2020 Agenda


  • * All session times are in Eastern Standard Time.

  • 9:45 am

  • Co-Chairs’ Opening Remarks & Opening Video

    Dan Karlin
    Dan Karlin, MD

    CEO, HealthMode

    Michelle Shogren
    Michelle Shogren

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

  • 10:00 am

  • How a Physician Transitioned from Traditional to Remote Clinical Trials for the Benefit of His Patients

    An early adopter of bringing clinical research to where the patient is located, Dr Dorsey will walk us through how he transitioned from traditional to remote trials through case examples. He will cover how he adapted to the use of mobile and digital technologies.

     


    Ray Dorsey, MD, MBA

    David M. Levy Professor of Neurology and Director of the Center for
    Health + Technology,
     University of Rochester Medical Center

  • 10:25 am

  • 5 Minute Break

  • 10:30 am

  • The Physician, Patient, Pharma and Service Provider Perspectives on the Rapid Transition to a Virtual Trial in the Era of COVID-19 and Beyond

    Dr Augustine will lead a multi-perspective panel where experts from a trial site, a sponsor, a
    patient and a service provider will describe take-aways from the urgent transition to virtual and hybrid models to move clinical trials forward.  More specifically:

    • Case example
    • What has the site experience been?
    • What has the patient experience been?
    • What lessons have been learned?

    Led by:


    Erika Augustine, MD

    Associate Professor of Neurology & Pediatrics, University of Rochester Medical Center

    With:


    Ariel Dowling

    Director of Digital Strategy, Takeda

    Jimmy Bechtel
    Jimmy Bechtel, MBA,

    Director, Innovation & Engagement, Society for Clinical Research Sites (SCRS)


    Christopher Ceppi

    Chief Product Officer, Science 37
     
    Beth Stroud
    Patient Advocate
     

    Kent Thoelke

    Chief Scientific Officer & Executive VP, PRA Health Sciences
  • 10:55 am

  • 5 Minute Break

  • 11:00 am

  • Boston Children’s Hospital Case Study on Rapidly Deploying a Digital Strategy to Meet the Needs and Expectations of Patients and Caregivers

    Hear how Boston Children’s Hospital rapidly deployed virtual care options during COVID-19 for patients and caregivers and about continuous plans for the next year as well as patient engagement pilot programs. More specifically:

    • What virtual care has been like for clinicians and staff
    • What virtual care has been like for patients and caregivers
    • What insights can be applied to clinical trials

    You will also learn about the cutting-edge technologies currently in development like voice projection, VR/AR and AI to change the digital landscape of healthcare.


    Caitlin Schumann
    Manager, Strategy & Business Development, Innovation & Digital Health Accelerator, Boston Children’s Hospital

    Hosted with:

    Dan Karlin
    Dan Karlin, MD

    CEO, HealthMode

  • 11:20 am

  • A New Framework to Assist Drug Developers in Determining which Device is Right for Your Trial

    With the proliferation of wearable devices on the market, drug developers need a framework to assess which ones fit the needs of their clinical trials. In this session, learn how to evaluate, select, and document the performance of connected sensor technologies through a worked example with a focus on:

    • Measurement performance (verification, analytical validation and clinical validation, or the ‘V3’ framework)
    • Usability and utility
    • Data rights and privacy
    • Security
    • Economic feasibility
    • Case study


    Jennifer Goldsack, MBA
    Executive Director, Digital Medicine Society (DiME)

  • 11:40 am

  • MyoKardia Case Study: Building Programs Incorporating Novel Digital Health Technologies

     


    Priyanka Agarwal, MD, MBA

    Director Digital Health, MyoKardia

    Hosted with:

    Dan Karlin
    Dan Karlin, MD

    CEO, HealthMode

  • 12:00 pm

  • Virtual Visits – Bringing Together Patients and Care Teams with HIPAA and HITECH Compliant Audio, Video and Screen Sharing

    Microsoft Teams enables simple, secure collaboration and communication with chat, video, voice, and healthcare tools in a single hub that supports compliance with HIPAA, HITECH and more.
    In this session, the following will be addressed:

    Bringing together patients and clinicians with high-quality audio, video, and screen sharing in a secure meetings experience to help support telehealth workflows.
    Orchestrating resources and care across departments, digitizing clinical workflows, and enabling coordinated care with instant access to people and patient information.
    Connecting with the people and information you need whether it’s across your care team or health system, through a multidisciplinary team (MDT) meeting, or while on the go.


    Ryan Tubbs
    Co-Founder & Managing Director, Clinical Research Innovation Hub, Microsoft

     

     

  • 12:10 pm

  • Meet the Technology & Service Companies in One Convenient Place

    On the left side of the virtual platform, you will see an icon called Meet the Sponsors.
    A great opportunity to easily explore a number of different companies providing essential solutions to advance clinical trials for the benefit of patients. Check out the raffles and giveaways! This is also where you can get information about the daily survey and customer service information. It’s informative and fun!

