Speakers

Commander Geoffrey Wu, Ph.D., PMP, CPH, Office Director (acting), Office of Pharmaceutical Quality Assessment I (OPQA I), Office of Pharmaceutical Quality (OPQ), joined the FDA’s Office of Testing and Research (OTR) in 2010, has served in multiple capacities, including research scientist, science staff, chemistry reviewer, staff supervisor, Associate Director of Sciences and Communication (ADSC), acting Division Director, acting Office 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 PDUFA and GDUFA programs. Between 2013 and 2017, he served as a founding member on the OPQ Emerging Technology Team (ETT). In the recent years, 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 Pharmaceutical Quality Submissions (SPQA)), novel complex generic drugs, and advanced analytics. He has training and education in pharmacy, pharmaceutical science, protein chemistry, polymer chemistry, process analytical technology, and data science.