Shelly Xiong has over 20 years of pharmaceutical industry experience in virology, clinical development, and regulatory affairs spanning Asia, Europe, and North America. Dr. Xiong most recently served as Director of Regulatory Affairs at InterMune where she was responsible for establishing and managing the product labeling function for European and Canadian commercialization and US labeling preparation for Esbriet NDA for Idiopathic Pulmonary Fibrosis. Previously, she served as Director of China Operations at Covance in Shanghai, responsible for business strategy, client and goverment interactions. Dr. Xiong was at Gilead for 15 years, where she held positions in Clinical Virology and Regulatory Affairs, leading the clinical virology development program for Hepsera for HBV from Phase 2 through product approval. She was involved in multiple IND and NDA filings as well as commercial product labeling for antiviral programs in the US with FDA and in China with CFDA while at Gilead. Dr. Xiong has extensive experience in drug discovery and development in viral diseases including HBV, HCV, HIV, and CMV. She is an author on over 30 publications in scientific journals and publications.Dr. Xiong received her Ph.D. in Biochemistry from University of Wisconsin-Madison and B.S. in Chemistry from Beijing University.
Organization Name | Title At Company | Start Date | End Date | |
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Eiger BioPharmaceuticals | Vice President, Regulatory Affairs | — | — | Detail |