Mary Ellen Cosenza, PhD, DABT, ATS, RAC is a regulatory consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. Most recently, she served as the Executive Director, U.S. Regulatory Affairs, at Amgen, Inc. During her 20-year tenure at Amgen, she led the International Emerging Markets Regulatory Department and served as an Executive Director of Global Regulatory Affairs and Safety. In addition to her leadership roles in Regulatory Affairs, she also served as the Senior Director of Toxicology at Amgen. Prior to joining Amgen, she served as a Principal Scientist for the Medical Research Division of American Cyanimid Company (now Pfizer).
While at Amgen, Mary Ellen was responsible for both early- and late-stage development programs resulting in numerous successful IND, CTA, NDA, MAA, and BLA submissions in a broad variety of therapeutic areas and modalities. In addition, 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. Mary Ellen is also experienced in the implementation of corporate integrity agreements and review of promotional materials.
Ms. Mire completed her pharmacy studies at the University of Louisiana at Monroe. She completed an ASHP-accredited residency in hospital pharmacy at University Hospitals in Birmingham, AL and earned her MBA in finance at Tulane University. Ms. Mire is a member of the American Academy of Colleges of Pharmacy (AACP).
She is recognized as an expert in preclinical biologic drug development as demonstrated by her participation as a member of an Expert Working Group, operating under the auspices of the International Conference on Harmonisation (ICH), where she influenced international policy guiding the development of both biologics and traditional small molecules in the U.S., Europe, and Japan.
Mary Ellen is a Diplomat of the American Board of Toxicology, a Fellow of the Academy of Toxicological Sciences, 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, serving as an active speaker and session chair. Most notably, she developed the first Study Director Training Course in 2001 and has served as a member of the ACT Education Committee, as Councilor, and as Treasurer. Mary Ellen is a Past-President of ACT. She is also 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.