2017 Agenda

  • 8:00 am

  • Registration & Breakfast

  • 8:30 am

  • Chair’s Opening Remarks

    Dan Karlin
    Daniel Karlin, MD
    Head of Experimental Medicine, Informatics, & Regulatory Strategy, Pfizer Innovative Research Lab, Pfizer Inc

  • 8:40 am

  • Time to Commit: How to Overcome the Cultural Barriers to Mobile Implementation

    Mobile apps, platforms and devices have been impressing the industry with their endless possibilities and opportunities for patients and clinical trials for five+ years now. But they are still not convincing the decision-makers.

    In this session the panel will discuss why, when and how to make the decision to implement a mobile strategy in your trial. More specifically:

    • When and why to reset your baseline metrics such as dropout rates and protocol deviations?
    • When and how to take advantage of mobile data?
    • How to convince top leadership it’s time to change the study design?
    • How to best engineer the efficiencies of technology into a study?
    • At what point should the evidence overshadow “the way we’ve always done it?”

    Moderator:


    Jeff Lee

    CEO, mProve Health

    Panelists:


    Munther Baara

    Senior Director, Clinical Paradigm, Pfizer

    Jacob LaPorte
    Jacob LaPorte, PhD

    Head of Digital Development, Novartis

    Jane Myles
    Jane Myles

    Head, Operational Intelligence and Innovation, Genentech/Roche

    Alex Simmonds
    Alex Simmonds
    Business Partner, Digital Clinical, R&D IT, Bristol-Myers Squibb
  • 9:20 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

  • 9:40 am

  • Designing an effective eSource Strategy to Empower Patients with Technology

    It’s 2017 and clinical trial patients expect the technology experience they have while in a clinical trial to be on par with the technology they experience in other parts of their lives. Unfortunately, that is not always the case. Join this session to learn how to design a clinical trial for today’s technology, from eConsent through data analysis, that allows you to provide a better patient experience. From eConsent, to ePRO and direct patient data capture with wearables and sensors – it’s about using digital approaches to improve patient engagement, increase trial efficiency, and reduce study risk. Empowered patients are engaged patients.

    Anthony Costello
    Anthony Costello

    VP, mHealth, Medidata

  • 9:55 am

  • How a Mobile App Can Offer Unique Value in Assessing Patient Reported Outcomes

    In this session, Crescendo Bioscience’s Chief Information Officer, Alex Bangs, reports on how a human-centered design approach was used to create MyRA, an award-winning app for patients living with RA.

    Alex Bangs
    Alex Bangs
    Chief Information Officer, Crescendo Bioscience
  • 10:15 am

  • Morning Networking Break

  • 10:45 am

  • 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

  • 11:10 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, Michelle Crouthamel, Digital Platform Leader 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


    Rob DiCicco

    VP, Clinical Innovation & Digital Platforms, GSK

  • 11:35 am

  • 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)

  • 12:00 pm

  • Case Studies: Capturing Objective Measures of Activity and Sleep in Clinical Trials

    • What to look for in an activity/sleep monitoring solution in order to ensure clinically meaningful data is being captured
    • Use cases examples: Actigraphy measures as a surrogate, screening tool, primary endpoint, and exploratory measure
    • Implementation example: Improving patient perceptions with remote monitoring


    Jeremy Wyatt

    CTO, Sr. VP Product Development, ActiGraph

  • 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 later in the day for further demonstrations.

    Moderator:

    Dan Karlin
    Daniel Karlin, MD
    Head of Experimental Medicine, Informatics, & Regulatory Strategy, Pfizer Innovative Research Lab, Pfizer Inc

    Presenting companies:

    Trial X Inc

    Sharib Khan, MD, MPH

    Co-founder & CEO

    Cmed Group

    David Connelly, PhD

    CEO

    Blinded Diagnostics

    Paul Savuto
    Paul Savuto, MBA
    President

    Preventice Solutions Group

    Thomas Campbell
    Thomas Campbell

    National Director, Federal & Clinical Accounts

    Aces Health

    Jen Wemstrom
    Jennifer Wemstrom

    EVP, Solution Strategy

  • 12:45 pm

  • Luncheon and Technology Showcase

  • 2:00 pm

  • How to Introduce a Digital Tool in a Clinical Trial from Start to Finish

    In this session, Bryan Yee, Strategic Planning and Operations Senior Manager, Amgen, leads the group in a task to mock up an implementation strategy for including a digital tool in a clinical trial. The audience will be assigned a clinical trial scenario. They will break off into groups and address the four considerations below helping to develop a suite of tools and a strategy.

    1.   Regulatory and legal constraints:

    • What are they?
    • How are you going to address them?

    2.  Requirements and partners:

    • BYOD or Provision?
    • iOs vs Android?
    • In-house or Outsource?

    3.  The role of each stakeholder:

    • Develop a feedback timeline?
    • Who do you involve in the process, when and why?

