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2018 Agenda

  • 9:30 am

  • Chair’s Opening Remarks

    Daniel Karlin, MD, MA

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

  • 9:45 am

  • How to Implement Mobile in a Fragmented Landscape with Cultural Barriers

    Factors for consideration include:

    • Roaming costs
    • Data privacy regulations
    • Different approaches in health care systems
    • eConsent interpretations
    • Addressing the challenges of remote clinical trials in Europe
    • Scalability: the reality and challenges
    • Assessing your internal IT architecture to handle the data
    • Integration challenges internally and with third parties
    • How to convince top leadership it’s time to change the study design?
    • How can the data be integrated into the trial?
    • Factoring in regulatory and compliance guidelines
    • Will the EMA and FDA accept the data?

    Jeremy Wyatt

    CTO, Senior VP Product Development, ActiGraph

  • 10:20 am

  • Janssen’s Suite of Smart Technologies to Transform Clinical Trials: From Concept to Implementation

    In this session, Dr Hilde Vanaken, Janssen Clinical Innovation Director and Transcelerate eConsent Workstream Leader, will walk the audience through the journey of ISTEP (Integrated Smart Trial and Engagement Program) and why it was so impactful. More specifically:

    • The flexible design and core features: patient app, kit tracking and smart packages
    • The numerous internal and external challenges
    • The power of partnerships with technology & software vendors
    • The benefits of directly involving patients & sites during the development
    • The value of pre-engagements with health authorities and ethics committees
    • The open and cross-industry nature
    • The preliminary results of a first phase II study with Alzheimer patients

    Hilde Vanaken, PhD

    Clinical Innovation Director, and eConsent Workstream Leader, Janssen and Transcelerate

  • 10:50 am

  • Balancing Patient Engagement with the Risk of Bias: the Effects of Mobile Technology on Clinical Trials

    • Are mobile devices introducing a new type of bias in clinical research?
    • Factors to consider when providing real-time data to patients
    • Interaction between technology and placebo effect
    • Positive and/or negative impact on clinical outcomes

    Daniel Karlin, MD, MA

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

  • 11:20 am

  • Networking Break

  • 11:50 am

  • Verily’s Study Watch Tackles Scalability of Wearables in Clinical Trials

    Tushar Parlikar, PhD

    Product Manager, Verily Life Sciences

  • 12:30 pm

  • Tech Showcase

  • 1:00 pm

  • Lunch

  • 2:00 pm

  • Roche’s Parkinson’s Disease Study and Digital Biomarker Measures: Where are They Now?

    This session is a powerful example of how to implement and scale up mobile technology in clinical research. First launched in 2015, Roche pRED developed a smartphone-based monitoring app for those with Parkinson’s disease that complimented the traditional physician-led assessments with automated tests that continuously measured their symptom fluctuations. In this session, get an update on the lessons learned.

    Christian Gossens, PhD, MBA

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

  • 2:30 pm

  • Trials and Tribulations of an Ongoing Mobile Clinical Study: UCSF’s Revolutionary Health eHeart Study

    This session provides an excellent example of the trials and tribulations of an ongoing mobile clinical study. Learn what the obstacles and challenges have been and how they are managed. The study aims to gather more data about heart health from more people than any research study has done before. With 122,871 participants to-date, 16 studies in progress and 6 research studies published using their data, they are on track to produce meaningful benefit. In this session, Carol Maguire of UCSF’s Division of Cardiology, will deliver an update on:

    • Where are they now?
    • What challenges have they faced? Expected and unexpected?
    • Lessons learned, including those around geo-fencing
    • Insights and realities on getting their data validated
    • Strategies for integrating multiple digital components in a study
    • What’s next? The Eureka Research Platform?

    Carol Maguire, RN

    Director of Clinical Research, Division of Cardiology, UCSF

  • 3:00 pm

  • Considerations in Selecting a Digital Technology Partner

    • Is the platform fit for purpose?
    • Is it reliable?
    • Is it affordable?
    • Does it have consumer grade elements that make it easy to use?
    • Is the supplier ready to provide the product in bulk?
    • Does your partner understand the pharma industry and/or are they willing to learn?
    • Is your partner willing to share the risk and invest?

