Dr. Stephen P. Spielberg is Deputy Commissioner for Medical Products and Tobacco of the US Food and Drug Administration, received an AB (Biology) from Princeton University, an MD and PhD (Pharmacology) from the University of Chicago. He then joined the faculty of Johns Hopkins University School of, moving to the University of Toronto, where he later served as the 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 represented the pharmaceutical industry on the FDA Pediatric Advisory Subcommittee 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.