  • 12:25 pm

  • Lunch Break

  • 12:55 pm

  • Eli Lilly Fireside Chat with the Key Investigator of a Global COVID-19 Early Detection System Study: Matching Mobile Science to Fit the Patients’ Needs

    In this session Eli Lilly’s Joe Kim sits down with UCSD Assistant Professor, Dr Benjamin Smarr, who is working on an early alert system for COVID-19 that includes monitoring ~50,000 international participants, including healthcare workers in the San Francisco Bay area and a number of sites across the US. Dr Smarr will discuss in particular:

    • his experience as a key investigator for a global COVID-19 early detection system study, that utilizes the Oura Ring
    • opportunities for disease tracking and surveillance through continuous data from wearables
    • his experience working with Oura as a researcher and scientist
    • aspects of devices that make them optimal for research
    • the future of data science in human health

     


    Benjamin Smarr, PhD

    Assistant Professor, Halicioğlu Data Science Institute and the Department of Bioengineering, UC San Diego

    with:


    Joseph Kim, MBA
    Sr Advisor, Digital Health Office, Translational Technology & Innovation, Eli Lilly and Company 

  • 1:15 pm

  • BrainBaseline Fireside Chat: Deploying Consumer-Grade Mobile Devices to Develop Digital Biomarkers for Parkinson’s Disease

    BrainBaseline partnered with multiple pharmaceutical companies and Dr Josh Cosman, Director of Digital Health Strategy at AbbVie, to create a mobile application available to WATCH-PD study participants on the iPhone and Apple Watch. The app allows researchers to remotely measure motor and cognitive features of Parkinson’s Disease that overlap with those measured using traditional clinician-rated exams (e.g., MDS-UPDRS). This method aids researchers to gather more sensitive, frequent, and objective measures of disease progression in early PD. This Fireside Chat will cover how BrainBaseline translated a battery of assessments to a digital format, why they deployed on consumer-grade hardware, and how their work is furthering the development of digital biomarkers for movement disorders.


    Joan Severson

    CEO, BrainBaseline 

    with:

    Josh Cosman, PhD

    Director Digital Health Strategy, Abbvie 

  • 1:30 pm

  • Five Minute Break

  • 1:35 pm

  • Choice Between 2 Tracks

    • Track A

      Moderated by:

      Michelle Shogren
      Michelle Shogren

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


    • 1:35 pm – 1:55 pm

      Janssen Case Study: Remote Assessments in a Virtual Trial

      Janssen is conducting a study on the use of a wearable device to remotely capture circadian rhythms in patients of Sjögren’s Syndrome and Lupus.  In this session, Janssen shares its successes and challenges from initiation to patient compliance and data capture. 

      Antonieta Sosa
      Antonieta Sosa

      Director, Clinical Innovation, Janssen

       

       


    • 1:55 pm – 2:30 pm

      Bayer Case Study: Amplifying the Patient Voice in a Hybrid Decentralized Trial in Heart Failure

      Bayer constructed a team to support patient participation in designing a trial in a hybrid decentralized environment. The team will tell us about the four styles of interaction involved in bringing in the patient voice, what the goal was for each type, and the insights and modifications that were made based on these interactions.

      Michelle Shogren
      Michelle Shogren

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

      With:


      Tiffany McGinnis
      Director, US Site Management, Bayer


      Amy Bohn
      Study Operations Specialist, Bayer


      Mala Kamal
      Manager, Clinical Trial Monitoring, Bayer


      Bob Greco
      Innovation Manager, Clinical Operations Innovation, Bayer


    • 2:30 pm – 2:45 pm

      Scale Your Hybrid Decentralized Study Approaches Through Technology

      This session will provide best practices for enabling proactive planning, scaled use and global adoption of hybrid decentralized studies within your organization.


      John Reites

      President, THREAD


    • 2:45 pm – 3:25 pm

      Traversing the Regulatory Road to Qualifying a Digital Endpoint; Twists and Turns

      This panel  will discuss a framework for the qualification of novel digital endpoints (NDE) and the regulatory feedback on these approaches. Panelists will cover:

      • regulatory engagements that included discussions of NDE(s)
      • ‘case studies’ that organizations have put forward, the types of information collected, questions asked to health authorities, their context and objectives, as well as responses from health authorities
      • insights we can leverage as we go forward

      Led By:


      Robert Joe Mather
      Executive Director, Digital Medicine & Translational Imaging, Early Clinical Development, Pfizer

      with:

      Mohammed Ali
      Mohammed Ali
      Global Head, Digital Trials & Clinical Operations, Boehringer Ingelheim


      Kelley Erb
      Director, Digital and Quantitative Medicine, Biogen

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

      Marie McCarthy
      Marie McCarthy, MBA
      Senior Director, Product Innovation, ICON


      Jeremy Wyatt
      CEO, ActiGraph

    • Track B

      Moderated by:

      Dan Karlin
      Dan Karlin, MD

      CEO, HealthMode


    • 1:35 pm – 1:55 pm

      AbbVie Case Study: How to Scale Digital Capabilities at the Clinical Development Enterprise Level

      In this session, the following key points will be addressed: 

      • Walking through the operating model needed to scale digital operations
      • Describing key tenets of a successful operating model for digital development
      • Discussing internal and external collaborations to deliver digital operations at scale


