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Incorporating Patient Input Into US Food and Drug Administration’s Medical Product Development and Regulatory Decision Making
Session Chair(s)
Pujita Vaidya, MPH
Director, US Patient Engagement
Novartis Pharmaceuticals Corporation, United States
This will discuss the FDA's history of including patient's voice in the regulatory process and current or new efforts that may be more advanced. How has their view of patient engagement changed? Evolution of the Patient Representative Program and Patient Engagement Advisory Council, for example. Engage in dialogue with the FDA and provide considerations for next steps, including from sponsor and patient.
Learning Objective : Describe current and upcoming FDA efforts to advance the incorporation of patient input into medical product development and FDA’s regulatory decision-making; Discuss regulatory and methodological considerations that must be addressed in order to realize the full potential for patient input to support medical product development and evaluation.
Speaker(s)
How FDA Involves Patients and Advocates
Andrea Furia-Helms, MPH
FDA, United States
Director of Patient Affairs, Office of Clinical Policy and Programs
Partnering for Patients: A Regulatory Framework to Advance Patient-Focused Drug Development
Eleonora Ford, PhD
Amgen Inc., United States
Global Regulatory Affairs and R&D Policy
Panelist
Theresa Mullin, PhD
FDA, United States
Associate Center Director - Strategic Initiatives, CDER
Panelist
Anindita Saha
FDA, United States
Associate Director Strategic Initiatives, Digital Health Center of Excellence
Panelist
Telba Irony, PhD, MS, MSc
Janssen R&D, United States
Senior Scientific Director, Quantitative Sciences
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