孙鹤，男,美藉华人。教授、博士生导师。美国康涅狄格大学博士。药物研发与管理专家。临床药理学和生物药学专家。现任天士力集团董事局董事、副总裁，天士力北美药业有限公司总经理。原美国食品药品监督管理局 (FDA) 转化医学 (Pharmacometrics) 专家资深评审官 (Expert Regulatory Scientist), 美国联邦亚裔执行官联席会成员。1982年毕业于上海复旦大学医科院，获药学学士学位，1993年毕业于美国康涅狄格大学，获临床药理学博士学位，随后进入美国食品药品监督管理局(FDA)工作。是FDA最高级别的首席科学家/评审专家之一，负责新药评审管理决策，提供学术顾问指导，参于全球药政协调化，及主持或参与制定药政法规管理政策等工作，同时负责FDA的计量药理学评审决策，及通过科学研究来创建FDA独特和创新的评审分析样板等职能。在13年美国食品药品监督管理局药品审评中心(FDA的CDER)任职期间，主持或参与完成了七部药政法规的编写。主持编撰了《FDA/CDER 群体药代动力学指导手册》、《OCPB PopPK实用指南》、《FDA/CDER多剂量/单剂量生物等效性研究指南》、《植物药研发及审批指南》、《FDA/CDER药物代谢物生物等效性指南》等多项FDA药品研发指南性文件，为美国食品和药品审评工作框架的制订做出了突出贡献。两次荣获美国FDA杰出贡献奖，并荣获美国国家Frances O.Kelsey药物安全监督特奖。

孙鹤博士从美国回国加入天士力后，一方面继续在科学上领导医药评价管理方法、临床优化应用、临床治疗学和临床药理学、及计量药理学和转化医学等方面的科学研究。致力于全球交叉研发模式、国际优质保健品开发、推动建立国际中药ISO标准、参与国际WHO协调组织、参与海外融资生产等一系列中国医药行业研发能力提升和产品国际化的战略实践。作为现代中药复方丹参滴丸美国FDA申报国际化项目技术总师，领军天士力团队取得了中国历史上第一个现代中药成功通过美国FDA 申报之Ⅱ期临床研究并进入Ⅲ期开发的里程碑性成果。

Sun He, male, Chinese American; Professor, Doctoral Supervisor; PhD from University of Connecticut; drug research, development and management expert; clinical pharmacology and biopharmacy expert; currently Director of Board of Directors and Vice-president of Tasly Group; General Manager of Tasly Pharmaceuticals (North America) Co., Ltd; former US FDA Expert Regulatory Scientist in Pharmacometrics, member of US Society of Asian Federal Officers; graduated from Medical College of Fudan University and obtained bachelor's degree in pharmacy in 1982; graduated from University of Connecticut and obtained doctor's degree in clinical pharmacology in 1993, afterwards joined US FDA; one of FDA chief scientists/evaluation experts at highest level, responsible for new drug evaluation management decision-making, provided academic adviser guidance, participated in global medicines regulatory harmonization, took charge of or participated in medicines regulatory administration policy etc, and also responsible for FDA metrological pharmacological evaluation decision-making, created unique and innovative FDA evaluation analysis template through scientific research etc; directed or participated in compilation of seven drug administration regulations during 13 years of work in US FDA Center for Drug Evaluation and Research (FDA CDER); directed compilation of FDA/CDER Guidebook for Population Pharmacokinetics, OCPB PopPK Practical Guide, FDA/CDER Research Guide for Multidose/Single Dose Bioequivalence, Guide for Botanical Drug Research, Development, Examination and Approval, FDA/CDER Guide for Drug Metabolite Bioequivalence etc, and made outstanding contributions to developing US food and drug evaluation framework; granted US FDA Outstanding Contribution Award twice, and US National Frances O.Kelsey Special Award for Drug Safety Supervision.

After returning to China from USA and joining Tasly, Dr. Sun He has been continuing scientifically leading scientific research on drug evaluation management method, optimal clinical application, clinical therapeutics and clinical pharmacology, metrological pharmacology and pharmacometrics etc on one hand, he has been dedicated to series strategic practice in enhancing research and development capability of China’s pharmaceutical industry and promoting production internationalization, including global cross research and development mode, development of international high-quality health care products, promotion of development of international ISO standard for traditional Chinese medicine, participation in international WHO harmonization organization and overseas financing and production etc; as chief technical engineer in international project for declaration of modern Chinese medicine - compound Danshen dripping pills to US FDA, he has led Tasly team to make milestone achievements in successfully declaring Phase II clinical study of the first modern Chinese medicine from China to US FDA and entering Phase II development.