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DPharm Day One Recap, September 7, 2017

  • September 7, 2017

  • The 7th annual DPharm: Disruptive Innovations to Advance Clinical Trials conference took place on September 7th in Boston. This year’s event featured a wide range of educational sessions and technology demonstrations to promote clinical trial innovation. DPharm day one highlights included:

    1. Patient Advocate Jessica Melore kicked off DPharm with Inspirational Keynote Address

    Patient advocate Jessica Melore described her experiences as a heart transplant patient in her keynote address to DPharm attendees. During her presentation, Melore shared her inspirational story, along with a universal message about the power and strength of the human spirit.

    At 16 years old, Melore suffered a massive heart attack. Although most doctors did not expect her to survive, Melore persevered.

    “No matter how angry or frustrated I was, I couldn’t change my past. But I could make the most of the present,” she stated.

    Melore received an experimental heart transplant that proved to be the difference between life and death. She realized that her life would never be the same after the transplant surgery. However, Melore continues to persevere through a variety of life challenges, including a leg amputation and three cancer diagnoses.

    Ultimately, Melore said she believes healthcare professionals must provide an outstanding patient experience in clinical trials. If healthcare professionals consider patients’ needs, they can inspire patients, leading to improved patient outcomes.

    “When patients know that you care about them and have their best interests in mind, it makes all the difference in the world,” Melore noted. “Having access to quality-of-life programs can make a huge difference, and quality of life is just as important as saving lives.”


    2. R&D Executives Examine Innovation Priorities and What It Takes to Disrupt the Clinical Trials Space

    Several R&D executives explored the innovation they are prioritizing and what they aim to disrupt in detail during a quick fire session at DPharm.

    Valerie Bowling, Executive Director, DPharm moderated the session with the following R&D executives:

    Rob Dicicco, PharmD, Vice President, Clinical Innovation and Digital Platforms, GSK

    Hassan Kadhim, Business Consultant, IS BP R&DM, Boehringer Ingelheim

    Ülo Palm, MD, PhD, Senior Vice President, Drug Development Operations, Allergan

    Dan Rothman, Chief Information Officer, Roivant Sciences

    Michelle Shogren, Portfolio and Operations Innovation Manager, Global Clinical Development, Bayer

    Jennifer Wulff, MBA, Director, Clinical Innovation, Pfizer

    R&D executives want clinical trials to move quickly and constantly search for ways to improve the patient experience, Dicicco stated. To accomplish these goals, Dicicco recommended R&D executives reimagine the clinical trials design process.

    Comparatively, Palm indicated innovation must be incorporated into a business’ day-to-day strategy. With this approach, R&D executives can determine how they want to innovate and plan accordingly, Palm stated.

    The Roivant team, conversely, emphasizes technology assessment, deployment and transformation to innovate, Rothman said. By doing so, Roivant can foster internal and external technology innovation to disrupt the drug development process.


    3. Clinical Trials Leaders Explore How to Make Innovation a Reality

    Several clinical trials leaders explored what it means to “bootstrap” innovation – as well as the opportunities and challenges associated with innovation – during a DPharm session.

    The following clinical trials leaders participated in the session also moderated by Bowling:

    Barry Crist, Lead Investigator, Lilly Clinical Open Innovation Team, Eli Lilly & Company

    Munther Baara, Senior Director, Clinical Paradigm, Pfizer

    Michelle Shogren, Portfolio and Operations Innovation Manager, Global Clinical Development, Bayer

    According to Crist, “hardcore design thinking” plays an important role in innovation. Moreover, Shogren noted Bayer understands that innovation offers no guarantees and tailors its innovation strategy to minimize risk.

    “Spending millions to drive innovation is a big risk because you don’t know if an innovation is going to succeed,” she said. “We build in kill clauses, partner with vendors and set up contracts in a way that makes it easy to make adjustments and control this risk.”

    On the other hand, Baara stated Pfizer evaluates both internal and external innovation opportunities. Pfizer also engages patients in ongoing conversations as part of its commitment to innovation.


