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Jane P. Bai, PhD (she/her/hers)

Expert Regulatory Scientist (Systems Pharmacology)
Center for Drug Evaluation and Research, US Food and Drug Administration
Silver Spring, Maryland, United States

Dr. Jane PF Bai is the Master Pharmacokineticist with expertise in systems pharmacology in the Office of Clinical Pharmacology, US Food and Drug Administration (FDA). Dr. Bai is leading several projects on quantitative systems pharmacology (QSP) for regulatory drug development and for assessing biomedical products. Since joining FDA in 2005, she has contributed to FDA’s regulatory drug development, guidance and policy, and predictive safety efforts. She co-founded FDA’s Systems Pharmacology Scientific Interest Group in 2015 and has since co-chaired QSP Seminar Series and co-organized several workshops on QSP with internal and external stakeholders. In addition to scientific exchange activities with the industry and academe, she served on NIH LINCS Consortium steering committee from 2012-2021 and is currently a member of NIH NIBIB IMG as the FDA CDER representative. Dr. Bai received a master’s degree in applied mathematics, and her Ph.D. in Pharmaceutics from the University of Michigan, Ann Arbor, Michigan. Between 1991 and 1996, she was a faculty member of Pharmaceutics, University of Minnesota. From 1996 to 2004, she was an entrepreneur exploring biotech ventures, and received NIH and state funding. She licensed to pharmaceutical companies an in-silico software, OraSpotter®, for predicting oral drug absorption in humans. In addition to publishing approximately 80 peer-reviewed papers and book chapters combined, she co-edited a book entitled “Systems Medicine (Methods in Molecular Biology),” Springer Protocols, 2022).

Disclosure(s): No financial relationships to disclose

Presentation(s):

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