuses on methods to improve the design, conduct and reporting of clinical studies and especially in the area of data quality in healthcare and healthrelated research including secondary use of EHR data.
What would disruptive innovation look like in your field?
Let me take the innovative angle first. For innovation, it’s really all about doing things that you couldn’t do before, or as an informaticist, enabling people to do things that they couldn’t do before through new or better information. Whether it’s being able to monitor a trial differently, whether it’s being able to manage a study differently, whether it’s being able to interact with patients or providers differently, or collecting data that you couldn’t collect before. All of those things mean innovation.
Right now, the chain of custody of data is broken. Because people abstract data manually out of medical records, there’s a break in the traceability between the EHR and the study database. But if we can get the data electronically and directly from the EHR, we can also get the audit trail electronically and directly from the EHR, and establish that complete chain of traceability in and along with the data that we receive for studies. This traceability in the data all the way back to the EHR source doesn’t exist now for the FDA.
And when you think about disruptive technology, if you think about some of the work that’s been done in grassroots clinical trials, or direct-to-consumer clinical trials, that doesn’t have to be so different from prospective research or site-based research. What if we can add in that interaction directly with patients to do things like assuring the quality of the data on an ongoing basis? That’s disruptive; it’s less expensive than split samples and independent ways of capturing the data.
The evidence that we have shows that patient selfreported data is capable of detecting errors in electronic health record data. People previously thought that detecting errors in EHR data was not possible. Where the EHR is the source (the original recording), once the patient visit has ended, you can’t go back and recapture the source. This use of direct interactions with patients and the technology and the approaches to do so could be very disruptive from a standpoint of assuring the quality of EHR data used in clinical studies. Similarly, other options exist for identification and correction of errors in the source. We are also pursuing those. Enabling identification and correction of errors in EHR data enables the use of EHR data by regulators. We’d like to see this possibility for marketing authorization, not just post-marketing, safety surveillance, etc.
Where would you like to see us in five years, in terms of how we utilize the EHR?
There’s so much that needs to change with respect to that. People think it’s a panacea, but for decades, people have acknowledged that the quality of the data in the EHR is lacking.
The first thing we need is better standardization of EHR data. The Health Level Seven (HL7) FHIR® standards are progress towards doing this but are relatively new for use in research. The HL7 Fast Healthcare Interoperability Resources (FHIR®) standards identify data elements and those can be mapped to studies. The mapping is like a thread that pulls the right data values through from the EHR to the right place in the study database. Both the National Institutes of Health (NIH; through NOT-OD-19-122) and the regulated industry through formation of the HL7 VULCAN accelerator are encouraging the use of FHIR® standards in clinical research. But also, there needs to be interventions within healthcare facilities to increase the quality of the EHR data. That’ll help some for research but will always be targeted to healthcare needs, i.e., the data that the facilities need, care about and use, and will never comprehensively address all of the research data.
The other thing as far as use of EHR data in years to come: right now, we do well-controlled clinical trials for marketing authorization. That’s a pretty slow, expensive process. That’s also a pretty limited process, from the standpoint of subgroup analysis, disparities and heterogeneity of treatment effect. Our well-controlled clinical trials, in a lot of cases, don’t do a great job at foreshadowing effectiveness in the real world.
I would love to see us, with respect to use of EHR data in five or 10 years, decreasing the dependence somewhat on well-controlled clinical trials. Yes, we need them. However, let’s speed that up; let’s get into the wild sooner, in a provisional way, where we’re getting data on every patient. That way, we don’t just have, say, 3000 patients that have been on a drug for a year or two, we have 30,000 patients or more that have been on that drug for a year or two. It allows us to get data earlier, and detect safety signals, disparities and heterogeneity that we usually are not able to detect in the way that we approach drug development today.
Can you describe your work with machine learning in ICU settings? How can we be utilizing AI/ML to greater effect?
The more immediate promise for AI and ML is on the clinical side, toward precision medicine and predictive analytics, and dropping that down to the front end of the electronic health record, for the physician to say, “This option may be better than that one for my particular patient.”
And I’m at a health system; so we’re seeing those uses being called for immediately. We’re seeing physicians that want to develop better models, rather than clunky risk scores where they have to type in 20 pieces of information. But we need much more scalable models. At the top 60 medical centers, everybody’s got data in one or more of the standard common data models. And crosswalks now exist between them through work at FDA and NIH and through the CD2H and N3C initiatives. It’s relatively easy to machine over those for training and to apply them in health systems that already use the common data models. The FHIR® standards can also be used in that way and are available now on most major EHRs in the US, so ML approaches are becoming more accessible. But It’ll be a while before community hospitals are used to doing that.
In clinical trials, it’s some of the same challenges. It’s the challenge of doing ML and AI at scale and building it into information flows in our drug development processes. On the clinical side, we can do it more easily at scale by getting it into the EHR and bumping up the predictive analytics up to the front-end clinical decision support features available in most major EHR systems.
In clinical trials, you’ve got these custom data processing pipelines that are based on EDC systems and maybe 3-5 more other data sources in a study. Right now, we don’t have the software that leverages the standards, and enables us to do things like machine learning and AI at scale. There are people that are trying it within large data processing operations, and they’re having to build it from scratch. It’s going to take a few years for the software and the standards to catch up to doing that in clinical trials. But the premise of signal detection, decision support and improving human performance in whatever they’re doing for the clinical trial is a worthy pursuit.
What would the better use of informatics in clinical research look like for you in the more immediate future?
There are multiple opportunities. Jules Mitchel has published something on this, as has Wolfgang Summa. These publications show that people aren’t looking at the data when it comes in through EDC as soon as they could be. They’re not setting expectations that the data to be entered the same or next day, and they’re not looking at it the same or next day; they’re waiting weeks. And so, they’re losing that opportunity to intervene on processes that adversely impact the study. That is one immediate use of informatics, with information systems we have today to start looking for signals, reviewing, and using data more quickly.
For the other, I’m going to go back to direct EHR data acquisition. The largest error rate of all the data quality and data processing methods is the medical record abstraction process. And so, although you’re not going to save time on it, that error rate for medical record abstraction is an order of magnitude larger than other data processing error rates such as entry, record linkage, or coding. People don’t realize this, they don’t talk about this. When you look at just getting wrong data, that’s an order of magnitude higher, and it’s more variable. There’s this latent source of error (in the human factors sense) and variability in our underlying data from the manual medical record abstraction process, from human inconsistency in which data to select under a myriad of available scenarios. Then we look around and wonder why we get equivocal results, or why a trial fails to show efficacy.
Using facilitative technology for direct EHR data capture allows you to intervene in the cognitive process of the person abstracting the data. Maryam Garza’s work showed that in the analyzed study, the medical record abstraction error rate could be reduced by a maximum of about 65% if you can get that data electronically. So, is it saving money? Not really, especially not the first few times you go out in the field with it. But from a standpoint of tightening down the data, and getting that unwanted variability out of the data, it’s huge for companies. That’s where the real value is. Aside from that, the FDA finds value in having that unbroken chain of custody back to the EHR data source. And we can clean EHR data; in fact, we can probably do it better than is currently done in traditional clinical data management processes.
What are the areas in clinical research where we could be doing better to innovate?
Other industries have catapulted themselves forward with use of the Internet, online interactions and direct interactions. We’ve really stumbled in a lot of ways in the earlier direct-to-consumer trials and using that, in part because we haven’t used it appropriately. You can’t cut the sites out. You need the sites to recruit the patients, and you still have to cover the site costs for doing that. Queries over the local data warehouse may be useful, or a trial may not be able to be recruited without decision support implemented in the EHR so study coordinators and providers know before or during the encounter that a patient is potentially eligible. These cost money to program and sites have to have the clinical research informatics expertise. These opportunities to accelerate recruitment and enrollment are huge. There is a lot of untapped potential here for Sponsors.
-
July 8, 2021
-
Preparing Clinical Research for the Patient of the Future
Hassan Kadhim is Director, Head of Clinical Trial Business Capabilities, Global Development Operations, at Bristol Myers Squibb. Mr Kadhim is very passionate about transforming the clinical research arena in the pharma industry through the use of technologies and patientcentric clinical trials, to improve access and experience for patients in clinical research within a digital world. […]
Hassan Kadhim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, at Bristol Myers Squibb
Hassan Kadhim is Director, Head of Clinical Trial Business Capabilities, Global Development Operations, at Bristol Myers Squibb. Mr Kadhim is very passionate about transforming the clinical research arena in the pharma industry through the use of technologies and patientcentric clinical trials, to improve access and experience for patients in clinical research within a digital world.
What are the parameters for identifying how and where to implement an innovation?
There’s always a need to improve something. There are always some pain points somewhere that we can certainly look to solve for. My team is well-positioned because our capabilities span the clinical trial journey spectrum. Our capabilities span from generating clinical trial awareness, into patient recruitment, all the way to collecting data from clinical trials and generating the study report. So we have plenty of pain points that we can look at, that could give us either some improvement for patients or sites or even our staff, or potentially in some cases, we think of a competitive advantage.
We start with the pain points that we or our stakeholders are facing. Then we look for solutions for these pain points. Then we quantify and qualify the risks that those innovative solutions come with. If the risk-reward ratio is favorable, and if there is a potential for scaling any particular innovation, then we make a business case and we embark on it.
What are some of the pain points that are coming up in your work?
In terms of the pain points, these are relatively the same across the industry. The biggest one during COVID was access to clinical trials. When COVID disrupted the industry, access became a much larger problem than it was before. Another is how to create more awareness for patients; how do we enable a referral process, for example, to support patients into enrolling or even just getting information about clinical trials? How do we enable a wider diversity of patients into our studies?
Another is automation. We all want to do more work more effectively and efficiently. And certainly anything related to decentralized trials today, especially post-pandemic, is definitely a focus, where it comes down to access again. Can we, through decentralized trials, enable more access to our clinical trials? Can we make it easier for patients and for sites to enroll in clinical studies? Can we make it more flexible for patients to participate, through different options? These are specific pain points that we are looking at improving through clinical innovation.
You mentioned COVID as a disrupter. What is the new, more sustainable equilibrium that you’d like to see in the industry, after we emerge post-pandemic?
What happened when COVID first struck, we were all in survival mode. We were looking for solutions that would help us immediately. We wanted to scale these solutions, because all of our clinical trials are suddenly affected. And scaling something that big in such a short period of time is not easy to do.
There were decisions to go fully remote in some cases, especially at the peak of the pandemic. But what we realized is that a fully remote world is not necessarily desirable. You look at, for example, grocery shopping: sometimes you want to go to the store. It’s the same for healthcare and for clinical research; there needs to be a blend of options that are available. The pandemic made us more used to doing remote visits or remote interactions throughout our lives and particularly in healthcare and research. What I would like to see is taking these and making them acceptable options for patients. Now, that doesn’t mean to transform all of our studies into being fully remote. I think what would be desirable is that decentralized channels are fully enabled. Then we allow our study teams to design their protocols in a way that provides these options for patients, where different patients, depending on the study or what happens in a specific visit, may choose to go to the site or to do things remotely from home. These would be options that are sustainable in the long term, so that it becomes a standard option for clinical researchers.
What would be necessary to get to that point, either in technology, process, change management, etc?
The technology is the first thing that we need, plus the implementation in actual studies and in real patients, not just proofs of concept. That’s where we need to start. During the pandemic, we’ve seen a lot of activity and a lot of investments in that space where the technology really quickly accelerated in terms of features and ability to solve the issues that we had.
But the other thing really needed is a cultural change in the way that we design our studies. We need to find ways to enable more control while we still have flexibility. Oftentimes, we interpret control as less flexibility. But we need to move to a way of thinking where we still maintain that control, while allowing for the flexibility that is required. And in some cases, it’s understandable that there is no flexibility, for example with specialized physical exams, or specialized procedures that must be done in a healthcare setting. But in many cases, we can write our protocols to provide for that flexibility without necessarily losing control. By distributing responsibilities for the clinical trials across different partners, we may be able to reach that point. Technology is one part but then a lot of the rest is processes, procedures, and working with different partners that enable this kind of flexible ecosystem and clinical research.
What does “innovation” mean to you, and your work?
I think, inherently when we talk about the word “innovation,” the word “risk” has to be considered as well. We do innovation to improve something but the very nature of innovation being something we’ve never tested, there’s some uncertainty around it and that uncertainty translates into risk. So in my mind, innovation comes with risk. And we have to accept that. And once we’ve done that, then it’s about managing the risk-reward ratio, making sure that when we bring in innovation, we understand what risks this innovation comes with, how to mitigate those risks to minimize the risk and maximize the value. If there’s no risk, that isn’t innovation. And if there’s no reward, if there’s no value, that would also not be called innovation. The true innovative companies are those that bring the risk down and optimize the value.
Part of your role involves change management. What is the required change management to facilitate the adoption of innovation?
Oftentimes, people spend a lot of time talking about innovation, because it’s exciting, but spend a little time thinking about the change that this innovation may bring, and how to manage this change to make it sustainable. Ultimately, innovation that you cannot implement in my mind is not innovation. For example, there must be a solid communication plan; there have to be considerations around training resources, who is impacted and who the stakeholders are; there must be measurements of adoption. Without them, innovations would not be sustainable and we would not observe real value in real progress.
You’re a strong advocate for using digital technology to cater to the patient of the future. What does “the Patient of the Future” look like?
We talk about millennials as the patients of the future, but millennials are in the marketplace today. They’re working there, they’re active. They may be the patients of the future, but there’s another generation behind them. That generation will be even more tech-savvy, that will have much more comfort with leveraging technology, and they may come to expect it in all of their interactions.
We want to create better health outcomes for the population of the future. But what does the patient of the future want? We see a patient that wants to interact with all kinds of industries at their own pace. We’re in the era of personalized everything. For a generation that’s growing up in that environment, I think they will want to have a personalized experience through their healthcare or if they have to participate in clinical trials. They will come to expect it. It’s today that we are making the change that will be sustainable for tomorrow.
You have advocated for greater patient data return. What are the broader implications for the patient research relationship?
If we try to extrapolate to the future, perhaps 10 years from now, we would hope that there is an increased comfort with exchanging data across the ecosystem. And that data will become even more of an asset across the healthcare ecosystem.
There could be more expectations from patients in all of their healthcare interactions, whether it’s standard of care or clinical research, to get their data after every interaction. You go to the doctor for a health care visit, you want to make sure you have access to your data, probably in a digital format, that you can review anytime, and that you can bring to another provider to get a second opinion. The ecosystem will hopefully evolve to a point where the exchange of data is just second nature – that after every interaction, you get your data – clinical research won’t be in a good place if we have not evolved in that direction by that time. That patient of the future will come to expect getting their data in some digital format that they could use and reuse abundantly.
Where could innovation impact and improve how sites are operating?
Right now a site that wants to participate in a clinical trial must create multiple versions of everything. I would like the industry to move forward with enabling research sites to use their own technologies across the board. That means, for example, delivering and designing standards for eSource so that we can get the electronic data either from health records or from the site’s own data capturing system into the sponsor systems. And in some cases, there will still be some sites that don’t have the ecosystem or they don’t have the resources. And these could benefit from leveraging the sponsor’s resources. It comes down to providing these options for sites and removing some of the rigidity that we currently have in the system, to make clinical research more streamlined and easy for sites, and therefore enable more access to research for patients.
-
July 6, 2021
-
Confronting Research Hurdles and Finding Solutions at Bayer
Michelle Shogren is currently Senior Director of Innovation, Pharma R&D Clinical Operations at Bayer. She has over 20 years of experience in Clinical Research across many different roles. Her greatest passion is customer focused innovation and responding to the voice of the patients and sites. What is the work you’re leading now at Bayer? I […]
Michelle Shogren, Senior Director of Innovation, 8 Pharma R&D Clinical Operations at Bayer
Michelle Shogren is currently Senior Director of Innovation, Pharma R&D Clinical Operations at Bayer. She has over 20 years of experience in Clinical Research across many different roles. Her greatest passion is customer focused innovation and responding to the voice of the patients and sites.
What is the work you’re leading now at Bayer?
I lead a function that is focused on innovation for clinical trials. My area is, “What are we doing inside? How are our ways of working, working for us? And is there an opportunity to innovate in how we’re doing things?” We also look to the future and plan for that, and imagine what could be coming down the pipe that we need to consider with our people, our processes and our technology, because all three of those are key and critical for a clinical trial to move forward.
Our current focus is looking at decentralized clinical trials, because that was the first major disruption to what we’ve been doing in decades, other than going to EDC from paper case report forms.
I prefer the term “flexible clinical trials,” because it allows for more interpretations of what that looks like and more freedom to operate without having a stigma associated with using the term “decentralized clinical trial” or “hybrid trial.” But what we’re finding is there are a lot of supporters for this new way of working, but there is the fear or the unwillingness to try these new things in their studies. “It’s a great idea, but not in my study.”
So in the Innovation Group we’re trying to figure out how we can help support and what can we do to de-risk this a little bit, at least for the study team, so they’re more willing to try new things. We’re running something called tech for trials, which is a way to try it out for under 30 days, to look at the operational burden, or considerations of that technology. To ask the questions, “What’s it like for the user? What would a patient have to go through? What would a site have to go through? What would his team have to look at? How does the data come in? What are the logistical considerations?”
When you say one of them, it doesn’t sound so bad, but when you start stacking them up, it gets a little overwhelming. We just did our first user test on that program, and it came back extremely valuable. Now, we have more people who want to do the testing than we have stuff to test yet.
We also are trying to shift the mindset of figuring out what the future looks like. What are the other things that we’re going to need to consider here? That’s going to be more of cell and gene therapy considerations: how you run trials with that, as well as imaging what an individualized clinical trial would look like, or the ability for a “Choose Your Own Adventure” clinical trial, where you could have people choose, “I’d like to do everything remote,” or “I’d like to do half of it remote and half of it with the doctor.” All within the same protocol in the same way of working. We’re playing around with a couple different scenarios there to see what could be possible, and what the main considerations are.
What is the process for identifying areas to innovate and applying those changes?
We have a couple different ways we approach it at Bayer. Within my group, we have something called the Idea Greenhouse, looking for that organic pain and solution. So in the midst of working on things, you sit there and you say, “There has to be a better way to do this.” And then you say, “I think I know how to make this better.” Teams can submit those ideas into the Greenhouse and we meet with them from the innovation function to talk through it, figure out if we are already doing it.
We look to see what could be done there, what the benefit would be of working on this, does a solution make sense. We take ideas all the way to the end of a proof of concept. Our proof of concepts have to be under six months, forcing people to go fast and make quick decisions, and allow for iterations and to make changes on a lower scale budget. This has worked really, really well. Because for the people that have the boots on the ground, they have their voice being heard. We also have it by looking at the landscape. DPHARM is one of the resources that I use to look at what’s coming. There’s also literature out there. There’s LinkedIn posts that are out there that really make you say, “I need to look into this.”
We also have the leadership. They might have a certain problem or pain point, or they say that we need to be working on this; they try to decide if it’s pushed to an initiative or if it needs to be experimented with first. If so, then it comes to us.
There’s a huge push to make sure we’re always bringing that customer voice in there. We’re constantly doing focus groups, with patients, healthcare providers and with our internal teams, to see if something would even work or be possible. Because if you mess something up, it’s like jamming a big machine and all those cogs aren’t going to work anymore.
How do you see the way that we engage with patients changing over the next few years in terms of trials or facilitating feedback for protocol design?
It does vary depending on which country you’re talking about and the cultural aspects. However, there is a strong push right now where people are getting more involved. It used to be that they would listen to their doctor and go with what the doctor thought was best. There are so many informed consents that were never even looked at, I’m sure.
Now it’s gotten to the point where people are really reading those informed consents; so now we have pushback for how long they are, or how cumbersome. There’s also study teams that are starting to figure out how they weave patient engagement in, because there’s some things that need that patient voice, especially any kind of operational or participation burden.
The tricky part is we’re going to have to start having more conversations about what is acceptable for patients versus how much burden it has. There’s a difference in those two questions. Some might say that the same, but they’re really very different. And the acceptability of what we’re asking patients to do, I think will be changing a lot. I see teams having patients already on their advisory board or joining in team meetings, to hear what they think is important to them. Maybe our endpoints aren’t what is important, maybe there’s a side effect that they’re really worried about.
What is a concrete goal that you would like to accomplish in five years time or a process that you believe could be changed fundamentally in five years time?
I really want to see two things happen. I want to see, on the operational front, more rolling studies. Currently, we do a phase and have a big break of time waiting for approvals or crunching the data, waiting to see if we get to go to the next phase. There could be at least a year, if not more, of just sitting and waiting for the decision for the next phase, and then you roll the next one, and then you have the same thing again.
If technology is improving to the point where we’re cleaning data so much faster, adjudicating data so much faster, having those interim analysis, we should be able to work together with the health authorities on a rolling basis while things are still going and get that moving approval where, if things are good so far, to go ahead and start planning. Instead of having these massive breaks. We saw this with COVID. Everybody was asking how it was moving so fast. Part of it is just not waiting for the administrative stuff to happen in between. Having those rolling studies will make a huge difference.
And the other thing is really questioning how much we need competitors that are standard-of-care of real people in a clinical trial? That’s the easiest way to leverage what we have for real world evidence. We keep hitting these problems: “Can we trace it back to the patient? Do we really know for sure what happened to that person? Are they really the exact match to what we’re asking for in a trial?” And of course, anytime you ask if something is an exact match to what we’re doing in trial, the answer will be no, because we always do things that are above standard of care.
We need to start questioning how much of that really needs to match. That way, you have more active people on the drug and less people that are being followed having to go through all this extra burden.
How do you encourage people to consider incorporating new tech or innovations?
The biggest thing is user stories coming from users like them. So if I have a user story from a tech company, and they’re talking to my study teams, that’s not going to be as valuable as having another study team that’s used it. If that study team can share with us their lessons learned, or what really went well, and what the pitfalls were, it shows that it gets better over time. We need more lessons learned that can be shared, from user to user.
With our tech for trials, we want to be able to have the user stories shared, of somebody who has gone through it. What you find is, there’s always going to be some little piece of it they don’t like: don’t be afraid of that. Don’t edit that out, because that’s what makes it authentic. And there’s a chance that if we know that, we can make it better next time.
What are the areas in research you believe are ripe for change?
Cell and gene therapy is an area that is going to be very hot moving forward. It’s going to have to be done a different way. That’s a perfect opportunity to apply some of these different innovative ways of working. We are starting fresh; we can build what we want to build. We can curtail it the way that makes sense, when we’re forward-looking instead of looking in the present. It’s hard to make renovations on your own house while you’re living there. It’s much easier to make renovations on that new house that you bought before you move in. This is the same kind of thing. If we band together, this could be potentially another catalyst for change and an innovation that can propel us forward.
-
July 2, 2021
-
FDA’s Principal Deputy Commissioner and Acting CIO Dr Amy Abernethy on Decentralization, Technology and the Future of Clinical Trials
Amy P. Abernethy, MD, PhD is an oncologist and internationally recognized clinical data expert and clinical researcher. At the FDA, she is the Principal Deputy Commissioner and Acting CIO. At the 2020 DPHARM conference, Dr Abernethy participated in a keynote Q&A about modernizing clinical trials. Key Takeaways for Industry: Use the pandemic to learn more […]
Dr Amy Abernethy, Principal Deputy Commissioner, Acting CIO, FDA
Amy P. Abernethy, MD, PhD is an oncologist and internationally recognized clinical data expert and clinical researcher. At the FDA, she is the Principal Deputy Commissioner and Acting CIO. At the 2020 DPHARM conference, Dr Abernethy participated in a keynote Q&A about modernizing clinical trials.
Key Takeaways for Industry:
- Use the pandemic to learn more around the role of telehealth and remote monitoring, whether other data sources (like EHR) can be reliable to fill in different parts of the data set
- When choosing a technology, understand how it affects data integrity, what burden it places on participants, and whether it’s capturing data you really need
- Innovative solutions require partnerships, particularly public-private ones, including academia, regulators, sponsors and vendors working together.
- In 2030, clinical trials should be inclusive of all different types of people and participating in a clinical trial should feels like a part of care strategy
Tammy Guld of Janssen welcomed Dr Amy Abernethy, FDA’s Principal Deputy Commissioner and Acting CIO, to discuss modernizing clinical trials. When Dr Abernethy joined FDA in February of 2019, she realized that if the agency was going to scale in the direction that personalized medicine was going into, “We needed to use data better as an agency,” and required more modern platforms to do so. As acting CIO, her focus has been on how to ensure that the FDA is in the modern era with a cloud-forward stance, how to house and manage data, and how to use data to solve questions of personalized medicine, real-world data and patient centricity.
Decentralizing clinical research
Dr Abernethy hoped that the pandemic provided the opportunity to create trials that are more patientcentric, to “meet people where they are.” A practical reality of the pandemic was experimentation: trials had to look at remote mechanisms to monitor, collect data and ensure safety. As a result, the industry is learning more around the role of telehealth, remote monitoring, direct-to-patient investigational product shipping. Dr Abernethy hoped that this period of experimentation wouldn’t be taken for granted and that we would take stock of what we’ve learned as we move forward.
Patient centricity and technology burden
Dr Abernethy discussed that in order to understand the disease and the real-world impacts of trial designs on participants, that patient engagement was crucial. She described one result of a patient survey: learning that sleep deprivation was a huge issue for participants and their family, which wasn’t necessarily obvious from understanding the disease in question. When designing a trial, think about if what you’re asking patients to do really is needed for the design integrity. She also touched upon eligibility criteria: opening up the pool of potential participants is one way to make research more patient-centric.
On technology burden and technology choice, it’s necessary to understand that what works for one person, or group, doesn’t mean it will work for everyone (voice activation was an example Dr Abernethy provided). Additionally, understand what happens to the integrity of the dataset when a technology is chosen, or when multiple are working together.
“As we think about what’s doable in real people’s lives, we can’t make assumptions,” said Dr Abernethy. “We can believe that there are technological solutions, but until we test them and ask patients and look at the integrity of the dataset, we’re not going to get it right.”
Public-private partnerships
Dr Abernethy spoke to the strength of public-private partnerships. “Innovation often happens at intersections,” she said. One of the advantages of public-private partnerships is providing a coherent opportunity for those intersections and the transparency to work together. They also allow for new partners to join the conversation (health-tech as an example).
Two things Dr Abernethy has learned from her role is that it’s necessary to make sure it’s safe to have different voices at the table; and establish a lingua franca. Different groups (academia, regulators, sponsors, vendors) have the same word, but different meanings, or vice versa. Common understanding is critical.
The future of clinical research and RWD
By 2030, Dr Abernethy hoped that clinical trials can be “inclusive of all different types of people” and that participating in a clinical trial doesn’t feel like experimentation, but instead “feels like a part of a care strategy” for patient health. Part of that, she acknowledged, was public relations. But a lot of it has to do with making trials feasible in the way that lives are conducted while maintaining a focus on safety and data integrity. By 2030, she also hopes that data will have been rethought: that we will have sourced the data elements needed for a clinical trial dataset from many different places, so that the data itself is a mosaic.
On the FDA’s vision and strategy for using realworld data, Dr Abernethy first defined it as information captured outside of the traditional clinical trial setting (including EHR data, claims data, wearables, etc). Dr Abernethy highlighted the Evidence Accelerator partnership, the idea of which is to have government, industry, health systems, nonprofits, academia to come together and brainstorm how to approach real-world data and to understand what data/analyses are “fit for purpose.” Especially in regards to COVID, where there was a paucity of data, real-world data provided a deeper understanding and context for how COVID existed in the real world. However she did say that the understanding of how to use these datasets was still new.
Final thoughts
Dr Abernethy foresaw that new innovations would make topics like the cost of telemedicine, patient data return, licensing, privacy and de-identified data sharing, and data curation, more feasible, easier, less time-consuming and less costly.
-
June 26, 2021
-
Sanofi’s Director of Digital Innovation on Lessons Learned from Clinical Trial Remote Visits
Laura Kling is Director of Digital Innovation at Sanofi, where she leads a team that focuses on digital transformation in clinical trials, incorporating technologies from wearables and sensors to telemedicine and social media. Can you provide us with an update on your work in remote visits and monitoring? What were some of the lessons learned […]
Laura Kling, Sanofi’s Director of Digital Innovation
Laura Kling is Director of Digital Innovation at Sanofi, where she leads a team that focuses on digital transformation in clinical trials, incorporating technologies from wearables and sensors to telemedicine and social media.
Can you provide us with an update on your work in remote visits and monitoring? What were some of the lessons learned and hurdles overcome?
When I spoke at DPHARM, we were preparing for our first remote visits. Since then, we completed several visits to patient’s homes which involved both telemedicine and in-person visits by nurses.
It’s been an educational process during these first visits. We’ve learned communication and coordination are absolutely critical. There are many moving pieces logistically, and many individuals have to work together to successfully conduct a visit. It’s also true in the clinic, but when you’re moving from the traditional setting, there are many additional factors to consider.
Even though we had really tightly controlled plans, and we went on test runs, we still had to make sure that we were all communicating and ready to adapt as we noticed gaps or encountered last-minute rescheduling due to COVID. This is a pivotal trial; we operate our trials in general as inspection ready. So the key is being flexible with situations as they come up, but also being extremely thorough, and making sure that we’re documenting everything clearly along the way.
How much of what you’re doing now is pandemic specific, and how much of it can translate across to remote monitoring and visits in the future?
We’re a global company with a big commitment to digital innovation, therefore we are going to continue to move forward with decentralized trials. The pandemic didn’t invent these challenges: it was always hard for patients with mobility issues to travel long distances to specialists to participate in trials. What the pandemic did is it made it imperative, in some cases, to solve them.
Going forward, we’re going to keep using these same fundamental tools. Telemedicine is not new; Zoom is not new in the pandemic era. Going forward, we’re going to keep using the same tools to solve the problems that our patients and our trial teams are facing. And what’s really important, is to keep the momentum and the commitment to doing this, even after the immediate public health emergency subsides.
You mentioned that communication and coordination is key. Who were the kind of people that are coordinating and making remote visits possible?
It’s a whole set of different people. Sanofi runs most of our trials in-house, so we involve everybody from our operations managers to our pharmacovigilance folks who are weighing on the design, to the drug shipment folks who are coordinating those pieces of it. We’ve then got the site, the PI and potentially the study coordinators who are at the site who need to be involved for all of the logistics. We’ve got folks who are going directly into the home, who are going to be facilitating the assessments, blood draws, etc. And then we may have other folks who are joining by telemedicine, depending on state laws, licensure requirements, etc., as well as couriers bringing the equipment and drugs to the patient’s home. And then, of course, the patient themselves and their caregiver if they have one.
Are the sites picking up any extra burden as a result of decentralization, either having to learn new systems, adding on systems to maintain privacy and security, or supporting patients in new and different ways?
Our sites’ experience is something that’s really important to us, because they are our most important partners in conducting this research. We do what we can to try to mitigate impact. Much of our strategy [for clinical digital innovation in general] has been around trying to find ways to support both our patients and our sites across the board.
All change takes work. It’s really important to acknowledge that we’re asking something of our sites when we’re asking them to work with us in a new way for our patients, whether it’s decentralized trials or something else.In addition to the learning curve, in some cases, there’s also duplicated supervision of assessments, or duplicate data entry. We’re working to minimize that wherever it comes up. We’re making sure to do lots of lesson-sharing within our company and with our partners, so that as we figure out how to do things, we can do them better next time.
When we look to the future, we’re changing the way that sites are supporting patients in the context of a trial. But that’s happening alongside a huge shift in the ways that these sites provide care as a whole. So it’s important throughout this transition to listen to our sites about what’s working and what is just extra work for them.
What impact do you think the more rapid expansion of DCTs will have on traditional trials?
Flexibility is the biggest thing that we’ve learned. A local situation can completely change overnight. What works in one place may not work in another necessarily. What we’re finding is that we need to do what we can to provide options for our sites and for our patients.
At Sanofi, we have a big commitment to digital: we’re setting a big goal of offering decentralized components for all appropriate trials. So, not every trial, and definitely not for every visit, but some visits for some patients in every trial where it’s feasible by the end of this year.
We’re really looking forward to bringing the innovations that provide value in the decentralized experience into the way that we operate all our trials going forward.
You’ve spoken about the idea of “life flow,” specifically the context of tools being incorporated into a patient’s life that made sense with how they live their lives. What types of data are needed to characterize and understand a patient’s life flow, so that before you add in the device, you understand how patients are living their lives?
With any decentralized trial or any patient-facing tool, the way to start is with patient interviews and surveys and looking at patient literature based on previous interviews and surveys, to understand what’s important to folks. Also talking with clinicians, because they have a different perspective, but one that’s important, especially when we’re talking about specific patient populations.
With this trial, we’ve also been paying attention as we go to the patient input and feedback. It’s still pretty early in this trial, we’ve only had a few decentralized visits, so we haven’t gotten formal feedback directly from the patients. But that whole extended team is tracking these first few visits so closely to watch for friction from any angle. At the end of the day, we’re still asking the patients to take a lot of time out of their day to participate in this home visit. Especially for a rare disease or a pivotal trial, it’s never going to be a totally seamless, invisible trial experience – meaning the patient is unaware that they are in a trial on a day to day basis. But the goal is to make it comfortable and to make them feel respected, and respect the fact that they’re allowing us into their home.
Is there a level of a different level of education or communication required to make sure that patients understand and feel comfortable in a DCT?
It all comes back to the need for flexibility, the need for options. It depends a lot on the patient population. One thing that’s important to remember is a lot of folks who are participating in clinical trials have been patients for quite a long time and are used to going into the clinic on a regular basis. It’s different levels of burden for different people.
We do hear from some patients that they would prefer to be seen in the clinic by their doctor. Ultimately, we want to preserve the relationship between the patient and the clinician and ensure that the location of the trial is agnostic.
What do you see as, on the pharma side, some of the biggest concerns with adopting DCT measures?
Last year really removed a lot of the ‘concerns’ per se. No one is skeptical that we need a way for patients to participate in trials without traveling long distances to hospitals. The question for DCT is no longer “if” but really “how.” The big issue is the complexity. No matter which way you approach this, you’re working with several complicated systems, hospitals, clinical trial regulations, telemedicine, home nursing, drug shipments, that have never worked together in exactly this way before.
With this trial, we’ve found one way to get these systems running together for this set of assessments and patients and investigators in this country. We’re working across the organization to look at this, to learn from it and to scale. However, we’re still going to encounter a complexity in the scaling everywhere we go.
Where do you see DCTs in the conversation a year from now?
This is a time of figuring out how to get these big organizations working at scale to pull off what we need to get done. We are all learning a lot as we encounter situations where these studies are finally live.
One of the issues that we’re really struggling with right now, in the US at least, is interstate licensure. The trial that we’re working in right now is a rare disease. We have a handful of specialists around the US. Normally patients fly from all over for visits. But for instance, if a patient lives in Massachusetts, but their doctor is in New York, they don’t necessarily have a license to practice medicine in Massachusetts. It’s not an issue if the patient traveled to New York, but if the doctor is sitting in New York, and the patient is in Massachusetts, they aren’t licensed there.
If there’s any safety issues that come up, we need someone licensed to be responsible for them. In this trial, we’ve worked with sub-investigators who have the appropriate licensure in the particular states. But it’s a challenge that we’re going to keep facing as long as we’re in this patchwork situation. There are a number of challenges like this that are arising as we’re trying to implement at scale.
What I’d hope to see a year from now is significant movement on expectations for how we as an industry can navigate these challenges together. Last year, we saw people sort of coming together and discussing with an open mind how to solve the real challenges ahead of us. There are still a number of challenges that we need to come together and solve.
-
June 24, 2021
-
Patient Perspective on Clinical Trial Participation: Tips for Pharma
Jeri Burtchell was the first patient advocate to speak at the DPHARM: Disruptive Innovations conference. She is a patient activist, writer and Director of Patient Initiatives at HealthiVibe. In this Q&A, Ms Burtchell provided tips for pharmaceutical companies and recommendations for fellow patients. Can you tell me what you spoke about at your first DPHARM? […]
Jeri Burtchell, Patient Activist, Writer, Director of Patient Initiatives of HealthiVibe
Jeri Burtchell was the first patient advocate to speak at the DPHARM: Disruptive Innovations conference. She is a patient activist, writer and Director of Patient Initiatives at HealthiVibe. In this Q&A, Ms Burtchell provided tips for pharmaceutical companies and recommendations for fellow patients.
Can you tell me what you spoke about at your first DPHARM?
I blogged my clinical trial from start to finish, and as it turns out, I was one of the first patients to ever chronicle their experience this way. It raised serious questions among the pharma industry about patients talking to each other, data being shared outside of the study, and possible unblinding or even sharing of bad experiences. As it turned out, my blog was instrumental in recruiting patients, I found out later. By sharing my fears and how I overcame them, others with MS were willing to consider participation as well.
Craig Lipset interviewed me at Disruptive Innovations in Clinical Trials in 2012 as the first patient speaker for the event. We discussed what compelled me to blog, how that led to meeting other study participants, and the conversations that transpired. I was really surprised to know most people in the room who had devoted entire careers to clinical research yet had never spoken to a patient.
If you had any, what were your perceptions or connotations of clinical trials before you participated in one?
I remember thinking I would have to stay at the research facility for the duration of the study – otherwise how would they control the medicines I took, everything I ate or drank, and other factors that might affect my MS or trigger a relapse? Also, I never knew there were “comparator” studies and thought all trials were placebo controlled. But I guess the biggest misconception I had prior to starting the study was that scientists conducting research studies are somehow exclusive of doctors who actually see patients. When I found out that my PI could also be my regular neurologist of choice, it was very reassuring. There would be no disruption of communication between study doctor and my personal HCP.
What are the areas of opportunity for pharma companies and those running clinical trials to involve patients?
Over the past 8 years I’ve seen this topic discussed from every angle and I think we know the many ways pharma as an industry should be involving patients. The real question is why isn’t Pharma fully embracing this or doing more to involve patients? I think the answer is that they are so risk-averse as to be almost paralyzed when it comes to implementation.
Even when a sponsor has made it clear that patient engagement and collaboration are part of their corporate core values, it seems only those who attend conferences like DPHARM and are part of newly created “patient engagement” divisions are trying to move the needle. When they do, they are met with resistance from within, whether struck down by Legal or Med Affairs, or even when ongoing projects are reassigned to a new team, the reaction to collaborating and communicating with patients is often a collective digging in of the heels. “We can’t do that” seems to be a mantra – even when corporate has mandated the need for this cultural shift in thinking within their organization. It’s uncomfortable for people who are used to doing business as usual to navigate this new co-creation model and those who are trying to implement it are faced with resistance at every turn.
So the real question the industry needs to be asking is not “how can we include patients?” since everyone has figured that out. Instead, it should be “why aren’t we mandating it so completely that every person in the organization understands and embraces it?” Until the industry figures that out, I believe that real collaborative innovations that involve patients will continue to be challenged at every turn.
What does an ideal trial design look like, from a patient perspective?
Here are a few bullet points for my updated ideal clinical trial design:
- Collecting the most information necessary to the study in the fewest number of visits
- Blood/urine collection at local lab Patient Perspective on Clinical Trial Participation: Tips for Pharma “By sharing my fears and how I overcame them, others with MS were willing to consider participation in clinical trials as well.” 7
- Vitals by smartwatch or other device supplied by the study
- Implement telemedicine visits and in-home visits to reduce the number of site visits
- Study portal for scheduling, completing questionnaires and e-diary, FAQs, chat with a study nurse
- Include the patient’s primary care physician as a study partner so everyone involved in their care is on the same page
On your website, you say that a copy of a patient’s data should be returned to that patient. What does that look like to you? Contextualized? Written in lay terms?
Patients own their data, so let them have access to the results of every test performed, whether that’s an X-ray, MRI, CT, biopsy, blood or urine tests and so on.
Unblind patients as soon after the study as possible – knowing if they were on investigational product, standard of care, or placebo can inform their other ongoing healthrelated issues.
Lay summary of study to see where you fell into the overall scheme of things. How did your experience compare with that of other participants?
Can you tell me about what you do at HealthiVibe as the company’s Director of Patient Initiatives?
As the Director, Patient Initiatives at HealthiVibe, I actually wear multiple hats. First and foremost, I lead a team that is a liaison between our company and patient groups–formal and informal–which include patient advocates, influencers, thought leaders, social media groups and more. I’m also closely involved with the development of patient materials that are used in trials to ensure they really speak to the patient and are developed with the goal of clarity and comprehension in mind.
I also chair our external Patient Steering Committee made up of 6 patient advocates across multiple therapeutic areas. And, as a member of our Management Committee, I also like to think that I play an important role in continually reminding our staff, and influencing our culture, to always put the patient first.
How do you think clinical trials have evolved on the patient side since you participated in one for Fingolimod (Gilenya)?
