Shen Xiao 肖申

肖申博士现任礼邦制药首席科学官,负责公司新药的临床前开发和全球药物注册,并协同首席医学官推进公司新药的临床开发工作。之前曾任海森生物医药有限公司首席医学官,思路迪医药的首席战略官和首席医学官。肖申博士曾在美国食品药物监督管理局(FDA)担任药理,毒理的非临床高级审评员负责内分泌,代谢疾病新药的非临床审评,和临床高级审评员负责心、肾、血管疾病新药的临床审评。在近二十年的 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(IDE510kPMA)。

加入 FDA 之前,曾作为内科临床主治医生、博士研究助理和博士后有十多年的临床工作和实验室研究经验,包括各类普通内科疾病诊治、抗生素临床药代动力学的研究、细胞信号传导的研究等。其间除了曾获国家科技进步三等奖一项,全军科技进步二等奖一项外,还获得 FDA,美国生理协会(APS),国际肾脏病协会(ISN),日本透析和人工脏器协会的多项奖励。

Be responsible for the setting of company’s R/D product pipelines, non-clinical and clinical product development, and global regulatory affairs. Previously, he served as the Chief Medical Officer at Hasten Biopharmaceutical Co, Ltd, and the Chief Medical Officer and Chief Strategy Officer at 3D Medicines Inc for taking the full responsibilities of company’s clinical product development and global regulatory affairs.  

Before that, Dr. Xiao worked in the US FDA as a senior medical officer and was responsible for the clinical review of new drugs in the areas of Cardiovascular, renal, diabetes, obesity and some other endocrine and metabolic diseases. During his nearly 20-year career at the FDA, he reviewed several hundreds of Investigational New Drug (IND) applications across various stages, including preclinical, clinical phases, and post-marketing drug efficacy and safety tracking, and follow-up. As a clinical reviewer and/or multiple discipline team leader, he approved over a dozen of NDAs/BLAs. He also worked at the FDA’s Center for Devices and Radiological Health (CDRH), where he reviewed and approved multiple medical devices (IDE, 510K, PMA). 

Prior to FDA, as an attending physician in Nephrology in China and research fellow in US, he had over a decade of clinical practice and laboratory research experience. His experience includes diagnosing and treating a variety of general internal medicine diseases, renal diseases, conducting the clinical pharmacokinetics studies for different antibiotics, and studying cell signaling pathways. During this time, he was awarded numerous honors including the China National Scientific and Technological Third Award,  and many other awards from the FDA, the American Physiological Society (APS), the International Society of Nephrology (ISN), and the Japanese Society for Dialysis Therapy and Artificial Organs (JSDAO).