Gene Williams

Dr. Williams has 25 years of experience in clinical pharmacology, 20 of which occurred at the FDA, first as an FDA Primary Reviewer and subsequently as an FDA Team Leader. He specializes in the development of drugs for oncology, medical counter-measures for radiation, and medical imaging. Dr. Williams worked on over 400 different drugs as an FDA Primary Reviewer and 600 as an FDA Team Leader. Over 150 of these drugs were reviewed as NDAs/BLAs (NMEs and supplements). He was a member of the FDA Working Groups that developed the boilerplate used by FDA Reviewers to complete NME NDA/BLA reviews and the draft FDA Guidance, Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations.