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

Roger Williams, MD

Practice Area Focus

  • Pharmaceuticals
  • Biologics

Biography

Dr. Williams is a Partner in NDA Partners. He is an expert in clinical pharmacology and Board certified in clinical pharmacology and internal medicine. He was most recently Chief Executive Officer and Chair of Council of Experts at the US Pharmacopeial Convention (USP). Prior to that he served in various positions at the FDA Center for Drug Evaluation and Research (CDER), including Director of the Office of Generic Drugs; Deputy Center Director, Office of Pharmaceutical Sciences; and Acting Director for New Drug Chemistry. He took on leadership roles nationally and internationally for the FDA at the World Health Organization, the Pan American Health Organization, and, as FDA lead, the International Conference on Harmonization. In these capacities, Dr. Williams contributed to many important initiatives, including a WHO guidance, which supported interchangeable multisource medicines, and many guidances on the topics of safety, efficacy, quality, and regulatory communications at ICH.

Dr. Williams is a fellow of the American Association of Pharmaceutical Scientists and a former expert member of the International Pharmacy Federation Board of Pharmaceutical Sciences. He has received a Doctor of Science degree, honoris causa, from Long Island University and has authored or co-authored more than 200 publications on topics related to applied regulatory and compendial science as well as national and international health.