    Led by:

    Daniel Karlin, MD, MA

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

  • 3:30 pm

  • Which Remote Clinical Trial Model is Right for You?

    In a lively format, we will demo remote trial model options and where they are appropriate. You will find out what is considered to be a “fully remote” trial and what it truly requires. You will also find out what it takes and why it may make sense for a “less site-centric” trial. In this session, companies that offer different models will discuss:

    • What needs to happen for a practical model to emerge?
    • What are the pros and cons of the different models; site-less vs hybrid (less site-centric) model
    • Which types of studies are most appropriate for each model?
    • During what phase should you implement?
    • How do you scale up and make the process ubiquitous?

    Michelle Longmire, MD

    CEO & Co-founder, Medable Inc

    If you are interested in participating, please contact Meredith Sands:

  • 4:00 pm

  • Afternoon Tea Networking Reception

  • 5:00 pm

  • Day One Concludes

2018 Agenda

  • 9:15 am

  • Chair’s Opening Remarks

    Daniel Karlin, MD, MA
    Head of Clinical, Informatics, and Regulatory Strategy, Digital Medicine, Pfizer Inc

  • 9:30 am

  • Janssen's First of Its Kind Collaboration Using Mobile Devices to Remotely Monitor Safety

    In this session, hear from Bert Hartog on their collaboration to test the quality of remote safety monitoring through the use of mobile devices. Specifically:

    • How they selected their partner
    • How they got management on board
    • Implementation strategy
    • Results to date
    • Plans for phase ll and lll trials

    Bert Hartog, PhD

    Senior Director, Clinical Innovation, R&D Operations, Janssen

  • 10:00 am

  • Where Are They Now and What Can We Learn From: GSK’s PARADE Study

    GSK was the first to launch a real-world study using the Apple ResearchKit to look at the impact of Rheumatoid Arthritis had on patients’ lives. The goal was to engage with patients in a new way that integrates the research into their daily lives. It sought to address the huge issue of patient attrition. In this session, Kevin Jenkins, Project Director, Clinical Innovation and Digital Platforms at GSK, will deliver an update on:

    • Where is the PARADE team now and what’s next?
    • What challenges did they have to overcome and how?
    • Findings from the joint learning session with other ResearchKit leaders to strategize on how to improve these technologies
    • Lessons learned around patient attrition
    • Strategies identified for scaling up

    Kevin Jenkins

    Project Director, Clinical Innovation and Digital Platforms, GSK (invited)

  • 10:30 am

  • Visionary Keynote Address: Data-Driven Decision Making

    Nuria Oliver, PhD

    Director of Research in Data Science, Vodafone

  • 11:10 am

  • Networking Break

  • 11:40 am

  • CTTI Findings are in from their Mobile Clinical Trials Program: Recommendations on Novel Endpoints

    CTTI’s Mobile in Clinical Trials program was launched three years ago to propose recommendations that clarify the pathway for developing novel endpoints for use in clinical trials from data generated using mobile technology. Jennifer Goldsack shares recommendations and insights from their findings on:

    • Developing an internal process for identifying endpoints
    • Strategies for reducing friction throughout the process
    • Executing the process
    • The science required to validate an endpoint
    • A suite of tools developed in the process to help facilitate implementation

    Jennifer Goldsack, MChem, MA, MBA, CPHQ

    Clinical Project Manager, CTTI

  • 12:05 pm

  • Patient Point of View: How Do You Feel About Being Monitored Continuously?

    Barry Pinnington

    Patient Advocate

    More patient participants to be announced.

  • 12:35 pm

  • NIHR Case Study: Strategizing for eConsent Across Clinical Research

    The UK’s NIHR have conducted a proof of concept trial for obtaining patient consent via mobile devices. Plans are underway to develop this concept work further. In this session, hear from Michael Mullane on:

    • Developing the vision
    • Factors considered prior to launch
    • Implementation strategy
    • Lessons learned
    • What comes next?

    Michael Mullane
    Michael Mullane

    Innovation Lead, NIHR Clinical Research Network

  • 1:00 pm

  • Luncheon

  • 2:00 pm

  • Conference Concludes