Mary Ellen Cosenza, PhD, DABT, ATS, ERT, RAC is a regulatory toxicology consultant with over 35 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. During her 20-year tenure at Amgen, she was an Executive Director of Regulatory Affairs and Safety and had several leadership roles included head of US Regulatory, head of Emerging Markets Regulatory and Safety and Therapeutic Area lead for Inflammation and Early Development. Previous to her roles in Regulatory Affairs, she served as the Senior Director of Toxicology at Amgen. 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, operating under the auspices of the International Conference on Harmonization (ICH) for ICH M3(R2). Mary Ellen is well published in the field of biological drug development. Mary Ellen is a Past-President of the American College of Toxicology (ACT) and is currently the Treasurer of the International Union of Toxicology (IUTOX).  She is also an adjunct professor at the University of Southern California.

Mary Ellen received her BA in Biology and Chemistry from Queens College, CUNY and her MS and PhD in Toxicology from St. John’s University, New York, and her MS in Regulatory Science from the University of Southern California, Los Angeles.