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#326: FDA Rare Disease Town Hall
Chair
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...
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Speakers
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...
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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...
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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...
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Wednesday June 29, 2016 10:30am - 11:45am EDT
103A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA