Dr. Mary Ellen Cosenza is a regulatory consultant with over 35 years of senior leadership experience in the biopharmaceutical industry in the US, Europe, and emerging markets. During her 20-year tenure at Amgen, she led the US Regulatory Department and the International Emerging Markets Regulatory Department and served as an executive director of global regulatory affairs and safety, focusing on early development and inflammation. In addition to her leadership roles in regulatory affairs, she also served as the senior director of toxicology at Amgen. Before joining Amgen, she served as a principal scientist in toxicology for the Medical Research Division of American Cyanamid Company (now Pfizer).
While at Amgen, Dr. Cosenza 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 US FDA, EMA, and regional country health authorities, including several US FDA Advisory Committee meetings.
Dr. Cosenza 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, operating under the auspices of the International Conference on Harmonization (ICH), for ICH M3(R2). Dr. Cosenza is well published in the field of biological drug development and has authored several chapters on this topic as well.
Dr. Cosenza is a Diplomate of the American Board of Toxicology, a Fellow of the Academy of Toxicological Sciences, and a member of the Society of Toxicology (SOT), Drug Information Association (DIA), and Regulatory Affairs Professional Society (RAPS). She also holds a Regulatory Affairs Certification for both the US and EU. Dr. Cosenza 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, has served as a member of the ACT Education Committee, and has served ACT as Councilor, Treasurer, and President. Dr. Cosenza remains active in ACT and is currently a member of the Outreach Committee. She is also an instructor at the University of Southern California, where she teaches a graduate-level course on food and drug toxicology
Dr. Cosenza received her PhD from St. John’s University, New York, and her MS in regulatory science from the University of Southern California, Los Angeles.
Service Award