Donna SupkoVP, Global Head Regulatory Affairs R&D at EMD Serono
Donna is the Head of Global Regulatory Affairs, Research and Development at EMD Serono. In this role, Donna is responsible for driving regulatory strategy and execution for products in the early stages of clinical development through marketing approval, which includes navigating all FDA requirements across the development portfolio.
A seasoned R&D leader, Donna has more than 25 years of regulatory affairs experience across a wide range of therapeutic areas in the biotechnology, medical device, and pharmaceutical industries. She has also led successful marketing authorization applications for drugs, biologics, devices, and combination products, in the U.S., Europe, Canada and Australia.
Prior to joining EMD Serono in 2017, Donna held oncology regulatory leadership roles at both Sanofi and Eisai Inc, and she started her career managing drug development programs in the Division of AIDS for National Institute of Allergy and Infectious Diseases within National Institutes of Health (NIH).
Donna holds a Ph.D. in Pharmacology, and an M.S. in Pharmaceutics and Pharmaceutical Chemistry, both from the Ohio State University, as well as a B.S. in Pharmacy from the Philadelphia College of Pharmacy and Science. She completed post-doctoral neuropharmacologic research at the Johns Hopkins University.