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Biographical Background on Dr. Stephen P. Spielberg

Spielberg is a graduate of Princeton University, where he received an A.B. degree (magna cum laude, Phi Beta Kappa), and the University of Chicago, where he received a Ph.D. in pharmacology and an M.D. (with honors). His post-graduate training included work as an intern and junior assistant resident with a specialty in pediatrics at Children's Hospital Medical Center in Boston, and as a clinical associate in pediatrics with the National Institute of Child Health and Human Development.

He was on the faculty of the Johns Hopkins University School of Medicine from 1977 to 1981, first as an instructor and later as an Assistant Professor in the Departments of Pediatrics, and Pharmacology and Experimental Therapeutics. His research there focused on genetic differences in susceptibility to adverse drug effects (human pharmacogenetics) and he also developed a focus on pediatric clinical trials.

Spielberg worked in Toronto from 1981 through 1992, serving in a number of capacities at several institutions. Throughout that period he was a member of the faculty of the University of Toronto, serving first as an Associate Professor and later as Professor in the Departments of Paediatrics and Pharmacology; and as director of the university's Centre for Drug Safety Research (1988-1992). Also throughout his time in Toronto, he was Senior Scientist at the Research Institute of the Hospital for Sick Children. While working with the Hospital for Sick Children, he helped establish a new Division of Pediatric Clinical Pharmacology and Toxicology and then headed the division from 1987 to 1992. The division included basic pharmacology research, clinical trials, responsibility for the Ontario Poison Center and the Palliative Care Program, and clinics focused on patients with adverse reactions to medicines.

During his time in Toronto, Spielberg was a Medical Research Council of Canada (MRC) Scholar, was a member of several MRC grant review committees, held multiple research grants, trained graduate students in pharmacology and toxicology, and continued to expand a focus on idiosyncratic adverse drug reactions and human pharmacogenetics. His work was recognized by the Rawls-Palmer Award from the American Society for Clinical Pharmcology and Therapeutics. He was also the first recipient of the Werner Kalow Award for Pharmacogenetics and Drug Safety.

He was at Merck Research Laboratories from 1992 through 1997, as Executive Director for Exploratory Biochemical Toxicology and Clinical and Regulatory Development. He established Merck's program in human pharmacogenetics, and worked on pediatric programs for several medicines. He also began work at a national level to encourage pediatric clinical trials.

At Johnson & Johnson, he established a Department of Pediatric Drug Development, now the largest in the pharmaceutical industry, focused on improving therapeutics for sick children. The department's investigative programs in multiple disciplines included infectious diseases, gastroenterology, neurology, psychiatry, and pain management. Spielberg and his department successfully developed new knowledge for labeling of several important medicines for safe and effective pediatric use and helped develop new approaches to clinical investigation in the pediatric population.

Spielberg has led pharmaceutical industry efforts in Congress in behalf of the Best Pharmaceuticals for Children Act, which passed and was signed into law in 2002. He has also led industry efforts to encourage pediatric investigation of new medicines; organized international efforts, through the International Conference on Harmonization, to harmonize drug development regulations for children among the U.S., Europe, and Japan; and helped initiate U.S. and international efforts to assure the highest ethical standards in pediatric clinical investigation. His work in this area was recognized by the William B. Abrams Award and Lectureship from the U.S. Food and Drug Administration (FDA) and the American Society of Clinical Pharmacology and Therapeutics, and by the Board of Directors Exceptional Service Award from Pharmaceutical Research and Manufacturers of America (PhRMA).

He is a member of the Federal Advisory Committee for the National Children's Study (National Institute of Child Health and Human Development), the Board of the Foundation for the National Institutes of Health, the Institute of Medicine Panel on Ethics in Pediatric Clinical Trials, the FDA Pediatric Advisory Subcommittee, and the Scientific Advisory Board of the Elizabeth Glaser Pediatric Research Network.