I remember leaving my first study thinking “That’s it? They don’t want to ask me what I thought?” So I’m incredibly proud of the fact that one of the many innovative solutions that HealthiVibe has devised for sponsors is to collect insights from patients while they are participating in an ongoing study. I believe Pharma truly understands the value of the patient as more than a participant, and the benefits of including them even during protocol development to understand how designing a trial that fits into patients lives will ultimately be more successful for recruitment and retention. Execution of the collaboration still has a long way to go, however.
How would you advise someone living with a chronic illness or condition to find a clinical trial?
First and foremost, I would tell someone living with a chronic condition or illness to learn all they can. Knowledge is power and you have to be your own advocate since nobody has as much at stake when it comes to your own health as you do. Talk to experts, get second and third opinions if what you’re hearing doesn’t make sense.
Learn about research options by asking your doctor or contacting an advocacy group. Most organizations have information about what’s currently in the pipeline. If your doctor is not open to discussing research as an option in a frank and objective way, I would find a different doctor.
Think of research as another treatment option to explore. It’s true that there are risks and benefits to consider with any medication (even those already FDA-approved) but once you’ve given them careful consideration you open yourself up to cutting-edge science that is continually finding better, safer, more effective treatments and cures for all diseases and conditions.
-
June 22, 2021
-
Where We’ve Been in Clinical Innovation, and Where We Might Be Headed
Craig Lipset was a founding chair and advisor to DPHARM and he most recently held the position of Head of Clinical Innovation and Venture Partner at Pfizer and on the founding Operations Committee for TransCelerate Biopharma. Mr Lipset designed and launched multiple industry firsts, from the first fully remote/ decentralized clinical trial for a new […]
Craig Lipset, MBA, Former Head of Clinical Innovations, Pfizer
Craig Lipset was a founding chair and advisor to DPHARM and he most recently held the position of Head of Clinical Innovation and Venture Partner at Pfizer and on the founding Operations Committee for TransCelerate Biopharma.
Mr Lipset designed and launched multiple industry firsts, from the first fully remote/ decentralized clinical trial for a new medicine to the first returning of results and data to research participants.
What is your background in innovation?
I worked at Pfizer for close to 13 years, and during most of that time, had the opportunity to lead clinical innovation for medicine development. As a large corporation, we had some enterprise innovation initiatives looking at ideation processes across the company. But I had also seen groups like our manufacturing area, as an example, put a focused team in place to try to advance new and innovative approaches within their part of the business.
Around that same time at Pfizer, we were shifting to a fully outsourced model; we were moving resources out of the organization and partnering heavily with CROs. It created an opportunity for me to position internally that we can’t outsource the future; we can’t outsource innovation. We can partner on conducting our current studies, but the innovation that we need to drive the future we had to maintain internally.
Being as far back as it was, we were one of the first innovation groups focused on medicine development inside of a pharma. I had some friends at different companies begin to ask me for job descriptions or “How did you create your scope?” What we were doing wasn’t competitive; we were trying to be very open and transparent. Around that time, the birth of the DPHARM meeting turned into an incredibly important way for us to create and accelerate a community, to meet the people that would ultimately become the leaders in these various pharma companies, where we could share the models we were each creating internally, and create this peer infrastructure in different pharma companies.
We came to the first DPHARM meeting ready to talk about the REMOTE trial, the first fully in-home trial of a new medicine. We had already begun to share information about the study earlier that year at DIA. But even at that first DPHARM, what signaled something different to me was this audience wasn’t as concerned about the process you had for X or Y in the model; they wanted to know, “How did you get this through your organization?” That marked something very different and special that DPHARM was starting to create 10 years ago. Not just the opportunity to share what we were doing, but how we were doing it in our organizations, and DPHARM created a space to help to amplify that.
Can you speak to the increased emphasis on virtual?
There’s been a lot of talk in the years since that first virtual trial. There have been investments by the venture community; there have been multipharma consortia and collaborations that have tried to chip away. And yet, up until last year, most major pharma companies had done one, or a couple of experiments, using a fully-remote or virtual approach.
Now if you were to google “remote” or “virtual studies” you may get results that look like there are lots of examples. But many of these are observational studies or examples without a new drug involved.
It gets much harder when you’re doing a drug trial and you want that to be done in a virtual or remote way. And that’s where most companies have done one, or a couple, and didn’t commit to the change. They didn’t change their processes; they didn’t change their vendors. They didn’t change the measurements that they needed to use remote approaches across new studies.
And without changing that, you can’t just make it go virtual. Until a pandemic hits. And now everyone is having that awakening moment of, “There is something out there that can help me here. There’s an ecosystem of solution providers that have been really ramping up and waiting to support this moment.”
What’s amazing to me now is that we don’t need to go back to the labs and cook up a new way to run studies in this environment. All the tools were right there; they just needed people to embrace them and adopt them.
That moment feels like it’s here. I don’t think the future is that all trials are virtual or remote. I think people like their doctors; they just want to see them on their own terms and make that engagement more accessible. I don’t mind online food shopping, but I do want to go back to a grocery store one day. And I don’t mind seeing my doctor online, but I might want to go back in there once in a while. I think the future is one of choice where patients participate on their terms. Where We’ve Been in Clinical Innovation, and Where We Might Be Headed 9
Obviously, the pandemic is changing how we run clinical trials in a traditional way. Are there changes you think will become permanent?
I think there are some folks who would say, almost instinctively, “Yes,” thinking the world will look different on the other side of the curve, on the other side of the pandemic. I am cautious about that, because the way people are course-correcting today is with things like protocol deviations and SOP waivers. Deviations and waivers are not commitments; they mean we’ll be going back to old ways soon.
Organizations need to commit to this change, likely by the summertime, to really change their processes, change their training, change the measurements that they use in trials. Organizations are starting to realize that this is not a three-month phenomenon. In the beginning, people had this mindset of, “If I can just get through the next three months, then I can get back to my old ways, and that will be fine.”
Today they’re realizing, “I’ve delayed study starts to later this year. Am I going to even be able to start those? Is there going to be a resurgence of COVID-19?” Are study sites going to be able to accommodate patients by then? Will patients with chronic diseases be willing and interested in going out and doing this study?
Study teams are starting to appreciate that these countermeasures that we’ve been using, with urgency right now, they actually are going to have to stick around. If you want to start a study in 2020, it’s almost the only risk mitigation you could imagine right now.
How do you see the role of the patient in the future? More patient-influenced design? Transparency of data?
Patient engagement in study design has progressed nicely from almost its beta 0.1 stage of anecdotes with “Here’s a study in rare disease that talked to patients” and “Here’s one in oncology.” We accumulated all that anecdote, and now in version 1.0, we see organizations that, consistently, are engaging with patients for input on how they’re designing and planning studies.
And that’s good, but it’s still a collection of a frenetic group of different approaches, from on-line communities, to focus groups to partnerships with advocacy and beyond. We still don’t see consistent ways, and we still aren’t able to honestly answer the question of “Are these insights truly diverse and representative of all patients on a global scale? Or are these insights limited to the patients who participate in this advocacy group, who are self-selected, or the patients who live in the zip code I was able to get to come into my meeting?”
It’s hard, and I think that’s where the next generation of this type of patient engagement will go. As somebody who leans towards playing the futurist and thinking about more disruption in this space, I think there are futures where the roles of a pharmaceutical company can be displaced by organized patients.
When you think about what a pharma company does: we have bench research, we fund the research, we control who comes to the table around research because we’re the ones who are paying for it, we drive research studies that have data being collected and aggregated. Can patients organize and do all of those things? Can they DIY and biohack and enable breakthroughs in bench science? Can they crowdfund or use venture philanthropy and raise the money that’s needed to drive a research program? Can they use existing data-sharing platforms that enable patients to control and share their health data how they wish to drive those research studies? It’s nice that pharma invites patients to the table today; I think the next iteration will be “Who is inviting who to the table.”
Anything else you’d like to end with?
One last observation is how special this industry is, People and companies in industry are viewed as fiercely competitive – from scientists racing to be first to publish, to commercial teams competing on sales.
Medicine developers, I find, operate in a shared economy. It’s probably one of the oldest shared economies, before Uber and Airbnb. Pharma does not own these sites, the infrastructure, the health data and the patients; we all have to put a piece into this shared space in which we all have to operate.
And watching the amount of collaboration that takes place in that space, whether right now around COVID-19 or in the years prior, is awesome. We see that at places like DPHARM we see that in collaborations like TransCelerate, and we will continue to see it when it will accelerate getting medicines to patients. I think it makes this community unique and special.
-
June 20, 2021
-
DPHARM Idol Disrupt: Special Edition
DPHARM Idol Disrupt is a live show that takes place during the conference, where representatives from startups or up-and-coming companies present what they believe to be an innovation that positively disrupts clinical research. This show is about identifying companies with promising tech and assessing them to see if they can really deliver on modernizing clinical […]
DPHARM Idol Disrupt is a live show that takes place during the conference, where representatives from startups or up-and-coming companies present what they believe to be an innovation that positively disrupts clinical research. This show is about identifying companies with promising tech and assessing them to see if they can really deliver on modernizing clinical trials. Before presenting, each company goes through a rigorous assessment process from pharma, biotech, patient and investor perspectives.To highlight the winners of this competition from over the years and celebrate a decade of innovation in clinical trials, disrupting the norms for the benefit of patients, this special edition interviews representatives from the seven companies about their experiences competing, their advice for new innovators and entrepreneurs, and how their organizations have fared since they won Idol.
-
June 17, 2021
-
Summer DPHARM Newsletter: What Does Innovation Mean to You?
Read the Summer DPHARM 2021 issue on What Does Innovation Mean to You? This issue reports a variety of perspectives on what innovation looks like in clinical research: beyond the bright and shiny objects, what are the technologies, processes and changes being implemented to disrupt research, accelerate medicines development and make it easier for patients […]
Read the Summer DPHARM 2021 issue on What Does Innovation Mean to You?
This issue reports a variety of perspectives on what innovation looks like in clinical research: beyond the bright and shiny objects, what are the technologies, processes and changes being implemented to disrupt research, accelerate medicines development and make it easier for patients to participate in trials.
The interviews in this issue are:
Dr Anthony Atala, Wake Forest University, describing Regenerative Medicine’s Powerful Promise for Drug Development and Clinical Innovation.
Dr Monique Adams, Janssen Clinical Innovation, discussing Reimagining Clinical Trials from Start to Finish for True Innovation.
Michelle Shogren, Bayer, talking about Confronting Research Hurdles and Finding Solutions at Bayer.
Dr Judith Reece, GSK, detailing How Innovation Begins with Breaking Down the Problem.
Dr Meredith Zozus, University of Texas Health San Antonio, describing What Data Informatics Could Do For Your Clinical Research.
Hassan Kadhim, Bristol Myers Squibb, gives his thoughts on Preparing Clinical Research for the Patient of the Future.
Read it here.
-
May 26, 2021
-
Fred Hassan On Digital Transformation for Companies: A Journey, Not Just a Destination
We are pleased to share a recent interview with Fred Hassan, Director, Warburg Pincus and R&D Leadership Summit advisor in PharmExec, discuss the key considerations Fortune 500 C-suites should make as they position their firms from pilots to enterprise-wide digital transformation. “This speed of transition to digital must be accompanied by sustainability,” Mr Hassan said. […]
We are pleased to share a recent interview with Fred Hassan, Director, Warburg Pincus and R&D Leadership Summit advisor in PharmExec, discuss the key considerations Fortune 500 C-suites should make as they position their firms from pilots to enterprise-wide digital transformation.
“This speed of transition to digital must be accompanied by sustainability,” Mr Hassan said. “Sustainability means taking your people with you in the change journey.”
Read the full conversation by clicking the link to the article here.
-
March 20, 2021
-
How to Get Clinical Trial Data Back to Patients, Webinar Series Announced
The Conference Forum announced that the Patients as Partners conference is collaborating with the Patient Data Access Initiative (PDAI) in presenting a webinar series on best practices and guidelines for providing patients with appropriate access to their clinical trial data. The four-part webinar series will kick off March 25, 2021. Over the course of four […]
The Conference Forum announced that the Patients as Partners conference is collaborating with the Patient Data Access Initiative (PDAI) in presenting a webinar series on best practices and guidelines for providing patients with appropriate access to their clinical trial data.
The four-part webinar series will kick off March 25, 2021. Over the course of four sessions, the series will cover PDAI’s learnings with: an introduction to patient data return; optimizing the patient experience in data return processes; patient data return pilots with lessons learned; and how to get started in patient data return.
The first session, March 25 at 11am EST, is dedicated to the current state of patient data return, including why sponsors have prioritized it, what the guiding principles are, and how sponsors can do it thoughtfully. The session will cover how patient data return benefits patients, sponsors and investigators, and the who/what/how basics of returning data.
The second session, April 1 at 11am EST, will focus on what the optimal patient journey looks like from a technology /process perspective, what stakeholders contribute to that journey, the process of returning data and what design elements are needed for an optimal patient experience.
The third session, April 15 at 11am EST, emphasizes lessons learned from pilots, including stages of capability-building for data return at organizations, an overview of example data return pilots, and learnings from pilots to inform organizations at each stage of capability building.
The final session, April 29 at 11am EST, is all about understanding the process for initiating data return, what the considerations that exist along the process are, and in what ways different data types could be shared.
PDAI is a multi-company collaboration and formed to advance patient data return practices as part of clinical trials. The series will share learnings from the members’ experiences in piloting data return, in order to support other sponsors who are interested in these topics and to further demonstrate a commitment to patients.
“With our commitment to showcasing and highlighting companies doing patient engagement in clinical research through our conferences, podcasts and newsletter, we are excited to partner with PDAI to facilitate greater patient involvement in healthcare decision-making in this webinar series,” said Kate Woda, Director of the Patients as Partners US meeting.
The webinar series is free, and for more information, click here.
About the Patients as Partners:
The Patients as Partners in Clinical Trials conference is co-produced with patients, industry, academia, FDA and nonprofit organizations to establish a well-rounded program that addresses the needs of all stakeholders seeking to implement and advance patient involvement across the entire clinical development continuum. The event is responsible for truly demonstrating how patient involvement gets done throughout the entire medicines development life cycle to drive greater efficiencies in clinical research. The program delves deep into patient involvement ideas, strategies and implementation processes that biopharma can utilize in order to help advance patient participation for better clinical outcomes.About PDAI:
PDAI is a pre-competitive collaboration of pharmaceutical companies. United by a vision for a future where all clinical trial participants can receive their data, the group was formed in 2017 with the goal of driving industry-wide adoption of data return practices. For more information, visit patientdataaccess.com
-
March 10, 2021
-
New Webinar: Insights into Co-Creating Solutions for Customers (Patients)
Dr Chip Bell, renowned author and authority on service innovation sits down with Valerie Bowling, Executive Director, Conference Forum to discuss his latest book about co-creating solutions for customers and in the case of R&D, our patients. Dr Bell goes through his 5 key points for creating breakthrough products, services and solutions covering: Curiosity […]
Dr Chip Bell, renowned author and authority on service innovation sits down with Valerie Bowling, Executive Director, Conference Forum to discuss his latest book about co-creating solutions for customers and in the case of R&D, our patients.Dr Bell goes through his 5 key points for creating breakthrough products, services and solutions covering:
- Curiosity
- Grounding
- Discovery
- Trust
- Passion
For professionals servicing patients in clinical research, you will walk away with helpful tips and ideas on how to approach innovation collaboratively to co-create solutions for patients.
About Chip Bell, PhD
Chip Bell is considered a world-renowned authority on customer loyalty and service innovation. In fact, Global Gurus ranked him in 2020 for the sixth straight year in a row in the top three keynote speakers in the world on customer service.
He also has written more than 700 columns for many business journals, magazines, and top blogs. He has appeared live on CNN, CNBC, CBS, Fox Business, Bloomberg TV, ABC, NPR Radio and his work has been featured in Fortune, Businessweek, Forbes, Fast Company, Inc. Magazine, Wall Street Journal, USA Today, CEO Magazine, Money Magazine and Entrepreneur.
Dr. Bell has authored numerous national best-selling books including his newest book, Inside Your Customer’s Imagination: 5 Secrets for Creating Breakthrough Products, Services, and Solutions.
-
March 8, 2021
-
Winter 2021 DPHARM Newsletter: The Decentralized Clinical Trials Issue
We are delighted to highlight six R&D executives who are demonstrating an aspect of DCTs. This issue highlights how the operations of decentralizing clinical research, through protocol structures, embracing new technology and rethinking community relationships is benefiting science and patients. Read it here.
We are delighted to highlight six R&D executives who are demonstrating an aspect of DCTs. This issue highlights how the operations of decentralizing clinical research, through protocol structures, embracing new technology and rethinking community relationships is benefiting science and patients.
Read it here.
-
March 4, 2021
-
The Practical Implementation of Sensors in the Changing Drug Development World
In this conversation, you’ll learn lessons of how to implement sensors for the most impact in your clinical trials. Join three sensor experts as they discuss: What phases of clinical trials are more suited for sensor use How to select and integrate the device How to ensure compliance Speaking: Keith Wenzel, Senior Director, Parexel’s Scientific Data […]
In this conversation, you’ll learn lessons of how to implement sensors for the most impact in your clinical trials. Join three sensor experts as they discuss:
- What phases of clinical trials are more suited for sensor use
- How to select and integrate the device
- How to ensure compliance
Speaking:
- Keith Wenzel, Senior Director, Parexel’s Scientific Data Organization: Keith’s areas of subject matter expertise include electronic clinical outcomes assessment, patient sensors and a broad range of eClinical technology used within clinical drug trials.
- Julia Lakeland, Solutions Architect and Program Director, Parexel: Julia is responsible for selection and implementation of real-world scientific data sources and wearables for clinical trial use. Her background is in product management, operational delivery and support of phase III/IV clinical trials.
- Thomas Wells, CEO, Precision Digital Health: Thomas is currently focused on bringing innovative big data solutions to market to support real-world evidence research and clinical trial research that scale to meet the shear volume and diversity of data sources with evolution of digital health and precision medicine.
Listen below:
For more information on PharmaTalk podcasts, click here.
For more discussions and updates on innovations in clinical trial operations and the use of devices in research, visit theconferenceforum.org to learn about the upcoming DPHARM: Disruptive Innovations conference, held September 28-29, 2021, and the Mobile in Clinical Trials event, held September 27, 2021.
-
February 20, 2021
-
New York Times on Shifting to Decentralized Trial Practices
A recent article released by The New York Times outlines the shift that clinical trials have taken out of the lab and into patients’ homes in the wake of the pandemic. There are many benefits to bringing clinical trials more directly to patients including reaching more people, increasing the speed of trials, and decreasing the cost […]
A recent article released by The New York Times outlines the shift that clinical trials have taken out of the lab and into patients’ homes in the wake of the pandemic. There are many benefits to bringing clinical trials more directly to patients including reaching more people, increasing the speed of trials, and decreasing the cost of them. Read the article below about how Johns Hopkins, University of Michigan, Massachusetts General Hospital, and more have quickly adjusted in these unprecedented times. Click here to read the article.
-
January 12, 2021
-
What a Veteran of the JP Morgan Healthcare Conference Is Looking Forward to at the 2021 Meeting
Dennis Purcell is the original Founder of the biopharmaceutical and life science investment firm Aisling Capital LLC. Prior to Aisling Capital, Mr. Purcell served as Managing Director of the Life Sciences Investment Banking Group at Chase H&Q (formerly Hambrecht & Quist, “H&Q”). What is your involvement with JP Morgan Healthcare Conference, and how have […]
Dennis Purcell, original Founder of the biopharmaceutical and life science investment firm Aisling Capital LLC.
Dennis Purcell is the original Founder of the biopharmaceutical and life science investment firm Aisling Capital LLC. Prior to Aisling Capital, Mr. Purcell served as Managing Director of the Life Sciences Investment Banking Group at Chase H&Q (formerly Hambrecht & Quist, “H&Q”).
What is your involvement with JP Morgan Healthcare Conference, and how have you seen it grow over the years?
I’ve been involved with it for almost 30 years. Before JP Morgan, it was called Hambrecht & Quist – the H&Q Conference. We tried to showcase up-and-coming technologies and companies. At the time, years ago, there was no such thing as an iPhone, so you had to go to the meeting to hear from the companies. Some people tried to trade stocks from what they heard at the conference, and they had to go out to find payphones and call people.
Then, we were acquired by JP Morgan. And JP Morgan, being a much larger company, started to showcase larger companies because it was more of their client base. And then several satellite conferences sprung up – such as the Biotech Showcase and the Digital Health Conference – and tried to take the place of the H&Q conference to showcase new and upcoming companies.
From a crowd standpoint, the conference has grown exponentially. The first conference, I believe, had six companies and 40 people there. Now, it’s so large that people complain that they can’t move. But most people end up going. It’s evolved, and it’s become the conference people feel they have to go to.
What do you anticipate as the trends and themes for 2021?
One thing we have to look at is for the last six to seven years, there have been almost 400 new IPOs. In the last year and a half, so many of them are companies that were preclinical or didn’t have drugs in the clinic. They’re priced very high; they had very nice valuations. One of the things we’ll be looking at is to see if these companies hit their milestones, because investors have a long memory. They invested in them, they were told about their milestones. Their milestones might be as easy as filing their IND. That’s going to be a theme; we’re going to have to watch all of these companies that are newly public and see whether they hit their milestones.
One of the things that kept the industry going is that a lot of times you saw follow-on financings, post-IPO. But the IPOs this year were very large; $150 or $200 million dollars. That gave a lot of these companies two, three or four years of cash on their balance. It may be that we won’t see as many follow-ons, in terms of raising capital.
On the disease side, what we’ve seen over the last couple of years is an incredible focus on cancer and rare diseases. It’s been incredibly successful. What we’re seeing in the industry right now is the culmination of 30 years of research and development that has now produced this innovation that is almost mind-boggling.
One of the things we’re going to be looking at is where the industry goes next after cancer and rare disease. I suspect that it’s going to go into the last large, untapped area – neuroscience – and I think we’re probably going to see more focus on the neuroscience side going forward. And given what we’ve gone through this year, even though it’s been a hard area to invest in, we’re going to see more emphasis on the anti-infective area.
We also saw a lot of generalist investors this year, first-time investors in the sector. For the sector as a whole, something we’ll have to look at is whether these people are going to stay here if we have a downturn. There’s no doubt that we’ve had an upturn for a number of years, and the business cycle would dictate that one of these days we’ll have a downturn. We’ll have to see if these generalist investors will stay. They are the ones who have driven up the valuations and given high valuations to these companies.
I think the industry has had a rebound in our reputation in the general public. Our reputation was so horrible, right down there below Congress and tobacco companies. And I think because of our response to COVID, and the way the vaccines were developed so quickly, our reputation has increased. One of the things we have to pay attention to is what we have to do to keep and build on that reputation. It’s things like diversity and social justice – things the public wants us to do. Something we have to watch out for is to make sure that a few bad actors do not pull us down.
Something from the industry that we haven’t seen this year was a lot of merger and acquisition activity. That will be interesting over the next year: the M&A activity pickup, because last year was clearly the year of raising money. The venture capital industry raised way more money than it ever has in the past. The biotech industry raised much more money than it has in the past. The industry is flush with money right now, though it has a lot of new companies that are going to need the capital.
How has the pandemic changed what investors are looking for or into?
The pandemic is working itself through the system, in that for the first time, we saw how collaboration and focus can help us, as well as the collection of data. Clinical trials are becoming decentralized.
We’re going to begin to see different ways of these companies running their business. We’re in the process of learning how to do that. We saw the ways companies came together during COVID that showed what happens when you do have that collaboration and focus.
Also, a lot of these companies are going to raise their capital through Zoom rather than in person. We’re finding that people are raising capital in four days where it would’ve taken three weeks to travel all around the world.
There are a lot of changes afoot; we’ll see how much the biotech industry adopts them.
What are the areas of interest that you are excited about, or that you hope to see addressed at this year’s JP Morgan Healthcare Conference?
One is that I’d like to see the industry start to move towards focusing on chronic diseases, because as we get older, we develop many more chronic diseases. That’s where the cost in the healthcare system comes from. It doesn’t come from small populations; it comes from chronic diseases. If you’re 70 years old, you have three chronic diseases on average. So something I’m curious about is this focus away from cancer and rare diseases to more chronic diseases.
The other thing I’d be looking for is the responsible use of new technologies, like gene editing and CRISPR. These new technologies are so powerful, so exciting and so innovative, but also have some questions that come with them. With gene editing, there’s the question of if you should be allowed to edit the germline so that it passes on generation after generation. That goes back to being responsible as an industry.
I’m looking forward to the industry evolving into new business plans because of what they’ve learned over COVID, evolving more into the chronic diseases where it’s taking up healthcare costs, and showing responsibility in using these new technologies. That’s what I’m looking forward to.
Interviewed by Danny McCarthy, Writer and Editor, The Conference Forum.
For upcoming conferences on key areas Mr Purcell mentioned, including oncology, decentralized trials and diversity, please see below:
-
January 8, 2021
-
Hospital Gowns and Investment Power Imbalance: Thinking about the Patient Perspective at JPM Healthcare Conference 2021
Jen Horonjeff, PhD, the cofounder of Savvy Cooperative wore a hospital gown while participating in a panel discussion at one of the conferences at the JPM Healthcare Conference 2020 to highlight her concerns on the power imbalance between the investor and the patient. We recently interviewed Dr Horonjeff to stimulate some thinking around patient impact […]
Jen Horonjeff, PhD, the cofounder of Savvy Cooperative wore a hospital gown while participating in a panel discussion at one of the conferences at the JPM Healthcare Conference 2020 to highlight her concerns on the power imbalance between the investor and the patient. We recently interviewed Dr Horonjeff to stimulate some thinking around patient impact for the JPM Healthcare Conference 2021.
Can you tell us about how you thought of the idea to wear a hospital gown to JP Morgan Healthcare Conference 2020?
It was a spur-of-the-moment idea. A couple of days beforehand, I was thinking of the fact that at JP Morgan Healthcare Conference, there are a lot of investors, executives and decision-makers, who essentially chart the course for what we all should be thinking about for that next year. Yet, there is such a dearth of any sort of patient or end- user perspective there. This is the power imbalance: all these people are making decisions on behalf of other people that don’t have a voice.
To highlight this, it dawned on me to use an opportunity I had to be onstage to exemplify this power imbalance, to show that – quite literally – patients feel naked in the decision-making around healthcare.
Dr Jen Horonjeff (in the hospital gown) on a panel that took place along side the 2020 JPM Healthcare conference.
What was the reaction to it?
At the event itself, people were certainly laughing and startled by it. But people that know me were not probably too surprised that I would do such a thing, I am always happy to be able to use my soapbox and privilege to spread key messages. It resonated with people andwent viral. It’s such a stark difference to see investors and executives in suits, and then seeing somebody who is stripped down and is in a hospital gown – this is the power imbalance in the healthcare innovation ecosystem.
What key topics did you see people focused on at JPM Healthcare?
People are focused on digital, which is funny because I do remember headlines from JPM2020 asking if digital health even worked. And so here we are – everyone wants to put so much money into digital health because it has the ability to be virtual and distributed. I want to caution people to make sure they are doing the work to understand if it’s actually meeting the needs of patients, and diverse patients specifically.
The experiences of the people who are building, designing and deciding if things get approved or not can be distinctly different from the experiences of those intended to use a product. This can lead to making choices about a product that might not work for the eventual end user.
How should investors be incorporating patient perspectives? Let’s first address why people think this is not the “right space.” I’ve been going to the JP Morgan Healthcare conference for years now, and every time I’m tweeting something along the lines of “Why aren’t more patients involved?” The knee-jerk reaction is “This isn’t the place for them; they’re not involved in these decisions. These are financial decisions.” And so they’re not included. This is an unfortunate, and dangerous, view.
Luckily, we are seeing more people getting excited about getting patient input earlier on.
Through working with Savvy, investors are able to give portfolio companies access to patients to make sure that they can continue to get user feedback and iterate upon it. Too many people are guessing what patients want, need, and how they behave without validating these assumptions.
Some things that 2020 has taught us: first, healthcare needed to be shaken up; there are a lot of things that patients wanted that we said we couldn’t do – telehealth, decentralized trials – when actually when people in positions of privilege are also affected, things happen. In that same vein, is the fact that there is a renewed focus on diversity, equity and inclusion. If we do that, we need to then talk to those diverse communities. This little echochamber of people making decisions, or the people who happen to have a seat at the table, may have similar backgrounds. We need to continue to challenge who we think about as part of the innovation process and bring more people into the fold. It’s just a smart business decision.
What do you hope comes out of JP Morgan Healthcare Conference 2021? With both the pandemic and racial justice, we need people to make a stand about that. Not just with various social media posts or nice things to say on virtual stages. I want to see people’s commitment to taking action in that space, because ultimately that is going to be one of the key drivers for improving patient outcomes. We need to make sure that we are being thoughtful about racial, ethnic and other diverse communities – to make sure they are included in the process.
From there, I think we’ll have more of a conversation around how we’re getting representation from diverse stakeholders, which needs to include patients.
How do you think the pandemic has changed the types of areas investors are looking into?
In light of all that’s happened, investors are seeing that patients, and people in general, need other options. They cannot be rooted in certain places or supply chains that can have failure points, and they are thinking through how to mitigate those failure points. So inevitably when the next crisis or disruption occurs, they are able to be nimble and solve those problems. There is certainly an element there of allowing more flexibility. We’re even seeing this as people are talking more about decentralized trials, which has been a huge area of investment from the industry.
We’re seeing more virtual care options popping up, but there are people that are wary of anything that is tracking them, coming to their home, having access to their data. That’s something that people have been concerned about for a long time but in light of the pandemic and so much happening from a virtual standpoint, people are thinking more critically about it from across the digital health ecosystem – data access and ownership and accessibility.
Especially when it comes to startups. If I as a patient or user sign up to use a startup app or technology; and then that startup might get acquired by a larger company, what are my rights as a patient to then take my data back, and not give access to this other company that I would never have given my data to had I known? So as more M&As are happening in the digital health space, we really need to be thoughtful about this, and make sure that patients feel comfortable. Otherwise, people will be more critical of sharing their data from the get-go.
JP Morgan Healthcare Conference is virtual and will be happening January 11th to January 14th, 2021.
Jen Horonjeff, PhD, has been both an advisor and speaker at past Patients as Partners conferences. For more information about the 2021 Patients as Partners conference, click here.
Interview by Danny McCarthy, Writer for the Conference Forum
-
November 24, 2020
-
Medable, DPHARM Idol 2018 Winner, Raises $91 million in a New Round of Financing
In a new round of funding, Medable has raised $91 million for its clinical trial management software. Medable’s software manages recruitment, remote screening, electronic consent, clinical outcomes assessment (eCOA), eSource, telemedicine and connected devices, and its software is already being used to work on vaccines and therapeutics targeting COVID-19. Dr Michelle Longmire, CEO of Medable, […]
In a new round of funding, Medable has raised $91 million for its clinical trial management software. Medable’s software manages recruitment, remote screening, electronic consent, clinical outcomes assessment (eCOA), eSource, telemedicine and connected devices, and its software is already being used to work on vaccines and therapeutics targeting COVID-19.
Dr Michelle Longmire, CEO of Medable, won the 2018 DPHARM Idol Disrupt after presenting the company’s approach to transform clinical trials by building a connected team of researchers and patients by providing rich digital experiences on their mobile app for the patient. Many congratulations to them!
We are sharing with you this article, which you can read here.
-
October 29, 2020
-
What Happens to the Patient When a Clinical Trial Finishes?
When an oncology clinical trial participant discovered over the summer that her clinical trial had ended, she discovered the sometimes-confusing nature of drug trials rules. The medication she had been on was approved, just not for her indication. Her experience raised the questions: What happens to a patient when the clinical trial finishes? And what […]
When an oncology clinical trial participant discovered over the summer that her clinical trial had ended, she discovered the sometimes-confusing nature of drug trials rules. The medication she had been on was approved, just not for her indication.
Her experience raised the questions: What happens to a patient when the clinical trial finishes? And what role should the sponsor company play post-trial?
We are sharing with you this article from the New York Times from the perspective of a clinical trial participant about how she regained access to her life-saving cancer drug.
Read the full article here.
-
October 29, 2020
-
Current Issues and Potential Solutions for Site Audit Readiness and Monitoring
In this podcast, learn what can be done to enhance site audit readiness and monitoring. Rick Arlow, CEO of Complion, recently spoke with DPHARM quarterly newsletter writer, Danny McCarthy, to discuss: Why he believes that the traditional model for site monitoring doesn’t serve the industry anymore How a purpose-built approach could free up valuable CRA time and reduce […]
In this podcast, learn what can be done to enhance site audit readiness and monitoring.
Rick Arlow, CEO of Complion, recently spoke with DPHARM quarterly newsletter writer, Danny McCarthy, to discuss:
- Why he believes that the traditional model for site monitoring doesn’t serve the industry anymore
- How a purpose-built approach could free up valuable CRA time and reduce costly delays and amendments
- What these new processes could mean for research moving forward, answering the question, “How do we make site monitoring better, not just digital?”
Rick Arlow is the CEO and founder of Complion, an eRegulatory and Document Management provider. Mr Arlow began his career in clinical research while participating in a NIH-funded MD/PhD medical scientist training program, and was shocked at how cumbersome operations and regulatory compliance were for the research sites and how much time was wasted on manual tasks and paper binders. Drawing on his engineering background, and inspired by his work in clinical research, Rick Arlow built the first version of the Complion software platform.
Mr Arlow spoke at the DPHARM: Disruptive Innovations in Clinical Trials conference on September 22-23rd, virtually, about bridging sites and sponsors with innovations in site regulatory.
-
October 21, 2020
-
Essays on Surviving COVID-19 – Lessons from the Ancients to the Present
We are pleased to share the work from Dr Jules Mitchel, CEO, Target Health with contributing authors Dr Christian Macedonia, Adjunct Associate Professor, Johns Hopkins University, School of Medicine, CEO Lancaster Life Sciences Group LLC and Joyce Hays, MS, VP Operation and Administration, Target Health LLC on COVID-19 from many perspectives. Click the image below […]
We are pleased to share the work from Dr Jules Mitchel, CEO, Target Health with contributing authors Dr Christian Macedonia, Adjunct Associate Professor, Johns Hopkins University, School of Medicine, CEO Lancaster Life Sciences Group LLC and Joyce Hays, MS, VP Operation and Administration, Target Health LLC on COVID-19 from many perspectives.
Click the image below to download the PDF.
-
October 16, 2020
-
The Future of Clinical Research and the Innovation from the COVID-19 Pandemic
In this PharmaTalk podcast, Benjamine Liu, DPhil, CEO of TrialSpark, discusses the impacts of COVID-19 on the future of clinical research and the innovation being created as a result. Ben recently spoke at DPHARM: Disruptive Innovations to Advance Clinical Trials, moderating an R&D leadership fireside chat with Drs Mark Fishman and Michel Mina. In this podcast, he recently […]
In this PharmaTalk podcast, Benjamine Liu, DPhil, CEO of TrialSpark, discusses the impacts of COVID-19 on the future of clinical research and the innovation being created as a result. Ben recently spoke at DPHARM: Disruptive Innovations to Advance Clinical Trials, moderating an R&D leadership fireside chat with Drs Mark Fishman and Michel Mina.
In this podcast, he recently spoke with DPHARM writer Danny McCarthy about:
- Embracing powerful technology into trials, particularly for the benefit of at-home monitoring
- Diversity in clinical research
- The growing and potential impact of artificial intelligence on clinical research
Ben will be demonstrating the value of OpenAI’s GPT-3 natural language processing model and artificial intelligence at an upcoming webinar, October 22 at 1pm EST. For more information and to register to attend, go to theconferenceforum.org.
Guest:
Benjamine Liu, DPhil, is the co-founder and CEO of TrialSpark, a technology company that is reimagining drug development. TrialSpark partners with doctors to create FDA compliant trial sites within their existing practices (like Airbnb), unlocking the 99% of patients and doctors not involved in trials today and democratizing access to research treatments. TrialSpark runs trials out of these sites using a roaming cohort of research coordinators (like Instacart), optimized by software, data, and machine-learning.
-
September 24, 2020
-
BBK Worldwide Study Voices 2020 Whitepaper Report
BBK Worldwide has released a new whitepaper reporting initial findings from a survey with healthcare consumers on telehealth and clinical trial interest. You can download it below:
BBK Worldwide has released a new whitepaper reporting initial findings from a survey with healthcare consumers on telehealth and clinical trial interest. You can download it below:
-
September 24, 2020
-
Remote Monitoring for Clinical Research in the Digital Age
In this PharmaTalk podcast, MaryAnne Rizk, PhD, of IQVIA leads a multi-perspective panel discussion on monitoring in the digital age as data becomes the new currency. Together they discuss how AI and ML are empowering sponsors and sites to predict risk before it happens, how modernization is expanding remote monitoring capabilities and the waterfall impact […]
In this PharmaTalk podcast, MaryAnne Rizk, PhD, of IQVIA leads a multi-perspective panel discussion on monitoring in the digital age as data becomes the new currency. Together they discuss how AI and ML are empowering sponsors and sites to predict risk before it happens, how modernization is expanding remote monitoring capabilities and the waterfall impact of that on analytical roles, and how this technology can be leveraged to benefit patient engagement and data standards.
Moderator:
- MaryAnne Rizk, Ph.D. – SVP Digital R&D, IQVIA
Guests:
- Michael Mittleman – Patient Advocate
- Ray Reilly – VP, Clinical Operations, TG Therapeutics
- Rajneesh Patil – Head, Process, Technology & Analytics, IQVIA
For more information about PharmaTalk podcasts, visit theconferenceforum.org. A special thanks to the team at IQVIA for their support in presenting this podcast.
-
September 23, 2020
-
King-Devick Wins DPHARM Idol Disrupt 2020!
The Conference Forum is pleased to announce that King-Devick is the winner of DPHARM Idol Disrupt at the 10th annual DPHARM: Disruptive Innovations to Advance Clinical Trials 2020 event. King-Devick technologies is a SaaS model digital/telehealth company that offers a broad set of evidence-based products utilizing integrated technology to accurately and objectively assess eye movement (oculomotor) […]
The Conference Forum is pleased to announce that King-Devick is the winner of DPHARM Idol Disrupt at the 10th annual DPHARM: Disruptive Innovations to Advance Clinical Trials 2020 event. King-Devick technologies is a SaaS model digital/telehealth company that offers a broad set of evidence-based products utilizing integrated technology to accurately and objectively assess eye movement (oculomotor) disorders, such as saccadic dysfunction. These products have been validated in more than 175 recent peer-reviewed published articles in regard to monitoring neurological function in a variety of conditions, including AD, PD, MS, AMD, migraine headache and other neurological conditions.
King-Devick had five minutes to present their innovation and demonstrate how it can disrupt clinical trials to DPHARM Idol’s esteemed panel of judges, with a rigorous Q&A to follow. The judges included:
- Esther Dyson, Executive Founder, Way to Wellville
- Cindy Geoghegan, Patient Advocate
- Yusuf Ghadiali, Senior Director, Global Clinical Operations, Biogen
- Hassan Kadhim, Director, Head of Clinical Trial Business Capabilities, Bristol-Myers Squibb
- Joseph Kim, MBA, Senior Advisor, Clinical Operations and Digital Registry, Digital Health Office, Translational Technology & Innovation, Eli Lilly & Company
- Ülo Palm, MD, PhD, Co-Founder/Chief Medical Officer and Co-Founder, APANDEMIC/Ordaos Bio
- Chandra Ramanathan, PhD, MBA, Global Head, Pharma R&D Open Innovation, Bayer Healthcare
- Douglas Schantz, VP, Clinical Operations, Alexion
- Jessica Scott, MD, JD, Head of R&D Patient Engagement Office, Takeda Pharmaceuticals
- Mark Travers, PhD, MBA, VP, Head of GCTO Regions, Monitoring Excellence, Global Operations, Merck & Co.
“We were really impressed with how King-Devick’s technology uses eye movements as an objective and promising new way to detect abnormalities in hard to diagnose neurological diseases, and the broad applications for scientific advancement and improved care in many prevalent and difficult disease areas,” said DPHARM Idol judge Jessica Scott, Takeda Pharmaceuticals, when asked to elaborate on the judges’ reasoning.
Patient advocate and DPHARM Idol judge Cindy Geoghegan added, “The judging for this year’s DPHARM IDOL was especially close, with so many of the competing companies demonstrating technology that is not just envisioned, but that is already being applied in clinical research in innovative ways. King-Devick was chosen as this year’s winner because it provides a validated solution to a major challenge, the ability to measure neurological function in real-time, which has the potential to transform the ability to do research in therapeutic areas (such as AD, PD, MS, AMD, Migraine headache and others).”
