Division Director
U.S. Food and Drug Administration
Silver Spring, Maryland
Dr. Hong Cai is a division director in the Office of Product Quality Assessment II (OPQA II) within the Office of Pharmaceutical Quality (OPQ) in the FDA’s Center for Drug Evaluation and Research (CDER). Her division performs drug product quality assessments supporting IND/NDA and ANDA applications. During her tenure at FDA, Dr. Cai has served as a quality reviewer, a CMC Lead, a Branch Chief, a division director of New Drug Product II in the Office of New Drug Product (ONDP) of OPQ focused on the quality assessments of INDs Meeting Packages and NDA in the disease areas of Immunology and Inflammation, Rare Diseases, Urologic, Reproductive and Neuroscience before assuming her current role. Additionally, she serves as the FDA liaison to the USP Expert Committees on Simple Excipients and Complex Excipients (2020-2025).
Prior to joining the FDA in 2015, Dr. Cai spent more than 17 years in the biotechnology and pharmaceutical industry. Her working experience expands from early drug discovery to late-stage development at ArQule, Johnson and Johnson, Bristol Meyer Squibb, and Glaxo Smith Kline.
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Speaker Spotlight: Patient-Focused Drug Development: CMC Considerations
Wednesday, October 23, 2024
11:30 AM – 12:30 PM MT