Back to Agenda
Digital Biomarkers as Clinical Endpoints: The Road to Regulatory Acceptability
Session Chair(s)
Lina AlJuburi, PHARMD, MSC
Head, Regulatory Science and Policy, North America, Sanofi, United States
This forum will review the current regulatory paradigms for the use of digital biomarkers as endpoints in clinical trials in the US and EU. A panel of experts will discuss validation pathways and compare regulatory approaches between regions.
Learning Objective : Describe the V3 process (verification, analytical validation, clinical validation) for validating digital health technologies as fit-for-purpose in a clinical trial; Identify validation pathways in the US and EU; Discuss outstanding challenges to the use of digital health technologies for remote data capture in clinical trials.
Speaker(s)
Max Wegner, PHARMD
Senior Vice President,Head Regulatory Affairs, Bayer, Germany
Enhancing Clinical Research in Europe: Navigating the Regulatory Landscape
Steve Berman, MPH
Deputy Vice President, Science and Regulatory Affairs, BIO, United States
Industry Perspective
Anindita Saha
Associate Director Strategic Initiatives, Digital Health Center of Excellence, C, FDA, United States
Panelist
Gul Erdemli, MD, PHD
Global Program Regulatory Director, Novartis Pharmaceuticals Corporation, United States
Industry Update
Have an account?