Leader in pediatric medical research named to USP Board of Trustees

“Stephen’s exceptional career spans more than 35 years in medicine, academia, industry and regulatory affairs,” said Roger L. Williams, M.D., chief executive officer of USP. “His broad knowledge of medical research, his background in drug discovery and development for pediatric care, and his academic and regulatory leadership experience make him a welcome addition to USP’s board. Without doubt, Stephen will play an important role in advancing USP’s mission of improving global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.”

Spielberg currently is editor-in-chief of Therapeutic Innovation & Regulatory Science (TIRS), the official journal of the Drug Information Association. Prior to assuming the position of TIRS editor, Spielberg served as deputy commissioner for medical products and tobacco at the U.S. Food and Drug Administration (FDA).

Spielberg served as dean of Dartmouth Medical School and vice president of Health Affairs at Dartmouth College.  He was also the Marion Merrell Dow Chair in Pediatric Pharmacogenomics and director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City, Mo. He was on the faculty of Johns Hopkins University School of Medicine as an assistant professor of pediatrics and pharmacology, and at the University of Toronto, Hospital for Sick Children as a professor for pediatrics and pharmacology, the director of the division of clinical pharmacology and toxicology and the director of the Centre for Drug Safety Research. He also has served as an adjunct professor at Thomas Jefferson University Medical College and UMDNJ–Robert Wood Johnson Medical School and as a principal investigator at the Institute for Pediatric Innovation. During his tenure in the pharmaceutical industry, Spielberg was executive director of exploratory biochemical toxicology and clinical and regulatory development at Merck Research Laboratories and vice president of pediatric drug development at Johnson & Johnson Pharmaceutical Research and Development.

Spielberg received an A.B. degree in biology at Princeton University and Ph.D. and M.D. degrees at the University of Chicago. He completed post-graduate training at Children’s Hospital Medical Center in Boston, Harvard Medical School and the National Institute of Child Health and Human Development, National Institutes of Health (NIH).

A chair of the Pediatric Task Force for the Pharmaceutical Researchers and Manufacturers of America (PhRMA), Spielberg represented the pharmaceutical industry on the FDA Pediatric Advisory Committee and was the rapporteur for the Pediatric International Conference on Harmonisation Initiative (ICH E–11) to harmonize pediatric drug development among Europe, Japan and the U.S.

Spielberg currently is an advisory board member of the Centre for Advancement of Sustainable Medical Innovation, Oxford University/University College London. On the editorial boards of several journals, Spielberg was an associate editor of Drug Metabolism and Disposition. He has served on the board of directors for the Foundation for the National Institutes of Health (FNIH), the Science Board Advisory Committee for FDA, the executive board of the Observational Medical Outcomes Partnership—FDA, FNIH, PhRMA and was president of the American Society for Clinical Pharmacology and Therapeutics. He has published over 130 papers in adverse drug reactions, human pharmacogenetics and personalized medicine and pediatric clinical pharmacology, and is the recipient of several prestigious awards.

Together with USP’s president, past–president and treasurer and ten other board members, Spielberg will help guide USP’s policies, finances and strategic direction.

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