Dr. Stephen P. Spielberg Joins Regulatory Practice

August 18, 2015 leah.vandeman


We are proud to announce the addition of Stephen P. Spielberg, M.D., Ph.D., to our Strategic Advisory Board and Regulatory Practice.

The YourEncore Strategic Advisory Board comprises experts with deep experience running regulatory departments for the world’s largest pharmaceutical companies. In addition, experts include former senior Food & Drug Administration (FDA) officials and current policy thought leaders with expertise spanning the entirety of drug development. This group informs YourEncore’s regulatory practice strategy and most members are available for client consultations.

Dr. Spielberg’s 40-year career in pediatrics, clinical pharmacology, drug safety and pharmacogenomics has spanned positions in academia in the United States and Canada, the pharmaceutical industry and drug regulation. He has served as Dean of Dartmouth Medical School, Vice President for Pediatric Drug Development at Johnson & Johnson, and as Deputy Commissioner for Medical Products at the FDA.

He was the chief negotiator for PhRMA to design and achieve passage of the Best Pharmaceuticals for Children Act, which instituted incentives to industry to drive pediatric drug development and labeling, and as the U.S. industry lead and rapporteur for ICH E-11, harmonizing pediatric drug development internationally.

“Dr. Spielberg is to pediatric drug development what Dr. Spock was to a generation of new parents,” said Tim Franson, M.D., YourEncore’s chief medical officer. “Dr. Spielberg has spent his career promoting the development of safe pediatric therapies, bridging the needs of policy makers, pharmaceutical companies, and patient groups, and forging common ground to accelerate pediatric therapeutic development. He will add an important specialty that can immediately benefit our clients.”

Dr. Spielberg currently serves as Editor-in-Chief of Therapeutic Innovation and Regulatory Science, the journal of the Drug Information Association, serves on the Advisory Board of the Centre for Advancement of Sustainable Medical Innovation (CASMI), a partnership between Oxford University and University College, London, and is a Medical Sciences Trustee on the Board of the U.S. Pharmacopeia. He has published more than 140 scientific papers, and has received numerous awards for his work advancing pediatric therapeutics.

Dr. Spielberg received a degree in biology from Princeton University, and a medical degree and Ph.D. in Pharmacology from the University of Chicago. He 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.

Click here to read the full press release.

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