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Digital Technology in Clinical Trials

This event is now offered in a new entirely virtual format.


Session 7 Track 1&2: Can You Hear Me Now? How Platform Digital Technologies Can Amplify the Patient Voice

Session Chair(s)

Lauren  Oliva, PharmD, RPh

Lauren Oliva, PharmD, RPh

  • Global Regulatory Policy Lead, New Technologies
  • Biogen, United States

As our knowledge of disease manifestations and treatment approaches becomes more sophisticated, new opportunities exist to quantify important features of serious diseases for the first time.

There are now digital tools available to sponsors with the potential to create value in the drug development process beyond a specific product or disease state. These so-called platform technologies are tools that enable sponsors to better measure and interpret symptoms that impact many disease indications. Examples include symptoms such as fatigue, pain, cognition, speech, and autonomic measures.

This session will explore the value of adopting platform technologies to drug development programs and the path to regulatory acceptance of data generated by these novel tools.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Identify case study examples of platform digital technologies tools in drug development programs.
  • Propose benefits of data generated by these tools for patients, caregivers, HCPs, regulators, and payers
  • Evaluate models for cooperative development and adoption of platform digital technologies in the biopharma ecosystem

Speaker(s)

Kelley  Erb, PhD

Industry Perspectives on a Platform Approach to Digital Endpoint Development

Kelley Erb, PhD

  • Director, Digital and Quantitative Medicine
  • Biogen, United States
Michelle  Campbell, PhD

Industry Perspectives on a Platform Approach to Digital Endpoint Development

Michelle Campbell, PhD

  • Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER
  • FDA, United States
Mintu  Turakhia, MD, MS

Operationalizing Digital Health and Virtual Visits for Clinical Trials

Mintu Turakhia, MD, MS

  • Executive Director, Center for Digital Health; Chief of EP, Palo Alto VA
  • Stanford University , United States
Channing  Barker

Speaker

Channing Barker

  • Patient Representative
  • Advocate, United States