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Audrey Jia Image

Audrey Jia, Ph.D.
Lead regulatory consultant and biologic product expert; ex-FDA

Dr. Jia has eighteen years of combined experience in biologic drug development and regulatory review. Dr. Jia spent ten years from 1999 to 2009 in biopharmaceutical companies working on monoclonal antibody engineering, humanization, affinity maturation, expression, and purification. She holds several antibody humanization patents internationally. Dr. Jia has extensive hands-on experiences with biologic product CMC. She worked at PDL BioPharma and Facet Biotech (acquired by AbbVie), and Pfizer as a group leader to lead antibody development projects.

During her time in US FDA from 2009 to 2015, Dr. Jia was a full time CMC reviewer for IND/BLA review of biological products including antibody fragments, fusion proteins, antibody drug conjugate, combination products, and radiolabeled antibodies. She performed numerous IND reviews, several BLAs (including post approval supplement reviews), and several US and international cGMP pre-approval inspections (PAIs). She is specialized in both novel proteins/ antibodies and biosimilar products reviews.

While working at the US FDA, Dr. Jia presented in international meetings for regulatory perspective of use of QbD for drug development, comparability studies, novel biological product development, and clonality of the cell banks to support the IND and BLA. She was also one of the co-instructors for the MIT short course of formulation studies annually. Additionally, Dr. Jia was a key member in the policy development of breakthrough therapy in FDA and is very familiar with the regulatory requirement for fast track and breakthrough request and how to develop a drug through the expedited pathway.

Dr. Jia holds a Master degree in Bioscience Regulatory Affairs from Johns Hopkins University, and a Ph.D. degree in Microbiology and Molecular Genetics from Emory University. Prior to that, Dr. Jia obtained her Bachelor degree of Medicine from Peking University. She also passed USMLE and obtained her ECFMG (certificates for foreign medical graduate).