2018 Agenda

  • 9:00 am

  • Registration, Coffee and Tea

  • 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?


    Daniel Karlin, MD, MA

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


    Jeremy Wyatt

    CTO, Senior VP Product Development, ActiGraph

  • 10:15 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

  • Bring Your Own Devices (BYOD) in Clinical Trials: Challenges and Solutions

    • Is BYOD the way forward for collecting patient reported outcomes
    • Key challenges foreseen with BYOD
    • Experiences with BYOD in clinical trials

    Led by:

    Narayanan Ramaswamy
    Narayanan Ramaswamy

    Chief Architect and Product Head, TCS Connected Clinical Trials, Tata Consultancy Services

    Panelists:
    Liz Alfonso
    ePRO Manager, Johnson & Johnson

    Michael Mullane
    Michael Mullane

    Innovation Lead, NIHR Clinical Research Network

    Nicole Noyens
    Nicole Noyens

    Director, Janssen Clinical Innovation

    Chiara Rustici
    Chiara Rustici

    GDPR and EU Privacy Analyst

  • 11:30 am

  • Networking Break

  • 12:10 pm

  • Visionary Keynote: Data-Driven Decision Making


    Nuria Oliver, PhD

    Director of Research in Data Science, Vodafone

  • 12:50 pm

  • The Road Towards Implementing Patient Adherence in a Clinical Trial

    • The importance of patient-centric design 
    • Adding flexibility to handle complex clinical trials 
    • Challenges in managing approval of patient facing content 
    • Adherence in a connected world 
    • Lessons learned

    Narayanan Ramaswamy
    Narayanan Ramaswamy

    Chief Architect and Product Head, TCS Connected Clinical Trials, Tata Consultancy Services

  • 1:20 pm

  • Lunch

  • 2:30 pm

  • Keynote: Verily's Study Watch Tackles Scalability of Wearables in Clinical Trials


    Tushar Parlikar, PhD

    Product Manager, Verily Life Sciences

  • 3:10 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)

  • 3:40 pm

  • 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

  • 4:00 pm

  • Afternoon Tea Networking Reception

    Welcome Remarks from Rachna Malik, Global Head, TCS Life Sciences Platformsx

    Graciously hosted by

  • 5:00 pm

  • Day One Concludes

2018 Agenda

  • 8:45 am

  • Coffee and Tea

  • 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

  • The Impact of GDPR on Medical Apps and Health-care Connected Mobile Devices

    Analogical, digital, device and sensor data linked to a living natural person is in scope of the EU’s new privacy framework, the GDPR. When such data is also biometric, genetic or carries information about someone’s health, it attracts an even higher protection. Medical and scientific research benefits from certain exemptions, but knowing which ones apply and how to design and use medical apps and connected devices lawfully is absolutely non-negotiable for the clinical deployment of digital biomarkers and innovation digital health-care. In this session, get the latest updates from GDPR analyst, Chiara Rustici.

    Chiara Rustici
    Chiara Rustici

    GDPR and EU Privacy Analyst

  • 10:30 am

  • 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

  • 11:00 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

    Annemarie Forest
    Annemarie Forrest

    Associate Director of Projects, CTTI


    Jennifer Goldsack, MChem, MA, MBA, CPHQ

    Clinical Project Manager, CTTI

  • 11:55 am

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

    Moderator:


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

    Panelists:


    Barry Pinnington

    Patient Advocate

    Alan-Thomas
    Alan Thomas

    Founder, Ataxia and Me

  • 12:30 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