Michael Manning

Michael L. Manning, Ph.D., is an instructor in the Regulatory Science program. Prior to teaching in the Regulatory Science program Michael earned his Ph.D. in pharmacology from the Johns Hopkins University School of Medicine and trained as a postdoctoral fellow at the National Cancer Institute. Michael’s career in regulatory science began as a reviewer in the Office of Oncologic Diseases at the FDA, where he remains today. Pharmacologists at the FDA review and make regulatory recommendations regarding the nonclinical aspects of regulatory submissions (INDs, BLAs, and NDAs). Michael has a strong interest in biologic products including monoclonal antibodies, bispecific constructs, antibody-drug conjugates, cytotoxins, fusion proteins, and other novel drug modalities. In addition to his review work, Michael participates in several areas of regulatory research, including research pertaining to first-in-human starting dose selection and IND clinical holds.