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FDA Rare Disease Town Hall
Session Chair(s)
James Valentine, JD, MHS
Director
Hyman, Phelps & McNamara, PC, United States
This forum will address the unique regulatory complexities and challenges specific to orphan drug development. It will provide key information about programs available to expedite the development of orphan products and will include audience Q&A.
Learning Objective : Identify unique regulatory complexities and challenges specific to orphan drug development; Describe FDA programs available to expedite the development of orphan products.
Speaker(s)
Panelist
Gayatri R. Rao, JD, MD
Rocket Pharmaceuticals, Inc., United States
Panelist
Jonathan C. Goldsmith, MD, FACP
FDA, United States
Associate Director for Rare Diseases, Office of New Drugs, CDER
Panelist
Ilan Irony, MD
Janssen Pharmaceutical Companies of Johnson and Johnson, United States
Senior Director, Global Regulatory Leader
Panelist
Michael Pacanowski, PHARMD, MPH
FDA, United States
Div of Translational and Precision Medicine, OCP, CDER