2021 Agenda


  • * All session times are in Eastern Standard Time.

  • 8:00 am

  • Virtual Platform Opens

  • 8:25 am

  • Co-Chairs’ Opening Remarks

    Dan Karlin
    Dan Karlin, MD

    CMO, MindMed

    Michelle Shogren
    Michelle Shogren

    Sr Director Innovation, Pharma R&D Clinical Operations, Bayer


  • KEYNOTE FIRESIDE CHAT

  • 8:40 am

  • Keynote Fireside Chat: Digital Trends in Health Impacting Clinical Research

    Consumer trends in digital health continue to outstrip digital progress in drug development.  In this fireside chat, DiME’s Jennifer Goldsack sits down with Donald Jones, a global leader in digital medicine, digital health and tech-enabled health services to expand on this theme. They will: 

    • Explore the widening gap between individuals’ experiences of digital tools in their personal health management compared with participants’ experiences of clinical trials protocols relying on digital tools 
    • Reflect on the implications of this widening gap for the success of decentralized clinical trials at scale
    • Consider possible solutions to speed the adoption of digital tools in clinical trials in order to provide the kind of experience that participants expect in this digital era


    Donald Jones, JD

    IMPACT Co-Founder, Chair, Virtual First Medical Practice Collaborative, Digital Medicine Society (DiMe)

    with


    Jennifer Goldsack, MBA
    CEO, Digital Medicine Society (DiMe)


  • LEVERAGING MULTIMODAL SENSORS & WEARABLES

  • 9:10 am

  • Leveraging Multimodal Sensors to Give Us More Precise Endpoints

    Digital health technologies, including wearable sensors and connected devices, enable us to simultaneously measure human physiology via heart rate and temperature, activity from body acceleration, and the environment based on light, sound, and location. When these different signal modalities are combined through statistical and machine learning approaches, they can provide more comprehensive digital phenotyping of patients, enabling the derivation of more precise and clinically meaningful endpoints for use in clinical trials. This session will discuss recent applications of multimodal sensor integration from the field, outline technical and methodological development opportunities and highlight future trends. 

    Led by:


    Charmaine Demanuele, PhD
    Director, Biostatistics, Early Clinical Development Statistics, Pfizer


    Tomasz Adamusiak MD, PhD
    Director, Data Science, Digital Medicine, Pfizer

    Panelists:


    Dmitri Volfson
    Head of Quantitative Sciences, Statistical & Quantitative Sciences, Takeda


    Giorgio Quer, PhD
    Director, Artificial Intelligence, Scripps Research Translational Institute


    Vadim Zipunnikov, PhD
    Associate Professor of Biostatistics, Johns Hopkins Bloomberg School of Public Health


    Emily Cerciello
    Associate Director, Digital Health and Engagement, Crohn’s & Colitis Foundation


    Matt Wilkes, MD, PhD 
    Head of Clinical Research, Current Health

  • 9:55 am

  • Results from a Survey of Biopharmaceuticals on Attitudes Towards the Use of Wearables and Sensors in Clinical Research

    This session will provide insights into:

    • How wearables and sensors are transforming clinical trials
    • The growing role of wearables and sensors, and projections for their future use
    • Feedback from users and sponsors on the use of wearables and sensors


    Nathan Noakes
    Solutions Architect & Program Director, Parexel

  • 10:10 am

  • Track Choices

    • Track Chair

      Dan Karlin
      Dan Karlin, MD

      CMO, MindMed

    • Choice A

      Regeneron’s Framework in Developing Novel Digital Endpoints: A Case Study for Gait Assessment in Patients with Osteoarthritis of the Knee 

      Regeneron will share how the company is leveraging the advancement and adoptability of fit-for-purpose consumer health monitors to further their goals of finding, developing and validating digital endpoints. The session will provide an overview of the different stages of digital endpoint validation the company used through a case study of gait assessment in patients with osteoarthritis of the knee. 


      Rinol Alaj
      Director, Head of COA & Patient Innovation, Regeneron

    • Track Chair

      Michelle Shogren
      Michelle Shogren

      Sr Director Innovation, Pharma R&D Clinical Operations, Bayer

    • Choice B

      Pfizer’s New Digital Study for Pediatrics: Lessons Learned

      Pfizer will share learnings from their MOSAIC study: Monitoring of Scratch via Accelerometry in Children between the ages of 2 and 11 with Atopic Dermatitis.  They will specifically provide insights into this condition that are not captured with current evaluation paradigms as well as: 

      • Identify what to think about when choosing devices for young children
      • Design considerations 
      • Opportunities and challenges in involving young patients
      • Validating algorithms for night-time scratch and sleep for children


