Dr. Andrew Chang has more than twenty years of experience in the development, regulation and quality of biologics and pharmaceuticals. At his current capacity as a Vice President, Quality and Regulatory Compliance, Product Supply Quality, Novo Nordisk, he is responsible for providing strategic advice and solutions for quality and regulatory related issues and expert support to inspection preparation. Since 2013, Andrew has represented Novo Nordisk at the Global Quality and Manufacturing Committee, PhRMA to advocate patient and industry’s interests by developing position papers and participating liaison meetings with the FDA. He is also a member of PhRMA’s ICH Coordinating Work Group, and representing PhRMA as an expert to ICH Q12 Expert Working Group for developing guideline on Pharmaceutical Products Lifecycle Management.
Prior to Novo Nordisk, Andrew served more than eleven years at US FDA, most recently as an Associate Director for Policy and Regulation, Acting Deputy Director and Senior Regulatory Scientist in the Division of Hematology, Center for Biologics Evaluation and Research (CBER). During his tenure, Andrew received numerus high level FDA awards for his exceptional and outstanding performance on regulatory review and management, GMP inspection, and policy development. These include, but are not limited to FDA Commissioner's Special Citation for successfully completing FDA’s initiative on product quality regulation and CBER’s Public Health Achievement Award for outstanding regulatory review performance that resulted in averting a crisis in product availability. In 2002, the FDA recognized Andrew as the FDA regulatory expert in the regulation of new and novel recombinant products as well as naturally-derived biological products.
Andrew’s formal scientific training includes post-doctor in immunology from the National Institutes of Health, Ph.D. in Biochemistry from the State University of New York, and B.S. in Pharmaceutical Chemistry from the China Pharmaceutical University. He has published numerus peer reviewed scientific papers in JAMA, J.Exp.Med., Blood, J.Immunol., Dev. Immunol. Thromb Haemost., Haemophilia, Pharmaceutical Engineering etc., and has been a frequent speaker at national and international conferences.