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分会场0306-2:病毒性肝炎治疗终点的认识及其在新药开发及审批过程中的思考

(二层2号厅B段)

时间: 05 月 25 日 10:30 - 12:00
内容介绍:

分会场主持人


刘佳

泰格医药国际业务部负责人,副总裁


病毒性肝炎药物临床试验的主要终点选择的思考


赵建中 博士

药品审评中心


DILI在新药研发中的重要性


陈成伟 教授

《肝脏》杂志主编

中华医学会肝脏病学分会前副主席,上海肝脏病学分会前主委


FDA病毒性肝炎药物临床开发指导原则解读


Edward COX医学博士

美国FDA药物评价和研究中心抗菌产品办公室主任


与FDA共同商讨明确其病毒性肝炎药物临床开发中的方案设计评价终点及生物标记物


John FLAHERTY

吉利德肝病领域临床开发高级总监


专家讨论: 讨论中美指导原则差异,如何结合临床发现企业需求做到审评的科学性及可执行性。

日程嘉宾
2018第十届DIA中国年会
宁毅 博士
北京大学Meinian健康研究所执行主任,教授
宁毅,葛兰素史克传染疾病和公共卫生研究院流行病学总监和临床流行病学家,葛兰素史克(GSK),以研发为基础的药品和保健品公司,年产药品40亿盒,产品遍及全球市场。 葛兰素史克由葛兰素威康和史克必成合并而成,于2000年12月成立。两家公司的历史均可追溯至19世纪中叶,各自在一个多世纪的不断创新和数次合并中,在医药领域都确立了世界级的领先地位。
2018第十届DIA中国年会
陈成伟 教授
《肝脏》杂志主编 中华医学会肝脏病学分会前副主席,上海肝脏病学分会前主委
陈成伟,1967年毕业于上海第二军医大学,主任医师、教授,文职1级将军。现任上海南京军医临床肝病中心主任,中华医学会肝病学会副主任委员,上海医学会肝病学会名誉主任委员,《中华肝脏病杂志》副总编辑,《肝脏》杂志主编兼编辑部主任,医学参考报《肝脏学频道》执行主编,中华肝脏病学网站主任。曾获全军科技进步奖多项、二等奖1项,上海市科技进步一等奖1项、国家科技进步二等奖1项,荣立二等功一次。1991年被评为上海市"十佳"中青年医师,获国家特殊津贴。 擅长肝脏病的诊断与治疗,在慢性肝炎,重症肝炎,肝硬化和肝癌等方面发 陈成伟 [1] 表过众多有创见性的论文和专著。于1985年首创用人胎肝细胞治疗重症肝炎,作为国家科委"七五"攻关主要治疗手段,使病死率大大下降,被认为是国内最早广意的同种异基因肝细胞移植治疗肝功能衰竭,并为以后研制问世以及克隆和基因工程生产肝细胞生长素奠定了基础。在慢性肝炎的抗病毒治疗方面积累了丰富的经验。在失代偿肝硬化治疗方面,于上世纪九十年代建立了快速腹水浓缩和腹腔-颈内静脉分流术,明显提高了这些患者的生活质量。对无手术指征的中晚期肝癌,形成了独特的免疫化疗治疗个体化体系,大大延长了这些患者的生存期,使不少患者获得Ⅱ期手术的机会。2002年成功编著了我国第一部《药物与中毒性肝病》专著,2012年将以再版。最近,与他的同事们一起完成了脐带间充质干细胞治疗终末期肝病的剂量爬坡安全性临床试验。
2018第十届DIA中国年会
John FLAHERTY
吉利德肝病领域临床开发高级总监
John F. Flaherty, Pharm.D. Dr. Flaherty holds a Doctor of Pharmacy degree from the University of Southern California, School of Pharmacy, in Los Angeles, and completed his postdoctoral residency and fellowship training at the University of California at San Francisco (UCSF). He was a member of the clinical pharmacy faculty at the UCSF School of Pharmacy for 13 years, and currently serves as Professor of Clinical Pharmacy on a volunteer basis. Dr. Flaherty transitioned to a career in the pharmaceutical industry in 1998 where he has held various positions within Clinical Research and Medical Affairs at Gilead Sciences for over 19 years working in both HIV and HBV clinical drug development. He is currently a Senior Director of Clinical Research in Liver Diseases Therapeutics at Gilead where he leads the clinical program for tenofovir alafenamide (Vemlidy), which was recently FDA-approved for the treatment of chronic hepatitis B. Dr. Flaherty is an author on 65 peer-reviewed journal articles and has delivered numerous presentations at national and international scientific and professional conferences while working in academia and within the pharmaceutical industry.
2018第十届DIA中国年会
Edward COX 医学博士
美国FDA药物评价和研究中心抗菌产品办公室主任
Dr. Edward Cox is Director of the Office of Antimicrobial Products, where he has served since 2007. As Director for the Office of Antimicrobial Products, Dr. Cox oversees the review, approval and safety of antimicrobial (antibacterial, antiviral, antifungal, and antiparasitic) drugs, ophthalmic drugs, and immunosuppressive agents for patients who have received solid organ transplants. Dr. Cox has worked extensively on the science and design of clinical trials for evaluating antimicrobial drugs. Dr. Cox received his M.D. from the University of North Carolina School of Medicine. He completed an internship and residency in Internal Medicine at the Hospital of the University of Pennsylvania and an Infectious Disease fellowship at the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. He also holds a Masters of Public Health Degree from the Johns Hopkins School of Hygiene and Public Health. He joined FDA in 1998.