The Role of Digital Health Technologies in Drug Development: A Workshop

When: March 24, 2020 (8:30 AM Eastern)
Where: Keck Center (100) • 500 Fifth St. NW, Washington, DC 20001

Topic Biomedical and Health Research
Activities: Forum on Drug Discovery, Development, and Translation, Roundtable on Genomics and Precision Health
Board: Board on Health Sciences Policy

The Role of Digital Health Technologies in Drug Development

Forum on Drug Discovery, Development, and Translation

Roundtable on Genomics and Precision Health

WORKSHOP ▪ March 24, 2020

Workshop Background and Format

As digital health technologies (e.g. smartphone apps, wearables, and mobile-device-based tools) – hardware and software – become increasingly available to consumers, providers, and researchers, there are new opportunities to address critical barriers or “pain points,” better connect patients and health care providers, and incorporate patient input throughout the drug research and development (R&D) life cycle. However, a lack of clarity when it comes to the evaluation, selection, and implementation of digital health technologies has impeded the practical application of these innovations. Lessons learned from the direct-to-consumer genomics industry, which has been increasingly moving into the clinical health space over the last 10 years, may help inform the integration of digital health technologies into drug R&D.

This workshop will provide a venue to discuss challenges and opportunities in digital health technologies for improving the probability of success in drug development and enabling precision medicine. Workshop participants may consider key components for an evidence-based framework for applying digital health technologies towards drug research and development.

The Forum on Drug Discovery, Development, and Translation and the Roundtable on Genomics and Precision Health will host a public workshop on March 24, 2020 which will feature invited presentations and discussions to:

  • Discuss challenges/questions that digital health technologies may be uniquely suited to address and opportunities for digital health technologies to enable better patient care and more efficient clinical trials;
  • Consider strategies for evaluating and selecting digital health technologies that are fit-for-purpose in drug development (e.g. establishing appropriate evidentiary criteria);
  • Discuss privacy, ethical, and regulatory issues related to the use of digital health technologies;
  • Examine currently validated and/or FDA-approved drug development applications for digital health technologies;
  • Consider opportunities to enable the practical application of digital health technologies for improving drug development (e.g. sharing best practices for the validation and use of digital health technologies, harmonizing guidelines across sectors).

Workshop Planning Committee Roster

  • Jennifer Goldsack (co-chair), Digital Medicine Society
  • Joseph Menetski (co-chair), Foundation for the National Institutes of Health
  • Linda Brady, Division of Neuroscience and Basic Behavioral Science, NIMH/NIH
  • Ray Dorsey, University of Rochester Medical Center
  • Deborah Estrin, Cornell Tech
  • Geoffrey Ginsburg, Duke University School of Medicine
  • Husseini Manji, Janssen Research and Development, LLC
  • Deven McGraw, Ciitizen Corporation
  • Lauren Oliva, Biogen
  • Bray Patrick-Lake, Evidation Health
  • Leonard Sacks, Office of Medical Policy, CDER/FDA
  • Joyce Tung, 23andMe
  • Effy Vayena, ETH Zurich

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