Wednesday, November 01, 2017 4:01:17 PM
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Dr. Emmanuel O. Fadiran, also known as Tayo, RPh, PhD serves as Senior Vice President of Regulatory Affairs at Anavex Life Sciences Corp. Dr. Fadiran 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). Dr. Fadiran has been involved in the formulation of significant strategic FDA regulatory initiatives including serving as a member of the Senior Management Teams for the Data Standard (Janus) and Sentinel Initiatives. He was an active member of the FDA Senior Science Council working group for the creation and launching of the FDA’s Strategic Plan for Regulatory Science in 2012. Recently, he has played an active role in the development of the Comprehensive in vitro Proarrhythmia Assay (CiPA) for future replacement of the thorough QT studies. As a long-term member of the FDA Institutional Review Board (IRB) he actively contributed to the development of standard operating procedures (SOP) for the committee. During his 24 years from 1993 to 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. Fadiran is a recipient of the prestigious Fogarty International Fellowship of the National Institutes of Health (NIH) as well as numerous awards from the FDA, among them the Commissioner’s Award of Excellence, in recognition of his outstanding contributions to regulatory review of applications and development of regulatory guidance and policies. Dr. Fadiran holds a BS (Pharmacy) and MS from Obafemi Awolowo University, Ile-Ife, Nigeria and a PhD in Pharmaceutical Sciences from the University of Strathclyde, Glasgow, UK.
http://www.bloomberg.com/research/stocks/people/person.asp?personId=429395163&privcapId=13580387
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