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Pre-Conference Program, Monday, September 24, 2018 – 8:00 am – 5:45 pm

Mobile in Clinical Trials Full Day Conference

2018 Agenda

  • 8:00 am

  • Networking & Exhibit Room Opens

    Registration Hosted by:

    Badge and Material Collection

    Tea/Coffee

  • 8:30 am

  • DPharm’s Got Talent Patient Survivor Opening Performance

    Caly Bevier is a teen cancer survivor, singer, America’s Got Talent quarter finalist and Golden Buzzer winner. Caly opens DPharm 2018 with a performance for the audience and tells her incredible story, from being diagnosed with late stage ovarian cancer at 16 to how she made it to the global stage in a matter of months.

    AGT Caly Bevier
    Caly Bevier
    Patient Advocate and Performer

  • 9:00 am

  • Co-Chairs’ Welcome


    Andreas Koester, MD, PhD
    VP and Global Head, Janssen Clinical Innovation, Janssen


    Craig Lipset, MBA

    Head of Clinical Innovation, Pfizer


    Sylke Poehling, PhD

    SVP and Global Head, Strategy, Portfolio & Clinical Operations, Pharma Research & Early Development, Roche

  • 9:10 am

  • Global Keynote: Estonia, the Digital Republic: Where Patients Own Their Data

    An Insight into our Possible Future Faster than You Think

    “E-Estonia is the most ambitious project in technological statecraft today, for it includes all members of the government, and alters citizens’ daily lives.” – The New Yorker

    Estonia is now a digital republic with a virtual government, blockchained and secure. Our keynote guest from Estonia, Indrek Õnnik, tells us how Estonia became the fastest country in the world to go digital. Its 1.3 million citizens pay with their mobile phones, have their health records stored in the digital cloud, and file their annual tax return online in five minutes. We will learn how Estonian citizens have come to own their personal health records, how doctors have to get their permission to use these records, and how patients choose their own medications digitally. We will also learn about their challenges, policies and, of course, their vision for digital clinical trials.


    Indrek Õnnik

    Program Manager, E-Estonia Showroom, a partner of the Estonian Government

  • 9:50 am

  • Keynote: Regenerative Medicine Maverick

    Regenerative Medicine as a Disrupter in Clinical Trials

    Dr Atala, a renowned key opinion leader on the topic of regenerative medicine, brings to the DPharm audience for the first time a fascinating presentation on how it’s possible to reduce the number of patients needed in clinical trials with the advancement of regenerative medicine, and how regenerative medicine can improve accuracy and speed up the clinical trial process.


    Anthony Atala, MD

    Director, Wake Forest Institute for Regenerative Medicine
    Boyce Professor and Chair of Urology, Wake Forest University

  • 10:20 am

  • Reserved Session

  • 10:35 am

  • Morning Networking Session

    Grand opening of the networking and technology room:

    • Meet the exhibitors
    • Ask the Patients
    • Meet the keynotes
    • B-to-B tables
    • Technology demos
    • Healthy morning snacks
    • Coffee/tea & chocolates by Boston’s oldest chocolatier
    • Patient-centric teachers with therapy dogs
  • 11:15 am

  • Polling Session: A View on the Software-enabled Clinical Trial Tech Universe – Where the Tide is Rising

    In this interactive audience polling session, digital rights advocate blogger, Andy Coravos, presents her latest map of the software-enabled clinical trial technology universe and gives an overview of today’s ecosystem, what’s new and when we can expect a paradigm shift in clinical trials. She will poll the audience on what we still need, what we want our ecosystem to innovate most, and for what reason.

    Andrea Andy Coravos
    Andy Coravos

    Fellow, Computational Health Informatics, Boston Children’s Hospital

  • 11:30 am

  • Track Choices of a Wide Variety of Technologies and Services with Innovations to Advance Clinical Research

    • Track One: Innovative Sources and Solutions

      This track features companies, who are new to presenting at DPharm and have interesting technologies and services to help with clinical trial management, consent, matching, acceleration and recruitment.

