Michele Dougherty, Ph.D.

Head of Regulatory Affairs Practice


Dr. Dougherty joined DataRevive in 2019 following a ten year career at the FDA.  Dr. Dougherty joined FDA in 2008 as a product quality reviewer in the Office of Biotechnology Products. During her 8 years with OBP, she developed expertise across the manufacturing and product quality lifecycle, including assessment 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.

Michele held multiple leadership roles within OBP, including Team Lead and Review Chief. In 2017, she joined the Therapeutic Biologics and Biosimilar Staff in the FDA’s Office of New Drugs, where she was focused on supporting review of biosimilar products and participated in guidance and policy initiatives related to the biosimilar development pathway.

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

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