Dr. Mary Ellen Cosenza is a regulatory and toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry. During her 20-year tenure at Amgen, she led the US Regulatory Department, the International Emerging Markets Regulatory Department and served as an Executive Director of Global Regulatory Affairs and Safety focusing on Early Development and Inflammation. Prior to working in Regulatory she served as the Senior Director of Toxicology at Amgen. While at Amgen she played a key leadership role in preparing teams for global health authority meetings with FDA, EMA, and regional country health authorities, including several FDA Advisory Committee meetings. Prior to joining Amgen, she served as a Principal Scientist in Toxicology for the Medical Research Division of American Cyanamid Company (now Pfizer).
Mary Ellen is recognized as an expert in preclinical biologic drug development and is a founding member of BIO’s BioSafe Preclinical Expert group. She was also a member of an Expert Working Group for the International Conference on Harmonization (ICH) for ICH M3(R2).
Mary Ellen is a Diplomate of the American Board of Toxicology, a Fellow of the Academy of Toxicological Sciences (ATS), a member of the Society of Toxicology (SOT), Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS), and holds Regulatory Affairs Certification for both the U.S. and EU. Mary Ellen has been a member of ACT since 1988. She has served as a member of the ACT Education Committee, as a Councilor and as Treasurer. She is also a Past-President of ACT. In addition, she is an instructor at the University of Southern California where she teaches a graduate level course on Food and Drug Toxicology.
Mary Ellen received her PhD from St. John’s University, New York, and her MS in Regulatory Science from the University of Southern California, Los Angeles.
Mary Ellen has worked with a small committee of other ATS members on an evaluation of our office staff model.