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 first as branch chief...
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Acting Associate Director, Rare Diseases Program, OND, CDER, FDA
Dr. Lucas Kempf is the Acting Associate Director for the Rare Disease program in the OND immediate office. Prior to joining FDA in 2012, Lucas spent 8 years at NIH with a focus on neuroscience research, working to understand the genetics of neuropsychiatric disease and developing...
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Head of Office for Orphan Medicines, European Medicines Agency (EMA)
Kristina Larsson joined the orphan team of the EMA as the Head of Office in July 2014. Before that she spent 8 years as a scientific officer in the scientific advice team of the EMA in charge of the Scientific Advice Working Party secretariat. Before joining the agency she worked...
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Director, Hyman, Phelps & McNamara, PC, United States
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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