2016 Agenda

  • 8:00 am

  • Registration

  • 8:30 am

  • Chair’s Opening Remarks

    Daniel Karlin_bw

    Daniel Karlin, MD
    Senior Director, Quantitative Medicine, Clinical Lead, BlueSky, Pfizer Inc

  • 8:45 am

  • How are we Using Mobile in Clinical Trials Today? What are the Current Barriers?

    • Use: to improve patient experience; reminders, BYOD, travel, etc.
    • Use: to improve data capture
    • Barrier: technical (is the technology ready?)
    • Barrier: regulatory, do regulators limit adoption?
    • Barrier: scientific, is there utility in the data?
    • Barrier: cultural
      • Of patients- privacy, security, etc.
      • Of sites- motivation, change
      • Of sponsors- inertia, caution, conservative
    • Address the disconnect between hype and evidence

    Daniel Karlin_bw

    Daniel Karlin, MD
    Senior Director, Quantitative Medicine, Clinical Lead, BlueSky, Pfizer Inc



    Ben Baumann
    COO, OpenClinica

    Jennifer Goldsack_bw2

    Jennifer Goldsack, MChem, MA, MBA, CPHQ
    Clinical Project ManagerCTTI


    David Haddad
    Executive Director, Open mHealth

    Nicole Miskel_bw

    Nicole Miskel, RPh
    Advisor, Clinical Innovation, Eli Lilly & Company

  • 9:30 am

  • Integrated Approaches to Using Digital as a Clinical Tool: Real world trials and population health in the North of England

    • Public-private pre-competitive partnerships
    • A need to approach data analysis differently
    • Share the load, work together
    • What does this new model look like?

    Hakim Yadi_bw

    Hakim Yadi, PhD
    CEO, The Northern Health Science Alliance

  • 9:50 am

  • Networking Break

  • 10:20 am

  • ResearchKit: How Beneficial is it Really and Where Are They Now?

    12 months into Apple’s clinical research shake-up, we hear from the mPower (Parkinson’s) app team on where they are now. More specifically:

    • What has the first set of data shown?
    • How are you using these learning’s?
    • How did you manage the analysis of millions of data points?
    • Have you seen a breakthrough in participation and adherence?
    • What do you hope to see from the introduction of the Care Kit platform?
    • Share insights on your evolution of thinking; HealthKit, ResearchKit and now CareKit

    John Wilbanks_bw

    John Wilbanks
    Chief Commons Officer, Sage Bionetworks

  • 10:50 am

  • Rethinking How we Use Sensors in Clinical Trials

    • Redefining patient outcomes
    • Opportunities in integrating and interpreting the data
    • Challenges in delivering a new measurement system


    Daniel Karlin_bw

    Daniel Karlin, MD
    Sr. Director, Quantitative Medicine, Clinical Lead, BlueSky, Pfizer Inc


    Spyros Papapetropoulos_bw2

    Spyros Papapetropoulos MD, PhD   
    VP, Global Head Clinical Development Movement Disorders & Neurodegenerative DiseasesTeva Pharmaceuticals


    Sagi Polani, DVM
    Medical Affairs LeadContinUse Biometrics

    Debbie Profit_bw

    Debbie Profit, PhD
    Leader, Otsuka Information Technology, Otsuka Pharmaceuticals

  • 11:30 am

  • Digital, Just What the Doctor Ordered

    Companies like WellDoc, Twine Health and Livongo have shown tremendous improvements of the use of their “Digital Coaching” platforms in treatment outcomes of chronic diseases like type-2 diabetes and hypertension, in treatment periods of as short as 12 weeks.

    The use of the Digital Coach may amplify the treatment outcome of your clinical trial, and so you will find out if the trial *really* works and when ultimately going to market with a drug supported by a digital coaching platform, this also has benefits for those patients treated with the drug (real world efficiency) and the physicians prescribing the drug (affordability of care). More specifically, why pharma should consider adopting digital coaching platforms in clinical trials.

    Joris Van Dam_bw2

    Joris Van Dam, PhD
    Strategic Projects Leader, Pharmaceutical DevelopmentNovartis

  • 11:55 am

  • No Phone or Patient Left Behind: The First Cross Platform ResearchKit Based Study

    One of the stand out restrictions of clinical research apps to date is that they were developed for either iOS or Android but never both which alienates an entire population of patients. In this session hear from TrialX CTO, Dr Chintan Patel, on how they ran the first cross platform app based research study. More specifically:

    • How to implement a mobile study across two platforms
    • Experiences and lessons learned along the way
    • How to ensure the validity of data sourced on two different platforms
    • How they managed and pulled value from the data


    Chintan Patel, PhD
    CTO and Co-founderTrialX, Inc

  • 12:10 pm

  • Luncheon

  • 1:10 pm

  • Fireside Chat: How Might We Reinterpret Neuro-Psychiatric Scales in a Digital Era?