Although they were triumphant, King-Devick had strong competition from the other DPHARM Idol Disrupt presenters:
Proof Pilot – Matt Amsden, CEO and Founder
Obvio Health – Susan Dallabrida, PhD, VP, Consultancy
Root Health – Raj Sharma, President and CEO
Trial Scope – Mike Wenger, VP, Patient Engagement
“All of the contenders generated enthusiasm and strong interest from judges on the panel, each providing innovative solutions to real challenges in drug development,” said the DPHARM Idol Disrupt 2020 judges.
-
September 16, 2020
-
Enabling Clinical Trial Continuity with Live Video Visits
In this PharmaTalk podcast, Kelly McKee of Medidata leads a multi-perspective panel discussion on the challenges and opportunities of adopting a decentralized model for clinical trials and ensuring clinical trial continuity with live video visits. Together they discuss lessons learned from the rapid adoption of technologies to allow for more decentralized trials, how incorporating multiple perspectives highlights […]
In this PharmaTalk podcast, Kelly McKee of Medidata leads a multi-perspective panel discussion on the challenges and opportunities of adopting a decentralized model for clinical trials and ensuring clinical trial continuity with live video visits. Together they discuss lessons learned from the rapid adoption of technologies to allow for more decentralized trials, how incorporating multiple perspectives highlights areas of growth when utilizing a decentralized approach, and the possibility of hybrid trials becoming the new normal for the near future.
Host:
Kelly McKee is the Senior Director of Patient Recruitment and Registries at Medidata
Guests:
Anne Marie Mercurio is a patient and research advocate and caregiver.
Rosamund Round is Vice President of PAREXEL’s Patient Innovation Center.
Jeff Kingsley, DO, is the founder and CEO of IACT Health.
A special thanks to the team at Medidata for their support in presenting this podcast.
-
September 14, 2020
-
Complimentary Open Session – Modernizing Clinical Trials with the FDA
Listen to FDA’s Dr Amy Abernethy discuss modernizing clinical trials in an open-access keynote conversation. Amy Abernethy, MD, PhD, Principal Deputy Commissioner and acting CIO, FDA is arguably one of the strongest and most knowledgeable voices in support of the modernization of clinical trials. For the first time, the DPHARM conference will be providing open […]
Listen to FDA’s Dr Amy Abernethy discuss modernizing clinical trials in an open-access keynote conversation. Amy Abernethy, MD, PhD, Principal Deputy Commissioner and acting CIO, FDA is arguably one of the strongest and most knowledgeable voices in support of the modernization of clinical trials.
For the first time, the DPHARM conference will be providing open access to a keynote discussion. The webinar will fill up on a first-come, first-serve basis with limited capacity. Among other topics, Dr Abernethy will be touching upon decentralized trials, the power of public-private partnerships and patient centrality.
Mark Your Calendars:
The live webinar will be taking place on September 22, 2020, virtually, from 9:40-10:30am, EST.How to Register for the Free Live Webinar – Click here to access the registration page
-
September 14, 2020
-
DPHARM Presents the Largest Number of Sessions Across R&D on Decentralized Clinical Trials Due to COVID-19
The Conference Forum’s DPHARM event, the world’s leading conference on decentralized clinical trials, today announced that it has received a record number of speaking submissions across the pharmaceutical industry to present on the rapid deployment of decentralized clinical trials at the 10th annual event, to be held virtually on September 22-23. DPHARM will feature more […]
The Conference Forum’s DPHARM event, the world’s leading conference on decentralized clinical trials, today announced that it has received a record number of speaking submissions across the pharmaceutical industry to present on the rapid deployment of decentralized clinical trials at the 10th annual event, to be held virtually on September 22-23.
DPHARM will feature more than 20 talks from pharma companies, which will share learnings from decentralizing clinical trials during the COVID pandemic, with representation from EMD Serono, Janssen, Pfizer, Novartis, GSK, BMS, Roche, Sanofi, Eli Lilly, Takeda, Boehringer Ingelheim UCB, Vertex, BMS, Regeneron and more. Leading CROs and tech, software and service companies that have been on the front lines partnering to rapidly decentralize clinical trial technologies and services will also be speaking. These include IQVIA, Parexel, PRA Health, Oracle Health Sciences, Microsoft, TrialSpark, Science37, Trialscope, Edetek, Thread, Saama, Tasso, BBK and Elligo to name a few.
“We are especially delighted to welcome Amy Abernethy, MD, PhD, Principal Deputy Commissioner of the FDA and one of the leading voices on modernizing clinical trials, to speak on decentralized clinical trials as well as real-world data, technology and patient centrality”, said Valerie Bowling, DPHARM Director.
DPHARM’s strong growth over the past 10 years is due to its commitment to a patient-centered vision that resonates with R&D leaders, who are united in the shared goal of increasing virtual and flexible trial options for patients. DPHARM’s additional achievements include:
- 300% growth in total attendance since launch
- 5X growth in speaking faculty since launch
- The most keynote-level speakers for a decentralized clinical trial-focused event
- One of the first R&D conferences to include patient perspectives
- The formation of DPHARM Idol which highlights young entrepreneurial companies demonstrating their ability to disrupt an aspect of clinical trials
- DPHARM-launched sister events to help reduce the gaps between care, industry and patients, including Patients as Partners, Mobile in Clinical Trials and CRAACO: Clinical – Research as a Care Option
- Technology sessions focused on solving industry issues
- A dedicated quarterly DPHARM newsletter highlighting voices from all sides of R&D committed to bold ideas to reduce barriers for patients to participate in clinical research
-
September 11, 2020
-
Solving for the Patient Retention Problem in Clinical Research
In this podcast below, PharmaTalk’s Danny McCarthy sits down with Thomas Klein, founder and CEO of Be the Partner, to discuss increasing patient retention throughout the entire clinical trial process. Some potential solutions include transparency of data, increasing communication before, during and after trials, and truly making patients “partners” in the research. Guest: Thomas Klein […]
In this podcast below, PharmaTalk’s Danny McCarthy sits down with Thomas Klein, founder and CEO of Be the Partner, to discuss increasing patient retention throughout the entire clinical trial process. Some potential solutions include transparency of data, increasing communication before, during and after trials, and truly making patients “partners” in the research.
Guest:
Thomas Klein is the CEO and founder of Be the Partner, a technology company that is focused on how patients can use their health data to improve outcomes for themselves and others around the world.
For more information go to or contact www.bethepartner.com.
-
September 8, 2020
-
Clinical Trials in a Pandemic Brief 5 Question Survey
If you work in R&D or patient advocacy, clinical operations technology or service, we would greatly appreciate getting your thoughts on this short survey. You will get a copy of the results and all surveys will be entered in a drawing to win a complimentary pass to attend DPHARM. The deadline to send in your […]
If you work in R&D or patient advocacy, clinical operations technology or service, we would greatly appreciate getting your thoughts on this short survey. You will get a copy of the results and all surveys will be entered in a drawing to win a complimentary pass to attend DPHARM. The deadline to send in your confidential survey is September 10th. The drawing will take place September 10th and 14th.
-
August 27, 2020
-
Will a Covid-19 Vaccine Change the Future of Medical Research?
The latest podcast from Freakonomics explores the science, scalability, and economics surrounding the global vaccine race. Host and DPHARM 2020 keynote, Stephen Dubner interviews Tal Zaks (Moderna), Margaret Hamburg, M.D. (FDA), Andrew Lo (MIT Sloan School of Management) – Listen to it here!
The latest podcast from Freakonomics explores the science, scalability, and economics surrounding the global vaccine race. Host and DPHARM 2020 keynote, Stephen Dubner interviews Tal Zaks (Moderna), Margaret Hamburg, M.D. (FDA), Andrew Lo (MIT Sloan School of Management) – Listen to it here!
-
August 20, 2020
-
New Initiative Launched to Facilitate More Effective Exchange of Clinical Data Amongst Healthcare Researchers and Upcoming Live Demo
We are pleased to share a press release from Health Level Seven International about their exciting new initiative to improve data exchange for clinical researchers, with the hope of reducing unnecessary delays in the discovery of crucial therapeutics. The effort, called Vulcan, aims to define a common set of standards that can be implemented internationally, […]
We are pleased to share a press release from Health Level Seven International about their exciting new initiative to improve data exchange for clinical researchers, with the hope of reducing unnecessary delays in the discovery of crucial therapeutics.
The effort, called Vulcan, aims to define a common set of standards that can be implemented internationally, built on current agreements to use the HL7 Fast Healthcare Interoperability (FHIR®) standard to facilitate data exchange.
Mark Your Calendars:
Leveraging the HL7® FHIR® for interoperability, Pfizer’s Amy Cramer, Debi Willis of PatientLink and Munther Baara of EDETEK will be presenting a free live data flow demonstration to highlight how to close the gap between clinical care and clinical research on September 2nd from 1:00pm EST – 2:00pm EST.How to Register for the Free Live Demo Webinar – Click Here – Create an Account on Hopin, done!
-
August 10, 2020
-
Do You Remember Who Has Won the Past DPHARM Idols?
Since 2012, DPHARM: Disruptive Innovation to Advance Clinical Trials has presented DPHARM Idol with companies who feel they have a capability to disrupt an aspect of clinical trials. Take the quiz to see what you remember. Send your answers in by August 12 and the highest score will win Apple AirPods. Do you remember who […]
Since 2012, DPHARM: Disruptive Innovation to Advance Clinical Trials has presented DPHARM Idol with companies who feel they have a capability to disrupt an aspect of clinical trials. Take the quiz to see what you remember. Send your answers in by August 12 and the highest score will win Apple AirPods.
Do you remember who the DPHARM Idol winners have been since 2012?
Can you name the company?
For extra bonus points, can you name the year they won?
The answers will be featured in our upcoming special edition of the DPHARM Newsletter celebrating the past winners of DPHARM Idol Disrupt, which we will distribute in mid August along with the name of the winners.
(Past DPHARM Idol Disrupt judges and winners are welcome to fill out the quiz, but are not eligible for the prize. You must have attended DPHARM in the past to be eligible to win.)
-
August 4, 2020
-
How a Covid-19 Research Study was Formed with Oracle, Javara and Wake Forest
This podcast interview with Kathy Vandebelt of Oracle Health Sciences tells the story of how a community-based COVID-19 research study was formed from a partnership between Oracle, Javara Research and Wake Forest Baptist Health, with the end goal of using regional infection patterns to understand the virus and develop strategies to contain it.
This podcast interview with Kathy Vandebelt of Oracle Health Sciences tells the story of how a community-based COVID-19 research study was formed from a partnership between Oracle, Javara Research and Wake Forest Baptist Health, with the end goal of using regional infection patterns to understand the virus and develop strategies to contain it.
-
July 27, 2020
-
DPHARM 2020 Overview in 5 Minutes
The goal of this podcast is to give you a brief overview on what you can expect from the 10th annual DPHARM conference in under 5 minutes. DPHARM takes place on September 22-23 and is focused on clinical innovation and how to accelerate the translation of innovation for patients and physicians. DPHARM is the annual gathering where R&D reports on innovation that has […]
The goal of this podcast is to give you a brief overview on what you can expect from the 10th annual DPHARM conference in under 5 minutes.
DPHARM takes place on September 22-23 and is focused on clinical innovation and how to accelerate the translation of innovation for patients and physicians. DPHARM is the annual gathering where R&D reports on innovation that has advanced clinical trials in the last 12 months. Executive Director, Valerie Bowling shares the highlights on reporting from the trenches, modernizing clinical trial keynotes, plenary speakers, track choices and virtual interactivity.
DPHARM: Disruptive Innovations to Advance Clinical Trials, September 22-23, Virtual EST. Mobile in Clinical Trials takes place the day before, September 21.
-
June 24, 2020
-
DPHARM Launches Quarterly Newsletter
We are delighted to announce the launch of the DPHARM newsletter. This is the first publication solely dedicated to highlighting the voices, including patient advocacy, pharma R&D and outside-industry perspectives, committed to bold ideas that shake up the way we conduct clinical trials to bring research to where the patients are and reduce the failure […]
We are delighted to announce the launch of the DPHARM newsletter. This is the first publication solely dedicated to highlighting the voices, including patient advocacy, pharma R&D and outside-industry perspectives, committed to bold ideas that shake up the way we conduct clinical trials to bring research to where the patients are and reduce the failure rates. The interviews in the newsletter’s inaugural issue cover:
- Clinical trial experience tips for pharma from the patient perspective with the first DPHARM patient speaker Jeri Burtchell
- Investing in implementable healthcare innovation with Esther Dyson, investor and executive founder of Wellville
- The future of innovation in clinical trials with Craig Lipset, former head of Clinical Innovation at Pfizer
- Project Covalence, a turnkey trial platform for the rapid launch of COVID-19 clinical research, with Benjamine Liu, DPhil, CEO and Founder of TrialSpark
- Pharmaceutical company innovations in collaboration with Tammy Guld, Global Team Lead, Janssen Clinical Innovation
- The impacts of innovation and COVID-19 on clinical trials operations with Deirdre BeVard, SVP, R&D Strategic Operations, CSL Behring
-
June 19, 2020
-
The Impact of COVID-19 on Clinical Trials: Where are We? And Where are We Going?
As the country goes through the phases of reopening, what does that mean for the patient and site experience in clinical trials? PharmaTalkRadio’s Valerie Bowling discusses the future of clinical trials with Dr Ray Dorsey, Matt Kibby and Craig Lipset. Together they address lessons learned from the rapid adoption of technologies to allow for more decentralized trials and their impact on […]
As the country goes through the phases of reopening, what does that mean for the patient and site experience in clinical trials? PharmaTalkRadio’s Valerie Bowling discusses the future of clinical trials with Dr Ray Dorsey, Matt Kibby and Craig Lipset. Together they address lessons learned from the rapid adoption of technologies to allow for more decentralized trials and their impact on study participation design moving forward, what sponsors can do to set themselves up for success, and the possibility of hybrid trials becoming the new normal for the near future.
Guests:
Ray Dorsey, MD, is the David M. Levy Professor of Neurology and Director of the Center for Health & Technology at the University of Rochester.
Matt Kibby is President, Principal of BBK Worldwide.
Craig Lipset is the founder of Clinical Innovation Partners and the former Head of Clinical Innovation and Venture Partner at Pfizer.
You can find all three of our guests speaking at either the upcoming Mobile in Clinical Trials conference or the 10th annual DPHARM conference virtually over September 21st-23rd. For more information about these conferences and other podcasts, visit theconferenceforum.org.
For more information about BBK, visit BBKworldwide.com
Dr Dorsey’s book on Ending Parkinson’s Disease can be found on Amazon.
You can keep up with Craig Lipset at twitter.com/craiglipset
A special thanks to the team at BBK for their support in presenting this podcast.
-
May 20, 2020
-
Clinical Trials Day
Join us in celebrating Clinical Trials Day this year, on May 20, 2020, by raising clinical trial awareness and honoring clinical research professionals across the globe.
Join us in celebrating Clinical Trials Day this year, on May 20, 2020, by raising clinical trial awareness and honoring clinical research professionals across the globe.
-
May 11, 2020
-
Interactive Map of COVID-19 Trial Sites
Here is an interactive map showing sites doing COVID-10 research from TrialScout. This is a useful resource for researchers looking to get sites listed, volunteers looking to participate in research, and finding the closest trial site to you. Check out the interactive map and other resources: https://trialscout.com/covid19-locations
Here is an interactive map showing sites doing COVID-10 research from TrialScout. This is a useful resource for researchers looking to get sites listed, volunteers looking to participate in research, and finding the closest trial site to you. Check out the interactive map and other resources:
-
May 10, 2020
-
KPIs that Support Innovation for Patient-Engagement
In this podcast, first recorded at the 9th annual DPharm: Disruptive Innovations conference, Takeda’s Dr Andrew Plump and Dr Jessica Scott discuss how they have developed KPIs that support innovation for patient-engagement. Dr Plump leads Takeda’s global R&D organization, where he provides strategic direction and oversights. He specializes in bringing and unwavering focus on patients […]
In this podcast, first recorded at the 9th annual DPharm: Disruptive Innovations conference, Takeda’s Dr Andrew Plump and Dr Jessica Scott discuss how they have developed KPIs that support innovation for patient-engagement.
Dr Plump leads Takeda’s global R&D organization, where he provides strategic direction and oversights. He specializes in bringing and unwavering focus on patients and a deep commitment to innovation and positive change in the healthcare industry.
Speakers:
Andrew Plump, MD, PhD, President, Research & Development, Takeda Pharmaceuticals
Jessica Scott, MD, JD, Head of R&D Patient Engagement, Takeda Pharmaceuticals
The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.
-
May 9, 2020
-
Starbucks: Innovation for the End User Experience
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Starbucks’ Robert Mercer sits down with Eli Lilly’s Joe Kim to discuss the end-user experience in mobile technology. This out-of-industry example covers how they approach innovation and in particular how they designed their mobile experience with the customer in mind. More specifically: […]
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Starbucks’ Robert Mercer sits down with Eli Lilly’s Joe Kim to discuss the end-user experience in mobile technology. This out-of-industry example covers how they approach innovation and in particular how they designed their mobile experience with the customer in mind. More specifically:
- Barriers and executive buy-in
- Rolling out the mobile experience
- Balancing the scale of new solutions across stores around the globe with the need to maintain existing operations and delivery
- How Starbucks engages with the customers to learn and develop innovative new solutions
Speakers:
Robert Mercer, Design Director, Global Digital products, Starbucks
Joseph Kim, MBA, Sr. Advisor, Clinical Operations and Digital Registry, Digital Health Office, Translational Technology & Innovation, Eli Lilly & Co.
The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.
-
May 8, 2020
-
Transparency and the Future of Patient Expectations
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Healthgrades’ founder Kerry Hicks sits down with Craig Lipset for a keynote discussion on transparency and the future of patient expectations. “Everyone likes progress and no one likes change.” – Kerry Hicks Kerry Hicks is the founder of Healthgrades, which puts the […]
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Healthgrades’ founder Kerry Hicks sits down with Craig Lipset for a keynote discussion on transparency and the future of patient expectations.
“Everyone likes progress and no one likes change.” – Kerry Hicks
Kerry Hicks is the founder of Healthgrades, which puts the power of transparency into millions of patients’ hands on provider visit experiences. The discussion begins with his vision for Healthgrades, what it was like to build it, early fears, and unintended consequences. Also covering: the intersection of patient experiences, technology, and clinical research as well as Kerry’s insights on why you must consider transparency with everything you build moving forward.
Speakers:
Kerry Hicks, MBA, Founder, Healthgrades
Craig Lipset, MBA, former Head of Clinical Innvation, Pfizer
The 10th annual DPharm: Disruptive Innovation is scheduled to take place on September 22-23, 2020. Learn more here.
-
May 7, 2020
-
The Collective Struggle to Evolve Data and Analytics Culture & Capabilities
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Cellarity’s Milind Kamkolkar presents on the collective struggle to evolve a drug development organization’s data and analytics culture and capabilities. Including: The theory of going digital in drug development Identifying hype from reality What is the program we are trying to solve? […]
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Cellarity’s Milind Kamkolkar presents on the collective struggle to evolve a drug development organization’s data and analytics culture and capabilities. Including:
- The theory of going digital in drug development
- Identifying hype from reality
- What is the program we are trying to solve?
- Take a big, complex organization and evolving it to be digitally modern
- What is the intended use of the data?
- Priorities, structure, culture and next steps
Speaker: Milind Kamkolkar, Chief Data Officer, Cellarity
The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.
-
May 6, 2020
-
Re-Thinking Clinical Development – Using Historical Data to Transform Trials
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Genentech’s Aaron Mann discusses the use of historical data to transform clinical trials and how to rethink clinical development. Speaker: Aaron Mann, Global Program Lead, Industry Collaborations Data Sharing Initiatives, Genentech, a member of the Roche Group The 10th annual DPharm: Disruptive […]
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Genentech’s Aaron Mann discusses the use of historical data to transform clinical trials and how to rethink clinical development.
Speaker: Aaron Mann, Global Program Lead, Industry Collaborations Data Sharing Initiatives, Genentech, a member of the Roche Group
The 10th annual DPharm: Disruptive Innovation event is scheduled to take place on September 22-23, 2020. Learn more here.
-
May 5, 2020
-
FDA Guide and Resources for Covid-19 Trials
We are happy to distribute slides from a recent FDA webinar on Conducting Clinical Trials During the COVID-19 Public Health Emergency. We hope you find them useful. View the slides.
We are happy to distribute slides from a recent FDA webinar on Conducting Clinical Trials During the COVID-19 Public Health Emergency. We hope you find them useful.
-
May 4, 2020
-
The Evolution of Using Real World Data to Create Trial Readiness Cohorts
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Johnson & Johnson’s Dr Martine Lewi discusses the evolution of their use of Real-World Data in their clinical programs. Including: What is the state of the art in real-world data and how is patient data being used today? Innovation initiatives at J&J […]
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Johnson & Johnson’s Dr Martine Lewi discusses the evolution of their use of Real-World Data in their clinical programs. Including:
- What is the state of the art in real-world data and how is patient data being used today?
- Innovation initiatives at J&J
- Accelerating the drug development cycle
Speaker: Martine Lewi, PhD, MBA, Janssen Clinical Innovation, Scientific Director, Johnson & Johnson
The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.
-
May 3, 2020
-
The PD-FIDI: Developing a Digital Endpoint for Parkinson’s Disease
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Sanofi’s Laura Kling discusses developing a digital endpoint for Parkinson’s Disease using wearables. Speaker: Laura Kling, Director, Digital Innovation, Sanofi The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Sanofi’s Laura Kling discusses developing a digital endpoint for Parkinson’s Disease using wearables.
Speaker: Laura Kling, Director, Digital Innovation, Sanofi
The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.
-
May 2, 2020
-
Balancing Innovation with Solid Common Sense to Deliver Innovative Medicines
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Merck’s Mark Travers presents a cornerstone discussion on Balancing Innovation with Solid Common Sense to Deliver Innovative Medicines. Merck is walking the walk in disrupting how to restore best practices for people, products, and productivity. With a clear vision on output, their remarkable team […]
In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Merck’s Mark Travers presents a cornerstone discussion on Balancing Innovation with Solid Common Sense to Deliver Innovative Medicines.
Merck is walking the walk in disrupting how to restore best practices for people, products, and productivity. With a clear vision on output, their remarkable team mapped a plan to an enterprise to change operational delivery. In this R&D Leadership session hear the story on how they are delivering what they promise:
- How to plan upfront once and do it properly
- Getting the basics right and what do you need to disrupt to get there
- Significant changes on greatly improving monitoring
- The use of iPad technology to monetize CRA visits
- How monitoring reports got reduced from 8 to 2
- Building a stable workforce with strong employee engagement
- Behavior, structure, systems and tools
- Scaling it
Speaker:
Mark Travers, PhD, MBA, VP, Head of GCTO Regions, Monitoring Excellence, Global Operations, Merck & Co.
The 10th Annual DPharm: Disruptive Innovations conference is scheduled for September 22-23, 2020. Learn more here.
-
April 30, 2020
-
CRAACO 2019 Speaker Dr Laura Esserman’s I-SPY 2 Trial Is Adapted for COVID-19
We are pleased to share this press release from Quantum Leap Healthcare Collaborative, the sponsor of the I-SPY and I-SPY 2 trials, which CRAACO speaker Laura Esserman, MD, is the lead architect of. The I-SPY 2 trial framework will be adapted for a COVID-19 trial to treat patients critically ill with Acute Respiratory Distress Syndrome. […]
We are pleased to share this press release from Quantum Leap Healthcare Collaborative, the sponsor of the I-SPY and I-SPY 2 trials, which CRAACO speaker Laura Esserman, MD, is the lead architect of. The I-SPY 2 trial framework will be adapted for a COVID-19 trial to treat patients critically ill with Acute Respiratory Distress Syndrome.
As CRAACO speaker Jennifer Byrne commented, “This is dogged determination to improve the lives of patients.”
-
April 30, 2020
-
Maintaining Patient Engagement When Trials Are On Crisis Management due to COVID-19
The COVID-19 outbreak has disrupted clinical trials for thousands of patients globally. Protocols are needing to be changed to maintain the safety and efficacy of the trial; recruitment has been suspended; and some studies have been stopped entirely. As the situation continues to rapidly evolve, the clinical response and communication to patients must adapt in […]
The COVID-19 outbreak has disrupted clinical trials for thousands of patients globally. Protocols are needing to be changed to maintain the safety and efficacy of the trial; recruitment has been suspended; and some studies have been stopped entirely. As the situation continues to rapidly evolve, the clinical response and communication to patients must adapt in turn.
But to do this well means keeping the patient at the center of the conversation. Without the continuous momentum and contact to guide patients through any changes or breaks, trials will lose patients as gaps in studies lengthen.
We recently spoke with Be the Partner who designed “Bridge,” a new solution on their Patient Portal specifically for continuing secure, ongoing connectivity with trial patients during any temporary changes or pauses in trials as a result of COVID-19. The end goal of “Bridge” is to maintain patient engagement throughout the trial’s indefinite turbulence and aid in a successful relaunch at the appropriate time.
“Bridge makes sure that sponsors can communicate directly and are keeping patients engaged through what is a tumultuous and challenging time,” said Thomas Klein, the founder and CEO of Be the Partner and part of the team that created Bridge. “If patients feel respected and included, they are more likely to stay in the trial, which is good for all stakeholders.”
“If patients feel respected and included, they are more likely to stay in the trial, which is good for all stakeholders.”Bridge begins by providing a template of communication for each affected trial, with plans that support trial teams and communication efforts for patients. It secures the necessary one-time IRB or ethics approval for that plan, and makes its Patient Portal available for patient self-registration. After giving each patient the appropriate Subject and Study IDs, Be the Partner delivers the information and messages, according to the relevant Bridge communication plan, directly to registered patients.
Without creating more burden on clinical sites, Bridge offers a solution for trials that remain ongoing and ones that have been temporarily suspending. For ongoing trials, Bridge guides trial participants through any changes in protocol and procedures. For trials that have been halted during the pandemic, Bridge secures communication during that pause and facilitates the subsequent restart of the trial. In all changes, Bridge ensures that engagement remains an independent conversation between the study and participants, without including a third party.
“The ultimate goal is a successful, effective and safe clinical trial,” said Mr Klein. “That benefits everyone: sponsors, patients and the community.” For more information go to or contact www.bethepartner.com.
Listen to the full podcast:
-
April 27, 2020
-
TrialSpark White Paper on Clinical Trials During and Beyond COVID-19
With significant disruptions to ongoing research and studies on the horizon due to COVID-19, TrialSpark has launched a white paper on React, Adapt, Evolve: Clinical Trials During and Beyond COVID-19 to share some of the strategies that have allowed them to successfully ensure continuity of care and data integrity for their trials in the face […]
With significant disruptions to ongoing research and studies on the horizon due to COVID-19, TrialSpark has launched a white paper on React, Adapt, Evolve: Clinical Trials During and Beyond COVID-19 to share some of the strategies that have allowed them to successfully ensure continuity of care and data integrity for their trials in the face of this pandemic. The paper was created by the TrialSpark team with input and support from their sponsor partners, and together we offer it as a resource to those who are currently planning to launch or reassess upcoming studies. The hope is that the adaptations our industry is making now, out of necessity, will become the norm as we overcome these challenges and continue to innovate.
-
April 15, 2020
-
CRAACO Speaker, Jennifer Byrne Announces Partnership with Wake Forest Baptist and Oracle for Community-Based COVID-19 Research Study
A community-based research study of the novel coronavirus was just announced, through a collaboration between Wake Forest Baptist Health, Oracle and Javara. The study will combine at-home rapid diagnostic tests for patients and online data-gathering to define infection patterns on a regional basis for effective containment strategies. For more information, see the linked press release. […]
A community-based research study of the novel coronavirus was just announced, through a collaboration between Wake Forest Baptist Health, Oracle and Javara. The study will combine at-home rapid diagnostic tests for patients and online data-gathering to define infection patterns on a regional basis for effective containment strategies.
For more information, see the linked press release. Read more here.
-
April 6, 2020
-
What Shakespeare Did While Sheltering
Patients as Partners upcoming keynote, Chip Bell wrote a wonderful piece on what William Shakespeare did in 1600 in very similar circumstances as the COVID-19 pandemic. The article recently appeared in CEOWorld Magazine. Help yourself to the PDF or the article link, enjoy.
Patients as Partners upcoming keynote, Chip Bell wrote a wonderful piece on what William Shakespeare did in 1600 in very similar circumstances as the COVID-19 pandemic. The article recently appeared in CEOWorld Magazine. Help yourself to the PDF or the article link, enjoy.
-
April 2, 2020
-
Virtual Trials in the Face of a Pandemic
In this article, DPharm advisor Craig Lipset, former Director of Clinical Innovation at Pfizer, shares why telemedicine and virtual trials in the face of a pandemic will push innovation in creating patient-centric clinical trials for the future. Read the article here.
In this article, DPharm advisor Craig Lipset, former Director of Clinical Innovation at Pfizer, shares why telemedicine and virtual trials in the face of a pandemic will push innovation in creating patient-centric clinical trials for the future.
-
March 31, 2020
-
A Call for Accelerated Patient Access and New Therapy Development in the COVID-19 Crisis
In a new paper, DPharm advisor and speaker, Ülo Palm, MD, PhD, SVP and Head, Digital Science, Allergan; Corporate Secretary, TransCelerate BioPharma together with Thomas A. Bock, MD, MBA, Chairman, Healthcare Advisory Board, Columbia Business School; Founder and past CEO, HeritX; and Lixia Wang, PhD, VP, Biostatistics and Data Management, Intercept Pharmaceuticals propose a five step model of drug […]
In a new paper, DPharm advisor and speaker, Ülo Palm, MD, PhD, SVP and Head, Digital Science, Allergan; Corporate Secretary, TransCelerate BioPharma together with Thomas A. Bock, MD, MBA, Chairman, Healthcare Advisory Board, Columbia Business School; Founder and past CEO, HeritX; and Lixia Wang, PhD, VP, Biostatistics and Data Management, Intercept Pharmaceuticals propose a five step model of drug development to modify traditional practices in favor of expediting treatment to save lives.
We are happy to share this paper. CLICK HERE TO READ THE REPORT
Dr Ülo Palm is currently SVP and Head Digital Science with Allergan. Before taking over this newly created role, Dr Palm led the Global Drug Development Operations organization at Allergan. Prior to Allergan, he was the SVP Clinical Operations & Biometrics and Therapeutic Area Head Respiratory Clinical Development with Forest Labs. Before joining Forest, Dr Palm held the positions of Global Head Laboratory & Preclinical Quality Assurance and Global Head Clinical Operations Oncology with Novartis Pharmaceuticals. Prior to Novartis, Dr Palm worked at Schering-Plough and Bayer in different operational and medical drug development functions. He has a total of 30 years of experience in the pharmaceutical industry.Dr Palm earned his MD from the University of Berlin, Germany, where he also received a postgraduate research training as a medical scientist. He completed his research training with a PhD. His scientific work focused on kidney and electrolyte physiology, biological rhythms and their mathematical analysis, as well as catheter related infections. He is author and co-author of a number of scientific articles in international journals.
He earned his MBA degree with a major in Information Technology/Computer Sciences from the AKAD University for Applied Science in Rendsburg, Germany.
Dr Palm is a Senior Member of the American Society for Quality and a certified Manager of Quality and Organizational Excellence. His work at the ASQ includes initiating and co-authoring the ASQ report on “Best Quality Practices For Biomedical Research In Drug Development”.
He has been a member and past chair of the TransCelerate BioPharma Oversight Committee and several sub-committees since 2013. He was appointed Corporate Secretary of TransCelerate BioPharma in 2017.
Dr Palm’s overall vision is to expedite the development of new drugs by linking top medical science to operational excellence and 21st century technology.
Dr Thomas Bock is the Founder and past CEO of HeritX Inc., the first company focused on developing preventive therapies for inherited cancer. As member of Alexion’s Executive Management Team responsible for its medical organization, he built a pioneer and leader in ultra-rare diseases, rated the second most innovative company in the world by Forbes. Prior to that, he led the medical departments of two forward-thinking oncology companies as Global Head, Medical Affairs of Novartis Oncology and Celgene. Thomas has co-developed and commercialized paradigm-changing, life-saving blockbuster therapies including Gleevec, Revlimid and Soliris. He led the medical marketing strategy and operations of five of the most successful therapy launches in life sciences.
Thomas holds an MD from RWTH Aachen University and an MBA from Columbia Business School where he is the Chair of its Healthcare Advisory Board. He is an Advisor for Columbia Technology Ventures and the Robertson Therapeutic Development Fund at Rockefeller University. Thomas received the Morgan Stanley Aegis Award for founding HeritX, tearing down traditional barriers to prevention through an accelerated R&D platform and a non-dilutive capital leverage model.
Lixia Wang, is the head of biostatistics and data management at intercept pharmaceutical. She has 20+ years’ experience supported drug development from pre-clinical, clinical development to commercial from pharma and biotech including Novartis, Merck, Cephalon, CTI. Lixia is passionate to use digital technology, data science, and innovated methodology to deepen the insights into complex diseases, enable data-driven decision making and accelerate the discovery, development and delivery of new medicines.
Lixia had multidisciplinary background with PhD in Biostatistics and training in Epidemiology, MS in Mathematics, BS in Electronical Engineering. She has been a champion of data science to integrate AI and Machine Learning, utilize the value of Real World Data and evidence to develop and expedite the deliver our innovative medicines to patients.
-
March 17, 2020
-
How to Deal with a Pandemic, with Baxter Healthcare President of Pharmaceuticals and Chief Science and Technology Officer, Sumant Ramachandra, MD, PhD
Baxter Healthcare’s Sumant Ramachandra, MD, PhD, spoke with Conference Forum reporter Danny McCarthy to give key insight on pandemic preparedness and COVID-19. Key Takeaways: – “Flattening the curve,” by taking appropriate cautionary measures to slow the spread of disease especially social distancing is crucial to avoid overwhelming hospital systems while solutions are being created […]
Baxter Healthcare’s Sumant Ramachandra, MD, PhD, spoke with Conference Forum reporter Danny McCarthy to give key insight on pandemic preparedness and COVID-19.
Key Takeaways:
– “Flattening the curve,” by taking appropriate cautionary measures to slow the spread of disease especially social distancing is crucial to avoid overwhelming hospital systems while solutions are being created
– The progress of genetic epidemiology, the genetic sequencing of COVID-19, and drug development has allowed scientists and industry leaders to begin understanding, and thus solving for, a potential antiviral or vaccine
– “Pandemic” does not mean “panic” or “pandemonium.” Take the necessary steps, outlined by the CDC and other reputable sources
– Concerns around trusting the sources of information
Questions:
– The World Health Organization officially called COVID-19 a pandemic. What does that mean?
– Why does it matter that we’re calling it a pandemic?
– Before a pandemic occurs, how can governments and companies be preparing? And how do you stay mindful of that process?
– How does that planning relate to something less expected than a worse-than-usual flu, like COVID-19?
– In the middle of a pandemic, what becomes a priority in terms of preparedness for governments?
– What do companies need to do?
– Scientific advances since SARS? What does that mean? What are the stages of that?
– Slowing down an epidemic or pandemic fast for hospital systems, but how?
– What should people keep in mind when it comes to pandemics and COVID-19?
The World Health Organization today officially called COVID-19 a pandemic. What does that mean?
The definition is that it’s a worldwide spread of typically a new disease or new strain, and typically affects a large number of people across international boundaries and has sustained transmission.
This is not a definition of “panic.” It is not a definition taken lightly. The World Health Organization is trying to ensure that countries, and citizens in those countries, take note that drastic action is necessary to slow down the spread of a disease. The WHO went through a stage process, calling it an “alert,” and then a “high alert,” and now they’re calling it a pandemic. That process was to get the world prepared to take action.
This pandemic designation will cause some countries to take emergency action. For example, India has already decided to close its borders, to limit transmission in and out of the country, because in a country like India the healthcare system is not robust enough to handle an influx of massive amounts of patients.
Editor’s Note: Since this interview, several countries, including Germany, Denmark and the Czech Republic, have also closed their borders.
Why does it matter that we’re calling it a pandemic?
Designating COVID-19 as a pandemic gives governments and countries – as well as citizens and businesses – the ability to take actions beyond “business as usual” or “life as usual.”
Take Italy for example. Officials there put the entire country into the red zone despite the outbreak being concentrated in the northern provinces. By doing so, they’re essentially alerting the country that they have to behave differently, or else this will continue spreading in the population.
In Italy, the mortality rate was about 5%. And one of the reasons for that is Italy, compared to other countries in Western Europe, has one of the highest if not the highest, populations of the elderly. And the two populations that are most susceptible to this are elderly, and/or individuals that have a susceptible, underlying medical condition.
The majority of those infected with SARS-CoV-2 will have some mild-to-moderate symptoms of COVID-19. If patients transmit it to others who are more vulnerable to getting ill and being hospitalized, a subset of those hospitalized will end up in a critical care situation. This can result in a case fatality rate (CFR) between 0.5-5% depending on the country – this is generally higher than the typical seasonal flu and even higher in the elderly population.
So that is one concept: Why do we even want to have quarantines and isolation, if someone has not even tested positive? It’s because you can break the chain of infection. In the process of breaking the chain of transmission and infection, you could potentially slow down the spread of the disease.
Before a pandemic occurs, how can governments and companies be preparing?
If someone goes into a hospital, they typically get intravenous fluids. They sometimes get monitored in the hospital by medical technologies. If they have an illness that requires an antimicrobial, they get an antibiotic. People who have blood pressure problems as a result of being ill get cardiovascular drugs to support them. People who go into the ICU get extracorporeal – or continuous renal replacement therapy – because the kidneys are not working, because that’s essentially sepsis or multi-system organ failure. And take patients who are in the intensive care unit for a long time: many times, they cannot process food or even gut-feeding that well, and sometimes they go on parenteral nutrition.
Baxter has these types of businesses; we’re basically a staple of any hospital system. Companies like us have to take it as our responsibility to always be prepared to have supplies needed. Now, it’s hard to predict when a pandemic comes or not, so we watch out for signals throughout the year for things like influenza. We know that influenza is a seasonal disease; some years are tougher than others. We look at data coming out of Asia. We look at data coming out of Australia, because they tend to generally have the flu before us. We look at how severe it was, and then we do our planning for the US.
This enables us to get a sense of what the data looks like and what products will be needed in the healthcare system. Because when the patient gets critically ill, the categories I just mentioned are the ones typically used. Baxter is operating in all those areas, so we have to be particularly mindful to do that.
And how do you stay mindful of that process?
To get a product into a hospital and into the field, you need actual product to be made and stored. We have to make sure we understand the full supply chain of starting materials: what it takes to build out the product, either manufacturing a pharmaceutical product or a medical technology product – because Baxter has both of them. How much inventory do you keep on hand? And how do you know what to release into the field? How long is that inventory valid for? Is it one year, two years, three years? If you have more flexibility, if you have the ability to move it out at a later date? And how much can you actually store, to actually sell? Because you’re not talking about tiny little things; you’re talking, for example, about bags that are five-to-six liters of peritoneal dialysis fluid.
We have to do a lot of detailed planning to ensure that, first and foremost, a company like Baxter can accomplish our mission to “save and sustain lives.” Literally four words, but those four words require a lot of thinking to make sure we’re actually doing it.
How does that planning relate to something less expected than a worse-than-usual flu, like COVID-19?
Something like COVID-19, which is basically SARS-CoV-2 (SARS Coronavirus 2, because the first one was back in 2002/2003), this particular virus came out of the blue. It came into consciousness I believe early January 2020, though it was identified in China in December 2019. We immediately started evaluating this to ask, “What is this? Is it a weird flu strain?”
It became evident that this was something else because science has progressed so much between 2002 and today. China was able to sequence it, so we knew it was coronavirus. That gives you a signal, weeks in advance, that something potentially serious is coming. At that point, it’s up to the governments to communicate, “This is a threat,” or “We don’t think it is a threat.”
That signal typically should be taken seriously. A disease outbreak cannot be contained in a single country; we’re a global population now. People that travel within a country’s borders and internationally will contribute to the rapid propagation of the virus. Preparing for that is very hard from a product-supply perspective, but we can prepare in other ways. That includes not just products and services, but things like personal protective equipment [PPE]. Healthcare workers who are treating these patients need appropriate PPE to take care of these patients, so they don’t fall victim and become infected and transmit illness to other patients who are vulnerable. Healthcare workers are the ones moving from patient to patient to patient. So not only are they at high-risk, but they are potentially modes of transportation for the virus from one patient to another.
Servicing is very important. Equipment out in the healthcare field has to be serviced, has to be renewed, has to be validated. All those pieces become really important to make sure our service personnel can go out to the hospital, can go out to patients’ homes. We need to make sure the right people have the right PPEs to do their work, and do it in a manner that’s unencumbered as much as possible.
