XIAO Shen 肖申

Shen Xiao, MD, PhD

  • Chief Medical Officer at 3-D Medicines

负责公司的整体战略规划,新药临床开发,和全球药物注册工作。

加入思路迪医药之前,曾在美国食品、药物监督管理局(FDA)担任临床高级审评员(senior medical officer)负责心、肾、血管疾病新药的临床审评。在近 20 年的 FDA 工作生涯中,负责审评了数百个新药开发(IND)的各个阶段,跨度 从临床前期、临床各期、及上市后的药物疗效、安全跟踪、随访;做为临床评审员和/或 综合评审小组负责人负责审批了十几个新药的上市工作。其间曾在 FDA 医疗器械审评中心 (CDRH),负责多个相关医疗设备的审评、审批(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.