Dr. Emmanuel O (“Tayo”) Fadiran, the Senior Vice President of Regulatory Affairs has over 26 years of experience in government service, of which 24 years were dedicated to the Food and Drug Administration (FDA). Prior to Anavex®, Dr. Fadiran served as Clinical Pharmacology Team Leader at the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). During his 24 years (1993-2017) tenure at the FDA he reviewed hundreds of NDAs, sNDAs, BLAs, ANDAs and INDs for approval and strategic recommendations for the development of several products across many therapeutic categories. He was also on review teams for several novel therapies including first in class approvals. Dr. Fadiran also led a cross-disciplinary NDA review team and authored the first Cross-Discipline Team Leader (CDTL) review for the Division of the Pulmonary & Allergy Products, Office of Drug Evaluation II, CDER. He was actively involved in the writing, internal/external training and the implementation of the US FDA Guidance for Industry for population pharmacokinetics. Dr. Emmanuel O (“Tayo”) Fadiran, the Senior Vice President of Regulatory Affairs has over 26 years of experience in government service, of which 24 years were dedicated to the Food and Drug Administration (FDA). Prior to Anavex®, Dr. Fadiran served as Clinical Pharmacology Team Leader at the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). During his 24 years (1993-2017) tenure at the FDA he reviewed hundreds of NDAs, sNDAs, BLAs, ANDAs and INDs for approval and strategic recommendations for the development of several products across many therapeutic categories. He was also on review teams for several novel therapies including first in class approvals. Dr. Fadiran also led a cross-disciplinary NDA review team and authored the first Cross-Discipline Team Leader (CDTL) review for the Division of the Pulmonary & Allergy Products, Office of Drug Evaluation II, CDER. He was actively involved in the writing, internal/external training and the implementation of the US FDA Guidance for Industry for population pharmacokinetics.
Biotechnology