In the middle of a pandemic, what becomes a priority in terms of preparedness for governments?
Governments have the ultimate responsibility to protect the lives of their citizens. But we, as citizens, also have a responsibility to make sure that we do our best to not propagate the disease in the process.
Some countries have managed this extremely tightly and extremely well. For example, Singapore had a number of COVID-19 cases; I believe, to date, they’ve had zero deaths. So how did they manage it?
They knew how close they are to China; they knew about the back-and-forth travel between China. They knew how much they depend on being a hub of trade for the Asia Pacific region. And they put some really strict rules in place. And they can do that in Singapore; the government can afford to do that.
They identified and isolated people very quickly. The streets of Singapore were very quiet. Many people moved to the home for work. But business continued. Officials made sure that the factories and other industries in Singapore continued operating and they worked with the population to provide PPEs where necessary. They made sure that their hospital system never got fully overwhelmed. They notified their residents via texts and websites about what was going on.
In South Korea, the COVID-19 outbreak got quickly out of hand, and they suspect it came from one congregation in a particular town that had communal services. It spread very quickly, but once South Korea saw this happening, officials stepped in as quickly as possible. They made tests available; they started rapid testing. They did a really large number of tests per day to identify people who contracted the virus and then isolate them from the general population. But then a day or two ago, they had another outbreak in a call center; people working together, and several employees of the call center got it.
So it shows you a pattern: people in close settings tend to have a higher probability of getting it. Being in close settings, circulating air, being near one another – these conditions help viruses propagate. And governments have the authority to make recommendations and implement rules and regulations to help manage and protect the population, as we are seeing now with officials recommending “social distancing” protocols to prevent the spread of COVID-19 within a population and potentially to other countries.
What do companies need to do?
Part of the government’s role is getting companies and industries talking about what they need from one another. Are your raw materials secure so you can manufacture products of need? Can you secure PPEs? Can you make medicine? Can you supply medical equipment? Can you staff the hospitals? What if a fire department or care personnel that’s helping a number of sick and elderly patients contracts the virus, just like what happened in Seattle? What do you do in that situation?
Being prepared for pandemics requires you to go through a lot of exercises: first on paper, and then you try it out. Sometimes being prepared means you run regular drills to ask, “What would we do if this particular scenario happened?” This allows organizations to test if their pandemic preparedness playbook is actually working, or if there is any confusion or areas for improvement.
Just like anything in life, if you don’t practice it, like a muscle, you’re never going to strong enough to remember it. You’re going to suddenly think, “Oh, I didn’t know how to do this,” and the chain can fall apart.
You mentioned that science has advanced so much since SARS? What does that mean?
Today there’s a field called genetic epidemiology. We are so rapidly able to conduct genetic testing, we can actually figure out when a new virus strain emerged based on the number of mutations it has undergone. For example, we knew how many weeks had gone by from the first case in Wuhan versus to the first identified cases in Seattle, because epidemiologists were able to observe mutations in the gene.
The government of China sequenced the genetics of the coronavirus that came out of Wuhan and they put it into the public domain very quickly. Scientists – including experts at the WHO and CDC, along with companies – were able to start testing antiviral molecules, including experimental molecules, against the coronavirus. A virus replicates typically in a cell-like structure and unless you test potential treatments in vitro, in the culture of this virus and cell itself, you don’t know whether you’re inhibiting the replicative ability of the virus. If it shows inhibitory activity, and it’s suppressing the viral load and actually stopping or slowing down the replication, then this is a promising potential antiviral.
The next step is to make sure that you go and test it in a population that has a high susceptibility of getting infected, or that may be sick.
So in the case of the drug from Gilead, remdesivir, I understood that they’ve shipped the molecule to test in China, and they’re doing compassionate use in the Washington State area, because it showed promise in this pre-clinical setting.
What are the stages of that?
So the first step is, “Can you quickly get a chemical, like an antiviral, out there?” or a small molecule that’s easy to chemically manufacture, to reduce the impact of the virus and slow down its replication or stop the replication cycle.
Now, we don’t know about the safety profile. But when you do any drug development, you always say, “What is the benefit versus what is the risk?” You therefore have the ability to go to very quick testing in this case, because the risk in certain populations is quite high. So you identify the [elderly and susceptible underlying medical condition populations] and you test in that population.
This has been very fast: from realizing in January that this illness could be a coronavirus and sequencing it out, to identifying something that has been declared as having potential antiviral activity and getting it shipped to China as well as compassionate use. That’s very fast. We don’t know the safety profile of the drug, but that’s why you need the human testing. There’s no other way of making sure you administer this drug because the benefit may outweigh the risk.
Vaccines, on the other hand, can be slightly different. Vaccines can be defined as created from the construct of the virus itself. For example, the flu vaccine is typically inactivated (killed), and it activates the immune system to fight against it. You build an immune response to it. When the real flu comes, your body is primed to attack.
In the case of COVID-19, vaccine scientists very quickly started going after both typical, transitional vaccines, as well as subcomponent vaccines and other approaches. They knew, for example, certain proteins or peptides from the coronavirus may be more immunogenic or may be more critical for its activity of binding a cell, or getting into a cell. So they started creating a subcomponent vaccine. And there’s even a forum discussing the fact that the coronavirus is a single-strand RNA virus, so they’re trying to create a strand against the RNA. The vaccine and therapy approaches are through multiple pathways.
That’s still experimental; one of the firms, Moderna, is already researching [a potential vaccine against COVID-19]. Again, that would be one of the fastest vaccine development processes that I’ve ever seen, if not the fastest. I believe they skipped some preclinical steps because the benefits may outweigh the risk.
From a drug development perspective, we are seeing something typically unprecedented, because science has progressed significantly. It’s been amazing how quickly we could get the gene sequence and virus samples out of China, which then enabled scientists to test small molecule drugs against, to have potential antiviral activity and create some vaccine candidates for consideration.
Companies are really coming together and testing their chemical entity base. Vaccine companies are saying, “Okay these are our approaches; let’s think about how we can actually bring something forward.”
From a science perspective, this is one of the most incredible revolutions I have seen, since SARS came out. Now they’re calling COVID-19 a pandemic, to see what we can do between governments and industry and healthcare systems, to at least abrogate the propagation of this virus or vaccinate people so that it does not propagate into others.
Slowing down an epidemic or pandemic is so important for hospital systems. How and why?
Let’s say a hospital typically has 100 beds on the floor and 10 beds in the ICU. In a typical flu season, let’s say six of the ICU beds are full with not just flu, but other types of illnesses also, and you get 80 of the hospital beds full. If you let the virus propagate, and by the way, the propagation is exponential (that means a single person who’s infected may not have symptoms or very mild symptoms, but could spread to two or more people), now you’re getting an influx of patients from a new disease.
If you don’t hold on to the disease, and you let it progress through its natural course, the healthcare system will get overburdened. And when any healthcare system has much more utilization than capacity, you have to trade off somewhere how adequately you treat patients. You can’t give them the same level of care because you’re flooded with patients.
People are recognizing that, absent an antiviral or vaccine, our best bet is to slow down the spread of disease through isolation, testing and quarantine. You slow down the flow of patients into a hospital system or critical care system, and manage the caseload so you do not overwhelm the system.
Healthcare personnel have to wear personal protective equipment. They have to change and modify some of their behaviors and protocols for care. So you’re going to lose some productivity in the hospital. You have potential exposure to other patients as a result of being in a hospital. The biggest issue will be some health systems are much more fragile. In some countries, the health systems are not robust enough even to deal with this current population. Imagine what happens when an influx occurs.
What should people keep in mind when it comes to pandemics and COVID-19?
Most importantly, I think there’s so much news out there, it’s confusing. Go to reliable sources as much as possible to get your information. The WHO and US CDC are two trustworthy sources and have done great work keeping the public updated with the latest news about this outbreak. There’s also a lot of false information being propagated out there. So first and foremost is a guidance: You have to trust the source of information. Governments need to be open about how they will be transparent and convince the public that they are a good source.
Number two, never panic. Because the reality is, even though it may strike close to home, the moment we do not think objectively, we’re going to make mistakes. We’re going to have irrational behavior. You’re going to have people doing things that they would not normally do. And that causes lots of problems, not only in society, but within the supply chain process. For example, people hoarding certain things – more than they may need – can prevent others from having access to those items, and that causes issues for a lot of other people.
Being reasonable about this outbreak is going to be super important.
So pandemic preparedness, like I said, if you prepare ahead of time, you’re using a well-rehearsed muscle. What we do during this period is important because when you come out of it, we have to think about as a health care system or a society, how do we strengthen our capabilities here and how do we strengthen our supply chain?
For COVID-19 specifically, can anyone have predicted this? No, not this specific disease. Can anyone have said we will have a pandemic in the next 10 or 20 years? Yes. They come in these cycles; they come out of the blue. What do we do? How severe will it be? And you won’t know any of this information or data until it comes out. We don’t know the effect of weather or temperature, in terms of propagation and illness. That is a matter of time until we find out.
While we’ve learned a lot through science and clinical epidemiology and statistical epidemiology and genetic epidemiology, we know so much more today than we knew in January. At the end of the day, we don’t know a lot, but we will learn a lot more.
Like any pandemic, things over time resolve. It moves through the population, depending on how much we can flatten the curve, at different rates. And once it gets through the population, it becomes basically an endemic disease.
We talked about “epidemic;” we talked about “pandemic;” and now it becomes an “endemic” disease. It just comes in and out of the population. It will come up and when a new strain of a new virus comes up for the next epidemic or pandemic, we will hopefully be better prepared.
Is there anything else you’d like to say?
I think it’s really important for all of us in the healthcare system: it is our responsibility, and our privilege, that we are in healthcare, to help patients. Whether you’re a clinician, you’re in the hospital system from an administration perspective, whether you’re a healthcare company, whether you’re a government entity, healthcare is an amazing calling. But that requires us to be highly collaborative, because the more we work together, I think we have a higher chance of minimizing, as much as possible, or abrogating the spread of any disease and helping treat it.
What I’ve seen from the healthcare community is very positive. People are willing and wanting to work with each other, because they know how important this is to society. I hope that through this process, we have new avenues of not only discovering new ways of working together after the pandemic, but we also then now think through how we prepare for any major emergency and work together as a society.
Source: CDC, “Community Mitigation Guidelines to Prevent Pandemic Influenza”
Source: Drew Harris via Twitter, adapted from CDC/The Economist
-
March 11, 2020
-
DPharm 2020 Planning Kicks off With Advisory Meeting
The DPharm Advisory Kick Off meeting took place on March 2nd as most members of the DPharm Advisory board met with the DPharm team to address how 2030 clinical trials cannot look like clinical trials in 2020 and how we are going to get there. The DPharm advisers generated lively discussions on topics to address […]
The DPharm Advisory Kick Off meeting took place on March 2nd as most members of the DPharm Advisory board met with the DPharm team to address how 2030 clinical trials cannot look like clinical trials in 2020 and how we are going to get there. The DPharm advisers generated lively discussions on topics to address at DPharm 2020 that will reduce the burden to patients and investigators and how to move this faster and scale. Among the many topics discussed around disruptive innovation and innovation from both inside and outside the pharma industry, we also addressed the negative perceptions of our industry and innovative ideas to combat this.
DPharm began in 2011 with the goal of convening experts to challenge disruptive ideas and discuss innovative ways to advance and modernize clinical trials. The advisory meeting discussed ideas to celebrate the 10th annual DPharm. We are excited to continue challenging ourselves to produce the most innovative and cutting-edge program and we value the support of our advisory board in adding their voices to this process.
DPharm: Disruptive Innovations to Advance Clinical Trials will take place on September 22-23, 2020 at the Westin Copley Plaza in Boston.
-
March 2, 2020
-
Addressing COVID-19 and Our Upcoming Conferences
As standard good health practices, we are confident all attendees will wash their hands frequently. We will have plenty of hand sanitizers throughout upcoming events. We are happy to institute a fist bump or elbow bump greeting alternative over handshakes. Best practices for preventing the spread of any viral illness are published by the CDC […]
As standard good health practices, we are confident all attendees will wash their hands frequently. We will have plenty of hand sanitizers throughout upcoming events. We are happy to institute a fist bump or elbow bump greeting alternative over handshakes.
Best practices for preventing the spread of any viral illness are published by the CDC and we are happy to share them with you at www.cdc.gov/covid19 and at the World Health Organization www.who.int websites. So far, the CDC has been emphatic that the exposure in the United States remains very low currently, but that they are planning for more cases. Comparatively, in the US, approximately 56,000 people die annually of general flu.
We encourage every member of our community to mitigate the risk of any infection by following some common practices:
1. Avoid close contact with people who are sick.
2. Cover your cough or sneeze with a disposable tissue and throw it in the trash. If you don’t have a tissue available sneeze or cough into your arm or clothing not your hand.
3. Avoid touching your eyes, nose and mouth.
4. Clean and disinfect frequently touched objects and surfaces.
5. Stay home if you are sick unless it is necessary to seek medical attention.
6. Wash your hands frequently with soap and water for at least 20 seconds or use an alcohol‐based hand sanitizer if soap and water are not available.
We will continue to monitor this situation and will provide updates as necessary. As with any issue that conjures public fear, it is important that we all maintain vigilance and appropriate perspective and let your judgment be guided accordingly. For any questions, please contact service@tcfllc.org. Thank you.
-
February 7, 2020
-
CRAACO Speaker, Dr Greg Licholai, PRA Health Sciences, Discusses the PRA-Janssen Collaboration on their 1st Fully Virtual Clinical Trial
2019 CRAACO speaker, Dr Licholai, Chief Medical Information Officer, PRA Health Sciences and faculty member of the Yale School of Management recently wrote an article on PRA’s collaboration with Janssen about the fully virtual trial for adults with heart failure. Happy to share what the work PRA and Janssen are doing. Enjoy the article. https://prahs.com/insights/janssen-pharmaceuticals-and-pra-health-launch-first-fully-virtual-trial-for-heart-failure-drug-approval
2019 CRAACO speaker, Dr Licholai, Chief Medical Information Officer, PRA Health Sciences and faculty member of the Yale School of Management recently wrote an article on PRA’s collaboration with Janssen about the fully virtual trial for adults with heart failure. Happy to share what the work PRA and Janssen are doing. Enjoy the article.
-
December 3, 2019
-
#GivingTuesday in Honor of Multiple Myeloma Research Foundation & Alzheimer’s Association
This #GivingTuesday the Conference Forum is proud to support the Multiple Myeloma Research Foundation and the Alzheimer’s Association for our annual holiday season donation. We want to thank them for their continued commitment to clinical research and supporting patients. Organizations like these make clinical research possible and continue to push the limits on lessening the […]
This #GivingTuesday the Conference Forum is proud to support the Multiple Myeloma Research Foundation and the Alzheimer’s Association for our annual holiday season donation. We want to thank them for their continued commitment to clinical research and supporting patients. Organizations like these make clinical research possible and continue to push the limits on lessening the burden to patients in all areas of the healthcare continuum.Learn more about the Multiple Myeloma Research Foundation here.
Learn more about the Alzheimer’s Association here.
Learn more about Giving Tuesday here.
-
November 27, 2019
-
Congratulations to DPharm Partner, Circuit Clinical and Speaker, Dr Irfan Khan
Congratulations to DPharm speaker, Dr Irfan Khan, CEO and Founder of Circuit Clinical, on their latest achievement. They have been named one of 8 winners in the 43North Competition. 43North is a startup competition that invests $5 million annually to attract and cultivate high-growth startups within Buffalo, NY. By partnering with Circuit Clinical, physicians are […]
Dr Irfan Khan, second from right, participating in a panel discussion.
Congratulations to DPharm speaker, Dr Irfan Khan, CEO and Founder of Circuit Clinical, on their latest achievement. They have been named one of 8 winners in the 43North Competition. 43North is a startup competition that invests $5 million annually to attract and cultivate high-growth startups within Buffalo, NY. By partnering with Circuit Clinical, physicians are able to offer their patients access to cutting edge treatment options within the comfort of their own doctors’ office. Over the past five years Circuit Clinical has grown its multi-specialty network and partnered with multiple Accountable Care Organizations. Seeing the difficulties that patients face firsthand when looking for a clinical trial empowered Circuit to develop TrialScout™. TrialScout is a powerful and dynamic platform that aims to help patients find, choose and rate their clinical trial experiences. “Our goal is to make it simple for people to find clinical trial centers across the country and improve the patient experience,” said Dr. Khan.
TrialScout competed in the 9th annual DPharm Idol competition at the 2019 DPharm conference where they ultimately were runners-up, but the judges admitted they had a very tough time making the decision between TrialScout and Tasso.
Read more about Circuit Clinical, TrialScout and the 43North Competition here.
The 2020 DPharm conference will take place on September 22-23 in Boston, MA. Learn more here.
-
October 4, 2019
-
Referring Physicians & Clinical Trial Enrollment: Moving Beyond the Myth
At the 9th annual DPharm conference that took place in September, BBK’s Aaron Fleishman and Matt Kibby presented The Myth: New Technology Inherently Equals Improved Outcomes on the Innovative Patient Solutions track. Now, BBK has published a new survey revealing physicians support referring patients to clinical trials and identifying a pressing need for greater education and communication. BBK […]
At the 9th annual DPharm conference that took place in September, BBK’s Aaron Fleishman and Matt Kibby presented The Myth: New Technology Inherently Equals Improved Outcomes on the Innovative Patient Solutions track. Now, BBK has published a new survey revealing physicians support referring patients to clinical trials and identifying a pressing need for greater education and communication.BBK Worldwide’s newest Study Voices survey challenges the long-held notion that physicians are not willing to refer their patients to other specialists for access to clinical studies. The survey, the latest in an ongoing series of surveys designed to shed light on key clinical research trends, features perspectives from pharmaceutical and biotechnology sponsors, physicians, and patients. The patient portion was conducted as part of BBK’s partnership with Health Union, a pioneer in online communities for people with chronic health conditions. Despite a growing body of research,
the myth that physicians won’t refer patients to clinical trials persists, perpetuated in part by the belief that physicians fear losing their patients to the care of the investigator following the completion of the study. The survey results challenge the myth, invoking a call to action for sponsors to take more dramatic measures to engage the physician community and build relationships to support clinical trial participation. This white paper provides insight into the perceptions, attitudes, and patterns surrounding physician referrals, as well as strategies sponsors can implement to realize
the full potential of physicians as partners in the clinical trial process.“There’s clearly a missed opportunity to engage physicians as partners in the clinical trial process – this not only impacts enrollment efforts, but it also impacts patients who miss out on learning about potential treatment options.” – Matt Kibby, Principal and President, BBK Worldwide
Read more here: BBKWorldwide-Article-Referring-Physicians-Trials.
-
September 18, 2019
-
Tasso Wins DPharm Idol Disrupt 2019 for Patient-Centric Blood Sampling Kits
Tasso was announced the winner of DPharm Idol Disrupt at the 9th annual DPharm: Disrupting Innovations to Advance Clinical Trials Conference. Tasso has a service that provides patient centric blood-sampling kits for use by participants in clinical trials. Tasso’s goal is to eliminate the need for site visits, and to lower the costs and inconvenience […]
Tasso was announced the winner of DPharm Idol Disrupt at the 9th annual DPharm: Disrupting Innovations to Advance Clinical Trials Conference. Tasso has a service that provides patient centric blood-sampling kits for use by participants in clinical trials. Tasso’s goal is to eliminate the need for site visits, and to lower the costs and inconvenience associated with traditional blood sampling methods. Tasso aims to provide a clinical trial participant a ready made kit for blood sampling with easy to understand instructions for at-home self blood sampling, much of the patient burden for gathering blood data is eliminated.
Tasso had six minutes to present their aims in disrupting the current paradigm of clinical trials, and pitch their product to DPharm’s esteemed panel of judges, which consisted of:Sandra Freeman
GCO U.S. Director, MAO Supported Studies, Johnson & JohnsonCindy Geoghegan
Cancer Veteran and Patient AdvocateHassan Kadhim
Director, Head of Clinical Trial Business Capabilities, BMSÜlo Palm, MD, PhD,
SVP and Head, Digital Science, AllerganDouglas Schantz
Executive Director, Development Operations, AstrazenecaJessica Scott, MD, JD,
Head of R&D Patient Engagement, Takeda PharmaceuticalsMark Travers, PhD, MBA,
VP, HEad of GCTO REgions, Monitoring Excellence, Global Operations, Merck & CoWhereas in previous DPharm Idols judges have deliberated for upwards of two hours, this years deliberation took only twenty minutes. Judges were taken by the ease of use, potential cost savings, and potential to radically change the methodology by which blood sampling is conducted in clinical trials. When asked to elaborate on their reasoning the judges stated:
”Tasso’s blood draw product impressed the DPharm Idol judges because it lay one more building block in the journey towards decentralizing clinical trials by enabling the collection of blood samples in an easy and seamless manner from the patient’s home. The potential combination of Tasso’s blood sample collection device with digital tools makes the promise of bringing the trial to the patient much closer to reality and it adds one more tool in the arsenal to enable patient centric clinical trials for the immediate future and beyond.”
The judges further stated that the length of time taken for them to deliberate in no way indicated that it was an easy decision and in fact gave TrialScout a big shout out for their second runner up. By all accounts, Tasso had strong competition from the other presenters which included:
TrialScout
Irfan Khan, MD, CEOxCures
Mika Newton, CEOShimmer Research
Geoff Gill, PresidentIntelligencia
Vangelis Vergetis, PhD, Co-FounderTrials.ai
Kim Walpole, Founder and CEODPharm Idol is the signature event that took place at the 9th annual iteration of DPharm: Disruptive Innovations to Advance Clinical Trials. DPharm, organized by the Conference Forum, reports on industry and out of industry innovation and how to change the paradigm of clinical trials to reduce the burden to patients and investigators, streamline processes and ultimately get therapeutics to patients faster. DPharm connects pharma, biotech, clinical research partners, as well as patient advocacy to inspire and encourage the most innovative technologies and ideas in clinical trials and drug development. Mark your calendars for next year’s event, which will be held September 22-23, 2020 in Boston.
-
September 13, 2019
-
Mobile in Clinical Trials & DPharm Speakers, Andy Coravos & Sara Holoubek discuss Digital Medicine & Hacking
Sara Holoubek, CEO of Luminary Labs, sat down with Andy Coravos, co-founder and CEO of Elektra Labs, ahead of the Mobile in Clinical Trials and DPharm: Disruptive Innovation conferences to discuss their digital measures discovery platform, their involvement in the newly launched Digital Medicine Society (DiMe), and why the medical device community should get to […]
Sara Holoubek, CEO of Luminary Labs, sat down with Andy Coravos, co-founder and CEO of Elektra Labs, ahead of the Mobile in Clinical Trials and DPharm: Disruptive Innovation conferences to discuss their digital measures discovery platform, their involvement in the newly launched Digital Medicine Society (DiMe), and why the medical device community should get to know hackers.
When asked what should be on our radar for 2020, Andy answered, “I do think people should rethink how to integrate white hat hacking and security research into healthcare products early in development. And security isn’t something you can slap onto your product afterward; it needs to be built from the beginning. Additionally, there is a difference between attacks on data, which security systems can help with — but that’s different from data leakages. In many instances, companies are sharing data by design; it’s not a security issue but rather a governance issue. Many data leaks are not due to hacking the system; they are a feature, not a bug. There’s a difference between making sure your systems are secure from an engineering standpoint versus from a legal standpoint — and making sure that your engineers are reading the end-user license agreements and terms of service, so that what the lawyers say the product does actually happens behind the scenes.”
Read more of the interview here.
-
September 6, 2019
-
The Conference Forum Announces Partnership with ACRP for 2019 DPharm Conference
The Conference Forum has announced a partnership with the Association for Clinical Research Professionals (ACRP) for the 2019 DPharm: Disruptive Innovations to Advance Clinical Trials conference. This partnership opens up access to ACRP members to Dpharm, who are interested in disrupting and innovating the pharma industry from within their own organizations. Synergies between the work […]
The Conference Forum has announced a partnership with the Association for Clinical Research Professionals (ACRP) for the 2019 DPharm: Disruptive Innovations to Advance Clinical Trials conference. This partnership opens up access to ACRP members to Dpharm, who are interested in disrupting and innovating the pharma industry from within their own organizations.
Synergies between the work ACRP is doing for clinical researchers and the topics covered at the 2019 DPharm conference has allowed for the two organizations to work together and provide further opportunities for researchers to learn and grow from key leadership in the pharma industry.
ACRP Executive Director Jim Kremidas will be leading a track on Wednesday, September 18 on Workforce Innovation to Upskill Staff for 21st Century Clinical Trials. This track will include sessions on workforce performance at the site level, developing career paths and building the competency of researchers at an organizational level, and collaborative efforts for workforce efficiency and productivity that are disruptive.
“I look forward to leading this section at DPharm with a talented team of speakers to address workforce performance at the site level and what we can do now, “ said Kremidas.
With more than 500 delegates in attendance, DPharm 2019 covers the full spectrum of clinical research including virtual trials, digital applications, real-world data, big data management, AI applications, MAPs, EHR eSource operations, patient-centric strategies, new business models, collaborations, technologies and more.
To learn more about DPharm taking place on September 17-18 in Boston, MA, please visit DPharm 2019.
About ACRP
In clinical research, people are everything. ACRP raises clinical research standards and accelerates careers. Better people. Better results. www.acrpnet.org
-
September 4, 2019
-
Drug Development Innovation Enabled by Real-World Data Studies
Michelle Hoiseth, Chief Data Officer, Parexel and Leanne Larson, Corporate Vice President and WW Head, Real-World Evidence, Parexel discuss the benefits of Real-World Data Studies in this podcast and article with PharmaVOICE. Drug development is stuck in a linear approach that is slow, complex, and increasingly expensive. The trajectory is unsustainable. Drug development costs are […]
Michelle Hoiseth, Chief Data Officer, Parexel and Leanne Larson, Corporate Vice President and WW Head, Real-World Evidence, Parexel discuss the benefits of Real-World Data Studies in this podcast and article with PharmaVOICE.
Drug development is stuck in a linear approach that is slow, complex, and increasingly expensive. The trajectory is unsustainable. Drug development costs are hovering around $2.6 billion per new drug and are expected to increase eight-fold in the next 30 years. And, a compound’s journey from bench to bedside can take more than a decade, delaying patient access to treatments and companies realizing investment returns. Despite the time and investment committed to R&D, success isn’t a guarantee; failure rates can exceed 90 percent.
In its March 14, 2019 statement, FDA called for new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development. Similarly, other regulatory bodies around the world are increasingly calling for innovative approaches to drug development. Their collective message is clear: The time for industry to embrace disruptive innovation is now, because sustained success requires it – and patients can’t wait.
Recognizing this as a major issue that the industry is facing, Parexel commissioned the Economist Intelligence Unit (EIU) to evaluate four existing clinical trial innovations – adaptive trials designs, patient-centric trials, precision medicine trials and trials that use real-world data (RWD) – to better understand how innovative approaches can influence the efficiency, productivity and sustainability of the drug development process and increase the likelihood of providing meaningful therapies to patients. The key findings of this research and analysis were presented in a report: The Innovation Imperative: The Future of Drug Development.
One of the key innovations this report focused on was the use of RWD in clinical trials, defined as: Including one or more measures of a therapy’s impact in the real-world, rather than just in the trial environment, and including both trials using existing data and those using digital health-monitoring devices. The report showed that drugs developed using RWD had a higher likelihood of launch (89%) across all therapy areas (including neurology, oncology and rare diseases), which is a 21-point increase compared to drugs developed without an innovative approach (68%). Additionally, RWD studies had some of the shortest times to recruit 100 participants – six months on average – compared to the average seven months.
Parexel believes a fresh bench to bedside / bedside back to bench philosophy must inform innovation and the discovery, design, development, regulatory approval and payer acceptance of new medicines. This philosophy involves bringing information learned from the bedside through real-world data and evidence back to the bench for additional indications and/or novel approaches to developing new treatments for patients.
Michelle and Leanne’s podcast and article examine how RWD trials can positively impact the drug development process. They provide concrete definitions of RWD along with specific examples and applications. They also note the increased interest from the FDA to provide frameworks for using this kind of data and associated evidence in clinical research.
Michelle Hoiseth will be moderating a panel discussion at DPharm on September 18 at 12:40pm as part of Track C: Big Data, AI & Machine Learning called “What Needs to be Assembled Among Teams and Infrastructure to Support AI Deployment?” Sy Pretorius, Executive Vice President, Chief Medical & Scientific Officer, also with Parexel, will be speaking on September 18 at 9:45am as part of the Today Show. DPharm takes place September 17 and 18 in Boston at the Renaissance Boston Waterfront Hotel.
-
August 1, 2019
-
9th Annual DPharm: Disruptive Innovations in Clinical Trials Overview in 5 Minutes
In this podcast, Valerie Bowling, Director of DPharm, walks you through what to expect at DPharm 2019 in under 5 minutes. This is the 9th annual DPharm conference featuring keynotes from: Dr Scott Gottlieb, 23rd Commissioner of the FDA Takeda’s CMO, Dr Andy Plump Merck’s VP of Global Operations, Dr Mark Travers Cellarity’s Chief Data Officer, […]
In this podcast, Valerie Bowling, Director of DPharm, walks you through what to expect at DPharm 2019 in under 5 minutes. This is the 9th annual DPharm conference featuring keynotes from:
- Dr Scott Gottlieb, 23rd Commissioner of the FDA
- Takeda’s CMO, Dr Andy Plump
- Merck’s VP of Global Operations, Dr Mark Travers
- Cellarity’s Chief Data Officer, Milind Kamkolkar
- Starbucks’ Design Director of Global Digital Products, Robert Mercer
- Fast Company’s Deputy Editor, David Lidsky
- Healthgrades’ Founder, Kerry Hicks
- Radio City Rockette and Patient Advocate, Alyssa Epstein
All of this plus: pharma reporting from the trenches, multiple track choices, opportunities to meet patients, and more.
The 9th annual DPharm will take place on September 17-18 in Boston, MA. Learn more at DPharm 2019
-
July 28, 2019
-
How to Innovate like Amazon to Modernize Clinical Trials
This session was presented at the 8th annual DPharm conference in September 2018. When Amazon announced that the creation of a new healthcare company with Berkshire Hathaway and JPMorgan Chase, the move signaled how the company is stepping into the healthcare industry. However, Amazon Web Services (AWS) has been working directly with the healthcare and life […]
This session was presented at the 8th annual DPharm conference in September 2018.
When Amazon announced that the creation of a new healthcare company with Berkshire Hathaway and JPMorgan Chase, the move signaled how the company is stepping into the healthcare industry. However, Amazon Web Services (AWS) has been working directly with the healthcare and life science industries for quite some time. Life Science Director, Mark Johnston, shares how AWS thinks about innovation, in particular for the life science industry, including clinical trials.
More specifically:
- How AWS looks at problems and transforms processes through new technologies
- How to think about going faster to be more effective in solving problems without the worries of infrastructure
- How to imagine what to do next if you were un-trapped by historical baggage and preceived limitations
- Opportunities to consider
- Examples
Speaker: Mark Johnston, Director of Global Business Development for Health Care, Life Sciences, and Agricultural Technology, Amazon Web Services
The 9th annual DPharm will take place on September 17-18, 2019 in Boston, MA. Click here for more information.
-
July 27, 2019
-
Bringing Blockchain to Life: Digitizing Clinical Supply Chain in Trials
In this podcast from DPharm 2018, Pfizer’s VP of Clinical Supply Chain, Michael Ku, speaks about some of Pfizer’s earliest work making blockchain real as well as some of their forward-leaning work digitizing supply chain for clinical trials. The 9th annual DPharm conference will take place on September 17-18, 2019 in Boston, […]
In this podcast from DPharm 2018, Pfizer’s VP of Clinical Supply Chain, Michael Ku, speaks about some of Pfizer’s earliest work making blockchain real as well as some of their forward-leaning work digitizing supply chain for clinical trials.
The 9th annual DPharm conference will take place on September 17-18, 2019 in Boston, MA. Learn more at DPharm 2019.
-
July 26, 2019
-
How Digital Biomarker Innovation is Modernizing Clinical Endpoints
In this session from DPharm 2018, Roche provides an update on the company’s progress in how they are collecting data with sensor technology and turning it into a clinically meaningful endpoint with multiple indications, including Parkinson’s disease and Multiple Sclerosis. Session takeaways include: Understand what Digital Biomarker innovation means for the future of clinical development and […]
In this session from DPharm 2018, Roche provides an update on the company’s progress in how they are collecting data with sensor technology and turning it into a clinically meaningful endpoint with multiple indications, including Parkinson’s disease and Multiple Sclerosis. Session takeaways include:
- Understand what Digital Biomarker innovation means for the future of clinical development and potentially personalized healthcare.
- Be inspired to use mobile sensors technology in the context of clinical trials and beyond.
- Develop a detailed understanding of the underlying complexity to run such efforts and be able to plan for it.
- Understand how regulators are looking at these novel approaches.
Speaker:
Christian Gossens, PhD, MBA, Global Head Early Development Workflows, pRED, Informatics, Roche Pharmaceutical Research and Early Development (pRED)
The 9th annual DPharm conference with take place on September 17-18, 2019 in Boston, MA. Learn more at DPharm 2019.
-
July 25, 2019
-
Bayer: Virtual Assistants for Sites and Patients in Clinical Trials
In this podcast from DPharm 2018, Bayer shares how they use virtual assistants and chatbots to support study teams, research sites, and patients. Learn how they are doing this and what you should consider. Speaker: Michelle Shogren, Head of Innovation, Portfolio & Operations, Bayer The 9th annual DPharm conference will take place on September 17-18 […]
In this podcast from DPharm 2018, Bayer shares how they use virtual assistants and chatbots to support study teams, research sites, and patients. Learn how they are doing this and what you should consider.
Speaker: Michelle Shogren, Head of Innovation, Portfolio & Operations, Bayer
The 9th annual DPharm conference will take place on September 17-18 in Boston, MA. Learn more at DPharm 2019.
-
July 24, 2019
-
Co-Creating the Industry’s Scalable Solution for EHR
In this session presented at the 2018 DPharm conference, Rob Goodwin and Amy Nordo share an exciting new collaboration – including industry and academia, as well as health authorities and leading technologists – positioned to break through the barriers to allow the power and the promise of eSource across companies and medical centers. The potential […]
In this session presented at the 2018 DPharm conference, Rob Goodwin and Amy Nordo share an exciting new collaboration – including industry and academia, as well as health authorities and leading technologists – positioned to break through the barriers to allow the power and the promise of eSource across companies and medical centers.
The potential for eSource has been discussed for years, but realizing its promise has been difficult. While most health data today can be captured within electronic health records, the diversity of systems across medical centers and around the world coupled with a lack of health data interoperability has limited our ability to source clinical trial data from existing electronic systems across thousands of investigator sites supporting trials globally.
Speakers:
Rob Goodwin, VP, Operations Center of Excellence, Global Product Development, Pfizer, Inc.
Amy Nordo, Program Director, Duke Center for Healthcare Informatics
The 9th annual DPharm conference will take place on September 17-18, 2019 in Boston, MA. Learn more at DPharm 2019.
-
July 23, 2019
-
Estonia, The Digital Republic: Where Patients Own Their Data
An Insight into Our Possible Future Faster than You Think This keynote session was presented at the 2018 DPharm conference. Estonia is now a digital republic with a virtual government, blockchained and secure. Our keynote guest from Estonia tells us how Estonia became the fastest country in the world to go digital. Its 1.3 million […]
An Insight into Our Possible Future Faster than You Think
This keynote session was presented at the 2018 DPharm conference. Estonia is now a digital republic with a virtual government, blockchained and secure. Our keynote guest from Estonia tells us how Estonia became the fastest country in the world to go digital. Its 1.3 million citizens pay with their mobile phones, have their health records stored in the digital cloud, and filed their annual tax return online in five minutes. This session demonstrates how Estonian citizens have come to own their personal health records, how doctors have to get their permission to use these records, and how patients choose their own medications digitally. We also learn about their challenges, policies, and of course their vision for digital clinical trials.
Speakers:
Indrek Onnik, Program Manager, E-Estonia Showroom, a partner of the Estonian Government
The 9th annual DPharm conference will take place on September 17-18, 2019 in Boston, MA. Learn more at DPharm 2019.
-
July 22, 2019
-
Regenerative Medicine as a Disrupter in Clinical Trials
This is a keynote session from DPharm 2018. Dr Atala, a renowned key opinion leader on the topic of regenerative medicine, brings the DPharm audience a fascinating presentation on how it’s possible to reduce the number of patients needed in clinical trials with the advancement of regenerative medicine, and how regenerative medicine can improve accuracy […]
This is a keynote session from DPharm 2018. Dr Atala, a renowned key opinion leader on the topic of regenerative medicine, brings the DPharm audience a fascinating presentation on how it’s possible to reduce the number of patients needed in clinical trials with the advancement of regenerative medicine, and how regenerative medicine can improve accuracy and speed up the clinical trial process.
Speaker:
Anthony Atala, MD, Director, Wake Forest Institute for Regenerative Medicine
The 9th annual DPharm conference will take place on September 17-18, 2019 in Boston, MA. Learn more at DPharm 2019.
-
July 21, 2019
-
Service & Patients in Clinical Trials
In this podcast from DPharm 2018, Chip Bell shows pragmatic ways to change our culture to support service-oriented thinking that benefits patients and investigators. The patient’s expectations are being quickly changed today by disruptors far beyond the Pharma industry. How will the concept of service make us better at drug development and help us become […]
In this podcast from DPharm 2018, Chip Bell shows pragmatic ways to change our culture to support service-oriented thinking that benefits patients and investigators. The patient’s expectations are being quickly changed today by disruptors far beyond the Pharma industry. How will the concept of service make us better at drug development and help us become more disruptive thinkers?
Speaker:
Chip Bell, PhD, Keynote Innovative Service Speaker, Author, Senior Partner, The Chip Bell Group
The 9th annual DPharm conference will take place on September 17-18, 2019 in Boston, MA. Learn more at DPharm 2019.
-
June 24, 2019
-
Announcing DPharm: Disruptive Innovations in Clinical Trials Event 2019 Keynotes
The 9th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference will take place on September 17-18, 2019 at the Renaissance Waterfront Hotel in Boston, MA, with a full day dedicated to Mobile in Clinical Trials on September 16. Dr Scott Gottlieb, 23rd Commissioner of the FDA, has chosen DPharm to deliver his perspective on […]
The 9th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference will take place on September 17-18, 2019 at the Renaissance Waterfront Hotel in Boston, MA, with a full day dedicated to Mobile in Clinical Trials on September 16.
Dr Scott Gottlieb, 23rd Commissioner of FDA
Dr Scott Gottlieb, 23rd Commissioner of the FDA, has chosen DPharm to deliver his perspective on how to modernize clinical trials in one of the opening keynotes for this year. Tammy Guld, Janssen Clinical Innovation Global Lead, Janssen will lead the event as co-chair, and in a patient advocate opening keynote, Radio City Rockette, Alyssa Epstein will share her patient story as a breast cancer survivor.
As one of DPharm’s R&D innovation leadership keynotes, Dr Andrew Plump, Chief Medical and Scientific Officer, Takeda, will discuss the development of KPIs that support innovation for patient engagement. Joining Dr Plump will be Dr Jessica Scott, Takeda’s Head of R&D Patient Engagement. Delivering a cornerstone presentation on disruptive restoration on internal clinical operations will be Merck’s Dr Mark Travers, VP, Head of GCTO Regions, Monitoring Excellence, Global Operations. Finally, Dr Ülo Palm, SVP, Head, Global Drug Development Operations, Allergan, asks what’s going to revolutionize medical research in a keynote on the implications for Pharma R&D.
Guest keynotes, David Lidsky, Deputy Editor, Fast Company, is joined by Dr Shwen Gwee, Co- Founder, Novartis Biome, and General Manager, Head of Open Innovation, Novartis, in a discussion on Fast Company magazine’s annual innovation report ranking the world’s 50 most innovative companies. Kerry Hicks, the founder of Healthgrades, leads a fireside keynote discussion on transparency and the future of patient expectations with Craig Lipset, Former Head of Clinical Innovation, Pfizer. Providing an out-of-industry perspective on customer engagement, Starbucks’ Robert Mercer, Design Director, Global Digital Products, is joined by Eli Lilly’s Joseph Kim, Senior Advisor, Clinical Operations and Digital Registry, Digital Health Office, Translational Technology & Innovation.
In the first of three Zeitgeist talks, Milind Kamkolkar, Chief Data Officer, Cellarity, joins DPharm to discuss big data and AI for drug development. Arguably, the most credible voice on operationalizing EHR e-source, Meredith Zozus, PhD, Associate Professor and Vice Chair for Academic Programs, University of Arkansas for Medical Sciences’ College of Medicine will speak to this and in particular separating the hype from reality. Dr Zozus is joined in a discussion with Michele Cherry, Senior Manager, Client Partner at Pfizer. In a talk on hacking and why it’s important for your clinical trials, Janine Medina, Executive Director, Biohacking Village, covers a subject not typically associated with clinical trial innovation. Joining her in conversation will be Andy Coravos, former entrepreneur-in-residence at the FDA.
