Dr. Stephen P. Spielberg 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 focusing on inborn errors of metabolism, pharmacogenomics, and pediatric clincal trials, 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.

From Sept. 2011-February, 2013, he served as Deputy Commissioner for Medical Products at the US FDA. In subsequent years, he served as editor-in-chief of Therapeutic Innovation and Regulatory Science, the journal of the Drug Information Association, as a medical sciences trustee of the US Pharmacopiea, and a member of NCATS Advisory Council and Cures Acceleration Network of NIH.