    4. PCORnet’s Adrian Hernandez Outlines the ADAPTABLE Study

    Adrian Hernandez, MD, Co-Principal Investigator, PCORnet, explained the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) study – and how patients were engaged throughout the study – during his DPharm presentation.

    ADAPTABLE served as a three-year clinical trial to compare the effectiveness of daily doses of aspirin. Additionally, the study highlighted the benefits of evidence generation in clinical trials, Hernandez said.

    With ADAPTABLE, researchers engaged patients in all aspects of the study to quickly transform real world data into real world evidence, Hernandez indicated. As such, the ADAPTABLE model showcased the true value of patient engagement and could have far-flung effects on clinical trials in the years to come.

    “The ADAPTABLE model wasn’t just a one-time model. It was designed to adapt to different things as we move along,” Hernandez stated.


    5. DPharm Introduced a Myth Buster Session

    Suzanne Caruso, VP, Clinical Solutions, WIRB-Copernicus Group, Laura Galuchie, TransCelerate Program Lead, Merck and Stephanie Petrone, Navigate Clinical Consulting, Novartis, challenged the myth of new technology can eliminate non-enrolling sites in clinical trials.


    6. Patient Disruptors Discuss the Clinical Trials Research Landscape

    Part two of DPharm day one included breakout sessions that highlighted two key clinical trial research disruptions:

    – Open Artificial Pancreas System (OpenAPS) Project: Dana Lewis, creator, Do-It-Yourself Pancreas System, and founder, OpenAPS, indicated the OpenAPS project makes APS technology widely available to type 1 diabetes patients. The project empowers individuals and medical device manufacturers alike to innovate, Lewis said, and makes APS technology available to thousands of people who are willing to participate in clinical trials.

    – Spontaneous Coronary Artery Dissection (SCAD) Research Program: Sharonne Hayes, MD, Principal Investigator, Mayo Clinic SCAD Research Program, Mayo Clinic, offered insights into the power of patient-initiated research and crowdsourced science. She stated SCAD is a complex disease, and thanks to crowdsourcing, Mayo Clinic engaged many patients from around the globe to perform extensive SCAD research.

    Both presenters showed clinical trial innovation can come from any location, at any time. They also illustrated the true value of global collaboration to disrupt the clinical trials research landscape. This section of the program was also joined by John-Peter Bradford, PhD, who shared a personal story of loss due to cancer and his motivation to change the way the healthcare system looks at protocols in research for lethal diseases.


    7. Track Choices

    The annual “Where are They Now” and “Innovative Sources and Solutions” tracks were moderated by Dr Ülo Palm, Allergan and Dr Jane Rhodes, Biogen and packed with quick fire presentations with companies offering an innovative solution to a variety of pressing problems faced by clinical trialists.


    8. Clinical Trials Companies Make Their Case to Become This Year’s DPharm Idol

    DPharm day one concluded with DPharm Idol, a competition that enables participating companies to showcase their disruptive clinical trial services or technologies to a panel of clinical trial experts.

    The following companies are competing for the title of 2017 DPharm Idol:

    Outcome Health: Provides a health intelligence platform for healthcare providers, medical associations, private physician practices and life sciences companies.

    Deep6 AI: Applies artificial intelligence to medical records to help healthcare professionals find patients for clinical trials faster than ever before.

    eClinical Solutions: Provides the elluminate data intelligence platform for clinical data analytics, clinical trial operations analytics and risk-based monitoring.

    VitalTrax: Offers a clinical trial recruitment solution designed to engage caregivers, patients and physicians.

    Prevail InfoWorks: Delivers a single, role-based platform to help healthcare professionals improve their clinical trial timelines, budgets and quality.

    PhysIQ: Empowers healthcare professionals with personalized physiology analytics to provide real world patient insights.

    This year’s DPharm Idol winner was announced on day two of the program, September 8th. See day two re-cap for details.