“What makes DPharm an extraordinary event is the leadership from all levels of the industry coming together to share their innovation insights with the goal of modernizing 21st-century drug development,” said Valerie Bowling, Executive Director, the Conference Forum.
DPharm Idol 2018 Judges, including Esther Dyson, investor of 23andMe (pictured with mic)
Legendary investor Esther Dyson, Executive Founder, Way to Wellville and Board Member, 23andMe, will be returning as a judge on DPharm Idol, the event’s annual live show featuring a select group of innovators, who present what they believe is a disruptive service or technology that could change clinical trials. DPharm Idol judges include:
– Sandra Freeman, Associate Director, Global Clinical Operations, Johnson and Johnson
– Cindy Geoghegan, Cancer Veteran and Patient Advocate
– Hassan Kadhim, Director, Head of Clinical Trial Business Capabilities, BMS
– Ülo Palm, MD, PhD, SVP, Head, Global Drug Development Operations, Allergan
– Chandra Ramanathan, PhD, MBA, Head, East Coast Innovation Center, Bayer, US
– Jessica Scott, MD, JD, Head of R&D Patient Engagement, Takeda
– John Varaklis, Head of Global Clinical Operations, Roche Pharmaceutical Research and Early Development (pRED)
With more than 20 pharma companies reporting on specific innovations they have implemented to better deliver new medicines, DPharm 2019 covers the full spectrum of clinical research. This includes virtual trials, digital applications, real-world data, big data management, AI applications, MAPs, EHR eSource operations, patient-centric strategies, new business models, collaborations, technologies and more.
-
May 6, 2019
-
Announcement: Successful Completion of Transparency Life Sciences’ VISITOR Study
We are pleased to announce the successful completion of the Transparency Life Sciences’ VISITOR (VIrtual, SIteless, Technology Open Research) study designed to assess the feasibility and ease of collecting clinical data directly from subjects in their homes using the Transparency Virtual Trials™ digital study hub. VISITOR was launched at the 2018 DPharm: Disruptive Innovations to Advance Clinical […]
We are pleased to announce the successful completion of the Transparency Life Sciences’ VISITOR (VIrtual, SIteless, Technology Open Research) study designed to assess the feasibility and ease of collecting clinical data directly from subjects in their homes using the Transparency Virtual Trials™ digital study hub. VISITOR was launched at the 2018 DPharm: Disruptive Innovations to Advance Clinical Trials and at the pre-conference day, Mobile in Clinical Trials where a number of attendees participated in the study.
Top-line results show that participants were quickly able to adapt to using telemedicine devices to capture data commonly collected in clinical trials. Compliance in completing the virtual study visits was very high and participants reported high levels of satisfaction with the study experience. The study also demonstrated excellent levels of data integrity and accuracy. You can read more about the top-line results here.
We look forward to sharing the full results of the study in the future.
-
April 26, 2019
-
A Tribute to Charity Tillemann-Dick, Opera Singer, Double Lung Transplant Recipient, Author, and Patient and Organ Donating Advocate
Charity Tillemann-Dick, patient and organ donating advocate, died earlier this week. Charity sang a beautiful opera aria at the DPharm conference and was the keynote speaker in September 2015. We are deeply grateful and honored to have worked with Charity whose incredible journey as a professional opera singer included receiving two double lung transplants. At […]
Charity Tillemann-Dick Performing
Charity Tillemann-Dick, patient and organ donating advocate, died earlier this week. Charity sang a beautiful opera aria at the DPharm conference and was the keynote speaker in September 2015. We are deeply grateful and honored to have worked with Charity whose incredible journey as a professional opera singer included receiving two double lung transplants.
At age 20, Charity was diagnosed with idiopathic pulmonary hypertension, a rare disease that caused extreme pressure on her heart. Despite her enormous health challenges, Charity had a renowned career, performing as a soprano at theaters around the world. She wrote The Encore, her memoir in three acts, which was published in 2017. To know Charity was such a treat. She had enormous talent, generosity, charisma and love for life. We will miss her greatly.
“Life is full of death. Music, full of sorrow. Great artists have always amplified both.”
– Charity “Sunshine” Tillemann-
Dick , The Encore
Valerie Bowling congratulating Charity Tillemann-Dick on publishing her amazing memoir, The Encore
-
April 18, 2019
-
Modernizing Clinical Trials with IQVIA’s Dr Cynthia Verst
Host: Valerie Bowling, Executive Director, Pharma Talk Radio and DPharm: Disrupting Clinical Trials Guest: Dr Cynthia Verst, President, Design and Delivery Innovation for the Research & Development Solutions organization at IQVIA [addtoany]
Host: Valerie Bowling, Executive Director, Pharma Talk Radio and DPharm: Disrupting Clinical Trials
Guest: Dr Cynthia Verst, President, Design and Delivery Innovation for the Research & Development Solutions organization at IQVIA
[addtoany]
-
March 28, 2019
-
DPharm 2019 Kickoff Advisory Board Meeting
The first advisory board meeting for the 9th annual DPharm: Disruptive Innovations in Clinical Trials conference took place March 7, 2019 in New York City with the following advisors in attendance: Karin Beckstrom, Sr. Director, Innovation Lab, ERT Chris Economos, VP, Business Development, PhysIQ Laura Galuchie, TransCelerate Program Lead, Merck Cindy Geoghegan, Patient Advocate Nikhil […]
The first advisory board meeting for the 9th annual DPharm: Disruptive Innovations in Clinical Trials conference took place March 7, 2019 in New York City with the following advisors in attendance:
- Karin Beckstrom, Sr. Director, Innovation Lab, ERT
- Chris Economos, VP, Business Development, PhysIQ
- Laura Galuchie, TransCelerate Program Lead, Merck
- Cindy Geoghegan, Patient Advocate
- Nikhil Kavimandan, Director of Innovation & Strategy, Global Development Operations, Novartis
- Joe Kim, Sr. Advisor, Patient Experience and Design Innovation, Eli Lilly
- Keith Koharski, Sr. Director, Analytics, Digital Solutions and Innovation, Global Clinical R&D, Celgene
- Craig Lipset, Head of Clinical Innovation, Pfizer
- Jules Mitchel, President, Target Health
- Robin Roberts, Co-Founder Novartis Biome, Head of Strategy & Innovation, Novartis
- Dan Rothman, Chief Information Officer, Roivant Sciences
- Jessica Scott, Head of R&D Patient Engagement Office, Takeda Pharmaceuticals
- Ian Shafer, Partner, R&D Strategy, PWC
Valerie Bowling, Executive Director of DPharm welcomed the group as they kicked off the meeting by reviewing the 2018 event and the group discussed where the industry is heading for 2019. Most of the conversation centered around the direct mission of DPharm – shaking up the way we do clinical trials to modernize drug development by making trials more accessible to patients, less burdensome to patients and investigators, less risky with fewer failures, and what new strategies are being implemented to lessen the burden to patients in clinical research?
Many questions were raised regarding specific elements of clinical development operations that really could benefit from disruption, including investigator training, study startup, data governance, and adoption of EMR/EHR technology. How does pharma begin to overcome these challenges and address a new and more efficient standard for operational practices?
AI is a hot button topic that continues to grow and evolve with the clinical trial ecosystem. Ideas of a trial simulator to predict outcomes, automated digital workers, and blockchain/AI optimized data capture were all mentioned as the future of the clinical trial experience.
The patient experience of trials remains a central topic of discussion. How can we leverage patients supporting other patients throughout their unique journey of clinical research? How are location flexible trials changing the landscape of the patient experience? Are we correctly harnessing the potential of mobile apps to enhance the patient experience? How are other industries creating new and personalized solutions that enhance users’ experience without sacrificing quality and improving reliability?
These questions are the driving forces and starting points for the DPharm planning process. The DPharm team continues to look internally to pharma and externally to other industries for examples of disruptions that can be applied throughout clinical development. We look forward to reporting from additional advisory meetings. If you would like to submit a topic idea, please do so at service@tcfllc.org. DPharm 2019 will take place September 17-18 at the Renaissance Boston Waterfront Hotel in Boston, MA.
-
September 26, 2018
-
Medable Wins DPharm Idol 2018
Medable was named the winner of DPharm Idol at this year’s DPharm: Disruptive Innovations to Advance Clinical Trials conference. Medable is a platform that aims to build the first human digitome, a digital representation of human health and disease, by removing the separation between clinical trial and real-world data through a seamless integration of all […]
Medable was named the winner of DPharm Idol at this year’s DPharm: Disruptive Innovations to Advance Clinical Trials conference. Medable is a platform that aims to build the first human digitome, a digital representation of human health and disease, by removing the separation between clinical trial and real-world data through a seamless integration of all data sources. Dr. Michelle Longmire, Co-Founder and CEO of Medable, explained that their approach aims to transform clinical trials by building a connected team of researchers and patients by providing rich digital experiences on their mobile app for the patient. Through the digitome, they hope to transform the idea of health from a binary perspective to one that is complex and includes actionable, real-world insights.Medable had six minutes to present their goals in disrupting the current paradigm of clinical trials and pitch their product to DPharm’s esteemed panel of judges, which consisted of:
Esther Dyson
Executive Founder, Way to WellvilleSandra Freeman
Associate Director, Global Clinical Operations, Johnson and JohnsonCindy Geoghegan
Patient AdvocateRob Goodwin
VP, Operations Center of Excellence, Global Product Development, PfizerChristian Gossens, PhD, MBA
Global Head Early Development Workflows, pRED, Informatics, Roche Pharmaceutical Research and Early Development (pRED)Hassan Kadhim, MSc
Senior Associate Director, Head, IT Clinical Trial Planning & Management, Boehringer Ingelheim Pharmaceuticals, IncJoseph Kim, MBA
Sr Advisor, Patient Experience and Design Innovation Design Hub Foundations, Eli Lilly and CompanyJacob LaPorte, PhD
Head of Digital Development, NovartisChandra Ramanathan, PhD, MBA
Head, East Coast Innovation Center, Bayer, USDan Rothman
Chief Information Officer, Roivant SciencesJohn Varaklis
Head of Global Clinical Operations, Roche Pharmaceutical Research and Early Development (pRED)The judges liked Medable’s idea of a human digitome providing a new possibility to explore data that did not exist before, by creating an ecosystem of the patient’s data both in clinical trials and in the real world. Several of the judges made comments about the potential of the digitome to transform healthcare, with Hassan Kadhim explaining that the technology is “very much futuristic and we’d love to see it implemented.”
The panel of judges deliberated for two hours to determine the winner. The judging process was not easy, as Esther Dyson commented, “I gave a five to everyone on the list, in the terms that they were all solving a lot of problems we have within clinical trials.” Although they were triumphant, Medable had strong competition from our other DPharm Idol presenters:
Edetek
Peter Smilansky, SVP of Product Strategy
Quest Diagnostics
David Freeman, MBA, General Manager, Information Ventures
WCG
Steven Beales, SVP IT and Market Owner, Safety Solutions
Clinical Pipe
Amit Shah, Founder and Chief Technology Officer
BioSensics
Joseph Gwin, PhD, VP of R&D
DPharm Idol is the signature event that took place at the 8th annual iteration of DPharm: Disruptive Innovations to Advance Clinical Trials. DPharm, organized by the Conference Forum, reports on industry and out of industry innovation and how to change the paradigm of clinical trials to reduce the burden to patients and investigators, streamline processes and ultimately get therapeutics to patients faster. DPharm connects pharma, biotech, clinical research partners, as well as patient advocacy to inspire and encourage the most innovative technologies and ideas in clinical trials and drug development. Mark your calendars for next year’s event, which will be held September 17-18, 2019 in Boston.
-
September 4, 2018
-
All of Us Research Program, a Nation-wide Initiative from the NIH
Podcast guest, Elise Felicione, who is currently a Scientific Collaborator at the Scripps Translational Science Institute, is playing an integral role under the direction of Dr Eric Topol on a nation-wide initiative from the NIH. The initiative is called All Of Us, a US Precision Medicine program that aims to enroll a million Americans and follow them for 10 […]
Podcast guest, Elise Felicione, who is currently a Scientific Collaborator at the Scripps Translational Science Institute, is playing an integral role under the direction of Dr Eric Topol on a nation-wide initiative from the NIH. The initiative is called All Of Us, a US Precision Medicine program that aims to enroll a million Americans and follow them for 10 years, during which time participants will contribute biological, environmental, and lifestyle data. One-third of participants will participate virtually (not via a research site). The cohort will mirror the projected 2040 census. Individual pharma companies are never going to create cohorts like this, so the importance of this open source frame work that drug developers can tap into will be highly beneficial in serving the patient of the future.
Discussion points include:
- What is the All Of Us Research Program?
- Why does this matter to biopharmaceutical companies?
- How far along is the program and how to get involved?
- What are your biggest challenges?
- How can biopharmaceutical companies get involved?
For more information on the All Of Us program, visit: https://allofus.nih.gov/
Elise will be speaking at DPharm on September 26th and will also have an exhibit booth to answer any questions are All of Us. For information on DPharm taking place September 25-26, 2018 in Boston. For information, please visit, www.theconferenceforum.org
Producer: Valerie Bowling, Executive Director, Pharma Talk Radio and DPharm
-
August 27, 2018
-
Reimagining Clinical Trials with Entrepreneur, Dr Ben Liu, CEO, Trialspark
During his graduate work, Dr Benjamine Liu observed the many bottlenecks that get in the way of clinical trials slowing the development of new treatments for patients. This challenge inspired him to launch Trialspark. Trialspark partners with doctors to create FDA compliant trial sites within their existing practices (like Airbnb), unlocking the 98% of patients and doctors not involved […]
During his graduate work, Dr Benjamine Liu observed the many bottlenecks that get in the way of clinical trials slowing the development of new treatments for patients. This challenge inspired him to launch Trialspark.
Trialspark partners with doctors to create FDA compliant trial sites within their existing practices (like Airbnb), unlocking the 98% of patients and doctors not involved in trials today and democratizing access to research treatments. In this podcast discussion with Ben, we discuss how to reimagine clinical trials, entrepreneurism, the rise of Trialspark and reducing the barriers for patients and investigators.
Ben will be speaking at DPharm on September 26th in Boston with Dr Ulo Palm, SVP Global Drug Development Operations, Allergan on a case study to scale more efficient clinical trials.
-
August 17, 2018
-
Blockchain Opportunities for Patient Data Donation and Clinical Research
Patients are at the center of research and their data is the foundation for clinical innovation. However, significant barriers exist that inhibit the secure and efficient sharing of patient data. In this podcast, Craig Lipset, Head of Clinical Innovation, Pfizer, Munther Baara, Head of New Clinical Paradigm, Pfizer and Aditya Kudumala, Principal, Deloitte discuss blockchain as a catalyst to significantly change how […]
Patients are at the center of research and their data is the foundation for clinical innovation. However, significant barriers exist that inhibit the secure and efficient sharing of patient data. In this podcast, Craig Lipset, Head of Clinical Innovation, Pfizer, Munther Baara, Head of New Clinical Paradigm, Pfizer and Aditya Kudumala, Principal, Deloitte discuss blockchain as a catalyst to significantly change how we can access and use data to improve patient lives. Where is the patient data storm going?
Discussion points include, but not limited to:
- Who owns my data and where it’s going?
- What are the interoperability challenges and progress?
- How can data be shared?
- How you can pull in your own health data?
- Where does blockchain fit in and how can it secure patient data?
- How blockchain gives us authentication without identification?
- Next steps?
For more information on this topic and to get access to the Blockchain Opportunities for Patient Data Donation & Cinical Research, click here.
Craig will be leading an entire section on the democratization of patient data at DPharm on September 25-26 in Boston.
-
August 16, 2018
-
DPharm: Disruptive Innovations to Advance Clinical Trials 8 1/2 Minute Podcast
This 8 1/2 minute podcast gives you an overview on what to expect from the 8th annual DPharm conference. DPharm is the annual event in the US to get the best access to innovative ideas, especially disruptive ones, to advance clinical trials with a view to reducing the burden to patients and investigators. DPharm 2018 is dedicated […]
This 8 1/2 minute podcast gives you an overview on what to expect from the 8th annual DPharm conference. DPharm is the annual event in the US to get the best access to innovative ideas, especially disruptive ones, to advance clinical trials with a view to reducing the burden to patients and investigators.
DPharm 2018 is dedicated to all things digital, data science, patient data ownership and new approaches to optimize clinical operation systems.
DPharm is September 25-26 at the Boston Marriott Copley Place.
Chaired by:
Sylke Poehling, PhD, SVP and Global Head, Strategy, Portfolio & Clinical Operations, Pharma Research & Early Development, Roche
Andreas Koester, MD, PhD, VP and Global Head, Janssen Clinical Innovation, Janssen
Craig Lipset, MBA, Head of Clinical Innovation, Pfizer
Producer: Valerie Bowling, Executive Director, DPharm
-
July 1, 2018
-
Announcing DPharm 2018 Dates and Keynotes
The Conference Forum has announced that the 8th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference will take place on September 25-26, 2018 at the Boston Marriott Copley Place in Boston, MA, with a full day dedicated to Mobile in Clinical Trials on September 24. “DPharm 2018 is the year of all things digital, […]
The Conference Forum has announced that the 8th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference will take place on September 25-26, 2018 at the Boston Marriott Copley Place in Boston, MA, with a full day dedicated to Mobile in Clinical Trials on September 24.
“DPharm 2018 is the year of all things digital, patient data ownership and new approaches to optimize clinical operation systems,” said Valerie Bowling, Executive Director, the Conference Forum.
2018 keynotes include Indrek Onnik of the E-Estonia Showroom, a partner of the Estonian Government. Indrek will tell the DPharm audience why and how Estonia became the first and fastest digital republic where patients own their own data, and about their modern view of clinical trials.
Amazon Web Services’ Mark Johnston, who heads up the Health Care and Life Sciences division, will provide a keynote on how Amazon develops a culture of innovation. Also keynoting is one of the most prominent leaders in the Regenerative Medicine space, Dr Anthony Atala, Director, Wake Forest Institute for Regenerative Medicine. Anthony will give an unbelievable insight in how regenerative medicine, for example 3D printing of organs, will impact clinical trials.
The DPharm patient keynote for 2018 is America’s Got Talent Teen Cancer Survivor and Patient Advocate, Caly Bevier.
Back by popular demand, keynote speaker Dr Chip Bell, the country’s preeminent author and speaker on customer service, will entertain the DPharm audience with his unusual style of teaching the “how” in creating a culture of service in drug development.
Legendary investor Esther Dyson, Executive Founder, Way to Wellville and Board Member, 23andMe, is confirmed to judge DPharm Idol. This annual live show features a select group of innovators, who present what they believe is a disruptive service or technology that could be a changing force for clinical trials.
VIP Clinical Operation Heads new to DPharm include John Varaklis, Head of Global Clinical Operations, Roche (pRED) and Rob Goodwin, VP, Operations Center of Excellence, Global Product Development, Pfizer.
For the first time, Dr Sylke Poehling, SVP and Global Head, Strategy, Portfolio & Clinical Operations, Pharma Research & Early Development, Roche joins veteran co-chairs Dr Andreas Koester, VP, Innovation, R&D Operations, Janssen and Craig Lipset, Head of Clinical Innovation, Pfizer to shake up the thinking on traditional routines in clinical operations to reduce the burden on patients, investigators and sites.
DPharm 2018 is divided into the following sections: keynotes, strategic level talks, pharma innovation reporting, new and advanced technologies, patient data access and ownership, digital biomarkers, digital/virtual trials, AI/machine learning, clinical research as a care option (CRAACO), and service as a disruptor in R&D.
Reserve your spot now. Never stop innovating!
-
June 6, 2018
-
DPharm Podcast Series: Reducing the Burden of Type 1 Diabetes with Patient, Dana Lewis
In this podcast, patient advocate star Dana Lewis, founder of OpenAPS, delivers a powerful session at DPharm on an idea to reduce the burden of type 1 diabetes with a smart system she created through open source. Learn how she drove the idea and creation of the “Self driving car for diabetes”. DPharm 2018 will be taking place September 25-26, 2018 […]
In this podcast, patient advocate star Dana Lewis, founder of OpenAPS, delivers a powerful session at DPharm on an idea to reduce the burden of type 1 diabetes with a smart system she created through open source. Learn how she drove the idea and creation of the “Self driving car for diabetes”.
DPharm 2018 will be taking place September 25-26, 2018 at the Boston Marriott Copley Place. Reserve your spot now. Never stop innovating!
Listen to the podcast here.
-
May 18, 2018
-
DPharm Podcast Series: Blockchain to Speed up Drug Development
We are happy to share one of the best rated sessions at DPharm 2017 on blockchain’s role in drug development. Presented by Sascha Mundstein, Mobile and Digital COE, Technology Evangelist, Pfizer, Inc. he addresses how blockchain can potentially change the business model of clinical development. Pfizer’s pioneering of a prototype application on the chain has […]
We are happy to share one of the best rated sessions at DPharm 2017 on blockchain’s role in drug development. Presented by Sascha Mundstein, Mobile and Digital COE, Technology Evangelist, Pfizer, Inc. he addresses how blockchain can potentially change the business model of clinical development. Pfizer’s pioneering of a prototype application on the chain has made them one of the leading companies in blockchain technology. Listen to this podcast to Sascha’s discussion on:
- The basics on how blockchain works and what the key advantages are
- Key benefits to empowering patients with control over their data
- The compliance implications of unalterable historic audit trails
- How in-house proof of concept development fosters innovation and new technology adoption
- The implications of rich and abundant patient data
DPharm 2018 will be featuring a member of the Estonian government on how most of the country has gone digital and with the use of blockchain keeps data private, secure and with the patient. Join us at the next DPharm conference, September 25-26 in Boston, to hear more about this and other ways disruptive innovations can advance clinical trials. Register now to take advantage of pre-early bird prices. Never stop innovating!
-
March 9, 2018
-
Patient Perspectives: Deciding on Participating in a Clinical Trial
By Marie Recine, Patient Advocate, Medical Writer and Speaker at the Patients as Partners Conference To me, clinical trials are an important treatment option at all stages of a disease. The benefits are numerous. Patients who enroll in clinical trials receive close monitoring and have the opportunity to be among the first to receive the […]
By Marie Recine, Patient Advocate, Medical Writer and Speaker at the Patients as Partners Conference
To me, clinical trials are an important treatment option at all stages of a disease. The benefits are numerous. Patients who enroll in clinical trials receive close monitoring and have the opportunity to be among the first to receive the newest drugs or drug combinations in development and to advance clinical research.
Unfortunately, many patients are not informed of clinical trials as an option, or they may only hear about clinical trials after all other options have been exhausted. Another important barrier to clinical trial participation is patient misconception about clinical trials in general.
Even when patients are aware of clinical trials, whether or not to participate is not an easy decision to make. Shared decision-making between patients and their physicians is critical. With shared decision-making, both parties work together to balance a physician’s experience and expertise with a patient’s preferences and values.
In my experience, some of the top considerations raised by patients when deciding on participating in a study include:
- The potential risks involved with the investigational treatment/study
- The benefits and risks of the other standard treatment options available to them
- The time commitment—not only the number of study visits, but whether their time will be utilized wisely at each visit
- Whether the study has a placebo or active control, and if a placebo control, what proportion of patients will be in the placebo arm (a friend declined to participate in a placebo-controlled trial for a new multiple sclerosis drug because she felt she could not risk the chance of being off medication for the duration of the study and experiencing a relapse)
- Whether there are results of any earlier studies of the treatment being investigated
- Whether participation in the study will limit their future treatment options
The Role of Advocacy Groups
Advocacy groups can play a key role in increasing the awareness of the need for clinical trial participation among healthcare professionals and encourage their consideration of clinical trials as a treatment option for their patients. They can also help support patients while deciding whether or not to participate in a clinical trial. As knowledge is a key component of patient-clinician decision-making, providing information to help facilitate these decisions is vital.
Below are suggestions for providing information, which can be both general to clinical trials, as well as more tailored to a specific condition.
- Start with the basics
Provide easy-to-understand information on the nuts and bolts of clinical trials, which can help dispel any myths or misconceptions patients may have about clinical trial participation.
- Provide suggested questions patients might ask to help their decision-making
These may include some basic questions to ascertain patient goals and expectations, but should focus on questions about the study design and goals, the possible risks and benefits, participation commitments and care received, and cost and logistics issues.
- Provide a decision aid
When patients are provided decision aids to help them make treatment choices, they are more knowledgeable and satisfied with their care. Decision aids can be presented in many forms, including interactive tools, videos, and educational literature. With a clinical trial decision aid, patients can learn more about clinical trial participation, balancing the potential benefits and risks, and helping them prepare for conversations with their doctor.
- Share patient stories
Presenting patient stories helps to put a human face on clinical trial participation. As patients often request to speak to others who have participated in a trial, having access to speak to other patients in the study or patient volunteers who have such experience is always welcomed.
Ms Recine is speaking at the Patients as Partners conference on March 15-16, 2018 at the Rittenhouse in Philadelphia. For more information, visit www.theconferenceforum.org.
[addtoany]
-
January 5, 2018
-
Turning Ideas from DPharm into Action with a Virtual Book Lovingly Created by gapingvoid
In collaboration with gapingvoid, here is a book filled with insights on how to take the concepts from the DPharm 2017 conference into actionable ideas. We hope to see you at the 2018 event! Link to book: Creating the Future [addtoany]
In collaboration with gapingvoid, here is a book filled with insights on how to take the concepts from the DPharm 2017 conference into actionable ideas. We hope to see you at the 2018 event! Link to book: Creating the Future
[addtoany]
-
December 13, 2017
-
Graphic Recording of Ideas to Share @DPharm
DPharm 2017 was delighted to welcome graphic recording artist, Jonny Goldstein. Jonny captured the ideas and information expressed throughout the conference combining deep listening with real-time visualization. Here’s the collection of ideas he captured: https://theconferenceforum.org/conferences/disruptive-innovations-us/graphic-illustrations-of-dpharm-2017/ [addtoany]
DPharm 2017 was delighted to welcome graphic recording artist, Jonny Goldstein. Jonny captured the ideas and information expressed throughout the conference combining deep listening with real-time visualization. Here’s the collection of ideas he captured:
[addtoany]
-
December 8, 2017
-
Congratulations to Cancer 101’s Sarah Krug on 15 Years!
Congratulations to Cancer 101’s CEO Sarah Krug on the 15th anniversary of the beloved non-profit. Cancer 101 was founded by Monica Knoll as the result of her own cancer journey, which came to an end in 2011, but her dream of helping so many others continue to shine through Sarah’s leadership. Cancer 101 provides tool kits […]
Sarah Krug presenting at Patients as Partners
Congratulations to Cancer 101’s CEO Sarah Krug on the 15th anniversary of the beloved non-profit. Cancer 101 was founded by Monica Knoll as the result of her own cancer journey, which came to an end in 2011, but her dream of helping so many others continue to shine through Sarah’s leadership. Cancer 101 provides tool kits to cancer patients from diagnosis to recovery, helping them be stronger advocates in their own care. They also provide helpful resources, information on clinical trials, questions to ask doctors, how to manage finances and so much more including:
Sarah is both a speaker and an advisor at the Conference Forum and we are so lucky to work with her on Patients as Partners and DPharm. Learn more about Cancer 101.
[addtoany]
-
November 16, 2017
-
Congratulations to our Friends at Otsuka and Proteus Digital
Congratulations to our friends at Otsuka and Proteus Digital Health on FDA Approval of the 1st Digital Medicine System. We have worked with both Otsuka and Proteus on past DPharm conferences and it has been exciting to watch the advancements of not only the technology, but also the collaboration between these two companies and to […]
Congratulations to our friends at Otsuka and Proteus Digital Health on FDA Approval of the 1st Digital Medicine System. We have worked with both Otsuka and Proteus on past DPharm conferences and it has been exciting to watch the advancements of not only the technology, but also the collaboration between these two companies and to see them cross the finish line to FDA approval. Their collective contribution to improving patient compliance helps raise the bar for the industry. For more information, please see the press release below.
Debbie Profit, Otsuka, speaking at DPharm Europe
Timothy Peters-Strickland, Otsuka, speaking at DPharm Europe
Lorenzo DiCarlo, VP, Clinical and Medical Affairs, Proteus, speaking at DPharm Europe
[addtoany]
-
October 9, 2017
-
Opera Singer and Double Lung Transplant Recipient Charity Tillemann-Dick Publishes The Encore
Congratulations to Charity Tillemann-Dick on her new memoir, The Encore. We recently had the opportunity to meet up with Charity at her NYC book signing, where we were also joined by DPharm patient keynote, Jessica Melore. Charity gave a deeply moving and memorable keynote at the 5th annual DPharm conference based on her experience as an opera singer, who […]
Congratulations to Charity Tillemann-Dick on her new memoir, The Encore. We recently had the opportunity to meet up with Charity at her NYC book signing, where we were also joined by DPharm patient keynote, Jessica Melore.
Charity Tillemann-Dick keynoting at the 5th Annual DPharm Conference
Charity gave a deeply moving and memorable keynote at the 5th annual DPharm conference based on her experience as an opera singer, who survived a debilitating and usually fatal lung disease by having two double-lung transplant operations at the Cleveland Clinic.
Valerie Bowling Congratulating Charity Tillemann-Dick on Publishing her Memoir, The Encore
Valerie Bowling, Jessica Melore and Charity Tillemnn-Dick Celebrating the Publishing of The Encore
Charity is one of 11 brothers and sisters and the granddaughter of Tom Lantos, the only Holocaust survivor to have served in the United States Congress. She was home schooled as a child and went on to study at the Franz Liszt Academy of Music in Budapest.
Charity’s memoir takes readers through her miraculous journey, which truly mirrors those of opera heroines, and includes her surgeries, her recovery and learning to sing with someone else’s lungs.
The Encore is published by Simon and Shuster and you can order it on Amazon here: https://www.amazon.com/dp/1501102311/ref=rdr_ext_tmb
[addtoany]
-
September 9, 2017
-
DPharm Day Two Recap, September 8, 2017
The 7th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference has reached its conclusion. Some of the highlights from day two of DPharm included: 1. PhysIQ Wins DPharm Idol 2017 PhysIQ was named this year’s DPharm Idol winner. The company offers a scalable cloud-based Personalized Physiology Analytics (PPA) platform that provides continuous vital sign […]
The 7th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference has reached its conclusion. Some of the highlights from day two of DPharm included:
1. PhysIQ Wins DPharm Idol 2017
PhysIQ was named this year’s DPharm Idol winner. The company offers a scalable cloud-based Personalized Physiology Analytics (PPA) platform that provides continuous vital sign and bio-signal data capture capabilities from clinical-grade wearable devices.
The PhysIQ PPA platform can be applied across multiple clinical use cases, hardware platforms and patient populations to generate personalized patient insights. As such, the platform may disrupt the clinical trials space for years to come.
“When it came to the winner of DPharm Idol, we really had a consensus opinion,” DPharm Idol judge Andreas Koester, said. “We are pretty confident, as in previous years, that this winner will show us in the years ahead that it is on a trajectory to change the way that clinical trials are run.”
2. Pfizer Technology Evangelist Discusses the Use of Blockchain Technology for Drug Development
Sascha Mundstein, PhD, MBA, Mobile and Digital COE, Technology Evangelist, Pfizer Inc., defined blockchain technology and its impact on drug development during his DPharm presentation.According to Mundstein, blockchain is more than just a block of chains that contain patient data. In fact, blockchain may help accelerate the drug development process and transform the business model of clinical development.
Blockchain for drug development offers many benefits, including:
– Improved Security: Blockchain is a cryptographic chain of data that delivers “an unbelievable amount of security,” Mundstein said.
– Enhanced Clinical Trials: Blockchain drives massive data sharing from millions of patients and non-patients, enabling healthcare professionals to perform queries to find the right people for any study, at any time.
– Increased Accountability: Blockchain provides outstanding data integrity and transparency to help increase accountability.
“With blockchain, everybody has access to their own data, everyone owns their own data and everything is distributed,” Mundstein said.
Blockchain also brings clarity to an expensive, inefficient and unsustainable healthcare system, Mundstein pointed out. By doing so, blockchain may drive meaningful healthcare system improvements.
3. “The Today Show” at DPharm
“The Today Show” at DPharm was hosted by Andreas Koester, MD, PhD, VP, Innovation, R&D Operations, Janssen and Bray Patrick-Lake, MFS, Director of Stakeholder Engagement at Duke Clinical Research Institute.
Koester and Patrick-Lake discussed several clinical research projects with the following guests:
– Esther Dyson, Executive Director, Way to Wellville: Dyson described Way to Wellville, a nonprofit organization that focuses on building community health initiatives. To date, Way to Wellville boasts five communities across the United States, and these communities focus on achieving long-term results. “Short-term desire is addiction, and long-term desire is purpose. We need to start thinking about the long-term,” Dyson stated.
– Sara Holoubek, MBA, CEO, Luminary Labs: Holoubek shared her thoughts on the Alexa Diabetes Challenge, which promotes the development of Alexa voice-enabled solutions to improve the lives of individuals with type 2 diabetes. Alexa voice-enabled solutions have been shown to reduce the friction in the lives of type 2 diabetes patients, Holoubek said. If healthcare professionals embrace Alexa voice-enabled solutions, these professionals may be able to drive unparalleled clinical trials innovation. “Voice involves using hardware plus machine learning to radically transform the interface of everything you touch,” Holoubek said. “Now, we need to rethink how everything is found through a conversational interface.”
– E.B. McLindon, Vice President, Healthcare Alliances, ICON: McLindon offered insights into what it takes to simplify patient research for both patients and sites. He pointed out that innovation reigns supreme in clinical trials. However, plenty of work lies ahead to ensure that healthcare professionals can consistently deliver an amazing patient experience. “There’s great innovation, but what I see right now is a lot of innovation on the fringe. At the heart of that is making sure that we’re getting to the patient. And we’re not there yet,” McLindon indicated.
There are many opportunities to drive clinical trials innovation, and healthcare professionals can work together to discover the best ways to deploy technology to innovate and improve clinical trial outcomes.
4. Antidote Leaders Explore the Next Generation of Clinical Trials Matching
Antidote CEO and founder Pablo Graiver and Entrepreneur-in-Residence Ed Godber discussed the evolution of clinical trial matching during an afternoon session at DPharm.
According to Graiver, the majority of medical research is delayed due to a lack of patient participation. Today, Antidote provides a clinical trials matching platform that makes it simple for health publishers and non-profit organizations to partner with patients. The Antidote platform is easy to embed within a website, Graiver said, and ensures clinical trial search capabilities are accessible to millions of individuals globally.
5. Lunch Session Focuses on Clinical Research as a Care (CRAACO) Option
DPharm attendees were treated to a lively lunchtime panel discussion of CRAACO that included insights from the following participants:
Moderator:
John McConnell, MD, CEO Emeritus, Wake Forest Baptist Medical Center/Executive Director & Chair, WF Healthcare Ventures
Panelists:
Jeremy Sohn, Vice President, Global Head of Digital Business Development, Novartis
Kenneth Mandl, MD, Professor of Biomedical Informatics and Pediatrics, Harvard Medical School, and Director of the Computational Health Informatics Program, Boston Children’s Hospital
Noah Craft, MD, PhD, Co-founder and CEO, Science 37
Clinical trial innovation is unlikely to happen overnight, Craft stated. Conversely, there have been substantial investments in clinical trial matching and other clinical trial technologies that could reshape CRAACO in the foreseeable future, Sohn indicated.
6. Clinical Trials Leaders Offer Practical Tips for Incorporating Mobile Technology Into Clinical Trials
Several clinical trial leaders provided practical recommendations to implement mobile technology into clinical trials during a panel discussion at DPharm. The discussion featured insights from the following clinical trials experts:
Moderator
Komanthi Stem, Founder, monARC BioNetworksPanelists
Ray Dorsey, MD, David M. Levy Professor of Neurology and Director of the CHET, University of RochesterCindy Geoghegan, Principal, Patient and Partners LLC
Gary Grabow, Esq., Assistant General Counsel, Genentech
Clinical trial research requires hard work and patience, according to Grabow. Fortunately, clinical trial leaders can measure their results to find the best ways to innovate and maximize the time and resources that are available, Geoghegan noted. Clinical trial leaders also must be ready to explore digital opportunities, Dorsey said, as this may lead to innovations in the treatment of Alzheimer’s disease and other complex diseases.
7. Eli Lilly Clinical Innovation Advisor Provides an Update on the Hero’s Journey Art Project
Kelly McKee, Advisor, Clinical Innovation, Eli Lilly & Company, provided details about the Hero’s Journey Art Project during an afternoon presentation at DPharm.
The Hero’s Journey is designed to honor clinical trial participants and raise awareness of clinical trials, McKee said. The first of three crowdsourced Hero’s Journey sculptures, “Departure,” recently was unveiled. Going forward, the Hero’s Journey will continue to celebrate clinical trials patients and highlight the value of clinical research, according to McKee.
8. Clinical Trials Leaders Evaluate the Importance of Digital Biomarkers
Joseph Kim, Senior Advisor, Clinical Innovation, Eli Lilly & Company, and Sohini Chowdhury, Deputy CEO, The Michael J. Fox Foundation, took a look at the importance of digital biomarkers in clinical trials during an afternoon session at DPharm.
Ultimately, technology provides many opportunities for continuous monitoring of diseases, Chowdhury stated. Digital biomarkers further drive clinical trials innovation by providing researchers with the ability to collect and measure a large assortment of patient data via mobile devices. Therefore, digital biomarkers may prove to be a future driver of health data.
9. IBM Innovators Examine Cognitive Computing in Clinical Trials
Jeff Beeler, Solutions Executive for IBM Watson Health, and Kimberly Kenna, Development Architect for Watson for Clinical Trial Matching at IBM, discussed cognitive computing and its impact on big data in clinical trials in an afternoon session at DPharm.
In a cognitive system, everything is based on data, Kenna said. The system enables business users to train a machine to learn and understand a domain, Kenna stated, and bring augmented intelligence to small and medium-sized enterprises (SMEs) so that they can do their jobs more effectively.
IBM for Clinical Trial Matching cognitive computing technology recently provided a 78 percent reduction in the time for researchers to screen patients for clinical trials. It may prove to be the first of many cognitive computing innovations to transform the way that healthcare professionals collect and analyze a broad assortment of clinical trial data.
“People think about patient data, but there is a lot of other data to think about too,” Beeler said. “We want to digitize the entire data collection process so that we can start to look at data in a different way.”
10. DPharm Day Two Break Out Sessions and Tracks
There were a number of choices featuring everything from aligning incentives for data sharing, remote monitoring, digital therapeutics, flipping the clinic, to the next generation of AI, machine learning and the lessons learned from the microbiome.
11. Pfizer Senior Director Explores the Possibility of a Data Donation App for Clinical Trials
Is a data donation app a viable option for clinical trials? Munther Baara, Senior Director, Clinical Paradigm, Pfizer, explained why a data donation app is possible in the closing session of DPharm.
Today’s patients want access to their data, but healthcare professionals frequently struggle to provide full data transparency, Baara stated. Now, biosensors can be used to track patient data over an extended period of time via a mobile app.
Meanwhile, blockchain technology empowers healthcare professionals to secure all patient data, at all times. If healthcare professionals incorporate blockchain into a mobile app, they can maintain two-way communication with patients, collect patient data in real-time and improve clinical trial data quality.
“With blockchain technology, you can enable others to see only certain pieces of information,” Baara said. “Blockchain ensures you can control what you share.”
The eighth-annual DPharm conference will take place on September 25 and 26, 2018 in Boston – stay tuned for more details.
[addtoany]
-
September 8, 2017
-
PhysIQ Wins DPharm IDOL 2017
PhysIQ was named DPharm Idol 2017 winner today. PhysIQ is determined to enable pharma companies to leverage an entirely new dimension of data in their clinical trials. PhysIQ can provide real world physiological insight to validate the safety and efficacy of your therapeutic products. They are the only company to apply FDA 510k-cleared machine learning […]
PhysIQ was named DPharm Idol 2017 winner today. PhysIQ is determined to enable pharma companies to leverage an entirely new dimension of data in their clinical trials. PhysIQ can provide real world physiological insight to validate the safety and efficacy of your therapeutic products. They are the only company to apply FDA 510k-cleared machine learning analytics and a device-agnostic platform to harness continuous data for personalized physiological insight in clinical research. Chris Economos, the VP of Business Development presented on behalf of PhysIQ.