      Presenting companies as of 6/15/18:

      • Global Care Clinical
      • Hawthorne Effect
      • MRN Medical Research Network
      • Quotient Sciences
    • Track Two: Where Are They Now?

      This track highlights companies who have shared their innovation at a previous DPharm conference, but have exciting advances to report on.

      Presenting companies as of 6/15/18:

      • Elligo Health Research
      • goBalto
      • Target Health
      • Forte Research
  • 12:45 pm

  • Lunch and Networking

  • 1:55 pm

  • Co-Creating the Industry’s Scalable Solution for EHR-Enabled eSource to Disrupt Clinical Trials

    The potential for eSource has been discussed for years, but realizing its promise has been difficult. While most health data today can be captured within electronic health records, the diversity of systems across medical centers and around the world coupled with a lack of health data interoperability has limited our ability to source clinical trial data from existing electronic systems across thousands of investigator sites supporting trials globally.

    Rob Goodwin and Amy Nordo share an exciting new collaboration – including industry and academia, as well as health authorities and leading technologists – positioned to break through the barriers to allow the power and the promise of eSource across companies and medical centers.


    Rob Goodwin

    VP, Operations Center of Excellence, Global Product Development, Pfizer


    Amy Nordo

    Program Director, Duke Center for Healthcare Informatics

  • 2:25 pm

  • Pharma Innovation 2018 Reporting from the Trenches

    This section of DPharm highlights several pharmaceutical companies in order to report on a specific example of innovation applied to advance clinical trials within the last 12 months. Each session addresses the milestones, challenges and problems with adoption.

  • 2:30 pm

    • Track A

      Innovation in Clinical Trial Operations and Patient Data Access

      Allergan: New Approach to Optimizing Clinical Systems – a Paradigm Shift

      Allergan walks through its new approach to running clinical trials with a strategic perspective, including the role of innovation and practical implementation.


      Sarah Luijpers

      AVP and Head of Business Operations, Allergan


      Bill Thornton, MBA

      VP, R&D IT, Allergan

    • 3:00 pm

      AstraZeneca: The Role of External Innovation in Transforming Complex Pharma Processes

      AstraZeneca’s Technology Innovation Director, Kim Smyth, shares how they are embedding new processes in their clinical trial business, along with insight into bridging external innovation to transform the way they are doing clinical trials. More specifically:

      • Executing learning pilots to evaluate the future
      • Strategizing to bridge the gap between internal stakeholders and the public


      Kim Smyth, MBA

      Technology Innovation Director, AstraZeneca

    • 3:15 pm

      How Roivant an Emerging Biotech is Innovating in Clinical Operations  

      Dan Rothman
      Dan Rothman

      Chief Information Officer, Roivant Sciences

    • 3:30 pm

      Amgen


      Jaydev Thakkar, MBA

      Product Innovation Lead, Technology Strategy and Innovation, Amgen

    • 3:45 pm

      Janssen: Patient Data Access in Clinical Trials – from Concept to Implementation

      The healthcare industry is transitioning into patient-centered care models and patients want to be empowered with their own health data. Janssen Clinical Innovation (JCI) has developed the Janssen Global Trial Community through which they aspire to empower patients by giving them access to their data, study information, feedback and new research opportunities, thereby fostering engagement and creating a long-term partnership built on transparency, trust and awareness. In this model of accelerating innovation through collaboration, they address:

      • Global implementation of data access through the Janssen Global Trial Community
      • Challenges, stakeholder acceptance and business value
      • Collaboration with stakeholders (including customers) and competitors: how a consortium creates new opportunities and greater value by increasing speed of innovation, adoption and responsiveness to customers.


      Andreas Koester, MD, PhD

      VP, Innovation, R&D Operations, Janssen

      (The topic of Patient Data Access and Ownership will extend into day two, Sept 26.)

