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Digital Technology in Clinical Trials

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


Session 9 Regulatory Sprint: Can We Develop an Agile Regulatory Decision Matrix for Digital Measurement?

Session Chair(s)

Lauren  Oliva, PharmD, RPh

Lauren Oliva, PharmD, RPh

  • Global Regulatory Policy Lead, New Technologies
  • Biogen, United States
Megan  Doyle, JD, MPH

Megan Doyle, JD, MPH

  • Global Policy Lead, Digital Health, Diagnostics, and Combination Products
  • Amgen, United States
Anindita  Saha

Anindita Saha

  • Assistant Director, Digital Health Center of Excellence, CDRH
  • FDA, United States
This interactive panel session will explore a fictional case study of a digital health technology (DHT) used as a measurement tool in a drug clinical trial. An expert panel will engage in a dialogue, including audience polls and Q&A, about regulatory considerations for selection of the most appropriate endpoint, how to measure the endpoint, and verification and validation as it applies to the hypothetical case study.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Explore evidence criteria to be addressed for digital health technologies (DHTs) in clinical trials through a case example
  • Evaluate regulatory questions based on drug program goals and DHT medical device status and intended use

Speaker(s)

Anindita  Saha

Speaker

Anindita Saha

  • Assistant Director, Digital Health Center of Excellence, CDRH
  • FDA, United States
Jeffrey  Siegel, MD

Speaker

Jeffrey Siegel, MD

  • Director, Office of Drug Evaluation Sciences, Office of New Drugs, CDER
  • FDA, United States
Elizabeth  Kunkoski, MS

Speaker

Elizabeth Kunkoski, MS

  • Health Science Policy Analyst, OMP, CDER
  • FDA, United States
Matthew  Diamond, MD, PhD

Speaker

Matthew Diamond, MD, PhD

  • Chief Medical Officer, Digital Health Center of Excellence, CDRH
  • FDA, United States
Samantha  Roberts, PhD

Speaker

Samantha Roberts, PhD

  • Group Director, US Regulatory Policy
  • Genentech, A Member of the Roche Group, United States
Simon  Bennett, MSc

Speaker

Simon Bennett, MSc

  • Director, EU Regulatory Policy
  • Biogen, United Kingdom