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

Dan Spyker, PhD, MD

Practice Area Focus

  • Drugs
  • Devices
  • Combination Products
  • Diagnostics
  • Orphan Designation
  • Toxicology
  • Drug Safety
  • Expert Witness
  • PKPD
  • Biostatistics
  • REMS


Dr. Dan Spyker joined NDA Partners as an Expert Consultant in 2016. Dr. Spyker previously served as the acting Deputy Director in the FDA Division of Cardiovascular, Respiratory, and Neurological Devices and Medical Officer in CDER’s Pilot Drug Evaluation Staff. He held positions as Senior Director of Drug Safety and Pharmacovigilance at Alexza Pharmaceuticals; Director, Pharmacokinetics and Pharmacodynamic Sciences, Genentech, where he established the clinical pharmacology unit; and Senior Medical Director, Clinical Risk Assessment and Coordination Department at Purdue Pharma.

Dr. Spyker was a member of the Internal Medicine faculty in the Division of Clinical Pharmacology at the University of Virginia for 10 years, where he fostered and nurtured the Blue Ridge Poison Center. He was also founder and CEO of a software company specializing in poison center data collection and Bayesian pharmacokinetic applications.

Dr. Spyker is board certified in Internal Medicine; a diplomate of the American Board of Medical Toxicology; and diplomate of the American Board of Clinical Pharmacology. He currently serves as Adjunct Professor of Clinical Pharmacology at the Uniform Services University of Health Sciences in Bethesda; Adjunct Professor of Biopharmaceutical Sciences at University of California, San Francisco; and Adjunct Professor of Emergency Medicine at the Oregon Health and Sciences University in Portland.