Education:
1991-1996: Jiangxi Medical College, Clinical Medicine, Bachelor's Degree
1999-2002: Institute of Clinical Pharmacology, Jiangxi Medical College, Clinical Pharmacology, Master's Degree
2006-2008: Shanghai Jiao Tong University School of Medicine, Pharmacology, Ph.D.
Professional Positions:
1996–1999: Department of Pharmacology, Jiangxi Medical College, Teaching Assistant
2002–2019: Center for Drug Evaluation, National Medical Products Administration, Senior Reviewer
2019–Present: Executive Director, Tsinghua Clinical Research Institute (TCRI), School of Medicine, Tsinghua University
Office Director, GCP Office, Beijing Tsinghua Changgung Hospital
Research Areas:
My research is directed toward regulatory science and new drug development and evaluation. Primary research focus include: 1) Innovating clinical research protocol designs for cutting-edge drugs and medical devices. 2) Promoting the establishment of internationally compliant clinical research quality management systems and providing high-quality clinical research services. 3) Conducting educational work related to clinical development and training clinical research talent. 4) Engaging in regulatory science research, studying how regulatory policies impact drug development, clinical practices, and patient access, and providing scientific recommendations for regulatory policy-making through descriptive, qualitative, and quantitative methods.
Scientific Contributions
Since joining the Center for Drug Evaluation at the National Medical Products Administration (NMPA) in 2002, Dr. Chen has served as a clinical reviewer for anti-infective drugs, gynecological products, radiopharmaceuticals, hematology products, and antineoplastic drugs. In 2005, Dr. Chen became the project lead for antineoplastic drug evaluations and was a primary contributor to the drafting of several key regulatory guidelines. These guidelines have provided crucial regulatory frameworks for the development of antineoplastic drugs in China.
In 2019, Dr. Chen joined the School of Medicine at Tsinghua University, where she serve as the Executive Director of TCRI and the Office Director of the GCP Office at Beijing Tsinghua Changgung Hospital. Her contributions to advancing the new drug development industry and regulatory science are focused on three key areas: 1)Facilitating the clinical translation of cutting-edge research, including immunotherapies, cell therapies, stem cell therapies, and novel antibiotics, through close technical collaboration with clinical, basic research, and industry stakeholders. 2) Conducting in-depth investigations and discussions on key and emerging topics such as orphan drug development, intelligent pharmacovigilance, patient-centered drug development, risk-based drug regulation, conditional approvals, vaccine development, and radiopharmaceutical development. This involves collaborating with regulatory and health institutions to produce high-quality research in regulatory science and policy, develop relevant guidelines, and provide data-driven decision-making support. 3) Promoting the development and smart infrastructure of clinical trial institutions, building research-oriented wards, and establishing dedicated clinical research teams to enhance drug development capabilities.
Selected Publications:
1. Zhang S, Yin Y, Xiong H, Wang J, Liu H, Lu J, Zhang Q, Zhang L, Zhong J, Nie J, Lei K, Wang H, Yang S, Yao H, Wu H, Yu D, Ji X, Zhang H, Wu F, Xie W, Li W, Yao W, Zhong D, Sun H, Sun T, Guo Z, Wang R, Guo Y, Yu Z, Li D, Jin H, Song H, Chen X, Ma W, Hu Z, Liu D, Guo Y, Tang J, Jiang Z (2024) Efficacy, Safety, and Population Pharmacokinetics of MW032 Compared With Denosumab for Solid Tumor-Related Bone Metastases: A Randomized, Double-Blind, Phase 3 Equivalence Trial. JAMA Oncol 10(4):448-455.
2. Ge C, An J, Chen X* (2024) Analysis of post-marketing requirements for oncology drug conditional approvals in the United States and China. Heliyon 10(15):E35454.
3. Chen R, Liu S, Han J, Zhou S, Liu Y, Chen X*, Zhang S*. (2023) Trends in rare disease drug development. Nat Rev Drug Discov 23(3):168-169.
