2017 Executive Sponsors

Antidote
Be The Partner
Parallel 6, a PRA Health Sciences Company

2017 Associate Sponsors

AiCure
ASD Healthcare
Biospective Inc
Cmed
DEEP6
eClinical Solutions
Elligo Health Research
ePharmaSolutions
Florence Healthcare
goBalto
Hexoskin
IBM
ICON
Medable Inc
Medpoint Digital
MMG
mProve Health
Outcome Health
PhysIQ
Prevail InfoWorks
RxSolutions
Science 37
Spaulding Clinical Research
Subjectwell
Target Health
Trialspark
TrialX
Veeva
VitalTrax
WCG
YPrime

2017 Supporting Sponsors

Bioclinica
Langland
Medidata

2017 Exhibiting Companies

Aces Health
AiCure
Andaman7
Antidote
ASD Healthcare
Be The Partner
Biospective Inc
Cmed
DataArt
DEEP6
eClinical Solutions
Elligo Health Research
ePatientFinder
goBalto
Greenphire
HealthiVibe
IBM
ICON
InSeption Group
Medidata
Medpoint Digital
MMG
mProve Health
Orchestrall Inc
Outcome Health
Parallel 6, a PRA Health Sciences Company
Pfizer Inc
Pfizer Innovation Research Lab
Philips Respironics
RxSolutions
Science 37
SOUSEIKAI
Spaulding Clinical Research
Subjectwell
Tactio Health Group
Tamr
Target Health
Trialspark
TrialX
Trifecta
Veeva
VitalTrax
YPrime

2017 Media Partners

Big3Bio
Biocompare
BioPharm Insight
CanBiotech
CenterWatch
Life Science Leader
Pharmalicensing
PharmaVOICE
Rebar Interactive
SciDoc Publishers
Technology Networks

Event Blog


  • 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-Keynote-2015

    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.

    Charity and Valerie

    Valerie Bowling Congratulating Charity Tillemann-Dick on Publishing her Memoir, The Encore

    Valerie Jessica Charity

    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

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  • 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, PhDVP, 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 BioNetworks

    Panelists:

    Ray Dorsey, MD, David M. Levy Professor of Neurology and Director of the CHET, University of Rochester

    Cindy 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.

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  • 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
    Chris Economos, MBA
    VP, Business Development, PhysIQ

    Chris 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 ButlerSVP, Clinical Research Solutions

    Deep6 AI
    Wout BrusselaersCEO and Co-founder

    eClinical Solutions
    Sam AnwarVP, Engineering

    VitalTrax
    Zikria Syed, CEO

    Prevail InfoWorks
    Patrick KeenanChief Strategist

     

    The DPharm Idol 2017  judges included:

    Esther Dyson
    Executive Founder, Way to Wellville

    Laura Galuchie
    TransCelerate Program Lead, Merck

    Christian 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 Ingelheim

    Andreas Koester, MD, PhD
    VP, Innovation, R&D Operations, Janssen

    Sarah Krüg
    Executive Director, Cancer 101 and President, Society of Participatory Medicine

    Jacob LaPorte, PhD
    Head of Digital Development, Novartis

    Ülo Palm, MD, PhD
    SVP, Drug Development Operations, Allergan

    Chandra Ramanathan, PhD, MBA
    Head, East Coast Innovation Center, Bayer, US

    Jane Rhodes, PhD
    Senior Director, New Initiatives, Biogen Idec

    Dan Rothman
    Chief Information Officer, Roivant Sciences

    Alicia Staley
    Patient Advocate

    DPharm: 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>>

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  • 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.

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  • 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.

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  • 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.

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  • 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.

     

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  • 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-msph

    About “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.

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  • 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 & Company

    The DPharm Pre-Conference Workshop takes place on September 6 in Boston. For more information, please click here.

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  • 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.

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  • 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.

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  • 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.

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  • 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

    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

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  • 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.

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  • 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 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 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.

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  • 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.

    logo_emea
    “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.

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  • 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 […]

    kvandebeltelililly

    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

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  • 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!

    fullsizerender

    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 Laboratories 

    Julian Jenkins, PhD
    VP, Innovation Performance & Technology, GSK

    Andreas Koester, MD, PhD
    VP, Innovation R&D Operations, Janssen

    Sarah Krüg
    CEO, Cancer 101 and President, Society of Participatory Medicine

    Stephanie Petrone
    Executive Director, Medical Operations, Novartis Oncology

    Chandra Ramanathan, PhD, MBA
    VP and Head, East Coast Innovation Center, Bayer HealthCare

    Jane Rhodes, MBA, PhD
    Senior Director of New Initiatives, Biogen Idec

    Darshan Shah
    Director Global Products, Global Medicines Director, AstraZeneca

    Katherine Vandebelt
    Global Head, Clinical Innovation, Eli Lilly & Company

    Which 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.

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  • 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:

    1. 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.

    1. 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.

    1. 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.”

    1. 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.”

    1. 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.

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  • 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.

    1. 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.”

    1. 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.”

    1. 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.

    1. 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.

