William R. Pfister, Ph.D., DABT, RAC

Bill has over 35 years of experience in pharmaceutical product research, development, and regulatory affairs that span lead selection to commercialization including formulation development, quality control, project management, preclinical, clinical development, and regulatory affairs. Dr. Pfister has consulted for a variety of pharmaceutical companies in early and late-stage product development providing leadership in global regulatory strategy, IND and CTA submissions, management of product development, technical transfer, preclinical safety, clinical development programs, and regulatory NDA, NDS, and MAA submissions and post-approval support.

Dr. Pfister has held senior regulatory affairs positions at Acorda Therapeutics, Inc., Aprecia Pharmaceuticals Company, and Sonar Products, Inc. He was Vice President, Scientific Affairs at NAL Pharmaceuticals, Inc. focused on formulation development, preclinical, clinical, and regulatory affairs. Prior to NAL Pharmaceutical, Dr. Pfister served as Senior Director, Product Development, Preclinical and Clinical Development & Regulatory Affairs during his tenure at NexMed USA, Inc. He was Director of Product Development and Project Management at Lavipharm Laboratories, Inc., and was Director of Transdermal Development, Project Planning and Regulatory Affairs & Quality Assurance at PharMetrix Corp. Prior to that, he managed the Controlled Release Laboratory at Dow Corning Biomedical Materials in Michigan. Dr. Pfister worked for American Critical Care as Senior Research Investigator, Toxicology and for Hoffmann-La Roche, inc. as Senior Scientist and Manager of Quality Control.

Dr. Pfister received his M.S. and Ph.D. in Pharmacology and Toxicology from Purdue University Pharmacy School and B.S in Biochemistry from the University of New Hampshire. Bill is a certified Regulatory Affairs Professional (RAC), Diplomate of the American Board of Toxicology (DABT), and is an author of several patents, publications, and books including: “Transdermal and Topical Drug Delivery Systems, (1997) and “Intraoral Drug Delivery: Molecules to Market” (2005).