2018 Agenda

  • 8:00 am

  • Registration, Coffee & Tea

  • 8:30 am

  • Chair’s Opening Remarks

    Dan Karlin
    Daniel Karlin, MD
    Assistant Professor of Psychiatry, Tufts University and Former Head of Clinical, Informatics, and Regulatory Strategy, Digital MedicinePfizer Inc

  • 8:40 am

  • Introducing Transparency Virtual Trials: The Future of Clinical Trials Today

    Exclusive to Mobile in Clinical Trials and DPharm, Transparency Life Sciences’ VISITOR study demonstrates the ease and viability of conducting clinical trials using integrated technologies.


    Tomasz Sablinski, MD, PhD

    Co-Founder and CEO, Transparency Life Sciences

  • 8:45 am

  • A Bayer Perspective on Key Considerations when Adding Apps and Devices to your Clinical Trials

    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

  • 9:10 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?


    Jyoti Shah

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

    with


    Kai Bode
    Director, Digital and Analytics Technologies, Merck
  • 9:35 am

  • A Novartis Case Study: Focal View and Empowering Patients

    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

  • 10:00 am

  • Pfizer: Lessons Learned from the Validation, Verification and Use of Digital Wearable Technology in a Atopic Dermatitis Clinical Trial

    Carrie Northcott
    Carrie Northcott, PhD

    Project Team Lead, Early Clinical Development, Digital Medicine, Pfizer, Inc

  • 10:25 am

  • Networking Break

  • 10:55 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

  • 11:20 am

  • Developments in the Use of Actigraphy in Clinical Trials: a Philips Case Study


    Jessie Bakker, PhD

    Senior Manager, Clinical Trials, Philips Respironics

  • 11:35 am

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


    Kelley Erb, PhD

    Director, Digital Medicine, Early Clinical Development, Pfizer Inc

  • 12:00 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


    Spyros Papapetropoulos, MD, PhD

    EVP, Head of R&D and CMO, Cavion Pharmaceuticals

    Blinded Diagnostics


    Paul Savuto, MBA
    President and CFO

    Virtrial


    Mark Hanley

    President and CEO

    with


    Kim Kundert

    VP of Clinical Operations

    TrialX


    Sharib Khan, MD, MA, MPH

    Co-Founder and CEO

    ClinOne


    Rob Bohacs, MBA

    Co-Founder and CEO

  • 12:30 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

    Assistant Professor of Psychiatry, Tufts University and Former Head of Clinical, Informatics, and Regulatory Strategy, Digital MedicinePfizer Inc

  • 2:45 pm

  • The Future of Mobile Data in Clinical Trials: Challenges and Opportunities

    Novel endpoints and new datatypes are being rapidly developed in the Mobile Health community. These new measurements differ in many ways from traditional measurements; they are often real world datapoints, they follow few or no accepted standards, they require validation and are only just becoming available at scale. Drs Karlin and Glimcher will discuss this rapidly evolving space with an emphasis on the barriers and opportunities in the mobile health arena. More specifically:

    • What are the Barriers to gathering an incorporating Mobile data into clinical trials?
    • What are the most important new datatypes that are evolving in the Mobile Health space?
    • How can we use Real World Measurements to identify new classes of clinically relevant endpoints to go beyond Billing Codes?
    • Can we expect to see large-scale Mobile databases for synthetic use on the model of EMRs and ICD codes?
    • How should we think of these new classes of data, are they just novel bioindicators or something else?


    Paul Glimcher, PhD

    Julius Silver Professor of Neural Science and Physiology / CEO, NYU / Data Cubed

    with 

    Dan Karlin
    Daniel Karlin, MD

    Assistant Professor of Psychiatry, Tufts University and Former Head of Clinical, Informatics, and Regulatory Strategy, Digital MedicinePfizer Inc

  • 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

    Assistant Professor of Psychiatry, Tufts University and Former Head of Clinical, Informatics, and Regulatory Strategy, Digital MedicinePfizer Inc


    Deanna Lennon

    Director, Business Development, Medable, Inc

  • 3:40 pm

  • Networking Break

  • 4:10 pm

  • 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

    Mohammad Ali-Mobile
    Mohammad Ali

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


    Joe Dustin
    Principal, Mobile Health, Medidata Solutions

  • 4:30 pm

  • The Hybrid Virtual Approach to Research: Replacing On-site Clinic Visits with Virtual Visits

    • What types of assessments are included in a Virtual Visit?
    • When can virtual visits replace an on-site clinic visit?
    • What technology features are required to make this shift?
    • What study phases and therapeutic areas are best suited for Virtual Visits?


    John Reites

    Partner and Chief Product Officer, THREAD Research

  • 4:45 pm

  • Unsolved Questions in Virtualized Studies

    In this session, mProve Health CEO, Jeff Lee will lead the panelists in a conversation to confront the challenges, mistakes made and lessons learned in virtual studies. There’s been a lot of discussion about the promise of virtual studies, but people tend to gloss over the thornier aspects of virtual studies. The panel will consider:

    • Identity Verification 
    • Medical History Verification
    • Direct2Patient drug supply 
    • Labs

    Led by:


    Jeff Lee

    CEO, mProve Health, a Bracket Company

    Panelists:

    Jacob LaPorte
    Jacob LaPorte, PhD

    Global Head of Digital Development, Novartis


    Craig Lipset, MBA

    Head of Clinical InnovationPfizer


    Lisa Shipley, PhD

    VP, Digital and Analytics Technologies, Merck Research Laboratories

  • 5:15 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?

    Moderator:


    Dina Katabi, PhD

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

    Panelists:


    Arthur Combs, MD, FCCP, FCCM

    Chief Medical Officer, MC10 Inc


    Adam S Halbridge, MBA

    Principle, Digital Health, PRA Health Sciences


    Kristin Hannesdottir, PhD

    Translational Medicine, Neuroscience, Novartis Institutes for BioMedical Research (NIBR)


    Krystyna Zaluski

    Global Business Development – Digital Innovation, Cambridge Cognition

  • 5:45 pm

  • Conference Concludes