Delegate Profile

Stephen Spielberg, MD, PhD

Job TitleCEO/President SAQS Alliance

Company NameSecure Affordable Quality Supply -SAQS Alliance


• • Dr. Spielberg is the CEO/President of the SAQS Alliance, a non-profit organization focused of drug shortages and the future of pharmaceutical manufacturing, is Editor-in-Chief of Therapeutic Innovation and Regulatory Science (the journal of the Drug Information Association), and is a Medical Sciences Trustee on the Board of the U.S. Pharmacopeia. • Educated at Princeton (AB, Biology), University of Chicago (MD-PhD (Pharmacology)), Children’s Hospital Boston (Pediatric Residency), and NICHD (genetics fellowship), his 40 year career in pediatrics, clinical pharmacology, drug safety, pharmacogenomics, and medical product development has spanned academia in the US and Canada (including serving as Dean of Dartmouth Medical School), the pharmaceutical industry (including being VP for Pediatric Drug Development at JNJ), and drug regulation (including serving as Deputy Commissioner for Medical Products at the US FDA). While in industry, he served as the chief negotiator for PhRMA to design and achieve passage of the Best Pharmaceuticals for Children Act (instituting incentives to industry to drive pediatric drug development and labeling), and as the US industry lead and rapporteur for ICH E-11, harmonizing pediatric drug development internationally. He has published over 140 scientific papers, and received numerous awards for his work advancing therapeutics.

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