    • Track B

      All Things in Digital Innovation in Clinical Trials

      Moving the Digital Needle: Lessons from Designing a Fully Digital, Remote, Interventional Clinical Trial


      Hassan Kadhim

      Senior Associate Director, Head, IT Clinical Trial Planning & Management, Boehringer Ingelheim

    • 2:45 pm

      BMS: Increasing Clinical Trial Awareness, Participation and Engagement through Study Connect, a BMS Digital Platform

      BMS developed Study Connect as a comprehensive clinical trial resource for patients, caregivers, parents and healthcare professionals to learn about and find clinical trials, and connect with others. Study Connect provides an experience that empowers patients, provides transparency, and supports patients and caregivers during their clinical trial experience. In this session, they review the key features of their innovation, as well as how they are supporting their ultimate goal in educating, connecting and engaging the clinical trial community.

      Carolyn Brehm
      Carolyn Brehm

      BMS Study Connect Business Lead, Global Clinical Operations, Bristol-Myers Squibb

    • 3:00 pm

      Sanofi: The Implementation of a Digital Strategy to Change the Way Clinical Trials are Done

      At Sanofi, the Digital Strategy team and the Operations team collaborated on implementing a digital strategy to change how clinical trials are done to reduce patient burden. Through their collaborations and work with online recruitment and wearables, this group has shifted its thinking to support the patient of the future. In this session, learn how they created a culture to shift the thinking and the enormous impact it’s had already on their trials.

      Led by:

      Amy Zwanziger

      Head of Digital Catalyst, Sanofi

    • 3:30 pm

      Bayer: Virtual Assistants for Sites and Patients in Clinical Trials

      Bayer shares how they use virtual assistants and chatbots to support study teams, research sites and patients. Learn how they are doing this and what you should consider.

      Michelle Shogren
      Michelle Shogren

      Head of Innovation, Portfolio & Operations, Bayer

    • 3:45 pm

      Roche: How Digital Biomarker Innovation is Modernizing Clinical Endpoints

      Roche provides an update on the company’s progress in how they are collecting data with sensor technology and turning it into a clinically meaningful endpoint with multiple indications, including Parkinson’s disease and Multiple Sclerosis. Session takeaways include:

      • Understand what Digital Biomarker innovation means for the future of clinical development and potentially personalized healthcare.
      • Be inspired to use mobile sensors technology in the context of clinical trials and beyond.
      • Develop a detailed understanding of the underlying complexity to run such efforts and be able to plan for it.
      • Understand how regulators are looking at these novel approaches.


      Christian Gossens, PhD, MBA

      Global Head Early Development Workflows, pRED, Informatics, Roche Pharmaceutical Research and Early Development (pRED)

  • 4:00 pm

  • Afternoon Networking Session

    • Ask the Patients
    • B-to-B tables
    • Technology demos
    • Meet the exhibitors
    • Afternoon snacks
    • Coffee/tea & chocolates by Boston’s oldest chocolatier
    • Patient empathy teachers with therapy dogs
  • 4:30 pm

  • DPharm Idol 2018

    Now in its 7th year, DPharm Idol is a live show featuring a select group of innovators, who present what they believe is a disruptive service or technology that could be a changing force for clinical trials. Each company delivers a quick-fire session followed by questions from the DPharm Idol judges. The questions from the judges provide great examples of how to assess technology/services to benefit drug development. Past DPharm Idol winners include Medidata, Spaulding Clinical Research, ePharma Solutions, Science37, Florence Healthcare and PhysIQ. Who will be the DPharm Idol 2018 winner?

    Approved Presenting Companies as of 6/20/18:

    Edetek

    Medable

    MonARC Bionetworks

    WCG Clinical

    For information on how to apply, contact Meredith@tcfllc.org.

