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Event Blog

Led by GSK, Janssen and Pfizer, this groundbreaking conference delivers only case studies that demonstrate either a disruptive or an innovative approach to advancing clinical trials. Mobile Clinical Trials, Virtual Trials, Open Source Clinical Development are just a few examples of case studies featured. This conference is designed to be engaging in a highly informative format, similar to the style of TED events. Each session will deliver a clear set of objectives, summary and key take-aways around:

  1. Challenges and opportunities in clinical development/trials
  2. Innovations in science applied to clinical development/trials
  3. Innovations in technology applied to clinical development/trials
  4. New business models for clinical development/trials

  • 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!

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    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.

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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.

    Read More

  • 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.

    Read More

  • 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 […]

    JRVBpic1

    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

    Read More

  • 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.

    Read More

  • 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 […]

    330_24529_full-800w

    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/

    Read More

  • 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 […]

    icimages

    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

    Read More

  • 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/

    Read More

  • 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.

    Read More

  • 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/

     

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  • 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.

     

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  • 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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