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Wednesday, June 29 • 10:30am - 11:45am
#326: FDA Rare Disease Town Hall

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Limited Capacity seats available
Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-608-L01-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Identify unique regulatory complexities and challenges specific to orphan drug development; Describe FDA programs available to expedite the development of orphan products.

Chair

James E. Valentine, JD

Speaker

Panelist
Jonathan C. Goldsmith, MD, FACP

Panelist
Andrew E. Mulberg, MD

Panelist
Debra Yvonne Lewis, MBA


Chair
avatar for James Valentine

James Valentine

Attorney, Hyman, Phelps & McNamara, PC
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →

Speakers
avatar for Jonathan Goldsmith

Jonathan Goldsmith

Associate Director for Rare Diseases, Office of New Drugs, CDER, FDA
Dr. Goldsmith is Associate Director for Rare Diseases in the Office of New Drugs/CDER/FDA. Prior to federal service, he was a tenured professor in academia and focused on clinical drug development in regulated industry, at NHLBI/NIH and at orphan disease foundations. He earned his... Read More →
avatar for Debra Lewis

Debra Lewis

Deputy Director, Office of Orphan Products Development, Food and Drug Administration
Dr. Debra Lewis is the Deputy Director of Office of Orphan Products Development (OOPD). She facilitates incentive programs that encourage the development of promising product for rare diseases & conditions. She served as the OOPD Grants Director, Humanitarian Use Device Director... Read More →
avatar for Andrew Mulberg

Andrew Mulberg

Deputy Division Director, Gastroenterology and Inborn Errors Products, OND, CDER, FDA
Andrew E. Mulberg, MD, FAAP, CPI, is Associate Professor of Pediatrics University of Pennsylvania and Professor of Pediatrics at Unviersity of Maryland. He has principally edited a book entitled Pediatric Drug Development: Concepts and Applications published in 2009 and 2013 with... Read More →

Wednesday June 29, 2016 10:30am - 11:45am
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 17: Rare-Orphan Diseases, Forum