Chris Economos, MBA
VP, Business Development, PhysIQChris had only six minutes to pitch on how PhysIQ can contribute to disrupting the future of clinical trials. They had tough competition with other DPharm Idol presenters who included:
Outcome Health
Don Butler, SVP, Clinical Research SolutionsDeep6 AI
Wout Brusselaers, CEO and Co-foundereClinical Solutions
Sam Anwar, VP, EngineeringVitalTrax
Zikria Syed, CEOPrevail InfoWorks
Patrick Keenan, Chief StrategistThe DPharm Idol 2017 judges included:
Esther Dyson
Executive Founder, Way to WellvilleLaura Galuchie
TransCelerate Program Lead, MerckChristian Gossens, PhD, MBA
Global Head Early Development Workflows, pRED Informatics, Roche Pharmaceutical Research and Early Development (pRED)Hassan Kadhim
Business Consultant, IS BP R&DM, Boehringer IngelheimAndreas Koester, MD, PhD
VP, Innovation, R&D Operations, JanssenSarah Krüg
Executive Director, Cancer 101 and President, Society of Participatory MedicineJacob LaPorte, PhD
Head of Digital Development, NovartisÜlo Palm, MD, PhD
SVP, Drug Development Operations, AllerganChandra Ramanathan, PhD, MBA
Head, East Coast Innovation Center, Bayer, USJane Rhodes, PhD
Senior Director, New Initiatives, Biogen IdecDan Rothman
Chief Information Officer, Roivant SciencesAlicia Staley
Patient AdvocateDPharm: Disruptive Innovations to Advance Clinical Trials presented their 7th annual event. DPharm is the event that the life science industry can rely on for the latest thinking in clinical trials for 21st century drug development. DPharm is organized by the Conference Forum and the 8th annual event will be held September 25 and 26, 2018 so mark your calendars now for DPharm Idol 2018.
Read More>>
[addtoany]
-
September 7, 2017
-
DPharm Day One Recap, September 7, 2017
The 7th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference took place on September 7th in Boston. This year’s event featured a wide range of educational sessions and technology demonstrations to promote clinical trial innovation. DPharm day one highlights included: 1. Patient Advocate Jessica Melore kicked off DPharm with Inspirational Keynote Address Patient advocate […]
The 7th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference took place on September 7th in Boston. This year’s event featured a wide range of educational sessions and technology demonstrations to promote clinical trial innovation. DPharm day one highlights included:
1. Patient Advocate Jessica Melore kicked off DPharm with Inspirational Keynote Address
Patient advocate Jessica Melore described her experiences as a heart transplant patient in her keynote address to DPharm attendees. During her presentation, Melore shared her inspirational story, along with a universal message about the power and strength of the human spirit.At 16 years old, Melore suffered a massive heart attack. Although most doctors did not expect her to survive, Melore persevered.
“No matter how angry or frustrated I was, I couldn’t change my past. But I could make the most of the present,” she stated.
Melore received an experimental heart transplant that proved to be the difference between life and death. She realized that her life would never be the same after the transplant surgery. However, Melore continues to persevere through a variety of life challenges, including a leg amputation and three cancer diagnoses.
Ultimately, Melore said she believes healthcare professionals must provide an outstanding patient experience in clinical trials. If healthcare professionals consider patients’ needs, they can inspire patients, leading to improved patient outcomes.
“When patients know that you care about them and have their best interests in mind, it makes all the difference in the world,” Melore noted. “Having access to quality-of-life programs can make a huge difference, and quality of life is just as important as saving lives.”
2. R&D Executives Examine Innovation Priorities and What It Takes to Disrupt the Clinical Trials Space
Several R&D executives explored the innovation they are prioritizing and what they aim to disrupt in detail during a quick fire session at DPharm.
Valerie Bowling, Executive Director, DPharm moderated the session with the following R&D executives:
– Rob Dicicco, PharmD, Vice President, Clinical Innovation and Digital Platforms, GSK
– Hassan Kadhim, Business Consultant, IS BP R&DM, Boehringer Ingelheim
– Ülo Palm, MD, PhD, Senior Vice President, Drug Development Operations, Allergan
– Dan Rothman, Chief Information Officer, Roivant Sciences
– Michelle Shogren, Portfolio and Operations Innovation Manager, Global Clinical Development, Bayer
– Jennifer Wulff, MBA, Director, Clinical Innovation, Pfizer
R&D executives want clinical trials to move quickly and constantly search for ways to improve the patient experience, Dicicco stated. To accomplish these goals, Dicicco recommended R&D executives reimagine the clinical trials design process.
Comparatively, Palm indicated innovation must be incorporated into a business’ day-to-day strategy. With this approach, R&D executives can determine how they want to innovate and plan accordingly, Palm stated.
The Roivant team, conversely, emphasizes technology assessment, deployment and transformation to innovate, Rothman said. By doing so, Roivant can foster internal and external technology innovation to disrupt the drug development process.
3. Clinical Trials Leaders Explore How to Make Innovation a Reality
Several clinical trials leaders explored what it means to “bootstrap” innovation – as well as the opportunities and challenges associated with innovation – during a DPharm session.
The following clinical trials leaders participated in the session also moderated by Bowling:
– Barry Crist, Lead Investigator, Lilly Clinical Open Innovation Team, Eli Lilly & Company
– Munther Baara, Senior Director, Clinical Paradigm, Pfizer
– Michelle Shogren, Portfolio and Operations Innovation Manager, Global Clinical Development, Bayer
According to Crist, “hardcore design thinking” plays an important role in innovation. Moreover, Shogren noted Bayer understands that innovation offers no guarantees and tailors its innovation strategy to minimize risk.
“Spending millions to drive innovation is a big risk because you don’t know if an innovation is going to succeed,” she said. “We build in kill clauses, partner with vendors and set up contracts in a way that makes it easy to make adjustments and control this risk.”
On the other hand, Baara stated Pfizer evaluates both internal and external innovation opportunities. Pfizer also engages patients in ongoing conversations as part of its commitment to innovation.
4. PCORnet’s Adrian Hernandez Outlines the ADAPTABLE Study
Adrian Hernandez, MD, Co-Principal Investigator, PCORnet, explained the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) study – and how patients were engaged throughout the study – during his DPharm presentation.
ADAPTABLE served as a three-year clinical trial to compare the effectiveness of daily doses of aspirin. Additionally, the study highlighted the benefits of evidence generation in clinical trials, Hernandez said.With ADAPTABLE, researchers engaged patients in all aspects of the study to quickly transform real world data into real world evidence, Hernandez indicated. As such, the ADAPTABLE model showcased the true value of patient engagement and could have far-flung effects on clinical trials in the years to come.
“The ADAPTABLE model wasn’t just a one-time model. It was designed to adapt to different things as we move along,” Hernandez stated.
5. DPharm Introduced a Myth Buster Session
Suzanne Caruso, VP, Clinical Solutions, WIRB-Copernicus Group, Laura Galuchie, TransCelerate Program Lead, Merck and Stephanie Petrone, Navigate Clinical Consulting, Novartis, challenged the myth of new technology can eliminate non-enrolling sites in clinical trials.
6. Patient Disruptors Discuss the Clinical Trials Research Landscape
Part two of DPharm day one included breakout sessions that highlighted two key clinical trial research disruptions:
– Open Artificial Pancreas System (OpenAPS) Project: Dana Lewis, creator, Do-It-Yourself Pancreas System, and founder, OpenAPS, indicated the OpenAPS project makes APS technology widely available to type 1 diabetes patients. The project empowers individuals and medical device manufacturers alike to innovate, Lewis said, and makes APS technology available to thousands of people who are willing to participate in clinical trials.
– Spontaneous Coronary Artery Dissection (SCAD) Research Program: Sharonne Hayes, MD, Principal Investigator, Mayo Clinic SCAD Research Program, Mayo Clinic, offered insights into the power of patient-initiated research and crowdsourced science. She stated SCAD is a complex disease, and thanks to crowdsourcing, Mayo Clinic engaged many patients from around the globe to perform extensive SCAD research.
Both presenters showed clinical trial innovation can come from any location, at any time. They also illustrated the true value of global collaboration to disrupt the clinical trials research landscape. This section of the program was also joined by John-Peter Bradford, PhD, who shared a personal story of loss due to cancer and his motivation to change the way the healthcare system looks at protocols in research for lethal diseases.
7. Track Choices
The annual “Where are They Now” and “Innovative Sources and Solutions” tracks were moderated by Dr Ülo Palm, Allergan and Dr Jane Rhodes, Biogen and packed with quick fire presentations with companies offering an innovative solution to a variety of pressing problems faced by clinical trialists.
8. Clinical Trials Companies Make Their Case to Become This Year’s DPharm Idol
DPharm day one concluded with DPharm Idol, a competition that enables participating companies to showcase their disruptive clinical trial services or technologies to a panel of clinical trial experts.
The following companies are competing for the title of 2017 DPharm Idol:
– Outcome Health: Provides a health intelligence platform for healthcare providers, medical associations, private physician practices and life sciences companies.
– Deep6 AI: Applies artificial intelligence to medical records to help healthcare professionals find patients for clinical trials faster than ever before.
– eClinical Solutions: Provides the elluminate data intelligence platform for clinical data analytics, clinical trial operations analytics and risk-based monitoring.
– VitalTrax: Offers a clinical trial recruitment solution designed to engage caregivers, patients and physicians.
– Prevail InfoWorks: Delivers a single, role-based platform to help healthcare professionals improve their clinical trial timelines, budgets and quality.
– PhysIQ: Empowers healthcare professionals with personalized physiology analytics to provide real world patient insights.
This year’s DPharm Idol winner was announced on day two of the program, September 8th. See day two re-cap for details.
[addtoany]
-
August 30, 2017
-
DPharm Idol Presenting Companies Announced!
A select group of innovators will present a disruptive service or technology, which they believe could be a changing force in clinical trials, at DPharm Idol 2017 on September 7, 2017 at the 7th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference. This year’s presenting companies are: Outcome Health Deep6 AI eClinical Solutions VitalTrax […]
A select group of innovators will present a disruptive service or technology, which they believe could be a changing force in clinical trials, at DPharm Idol 2017 on September 7, 2017 at the 7th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference.
This year’s presenting companies are:
Ryan Jones (2nd left) and Jordan Tabley (3rd left) of Florence Healthcare, winner of the 2016 DPharm Idol, with DPharm Idol judges.
DPharm Idol 2016 winner Florence Healthcare will open this year’s event with an update on where they are a year later. Each innovator will then deliver a quick-fire presentation in DPharm Idol’s live-show format to a panel of judges from Allergan, Bayer US, Biogen Idec, Janssen, Merck, Novartis Pfizer and Way to Wellville. Detailed questions from our judges on each service or technology enable you to see what you should either be asking or communicating for your own trials.
Who will be the DPharm Idol 2017 winner? And what will be their disruptive innovation? Find out in September at DPharm 2017.
[addtoany]
-
August 25, 2017
-
Blockchain for Drug Development: An Historic Opportunity!
The 7th annual DPharm conference is proud to open the final day of the program on September 8th with Blockchain for Drug Development. We are delighted to welcome for the first time to DPharm, Dr Sascha Mundstein, Mobile and Digital COE, Technology Evangelist, Pfizer, Inc who will lead the session. Pfizer is making advances in working with blockchain and has been one of the first companies to deliver prototype applications […]
The 7th annual DPharm conference is proud to open the final day of the program on September 8th with Blockchain for Drug Development. We are delighted to welcome for the first time to DPharm, Dr Sascha Mundstein, Mobile and Digital COE, Technology Evangelist, Pfizer, Inc who will lead the session.
Pfizer is making advances in working with blockchain and has been one of the first companies to deliver prototype applications on the chain early this year. Sascha will talk to us about how blockchain can speed up the drug development process and change the business model of clinical development. He will tell us why it is imperative to embrace blockchain and more specifically:-The basics on how blockchain works and what the key advantages are
-Key benefits to empowering patients with control over their data
-The compliance implications of unalterable historic audit trails
-How in-house proof of concept development fosters innovation and new technology adoption
-The implications of rich and abundant patient data for the drug development process
DPharm takes place September 6-8th in Boston. For more information about DPharm, please click here.
[addtoany]
-
August 25, 2017
-
PharmaTalkRadio: Why Pharma R&D has to Start Thinking Like a Service Industry and How?
The Conference Forum is pleased to share a podcast featuring keynote speaker and world renowned customer service expert, Dr Chip Bell who spoke at the 6th annual DPharm: Disruptive Innovations to Advance Clinical Trials on the topic of service in clinical trials. To truly service our patients, we need to understand service together with science. Can service be a […]
The Conference Forum is pleased to share a podcast featuring keynote speaker and world renowned customer service expert, Dr Chip Bell who spoke at the 6th annual DPharm: Disruptive Innovations to Advance Clinical Trials on the topic of service in clinical trials.To truly service our patients, we need to understand service together with science. Can service be a disrupter in clinical research? In this keynote, Dr Bell tells us how to think like a service industry, why it’s worth it for R&D and how to get started. Dr Bell gives the listener practical insights on how to give patients a great experience. Although this podcast is primarily focused on serving patients in clinical research, you will find that hospitals and physician offices/medical groups will also benefit.
The 7th annual DPharm conference will continue to cover service, but through a patient perspective. DPharm 2017 takes place September 7-8 in Boston. For more information, click here.
About Dr Chip Bell:
Dr Bell is considered a world-renowned authority on customer loyalty and service innovation. He has authored eight national best-selling books. For more information visit, www.chipbell.com.[addtoany]
-
August 25, 2017
-
Patient Advocate Kristina Figueroa Joins “Ask the Patient” @DPharm & Writes about Healthy Living with Type I Diabetes
We are delighted to welcome Kristina Figueroa who will be a first time participant at DPharm where she will be part of the “Ask the Patients” program. Kristina is a patient advocate for type 1 diabetes and has experienced clinical research. Kristina is also an active writer for the health care community and we wanted to share one of […]
We are delighted to welcome Kristina Figueroa who will be a first time participant at DPharm where she will be part of the “Ask the Patients” program. Kristina is a patient advocate for type 1 diabetes and has experienced clinical research. Kristina is also an active writer for the health care community and we wanted to share one of her articles that talks about living a happy healthy life with type 1 diabetes.Article:
https://www.linkedin.com/pulse/declaration-dependence-kristina-figueroa-msphAbout “Ask the Patient”
“Ask the Patient” started in 2016 and provides an opportunity for those in the drug development industry at the DPharm conference to meet and speak with patients or patient advocates who’ve experienced a clinical trial. The DPharm community is made up of people from R&D operations, inventors of technologies and services to help patients, including app developers, members from the CRO and sites industry (people who coordinate and conduct trials), FDA, non-profits and academia.The “Ask the Patient” program aims to bring patients closer to industry and industry closer to patients, so we can learn from one and other on how to improve the way we currently design and conduct clinical trials, how to find them and communicate the availability of data post trials. DPharm takes place September 7-8, 2017 in Boston.
[addtoany]
-
August 17, 2017
-
Be the Innovator in a Clinical Trial Co-Design Workshop to Benefit Patient Participants
DPharm 2017 has announced a first time opportunity where you get to be the innovator at a pre-conference workshop on co-designing to help patients in clinical trials. Led by Barry Crist, Lead Investigator, Lilly Clinical Open Innovation Team, Eli Lilly & Company, attendees work with a small team to brainstorm and design an innovation to […]
DPharm 2017 has announced a first time opportunity where you get to be the innovator at a pre-conference workshop on co-designing to help patients in clinical trials. Led by Barry Crist, Lead Investigator, Lilly Clinical Open Innovation Team, Eli Lilly & Company, attendees work with a small team to brainstorm and design an innovation to assist participants in clinical trials. This interactive workshop guides you through a collaborative design process that helps create practical solutions using tools such as Ambient Intelligence, the Internet of Things and Smart Devices.
We are delighted to have Barry at the 7th annual DPharm as leader of the Trial Innovation Co-Design Workshop. Barry has spent his career leveraging information to transform the way people do work. As a technologist, architect, seeker and problem solver, he has a passionate vision that drives his unique ability to make big ideas come to life. Currently the Lead Investigator for the Lilly Clinical Innovation and Optimization Team, in this workshop Barry, along with colleague Dave Crumbacher, Technology Architect, Clinical Innovation, Eli Lilly & Company, will help you learn how to create solutions to assist participants in clinical research.
Barry Crist
Lead Investigator, Lilly Clinical Open Innovation Team, Eli Lilly & Company
Dave Crumbacher
Technology Architect, Clinical Innovation, Eli Lilly & CompanyThe DPharm Pre-Conference Workshop takes place on September 6 in Boston. For more information, please click here.
[addtoany]
-
August 10, 2017
-
New Guest Co-Chair Joins DPharm: Disruptive Innovations to Advance Clinical Trials
We are delighted to welcome Bray Patrick-Lake as our guest co-chair at DPharm: Disruptive Innovations to Advance Clinical Trials. The 7th annual DPharm takes place Sept 7-8 in Boston where Bray, together with Pfizer’s Craig Lipset and Janssen’s Dr Andreas Koester, will host 70 speakers who either demonstrate innovation in clinical trials or get us to think differently about 21st C drug development. Bray is the Director of […]
We are delighted to welcome Bray Patrick-Lake as our guest co-chair at DPharm: Disruptive Innovations to Advance Clinical Trials. The 7th annual DPharm takes place Sept 7-8 in Boston where Bray, together with Pfizer’s Craig Lipset and Janssen’s Dr Andreas Koester, will host 70 speakers who either demonstrate innovation in clinical trials or get us to think differently about 21st C drug development. Bray is the Director of Stakeholder Engagement at Duke Clinical Research Institute and supports efforts to actively engage patients, health advocacy organizations, and other stakeholders in local and national research programs.Bray Patrick-Lake has led extensive efforts through the Clinical Trials Transformation Initiative to incorporate patient voice into clinical trial design, conduct, oversight, and regulatory frameworks, as well as improvement of the clinical trial enterprise. She co-chaired the Advisory Committee to the NIH Director’s Working Group responsible for authoring the vision and roadmap to launch the Precision Medicine Initiative Cohort Program. Ms Patrick-Lake served as the Interim Director of Engagement for several months after the program launched and became the All of Research Program, for which she currently serves on the National Advisory Panel. She also leads engagement work at Duke’s Coordinating Center for the NIH Environmental Influences on Child Health Outcomes (ECHO) program and serves on the National Academies of Sciences, Engineering, and Medicine Health Sciences Policy Board.
Ms Patrick-Lake founded a disease advocacy organization for cardiac patients and served as a patient representative at the FDA on a variety of advisory committees and panels, in workgroups for EMA, IMI, NIH, and NAM/IOM, and as a patient stakeholder or co-investigator for AHRQ and PCORI research projects. She is member of the America Cancer Society’s Clinical Trials Steering Committee and has served on the MDEpiNet’s National Medical Device Registry Task Force, the Medical Device Innovation Consortium’s Patient-centered Benefit-Risk Steering Committee, American College of Cardiology (ACC) Foundation’s Patient-centered Care Shared Decision Making and Patient-generated Health Data working groups, and the ACC Transcatheter Valve Therapy Registry Stakeholder Advisory Committee. Ms Patrick-Lake currently also serves as a PCORI reviewer and ambassador.
For information about DPharm, click here.
-
August 10, 2017
-
Blockchain for Drug Development: A Historic Opportunity!
The 7th annual DPharm conference is proud to open the final day of the program on September 8th with Blockchain for Drug Development. We are delighted to welcome for the first time to DPharm, Dr Sascha Mundstein, Mobile and Digital COE, Technology Evangelist, Pfizer, Inc who will lead the session. Pfizer is making advances in working with blockchain and has been one of the first companies to deliver prototype applications […]
The 7th annual DPharm conference is proud to open the final day of the program on September 8th with Blockchain for Drug Development. We are delighted to welcome for the first time to DPharm, Dr Sascha Mundstein, Mobile and Digital COE, Technology Evangelist, Pfizer, Inc who will lead the session.
Pfizer is making advances in working with blockchain and has been one of the first companies to deliver prototype applications on the chain early this year. Sascha will talk to us about how blockchain can speed up the drug development process and change the business model of clinical development. He will tell us why it is imperative to embrace blockchain and more specifically:-The basics on how blockchain works and what the key advantages are
-Key benefits to empowering patients with control over their data
-The compliance implications of unalterable historic audit trails
-How in-house proof of concept development fosters innovation and new technology adoption
-The implications of rich and abundant patient data for the drug development process
DPharm takes place September 6-8th in Boston. For more information about DPharm, please click here.
-
July 20, 2017
-
What to Expect at DPharm 2017
The Conference Forum has announced the 7th annual DPharm: Disruptive Innovations to Advance Clinical Trials event on September 7 and 8, 2017 in Boston. As the annual event the life science industry can rely on for the latest thinking in clinical trials for 21st century drug development, the conference promises to challenge conventional thinking and […]
The Conference Forum has announced the 7th annual DPharm: Disruptive Innovations to Advance Clinical Trials event on September 7 and 8, 2017 in Boston.
As the annual event the life science industry can rely on for the latest thinking in clinical trials for 21st century drug development, the conference promises to challenge conventional thinking and inspire new ideas. Here is a brief summary of what you can look forward to at this year’s event.
Pre-Conference Workshop – September 6, 2017
Kicking off the proceedings is an optional pre-conference, hands-on workshop in which you get to be an innovator! Led by Barry Crist, Lead Investigator, Lilly Clinical Open Innovation Team, Eli Lilly & Company, attendees work with a small team to brainstorm and design an innovation to assist participants in Clinical Trials using co-design and human-centered approaches with tools such as Ambient Intelligence, the Internet of Things and Smart Devices.Day One – September 7, 2017
Co-chairs Andreas Koester, MD, PhD, VP, Innovation, R&D Operations, Janssen, Craig Lipset, MBA, Head of Clinical Innovation, Pfizer, Inc and Bray Patrick-Lake, MFS, Director of Stakeholder Engagement, Duke Clinical Research Institute, provide the opening remarks for the event, which is broken down into four parts.Part I focuses on “Patients, Innovation and Disruption” with sessions on: what R&D executives want to disrupt; how to bootstrap innovation; ADAPTABLE, a new system to do clinical trials; busting the myth that you can’t bring a trial to the patient; and turning opportunity into reality.
After lunch, Part II deals with “New Ideas and Progress.” Sessions include: patient disrupters as the ultimate partner; a case study on Turbo Tax for clinical trials; a choice of two tracks allowing you to hear from either companies who have previously presented their innovation at DPharm or companies presenting for the first time; and DPharm Idol 2017. The day concludes with the DPharm Annual Reception.
2016 DPharm Idol Winners, Florence Healthcare
Day Two – September 8, 2017
Our event co-chairs open day two by announcing the winner of DPharm Idol 2017.Part III of the event covers “The Next Generation of Ideas”. Included in this section are sessions on: the historic opportunity to use blockchain for drug development; how to align incentives to share clinical data; innovative projects with guest speakers interviewed by co-chair Craig Lipset; engaging patients by giving them their data; building a strategic community of patients; and a choice of three tracks centering on new digital innovations.
Part IV brings together a series of brief, impactful sessions from all stakeholders on: the NHS Patient Ambassador Program; Eli Lilly’s Hero’s Journey Project; investing in digital biomarkers; monitoring patients remotely by wireless; the strategic priorities of TransCelerate; and the Data Donation App.
To find out more about DPharm 2017, click here for full event details.
-
July 20, 2017
-
Announcing the DPharm 2017 Program
Dear DPharm Community, After several months of research, including three advisory board meetings, numerous one-on-one interviews and feedback from 2016 attendees, I am pleased to announce that the 7th annual DPharm agenda is published and registration is open. When organizing an event that presents the latest examples of innovative thinking in clinical trials, our research has to carefully find the right […]
Dear DPharm Community,
After several months of research, including three advisory board meetings, numerous one-on-one interviews and feedback from 2016 attendees, I am pleased to announce that the 7th annual DPharm agenda is published and registration is open. When organizing an event that presents the latest examples of innovative thinking in clinical trials, our research has to carefully find the right balance between new ideas/ projects/ accomplishments, the growth of previously presented ideas and new technologies.
Next Generation Ideas
A vital part of DPharm is looking at next generation ideas. For 2017 these include an industry insider from Pfizer on how blockchain can speed up the drug development process and change the business model of clinical development. Other examples are the impact of artificial intelligence in clinical research, digital therapeutics for enhanced clinical outcomes, lessons from the hurdles of the microbiome for clinical trials, and next steps for digital biomarkers.Benchmarking Ideas and Progress
This year, we are including a panel with R&D leaders on what they are trying to disrupt and the status of their ambitious projects, to help you benchmark how the industry is progressing. We also cover examples on how two different pharma companies bootstrap their innovation to accelerate the adoption of new ideas and technologies.New Speakers
We are excited to welcome many new speakers, including Dr Adrian Hernandez, the co-investigator of the ADAPTABLE Study from PCORnet; Barry Crist from Eli Lilly, who will lead an optional workshop on Co-Designing; Dana Lewis, the patient who is democratizing R&D to reduce the burden of type 1 diabetes; Dr John-PeterBradford, another patient disrupter, who is making real-world inclusion criteria a reality; MIT Professor Dina Katabi on wireless remote monitoring; and Esther Dyson, one of the most creative innovative futurists in healthcare, to name a few.Wide Range of Technologies
DPharm now includes more track choices to allow you to customize what technology and services can help you. DPharm Idol is already filling up with exciting possibilities for clinical researchers, and we have an outstanding group of judges, who will oversee a helpful Q&A.Pre-Conference Events on September 6
- 4th Annual Mobile in Clinical Trials from 8am – 6pm
- Trial Innovation Co-Design Workshop: Help Create Solutions to Assist Clinical Research Participants from 7pm – 9pm
Networking
The event’s networking sessions will be educational, interactive and entertaining. The exhibit hall is not generalized, but focused on innovative solutions and technologies for clinical researchers. You will have the opportunity to meet patients who have experienced a clinical trial, reserve tables for group and one-on-one meetings, and yes, we will have the empathy section with therapy dogs, an art therapy booth and virtual reality demos. Meals, snacks, tea/coffee and chocolates will be provided in the hall.Agenda and Registration Open with First Time Offer
With the first draft of the agenda now published, take advantage of the earliest rates. For the first time, we are offering a guest pass to pharma and biotech companies that would like to invite a member of their team who has not yet attended DPharm. This offer was suggested by advisory board members to help support the spread of innovation within pharma/biotech. Please note this offer expires August 18.Please let us know if you have any questions. My team and I are busy preparing to make this the best on-site experience, and we hope you will be able to attend DPharm 2017!
Sincerely,
Valerie Bowling
Executive Director, DPharm
-
June 12, 2017
-
CMO Speaker, Dr David Schenkein Writes About Bringing Clinical Trials to Patients
Recently, the Conference Forum presented Clinical Research as a Care Option, which was chaired by Katherine Vandebelt, Formerly, Global Head, Clinical Innovation, Eli Lilly and Jeff James, CEO, Wilmington Health. So we were thrilled to see that Dr David Schenkein, CEO, Agios Pharma, who keynoted in 2015 at the Chief Medical Officer Summit recently published […]
Recently, the Conference Forum presented Clinical Research as a Care Option, which was chaired by Katherine Vandebelt, Formerly, Global Head, Clinical Innovation, Eli Lilly and Jeff James, CEO, Wilmington Health. So we were thrilled to see that Dr David Schenkein, CEO, Agios Pharma, who keynoted in 2015 at the Chief Medical Officer Summit recently published on Linkedin his view on the topic of bringing trials closer to patients. See below:
To Get Patients into Clinical Trials, We Need to Get Clinical Trials to Patients
The other day, an Agios employee, Holly, took an Uber to make a midday meeting. The driver mentioned that he was from out of town and welcomed any shortcuts to get to their destination. She asked where he was from, and during her brief ride, she learned that he drove an elderly woman from New Hampshire to Boston twice a week so she could participate in a clinical trial for a new cancer treatment at Mass General Hospital. It was a two-hour trip each way, and the treatment took four hours, so he filled that time giving rides close to the hospital.
For the rest of the day, this woman’s story clung with Holly, who found herself wondering if she had friends or family with her at the hospital, what investigational medicine she was taking and if it made her sick on the long drive home. When Holly shared her experience with me, despite the pangs of sympathy, I found solace in the fact that this woman lives within driving distance of one of the leading cancer centers in the U.S., giving her access to the most advanced cancer care and potentially lifesaving clinical trials.
Though the time commitment is significant and the cost of transportation is likely high, her situation is a stark contrast to the estimated 85 percent of cancer patients around the country who receive care in a community setting, where clinical trials are less likely to be offered. I’ve written before about my own experiences with the harsh emotional reality of participating in studies of new treatments, but low enrollment can also be attributed to geography. The truth is, most patients don’t live near a hospital or academic center that offers clinical trials, which can often be life-saving options for people who have already received approved therapies. Recent studies suggest that outcomes can vary widely depending on where patients receive care.
There are many factors driving the inequities between cancer care and clinical trial access at academic health centers vs. community hospitals – including infrastructure costs, required FDA guidelines for clinical trials, necessary staff support, etc. Bridging that divide is something a colleague and friend of mine, Keith Flaherty, M.D., has spent much of his career trying to address. Dr. Flaherty is the Director of Developmental Therapeutics Clinical Research at the Massachusetts General Hospital Cancer Center and professor of medicine at Harvard Medical School. He also serves as the principal investigator for a clinical trial called NCI-MATCH, which is a study launched in August 2015 that analyzes patients’ tumors to determine whether they contain gene abnormalities for which a targeted drug exists and assigns treatment based on the abnormality. This study brings genomic testing and access to 30 targeted therapies to 6,000 patients at hundreds of hospitals and more than 1000 healthcare locations across the U.S. at no cost to the patient or treatment center.
I spoke with Dr. Flaherty a few weeks ago to get his perspective on NCI-MATCH and the future of clinical trial access outside of big research centers. Here’s what he had to say.
David:
What does the future look like for clinical trials over the next few years?Dr. Flaherty:
It’s suffice to say there’s a big gap and a big unmet need, and we must figure out how to move forward given that NCI-MATCH is about to end and a large clinical investigation community is going to lose access to genetic testing and clinical trial options. I recently co-founded a company called Strata Oncology, which aims to potentially perform an NCI-MATCH-like function. We’re focusing on driving clinical trial participation in regional networks outside of academic medical centers, which allows patients to stay in their community and creates a much more efficient process for matching them to clinical trials of targeted therapies.David:
Certainly this addresses one of the bigger issues of identifying patients for biomarker-driven studies, which is critical. How has NCI-MATCH created the infrastructure in smaller community settings to make it easier to put a patient on a study and/or get a sponsor to use a small hospital that may only bring in one or two patients?Dr. Flaherty:
Providing small hospitals with the genomic tests to identify biomarkers is pretty straightforward and a good place to start. Creating the necessary clinical trial infrastructure piece is doable. It just requires stripping out some of the bells and whistles. Part of this is reducing the amount of data that these hospitals are required to collect for trials. With fewer resources, community centers can only do so much, so studies have to be structured in a way that allows them to capture registration-quality data, which isn’t feasible if they’re being asked for 1,000 data points per patient.David:
As you look ahead of the next 5 years, in terms of a change to the model and how we conduct clinical trials, do you believe we’ll see more biomarker-driven trials being offered in communities?Dr. Flaherty:
I do believe that some version of democratizing clinical trial access will happen. I think it has to start with a coalition of sponsors who are looking for sparsely distributed, genetically defined patients in order to make it reasonably efficient. Together, we need to figure out a geographically smart way to get these clinical trials to where patients are, and streamline what we’re asking for in these community settings. This could easily double the percentage of patients who enroll in trials nationwide.For the benefit of the millions of people with cancer who are or will be treated in a community hospital, I hope Dr. Flaherty is right.
-
April 3, 2017
-
Congratulations to Conference Forum Speakers Dr Robert Califf, Craig Lipset, and Marc Boutin on their Leadership Roles in the Newly Formed People-Centered Research Foundation
Source: Healthcare Informatics March 27, 2017 by David Raths Robert Califf, M.D., who stepped down as commissioner of the U.S. Food and Drug Administration in January, has been named chair of a new nonprofit organization, the People-Centered Research Foundation, which has been created to sustain and expand a national network for clinical research that originated […]
Source:
Healthcare InformaticsMarch 27, 2017
by David RathsRobert Califf, M.D., who stepped down as commissioner of the U.S. Food and Drug Administration in January, has been named chair of a new nonprofit organization, the People-Centered Research Foundation, which has been created to sustain and expand a national network for clinical research that originated with funding from the Patient-Centered Outcomes Research Institute (PCORI) and studies conducted by the national Patient-Centered Clinical Research Network (PCORnet).
The PCORI web site said its board of governors has agreed to provide up to $25.4 million in additional infrastructure-building funds to support the long-term sustainability of PCORnet through PCRF, which was formed by PCORnet investigators to advance and support the network’s sustainability.
On its web site, PCRF said it would provide retrospective observational research using its data network, prospective research that collects new data from patients, and high-impact clinical trials. “Each study will deeply engage patients and clinicians in its design, conduct, and dissemination. A balanced mix of support from government, foundations, and industry will sponsor the studies. All projects will be aligned with the foundation’s mission of centering projects around the needs of people and their health.”
Califf also has returned to the Duke Clinical Research Institute, which he founded in 2006, as the Donald F. Fortin professor of cardiology. In a letter on the nonprofit’s web site, he said that PCRF would integrate people into all phases of research and the learning health system. “Patients, participants, patient advocates, and caregivers will constitute a meaningful percentage of our board; be involved in leadership roles in all committees; and participate in the development and execution of the research.”
He added that PCRF has a robust business plan in place, with seven members of what could grow to be a 13-member board, and plans to build a program management office that will be led by an executive director.
The other board members are:
- Richard Bankowitz, MD, MBA, FACP, Executive Vice President, Clinical Affairs, America’s Health Insurance Plans (AHIP)
- Josephine P. Briggs, MD, Director, National Center for Complementary and Integrative Health (NCCIH)
- Marc M. Boutin, JD, Chief Executive Officer, National Health Council (NHC)
- Donna Cryer, President & CEO of the Global Liver Institute
- Craig Lipset, MBA, Head of Clinical Innovation, Worldwide Research & Development, Pfizer Inc.
- Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson
Dr Robert Califf recently spoke at the R&D Leadership Summit and spoke at the Clinical Trial Collaborations conference. Marc Boutin also recently spoke at the R&D Leadership Summit and is a lead advisor and speaker at the Patients as Partners US conference. Craig Lipset is the co-chair of the DPharm: Disruptive Innovations to Advance Clinical Trials conference and spoke at the inaugural Clinical Research as a Care Option program.
-
November 18, 2016
-
EMA Begins Providing Public Access to Clinical Reports
Beginning in October 2016, the European Medicines Agency (EMA) has made a decision to support transparency in clinical trials by giving open access to clinical reports for new medicines for human use authorized in the European Union (EU). EMA is the first regulatory authority worldwide to provide such broad access to clinical data. “Transparency on clinical data is a […]
Beginning in October 2016, the European Medicines Agency (EMA) has made a decision to support transparency in clinical trials by giving open access to clinical reports for new medicines for human use authorized in the European Union (EU). EMA is the first regulatory authority worldwide to provide such broad access to clinical data.
“Transparency on clinical data is a longstanding commitment from EMA and today, we are delivering on our promise to give access to the data on which our recommendations are based”, explained EMA’s Executive Director Guido Rasi. “Our initiative has shaped the global debate towards more transparency. It will benefit academic research and the practice of medicine as a whole.”With the EMA’s new, proactive approach to providing access to the data, increased transparency will allow for:
– Patients and healthcare professionals to find out more information about the data concerning the approval of medicines they are taking or prescribing
– Independent re-analysis of data by academics and researchers after a medicine has been approved, thus increasing scientific knowledge, and potentially further informing regulatory decision making in the future
– Innovation, as the shared knowledge about a medicine helps developers learn from the experience of others and can lead to more efficient medicine development programs.
To read the full article, click here.
For more information on DPharm EU, click here.
-
November 17, 2016
-
Lilly is Making It Easier For Physicians To Become Investigators
We are so proud of Conference Forum speaker Katherine Vandebelt, Head of Clinical Innovation at Eli Lilly for her vision and leadership in making it easier for physicians to become investigators. She understands the burden on the physician in navigating the clinical research process and is leading efforts to reduce this burden. Katherine spoke to […]
Katherine Vandebelt, Global Head, Clinical Innovation, Eli Lilly & Company
We are so proud of Conference Forum speaker Katherine Vandebelt, Head of Clinical Innovation at Eli Lilly for her vision and leadership in making it easier for physicians to become investigators. She understands the burden on the physician in navigating the clinical research process and is leading efforts to reduce this burden. Katherine spoke to this at the Dpharm US conference in September and is featured in Clinical Leader this month. See below for details on the Clinical Leader article featuring Katherine.
http://www.clinicalleader.com/doc/lilly-makes-it-easier-for-physicians-to-become-investigators-0001
-
September 21, 2016
-
Florence Healthcare Wins DPharm Idol 2016
Congratulations to Florence Healthcare, this year’s DPharm Idol winner! Florence was founded by Andres Garcia (CTO), Mike Kassin, MD (CMO), and Ryan Jones (CEO), — who previously held positions at Microsoft SharePoint, Pubget and BCG. The company name echoes Florence Nightengale, the mother of modern nursing, and embodies the ideals of empathy, reliability and consistency. […]
Congratulations to Florence Healthcare, this year’s DPharm Idol winner!
Florence was founded by Andres Garcia (CTO), Mike Kassin, MD (CMO), and Ryan Jones (CEO), — who previously held positions at Microsoft SharePoint, Pubget and BCG. The company name echoes Florence Nightengale, the mother of modern nursing, and embodies the ideals of empathy, reliability and consistency. Core users of the solution are site-based research nurses and coordinators.
Florence offers the eBinder Suite, a software-as-a-service (SaaS) platform that is designed to simplify clinical trial document management at the trial site. The eBinder Suite enables clinical trial sites to store and manage paper files in the cloud, and automates some of the most time-consuming manual processes for both the site and the pharmaceutical sponsor.
eBinders ultimately ensures clinical teams are able to spend more time helping patients and less time dealing with paperwork. Meanwhile, it speeds study time by enabling remote sponsor access for monitoring and queries.
“The opportunity for long-term archiving in a digital format is really, really appealing,” said DPharm Idol judge Julian Jenkins, PhD. “eBinders are a real difference-maker.”
Furthermore, Florence recently received seed funding, and Jones pointed out that Florence has grown at a rate of 80% month to month over the past year thanks in part to the success of eBinders.
DPharm Idol encourages participating companies to showcase what they believe to be a disruptive clinical trial service or technology. Each DPharm Idol participant receives only a few minutes to highlight its clinical trial service or technology, followed by a brief Q&A session with a panel of judges.
This year’s DPharm Idol judges included:
Laura Galuchie
Head, Clinical Performance, Analysis & Innovation, Merck Research LaboratoriesJulian Jenkins, PhD
VP, Innovation Performance & Technology, GSKAndreas Koester, MD, PhD
VP, Innovation R&D Operations, JanssenSarah Krüg
CEO, Cancer 101 and President, Society of Participatory MedicineStephanie Petrone
Executive Director, Medical Operations, Novartis OncologyChandra Ramanathan, PhD, MBA
VP and Head, East Coast Innovation Center, Bayer HealthCareJane Rhodes, MBA, PhD
Senior Director of New Initiatives, Biogen IdecDarshan Shah
Director Global Products, Global Medicines Director, AstraZenecaKatherine Vandebelt
Global Head, Clinical Innovation, Eli Lilly & CompanyWhich company will follow in Florence’s footsteps to become the next DPharm Idol? Check out next year’s DPharm Idol to discover new innovations in clinical trials and find out which company will be crowned the next DPharm Idol.
-
September 21, 2016
-
DPharm 2016 Day Two Recap
September 21st, Boston, the 6th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference has drawn to a close. DPharm day two featured engaging discussions on a variety of topics, including: DPharm Idol Florence Healthcare, an Atlanta-based provider of a software-as-a-service (SaaS) clinical trial document management platform, won this year’s DPharm Idol competition. The Florence […]
September 21st, Boston, the 6th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference has drawn to a close. DPharm day two featured engaging discussions on a variety of topics, including:
- DPharm Idol
Florence Healthcare, an Atlanta-based provider of a software-as-a-service (SaaS) clinical trial document management platform, won this year’s DPharm Idol competition.
The Florence eBinder Suite enables clinical trial sites to transfer paper files to the cloud. As such, eBinders help eliminate a “key bottleneck” by providing a digital workspace that connects sites directly to sponsors and contract research organizations (CROs), according to Florence founder Ryan Jones.
In addition, DPharm Idol judge Andreas Koester, MD, PhD, said he believes Florence’s eBinders could serve as a key time-saver for clinical investigators.
