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 hi...
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Deputy Director, DCEPT, OTAT, CBER, FDA
After training at UCSF and NIH and years of practice in Internal Medicine and Endocrinology, Dr. Irony joined FDA CBER in 2000 as a clinical reviewer. He also worked in the Endocrine Division in CDER as a reviewer and team leader. In 2011, he returned to CBER as the branch chief...
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Associate Director for Genomics and Targeted Therapy, OCP, CDER, FDA
Dr. Pacanowski is the Associate Director for Genomics and Targeted Therapy in the Office of Clinical Pharmacology at FDA. His team of translational scientists works to advance the use of pharmacogenomics and other biomarker innovations in drug development through review of invest...
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Director, Office of Orphan Products Development, Office of the Commissioner, FDA
Gayatri R. Rao is the Director for the Office of Orphan Products Development (OOPD) at FDA. The Office’s mission is to advance the development of promising drugs, biologics, devices, and medical foods for rare diseases. Dr. Rao oversees several programs that promote product dev...
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Attorney, Hyman, Phelps & McNamara, PC
James Valentine is an associate at Hyman, Phelps & McNamara, P.C., a law firm in Washington, D.C. There he assists medical product industry clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Prior to joining the firm, h...
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