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Incorporating Patient Input into Medical Product Development and the US Food and Drug Administration’s Decision-Making
Session Chair(s)
Meghana Chalasani, MHA
Lead, Advisory Committees, Office of New Drugs, CDER
FDA, United States
This forum will provide an opportunity for key stakeholders, including regulators, product developers and patients, to discuss the incorporation of patient input into medical product development and regulatory decision-making.
Learning Objective : Describe current and upcoming efforts across FDA’s medical product centers to advance the incorporation of patient input into medical product development and FDA’s regulatory decision-making; Describe considerations that should be addressed in order to realize the full potential for patient input to support medical product development and regulatory decision-making.
Speaker(s)
The CDER PFDD Program 2020 Updates
Robyn Bent, MS, RN
FDA, United States
Director, Patient Focused Drug Development, OCD, CDER
CDRH Patient Science and Engagment Program
Michelle Tarver, MD, PhD
FDA, United States
Deputy Center Director for Transformation, CDRH
Three CBER Patient Preference Studies
Martin Ho, PhD, MS
Google, United States
Head of Biostatistics
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