Speakers

Tao Bai, Ph.D. is the Associate Director for Innovation and Partnership in the Office of Bioequivalence (OB) at the FDA’s Center for Drug Evaluation and Research (CDER), where she leads the planning, development, and execution of bioequivalence assessment programs across all Divisions within the Office of Generic Drugs (OGD). She drives OB’s regulatory decision-making and knowledge-sharing initiatives by developing and implementing innovative data analytics and knowledge management strategies to support the evaluation of in vivo and in vitro bioequivalence data for Abbreviated New Drug Applications (ANDAs). In this role, she also spearheads the Generic Drug Structured Assessment for Bioequivalence (GDSA-BE) program, collaborating with CDER offices to modernize review tools, address data integrity issues, and advance novel bioequivalence methodologies across all dosage forms. Dr. Bai holds a Ph.D. in Pharmaceutical Sciences from the University of Maryland School of Pharmacy and brings over 15 years of FDA experience in bioequivalence science, regulatory policy, and innovation leadership