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2018 Agenda

  • 8:00 am

  • Registration, Coffee & Tea

  • 8:45 am

  • Chair’s Opening Remarks

    Dan Karlin
    Daniel Karlin, MD

    Head of Clinical, Informatics, and Regulatory Strategy, Digital Medicine, Pfizer Inc

  • 9:00 am

  • A Bayer Perspective: The Good The Bad and The Ugly of Mobile Health

    What are the key things you should consider when adding apps and devices to your clinical trials? Bayer shares valuable lessons learned on customer insights and data discovery.

    Bayer ran a 3-month user acceptance and data flow study with 20 subjects to look at the possible adoption of a multi-functional application combined with an Actigraph and a Bluetooth Weight Scale.

    In this session, Bayer’s Chrysanthi Dori brings her expertise in data science:

    • What was hoped to be accomplished, described in the practical language of business or decision-making,
    • Data inventory and understanding,
    • Assessment of Data for Suitability,
    • Prepare and explore the data,
    • Evaluation/Interpretation/Understanding

    Bayer’s Michelle Shogren shares insights from an operations, site, and patient experience:

    • How to onboard sites to new technology
    • What training is needed for sites and patients
    • Recommendations for training and support tools
    • Views from the patient point of view on devices and apps fitting into their lives

    Chrysanthi Dori
    Chrysanthi Dori, MBA

    Associate Director, Clinical Digital Data, Technology and Analytics, Bayer

    Michelle Shogren
    Michelle Shogren

    Head of Innovation, Portfolio and Operations, Bayer

  • 9:30 am

  • Merck’s Digital Health and AI Strategy: Progress Report

    • What Merck is doing in Digital Health and AI
    • External collaborations on AI
    • Smart trials initiative to enable patient-centric studies
      • Strategy development and leadership buy-in
      • Lessons learned
      • What’s next?


    Joseph Lehar

    Executive Director, Computational Biology, Merck Research Laboratories

    Jyoti Shah
    Associate Director, Data Development MRL IT, Merck & Co, Inc

  • 10:00 am

  • A Novartis Case Study: Utilizing ResearchKit Apps to Accelerate Drug Development

    This session is an exciting example of how to utilize the ResearchKit platform and make clinical trials more accessible and flexible. Hear from the team on what it took to design and implement mobile apps into a phase ll ophthalmology study and the ELEVATE MS study.


    Mohanad Fors, MBA

    Global Head Digital Innovation Lab, Global Drug Development, Novartis

  • 10:30 am

  • Networking Break

  • 11:00 am

  • Eli Lilly: How to Launch Multiple Mobile Devices in a Hybrid Setting both Siteless and Traditional

    This session reports on incorporating a variety of mobile devices – including a smart phone, smart insulin pens, connected devices, mifi, and laptops, into a clinical trial. Considerations and lessons learned for:

    • Connecting all the devices
    • Implementation differences between traditional vs siteless
    • Coordinating the equipment; challenges and successes
    • Lessons learned
    • What’s next?

    Joseph Kim
    Joseph Kim, MBA

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

  • 11:30 am

  • Pfizer: Considerations and Lessons Learned from a Regulatory Interaction for a Parkinson’s Disease Trial with Digitally Collected Data

    Pfizer Speaker TBA

  • 12:00 pm

  • Philips Case Study

    Jessie Bakker, PhD
    Senior Manager, Clinical Trials, Philips Respironics

  • 12:15 pm

  • Live Tech. Demos

    In this section, hear from a select group of companies who have technologies that can impact your clinical trials. Each company will present a five-minute demo of their technology and will be present during the showcase at lunch for further demonstrations.

    Presenting Companies:

    BBK Worldwide

    Additional companies TBA

  • 12:45 pm

  • Luncheon and Technology Showcase

  • 1:45 pm

  • Hands-on Interactive Group Activity

    In this session, the group is led in an interactive task to gather a 360-degree view on data sharing in clinical research. The audience will be broken into four stakeholder groups:

    1. FDA & regulatory
    2. IRB
    3. Researchers & clinical trial leaders
    4. Patients

    Each group will be asked to consider the following questions from the perspective of the stakeholder group they’ve been assigned:

    1. What is your goal of data sharing?
    2. What information do you still require to make this a reality?
    3. Do you have any concerns?

    Led by:
    Dan Karlin
    Daniel Karlin, MD

    Head of Clinical, Informatics, and Regulatory Strategy, Digital Medicine, Pfizer Inc

  • 2:45 pm

  • Reserved Session

    Speaker TBA

  • 3:00 pm

  • How to Align the Promise of Technology with the Patient Voice

    • How do we identify shared value for both pharma and patients?
    • Patient perspective on being monitored continuously
    • What data is appropriate to share?
    • Data privacy: pharma perceptions of what patients want versus what patients really want

    cindy geoghegan
    Cindy Geoghegan

    Patient Advocate

    Dan Karlin
    Daniel Karlin, MD

    Head of Clinical, Informatics, and Regulatory Strategy, Digital Medicine, Pfizer Inc

  • 3:30 pm

  • Networking Break

  • 4:00 pm

  • Panel: Pre-Competitive Collaborations to Maximize the Impact of Mobile/Digital Tools

    • How collaboration can accelerate the advancement and broad acceptance of mobile/digital tools
    • Identify measures and streamline development
    • How can we better cooperate to make this more efficient for everyone?
    • Does ownership of the algorithm really matter?
    • What is it going to take to make this happen so that we can drive acceptance of these

    Moderator:

    Jennifer Goldsack, MChem, MA, MBA, CPHW

    Clinical Project Manager, CTTI

    Panelists:

    Stephen Arneric, PhD
    Executive Director, C-PATH (invited)

    Rob DiCicco
    Principal Consultant, TransCelerate (invited)

  • 4:30 pm

  • Panel Discussion: A Roadmap to Organizational and Digital Restructuring to Scale Mobile Clinical Trials

    With the number of datasets collected in clinical research rapidly expanding, how can these novel data streams be integrated into existing pharma structures for meaningful use? In this session the panel discuss the internal infrastructure that is required for the successful scaling of mobile/digital tools in clinical trials. More specifically:

    • How to come to terms with the weight and demand of data
    • Understanding the skillsets/talent required to purposefully use the data
    • Implementing an internal system to allow for efficient and effective scaling of mobile trials

    Moderator:
    Mohammad Ali-Mobile
    Mohammad Ali

    Global Head Digital Trials- Global Clinical Operations, Boehringer-Ingelheim

    Panelists:

    Bill Kesil
    Director, Program Lead, and Clinical Data Sciences, Pfizer (invited)

    Irene Pak
    Lead R&D Data Architect, Bristol-Myers Squibb (invited)

  • 5:00 pm

  • Panel Discussion: Moving Beyond the Accelerometer, What’s Next for Mobile Clinical Trials?

    • How can the industry shift it’s focus to sense modalities more broadly?
    • What will it take to penetrate different domains?


    Dina Katabi, PhD

    MacArthur Fellow, Andrew & Erna Viterbi Professor and Director of MIT Center for Wireless Networks & Mobile Computing, MIT

  • 5:30 pm

  • Conference Concludes