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分会场0408:新形势下临床研发多方协作高效执行的关键策略和实施

(二层2号厅C段)

时间: 05 月 25 日 15:30 - 17:00
内容介绍:

分会场主持人


任科

上海药明康德新药开发有限公司副总裁兼SMO事业部津石医药负责人


近年我国的新药研发事业比以往有了很大进展,国家药监局正在通过多方面的努力加快新药能够进入临床试验阶段的节奏,大量新药临床试验项目在等待启动和实施。在当今新药研发日趋严谨和科学的形势下,临床研究设计和实施日益复杂,分工精细,需要外包的工作量大,分工和品类也更加繁多,能否准确选择适合自己的合作伙伴并有效整合各方资源形成合力对临床项目的成败形成了关键影响。


同时,在这么多更加复杂的项目蜂拥进入临床阶段,急需大量合格的临床研究中心和专业研究人员的参与,这两者的短缺又成为当前临床研究执行最大的痛点。


本分会场将从3个角度进行探讨:


•从与合作方的选择和管理的成功案例中得到的启发

•临床研究中的痛点和多方协作所形成合力带来的解决办法

•CRO和其他临床研究供应商如何在机会与挑战面前突围


临床研究多方协作的成功案例分享-新形势下创新药开发中如何建立有效的多方协作模式


吴䶮 博士

和黄医药副总裁


在新形势下CRO如何面对中国临床研究的挑战?


刘致显

精鼎董事会副主席


嘉宾讨论:在机会和挑战面前CRO及其他临床研究供应商如何突围


以上讲者及特邀讨论嘉宾:


