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Stephen Spielberg

Deputy Commisioner for Medical Products and Tobacco, US Food and Drug Administration

Dr. Stephen P. Spielberg is Deputy Commissioner for Medical Products and Tobacco of the US Food and Drug Administration.

He received an AB (Biology) from Princeton University, an MD and PhD (Pharmacology) from the University of Chicago, did a pediatric internship and residency at Children’s Hospital, Boston, and a post-doctoral fellowship in human biochemical genetics at the National Institute of Child Health and Human Development.  He then joined the faculty of Johns Hopkins University School of Medicine as Assistant Professor of Pediatrics and Pharmacology, moving to the University of Toronto, Hospital for Sick Children where he was Professor of Paediatrics and Pharmacology, Director of the Division of Clinical Pharmacology and Toxicology, and Director of the Centre for Drug Safety Research. After 15 years in academic medicine, he moved to Merck Research Laboratories as Executive Director, Exploratory Biochemical Toxicology and of Clinical and Regulatory Development in 1992, and subsequently to Johnson & Johnson from 1997 to 2003 to become Vice President for Pediatric Drug Development.  He chaired the Pediatric Task Force for PhRMA, represented the pharmaceutical industry on the FDA Pediatric Advisory Subcommittee and on pediatric legislative initiatives in the US and EU, and was the Rapporteur for the Pediatric ICH Initiative (ICH E-11) to harmonize pediatric drug development regulations among Europe, Japan, and the US.   He then returned to academic medicine as Dean of Dartmouth Medical School and Vice President for Health Affairs at Dartmouth College from 2003-2007.  From 2007-Sept., 2011, he was the Marion Merrell Dow Chair in Pediatric Pharmacogenomics, and Director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital, Kansas City, MO. He also served as Principal Investigator for the Institute for Pediatric Innovation, a non-profit organization focused on developing improved medicines and devices to meet the therapeutic needs of sick children.

He has served as Associate Editor of Drug Metabolism and Disposition, and on the editorials boards of multiple pediatric and pharmacology journals.  He served on the Board of Directors of the Foundation for the National Institutes of Health, the Science Board Advisory Committee for the FDA, the Executive Board of OMOP (Observational Medical Outcomes Partnership – FDA, FNIH, PhRMA), and was President of the American Society for Clinical Pharmacology and Therapeutics (2006).

His research interests include:  mechanisms of idiosyncratic adverse drug reactions, human pharmacogenetics and personalized medicine, and pediatric clinical pharmacology; he has published over 130 papers in these areas.  He is the recipient of the Rawls-Palmer Award and Lectureship from the American Society of Clinical Pharmacology and Therapeutics (1992), the first recipient of the Werner Kalow Award in Pharmacogenetics and Drug Safety (1995), the Williams B. Abrams Lectureship from FDA/ASCPT (2001), Award in Excellence in Clinical Pharmacology, PhRMA Foundation (2007), the Distinguished Service Award from the University of Chicago, Pritzker School of Medicine (2008), presented the FDA Chief Scientist’s Distinguished Lecture (2009), and received the Sumner J. Yaffe Lifetime Achievement Award in Pediatric Pharmacology and Therapeutics from the Pediatric Pharmacy Advocacy Group (2009).

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