Pengfei Song
VP, Regulatory Strategy @Parexel
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WORK HISTORY
VP, Regulatory Strategy @Parexel
MD, US
1) Responsible for providing strategic regulatory and technical clinical pharmacology drug development advice to pharmaceutical clients across all phases of product development. 2) Provide expert consultation on trial designs to expedite development programs, such as cohort expansion trials; dose selection and optimization through modelling, simulation, and extrapolation; and on clinical pharmacology approaches for pediatric and rare disease development programs. A key aspect of strategic advice includes assisting clients in interacting with regulatory agencies to identify areas in which regulatory flexibility and judgment may be applied.3) Provide technical advice and oversight on preparation of all sizes and complexity of regulatory submissions
EDUCATION
China Pharmaceutical University
Master of Science - MS, Biopharmaceutics
China Pharmaceutical University
BE, Biopharmaceutics
The University of Tennessee Health Science Center
Ph.D, Pharmaceutical Science
ABOUT PENGFEI SONG
Senior VP, Regulatory Strategy at Parexel; Former FDA Clinical Pharmacology Team Leader in Oncology
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