Replies to post #188089 on Anavex Life Sciences Corp (AVXL)

[kevli33]

Nidan, let me first start off by saying i always look forward to your posts over the "years".
It seems a lot of the focus has turned away from the FDA (U.S.) as they have been behind and not
leading as you state. What are your feelings on someone on the Anavex management team (Dr. Fadiran)
having such extensive inner workings of the FDA? Do you think he has helped "steer" TGD away from
the old thinking of the FDA...or perhaps he has helped guide him in the new 21st century way (precision
medicine etc..)?

Dr. Emmanuel O (“Tayo”) Fadiran, 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. 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.

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. Dr. Fadiran is a recipient of the prestigious Fogarty International Fellowship of the National Institutes of Health (NIH) (1991-1993) 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.

https://www.anavex.com/our-team/