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Senior Investigator, Office of Biotechnology Products/OPQ/OBP at CDER, FDA
Dr. Wen Jin Wu is currently a Senior Investigator in Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA. He earned his M.D. from Wannan Medical College, China and finished his Ph.D. at Cornell University in 2002. He was recruited as a Principal Investigator (PI) in the Division of Monoclonal Antibodies in 2004. In addition to his regulatory duty as a product quality reviewer with expertise in the area of therapeutic monoclonal antibodies, antibody-drug conjugates, and biosimilars, Dr. Wu’s laboratory focuses on understanding the roles of ERBB family receptors in breast cancer progression and the mechanisms of trastuzumab resistance, and trastuzumab and T-DM1-induced toxicity. He has published a number of papers in highly reputed journals, including Journal of Biological Chemistry, Nature, Cell, Molecular Cancer Therapeutics, and Cancer Research, and has been invited to give talks in a number of national and international conferences.