    Joe Kim_bw

    Joe Kim, MBA
    Senior Advisor, Clinical Innovation, Eli Lilly & Company


    Zen Chu, MBA
    Faculty Director and Entrepreneur-in-Residence, MIT

  • 1:35 pm

  • Enhancing ResearchKit and Addressing its Limitations for Research

    This session will explore how to utilize ResearchKit in research programs and how to address challenges such as long-term patient engagement, integrating within research programs, scaling the solution globally, converting to Android and moving beyond proof of concept. This presentation will provide case studies on use of these mobile health solutions including lessons learned and experiences gained.

    • Adding a patient engagement element
    • Make it more accessible to all stakeholders
    • How do we scale up?
    • How do we use it beyond proof of concept?
    • How does it replace/challenge things we’re doing today?
    • How do we get it to go onto android?

    John Reites_bw

    John Reites
    Head of Digital Health Acceleration, Quintiles

    Dan Webster_new_bw_2

    Dan Webster, PhD
    Research FellowNational Cancer Institute

  • 2:00 pm

  • How Does Mobile Fit Into the Site-Sponsor-Patient Ecosystem?

    Mobile technologies certainly stand to improve the patient experience in the study, but it is very easy to overlook the implications for research sites of the increasingly complex array of technologies used in clinical trials. This session will discuss:

    • Specific site-based anecdotes of how mobile technologies have been implemented well, and where they have fallen short
    • Data from sites and patients about their perspectives on utilizing new technologies
    • Discussion of the inevitable change in site-level roles in order to properly support these new technologies.
    • Ideas on how to ensure that the growing number of site-facing technologies can be managed to create a coherent patient experience.


    Jeff Lee
    CEO, mProve Health

    Jane Shen_bw2

    Jane Shen, PharmD
    Senior Director of Innovation, PMG Research, Inc

  • 2:25 pm

  • Pfizer Case Study

    In this session, Pfizer’s Munther Baara, Senior Director, Clinical Paradigm, shares insights and experience on:

    • An enterprise vision for mobile tools supporting the development portfolio
    • Functionality for today and tomorrow
    • Utilization of the Apple ResearchKit in the interventional studies in oncology, rare disease, etc.

    Munther Baara_bw

    Munther Baara
    Senior Director, Clinical Paradigm, Pfizer, Inc

  • 2:45 pm

  • Networking Break

  • 3:00 pm

  • Science 2.0: How to Get a New Technology Written Into an Upcoming Protocol

    • How do innovation teams push to see new technologies embraced more widely across the business?
    • What are the challenges of taking a newish technology (for which people are still figuring out the best way to use it) and describing it in a new protocol in a way that is accurate but flexible?
    • How do you span the gap between Innovation Team -> Individual Study Team -> Protocol Writers so that they all have a common understanding of the technology and how it’s used?

    Craig Lipset_bw

    Craig Lipset, MBA
    Head of Clinical Innovation, R&D, Pfizer Inc

    Dimitri Talantov_bw

    Dmitri Talantov, MD
    Director, R&D Operations Innovation Medical Leader, Janssen Research & Development

  • 3:30 pm

  • Biopharma's First ResearchKit App Study

    GSK recently launched a tool designed to gather in-life data from subjects without the use of traditional investigative sites. This trial was designed to gather nuanced, sensitive data on patients with Rheumatoid Arthritis to better understand symptoms and disease trajectory, as well as evaluate the potential for enrollment and compliance in a siteless model.

    In this session Julian Jenkins, VP, Innovation Performance & Technology at GSK, and Kara Dennis, Managing Director – mHealth at Medidata will discuss how GSK partnered with Medidata Solutions to plan, deploy and analyze this study with specific focus on:

    • outlining study objectives
    • recognizing and overcoming technical challenges
    • evaluation of the subject experience
    • regulatory compliance
    • data analysis and algorithm development
    • how this type of exercise will inform future mobile trials

    Kara Dennis_bw2a

    Kara Dennis, MBA
    Managing Director, Mobile HealthMedidata Solutions


    Julian Jenkins, PhD
    VP, Innovation Performance & TechnologyGSK

  • 3:50 pm

  • Navigating Intellectual Property

    Using digital assessment tools for clinical data collection means thinking through a set of legal and IP issues not conventionally considered in drug development. In this session we will discuss a variety of potential legal issues unique to mobile in clinical trials, including:

    • Software IP access and/or invention
    • Overcoming BYOD issues
    • Copyright and Trademarking of clinical instruments

    Jane Rhodes_bw

    Jane Rhodes, MBA, PhD
    Senior Director of New Initiatives, Biogen Idec


    Willie Muehlhausen
    VP, Head of InnovationICON plc


    William Shaw
    IP CounselBiogen Idec

  • 4:20 pm

  • Town Hall Discussion: How Do We Get Mobile to Go Global

    • How are you planning for long-term success?
    • Moving past proof of concept in a fragmented market
    • Scaling up

    Led by:
    Daniel Karlin_bw

    Daniel Karlin, MD
    Sr. Director, Quantitative Medicine, Clinical Lead, BlueSky, Pfizer Inc

  • 4:45 pm

  • Technology Showcase (Hands-on Time)

  • 5:30 pm

  • Program Concludes