      Carrie Northcott, PhD
      Director/Project Lead, Digital Medicine and Translational Imaging, Early Clinical Development, Pfizer

  • 10:35 am

  • Networking Break


  • DCT’S & THE PATIENT VOICE IN DESIGNING TRIALS

  • 10:45 am

  • Moving Beyond Your Initial Decentralized Clinical Trials (DCTs)

    In this session, attendees will learn key strategies and adoption approaches to move from your initial DCTs to the next level of scale. Topics include:

    • How to form the right team
    • The most important key performance indicators (KPIs)
    • Scaling your partnerships
    • Global implementation strategy
    • How to move participant inclusion efforts to the forefront


    John Reites
    CEO, THREAD

  • 11:00 am

  • Patient Experiences with Mobile Technologies and Their Input in Designing Digital Trials

    Hear from two patient advocates with different viewpoints on decentralized trials with connected devices. What are the strengths and limitations? This will be followed by a panel discussion about patient input in designing digital trials, including working with patient panels during study design planning as well as hurdles to implementing digital tools and how to overcome them.

    Led by:


    Tairmae Kangarloo
    Senior Manager, Digital Strategy, Takeda

    Panelists:


    Shari Short
    Patient Advocate


    Mike Shafer
    Patient Advocate


    Xuemei Cai
    Senior Medical Director, Digital Medicine, Pfizer


    Daniel Fulford, PhD
    Assistant Professor, Occupational Therapy, Rehabilitation Sciences, and Psychological & Brain Sciences, Boston University


    Kyle Hogan
    EVP, Strategy, DataCubed Health


    Bernadette Tosti
    VP, Patient Experience, Science 37


  • TECH DEMOS, POP-UP PRESENTATIONS, AND NETWORKING

  • 11:45 am

  • Three Featured Tech Demos

    In this section, hear from three companies that will present a five-minute demo of their technology and will be present during the Breakout Networking  Session to provide information and answer questions.

    Moderated by:

    Dan Karlin
    Dan Karlin, MD

    CMO, MindMed

    Presenting Companies:

    Curebase


    Shawn Malloy
    Director of Marketing

     

    Biofourmis


    David Kiger
    Global Vice President, Therapeutics

     

    Shimmer Research


    Martina Donohue
    Marketing Manager

  • 12:00 pm

  • Pop-Up Presentations

    Hear from five companies presenting a one-minute overview of their technologies or services in the mobile space for clinical trials.

    Moderated by:

    Dan Karlin
    Dan Karlin, MD

    CMO, MindMed

    Presenting Companies:

    ActiGraph

    Clinical Ink

    Halloran Consulting Group

    Philips North America

    Tasso

  • 12:10 pm

  • Breakout Networking Session

    Have a quick live Q&A with one of the companies from the morning sessions.  Feel free to change rooms as often as you’d like to gain an understanding of the wide range of different technologies in the mobile space for clinical trials.  Meet the following companies: 

    • ActiGraph
    • Biofourmis
    • Clinical Ink
    • Curebase
    • Current Health
    • DataCubed Health
    • Halloran Consulting Group
    • Parexel
    • Philips North America
    • Science 37
    • Shimmer Research
    • Tasso
    • THREAD
  • 12:30 pm

  • Lunch


  • DIGITAL IN EARLY DRUG DEVELOPMENT, BIOMETRICS, & A NEW TOOLKIT

  • 1:15 pm

  • Opportunities for Digital Technology in Early Drug Development that Can Help Support Later Stage Clinical Studies

    One of the challenges the R&D industry faces is introducing digital technology late in the development cycle with a focus on efficacy and novel endpoints.  However, evidence for both safety and efficacy of therapeutics can be generated in early development trials.  In this session, Genentech will discuss the ways early introduction of digital tech can help support studies.  More specifically:

    • Safety monitoring for adverse events
    • Proof of Activity
    • Early evidence of efficacy measures, such as activity and sleep.


    Thomas Switzer
    Digital Health Scientist, Genentech Research and Early Development, Genentech

     

  • 1:35 pm

  • Evaluation of Biometrics in a Diverse Sleep Disordered Population

    This session will provide insights into:

    • Objective Data Capture
    • Validation outcomes of biometrics
    • Leveraging current reference standards


    Krishna Jhaveri, MD, PhD
    Sr. Clinical Scientist Motion Biosensors, Philips North America

  • 1:50 pm

  • A New Toolkit for Operationalizing Digital Data Collection in Clinical Trials to Help Make Better Decisions Faster

    DiMe produced the Clinical Trials dossier in The Playbook to answer the 24 top questions that clin-ops teams have for deploying digital endpoints in a clinical trial. DiMe highlights approaches and solutions to help clinical teams overcome common sources of fear, uncertainty and doubt when implementing digital clinical measures into their studies.


