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FDA’s Patient-Focused Drug Development Initiative: What Have We Learned?


One of the high-profile provisions of the 2012 Food and Drug Administration Safety and Innovation Act was the Patient-Focused Drug Development (PFDD) initiative. It required FDA to hold 20 meetings with the patient community over five years to hear directly from those with lived experience about the symptoms that most impact their lives and the variety of measures they take to manage their condition.
This series of meetings, which numbered 24 by the end of FY2017, has now been expanded to include externally-led meetings, for a total of 34 sessions to date. There are more externally-led meetings on the calendar, plus a robust pipeline of requests before the agency.

Our panelists will share their experiences in working with patient communities to plan for these often-intense listening sessions, as well as what they’ve learned from them and how they are applying this information. Please join us for an update and a forecast for what’s next in patient-focused drug development.

Speakers include:

Meghana Chalasani, Analyst, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Annie Kennedy, Senior Vice President for Legislation & Public Policy, Parent Project Muscular Dystrophy
Colleen Rye, Director, Research and Regulatory Policy, FasterCures, a center of the Milken Institute
Cynthia Grossman, Director, Science of Patient Input, FasterCures, a center of the Milken Institute (moderator)