Expertise: Regulatory considerations for natural, recombinant, and combination products, product comparability, viral safety, immunogenicity, cGMP audit, and interpretation of FDA regulations, policies, and guidances

Dr. Chang has served more than 11 years at the FDA in increasingly senior positions. Prior to joining PharmaNet, he was the Associate Director for Policy and Regulation and Senior Regulatory Scientist in the Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER). He is known nationally and internationally for his significant scientific and regulatory contributions to the development, approval and post market surveillance of recombinant and naturally derived products used in therapy. During his tenure at FDA, Dr. Chang had served as the review committee chairperson for the licensures of four new and novel recombinant and naturally derived products, and for the approval of hundreds of post-marketing supplements. In 2002, FDA recognized Dr. Chang as the FDA regulatory expert in the regulation of new and novel recombinant products as well as naturally-derived biological products. He clearly is considered one of the foremost regulatory experts in recombinant and naturally derived protein products.

While at FDA, Dr. Chang was known as a leading FDA and CBER spokesperson and has presented the FDA perspective at many national and international meetings. In addition, he has served on numerous committees, including FDA Committee for Follow-On Protein Pharmaceuticals, CBER’s Chemistry, Manufacturing and Control (CMC) Coordinating Committee (CMCCC), CBER CTD Core Team, FDA Team Biologics Evaluation Group, CBER representative at CDER Complex Drug Substances Coordinating Committee (CDSCC) and Manufacturing Science Working Group, Bioengineered Plants Working Group, CMC Review Template Working Group, FDA Comparability Working Group, FDA Working Group for Biotech Comparability Database, and CBER Working Group for Manufacturing Changes. Dr. Chang also served as the FDA deputy topic leader for ICH Q5E guideline, and the FDA observer for European and US Pharmacopeia’s Expert Groups on Blood and Blood Derived Products. Furthermore, he worked closely with CBER’s Office of Compliance and Biologics Quality on FDA inspection program including Team Bio and CBER pre-license/approval inspections.