AVXL "today announced the appointment of Emmanuel
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Posted On: 05/01/2017 9:51:14 AM
Re: chemist823 #606
AVXL "today announced the appointment of Emmanuel O. Fadiran, RPh, PhD, as Senior Vice President of Regulatory Affairs. Dr. Fadiran has 24 years of regulatory experience within the U.S. Food and Drug Administration (FDA), having held leadership positions at the FDA?s Center for Drug Evaluation and Research (CDER). "Dr. Fadiran has an accomplished track record of working within the FDA," said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "His depth of experience makes him an excellent choice to manage the considerable number of regulatory filings that Anavex has planned." Prior to joining Anavex, Dr. Fadiran served as a Clinical Pharmacology Team Leader at the FDA's CDER. During his 24-year (1993-2017) tenure at the FDA, Dr. Fadiran reviewed hundreds of New Drug Applications (NDAs), supplemental New Drug Applications (sNDAs), Biologics License Application (BLAs), Abbreviated New Drug Applications (ANDAs) and Investigational New Drug applications (INDs) for approval and made strategic recommendations for the development of several products across many therapeutic categories.
He was 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 and Allergy Products, Office of Drug Evaluation II, CDER. He was actively involved in the writing, internal/external training and implementation of the U.S. FDA Guidance for Industry for population pharmacokinetics. "I am very pleased to be joining Anavex at this important and exciting time for the company," stated Dr. Fadiran. "There are tremendous opportunities ahead, and I look forward to working with the Anavex team to deliver on the corporate objectives for 2017 and beyond." 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.
He was 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 and Allergy Products, Office of Drug Evaluation II, CDER. He was actively involved in the writing, internal/external training and implementation of the U.S. FDA Guidance for Industry for population pharmacokinetics. "I am very pleased to be joining Anavex at this important and exciting time for the company," stated Dr. Fadiran. "There are tremendous opportunities ahead, and I look forward to working with the Anavex team to deliver on the corporate objectives for 2017 and beyond." 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.
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