    1. 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 Laboratories 

    Julian Jenkins, PhD
    VP, Innovation Performance & Technology, GSK

    Andreas Koester, MD, PhD
    VP, Innovation R&D Operations, Janssen

    Sarah Krüg
    CEO, Cancer 101 and President, Society of Participatory Medicine

    Stephanie Petrone
    Executive Director, Medical Operations, Novartis Oncology

    Chandra Ramanathan, PhD, MBA
    VP and Head, East Coast Innovation Center, Bayer HealthCare

    Jane Rhodes, MBA, PhD
    Senior Director of New Initiatives, Biogen Idec

    Darshan Shah
    Director Global Products, Global Medicines Director, AstraZeneca

    Katherine Vandebelt
    Global Head, Clinical Innovation, Eli Lilly & Company

    Which 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.

    Read More

  • 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:

    1. What have you found most valuable about attending dPharm in prior years?
    2. What are you most looking forward to this year?

    Here are their replies: goo.gl/08AA44

    New DPharm logo

    Matt Winslow
    Matt Winslow

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  • 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.

    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

    CRAACO 2015 Group Meeting

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  • 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.

    Screen Shot 2016-08-23 at 6.41.46 PMMore 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

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  • 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.

    Listen Here

    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:
    http://theconferenceforum.org/conferences/disruptive-innovations-us/overview/

    DPharm Team Members:

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  • 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.

    KirstenGillibrandValerie 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.

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  • 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.

    Valerie Bowling at DPharm EuropeDPharm 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

    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.

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  • 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.

    ZacatDpharm

    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

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  • 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.

    JulesMitchelAs 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.

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  • 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.

    Photo Mark Earthy www.earthyphotography.co.uk This image is protected by Copyright

    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, Pfizer

    Guest:

    Alexander Masters, Author, Campaigner and Co-Founder, iCancer.org.uk

    Producer:
    Valerie Bowling, Executive Director, Conference Forum & Pharma Talk Radio

    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/

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  • 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

    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 Forum

    Guest Host:
    Bruce Bloom, JD, 
President & CSO, Cures Within Reach

    Panelists:
    James Potter, 
Investment Director, Numbers for Good
    Flóra Raffai
, Executive Director, Findacure
    Dr Rick Thompson
, Scientific Officer, Findacure

    Listen to the show here: http://www.blogtalkradio.com/pharmatalk/2016/04/01/a-new-economic-solution-to-drive-cures-to-patients

     

    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

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  • 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.

     

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  • 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

    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

    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 Europe Logo NewDpharm: Disruptive Clinical Trials Europe, February 9-10, 2016, London, UK

    PatientsAsPartnersLogoPatients as Partners, March 14-15, 2016, Philadelphia, PA

    Collaborations logo 210 x 62 new
    Clinical Trial Collaborations, March 21-22, 2016, Boston, MA

    For information, visit www.theconferenceforum.org

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  • 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 […]

    GregSimon-1

    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.

    JeriC

    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

     

    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!

    Read More

  • 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.

    25b9f3a   pmilogo_blog

    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.

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  • 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 […]

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    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.

    Idol judges

    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.

    Gamification speakers Dr Eddie Martucci, Akili Interactive Labs and Annik Willems, Janssen

    Dpharm: Disruptive Innovations for Clinical Trials 2014

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  • 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:
    Rob WrightRobert Wright
    Editor-in-Chief, Life Science Leader

     

     

     

    Keynote panelists:

    30c661fCamilo Cobos, MBA
    VP, Human Resources, Janssen Pharmaceutical Companies of Johnson and Johnson

     

    Kathleen LigockiKathleen Ligocki, MBA
    CEO, Harvest Power

     

    Chandra Ramanathan

     

    Chandra Ramanathan, PhD, MBA
    Senior Director, Innovation Strategy & Global Lead, External Innovation, Bayer AG

    David Shrier

     

    David Shrier
    Managing Director, Connection Science & Engineering, MIT

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  • 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 […]

    AllerganNYStockExchangeNewAllergan’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.

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  • 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 […]

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    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/

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  • 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 […]

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    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.

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  • 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

    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 forward

    Dpharm Europe takes place in London on February 10-11, 2015.

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  • 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

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  • 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.

    Dr Jeff Kasher, Eli Lilly, putting on our ‘patient glasses’ to see innovation through their lensAs 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: http://theconferenceforum.org/conferences/disruptive-innovations-europe/overview/

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  • 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.

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  • 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/

     

    Read More

  • 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


    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.

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  • 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

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  • 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 and valJulie 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.

     

    Read More

  • 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, Genentech

    ePharmaSolutions 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.


    About ePharmaSoultions

    ePharmaSolutions 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.

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  • 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.

    WHoward Golub BWe 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.

     

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  • 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/

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  • 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

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  • 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
    DonJones

    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.

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  • 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.

    diana degHigh Res 5x7_1

    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: http://theconferenceforum.org/conferences/disruptive-innovations/agenda/#day-22844-tab

     

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  • 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.

    jeff-allen-bio-pic

    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.

     

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  • 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:
    MLim
    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.

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  • 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 Stem - DPharm OverviewKomathi 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.

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  • 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 

     

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  • 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 JannsenMerck 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

    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.

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