Leiyun (Janney) Boone is a product quality Team Lead at the Office of Pharmaceutical Quality, CDER, FDA. Her responsibility includes biological product quality related submissions covering from pre-IND to post-approval stage, as well as participating in pre-license inspections. After obtaining her PhD in Microbiology, Dr. Boone received post-doctoral training in immunology and immuno-oncology. Prior to joining the FDA, Dr. Boone worked in pharmaceutical industry for 5 years.