NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Mary Ellen Cosenza PhD, DABT RAC

Practice Area Focus

  • Development Strategy
  • Regulatory Strategy (US and EU)
  • Emerging Markets Clinical Trials
  • FDA Compliance
  • Toxicology
  • Regulatory Submissions

Biography

Mary Ellen Cosenza joined NDA Partners as an Expert Consultant in 2014. Dr. Cosenza is a senior executive and business team leader, with broad US and international drug development experience. She has led successful teams in both early-stage and full development of new drugs in a variety of therapeutic areas and modalities. She is a recognized expert in preclinical biologic drug development, and her experience includes implementation of a Corporate Integrity Agreement for a US regulatory organization.

Dr. Cosenza was formerly the Executive Director for US Regulatory Affairs for Amgen, where she led the development and execution of regulatory strategy and plans for a pipeline of over 40 products. She has also served as Amgen's Executive Director for Emerging Markets in which she led the team in the development of processes and organizational alignment for regions including Latin America, Asia Pacific, Middle East, Africa, Eastern Europe, Russia, and CIS countries. She is a member of the Expert Working Group for ICH M3(R2) and teaches Food and Drug Toxicology at the University of Southern California.