Michele Dougherty

DataRevive USA LLC

Dr. Michele K. Dougherty received her Ph.D. from Georgetown University in Tumor Biology and completed her post-doctoral training in the Laboratory of Cell and Developmental Signaling at the National Cancer Institute.

Dr. Dougherty joined the 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 was focused on supporting review of biosimilar products and participated in guidance and policy initiatives for biosimilar development.

Dr. Dougherty joined DataRevive, LLC as a lead CMC consultant in 2019. She advises clients on CMC regulatory strategy for biological products at all phases of development.