      Aman Thukral

      Head, Digital Operations and eCOA, AbbVie


      Michelle Crouthamel
      Managing Director, Digital Health Strategy & Implementation, Abbvie

       


    • 1:55 pm – 2:30 pm

      Eli Lilly Collaborative Case Study: Supporting Patients in a Remote (BYOD) Wearable Sensor Trial with No Clinic Staff

      The future of clinical research in many cases will require patients to BYOD. Serving patients in this environment will require really careful planning with unexpected obstacles.  Eli Lilly shares the lessons learned in patient recruitment, remote consent, device management, wearable device compliance, and data capture design when there are no clinic staff to run the trial. The second part of this session will feature the collaborators and how they worked together for the benefit of the patients.


      Cora Sexton
      Clinical Operations Lead Translational Technology & Innovation, Eli Lilly and Company


      Joseph Kim, MBA
      Sr Advisor, Digital Health Office, Translational Technology & Innovation, Eli Lilly and Company 


      Rahlyn Gossen
      Founder and Principal, Rebar Interactive 


      Matthew Amsden
      CEO & Founder, ProofPilot 


      Carie Downes
      Account Director, The Hibbert Group 


    • 2:30 pm – 2:45 pm

      Build a Work Force that’s ready to scale Decentralized Trials

      This session will offer an overview of how to solve the challenge of equipping the workforce (internal and site-based) to use DCT solutions at scale.


      Jane Myles
      Director Decentralized Trials Implementation, Covance


    • 2:45 pm – 3:25 pm

      Addressing Security and Data Rights Issues to Protect Patients as Remote Access Goes Mainstream

      In this session, the following key points will be addressed:

      Introduction to a Cybersecurity Informed Consent

      Megan Doerr
      Megan Doerr
      Principal Scientist, Governance, Sage Bionetworks

      An Overview of Security-Related Issues, Particularly for Internet-Connected Products like Wearables

      • Regulatory considerations for cybersecurity and medical devices
      • A Hippocratic Oath for Connected Medical Devices – do we need one?  What would it entail?
      • Myth-busting:  Cybersecurity and data rights issues

      Andy Coravos
      Andrea (Andy) Coravos
      Co-Founder & CEO, Elektra Labs


      Dena Mendelsohn
      Director, Health Policy & Data Governance, Elektra Labs

      Security/Privacy in RWE Sensors and Infrastructure for Clinical Trials 

      • Align corporate goals with the regulatory environment that allows your work
      • BYOD, a cautionary tale
      • Data rights of the patient/subject


      Joel Splan
      COO & CSIO, physIQ

  • 3:40 pm
    - 4:15 pm

  • Small Group Zoom Interactive Discussions

    The day will conclude with 30 minute small group discussion choices.  These interactive discussions are first come first serve and have limited capacity.  Registration is required in advance.  Attendees may choose one discussion group to attend live.  All discussions will be available on demand.

     

    To register for your topic of choice, please email service@tcfllc.org with the Subject Line:  Mobile in Clinical Trials Small Group Discussion Choice.  


    3:40 pm – 4:15 pm

    A: Taking Remote Monitoring in Clinical Trials to Scale

    • Describing the value proposition in scaling a successful proof of concept.
    • Tackling interoperability and compatibility challenges.
    • Addressing operational considerations.


    Jamileh Jemison, MD, MS
    Head of Clinical Development, HealthMode


    3:40 pm – 4:15 pm

    B:Digital Wearable Endpoints; Demonstrating Value and Validation When There Aren’t Truly “Gold” Standards For Comparison

    • How do you “argue” a digital endpoint (derived from a wearable) is “better” than the current standard?
    • What if your digital endpoint doesn’t align with the current accepted standard?
    • Approaches to demonstrate value of the new digital endpoint.

    Led by:

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


    3:40 pm – 4:15 pm

    C: Stakeholders Perspectives for Remote Trial Attributes Rolled Out Pre and Post Pandemic

    • How to future proof your trial and trial documents.
    • What are the best flexible designs and do they vary by TA?
    • What are the perceptions of the investigators, patients, regulators, pre and post?
    • What prioritization methodologies are being used now in your company, now that everything seems to be accelerated and is looking to be prioritized with respect to mobile integrations?

    Led by:

    Mohammed Ali
    Mohammed Ali
    Global Head, Digital Trials & Clinical Operations, Boehringer Ingelheim


    3:40 pm – 4:15 pm

    D: Navigating the Data Integrity Challenges Associated With the Wide Range of Technology Utilized in Virtual Clinical Trials

    • The rapid adoption of virtual clinical trials and advances in technology to support them have resulted in challenges for regulators and companies alike to assure data integrity is maintained throughout a virtual trial.
    • What are the ways in which sponsors can assure that appropriate data integrity controls are in place throughout the entire flow of trial data?

    Led by:


    Doug Shaw, CISA
    Principal Consultant, Halloran Consulting Group

  • 4:15 pm

  • Partnering Meetings Begin

    Partnering Meetings Through Meeting Mojo Platform Continues to 7:00 pm ET