    Jennifer Goldsack, MBA
    CEO, Digital Medicine Society (DiMe)

  • 2:15 pm

  • Track Choices

    • Track Chair

      Michelle Shogren
      Michelle Shogren

      Sr Director Innovation, Pharma R&D Clinical Operations, Bayer

    • Choice A

      2:15 pm

      Flexible Data Collection: Mobile Strategies that Work for Decentralized Clinical Trials

      While the pandemic accelerated the increased adoption of digital technology in clinical trials, issues around patient recruitment, retention, and diversity remain unsolved. A flexible approach powered by mobile technology helps sponsors overcome these issues while improving efficiency and accuracy. Through case studies, this session explores how mobile technology, coupled with eSource direct data capture, gives clinical trials the flexibility needed to attract and retain patients


      Jonathan Andrus
      Chief Strategy Officer , Clinical Ink


      2:30 pm

      Developing a Foundation for Working with Connected Devices in Clinical Trials 

      This session will provide guidance on operationalizing clinical trials with connected devices and provide examples as well as solutions for overcoming challenges.  More specifically:

      • Considerations for both the site and the patient 
      • Proactive troubleshooting
      • Setting smaller companies up for success
      • Ensuring the tool being deployed is generating data that is robust and valid.

      Led by:

      Michelle Shogren
      Michelle Shogren

      Sr Director Innovation, Pharma R&D Clinical Operations, Bayer

      Panelists:


      Tairmae Kangarloo
      Senior Manager, Digital Strategy, Takeda


      Josh Cosman, PhD
      Director Digital Health Strategy, AbbVie


      Isaac Rodriguez-Chavez, PhD
      SVP, Scientific & Clinical Affairs, Strategy for DCTs, Icon plc


      John Ferraro
      Sr Principal Consultant, West Coast Site Head & Innovation LeadHalloran Consulting Group 


      3:00 pm

      How Bayer “Test-Drives” Digital Technology with their Tech4Trials Program to Reduce Barriers to Adoption

      You’ll learn about Bayer’s model to reduce barriers to adoption for new digital technologies in clinical trials. “Tech4Trials” is an operational improvement initiative used to de-risk concerns with adoption and most importantly increase the understanding of the benefit/burden for patients.  This session will cover how the approach works and include example case studies.

      Michelle Shogren
      Michelle Shogren

      Sr Director Innovation, Pharma R&D Clinical Operations, Bayer


      Julien Kroll
      Clinical Trial Technology Strategist, Bayer


      Amy Bohn
      Director, DCT Operations, Bayer

    • Track Chair

      Dan Karlin
      Dan Karlin, MD

      CMO, MindMed

    • Choice B

      2:15 pm

      Making Virtual Sites a Reality: Introducing the Decentralized Clinical Trial Investigator Network

      While many trials still require in-person site visits, a growing variety of studies can be accomplished in a fully decentralized fashion. However, identifying investigators to provide oversight in each U.S. state necessary has proven to be a challenge, along with the contracting and management of these investigators.  Labcorp will share its innovative, nationwide solution. In partnership with Circuit Clinical, they have deployed the DCT Investigator Network to support fully virtual trial designs. This session will introduce the concept and describe how it works through a detailed use case.


      Kristen Andrews
      Sr Director, Site Centric Solutions, Labcorp


      2:30 pm

      Advanced Questions with Keynote Donald Jones for the More Experienced Digital Executive


      Donald Jones, JD

      IMPACT Co-Founder, Chair, Virtual First Medical Practice Collaborative, Digital Medicine Society (DiMe)

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       


      3:00 pm

      How Janssen is Utilizing Voice Interface to Allow Patients to Verbally Interact with Digital Devices

      Janssen is working on a voice-user interface that will allow patients in clinical studies to verbally interact with their digital devices to engage in such tasks as completing study questionnaires, scheduling appointments or asking questions related to their studies. Additionally, it will function as a “behind-the-scenes” speech measurement tool that can predict various aspects of cognition.  Hear how Janssen developed this new technology with their partners for the benefit of patients.


