Academic Experience

2023 – Present: Leading Scientist, Changping Laboratory

2015 – 2023: Director, Office of Biological Products Clinical Evaluation, Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA)

2010 – 2015: Deputy Director, Office I of Chemical Drug Clinical Evaluation, CDE, China Food and Drug Administration (CFDA)

2005 – 2010: Director, Review Office VII, Review Department IV, CDE, CFDA

1988 – 2005: Reviewer, Office of Drug Evaluation, Ministry of Health (currently CDE, NMPA)

1985 – 1988: Ophthalmologist, Beijing Electronic General Hospital

Overview of Academic Research

With 35 years of experience in drug evaluation, Gao Chenyan has been deeply involved in the technical review of cell and gene therapy (CGT) products, vaccines, large and small molecule innovative drugs, and generic drugs (biosimilars). She has also conducted extensive research in the fields of regulatory science and translational medicine. She has presided over the drafting of multiple technical guidelines, including the Technical Guideline for Research and Evaluation of Cell Therapy Products (Trial), Technical Guidelines for Clinical Trials of Human Stem Cells and Derived Cell Therapy Products (Trial), Technical Guidelines for Clinical Trials of Immune Cell Therapy Products (Trial), Technical Guidelines for Clinical Trial Design of Gene Therapy for Hemophilia, Technical Guidelines for Clinical Trial Design of Oncolytic Virus Drugs (Trial), and Technical Guidelines for the Research and Development of Prophylactic Vaccines against SARS-CoV-2 (Trial).

Upon joining Changping Laboratory, her team has strategically focused on regulatory science research, spearheading the project "Regulatory Pathways for Investigator-Initiated Trials (IIT)." Targeting the critical early concept-verification stages of innovative products and medical technologies, the project conducts in-depth research into current regulatory landscapes and existing challenges. The objective is to develop novel tools and methodologies, establishing a scientific, comprehensive, and standardized regulatory system to enhance the reliability of IIT research data and elevate the evidence level of their outcomes.

Major Honor and Awards

2022 National March 8th Red Banner Pacesetter

2021 March 8th Red Banner Pacesetter of Central and State Organs

2021 Outstanding Communist Party Member of Central and State Organs

2020 Advanced Individual in Fighting the COVID-19 Pandemic in the National Market Regulation System

2020 Meritorious Personnel in Fighting COVID-19, CDE

2020 Communist Party Member Vanguard Post, CDE

2017 Advanced Individual in Deepening Reform, CDE

2017 Outstanding Communist Party Member, CDE

2008 Advanced Worker, CDE

2005 Advanced Worker, CDE

Representative Research Achievements 

1.     Yang Y, Bian L, Cheng Y, Xu Y, Shao H, Rao J, Ge S, Gong J, Jiang M, Zheng X, Liu L, Ma S, Liu X, Cheng T, Gao C. The Role and Challenges of Investigator-Initiated Trials in the Cell and Gene Therapy Products Boom in Mainland China. Clin Transl Sci. 2025 Feb;18(2):e70148. doi: 10.1111/cts.70148. PMID: 39936621; PMCID: PMC11815567.

2.     Gao J, Gao C. Development and regulation of stem cell-based therapies in China. Cell Prolif. 2022 Aug;55(8):e13217. doi: 10.1111/cpr.13217.

3.     Gou L, Gao J, Yang H, Gao C. The landscape of CAR T-cell therapy in the United States and China: A comparative analysis. Int J Cancer. 2019 Apr 15;144(8):2043-2050. doi: 10.1002/ijc.31924.

4.     Liu Y, Zhao C, Gao L, Yang H, He R, Gao C. Considerations for Clinical Review of Cellular Therapy Products: Perspectives of the China Food and Drug Administration Center for Drug Evaluation. Hum Gene Ther. 2018 Feb;29(2):121-127. doi: 10.1089/hum.2017.216.

5.     Guo Jingli, Gao Jianchao, Bian Lianlian, et al. Research progress of regulatory science for cell and gene therapy products in China and abroad [J]. Chinese Journal of Cell Biology, 2026, 48(01): 20-32.

6.     Gao Jianchao, Hu Baoyang, Deng Hongkui, et al. Challenges and Strategic Recommendations for Collaborative Innovation in China's Cell and Gene Therapy Industry [J]. Chinese Medical Biotechnology, 2025, 20(05): 481-489..

7.     Gao Jianchao, Ma Jun, Li Haiyan, Wang Huanling, Lu Shuang, Gao Chenyan. Analysis of the Contribution Degree of China's Medical Research to Domestic and International Clinical Diagnosis and Treatment Guidelines [J]. Chinese Clinical Oncology, 2022, 27(04): 289-296.

8.     Liu Xiao, Huang Yunhong, Gao Chenyan. Progress in Clinical Research on Intracavitary Administration of Oncolytic Virus Drugs [J]. Chinese Journal of New Drugs, 2021, 30(19): 1814-1818.

9.     Gao Jianchao, Wan Zhihong, Huang Yunhong, Wang Huicheng, Gao Chenyan. Considerations on Clinical Trials of Mesenchymal Stem Cells for the Treatment of Novel Coronavirus Pneumonia [J]. Chinese Journal of New Drugs, 2020, 29(15): 1734-1737.

10.  Gao Jianchao, Wei Wei, Huang Yunhong, et al. Reflections on the Use of Non-Registration Clinical Trials in Drug Registration and Evaluation [J]. Chinese Journal of New Drugs, 2018, 27(11): 1249-1253.