Audrey Jia

Dr. Jia has 20 years of combined experience in biologic drug development and regulatory review. Dr. Jia spent 10 years from year 1999 to year 2009 in the biopharmaceutical companies working on monoclonal antibody engineering, humanization, affinity maturation, expression, and purification. During her time in US FDA from year 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, BLAs (including post approval reviews), and several US and international cGMP pre-approval inspections (PAIs). She is specialized in both novel proteins/antibodies and biosimilar products reviews.Dr. Jia currently works as the principal consultant for regulatory and CMC of drug and biologic products. She has helped many companies filed their US and China INDs/BLAs/NDAs successfully.