Janet Rose Rea, MSPH, Regulatory and Drug Development Expert

Janet Rose Rea is an independent consultant providing regulatory services (e.g., Quality, Regulatory Affairs, Clinical, etc.) for organizations developing small molecule and biologic drugs with a variety of modalities, including gene and cellular therapies, rDNA biologics, and biosimilars. Her industry career has spanned over 40 years, from development through commercialization, with increasing levels of responsibility and scope in the areas of oncology and rare diseases. She has extensive interactions with worldwide health regulatory authorities, especially with the FDA.

She most recently worked for AVM Biotechnology and Atossa Therapeutics. Companies for whom she has worked include Immunex (Amgen), MDS Panlabs, Targeted Genetics, AVI Biopharma (Sarepta) and Protein Sciences Corp (Sanofi), and a number of other companies as a consultant. She was an Assistant Clinical Professor for the University of Washington in the Department of Pharmacy and is currently an instructor for Biotech Primer.