4. Liu Y, Xie Y, Qin Y, Xie Q*, Chen X* (2023) Control Groups in RCTs Supporting Approval of Drugs for Systemic Rheumatic Diseases, 2012-2022. JAMA Netw Open 6(11):e2344767.
5. Ge C, Guo K, Li Y, Li G, Zhang H, Yang J, Liu Y, Yin C, Liu S, Xie S*, Chen X* (2023) Analysis of patient-reported outcomes in the approval of novel oncology drugs in the United States, 2017-2022. EClinicalMedicine 59:101953.
6. Zhang H, Liu S, Ge C, Liu X, Liu Y, Yin C, Li Y, An J, Yan Z, Chen X* (2023) Single-arm trials for domestic oncology drug approvals in China. Cancer Biol Med 20(11):799-805.
7. Xie Y, Liu Y, Qin Y, Chen X*, Xie Q* (2023) Characteristics of race/ethnicity in trials leading to anti-rheumatic drug approval for inflammatory arthritis by the US Food and Drug Administration. Int J Rheum Dis 26(12):2489-2497.
8. Su L*, Liu S, Li G, Xie C, Yang H, Liu Y, Yin C, Chen X* (2023) Trends and Characteristics of New Drug Approvals in China, 2011-2021. Ther Innov Regul Sci 57(2):343-351.
9. Xie Y, Liu Y, Qin Y, Chen X*, Xie Q* (2023) Characteristics of race/ethnicity in trials leading to anti-rheumatic drug approval for inflammatory arthritis by the US Food and Drug Administration. Int J Rheum Dis 26(12):2489-2497.
10. Zhao S, Wang D, Zhao H, Gong J, Zhang J, Fang W, Ma F, Xu B, Li J, Hu X, Ba Y, Chen X, Yang Z, Shen L, Jiang J, Zhang L; Chinese Phase 1 Oncology Trial Consortium (2022) Time to raise the bar: Transition rate of phase 1 programs on anticancer drugs. Cancer Cell 40(3):233-235.
11. Li G, Liu Y, He R, Su L, Chen X* (2022) FDA decisions on new oncological drugs. Lancet Oncol 23(5):583-585.
12. Ge C, Du K, Luo M, Shen K, Zhou Y, Guo K, Liu Y, Yin C, Li Y, Li G*, Chen X* (2022) Serologic response and safety of COVID-19 vaccination in HSCT or CAR T-cell recipients: a systematic review and meta-analysis. Exp Hematol Oncol 11(1):46.
13. Li G, Jiang Y, Qin Y, Yuan S, Chen X* (2022) Comparing development strategies for PD1/PDL1-based immunotherapies. Nat Rev Drug Discov 21(7):484.
14. Yin C, Gao J, Li G, Hu H, Zhou L, Lu S*, Chen X* (2022) Gene and cell therapies in China: booming landscape under dual-track regulation. J Hematol Oncol 15(1):139.
15. Li G, Liu Y, Hu H, Yuan S, Zhou L, Chen X* (2022) Evolution of innovative drug R&D in China. Nat Rev Drug Discov 21(8):553-554
16. Liu Y, Zhang N, Xie C, Jiang Y, Qin Y, Zhou L, Fan Y, Ren L, Yin C, Yang H, Xie W, Zhai Q, Li G*, Chen H*, Chen X* (2022) Evolution of drug regulations and regulatory innovation for anticancer drugs in China. Acta Pharm Sin B 12(12):4365-4377.
17. Li G, Liu Y, Xie C, Zhou Q, Chen X* (2021) Characteristics of expedited programmes for cancer drug approval in China. Nat Rev Drug Discov 20(6):416.
18. Li G, Liu X, Chen X* (2020) Simultaneous development of zanubrutinib in the USA and China. Nat Rev Clin Oncol 17(10):589-590.
19. Li G, Yin C, Zhou Y, Wang T, Chen J, Liu Y, Chen T, Wang H, Zhang L, Chen X* (2020) Digitalized Adaptation of Oncology Trials during and after COVID-19. Cancer Cell 38(2):148-149