    4.  Execution: risk mitigation strategy and deployment

    Jaydev Thakkar
    Jaydev Thakkar
    Product Innovation Lead, Digital Health, Amgen

  • 3:00 pm

  • Demonstrating Value Added to a Phase IV Trial with the Introduction of a Validated Wearable: A Sunovion Case Study


    Georgia Mitsi, PhD, MBA

    Sr. Director, Search & Evaluation, Digital Healthcare, Sunovion Pharmaceuticals

  • 3:20 pm

  • Afternoon Networking Break

  • 3:40 pm

  • The Current Realities of the Virtual Trial Model and What Model is Right for You?

    In a lively format, we will demo virtual trial model options and where they are appropriate. You will find out what is considered to be a “fully virtual” 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 join Angela Walker, Emergent Strategy Consultant, Clinical Innovation, Eli Lilly & Company to 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? 

    Hosted by:

    Angela Walker
    Angela Walker
    Emergent Strategy Consultant, Clinical Innovation, Eli Lilly & Company

    with


    Noah Craft, MD, PhD
    Co-founder & CEO, Science 37

    Jeff Frazier
    Jeff Frazier

    Founder & CEO, THREAD

    Michelle Longmire
    Michelle Longmire, MD

    Co-founder & CEO, Medable Inc

    David Turner
    David Turner Jr, MS, CISA

    CEO, Parallel 6, a PRA Health Sciences Company

  • 4:20 pm

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


    Tushar Parlikar

    Program Manager, Verily Life Sciences

  • 4:50 pm

  • The Why, What, Where and How of the Digital Coach in Clinical Trials

    The use of a Digital Coach platform 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:

    • Dr Joris Van Dam, Director Project Management Planning, Strategic Projects Leader, Novartis explains why pharma should consider adopting digital coaching platforms in clinical trials
    • The platform providers highlight what is on offer
    • Clinical trial leaders discuss where in the life cycle are they applicable and how to implement them.

    Moderator:

    Joris Van Dam
    Joris Van Dam, PhD

    Director Project Management Planning, Strategic Projects Leader, Novartis

    Panelists:

    Lisa LaLuna

    SVP of Corporate Development & Implementation, ePharmaSolutions, a WIRB-Copernicus Company

    Jorge Palacios
    Jorge Palacios, MD, PhD 

    Senior Clinical Researcher, SilverCloud Health

  • 5:20 pm

  • Town Hall Meeting- A Call to Action

    Program Chair, Dr Dan Karlin, reflects on the day’s learnings and opens the discussion to the floor to review:

    • What does it all mean?
    • How do we take action on the ideas shared?
    • Expand on issues, ideas and/or solutions shared during the day
    • What’s next for mobile clinical trials? AI? VR? Machine Learning?

    Dan Karlin
    Daniel Karlin, MD
    Head of Experimental Medicine, Informatics, and Regulatory Strategy, Pfizer Innovative Research Lab, Pfizer Inc

  • 5:45 pm

  • Conference Concludes

2017 Agenda


  • DPharm Pre-Conference Workshop

    Wednesday, September 6, 2017   |   7:00 pm – 9:00 pm

    Limited Seating Available. Attendance Optional.


    Trial Innovation Co-Design Workshop: Help Create Solutions to Assist Clinical Research Participants

    Overview

    In this optional pre-conference hands-on workshop, you get to be an innovator! Using co-design and human-centered approaches, you will work with a small team to brainstorm and design an innovation to assist participants in Clinical Trials. For the purpose of this co-design workshop, you might think a smart pill bottle could help patients remember to take their trial medication, or maybe a smart refrigerator could help trial staff manage their supply of study drug. In this interactive workshop, we will guide you through a collaborative design process that helps you create practical solutions using Ambient Intelligence, the Internet of Things, and Smart Devices.

    Led by:

    Barry Crist
    Lead Investigator, Lilly Clinical Open Innovation Team, Eli Lilly & Company

    Barry leads a group of designers and techies in Lilly’s Clinical Development Innovation Lab, where they do imagineering for patient-centric research. He is the Lead Investigator for the Lilly Clinical Innovation and Optimization Team. Barry has spent his career leveraging information to transform the way people do work. He is a technologist, an architect, a seeker, a problem solver – and has a passion-fueled vision that drives a unique ability to make big ideas come to life. Prior to Lilly, Barry worked for many years at the U.S. Department of Energy’s Savannah River Site. This is a 300 square-mile facility with multiple nuclear reactors and chemical processing facilities. Barry was responsible for digitizing a half a million paper engineering drawings (blueprints, essentially) and make them smarter. Barry is a graduate of Purdue University where he studied computer technology. 


    Dave Crumbacher
    Technology Architect, Clinical Innovation, Eli Lilly & Company

    Workshop Information

    • Open to registered DPharm attendees.
    • The workshop is limited to 50 people.

    Registration Instructions