“We thought the solution that Florence has developed can make a difference and free up time for investigators, giving them more time to work with patients,” he stated.
The arrow appears to be pointing upward for Florence, too. Jones pointed out that his company has grown 80% month over month in the last year, and the typical eBinder user spends an average of 30 minutes or more per session – both of which are positive signs for Florence moving forward.
- Customer-Centricity
What does it take to implement a “customer-centric” strategy in clinical trials? Customer service keynote speaker Chip Bell explored the topic in detail during his address to DPharm attendees.
According to Bell, a customer-centric strategy encompasses:
- Advocacy
- Brand protection
- Retention
- Volunteerism
Furthermore, he pointed out that customer expectations continue to rise, which means clinical sites will need to differentiate themselves to meet or exceed these expectations.
“It seems to me that there is a great return on investing in creating a great customer experience,” Bell stated. “It is the unexpected little things that we do that create that memorable experience.”
Building a customer-centric strategy is “a never-ending journey,” Bell said. However, clinical sites that drive “a culture of scouts,” Bell said, will be better equipped to learn about customers, anticipate their needs and deliver an unparalleled experience.
- Community
Consistent community engagement is a goal for many clinical sites, yet it often seems impossible to achieve. But Roni Zeiger, co-founder of online community Smart Patients, explored how clinical sites can build and maintain a community for an extended period of time.
Zeiger noted the key tenet of a successful community involves “not just listening, but listening forever.”
If clinical sites understand the needs of community members, they may be better equipped to engage with them consistently.
Also, Zeiger said clinical sites should operate fearlessly, particularly when it comes to community engagement.
“We have to design to allow for failure,” he noted. “We have to expect failure with some of these new things that we’re trying.”
- Zika Virus
The Zika virus has raised many questions among medical professionals, and at times, has appeared unstoppable. Conversely, David O’Connor, PhD, created the Zika Experiment-Science Team (ZEST) to help scientists learn about the Zika virus, and he shared some of his ZEST experiences with DPharm attendees.
O’Connor launched the ZEST data portal, empowering scientists with up-to-date information about the Zika virus. By doing so, he was able to educate and inform scientists about the dangers associated with the Zika virus and facilitate collaborative research like never before.
Ultimately, the ZEST data portal has become a leading resource for Zika information, and O’Connor said the portal results have extended beyond his expectations.
“It’s really been far more successful than we could have ever imagined,” he noted. “If we had waited until June to announce our intentions … we would not be in the position that we’re in right now in respect to knowing what we do now about the Zika virus.”
- Big Pharma and Startups
What does it take for a startup to succeed in the pharmaceuticals sector? It may seem like a case of David versus Goliath at times, particularly as startups search for ways to grow in a market dominated by big pharma. Comparatively, partnerships between startups and big pharma can be mutually beneficial, and several startup and big pharma experts discussed the importance of collaboration between these two distinct groups as part of the DPharmX section of DPharm.
Driving innovation in the pharmaceuticals space often requires patience and resources, leading many startups to shy away from this segment entirely. But with the right data at its disposal, a startup may be able to make headway in the pharmaceuticals space.
“Data is critical to make a case as to why you should be adopted,” said Adam Hanina, MD, CEO of advanced medication adherence solutions provider AiCure.
At the same time, startups must understand their role within the pharmaceuticals space. Meanwhile, failure to do so may lead a startup to overpromise – something that could prove to be extremely costly and time-consuming.
“I think it is important for industry to understand where the startup is coming from. And I think it is important for the startup to understand that is unacceptable in the healthcare space,” said Matthew Amsden, CEO of startup ProofPilot. “Together, industry and startup can meet in the middle.”
Although the 2016 DPharma conference is over, next year’s conference will be here soon. Be sure to check out our blog for updates on the 2017 DPharma conference.
DPharm is researched and produced by the Conference Forum, a research and conference development firm dedicated to the the overall topic of how to get therapeutics to patients faster. For more information, www.theconferenceforum.org.
-
September 20, 2016
-
DPharm 2016 Day One Recap
The 6th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference is officially underway this week in Boston. Did you miss out on DPharm day one? Here’s a look at five key topics that were discussed during DPharm’s day one sessions. Embracing Limitations Pointillist artist Phil Hansen delivered DPharm’s patient address and described how he […]
The 6th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference is officially underway this week in Boston.
Did you miss out on DPharm day one? Here’s a look at five key topics that were discussed during DPharm’s day one sessions.
- Embracing Limitations
Pointillist artist Phil Hansen delivered DPharm’s patient address and described how he seized his limitations to unlock creativity.
Hansen suffered a severe hand tremor that initially appeared to derail his artistic career. However, he “embraced the shake” in his hand and began using unconventional materials – everything from greasy hamburger wrappers to matchsticks – to create awe-inspiring art.
Ultimately, Hansen accepted his hand limitation. And by doing so, Hansen opened himself up to new opportunities – something that everyone can do if they choose to embrace their limitations.
“We first need to be limited in order to become limitless,” Hansen told DPharm attendees. “When we change the way we look at a limitation, it changes how [the limitation] affects us.”
- Open Source Clinical Research
Greg Simon, JD, Executive Director of the White House Cancer Task Force, shared his thoughts on open source clinical research and the lack of medical data transparency during his DPharm keynote address.
According to Simon, nearly every aspect of life is connected thanks to smartphones, tablets and other state-of-the-art mobile devices. Conversely, he pointed out that the health sector remains siloed due to a lack of data standardization.
“I’m still dealing with the same problems I was dealing with in 2013,” Simon noted. “That just isn’t right.”
Comparatively, the Cancer Moonshot may help accelerate the push for open source clinical research. This initiative, led by U.S. Vice President Joe Biden, encourages members of the medical community to change their attitudes and views about clinical research and may drive “a decade’s worth of progress in diagnosing cancer in five years,” Simon said.
“We’re trying to get everyone involved in the cancer enterprise to double our goals and shorten our time to achieve these goals by half,” Simon noted. “If we work together … then we have a chance.”
- Patient Engagement Transformation
Imagine what it would be like to enjoy an Apple Genius Bar experience at a hospital. Now, you can, thanks to Oschner Health System.
Oschner Chief Clinical Transformation Officer Richard Milani, MD described the Oschner “O Bar” and some of its other patient engagement efforts during his DPharm presentation.
He pointed out that Oschner created an “O Bar” that is designed to “promote engagement and curate health and wellness apps.” By doing so, Oschner has been able to drive its patient engagement levels.
“The more we involve people in a behavior change, the more likely people are to make a change,” Milani stated. “We look for every opportunity.”
Furthermore, Uber has revolutionized ridesharing for travelers in more than 500 cities across the United States, and the “uberization” of clinical trials may transform the way medical professionals and patients connect with one another as well.
John Brownstein, Boston Children’s Hospital’s Chief Innovation Officer, explained how this uberization is benefiting medical professionals and patients during a DPharm session. He even noted that Boston Children’s has worked with Uber to make it easier than ever for patients to reap the benefits of vaccines.
- Different Approaches to Clinical Trials
How does a contract research organization (CRO) disrupt clinical trials? It all might come down to how CROs approach their role in these trials.
Ira Spector, PhD, MBA, Executive Vice President of Analytics and Consulting at ICON, noted that CROs “are responsible to make the changes” in clinical trials. As such, CROs serve as “integrators” that may play a crucial role in clinical trials going forward.
“Our jobs are largely to be integrators and to take technologies from wherever we can find them and integrate them,” Spector said.
Let’s not forget about the digitization of clinical trials, either. This subject remains a hot topic, particularly among officials at the U.S. Food and Drug Administration (FDA).
FDA regulations related to the digitization of clinical trials were originally implemented in 1997, i.e. a time when Netscape Navigator was the leading web browser and few people knew about Google.
Clearly, a lot has changed over the past two decades, and the FDA continues to explore ways to revamp its requirements for the digitization of clinical trials.
Kaveeta Vasisht, MD, Medical Officer at the FDA’s Office of Medical Policy, said the FDA recognizes that “there is a tremendous amount of opportunity” with new technologies. Meanwhile, the Clinical Trials Transformation Initiative and other programs may push the digitization of clinical trials, too.
Lastly, Eli Lilly is working with artist John Magnan to create crowdsourced art that illustrates heroic efforts of those who participate in clinical trials.
Known as “The Hero’s Journey,” the crowdsourced art is designed to honor clinical trial volunteers as well as raise awareness of clinical trials. The art also highlights how each clinical trial participant is his or her own hero and encourages everyone to share their thoughts and feelings about clinical research by using the Twitter hashtag #herosjourneyart.
- Disruptive Technology in Clinical Trials
At McLaren, data drives everything. Therefore, the automaker relies on real-time data that “underpins everything that McLaren does,” according to McLaren Applied Technologies Chief Medical Officer Adam Hill, MD.
Hill noted that McLaren strives to achieve “optimization based upon data management” in clinical trials. He also stated that McLaren recognizes that the future of clinical trials requires an underpinning distributed technology platform that can support continuous improvement.
“Analysis allows us to derive insight,” Hill said. “And that insight drives more informed decisions.”
Moreover, the DPharm Idol competition gave DPharm attendees the chance to learn about disruptive technology that could enhance clinical trials for years to come.
This year’s DPharm Idol presenting companies included:
- Optimal Strategix Group (OSG)
- Florence Health
- N-of-One
- HealthVerity
- 4G Clinical
- TriNetX
The aforementioned companies will be evaluated by a panel of judges that includes:
Laura Galuchie
Head, Clinical Performance, Analysis & Innovation, Merck Research LaboratoriesJulian Jenkins, PhD
VP, Innovation Performance & Technology, GSKAndreas Koester, MD, PhD
VP, Innovation R&D Operations, JanssenSarah Krüg
CEO, Cancer 101 and President, Society of Participatory MedicineStephanie Petrone
Executive Director, Medical Operations, Novartis OncologyChandra Ramanathan, PhD, MBA
VP and Head, East Coast Innovation Center, Bayer HealthCareJane Rhodes, MBA, PhD
Senior Director of New Initiatives, Biogen IdecDarshan Shah
Director Global Products, Global Medicines Director, AstraZenecaKatherine Vandebelt
Global Head, Clinical Innovation, Eli Lilly & CompanyWhich company will win this year’s DPharm Idol? We’ll find out tomorrow during day two of DPharm 2016, so be sure to check out our blog for updates.
-
September 8, 2016
-
DPharm 2016: Five Innovators Explain Why You Don’t Want To Miss Out
Matt Winslow of RebarInteractive, highlights five innovators as to why they don’t want to miss DPharm 2016. Each year, hundreds of clinical trial innovators gather to exchange ideas and network with like-minded peers at the Disruptive Innovations to Advance Clinical Trials conference. This year the conference, which is also known as DPharm, is being held […]
Matt Winslow of RebarInteractive, highlights five innovators as to why they don’t want to miss DPharm 2016. Each year, hundreds of clinical trial innovators gather to exchange ideas and network with like-minded peers at the Disruptive Innovations to Advance Clinical Trials conference. This year the conference, which is also known as DPharm, is being held September 20-21st at the Fairmont Copley Plaza in Boston, MA.
We caught up with five leading innovators who regularly attend DPharm and asked two questions:
- What have you found most valuable about attending dPharm in prior years?
- What are you most looking forward to this year?
Here are their replies: goo.gl/08AA44
Matt Winslow
-
September 5, 2016
-
Conference Forum Hosts Clinical Research as a Care Option (CRAACO) Roundtable at DPharm
New York, NY, the Conference Forum announced they are hosting the 2nd Clinical Research as a Care Option (CRAACO) round table at DPharm on September 21st at 12:30 in Boston. A diverse group of stakeholders representing healthcare, pharma, technology and policy agents come together to discuss the integration of research and care to optimize patient […]
Eli Lilly’s Katherine Vandebelt hosting DPharm 2015 session with Wilmington Health, CEO Jeff James and PMG Research’s CEO, Jennifer Byrne.
New York, NY, the Conference Forum announced they are hosting the 2nd Clinical Research as a Care Option (CRAACO) round table at DPharm on September 21st at 12:30 in Boston. A diverse group of stakeholders representing healthcare, pharma, technology and policy agents come together to discuss the integration of research and care to optimize patient care delivery within a value-based healthcare system. The key objective is to gather like-minded/progressive participants for an interactive discussion, with the ultimate goal of encouraging a movement to bridge research as continuum of patient care- transforming patient care/research delivery model. This discussion builds on the work initiated by Eli Lilly, PMG Research and Wilmington Health in building evidence of the value of research participation.
Katherine Vandebelt, Global Head, Clinical Innovation, Eli Lilly & Company and Craig Lipset, Head of Clinical Innovation, R&D, Pfizer are co-moderating the roundtable session and will seek the support from the CRAACO team to navigate the discussion.
We look forward to discussing highlights and next steps post the meeting.
CRAACO 2015 Group Meeting
-
August 23, 2016
-
Pfizer’s “Blue Sky” Team Featured on PharmaTalkRadio
Members of Pfizer’s “Blue Sky” team join DPharm’s Director, Valerie Bowling and Clinical Leader’s Chief Editor, Ed Miseta on PharmaTalkRadio to discuss the work they are doing to transform clinical research in Parkinson’s disease and patient-centric innovation. Together they discuss the vision, goals and journey in taking a new approach to advancing drug development. More […]
Members of Pfizer’s “Blue Sky” team join DPharm’s Director, Valerie Bowling and Clinical Leader’s Chief Editor, Ed Miseta on PharmaTalkRadio to discuss the work they are doing to transform clinical research in Parkinson’s disease and patient-centric innovation. Together they discuss the vision, goals and journey in taking a new approach to advancing drug development.
More specifically, the Blue Sky team talks about their partnership with IBM, the first of its kind research collaboration, decisions on how to use a device in a trial, real time data collection, an 1800s house for a 21st Century research and more.Pfizer’s Blue Sky Guests:
Stephen Amato, PhD, Project Manager, BlueSky, Pfizer
David Caouette, MBA, Senior Director, Strategy and Operations Lead, BlueSky and Quantitative Medicine, Pfizer
Daniel Karlin, MD, Senior Director, Quantitative Medicine, Clinical Lead, BlueSky, Pfizer
Both Drs David Caouette and Daniel Karlin are co-presenting at the DPharm conference on September 20th in Boston. For more information go to www.theconferenceforum.org.
Click here to hear the radio program: http://www.blogtalkradio.com/pharmatalk/2016/08/10/pfizers-blue-sky-approach-to-help-transform-clinical-research-1
-
August 18, 2016
-
PharmaTalkRadio: DPharm Team Discuss the 2016 Highlights
Members of the DPharm team engage in an informal conversation to highlight what’s happening in innovation and the latest thinking to disrupt clinical trials at the 6th annual event. Also discussed is a brief history of how this conference dedicated to applying disruptive thinking to clinical trials came to be. This conversation is well worth […]
Members of the DPharm team engage in an informal conversation to highlight what’s happening in innovation and the latest thinking to disrupt clinical trials at the 6th annual event. Also discussed is a brief history of how this conference dedicated to applying disruptive thinking to clinical trials came to be. This conversation is well worth listening to if you plan to attend DPharm or want to get a sense of the quality and depth this program brings to clinical trial executives.
DPharm takes place September 20-21, 2016 at the Fairmont Copley Plaza Hotel in Boston. Also featured on September 19 is a full day on Mobile Applications to Enhancing Clinical Trials.
DPharm Link for More information or to Register:
https://theconferenceforum.org/conferences/disruptive-innovations-us/overview/DPharm Team Members:
-
- Valerie Bowling, Executive Director, DPharm (Host)
-
- Elizabeth Bard, Business Development Director, DPharm
-
-
August 9, 2016
-
Conference Forum Speaks with NY State Senator Kirsten Gillibrand at Hillary Clinton Event
Conference Forum co-executive directors, Valerie Bowling and Meredith Sands took the opportunity to voice their concerns about the support needed for innovation to advance drug development at a Hillary Clinton Fundraiser recently held in NYC. NY State Senator Kirsten Gillibrand, who was graciously introduced by Tony and Grammy award winner, Audra McDonald was the main […]
Conference Forum co-executive directors, Valerie Bowling and Meredith Sands took the opportunity to voice their concerns about the support needed for innovation to advance drug development at a Hillary Clinton Fundraiser recently held in NYC. NY State Senator Kirsten Gillibrand, who was graciously introduced by Tony and Grammy award winner, Audra McDonald was the main speaker at the event.
Valerie spoke with the senator about the need to support innovation to get therapeutics to patients faster and the importance of not allowing the few Shkrelis of the world to overshadow the amazing work and progress of the industry and its impact on human lives and economic growth. The event was attended by over 200 people including both Democrats and Republicans.The senator from New York is currently holding Democratic presidential nominee Hillary Clinton’s former U.S. Senate seat. Senator Gillibrand was named as part of Clinton’s New York “Leadership Council,” that includes elected officials, activists and donors in the state who endorsed her for president.
On a related note, we want to thank our friends at Faster Cures on the formation of Rx for Innovation: Recommendations for the New Administration. This is their initiative to inform the transition teams of #Election2016 and the next administration. The transition is a chance to focus policy working groups on improving the health and productivity of the American people and reducing the cost of disease to society. Their recommendations will be a shared vision of the biomedical research landscape during the course of the next president’s tenure. They will provide a guide that both synthesizes the current state of the R&D ecosystem and provides actionable recommendations for the administration in its first 100 days, first year, first term and beyond.
-
- Award Winning Performing Artist, Audra McDonald and NY State Senator Kirsten Gillibrand
-
- Valerie Bowling, Executive Director, Conference Forum and NY State Senator Kirsten Gillibrand
-
- Valerie Bowling, Executive Director, Conference Forum
-
-
June 30, 2016
-
6th Annual DPharm Agenda Published
We are excited to announce the first draft of the agenda for the 6th Annual DPharm: Disruptive Innovations to Advance Clinical Trials is published. DPharm 2016 opens with artist Phil Hansen, who provides his perspective as a patient on turning a nearly tragic disability into an overflowing amount of creativity. To demonstrate innovative ways to transform patient […]
We are excited to announce the first draft of the agenda for the 6th Annual DPharm: Disruptive Innovations to Advance Clinical Trials is published.
DPharm 2016 opens with artist Phil Hansen, who provides his perspective as a patient on turning a nearly tragic disability into an overflowing amount of creativity. To demonstrate innovative ways to transform patient engagement, examples from other industries are featured, including:
- Formula One race car engineering company, McLaren
- FitBit
- Ochsner Healthcare system
The 2016 agenda is packed with examples of progress in advancing clinical trials from Eli Lilly, Novartis, Pfizer, Janssen, Genentech and more will be added.
DPharm Executive Director, Valerie Bowling says, “This year’s event addresses tough questions on getting R&D to think like a service industry and to how to get the other 98% on board to make significant changes.”DPharm brings a new line-up of technology presenters for DPharm Idol, keynotes, plenary and break out sessions, “Where Are They Now”, and the “Today Show @ DPharm” with one-on-one interviews.
Craig Lipset, Head of Clinical Innovation, R&D, Pfizer at DPharm Europe
“Collaboration is critical to bringing innovation in clinical development, but it requires the right environment,” says Craig Lipset, Head of Clinical Innovation in Pfizer Global Product Development. “DPharm provides the ideal space for drug developers, patients, technologists, regulators and other partners who want to drive change. It creates an environment to share and connect, with new partnerships sparked there each year. Seeing peers leave DPharm with the ideas and tools to innovate in their organizations gives me optimism that we can reinvent drug development together.”
A new section, DharmX, has been introduced to help stimulate fresh ideas, such as how to make it easy for physicians to be investigators. Also debuting is a session on the investor’s view on what they see as up-and-coming innovation for clinical trials, and two examples of open source clinical research from the Moonshot Cancer 2020 and Zika Virus.
For more information on the conference, agenda and speakers click here.
-
June 20, 2016
-
Dr Isaac Kohane to Lead Rogue Therapeutics Event this Week – DPharm Speaker Series
We are so proud to announce that DPharm speaker Dr Isaac (Zak) Kohane is going rogue by presenting an amazing conference this week in Boston with disruptive leaders in Precision Medicine. See link for more details: https://dbmi.hms.harvard.edu/precision-medicine-2016
We are so proud to announce that DPharm speaker Dr Isaac (Zak) Kohane is going rogue by presenting an amazing conference this week in Boston with disruptive leaders in Precision Medicine.
Dr Isaac Kohane Speaking at Dpharm 2014 will Lead Precision Medicine 2016: Rogue Therapeutics on June 22nd in Boston
See link for more details: https://dbmi.hms.harvard.edu/
precision-medicine-2016
-
April 11, 2016
-
Congratulations to Conference Forum speaker, Dr Jules Mitchel
Congratulations to Conference Forum speaker, Dr Jules Mitchel, President of Target Health for his company’s recognition by the International World Trade Week in NYC, where he will receive an award for cost effective streamlining of the clinical research process on May 16, 2016. This award is from New York City, where Jules works and lives […]
Congratulations to Conference Forum speaker, Dr Jules Mitchel, President of Target Health for his company’s recognition by the International World Trade Week in NYC, where he will receive an award for cost effective streamlining of the clinical research process on May 16, 2016. This award is from New York City, where Jules works and lives so this recognition is quite an honor for him and Target Health.
As a backgrounder, every year, the President declares the third week of May as World Trade Week. Trade organizations, businesses and other stakeholders come together both nationally and locally to promote and facilitate international trade. World Trade Week NYC 2016 is an active network of more than 40 organizations in the New York metro region working together to underscore the importance of international trade, logistics and port operations on the region’s economy and to use their collective expertise to help the region’s businesses grow through international trade.
-
April 7, 2016
-
Pfizer’s Craig Lipset and Medical Campaigner, Alexander Masters on Pharma Talk Radio Discussing an Alternative Funding Model for Rare Disease
An Alternative Model to Transform a Funding Gap in Rare Disease Clinical Research Frustrated that a promising therapy for a rare cancer was sitting in a freezer due to the lack of a relatively modest amount of funding, author Alexander Masters helped lead a campaign to crowd-fund a clinical trial: the result, iCancer.org.uk. The money […]
An Alternative Model to Transform a Funding Gap in Rare Disease Clinical Research
Frustrated that a promising therapy for a rare cancer was sitting in a freezer due to the lack of a relatively modest amount of funding, author Alexander Masters helped lead a campaign to crowd-fund a clinical trial: the result, iCancer.org.uk. The money required was indeed raised – by one wealthy individual primarily, in return for being in the trial.
Craig Lipset interviewing Alexander Masters and Dr Magnus Essand at DPharm Europe
At DPharm Europe, Pfizer’s Craig Lipset interviewed on stage Alexander Masters to share his innovative story. We are delighted to share the journey and the latest updates on PharmaTalk Radio. In this disruptive discussion, we address:
- The remarkable story of the formation of iCancer.org.uk and the Oncolytic Virus Fund
- An alternative way to make clinical trials more accessible
- Ethical and moral issues
- A possible disruptive and sustainable business model for other neglected medicines
Listen to the show here.
The next DPharm: Disruptive Innovations to Advance Clinical Trials event takes place September 20-21 in Boston. The DPharm Europe event is scheduled for early February 8-9, 2017 in London. For more information about these events or our Immuno-Oncology events (IO 360° and Rational Combinations 360°), visit www.theconferenceforum.org.
Guest Host:
Craig Lipset, MBA, Head of Clinical Innovation, R&D, PfizerGuest:
Alexander Masters, Author, Campaigner and Co-Founder, iCancer.org.uk
Producer:
Valerie Bowling, Executive Director, Conference Forum & Pharma Talk Radio-
- Craig Lipset, Head of Clinical Innovation, R&D, Pfizer
-
- Alexander Masters, Author, Campaigner and Co-Founder, iCancer.org.uk
-
- Valerie Bowling, DPharm Europe Director
Telegraph Article Referenced by Craig During the Program: It’s time to sell tickets for places on life-saving medical trials
http://www.telegraph.co.uk/science/2016/04/05/its-time-to-sell-tickets-for-places-on-life-saving-medical-trial/
-
April 4, 2016
-
PharmaTalkRadio Covers A New Economic Solution to Drive Cures to Patients
PharmaTalkRadio features a radio discussion on a new model to repurpose drugs in unsolved diseases. Generic drugs can be repurposed to create effective treatments in unsolved diseases. However, there is no economic incentive for industry to pay for a clinical validation and regulatory approval process for most generic drug repurposing because it will not achieve […]
PharmaTalkRadio features a radio discussion on a new model to repurpose drugs in unsolved diseases.
Generic drugs can be repurposed to create effective treatments in unsolved diseases. However, there is no economic incentive for industry to pay for a clinical validation and regulatory approval process for most generic drug repurposing because it will not achieve the necessary ROI.
Bruce Bloom, Cures Within Reach presenting at Dpharm Europe 2016
Cures Within Reach, FindaCure, Numbers For Good and the National Health Service in England are working together to the create a new economic solution to this problem by piloting the first ever Rare Disease Generic Drug Repurposing Social Impact Bond (SIB).
This SIB would be a “pay for success” initiative, in which investors fund the proof of concept repurposing clinical trials and the government provides a payment to the SIB for any repurposed therapies that both improve patient outcomes and reduce healthcare costs. The government success payment would allow the SIB to repay the investors, and have additional funds for the next group of repurposing clinical trials, creating a sustainable funding source for generic drug repurposing.
Producer:
Valerie Bowling , Executive Director, Conference ForumGuest Host:
Bruce Bloom, JD, President & CSO, Cures Within ReachPanelists:
James Potter, Investment Director, Numbers for Good
Flóra Raffai , Executive Director, Findacure
Dr Rick Thompson , Scientific Officer, FindacureListen to the show here: http://www.blogtalkradio.com/pharmatalk/2016/04/01/a-new-economic-solution-to-drive-cures-to-patients
-
- Flora Raffai, Findacure presenting at Dpharm with Bruce Bloom (left) and James Potter (second from right)
-
- James Potter, Numbers for Good presenting at Dpharm Europe 2016
-
- Rick Thompson, Findacure
-
- Flora Raffai, Findacure presenting at Dpharm Europe 2016
-
- Valerie Bowling at DPharm Europe
Bruce Bloom led panels at both the Dpharm, Disruptive Innovations to Advance Clinical Trials conferences in Europe as well as in the US. Our next DPharm event will take place September 20-21 in Boston. For more information about other radio programs and the next DPharm event, please visit www.theconferenceforum.org.
Helpful Websites:
findacure.org.uk
numbersforgood.com -
-
January 19, 2016
-
Singing Opera with Someone Else’s Lungs
In September 2015, we were honored to open the 5th annual DPharm conference with Charity Sunshine Tillemann-Dick, a coloratura soprano and composer. After being diagnosed with Idiopathic Pulmonary Hypertension she received two double lung transplants. We share her story, a journey you will never forget and it reminds all of us the central reason why […]
In September 2015, we were honored to open the 5th annual DPharm conference with Charity Sunshine Tillemann-Dick, a coloratura soprano and composer. After being diagnosed with Idiopathic Pulmonary Hypertension she received two double lung transplants. We share her story, a journey you will never forget and it reminds all of us the central reason why we must never stop innovating to advance drug development.
The next Dpharm US conference is scheduled for September 20-21, 2016 in Boston. The DPharm Europe conference is scheduled for February 9-10, 2016 in London.
-
December 8, 2015
-
Making Clinical Trials a Care Option for Patients on PharmaTalk Radio
At Dpharm US 2015, Katherine Vandebelt, Global Head, Clinical Innovation, Eli Lilly hosted a talk show on Making Clinical Trials a Care Option for Patients to fantastic reviews. Dpharm Director, Valerie Bowling, welcomes Katherine as she hosts a similar session on Pharma Talk Radio. Katherine (Kathy) discusses how an organized multispecialty healthcare system, clinical research […]
Katherine Vandebelt, Global Head, Clinical Innovation, Eli Lilly at DPharm US
At Dpharm US 2015, Katherine Vandebelt, Global Head, Clinical Innovation, Eli Lilly hosted a talk show on Making Clinical Trials a Care Option for Patients to fantastic reviews. Dpharm Director, Valerie Bowling, welcomes Katherine as she hosts a similar session on Pharma Talk Radio. Katherine (Kathy) discusses how an organized multispecialty healthcare system, clinical research site network and pharma company used clinical research as a tool and connector to help improve patient engagement in their overall healthcare management and compliance.
More specifically:
– Healthcare System: improving health and service to patients and advocators of clinical research participation
– Clinical Research Site Network: bringing the right patients to the right trials with increased quality of data and engagement of patients
– Pharma: expanding our reach to patients and getting trials done faster
– Shifting the paradigm: Applying a Value Based Health Care Delivery Framework to improve outcomes and reduce healthcare costs
Panelists at DPharm US
Radio Show Participants:
– Host: Katherine Vandebelt, Global Head, Clinical Innovation, Eli Lilly and Company
– Jeff James, MBA, CEO, Wilmington Health
– Jennifer Byrne, CEO, PMG Research
– Allen Buechler, MBA, Advisor, Strategy and Operations, Eli Lilly and Company
– Toyin Okanlawon, MD, MPH, Senior Health Care Researcher, Harvard Business School Health Care Team
Click Here to Listen to the Show
Upcoming Clinical Research/Trial Conferences:
Dpharm: Disruptive Clinical Trials Europe, February 9-10, 2016, London, UK
Patients as Partners, March 14-15, 2016, Philadelphia, PA
Clinical Trial Collaborations, March 21-22, 2016, Boston, MAFor information, visit www.theconferenceforum.org
-
November 12, 2015
-
How Patient Research Changed the Way We Present Clinical Trial Conferences
Valerie Bowling, Executive Director of The Conference Forum discusses how her research with patients changed the way she looks at and presents all clinical trials conferences. ____________________________________________________ Five years ago, Greg Simon, who was the Head of Policy at Pfizer at the time and is now CEO of Poliwogg, asked our DPharm audience when was […]
Greg Simon, CEO, Poliwogg challenging the first Dpharm audience.
Valerie Bowling, Executive Director of The Conference Forum discusses how her research with patients changed the way she looks at and presents all clinical trials conferences.
____________________________________________________
Five years ago, Greg Simon, who was the Head of Policy at Pfizer at the time and is now CEO of Poliwogg, asked our DPharm audience when was the last time you thanked your patients for being in a clinical trial. No one raised their hand. My immediate thought was that there was an urgent need for a conference on customer service for patients in clinical trials.
Graphic illustration of Jeri Burtchell, Founder of PatientsinResearch.org and our first patient speaker!
I began to research the topic within the pharmaceutical industry and received enlightening feedback: we can’t look at patients as customers, we can’t directly communicate with patients, there are privacy laws, we don’t directly work with patients, and more. I learned that often people who have direct contact with patients are not necessarily trained to work with patients to empathize with their condition and life style.
What To Do?
I knew that something drastically had to change and a paradigm shift in how the industry views and works with patients was paramount. I also realized that as a researcher, I needed to start with myself. I needed to make that paradigm shift in who and how I do research. With that, five years ago, for the first time I began to research directly with patients. Getting their feedback changed the way I produce conferences and, more importantly, how I can potentially affect positive change for patients through my conferences.What Patient Research Taught Me
Patients taught me empathy with their disease, but also with their lifestyle and their struggles in finding and experiencing a clinical trial. In particular, I learned the vital need to cover sessions that:1. Understand and incorporate the patient’s voice in designing clinical trials and developing a clinical endpoint
2. Vastly improve the patient’s entire experience in a clinical trial
Patient Advocate Speakers
-
- The indomitable Tom Isaacs, Co-Founder, the Cure Parkinson’s Trust presenting at Dpharm Europe.
-
- Julie Flygare, Patient Advocate, talks About Narcolepsy and Developing a Clinical Endpoint for FDA.
-
- Opera singer and double lung transplant recipient, Charity Sunshine Tillemann-Dick, one of the most inspiring presenters ever!
-
- Jamie Goldfarb, medical hero and patient advocate spoke about her journey through immuno-oncology at the IO360 conference.
-
- Tim Omer, Patient Inventor and Advocate to speak at Dpharm Europe 2016.
-
- One of the greatest patient voices, Pat Furlong, Founding President & CEO, Parent Project Muscular Dystrophy speaking at Patients as Partners.
Dpharm US, Dpharm Europe, Patients as Partners, and Immuno-Oncology 360 would not be possible without the many supportive patients and industry executives who helped my team and I gain a better understanding of the science of patient-centricity in clinical research. Thank you!
-
-
September 3, 2015
-
Dpharm News: The White House Confirms Speaker for Precision Medicine Initiative Update
We are pleased to welcome Mina Hsiang, Digital Services Expert for the US Digital Service at the White House to the Dpharm speaking faculty. Ms Hsiang will give the Dpharm audience an update on the Precision Medicine Initiative on September 11th at 3:45. The mission of the Initiative is to enable a bold new […]
We are pleased to welcome Mina Hsiang, Digital Services Expert for the US Digital Service at the White House to the Dpharm speaking faculty. Ms Hsiang will give the Dpharm audience an update on the Precision Medicine Initiative on September 11th at 3:45.
The mission of the Initiative is to enable a bold new research effort to revolutionize how we improve health and treat disease. The future of precision medicine will enable health care providers to tailor treatment and prevention strategies to people’s unique characteristics, including their genome sequence, microbiome composition, health history, lifestyle, and diet. Many different types of data is needed from metabolomics, the microbiome, and data about the patient collected by health care providers and the patients themselves. Success will require that the health data is portable and that it can be easily shared between providers, researchers, and most importantly, patients and research participants.
Join us at Dpharm to find out the progress on the Initiative and next steps.
-
July 24, 2015
-
5 Questions for Dpharm Director, Valerie Bowling
Jessica Rothenberg, Marketing Director at the Conference Forum, asks Valerie Bowling, Dpharm Director, five questions to give both past and future attendees an insight into DPharm 2015. Q: What are you most excited about for Dpharm 2015? A: I’m really look forward to seeing the diverse examples of innovation to advance clinical trials from so […]
Jessica Rothenberg & Valerie Bowling
Jessica Rothenberg, Marketing Director at the Conference Forum, asks Valerie Bowling, Dpharm Director, five questions to give both past and future attendees an insight into DPharm 2015.
Q: What are you most excited about for Dpharm 2015?
A: I’m really look forward to seeing the diverse examples of innovation to advance clinical trials from so many different companies. I am also keen to hear about the ongoing results of which technologies, processes and strategies are actually reducing the length and cost of drug development. What will be transformative and sustainable? I am pleased to welcome some terrific new speakers to the program, and I’m excited to see what impact our patient speakers will have this year. One of our patient speakers is an opera singer with a lung transplant, who has the most extraordinary story that will remind us why we are at Dpharm to begin with.
Q: What is the process like putting the Dpharm agenda together when expectations get higher each year for the program?
A: The process begins as soon as the previous annual event ends. Feedback pours in from passionate attendees who were at the event. We combine this with new research before meeting with the Dpharm advisory board. In addition to this long list of topics, we also get additional submissions from companies that have something new to report.
From this point, a painful selection process takes place, as we don’t have enough stage time for every worthy talk. 90% of the sessions have never been presented before and about 10% have, but these are usually in unrelated or non-public venues.
Each year, our audience does have higher expectations. Companies are at vastly different stages in the evolution of innovative approaches to advance clinical development, and what one company thinks is really innovative is not so innovative for another company. Determining this can be challenging and requires careful research.
Q: What can we expect that is new at DPharm 2015?
A: Almost everything on the agenda is new, but to name a few… For the first time, we have a large pharma HR Director talking about the future of staffing to drive and support innovation. We also have a top CEO from a renewable energy company sharing how she creates a culture to drive sustainable innovation. Dpharm Idol judges will be led by the patient voice for the first time. This is very exciting as they have some of the best insights into which technologies or services can truly impact the patient experience.
2014 Dpharm Idol Judges with presenter Helen West, MMG
J&J unveil what’s happening with their three new research platforms. Genentech shares the learnings from three decentralized clinical trials. Scripps Clinical presents on the results of a brand new out-of-the-box study called mSToPS. Eli Lilly talks about a couple of cool new concepts, in particular one on an “Open Table” concept to patient scheduling. I am especially looking forward to seeing the big elephant in the room addressed for the first time: disrupting the CRO.
We also welcome Google [x] and other tech companies to the stage. I am very intrigued by a new topic being featured on day two of the program on disrupting the process to accelerate cures through repurposing research. We have a special session with pediatric patients, who give us an incredible insight into how we can make clinical trials better for all patients. You can see all the new topics on the agenda on our website.
Q: What do you want attendees to get out of Dpharm 2015?
A: Let me start by saying that the our past attendees have told us that the networking is as valuable as the conference itself. The connections and support with like-minded individuals have provided enormous value to our attendees. We keep seeing examples in the press where companies have collaborated as a result of attending DPharm. For example, Trial Reach was recently featured in Forbes from their work with Pfizer, Novartis and Eli Lilly with a consortium created called Patients to Trials formed as a result of meeting at Dpharm.
The exhibitors and sponsors love meeting the most innovative thinkers and doers in the industry and they know Dpharm is the best place to meet them. The product and service companies at Dpharm are so passionate about helping pharma innovate, especially when it impacts patients.
We purposely keep Dpharm at a reasonable size so that people have the chance to engage in more meaningful conversations. Most of all we want Dpharm attendees to leave the event well-networked, inspired and armed with something tangible to help advance and improve their clinical trials.
Dpharm: Disruptive Innovations for Clinical Trials 2014
-
July 16, 2015
-
Dpharm Announces Opening Keynote Panel: How To Build A Corporate Culture of Sustainable Innovation
The Dpharm conference is delighted to announce the opening keynote panel is on, How To Build A Corporate Culture of Sustainable Innovation. In the biopharmaceutical industry, building a corporate culture that encourages people to embrace and act upon the various forms of innovation is no small task. Perhaps even more difficult is the process of […]
The Dpharm conference is delighted to announce the opening keynote panel is on, How To Build A Corporate Culture of Sustainable Innovation.
In the biopharmaceutical industry, building a corporate culture that encourages people to embrace and act upon the various forms of innovation is no small task. Perhaps even more difficult is the process of changing a Big Pharma company culture away from the “that’s not how we do things around here” mindset, to one that fully embraces sustainable, incremental, as well as game changing innovation. Why then do companies like Bayer and J&J, which have a combined 281 years, and over 240,000 employees, continue to be recognized for their ability to innovate?
For those who think it is easy for academics to be innovative, you obviously haven’t experienced the bureaucracies that exist in many of our institutes of higher education. MIT was founded two days before the civil war, and yet today is one of the most innovative schools in the world. Yes, getting a drug approved by the FDA is difficult. But imagine you are attempting to create a sustainable business that is going to generate power from garbage, while successfully collaborating with 50 individual state regulatory commissions. This is what one of Fast Company’s top rated innovative companies, Harvest Power, does.
Moderated by Rob Wright, chief editor of Life Science Leader magazine and author of numerous articles on innovation and corporate culture, this hand selected keynote panel will explore what it really takes to create a corporate culture of sustainable innovation.
Join us on September 10th to be part of this game changing session.
For more information on all the sessions, click here.
Moderator:
Robert Wright
Editor-in-Chief, Life Science LeaderKeynote panelists:
Camilo Cobos, MBA
VP, Human Resources, Janssen Pharmaceutical Companies of Johnson and Johnson
Kathleen Ligocki, MBA
CEO, Harvest Power
Chandra Ramanathan, PhD, MBA
Senior Director, Innovation Strategy & Global Lead, External Innovation, Bayer AG
David Shrier
Managing Director, Connection Science & Engineering, MIT
-
June 21, 2015
-
Congratulations to Allergan’s Brent Saunders and David Nicholson, R&D Leadership 2015 Keynote Speakers, on Ringing the Opening Bell at the NY Stock Exchange
Allergan’s CEO, Brent Saunders and Dr David Nicholson, EVP, Brand R&D, both 2015 keynotes at the R&D Leadership Summit along with other company members had the honor to ring in the opening bell of the NY Stock Exchange earlier this week. They have much to celebrate with a new deal they are closing to add […]
Allergan’s CEO, Brent Saunders and Dr David Nicholson, EVP, Brand R&D, both 2015 keynotes at the R&D Leadership Summit along with other company members had the honor to ring in the opening bell of the NY Stock Exchange earlier this week. They have much to celebrate with a new deal they are closing to add to their lineup of cosmetic medicines. They agreed to buy Kythera’s newly approved double-chin treatment in a $2.1 billion deal.
-
April 30, 2015
-
DPharm Makes Stuff Happen!
