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Session 9 Regulatory Sprint: Can We Develop an Agile Regulatory Decision Matrix for Digital Measurement?
Session Chair(s)
Lauren Oliva, PharmD, RPh
US Lead, Global Regulatory Policy
Biogen, United States
Megan Doyle, JD, MPH
Global Policy Lead, Digital Health, Diagnostics, Oncology
Amgen, United States
Anindita Saha
Associate Director Strategic Initiatives, Digital Health Center of Excellence
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)
Speaker
Anindita Saha
FDA, United States
Associate Director Strategic Initiatives, Digital Health Center of Excellence
Speaker
Jeffrey Nahum Siegel, DrMed, MD
FDA, United States
Director, Office of Drug Evaluation Sciences, OND, CDER
Speaker
Elizabeth Kunkoski, MS
FDA, United States
Health Science Policy Analyst, OMP, CDER
Speaker
Matthew Diamond, MD, PhD
FDA, United States
Chief Medical Officer, Digital Health Center of Excellence, CDRH
Speaker
Samantha Roberts, PhD
Genentech, A Member of the Roche Group, United States
Group Director, US Regulatory Science
Speaker
Simon Bennett, MSc
Biogen, United Kingdom
Director, EU Regulatory Policy