XIAO Shen 肖申

Shen Xiao, MD, PhD

  • Chief Medical Officer at 3-D Medicines

負責公司的整體戰略規劃,新藥臨床開發,和全球藥物註冊工作。

加入思路迪醫藥之前,曾在美國食品、藥物監督管理局(FDA)擔任臨床高級審評員(senior medical officer)負責心、腎、血管疾病新藥的臨床審評。在近 20 年的 FDA 工作生涯中,負責審評了數百個新藥開發(IND)的各個階段,跨度 從臨床前期、臨床各期、及上市後的藥物療效、安全跟踪、隨訪;做為臨床評審員和/或 綜合評審小組負責人負責審批了十幾個新藥的上市工作。其間曾在 FDA 醫療器械審評中心 (CDRH),負責多個相關醫療設備的審評、審批(IDE, 510k, PMA) 

Prior to FDA, as an attending physician in Nephrology in China and research fellow in US, he had more than ten years of experience in clinical nephrology practices, studies in pharmacokinetics and dose regimens of various antibiotics in dialysis populations, and research in cellular signal transduction in various endothelial and epithelial cells under different human pathological conditions. He has received several scientific awards including the Excellence in Analytical Science Award by CDER/FDA, Hoechst Marion Roussel Excellence in Renal Research Award by the American Physiological Society, Young Investigator Award by Japan National Society of Dialysis and Artificial Organs, Young Investigator Travel Grant by International Society of Nephrology, China National Scientific and Technological Third Award, and more.

He obtained his PhD in Renal Physiology and Cell biology from West Virginia University Graduate School of Health Science Center. He had his postdoctoral training from Department of Nephrology, Johns Hopkins University, and the Department of Cardiology, University of North Carolina prior to joining in FDA.