个人简介
杨悦本硕博毕业于沈阳药科大学,2004年获得沈阳药科大学药学博士学位,是我国第一位药事管理方向的药学博士学位获得者。曾任沈阳药科大学教授,博士生导师(2011.11-2020.9)。2020年10月,加入清华大学药学院,担任研究员,博士生导师(药学一级学科下社会与管理药学招生)。 现为药品监管科学学科带头人,清华大学药学院药品监管科学研究院院长,国家药品监督管理局创新药物研究与评价重点实验室主任。海南大学兼职博士生导师(与海南省真实世界数据研究院联合培养硕士和博士),国家医疗保障局医药价格与招标采购专家组专家。
研究领域
主要从事药品监管科学以及药物政策和制度的顶层设计,监管路径和程序优化研究,以及评价创新药、仿制药(生物类似药)、罕见病用药等的安全性、有效性和质量等的新工具、新标准、新方法研究等。研究范围涵盖药品的全生命周期。
近期论文
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Luo X, Guo Q, Du X, Huang L, Chow SC*, Yang Y*. Evaluation of clinical trial designs for novel anticancer drugs in China: a cohort study of drugs approved between 2015 and 2021. Drug Discov Today. 2023 Mar 31:103578.
Luo X, Du X, Huang L, Guo Q, Tan R, Zhou Y, Li Z, Xue X, Li T, Le K, Qian F, Chow SC*, Yang Y*. The price, efficacy, and safety of within-class targeted anticancer medicines between domestic and imported drugs in China: a comparative analysis. Lancet Reg Health West Pac. 2022;32:100670.
Luo X, Du X, Li Z, Qian F, Yang Y*. Assessment of the Delay in Novel Anticancer Drugs between China and the United States: A Comparative Study of Drugs Approved between 2010 and 2021. Clin Pharmacol Ther. 2023;113(1):170-181.
Luo X, Yang L, Du X, Yang J, Qian F, Yang Y*. Analysis of Patent and Regulatory Exclusivity for Novel Agents in China and the United States: A Cohort Study of Drugs Approved Between 2018 and 2021. Clin Pharmacol Ther. 2022;112(2):335-343.
Luo X, Qian F, Yang L, Li Y, Yang Y*. Assessment of the breakthrough-therapy-designated drugs granted in China: A pooled analysis 2020-2022. Drug Discov Today. 2022;27(12):103370.
Li Y, Jiang Y, Wang H, Zhang L, Yang Y*. Safety-Related Drug Withdrawals in China Between 1999 and 2021: A Systematic Investigation and Analysis. Drug Saf 45, 737–745 (2022).
Chen, S., Chen, X., Liu, M, Xu Z, Yang Y*. Regulation of Generic Drugs in China: Progress and Effect of the Reform of the Review and Approval System. J Pharm Innov (2022).
Aslam F, Babar ZU, Madni A, Asghar M, Yang Y*. Unveiling and addressing implementation barriers of vaccination communication strategy: Perspectives from government officials at national and provincial levels. Hum Vaccin Immunother. 2022 Dec 30;18(7):2153513.
Aslam F, Ali I, Babar Z, Yang Y. Building evidence for improving vaccine adoption and uptake of childhood vaccinations in low- and middle-income countries: a systematic review. Drugs Ther Perspect. 2022;38(3):133-145.
Li, X., Yang, Y. The drug lag issue: a 20-year review of China. Invest New Drugs 39, 1389–1398 (2021).