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专题3:E9(R1): 临床研究中的估计目标和敏感性分析

(二层, 2号厅后段)

时间: 05 月 22 日 10:30 - 14:30
内容介绍:

组委会主席


刘恋 博士

诺华生物统计总监


组委会成员


Vlad DRAGALIN 博士

杨森量化科学咨询全球负责人,副总裁

ICH E9(R1)工作组成员


陈峰 博士

南京医科大学公共卫生学院院长中国卫生统计学会统计理论与方法专业委员会主任委员

中国临床试验生物统计学组(CCTS)组长


陈韶风 博士

艾伯维公司数据和统计科学,渠道统计和编程副总裁


10:30–10:40     欢迎致辞


10:40–11:00     ICH E9(R1)的背景及历史


王骏

药品审评中心


11:00–11:30     估计目标在E9(R1)中的修改对临床试验的潜在影响


Vlad DRAGALIN 博士


11:30–12:00     刍议估计目标


陈峰 博士


12:00–13:30     午餐


13:30–14:00     在临床试验中实施估计目标的机会和挑战


陈韶风 博士


14:00–14:30     嘉宾讨论


全体讲者及特邀讨论嘉宾:


夏结来 教授


戴鲁燕 博士


郭翔 博士


14:30–15:00     茶歇

日程嘉宾
2018第十届DIA中国年会
刘恋 博士
诺华生物统计总监
Dr. Lian Liu is Director, Biostatistics, heading the Early Development Biostatistics team in China in Novartis. Before joining Novartis, Lian worked as a biostatistician for over 10 years with increasing responsibilities in global pharmaceutical companies including Merck in Pennsylvania, USA and Roche in Shanghai, China. His most recent position is Associate Director, Statistics in GSK R&D China leading a team to support both China registration studies and global preclinical/early clinical studies. His working experience covers several therapeutic areas including neuroscience, oncology, respiratory, cardiovascular, and dermatology. He received a Ph.D. in Statistics from Texas A&M University, USA and a B.S. in Probability and Statistics from Peking University, China.
2018第十届DIA中国年会
Vlad DRAGALIN 博士
杨森量化科学咨询全球负责人,副总裁 ICH E9(R1)工作组成员
Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QS Technical Excellence and Program Strategy) Advisory Committee. He joined Janssen in 2014 as the Head the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 30 years of experience in developing the statistical methodology of adaptive designs and with 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. He has made significant contributions to the development of the methodology of adaptive designs and to their application in clinical trials and has more than 75 publications in peer reviewed journals and books. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group. He is Fellow of the American Statistical Association, a Member of the Drug Information Association, the Society for Clinical Trials, the International Society for CNS Clinical Trials and Methodology, and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research.
2018第十届DIA中国年会
陈峰 博士
南京医科大学公共卫生学院院长 中国卫生统计学会统计理论与方法专业委员会主任委员 中国临床试验生物统计学组(CCTS)组长
陈峰 教授 南京医科大学研究生院院长 中国卫生统计学会统计理论与方法专业委员会主任委员 中国临床试验生物统计学组(CCTS)组长
2018第十届DIA中国年会
陈韶风 博士
艾伯维公司数据和统计科学,渠道统计和编程副总裁
Dr. Ivan S.F. Chan has 20+ years of experience in pharmaceutical industry. He is Vice President, Pipeline Statistics and Programing, Data & Statistical Sciences, at AbbVie Inc. In this capacity, he leads the statistics and programing groups supporting discovery, biomarker development, clinical development and global medical affairs for all therapeutic areas. Prior to joining AbbVie, Ivan was Executive Director of Biostatistics at Merck Research Laboratories. Ivan earned his B.S. and M.S. in Statistics from The Chinese University of Hong Kong and a Ph.D. in Biostatistics from University of Minnesota, United States. Professionally, Ivan serves as Executive Director of the International Society for Biopharmaceutical Statistics (ISBS) and as an External Advisor to the University of Hong Kong. Also, he is an Associate Editor (AE) for Statistics in Biosciences, Statistics in Biopharmaceutical Research, and Journal of Biopharmaceutical Statistics. He was the 2012 President of the International Chinese Statistical Association. He has 80+ publications in statistical and clinical journals. Ivan is a Fellow of the American Statistical Association (ASA) and a Fellow of the Society for Clinical Trials (SCT).
2018第十届DIA中国年会
夏结来 博士
教授,空军军医大学(第四军医大学)卫生统计学教研室主任
夏结来,博士,空军军医大学(第四军医大学)卫生统计学教研室主任、教授、博士生导师,国家食品药品监督管理总局审评咨询专家(生物统计)、中国信息协会统计理论与方法专业委员会副主任委员、中华预防医学会生物统计学分会侯任主任委员,中国卫生统计杂志编委、CCTS副组长、CDMC组长。 先后获7项国家自然科学基金项目资助,参与3项十一五科技创新项目研究,与CDE联合申报获得十三五重大科技专项一项。获国家科技进步二等奖一项、军队科技进步一、二等奖各一项、陕西省科技进步二等奖一项。 提出了回归系数有偏估计方法––根方估计和广义根方估计。先后在香港中文大学威尔士亲王医院临床与流行病学研究中心、美国鲁易斯安娜州立大学医学中心遗传与统计系访问研究。主要研究方向是临床试验设计与统计分析方法。参与了数十项的涉及化药、中药、生物制品、医疗器械等临床试验相关指导原则制定。
2018第十届DIA中国年会
戴鲁燕 博士
勃林格殷格翰泛亚太生物统计负责人
Dr. Luyan Dai is currently heading the Asia statistics group overseeing both teams in China and Japan and contributing to the global development at BI. She was relocated to Asia in 2012 to build up the statistics team in Shanghai for Boehringer Ingelheim. Prior to this, she worked at Boehringer Ingelheim in USA. Dr. Luyan Dai received her PhD in statistics at the University of Missouri-Columbia, USA.
2018第十届DIA中国年会
郭翔 博士
中国统计负责人/执行总监,百济神州
郭翔博士毕业于美国北卡州立大学(NCSU)统计系,目前是百济神州中国统计负责人,执行总监。加入百济之前,郭翔博士于2013-2017年担任默沙东实验室生物统计亚太负责人,高级总监,领导默沙东中国位于北京和上海的生物统计团队。在加入默沙东中国之前,郭翔博士曾于赛诺菲美国研发中心和中国研发中心担任高级统计经理以及来得时(LANTUS)项目统计负责人。 郭博士的研究兴趣主要集中在缺失数据的统计方法,适应性临床研究设计和国际多中心研究设计与分析等研究领域。郭博士目前是药物信息协会(DIA)中国统计分会主席,DIA 中国顾问委员会成员,中国临床研究统计专家组(CCTS)成员和北京生物统计和数据管理研究会(BBA)秘书长。