Duu-Gong Wu
Director of Regulatory Consulting PPD, USA
Biography
Duu-Gong Wu, Director of Regulatory Consulting at PPD has more than 25 years of combined US FDA and industry experience, working for 14 years at FDA as a reviewer/supervisors and 12 years as a regulatory and CMC technical consultant. He is a well-known expert in regulatory and scientific issues of biosimilar development. Prior to his works as a consultant, he worked at US FDA with the last position as Deputy Division Director of Division of New Drug Chemistry II in CDER Office of New Drug Chemistry, specializing in the review of biological products. In addition to the reviews of a large number of biotech products approved by FDA, He represented CDER as a member of ICH Expert Working Groups for both Q5E (biotech comparability) and Common Technical Document-Quality (CTD-Q) for biotech products from 1998 to 2004. Previously, he also participated in drafting ICH Q6B and Q5C guidance documents for biotechnological drug products. He served as a member of FDA Follow-on Biologic (biosimilar) Working Group, Ad Hoc Reviewer associated with USP Biotechnology Committee and the chairman of FDA CDER Follow-on Growth Hormone and Insulin Working Group responsible for setting the regulatory requirements for the approval of Omnitrope®. Currently, Dr. Wu has been assisting clients in the development of a number of MAb and therapeutic protein biosimilars at various stages with two successful IND submissions to FDA. Dr. Wu completed his Ph.D. degree in Biochemistry and Molecular Biology at University of Maryland School of Medicine and postdoctoral study at Johns Hopkins University School of Medicine, before he joined US FDA.