Senior executive, NDA Partners LLC; President, MEC Regulatory & Toxicology Consulting LLC
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).
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.
Through presentations and a panel discussion, industry and legal experts examine regulatory frameworks and updates surrounding cell and gene therapy, diagnostics, and digital health, both in the US and Japan.