    DPharm Idol Judges:

    Esther Dyson
    Esther Dyson

    Executive Founder, Way to Wellville

    cindy geoghegan
    Cindy Geoghegan

    Patient Advocate


    Christian Gossens, PhD, MBA

    Global Head Early Development Workflows, pRED, Informatics, Roche Pharmaceutical Research and Early Development (pRED)


    Hassan Kadhim

    Senior Associate Director, Head, IT Clinical Trial Planning & Management, Boehringer Ingelheim


    Joseph Kim, MBA

    Sr Advisor, Patient Experience and Design Innovation Design Hub Foundations, Eli Lilly and Company

    Jacob LaPorte
    Jacob LaPorte, PhD

    Head of Digital Development, Novartis

    Chandra Ramanathan
    Chandra Ramanathan, PhD, MBA

    Head, East Coast Innovation Center, Bayer, US

    Dan Rothman
    Dan Rothman

    Chief Information Officer, Roivant Sciences


    John Varaklis

    Head of Global Clinical Operations, Roche Pharmaceutical Research and Early Development (pRED)

  • 5:45 pm

  • Networking Reception

2018 Agenda

  • 8:00 am

  • Opening Networking

    Breakfast

    B-to-B tables

    Meet the Exhibitors

    Networking

  • 8:30 am

  • Co-Chairs’ Welcome and Announcement of the 2018 DPharm Idol Winner


    Andreas Koester, MD, PhD

    VP, Innovation, R&D Operations, Janssen


    Craig Lipset, MBA

    Head of Clinical Innovation, Pfizer


    Sylke Poehling, PhD

    SVP and Global Head, Strategy, Portfolio & Clinical Operations, Pharma Research & Early Development, Roche

  • 8:45 am

  • Keynote: How to Innovate like Amazon in the Drug Development Industry with a View to Modernizing Clinical Trials

    When Amazon announced that it’s creating a new healthcare company with Berkshire Hathaway and JPMorgan Chase, the move signaled how the company is stepping into the healthcare industry. However, Amazon Web Services (AWS) has been working directly with the healthcare and life science industries for quite some time. Life Science Director, Mark Johnston, shares how AWS thinks about innovation, in particular for the life science industry, including clinical trials. More specifically:

    • How AWS looks at problems and transforms processes through new technologies
    • How to think about going faster to be more effective in solving problems without the worries of infrastructure
    • How to imagine what to do next if you were un-trapped by historical baggage and perceived limitations
    • Opportunities to consider
    • Examples

    Mark Johnston
    Mark Johnston

    Director of Global Business Development for Health Care, Life Sciences and Agricultural Technology, Amazon Web Services

  • 9:30 am

  • Bringing Blockchain to Life: Digitizing Clinical Supply Chain End-to-End for Clinical Trials

    We are pleased to welcome to the DPharm stage for the first time Michael Ku, who will speak about some of Pfizer’s earliest work making blockchain ‘real’, as well as some of their forward-leaning work digitizing supply chain for clinical trials.


    Michael Ku

    VP, Clinical Supply Chain, Pfizer

  • 9:50 am

  • The Today Show @DPharm


    Ülo Palm, MD, PhD

    SVP, Global Drug Development Operations, Allergan

  • 10:30 am

  • Morning Networking Session

    • Ask the Patients
    • B-to-B tables
    • Technology demos
    • Meet the exhibitors
    • Coffee/tea & chocolates by Boston’s oldest chocolatier
    • Patient empathy teachers with therapy dogs
  • 11:15 am

  • Flipping the Paradigm of Clinical Research with The All Of Us Research Program

    All Of Us is a US Precision Medicine program from the NIH that aims to enroll a million Americans and follow them for 10 years, during which time participants will contribute biological, environmental, and lifestyle data.  One-third of participants will participate virtually (not via a research site).  The cohort will mirror the projected 2040 census: <50% non-Hispanic white.  All one million will be direct partners throughout.

    Individual pharma companies are never going to create cohorts like this, so the importance of this open source frame work that drug developers can tap into will be highly beneficial in serving the patient of the future.

    Learning objectives:

    • About All Of Us – context, objectives, progress to date, and what’s to come
    • What we’ve learned so far
    • How might pharmaceutical companies become involved in the years ahead?

