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Challenges in Exceeding the Quality of Existing Endpoints and Approaches Using Digital Tools
Session Chair(s)
Rob Berlin, JD, MPH
Executive Director Regulatory Policy, Vertex Pharmaceuticals, 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
Director, Office of Drug Evaluation Sciences, OND, CDER, FDA, United States
Industry Perspective
Director, GRA, Precision Medicine and Digital Health, GlaxoSmithKline, United States
Industry Perspective
US Regulatory Policy Lead, Biogen, United States
Industry Perspective
Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
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