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The Patient's Assessment of the Patient-Focused Drug Development Meeting Initiatives
Session Chair(s)
James Valentine, JD, MHS
Director
Hyman, Phelps & McNamara, PC, United States
This forum will review lessons learned from the Patient-Focused Drug Development meetings held to date, including externally-led meetings, and provide patient perspectives on their experiences and what has changed in their field as a result. Representation will include both rare, life threatening and chronic disease communities, as well as FDA.
Learning Objective : Appraise recent examples of FDA’s current efforts to incorporate the patient perspective into regulatory decision-making; Discuss implementation of patient engagement provisions in 21st Century Cures Act and PDUFA VI; Evaluate current proposals of methods collecting patient experience data.
Speaker(s)
FDA Perspective on the Value and Potential of PFDD
Theresa Mullin, PhD
FDA, United States
Associate Center Director - Strategic Initiatives, CDER
Experience From an FDA-Led PFDD Meeting - NTM Case Study
Amy Leitman, JD
NTM Info & Research, United States
President
Experience From an Externally-Led PFDD Meeting; TSC Case Study
Steven L. Roberds, PhD
Tuberous Sclerosis Alliance, United States
Chief Scientific Officer
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