XIAO Shen 肖申

Shen Xiao, MD, PhD

  • Chief Medical Officer at 3-D Medicines

Be responsible for the setting of company’s product pipelines, globally clinical development and regulatory affairs.

20 years review experience at the US. Food and Drug Administration (FDA). At the FDA, he started as a Pharmacology/Toxicology reviewer, then became a Medical Officer after passing the US Medical Licensing Examination and was later promoted to Senior Medical Officer. He has provided non-clinical and clinical reviews for several hundred INDs including all the stages of the drug development process. He has also reviewed and approved more than ten NDAs/BLAs as a primary clinical reviewer and as a multi-discipline review team leader. In addition, he worked in the FDA Center for Devices and Radiological Health (CDRH) for short-term as a clinical reviewer to review and approve medical device products such as IDEs, 510Ks, and PMAs. 

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.