We are so pleased to see another exciting outcome from the DPharm conference. Congratulations to TrialReach on making news in Forbes from their work with industry in registering patients in trials faster. Drug Companies Pin Hopes On TrialReach To Enroll Patients In Clinical Trials Faster Two years ago, Pfizer, Novartis, and Eli Lilly set aside […]
Jeff Kasher, formerly vice president of Clinical Innovation and Implementation at Eli Lilly and president of Patients Can’t Wait with Pablo Gravier, CEO, TrialReach at the inaugural DPharm Europe
We are so pleased to see another exciting outcome from the DPharm conference. Congratulations to TrialReach on making news in Forbes from their work with industry in registering patients in trials faster.
Drug Companies Pin Hopes On TrialReach To Enroll Patients In Clinical Trials Faster
Two years ago, Pfizer, Novartis, and Eli Lilly set aside competition to form a consortium called Patients to Trials. Goal: To solve an issue that has bedeviled their industry and slowed drug development—namely how to enroll patients in clinical trials faster. According to CenterWatch, 75% of the public is unaware of clinical studies, and nearly half of trials don’t fulfill their recruitment goals, causing delays. “If we can compress the time it takes to enroll a trial, we can get medicines to patients much faster,” says Jeff Kasher, formerly vice president of Clinical Innovation and Implementation at Eli Lilly, and president of Patients Can’t Wait.
Continue Reading here: http://www.forbes.com/sites/
zinamoukheiber/2015/04/23/ drug-companies-pin-hopes-on- trialreach-to-enroll-patients- in-clinical-trials-faster/
-
December 3, 2014
-
Building a European Adaptive Trial Delivery Machine for Dementia @ Dpharm Europe
We are so pleased to welcome Professor Craig Ritchie, Professor of the Psychiatry of Ageing, Centre for Clinical Brain Sciences University of Edinburgh and Visiting Professor Imperial College London to the DPharm Europe conference. DPharm Europe features global examples of disruptive innovation in clinical trials. Not all innovation is disruptive, but in the case of […]
Professor Craig Ritchie
We are so pleased to welcome Professor Craig Ritchie, Professor of the Psychiatry of Ageing, Centre for Clinical Brain Sciences University of Edinburgh and Visiting Professor Imperial College London to the DPharm Europe conference.
DPharm Europe features global examples of disruptive innovation in clinical trials. Not all innovation is disruptive, but in the case of Dr Ritchie’s work, a first of its kind, we believe it is a unique example of innovation.
The professor will share his journey on how he challenged a traditional system to propose substantial changes to develop a public-private collaborative European clinical platform for preventing dementia: The EPAD (European Prevention of Alzheimer’s Dementia). More specifically Dr Ritchie addresses:
- – The questions to ask in challenging old ways of doing things
- – Forming and communicating a vision
- – What it takes to build public, private and patient collaboration
- – Execution and next steps
Dpharm Europe takes place in London on February 10-11, 2015.
-
December 1, 2014
-
Eli Lilly Confirmed to Discuss Trial Match “Patient 2 Trial” Progress @ Dpharm Europe
We are so pleased to welcome Thomas Krohn, Director, Lilly Open Innovation, Eli Lilly to Dpharm: Disruptive Innovations to Advance Clinical Trials Europe. Tom will give the latest update and progress on the Patients 2 Consortium effort between Lilly, Pfizer and Novartis. This effort is focused on enabling patients and those who serve patients to […]
We are so pleased to welcome Thomas Krohn, Director, Lilly Open Innovation, Eli Lilly to Dpharm: Disruptive Innovations to Advance Clinical Trials Europe. Tom will give the latest update and progress on the Patients 2 Consortium effort between Lilly, Pfizer and Novartis. This effort is focused on enabling patients and those who serve patients to easily pre-screen patients to clinical studies, including using their electronic medical record such as a Blue Button+ document. Through consistent, structured clinical trial eligibility criteria made available through an open API technical platform, so-called “matching services” can be enabled to streamline patient engagement and potential clinical trial participation.
Thomas Krohn at Dpharm US 2014
The update will include:
• What is “P2T” or Match project
• Where are we today and what is current focus and activity including end-user collaborations
• What types of end-user collaborations are in place, what have we learned, and anticipated benefits to end-users
• What are the key learnings we have had in the consortium that have helped move this project forwardDpharm Europe takes place in London on February 10-11, 2015.
-
November 14, 2014
-
Learning From Mistakes: Ulo Palm, SVP, Drug Development and Research Operations, Forest Laboratories
Outsourced Pharma and Clinical Leader’s Chief Editor, Ed Miseta reports on Ulo Palm’s Dpharm session: I have always been taught you can learn as much from your mistakes as you can from your successes. Oftentimes the lessons learned are much more valuable than what you glean from those positive outcomes. While all learning experiences are […]
Outsourced Pharma and Clinical Leader’s Chief Editor, Ed Miseta reports on Ulo Palm’s Dpharm session:
I have always been taught you can learn as much from your mistakes as you can from your successes. Oftentimes the lessons learned are much more valuable than what you glean from those positive outcomes. While all learning experiences are valuable, unfortunately some can come at a fairly high price. If the lesson is learned at work, and the cost is sufficiently high, you may even have concerns about your career. That is a situation that Ulo Palm, SVP of Drug Development and Research Operations for Forest Laboratories (recently acquired by Actavis), once faced. Palm shared this personal story during the Dirty Laundry session at the 2014 Disruptive Innovations conference.
“This lesson happened years ago during what I like to call the dark ages of patient recruitment,” says Palm. “Back then, we did not have the Internet, social media, and other sophisticated tools. You had to review investigator lists and call them to find out how many patients they could enroll in a study. Those who have done this can tell you it is not a very efficient way of managing recruitment.”
Read the rest of the article here: http://www.clinicalleader.com/doc/learning-from-mistakes-ulo-palm-svp-drug-development-and-research-operations-forest-laboratories-0001
-
October 10, 2014
-
Learning From Clinical Mistakes: Jeff Kasher, VP Of Clinical Innovation & Implementation For Lilly
We are pleased to share this posting from Ed Miseta, Chief Editor, Outsourced Pharma and Clinical Leader. Ed highlights an important piece of content from the DPharm 2014 meeting where clinical leaders shared mistakes and lessons learned in clinical trials. As the head of clinical innovation for Eli Lilly and Company, Jeff Kasher, Ph.D. likes […]
We are pleased to share this posting from Ed Miseta, Chief Editor, Outsourced Pharma and Clinical Leader. Ed highlights an important piece of content from the DPharm 2014 meeting where clinical leaders shared mistakes and lessons learned in clinical trials.
As the head of clinical innovation for Eli Lilly and Company, Jeff Kasher, Ph.D. likes to spend time thinking about different parts of the clinical business and how they can be improved. Speaking during the Dirty Laundry session at the 2014 Disruptive Innovations conference, he noted a recent experiment where he toyed with the idea of eliminating central labs from the clinical trial process.For the full posting, see link below.
http://www.clinicalleader.com/doc/learning-from-clinical- mistakes-jeff-kasher-vp-of- clinical-innovation- implementation-for-lilly-0001? sthash.WCJbzKG7.mjjo The Dirty Laundry session will also be part of Dpharm Europe taking place February 10-11, 2015 in
London. For more information about the Dpharm Europe program visit: https://theconferenceforum.org/conferences/disruptive-innovations-europe/overview/
-
October 9, 2014
-
CISCRP to Launch a Museum Exhibit to Educate Kids about the Clinical Research Process
We are so pleased to tell you that our friends at CISCRP will be launching a museum exhibit in 2015 to educate elementary through high-school aged children about the clinical research process and what it means to be a participant in clinical trials. This new exhibit is slated to travel to major science museums in […]
We are so pleased to tell you that our friends at CISCRP will be launching a museum exhibit in 2015 to educate elementary through high-school aged children about the clinical research process and what it means to be a participant in clinical trials. This new exhibit is slated to travel to major science museums in 12 cities over a three year tour. Exhibit content will be integrated into local school curricula and it will receive significant public relations exposure raising general public awareness about clinical research.
The exhibit content has been reviewed with a variety of stakeholders including the NIH, FDA, clinical research professionals and bioethicists. The project is now entering its final stage of development requiring substantial funding to complete production and begin its launch. Astra-Zeneca, Pfizer, INC, ACRP and ACRO are among companies that have already provided their support.
Please email ellyngetz@ciscrp.org if you are interested in learning more about sponsoring this important traveling museum exhibit.
-
September 29, 2014
-
DrugDev’s Review on DPharm: Disruptive Innovations to Advance Clinical Trials
There were so many inspirational talks at this year’s conference it was hard to know where to start. So, we decided to split this post into three main themes: patient-centricity, ‘real-world’ integration into research, and innovative trial design. (For more on DrugDev’s review, see link below: http://www.drugdev.org/2014/09/19/disruptive-innovations-conference-review/
There were so many inspirational talks at this year’s conference it was hard to know where to start. So, we decided to split this post into three main themes: patient-centricity, ‘real-world’ integration into research, and innovative trial design. (For more on DrugDev’s review, see link below:
http://www.drugdev.org/2014/09/19/disruptive-innovations- conference-review/ -
- Dr Jeff Kasher, Eli Lilly, putting on our ‘patient glasses’ to see innovation through their lens
-
- Ibraheem Mahmood at Dpharm 2015
-
- Julie Flygare, narcolepsy patient advocate and author with DPharm Director, Valerie Bowling
-
- Gamification speakers Dr Eddie Martucci, Akili Interactive Labs and Annik Willems, Janssen
-
-
September 24, 2014
-
Congresswoman Diana DeGette Discusses Path 2 Cures Initiative at DPharm
We were honored to welcome Congresswoman Diana DeGette as our Keynote speaker at DPharm on September 12, 2014. Rep. DeGette is helping lead a landmark initiative dedicated to creating a path to 21st century cures. For the first time ever, Congress is taking a comprehensive look at what can be done to accelerate the pace […]
We were honored to welcome Congresswoman Diana DeGette as our Keynote speaker at DPharm on September 12, 2014. Rep. DeGette is helping lead a landmark initiative dedicated to creating a path to 21st century cures. For the first time ever, Congress is taking a comprehensive look at what can be done to accelerate the pace of cures in America. They are looking at the entire spectrum, from discovery and development to delivery of medicines. Rep. DeGette gave the DPharm audience of more than 300 life science industry professionals an update on the progress of the initiative and generously answered many audience questions. The genuine support from Rep. DeGette’s message could be felt by the audience throughout the conference venue. The coming together of true collaboration from all walks of the pharma/biotech industry, including non-profits, academia and more government initiatives, is truly inspiring drug developers.
See more at: http://energycommerce.house.gov/cures#sthash.Kw7FVj3d.dpuf -
- Komathi Stem, Genentech greets U.S. Rep. Diana DeGette
-
- U.S. Rep. Diana DeGette keynoting at DPharm
-
- Congresswoman Diana DeGette discussing Path 2 Cures initiative with DPharm Director, Valerie Bowling
-
- Breakfast Meeting with Congresswoman Diana DeGette with DPharm Director, Valerie Bowling and members of the DPharm Advisory Board
-
- Joseph Kim, Eli Lilly, Dr Jules Mitchel, Target Health, Komathi Stem, Genentech, Dr Jeffrey Kasher, Eli Lilly, Congresswoman Diana DeGette, Dr Joris Van Dam, Novartis, Valerie Bowling, Conference Forum, Craig Lipset, Pfizer and Linda Morgan, Parkinson’s Disease Foundation
About U.S. Rep. DeGette
Chief Deputy Whip Diana DeGette is serving her 9th term in Congress as Representative for the First District of Colorado. As a member of the powerful Committee on Energy and Commerce, an exclusive congressional committee with vast jurisdiction over health care, trade, business, technology, food safety, and consumer protection, she is one of the leading voices in the health care debate in this country. She also serves as the Ranking Member of the Subcommittee on Oversight and Investigations, which conducts the oversight of, and investigations into, issues falling under the jurisdiction of the full committee. As a member of the Democratic leadership, she played a vital role in the reauthorization of the Children’s Health Insurance Program, has fought for tough food safety legislation, and was a key player in crafting a comprehensive consumer product safety bill.U.S. Rep. DeGette is also the chief architect of legislation to expand stem cell research, which has been passed twice with broad, bipartisan support in Congress.
-
-
September 22, 2014
-
Once Upon a Time, 3D Printing, Crowdsourcing & Open Innovation Came Together to Create a Medical Device That Enabled 800 People
This was the theme of our interview keynote with Robohand Founder, Richard Van As. Craig Lipset, Head of Clinical Innovation, R&D, Pfizer interviewed Richard on how he disrupted the cost of prosthetics and created Robohand. Richard had a woodworking accident in May 2011 severing all his fingers on his right hand. Straight out of the […]
This was the theme of our interview keynote with Robohand Founder, Richard Van As. Craig Lipset, Head of Clinical Innovation, R&D, Pfizer interviewed Richard on how he disrupted the cost of prosthetics and created Robohand. Richard had a woodworking accident in May 2011 severing all his fingers on his right hand. Straight out of the hospital, Richard set to work in researching and developing a finger replacement for himself. He discovered after his accident that prosthetics are not affordable for the lay-man, and there are no functioning replacement digits. Richard changed that not just for himself, but for hundreds of others and counting by making the so called impossible, possible. For more information on Richard’s story, see: https://www.youtube.com/watch?
v=WT3772yhr0o -
- Richard Van As on the Dpharm stage with Craig Lipset, Pfizer
-
- Richard Van As, Robohand with DPharm Director, Valerie Bowling
-
- Richard Van As on the Dpharm stage with Craig Lipset, Pfizer
-
- Richard Van As, Robohand with Jennifer Moran and Valerie Bowling of the Conference Forum
-
-
September 19, 2014
-
Bringing the Patient Voice to Disruptive Innovations Conference
A huge thanks to our patient speaker, Julie Flygare for her excellent presentation on “How a Patient Helped to Define a New Clinical Endpoint in Narcolepsy.” Diagnosed with narcolepsy with cataplexy in 2007, award-winning author and founder of Project Sleep, Julie shared her story to an audience of just over 300 disruptive thinkers in drug […]
A huge thanks to our patient speaker, Julie Flygare for her excellent presentation on “How a Patient Helped to Define a New Clinical Endpoint in Narcolepsy.” Diagnosed with narcolepsy with cataplexy in 2007, award-winning author and founder of Project Sleep, Julie shared her story to an audience of just over 300 disruptive thinkers in drug development.
Julie is one of those exceptional people who is taking her disease to help all kinds of patients through her involvement with the FDA in helping them develop a clinical end point.See Julie’s blog post from the DPharm conference.
http://julieflygare.com/bringing-the-patient-voice-to-disruptive-innovations-conference/We were also honored to welcome our first patient judge to Dpharm Idol, Linda Morgan. Linda a research advocate and chair of the patient’s council at the Parkinson’s Disease Foundation helped define the Dpharm Idol 2014 winner, ePharmaSolutions.
-
- Julie Flygare in an interview with DPharm Director, Valerie Bowling
-
- Julie Flygare presenting at DPharm
-
- Julie Flygare signing her book for a DPharm attendee
-
- Linda Morgan, with DPharm Idol judges
-
-
September 17, 2014
-
Congratulations to ePharmaSolutions on Disruptive Innovator of the Year at DPharm 2014!
Congratulations to Lisa La Luna, SVP, Corporate Development and Implementation and her team on winning Disruptive Innovator of the Year at DPharm 2014. They won for their excellent presentation on paperless clinical trials. The judges included: Andreas Koester, MD, PhD VP, Clinical Trial Innovation & External Alliances, Janssen Craig Lipset, MBA, Head of Clinical Innovation, R&D, […]
Congratulations to Lisa La Luna, SVP, Corporate Development and Implementation and her team on winning Disruptive Innovator of the Year at DPharm 2014. They won for their excellent presentation on paperless clinical trials.
The judges included:
Andreas Koester, MD, PhD VP, Clinical Trial Innovation & External Alliances, Janssen
Craig Lipset, MBA, Head of Clinical Innovation, R&D, Pfizer, Inc.
Paulo Moreira, VP, GCO, Head of External Innovation, EMD Serono
Linda Morgan , Research Advocate & Patients Advisory Council Member, Parkinson’s Disease Foundation
Ulo Palm, MD, PhD, MBA , SVP, Drug Development & Research Operations, Forest Labs
Komathi Stem, Senior Director, Product Development, Innovation Lead, GenentechePharmaSolutions competed bravely with other excellent disruptive companies including MMG, medpoint, Patient Profiles, Veeva, iCTRS and AiCure.
“They presented the benefits of their PharmaONE eClinical platform with tremendous transparency. It was an exciting win and lovely to see the support and camaraderie between our ‘Disruptive Innovator of the Year’ 2013 winner, Glen de Vries, President of Medidata Solutions and Lisa La Luna and her team,“ says Valerie Bowling, Director, DPharm.
-
- ePharmSolutions Team
-
- ePharmSolutions Team
-
- Glen de Vries, President, Medidata Solutions, winner of Disruptive Innovator of the Year at DPharm 2013 presenting at the 2013 event
-
- Valerie Bowling, DPharm Director with 2013 Disruptive Innovator winner, Glen De Vries, President, Medidata Solutions
-
- Discusing the Dpharm Idol Trophy!
-
- Lisa La Luna, ePharmaSolutions 2014 winner with Glen De Vries, President, Medidata Solutions, 2013 winner
About ePharmaSoultionsePharmaSolutions is a leading provider of technology-driven clinical services that help accelerate and improve site feasibility, study start-up, and patient recruitment/retention. Our award winning patient engagement solutions help patients find suitable trials, consent for those trials electronically, and be alerted of study visits and medication reminders globally. ePharmaSolutions is headquartered in Philadelphia and London. For more information, visit www.epharmasolutions.com.
-
-
August 27, 2014
-
Why Walgreens is Dedicating Resources to Clinical Research?
Dr Howard Golub was recently appointed in a new role as Vice President, Clinical Research at Walgreens. We caught up with Dr Golub who shared a bit about his plans to build a research team to handle some pre-approved drugs, but mostly post approvals. This new area for Walgreens is part of their overall plan […]
Dr Howard Golub was recently appointed in a new role as Vice President, Clinical Research at Walgreens. We caught up with Dr Golub who shared a bit about his plans to build a research team to handle some pre-approved drugs, but mostly post approvals. This new area for Walgreens is part of their overall plan to enhance health and wellness and to increase the utilization of their talented staff of pharmacists.
W
e are delighted to welcome Dr Golub to the Dpharm speaking faculty where he will present more on the strategy behind clinical research at Walgreens on September 11 in Boston. He will also discuss how they plan to leverage internal assets and their vision for providing best in class health and wellness.
-
August 26, 2014
-
Medtech Boston talks with Valerie Bowling about Conference Forum events
If you’re interested in disruptive innovations in clinical trials or drug delivery, Boston is prime real-estate. That’s why The Conference Forum will be hosting four major events in September and October 2014: Mobile and Clinical Trials; Global Clinical Trials; DPharm: Disruptive Innovations to Advance Clinical Trials; and Partnerships in Drug Delivery. We caught up with […]
If you’re interested in disruptive innovations in clinical trials or drug delivery, Boston is prime real-estate. That’s why The Conference Forum will be hosting four major events in September and October 2014: Mobile and Clinical Trials; Global Clinical Trials; DPharm: Disruptive Innovations to Advance Clinical Trials; and Partnerships in Drug Delivery. We caught up with conference director Valerie Bowling to find out about these meetings. Click here for more…
http://medtechboston.medstro.com/conference-forum-events- in-boston-to-focus-on- clinical-trial-innovation/
-
August 11, 2014
-
Speakers Recognized by PharmaVoice100
PharmaVOICE 100 is an annual list of individuals recognized for their positive contributions to the life-sciences industry. These people actively demonstrate what it means to think bigger and lead with passion and integrity. They are nominated by thousands of PharmaVOICE readers throughout the year. We are so pleased to see several of our speakers make […]
PharmaVOICE 100 is an annual list of individuals recognized for their positive contributions to the life-sciences industry. These people actively demonstrate what it means to think bigger and lead with passion and integrity. They are nominated by thousands of PharmaVOICE readers throughout the year. We are so pleased to see several of our speakers make the list including:
Aaron Fleishman, BBK Worldwide, Regina Holliday, Artist and Patient Advocate, Dr Jules Mitchel, Target Health, Dr Ibraheem Mahmood, DrugDev and Badhri Srinivasan, Quintiles. Congratulations to all of them! Congratulations as well to Taren Grom, editor and her team on a beautifully written issue. We are so proud to have PharmaVoice as a media partner on our events.
To view the 2014 list of the PharmaVOICE 100: http://www.pharmavoice.com/
content/digitaledition.html? pg=14
-
July 29, 2014
-
Donald Jones, Chief Digital Officer at the Scripps Translational Science Institute joins Dpharm
We are delighted to welcome Don Jones, global expert on wireless technologies and mobility to the DPharm speaking faculty. Don will share his insights on how we can marry a digital solution with our drugs to allow us to understand outcomes and the ability to manage regulatory and reimbursement demands. Bio Donald Jones is globally […]
We are delighted to welcome Don Jones, global expert on wireless technologies and mobility to the DPharm speaking faculty. Don will share his insights on how we can marry a digital solution with our drugs to allow us to understand outcomes and the ability to manage regulatory and reimbursement demands.
Bio
Donald Jones is globally recognized for his expertise in wireless technologies, mobility and network effect for fitness, health and healthcare products, apps and therapies. For eleven years, through 2014, Mr Jones served as Qualcomm’s Vice President of Wireless Health Global Strategy and Market Development. In 2011, working with the XPRIZE Foundation and Qualcomm’s CEO, he conceived the $10M Qualcomm Tricorder XPRIZE for a consumer device capable of making multiple diagnosis. He is Chairman of the Wireless Life Sciences Alliance. Mr Jones was a founding board member of the West Wireless Health Institute (now West Health Institute) with the renowned physician, Eric Topol, MD and philanthropists, Gary and Mary West, raising over $100M. In 2010, the San Diego Transcript named Jones one of San Diego’s Top Influential ‘s and Fierce Health IT named Jones ‘One of 10 Disruptive Forces in Health IT’.
Mr Jones has spent over 30 years developing, founding and growing healthcare enterprises. Mr Jones holds a bachelors’ degree in biology and bioengineering from the University of California, San Diego, a Juris Doctor from the University of San Diego and an MBA from the University of California, Irvine. Mr Jones has multiple issued and pending patents in the use of wireless technologies in healthcare.
-
July 16, 2014
-
Rep. Diana DeGette (D-CO) Addresses 21st Century Cures at Dpharm
21st Century Cures is a new initiative that aims to accelerate the pace of cures and medical breakthroughs in the United States. Rep. Diana DeGette (D-CO) and House Energy and Commerce Committee Chairman Fred Upton (R-MI) are leading this initiative. This is a rare effort in Congress and we are thrilled to have Diana DeGette as […]
21st Century Cures is a new initiative that aims to accelerate the pace of cures and medical breakthroughs in the United States. Rep. Diana DeGette (D-CO) and House Energy and Commerce Committee Chairman Fred Upton (R-MI) are leading this initiative. This is a rare effort in Congress and we are thrilled to have Diana DeGette as our keynote and for her to give an update on the progress at DPharm on September 12th in Boston.
From ENERGY & COMMERCE COMMITTEE
A Path to 21st Century Cures Mission
In the 21st century, health care innovation is happening at lightning speed. From the mapping of the human genome to the rise of personalized medicines that are linked to advances in molecular medicine, we have seen constant breakthroughs that are changing the face of disease treatment, management, and cures. Health research is moving quickly, but the federal drug and device approval apparatus is in many ways the relic of another era. We have dedicated scientists and bold leaders at agencies like the NIH and the FDA, but when our laws don’t keep pace with innovation, we all lose.
If we want to save more lives and keep this country the leader in medical innovation, we have to make sure there’s not a major gap between the science of cures and the way we regulate these therapies.
That is why, for the first time ever, we in Congress are going to take a comprehensive look at what steps we can take to accelerate the pace of cures in America. We are looking at the full arc of this process – from the discovery of clues in basic science, to streamlining the drug and device development process, to unleashing the power of digital medicine and social media at the treatment delivery phase.
We know we don’t have all the answers. That’s why we’re asking questions first. We are listening. We want to know how to close the gaps between advances in scientific knowledge about cures and the regulatory policies created to save more lives.
Over the next several months, members will take a comprehensive look at the full arc of this process – from the discovery to development to delivery – to determine what steps we can take to ensure we are taking full advantage of the advances this country has made in science and technology and use these resources to keep America as the innovation capital of the world.
– See more at: http://energycommerce.house.
gov/cures#sthash.b9sN3IrS.dpuf For more information on Path to 21st Century Cures: https://theconferenceforum.org/
conferences/disruptive- innovations/agenda/#day-22844- tab
-
July 14, 2014
-
Collaborative Clinical Trials (Lung-MAP) to be Featured at Dpharm
Dr Jeff Allen of Friends of Cancer Research joins Dpharm to share the journey of a new paradigm in clinical research. Lung Cancer Master Protocol (Lung-MAP) is the product of years of collaboration with government, research institutions, patient advocacy groups, and industry. Will cooperative trials provide a more efficient model? On Sept 11th in Boston […]
Dr Jeff Allen of Friends of Cancer Research joins Dpharm to share the journey of a new paradigm in clinical research. Lung Cancer Master Protocol (Lung-MAP) is the product of years of collaboration with government, research institutions, patient advocacy groups, and industry. Will cooperative trials provide a more efficient model? On Sept 11th in Boston at Dpharm, Jeff will be joining Dr Lynn Marks, SVP, Projects, Clinical Platforms & Sciences GSK and Dr Santiago Arroyo, VP, CMO & Head of Clinical Research for Pharma Therapeutics, Pfizer Worldwide R&D to explore the idea of doing trials together.
From the June 16, 2014 press release:
Groundbreaking Collaborative Clinical Trial Launched
The Lung-MAP trial uses a multi-drug, targeted screening approach to match patients with promising new cancer treatments based on their unique tumor profiles.
A unique public-private collaboration among the National Cancer Institute (NCI), part of the National Institutes of Health, SWOG Cancer Research, Friends of Cancer Research (Friends), the Foundation for the National Institutes of Health (FNIH), five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global biologics R&D arm, MedImmune), and Foundation Medicine today announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial.
Lung-MAP is a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Squamous cell carcinoma represents about a quarter of all lung cancer diagnoses, but there are currently few treatment options beyond surgery for the disease. The trial will use genomic profiling to match patients to one of several different investigational treatments that are designed to target the genomic alterations found to be driving the growth of their cancer. This innovative approach to clinical testing should both improve access to promising drugs for patients and ease the significant recruitment and infrastructure burdens on researchers involved in traditional clinical trials.
“This diverse, collaborative approach, with support from leading lung cancer advocacy organizations, helps to ensure that the needs of patients, clinicians, developers, and regulators are all considered in the design and operation of the trial,” said Dr. Ellen Sigal, Chair & Founder of Friends of Cancer Research.
The trial will initially test five experimental drugs-four targeted therapies and an anti-PD-L1 immunotherapy. It is anticipated that between 500 and 1000 patients will be screened per year for over 200 cancer-related genes for genomic alterations. The results of this test will be used to assign each patient to the trial arm that is best matched to their tumor’s genomic profile.
“Lung-MAP represents the first of several planned large, genomically-driven treatment trials that will be conducted by NCI’s newly formed National Clinical Trials Network (NCTN),” said Jeff Abrams, M.D., Associate Director of NCI’s Cancer Therapy Evaluation Program. “The restructuring and consolidation of NCI’s large trial treatment program, resulting in the formation of the NCTN, is quite timely, as it now can offer an ideal platform for bringing the benefits of more precise molecular diagnostics to cancer patients in communities large and small.”
“Squamous cell lung cancer, like many other neoplasms, is increasingly recognized as consisting of a host of relatively rare genomic subsets, each of which may require treatment with a different targeted drug,” said Dr. Charles Blanke, Chair of SWOG Cancer Research. “The Lung-MAP S1400 trial models a way to efficiently study a large number of these rare squamous cell subsets under one master protocol.”
Lung-MAP aims to establish a model of clinical testing that more efficiently meets the needs of both patients and drug developers. Whereas a typical clinical trial for a targeted therapy tests each potential patient for a single biomarker and enrolls only a portion-sometimes a very small portion-of patients tested, Lung-MAP will simultaneously test patients for many biomarkers including selected base substitutions and small in/dels, gene fusions, and amplifications in order to assess compatibility with several different experimental treatments. All patients tested will then be enrolled into one of Lung-MAP’s five trial arms.
“Traditional clinical trials have long imposed significant recruitment and infrastructure burdens on researchers and patients, with frustratingly slow results,” said Maria Freire, Ph.D., President and Executive Director of the FNIH. “This master protocol will allow multiple enrollees to be tested once and assigned to a treatment most likely to work for them, rather than separate tests for separate trials with most patients ineligible. This strategy will validate biomarkers and facilitate drug development in one infrastructure, to more rapidly provide safer and more effective treatments to patients.”
Lung-MAP will make it easier for patients and researchers to find one another. It will also be more flexible than traditional clinical trial models. Where typical clinical trials require the development of new protocols for each new drug tested, Lung-MAP uses a single “master protocol,” which can be amended as needed as drugs enter and exit the trial, preserving infrastructure and patient outreach efforts.
The trial will be conducted at over 200 medical centers by NCI’s NCTN, led by SWOG, and partly funded by NCI through its Cancer Therapy Evaluation Program. Significant additional funding will be provided by the participating companies as part of a partnership managed by FNIH that also involves the Food and Drug Administration (FDA), Friends, and other patient advocacy organizations. The trial infrastructure is capable of testing as many as 5-7 additional drugs over the next 5 years, and will cost up to $160 million.
In addition to the individuals quoted above, key members of the Lung-MAP trial leadership also include: David Gandara, Chair, Lung Committee, SWOG and director, The Thoracic Oncology Program at UC Davis Cancer Center; Roy Herbst, Ensign Professor of Medicine and Chief of Medical Oncology at Yale Cancer Center; Vali Papadimitrakopoulou, Professor, Department of Thoracic/Head and Neck Medical Oncology at MD Anderson; and David Wholley, Executive Director, The Biomarkers Consortium, FNIH.
Said Vincent Miller, M.D., Chief Medical Officer of Foundation Medicine, “Squamous cell carcinoma of the lung is a deadly cancer killer and like many common solid tumors, analysis of no one or even several genes provides a sufficiently comprehensive characterization of the actionable alterations present in a population of patients to ensure a high screen hit rate when evaluating patients for a targeted therapy approach. Rather, multiple genes often altered by one or more classes of DNA changes and often co-occurring are unpredictably altered in any given patient. The comprehensive, broad based nature of FoundationOne testing allowed us to be uniquely suited to provide reliable results across an unprecedented broad swath of predictive biomarkers in a clinically relevant turnaround time to attract multiple interested pharma partners with distinct therapeutic targets”.
###
Website: www.Lung-MAP.org
About Dr Jeff Allen
Jeff Allen, PhD serves as the Executive Director of Friends of Cancer Research (Friends), a think tank and advocacy organization based in Washington, D.C. Friends is our country’s leading voice in advocating for policies and proposing and promoting real solutions that will get treatments to patients in the safest and quickest way possible. Friends develops new, groundbreaking partnerships, creates a more open dialogue among both public and private sectors and tears down the barriers that stand in the way of conquering cancer. By collaborating with federal health and regulatory agencies, premier academic research centers, professional societies, members of congress and other advocacy organizations, Friends is able to accelerate innovation.
For over 5 years as Executive Director of Friends, Jeff has been a driving force in the growth and success of the organization. Under his leadership, Friends has evolved into a nimble, forward-thinking policy, public affairs and research think tank. Jeff leads the development and implementation of Friends’ health and research policy portfolio, scientific initiatives, and oversees Board governance and organizational operations.
-
July 7, 2014
-
Consortia-pedia Author, Mark Lim, PhD of Faster Cures Joins Dpharm Speaking Faculty
We are pleased to welcome Mark Lim, PhD of Faster Cures and author of the Consortia-pedia project to DPharm. Mark will provide highlights on the project to help us better understand the approaches that a wide range of consortia have adopted to bring together non-traditional partners with a shared R&D goal. Mark will also address […]
We are pleased to welcome Mark Lim, PhD of Faster Cures and author of the Consortia-pedia project to DPharm. Mark will provide highlights on the project to help us better understand the approaches that a wide range of consortia have adopted to bring together non-traditional partners with a shared R&D goal. Mark will also address challenges that some consortia are facing as well as opportunities to further collaboration.
More info on the report:
http://www.fastercures.org/
reports/view/39 About Mark:
Mark D. Lim is the medical research innovation associate director at FasterCures and also serves on the scientific advisory board of the Quebec Consortium for Drug Discovery. Prior to joining FasterCures, Lim served a supporting role as the chief of technical staff at DARPA’s Defense Sciences Office on a biomedical program that had efforts in new diagnostic and vaccine capabilities. He was the deputy program director for the Program for Innovative Molecular Analysis Technologies, an extramural funding program at the National Cancer Institute (NCI), and also served as an AAAS Science and Technology Policy Fellow at the NCI Office of Biorepositories and Biospecimen Research. Lim received his doctorate in chemistry at University of California, Santa Barbara and completed an NCI-funded postdoctoral fellowship in cancer nanotechnology at University of California, San Francisco and University of California, Berkeley. He has authored or co-authored 23 publications and book chapters on biospecimen quality challenges, federal funding opportunities for innovation, nanotechnology, and inorganic chemistry.
-
May 21, 2014
-
Komathi Stem named 4th co-chair to DPharm 2014
The Conference Forum is thrilled to announce the appointment of Komathi Stem, Senior Director, Product Development, Innovation Lead at Genentech as the 4th co-chair for DPharm 2014. Komathi is a Biomedical Engineer with over 20 years of broad Pharma/Biotech industry experience ranging from Sales, Medical Affairs and Clinical Operations. She has built and led field […]
The Conference Forum is thrilled to announce the appointment of Komathi Stem, Senior Director, Product Development, Innovation Lead at Genentech as the 4th co-chair for DPharm 2014.
Komathi is a Biomedical Engineer with over 20 years of broad Pharma/Biotech industry experience ranging from Sales, Medical Affairs and Clinical Operations. She has built and led field teams (Sales, Medical Liaisons, Regional Monitors) as well as Global Study Management and Data Management functions across multiple headquarter sites. Komathi graduated from St. Olaf College in Minnesota with a BA in Mathematics and received her MS in Biomedical Engineering from the University of Virginia in Charlottesville.“Komathi is an invaluable member of our advisory board team and is never without new ideas. We are honored to have her as our newest addition to our conference leadership,” said Valerie Bowling, Director of DPharm.
Also co-chairing DPharm are Andreas Koester, MD, PhD, VP, Clinical Trial Innovation & External Alliances, Janssen, Jeffrey Kasher, PhD, VP, Clinical Innovation & Implementation, Eli Lilly and Craig H. Lipset, Head of Clinical Innovation, R&D, Pfizer, Inc.
-
November 25, 2013
-
Pfizer launches trial data sharing service
Pfizer has launched a first-of-its-kind project that enables patients who have participated in clinical trials the ability to download their individual clinical data. Using the Blue Button standard, an initiative first launched by the White House in 2010, patients “will be empowered to use the data to improve their overall health and wellness, from sharing […]
Pfizer has launched a first-of-its-kind project that enables patients who have participated in clinical trials the ability to download their individual clinical data.
Using the Blue Button standard, an initiative first launched by the White House in 2010, patients “will be empowered to use the data to improve their overall health and wellness, from sharing with healthcare providers to powering clinical risk assessments”, according to Pfizer.
Announced at this year’s Dpharm ‘disruptive innovations’ conference in Boston, US, Pfizer’s new project comes at a time when clinical trial transparency is becoming a major issue.
Allowing the digital sharing of data via the Blue Button is a new way forward for pharma, but falls short of allowing independent scrutiny of all study data, something being called for in the UK and Europe.
Typically as clinical trials conclude results are posted online and published in scientific journals, but little information is routinely given back to the patient to acknowledge their contribution.
But new data shows that over 90% of patients with access to a personally controlled health record are willing to share that data for research. Pfizer says that early results from its new project demonstrates the ability of research sponsors to engage patients in this new ecosystem, by first sharing their data with patients setting “a new standard for trust and collaboration”.
The Blue Button is a literal button appearing on many websites that lets consumers get their health information online.
The US Veterans Administration (VA) was first to display the Blue Button symbol on its patient portal in 2010 – it allows US military veterans the ability to click on the Blue Button icon to securely download their health information electronically.
The VA’s definition of Blue Button specified a particular technical format (ASCII text or PDF), which enabled patients to read, print, or store their health records in a straightforward but bare bones way.
Since then many sectors working in health in the US have begun to use this system, but Pfizer is the first pharma firm to do so. More data on the project is set to be released next year.
Ben Adams
-
November 7, 2013
-
Change is Coming to Clinical Trials
Jerry Matczak, Community Manager for the Lilly Clinical Open Innovation team provides us with a few key takeaways from this year’s conference: 1. Pharma’s commitment to collaboration is real. As evidence, look to TransCelerate BioPharma, Inc., a non-profit consortium of 17 pharmaceutical companies who are working together to solve common problems in drug research and development. After only one year of operation, […]
Jerry Matczak, Community Manager for the Lilly Clinical Open Innovation team provides us with a few key takeaways from this year’s conference:
1. Pharma’s commitment to collaboration is real. As evidence, look to TransCelerate BioPharma, Inc., a non-profit consortium of 17 pharmaceutical companies who are working together to solve common problems in drug research and development. After only one year of operation, the consortium has set a number of actionable deliverables, and is poised to make a real difference in clinical trial efficiency. The intent of the consortium is to allow the industry to collaborate in common areas like site qualification and training, risk-based monitoring, coordination with regulators and leveraging data standards. TransCelerate is all about making clinical research more efficient, and improved efficiency means valuable treatments can be delivered to patients more quickly and at a lower cost.
Similarly, the Investigator Databank, sponsored by Jannsen, Merck and Lilly, has also progressed in its objective to share investigator site data. By pooling important data from investigator sites like training records and site qualification data into a single source, it’s easier to identify the appropriate sites to conduct clinical trials. I was impressed to hear that more than 80 percent of study sites who have been approached have been willing to opt-in to sharing their information in the data bank.
2. Steps are being taken to provide patients access to their clinical trial data. Pfizer‘s announcement of its upcoming launch of their Blue Button pilot caused quite a bit of excitement among the conference attendees. The first-of-its-kind initiative will enable patients who have participated in clinical trials to download their individual clinical trial data using the Blue Button standard. Clinical trial participants will be able to download and use their data as they wish – with caregivers and providers, to add to their personal health records, or in any way of their choosing. Craig Lipset, Pfizer’s Head of Clinical Innovation explained the company’s reason for launching this project by saying, “Sometimes, it’s just the right thing to do.”
Photo by @medidata
3. Clinical trials are being integrated into day-to-day living. Walgreens and Novartis have continued with the pilot program they announced last year in which they integrate certain aspects of clinical research into patients’ regular pharmacy visits. Also, Medidata and Spaulding Clinical have partnered for their first clinical trial, which will use mhealth devices to “evaluate the impact of mobile and cloud-based technology on patient engagement for improved health outcomes in the diabetes community.” The trial will serve to demonstrate how tracking devices like Fitbit can be combined with Withings health-tracking scale to collect data in any clinical trial setting.
4. eConsent is happening. Joe Kim of Shire has shared how the patient experience can be better, audit-ability can be improved and overall efficiency can be gained by capturing clinical trial eConsent on an iPad. It became evident during the conference that most pharma companies are either piloting an eConsent program or are planning to pilot one.
One Thing I Wish There Was More of…
I am struck by the potential value of these efforts and inspired by the industry’s alignment on them. However, if there’s one thing I would like to see more of at DPharm, it would be a bit more spirited discussion on how the implementation of these efforts lands on stakeholders. I would have liked to have heard more direct engagement with those who will be most affected by the changes, like site investigators and, most importantly, patients.
We did hear a bit of that kind of feedback during the “The Investigator POV: What Disruption is Needed to Achieve Better Relationships” panel discussion. When the panel of site investigators was asked about what they wish sponsors would change in clinical trials they mentioned streamlined payment, more input into trial design, a better compensation model for screening failures and, overall, a bit of a behavior change between trial sponsor and site investigator. It was great to hear a number of diverse perspectives and see opportunities there for alignment. I just wish there was a few more opportunities to hear those perspectives in other sessions.
Looking Forward
There is no doubt that the industry is aware of the need for change. It’s extremely encouraging to see year-to-year progress being made in driving efficiency and improving the patient experience in clinical trials. DPharm is THE place for the pharma industry to come together to share ideas in clinical trial innovation and forge collaborations. It’s an unmatched opportunity to build individual relationships and to network. It’s also a place to catch a glimpse of the future of clinical trials, and a place where you can see the hope for better treatments turned into actionable ideas to disrupt and innovate in clinical trials.