Dr. Chen Xiaoyuan is a Professor who serves as the Deputy Director of the Institute of Regulatory Science for Medical Products at Tsinghua University, as well as the Director of the Clinical Trial Center for Drug and Device at Beijing Tsinghua Changgung Hospital.
During 2002-2019, she worked for 17 years at the Center for Drug Evaluation of the National Medical Products Administration, where she was responsible for the clinical review of drugs in various therapeutic areas, including anti-infectives, gynecology, radiology, hematology, and oncology. She possesses in-depth knowledge of policies, regulations, and technical guidelines related to clinical research of new drugs both in China and internationally, with particular expertise in key aspects of clinical development for anticancer drugs.
Dr. Chen has organized and drafted multiple regulatory documents, such as the Technical Guidelines for Clinical Research of Anticancer Drugs, Guidelines on Endpoints in Clinical Trials of Anticancer Drugs, and Guidelines on the Application of Biomarkers in Anticancer Drug Development.
In February 2019, she joined Tsinghua University, where her research focuses on regulatory science and clinical develpment. In recent years, she has conducted in-depth analyses of the current landscape of anticancer drug development and regulatory approval in China, along with case studies of representative drugs. Her work has been published in leading international journals, including Nature Reviews Drug Discovery, Nature Reviews Clinical Oncology, and The Lancet Oncology.