    Elise Felicione, MPH, MBA
    Scientific Collaborator, Scripps Translational Science Institute, Sr. Director, Janssen Research & Development

  • 11:45 am

  • Two Track Choices

    • Track 1

      The Democratization of Patient Data Ownership

      We anticipate a future with secure patient data ownership, where patients are empowered to provide permissions. In this series of talks on patients ‘donating’ data, patient data ownership, data rights, and why this is a disruptive force in advancing clinical trials, we address the need to ensure we have the appropriate systems, security, and ability to withstand a Facebook/Cambridge Analytica scenario.

      We welcome to the DPharm stage for the first time this coordinated series of talks with special guests, hosted by Co-Chair, Craig Lipset.


      Craig Lipset, MBA

      Head of Clinical Innovation, Pfizer

    • #1 Patient and Provider Perspective on Patient Data Access, Control, Ownership & Non-Health Data


      Harlan Krumholz, MD

      Harold H. Hines, Jr. Professor of Medicine, Yale and Founder, Hugo


      Bray Patrick-Lake, MFS

      Director of Stakeholder Engagement, Duke Clinical Research Institute

    • #2 Technology and Policy Supports for Patients to Access and Control their Data

      Addressing a widespread uptake of data standards enhancing patient access to their data and the emergence of data control as a leading bipartisan issue


      Mark Scrimshire

      Entrepreneur in Residence, NewWave, on assignment as Medicare Blue Button 2.0 Innovator, CMS

      #3 Clinical Trials and the Life Science Industry’s Crucial Role: the Patient Data Access Initiative


      Richie Etwaru

      Human Rights Data Advocate and Founder and CEO, Hu-manity


      Jessica Scott, MD, JD

      Director Med Advocacy and Policy, Global Medical Governance, GSK

      #4 An Emerging Ecosystem of Entrepreneurs Making Patient Data Ownership a Reality

      In this section, we discuss:

      • Enabling access and use of data
      • Permissions and sharing


      Richie Etwaru

      Human Rights Data Advocate and Founder and CEO, Hu-manity


      Harlan Krumholz, MD

      Harold H. Hines, Jr. Professor of Medicine, Yale and Founder, Hugo

    • Track 2

      Artificial Intelligence / Machine Learning to Advance Clinical Trials

      MIT and Johns Hopkins Collaboration: Applying Machine Learning to Calculate Clinical Trial Complexity and Predict Odds of Success

      MIT and Johns Hopkins formed a collaboration to look at the difficulties in clinical trials and to come up with a model to predict the failure/success of the trial. Together they developed data-driven models (machine learning) to predict the failure/success of trials entering Phase I-IV. In this session, you will hear about both the collaboration and the model.


      Felipe Feijoo, PhD

      Postdoctoral Researcher, Provosts’ Diversity Fellowship Recipient, Johns Hopkins University

    • Harvard Medical School: The Use of AI and Big Data to Increase Reproducibility and Greater Accuracy in Drug Development


      Arjun (Raj) Manrai, PhD

      Assistant Professor, Harvard Medical School

    • Novartis: Are Healthbots the Future of Healthcare Engagement?

      Healthcare, and in particular the biopharma industry, has struggled with patient engagement for a very long time. With our strict regulations, extended timelines for review of materials, and the need for only sharing scripted, pre-approved content, even our most personalized engagements – like human-led call centers – can often sound robotic and impersonal. With the rise of AI, machine learning and new conversational platforms like Facebook Messenger and Alexa, could chat/voice-bots become more engaging and more personalized than humans can ever be in this industry? Is there an opportunity for us to change the current clinical trial experience by utilizing healthbots? More specifically:

      • How can we make bots that are more engaging than humans?
      • Can we leverage what we already have developed (existing content) when developing these new platforms?
      • What are some examples and real-world use case studies in healthcare?
      • How can we leverage healthbots to change the clinical development customer experience?

