Duu-Gong Wu, PhD

Senior Director, Regulatory Consulting, PPD at PPD

Speaker

Dr. Wu has over 25 years of combined experience working at US FDA as a reviewer/supervisor and industry as a regulatory consultant. Prior to joining PPD, Dr. Wu was a member of consulting group at PharmaNet. Before that, he had been with US Food and Drug Administration for thirteen years working as a CMC Reviewer and Chemistry Team Leader before being promoted to Deputy Division Director of Division of New Drug Chemistry II in CDER Office of New Drug Chemistry.

In addition to the participation in the reviews and approval of more than 20 peptide and biotech products at FDA, Dr. Wu served as member of many FDA Technical Committees and represented US CDER/FDA 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. He also participated in drafting many domestic and ICH biotech guidance documents including those related to the CMC regulatory requirements for peptides. As a consultant, Dr. Wu worked with many pharmaceutical companies in US, EU and Asian countries on the development of biological products. Currently, he has been assisting clients on the technical and regulatory development of a number of peptide products including new and generic peptide drugs and peptide cancer vaccines at various stages of development.

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 FDA.