专家介绍
王亚宁教授
createrna science and technology
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Dr. Yaning Wang is the CEO of Createrna Science & Technology, a clinical-stage biopharmaceutical company developing novel therapeutics for cardiovascular, respiratory, autoimmune, and renal diseases. He was the Director of the Division of Pharmacometrics in the Office of Clinical Pharmacology at US FDA until September 2021 and oversaw reviews, research projects, and policy development for all disease areas. During his 18 years of service at FDA, Dr. Wang was involved in the approval of many new drugs and the publication of various guidance. He also received numerous awards, including Award of Merit (highest award at FDA), FDA Outstanding Service Award and many other awards. Before joining FDA, Dr. Wang received his Ph.D. in Pharmaceutics and master’s degree in Statistics from the University of Florida in 2003. He also obtained a master’s degree in Biochemistry (1999) from National Doping Control Center and a bachelor’s degree in Pharmacy (1996) from Peking University in China. Dr. Wang served as a committee member for multiple Ph.D. candidates from various universities. He mentored more than 70 former research fellows (visiting scholars, post-doctoral scholars, and Ph.D. candidates) at FDA. Dr. Wang is a regulatory expert lecturer for three new drug development and regulatory courses (American Course on Drug Development and Regulatory Sciences, European Course in Pharmaceutical Medicine, Chinese Course on Drug Development and Regulatory Sciences). He served as a board member of the International Society of Pharmacometrics (ISoP) and is a fellow of ISoP. He is a member of the Advisory Committee for Chinese Pharmacometrics Society and a member of the Editorial Advisory Board for the Journal of Pharmacokinetics and Pharmacodynamics.  Dr. Wang is an Adjunct Professor in University of Florida, Beijing University, and Shanghai University of Traditional Chinese Medicine. Dr. Wang has published over 120 papers and given over 380 presentations at various national and international meetings as an expert in new drug development and regulation. He was selected to be one of the top Healthcare Technology Leaders of Washington, DC for 2023.

王亚宁博士现任朗来科技发展公司CEO,之前担任美国食品药品监督局(FDA)临床药理审评室定量药理学审评部部长至20219月,负责所有疾病领域的定量药理学审评,研究项目和政策制定。该部门是FDA唯一一个覆盖所有疾病领域的审评部。在FDA期间,王亚宁博士参与多个重大疾病新药批准的决策,尤其在心血管,癌症,自身免疫,肾脏,代谢,呼吸,移植,疼痛和神经领域多个有争议的品种的批准决策中起到了关键性的作用,指导了多项指南和法规的制定,并获得了许多奖项,包括FDA最高奖项(Award of Merit)和杰出服务奖。加入FDA之前,他于2003年在佛罗里达大学获得药学博士和统计学硕士双学位。1999年获得了国家兴奋剂检测中心的生物化学硕士学位,1996年获得北京大学的药学学士。他还担任三个国际(美国、欧洲和中国)新药研发培训的监管专家讲师 ,担任多个大学博士导师以及学位授予委员会成员,指导了70多位访问学者、博士后学者和博士学位候选人。同时,王亚宁博士曾担任国际药物定量药理学会(ISoP)的理事并获得ISoP终身成就奖,是中国定量药理学委员会常务委员、《药代动力学与药效学杂志》的编辑顾问委员会成员、佛罗里达大学、北京大学、上海中医药大学客座教授。王亚宁博士发表了120余篇论文,并作为新药研发和监管专家在各种国内和国际会议上发表了380多次报告。2023年荣获美国华盛顿特区健康领域杰出领导人称号。王亚宁博士是目前ICH E14(新药导致QT延长和心率失常风险评估)指南中推荐的CQT方法的主要开发者。