      Attendees will walk away with an understanding of:

      • Why healthcare is uniquely suited to leveraging chat/voice-bots
      • Real-world examples of existing healthbots and what they are delivering
      • What to consider when planning for your own chat/voice bot


      Shwen Gwee

      General Manager, Digital Accelerator, Novartis

  • 1:00 pm

  • Lunch

  • 2:00 pm

  • Ready for Launch: CTTI’s Decentralized Clinical Trials (DCT) Recommendations and the Patient of the Future

    The Clinical Trials Transformation Initiative (CTTI), a public private partnership co-founded by Duke University and the U.S. Food and Drug Administration, is proud to unveil its Decentralized Clinical Trials (DCT) recommendations at DPharm 2018. Through implementation of these recommendations, sponsors, CROs, and others can help advance the appropriate use of DCTs and experience the resulting benefits.

    DCTs using telemedicine, mobile and/or local healthcare providers (HCPs) continue to evolve and offer several potential advantages compared to traditional clinical trial sites, including:

    • Faster trial participant recruitment, which can accelerate trial participant access to important medical interventions and reduce costs for sponsors.
    • Improved trial participant retention, which may reduce missing data, shorten clinical trial timelines, and improve data interpretability.
    • A greater amount of control, convenience, and comfort for trial participants by offering at-home or local patient care.
    • Increased diversity of the population enrolled in clinical trials.
    • An opportunity for home administration or home use of the investigational medicinal product (IMP), which may be more representative of real-world administration/use post-approval.

    Join us in this session to change the clinical trial experience to meet the expectations of the patient of the future.  

    Led by:

    Gary Grabow new
    Gary Grabow

    Head of Contracts and Compliance, Genentech

  • 2:30 pm

  • Choice of Two Concurrent Programs

    • Clinical Research as a Care Option (CRAACO)

      Bringing clinical research as a care option to patients is arguably the greatest change we can collaborate on to give patients the best choices of care and to help make clinical trial options easier for providers to access. Higher rates of clinical trial participation inside a health system produces better patient outcomes, lower cost of care and happier patients. Health systems and patients get access to the latest research and pharma can get access to more patients in need of clinical research options.

      The concept of CRAACO was introduced at DPharm 2014. We have supported this topic each year and are delighted to bring all stakeholders together to identify next steps in supporting this movement to make it more realistic for physicians to offer clinical trials to patients.

      Led by:

      Murray Abramson
      Murray Abramson, MD

      VP, Clinical Operations, Biogen

      Jennifer Byrne
      Jennifer Byrne

      Founder, The Greater Gift

      cindy geoghegan
      Cindy Geoghegan

      Patient Advocate

      Bridget Gonzales
      Bridget Gonzales

      Director, Training and Professional Development, ACRP

      Judy Hung
      Judy Hung, MD

      Director, Trial Innovation Unit, Division of Clinical Research, Massachusetts General Hospital

      Jonathan Jackson
      Jonathan Jackson, PhD

      Director CARE Research Center, Massachusetts General Hospital


      Kelly McKee

      Head, Patient Recruitment, Rare Diseases, Vertex Pharmaceuticals

      John Stewart
      John Stewart, MD, MBA

      Professor of Surgery / Associate Director for Clinical Research, University of Illinois College of Medicine / Chicago Cancer Center

    • How to Create a Service Oriented Culture in Drug Development

      The commercial side of pharma, if done right, is built around a culture of service. Today, this is the exception not the rule for the R&D side of the business. However, R&D ultimately is serving patients and must help partner with its investigators and sites.

      This section of DPharm begins with a panel of patients and investigators, who identify vital areas of service improvement. Following the panel, keynote speaker, Dr Chip Bell, prominent author and advisor to organizations on ways to create a culture of service, will speak to our audience of drug developers about this paradigm shift and ways to become a service anthropologist and innovator. The patient’s expectations are being quickly changed today by disruptors far beyond the Pharma industry. Chip will show pragmatic ways to change our culture to support service-oriented thinking that benefits patients and investigators.

      How will the concept of service make us better at drug development and help us become more disruptive thinkers? How do we make this a reality for ourselves and our organization? Attendees will have an opportunity to ask questions to Chip directly.

      Keynote Leadership:


      Chip Bell, PhD

      Keynote Innovative Service Speaker, Author and Senior Partner, The Chip Bell Group

  • 4:45 pm

  • DPharm 2018 Concludes