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Challenges in Exceeding the Quality of Existing Endpoints and Approaches Using Digital Tools
Session Chair(s)
Rob Berlin, JD, MPH
Head, US Regulatory Policy
GlaxoSmithKline, United States
This forum will discuss how novel technologies provide the means to measure new endpoints and can assess existing endpoints in new ways. Regulatory models are needed to encourage the acceptance of these novel approaches.
Learning Objective : Identify a clear understanding of regulatory frameworks surrounding digital endpoints; Describe the challenges that may arise when a new tool can measure endpoints more effectively than existing tools; Discuss how to build regulator confidence in novel endpoints and tools.
Speaker(s)
FDA Perspective
Jeffrey Nahum Siegel, DrMed, MD
FDA, United States
Director, Office of Drug Evaluation Sciences, OND, CDER
Industry Perspective
Julie Tai, PhD
GlaxoSmithKline, United States
Director, GRA, Precision Medicine and Digital Health
Industry Perspective
Lauren Oliva, PharmD, RPh
Biogen, United States
US Lead, Global Regulatory Policy
Industry Perspective
Rasika Kalamegham, PhD
Genentech, A Member of the Roche Group, United States
Head, US Regulatory Policy
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