韩滢滢

索元生物临床运营副总裁


曹晓春

泰格医药科技股份公司执行副总裁兼董事会秘书


刘群

诺华制药临床研究开发部肿瘤临床研究经理负责人


郭彤 博士

IQVIA大中华区销售副总裁

日程嘉宾
2018第十届DIA中国年会
任科
上海药明康德新药开发有限公司副总裁兼SMO事业部津石医药负责人
任科,药明康德津石医药科技有限公司副总裁 担任DIA中国SMO协作组主任委员,中国药物临床试验机构联盟青年委员会副主任委员。在《医药经济报》、《China Sourcing》、《E药经理人》等专业杂志发表十多篇文章 在临床研究领域工作15年,在药明康德、CCBR、PPD/依格斯、阿斯利康、三九医药积累了包括跨国药企、国内药企、跨国CRO、本土CRO和SMO各个业态的工作经验 从事过包括CRA, 临床研究经理,商务总监,数据管理总监,总经理的全面工作 参与过上百项肿瘤、心血管、呼吸、消化、内分泌、免疫、神内、眼科、感染等多方面创新药的临床开发
2018第十届DIA中国年会
吴䶮 博士
和黄医药副总裁
Dr. Yan Wu is vice president, head of Clinical Operation and head of Immunology Development in Hutchison MediPharma. He leads the clinical team to manage 30 studies in oncology and immunology worldwide. Over the past 20+ years, Yan has worked at several multinational companies with increasing responsibilities, including Project Manager with Astra, Clinical Manager with Quintiles, Head of Clinical Development with Boehringer Ingelheim, Biogen and Daiichi Sankyo. Yan has extensive experience in medical affairs and clinical development of pharmaceutical products including building up and leading Asia clinical research hubs and managing collaborations with academic institutions, hospitals and CROs.
2018第十届DIA中国年会
刘致显
精鼎董事会副主席
Albert Liou serves as Vice Chairman of the Board for Asia-Pacific and is responsible for the overall business and operations for the region Before joining PAREXEL, Albert founded APEX International Clinical Research, which PAREXEL acquired in 2007. Under his leadership, APEX grew rapidly over nine years to become one of the largest CROs in the Asia-Pacific region with a presence in China, Taiwan, Hong Kong, South Korea, Malaysia, Thailand, Singapore, The Philippines, Australia, Indonesia and India. Work Experience Mr. Liou has over 30 years of clinical research experience, of which 11 years were spent in the United States and 19 years in Asia. After working at Harvard Medical School as a Senior Statistician, he had managerial role in biopharmaceutical companies such as Liposome Technology Inc. which later became part of Johnson & Johnson. He then worked at Amgen where he was a member of the senior management team, responsible for clinical data management. He then returned to Asia and founded APEX International which became a leading CRO in the Asia/Pacific region. In addition to his professional responsibilities, Albert was an Advisor Committee member in the Development Center for Biotechnology of the Republic of China. He also has served as an Assistant Professor at Fu-Jen Catholic University from 2006~2010 and 2015.
2018第十届DIA中国年会
韩滢滢
索元生物临床运营副总裁
韩滢滢 Isabel Han Executive Director, Clinical Operations, Denovo Biopharma 公司名称Denovo Biopharma 入职日期2016 年 9 月 - 至今 任职时长•1 年 8 个月 Covance Director, Head of Operations, Clinical Development Service, China 入职日期 2013 年 1 月 - 2016 年 7 月 Actelion Clinical Development Director 入职日期 2011 年 11 月 - 2013 年 1 月 教育经历 • Beijing Medical University, now as Peking University Health Science Cente
2018第十届DIA中国年会
曹晓春
泰格医药科技股份公司执行副总裁兼董事会秘书
曹晓春 联合创始人、董事、执行副总裁、 董事会秘书、思默总经理 • 协助泰格医药总裁一起负责管理泰格医药集团整体事务,分管集团人力资源、行政、政府事务等职能部门。全面负责杭州思默医药科技有限公司日常工作 • 浙江中医药大学中医专业毕业,浙江大学药学院药学硕士,执业药师,高级工程师 • 近25年药品研发、注册和临床研究工作经验,15年企业管理经验。 Xiaochun Cao Co-founder, Board Director, Executive Vice President,, Board Secretary,, General Manager of SIMO • Assist the chairman to manage the whole business of Tigermed. Be responsible for the functional departments of Human Resources, Administration, Government Affairs, and etc. Be totally responsible for the daily work of Hangzhou Simo Co., Ltd. • Assist the chairman to manage the whole business of Tigermed. Be responsible for the functional departments of Human Resources, Administration, Government Affairs, and etc. Be totally responsible for the daily work of Hangzhou Simo Co., Ltd. • Nearly 25-year working experience of drug research and development, register, and clinical research, with 15 years of experience in business management.
2018第十届DIA中国年会
刘群
诺华制药临床研究开发部肿瘤临床研究经理负责人
刘群 北京诺华制药有限公司临床开发部肿瘤临床研究负责人 从2008年起至今就职于北京诺华制药有限公司临床开发部担任肿瘤临床研究负责人。从临床监查员、临床项目经理、临床研究经理到现在作为所有肿瘤临床研究的负责人,从事临床研究工作近16年,积累了丰富的经验。特别是最近十年在诺华一直专注于肿瘤领域的临床研究管理工作。多次顺利通过中国、美国、欧盟和日本官方的核查。对整个临床研究的管理有自己一套独特的思路。刘群女士本科毕业于上海第二军医大学药学系,并获得第二军医大学医学统计专业硕士学位,现于清华大学经管学院攻读MBA。
2018第十届DIA中国年会
郭彤 博士
IQVIA大中华区销售副总裁
Tong GUO, PhD Head of Global Biostatistics Africa & Asia Group at QuintilesIMS Dr. Tong Guo is the Head of Global Biostatistics Africa & Asia Group at QuintilesIMS. In this position, Dr. Guo oversees the off-shore Biostatistics functions in Africa and Asia. Prior to QuintilesIMS, Dr. Guo was the Head of Global Data Sciences & Analytics Beijing R&D Center at Bayer HealthCare, leading a team of biostatisticians, clinical programmers and clinical data managers to support the global, regional and local clinical development programs. Dr. Guo had worked as the Vice-President and Head of Clinical Informatics & FSP at WuXiPRA, and had successfully established & grown the FSP Business Unit at WuXiPRA. Before joining WuXiPRA, Dr. Guo was the Head of Biostatistics and Life Sciences BPS at Cognizant Technology Solutions (Shanghai) and led the establishment and enhancement of Biometrics capacities in China. Dr. Guo began his clinical research career in 1998 as a Biostatistician at McMaster University in Ontario, Canada. He was a Biostatistician in the United States in both CRO (MDS Pharma Services) and pharmaceutical companies (Bristol-Myers Squibb and Johnson & Johnson) with increasing responsibilities. Tong received his M.Sc and Ph.D. degrees in Biostatistics from McGill University, Montreal Canada. 郭彤博士现任昆泰艾美仕公司亚太及非洲生物统计执行总监,负责昆泰公司生物统计全球欧美以外的离岸团队及交付业务。郭彤博士曾获加拿大麦吉尔大学生物统计学硕士及博士学位。具有近二十年的国际大制药公司新药研发经验。曾任拜耳医药保健有限公司北京国际研发中心,数据科学与分析亚太总监;上海康德保瑞医学临床研究有限公司副总裁,临床信息及FSP业务部门负责人;高知特信息技术(上海)有限公司生物统计及生命科学BPS部门主管;美国百时美施贵宝主任生物统计师及美国强生研发总部生物统计师;并在加拿大麦科马思特大学心血管项目中心及兰州生物制品研究所从事过研究工作。主持过多个全球多中心临床试验的统计设计及分析。特别是对生物统计及大数据分析在生命科学及新药研发上的应用方面颇具建树。