Geoffrey_Wu

Geoffrey Wu

Commander Geoffrey Wu, Ph.D., PMP, CPH, Deputy Office Director, Office of Lifecycle Drug Products (OLDP), Office of Pharmaceutical Quality (OPQ), joined the FDA’s Office of Testing and Research (OTR) in 2010, has served as research scientist, science staff, chemistry reviewer, special assistant to the Office Director, staff supervisor (Division Director equivalent), Associate Director of Sciences and Communication (ADSC), acting Division Director, and Deputy Office Director. He is a scientist officer in the United States Public Health Service. Throughout his FDA tenure, he has been deeply involved, leading or co-leading regulatory review and research for generic drugs premarketing assessment, post-approval changes for both new and generic drugs. Between 2013 and 2017, he served as a founding member on the OPQ Emerging Technology Team (ETT). He has been a core and/or leading member in multiple policy and/or scientific development efforts, such as emerging technology, continuous manufacturing, comparability protocols, knowledge-aided assessment and standard submissions (KASA), pharmaceutical quality chemistry manufacturing and controls (PQ/CMC, aka structured product quality submissions), novel complex generic drugs, and advanced analytics using NLP/AI. He has training and education in pharmacy, pharmaceutical science, protein chemistry, polymer chemistry, process analytical technology, and data science. He has more than 20 peer-reviewed publications, and been invited to multiple national and international conferences to present or discuss the above related topics. Under Dr. Jindrich Kopecek’s supervision and guidance, his Ph.D. thesis from the University of Utah focused on self-assembly of hybrid hydrogels containing coiled-coils and drug-free macromolecular therapeutics to induce apoptosis by coiled-coiled mediated crosslinking of antigens.

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