      Stephen Ruhmel
      Associate Director, Janssen Clinical Innovation at Johnson & Johnson

       

      Kosmas Kretsos, PhD, MBA
      Global Life Sciences Business Development Lead, Amazon Web Services

  • 3:30 pm

  • Networking Break


  • DIGITAL BIOMARKERS & REMOTE BLOOD COLLECTION

  • 3:40 pm

  • Getting Digital Biomarkers Across the Finish Line: Leveraging Lessons from Traditional Biomarkers

    The session begins with a brief discussion on the state of digital biomarkers. This includes learnings from the discovery and approval of well-defined traditional biomarkers such as fluid or imaging. The discussion will move to what’s required to get digital biomarkers across the finish line, including: 

    • Data gathering needs to determine the robustness of digital biomarkers
    • Contributing factors to successful endorsement of traditional biomarkers
    • Closing the gap to make ‘digital’ biomarkers part of standard biomarker strategies
    • What the future looks like for digital biomarkers

    Led by:


    Josh Cosman, PhD
    Director Digital Health Strategy, AbbVie

    Panelists:


    Charmaine Demanuele, PhD
    Director, Biostatistics, Early Clinical Development Statistics, Pfizer


    Derek Hill, PhD
    Professor of Biomedical Engineering, University College London (UCL)


    Elizabeth Kunkoski
    Health Science Policy Analyst, FDA Center for Drug Evaluation and Research (CDER)


    Christine Guo, PhD
    Chief Scientific Officer, ActiGraph


    Jaydev Thakkar 
    Chief Operating Officer, Biofourmis

  • 4:15 pm

  • Scaling Remote Blood Collection to Dramatically Reduce the Burden to Patients

    With an increase in more “mobile” in clinical trials, one facet that is less obvious to implement at home is collecting blood-based biomarkers. And yet, they form a backbone common to most clinical trials: the vast majority of clinical development relies on the ability to assess biomarkers that are traditionally collected by drawing blood in the clinic to monitor/measure one’s disease (or health) status.  This panel will focus on rethinking our approach to blood-based biomarkers. Can we achieve the same result with different means? Are there ways to enable home collection in a more patient-centric approach? What are the challenges ahead, more specifically:

    • Challenges faced by pharma, devices, regulators
    • Options to replace (e.g. sweat, interstitial, optical) and/or re-think blood draws
    • Develop better methods to address blood and plasma-based biomarkers

    Led by:


    Tony Fantana, PhD
    Lead, Emerging Technology Strategy, Clinical Design Delivery & Analytics, Eli Lilly and Company

    Panelists:


    Enaksha Wickremsinhe, PhD
    Research Advisor, Eli Lilly and Company


    Lisa Shipley
    VP, Global Digital and Analytics Technologies, Merck


    Clay Smith, MD
    Director, Blood Disorders and Cell Therapies Center, UC Health


    Vasum Peiris, MD, MPH, FAAP, FACC, FASE
    CMO, Pediatrics and Special Populations, FDA Center for Devices and Radiological Health (CDRH)


    Erwin Berthier, PhD
    CTO and Co-Founder, Tasso


  • OPPORTUNITIES IN DIGITAL DATA COLLECTION

  • 4:50 pm

  • AbbVie: A Detailed Framework for Operationalizing a BYOD Study with Solutions for Data Challenges

    As sponsors explore new modes of digital tools, they are questioning current industry best practices for the provision of sponsor-owned devices that include pre-programmed applications for subject data collection. As R&D transitions into a more technology-patient focused world, many sponsors have taken an interest in the “Bring Your Own Device” (BYOD) strategy, as this permits patients to record PRO data on personal tablets and smartphones.  This session provides a detailed framework for consideration of BYOD adoption.


    Aman Thukral
    Head of Digital Operations and Clinical Systems, AbbVie


    Kelsey Linsmeier
    Program Lead Associate, Clinical Data Strategy and Operations, AbbVie

  • 5:10 pm

  • Moving Toward a Big Tech Data Model to Improve Statistical Power in Small Trials and Develop Robust, Generalizable Features

    The ability to learn robust models from complex data is most often limited by the quantity of data. As a result, the development of biomarkers for precision medicine typically faces a Catch-22 in which sufficient data for biosignature discovery may not exist until phase 3, by which time it is too late to leverage those results in a phase 3 program. This session will discuss:

    • The value of taking a wholistic view, unifying measures across trials, to create a large uniform data layer to drive learning
    • Opportunities on the horizon for real world digital data to enable clinical development through a back-translation model


    Gayle Wittenberg, PhD
    Interim Head, Neuroscience Data Science, Janssen

  • 5:30 pm

  • Conference Concludes


  • VIRTUAL NETWORKING RECEPTION


  • 5:30 pm – 6:30 pm

    Virtual Networking Reception hosted with DiMe         

     

    Join Jennifer Goldsack, CEO of DiME, for an informal virtual gathering to discuss the day’s topics and get a first look at what’s coming down the pike at DiME to support the industry in furthering the adoption and scale of mobile digital technologies.

     

    Save the Date!

    Mobile 2022, September 12

    Westin Copley Place Boston