Expertise: FDA regulatory issues and CMC developmental strategy for drugs of small molecules, peptide, oligonucleotides, liposomal products, botanical drug products, recombinant-DNA derived protein products, monoclonal antibodies and follow-on biological products

Prior to joining PharmaNet in 2004, Dr. Wu served at the FDA for more than 12 years as a reviewer, Chemistry Team Leader, and, most recently, as Deputy Division Director of Division of New Drug Chemistry II, Office of New Drug Chemistry (ONDC) in the Center for Drug Evaluation and Research. His career at FDA encompassed a unique combination of regulatory experience in both drugs of small molecules, peptides, botanical products and biotechnological/biological products.

Dr. Wu served on many technical Committees and working groups in FDA and CDER, including as a member of CDER Complex Drug Substance Coordinating Committee, Chairman of CDER Follow-on Growth Hormone/Insulin Working Group, and a member of FDA Follow-on Biologic Working Group Between 1999 and 2003, he represented CDER as a member of ICH Expert Working Groups for both Q5E and Common Technical Document-Quality for biotech products. He also participated in the drafts of ICH Q6B and Q5C for biotechnological drug products and many FDA CMC guidances and worked as an FDA Ad Hoc Reviewer for USP Biotechnology and Natural Therapeutics Expert Committee.