Michele Dougherty
Dr. Michele K. Dougherty is Vice President, CMC Biologics at DataRevive Regulatory Consulting. Dr. Dougherty joined DataRevive in 2019 and advises clients on CMC regulatory strategy for biological products at all phases of development.
Prior to joining DataRevive, Dr. Dougherty spent 10 years at the US FDA She joined FDA in 2008 as a product quality reviewer in the Office of Biotechnology Products. During her 8 years with OBP, she developed regulatory expertise across the manufacturing and product quality lifecycle, including review of early phase INDs, BLAs, post-approval manufacturing changes, and participating in GMP inspections. She managed a diverse portfolio of products including monoclonal antibodies, antibody drug conjugates, antibody cocktails, growth factors, enzymes, and biosimilar products. She held multiple leadership roles within OBP, including Team Lead and Review Chief. In 2017, she joined the Therapeutic Biologics and Biosimilar Staff in CDER’s Office of New Drugs, where she supported review of biosimilar products and participated in guidance and policy initiatives for biosimilar development.
Dr. Dougherty received her Ph.D. in Tumor Biology from Georgetown University. She completed her post-doctoral training in the Laboratory of Cell and Developmental Signaling at the National Cancer Institute, where she defined novel mechanisms of c-Raf and B-Raf regulation and characterized the function of Kinase Suppressor of Ras 2, a scaffold protein for the ERK signaling pathway.
