NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Stephen Spielberg, MD, PhD

Practice Area Focus

  • Regulatory Strategy
  • Clinical Pharmacology
  • Toxicology
  • Pediatric Drug Development
  • Diagnostics/Biomarkers


Dr. Stephen Spielberg joined NDA Partners as an Expert Consultant in 2014. He was formerly Deputy Commissioner for Medical Products and Tobacco at the US Food & Drug Administration (FDA). Dr. Spielberg is Editor-in-Chief of Therapeutic Innovation and Regulatory Science, the journal of the Drug Information Association. He is currently on the Advisory Board of CASMI (Centre for Advancement of Sustainable Medical Innovation), a partnership between Oxford University and University College, London, and is a Medical Sciences Trustee, Board of Trustees of the U.S. Pharmacopeia.

For more than 40 years, Dr. Spielberg has maintained his focus on
pediatric clinical pharmacology/drug development, and pharmacogenomics/personalized medicine in academic, pharmaceutical industry, and regulatory settings. He was a medical school dean, and while in industry represented PhrMA in the successful passage of the Best Pharmaceutical for Children Act, and served as rapporteur for ICH E-11. His expertise includes: pediatric drug development, orphan drugs, targeted therapeutics/companion diagnostics, and adverse drug reactions. Dr. Spielberg has published over 140 papers in these areas.