活动首页 >日程安排

1208 | 从非临床到临床的早期开发设计考量

时间: 05 月 23 日 15:30 - 17:00
内容介绍:

分会场联席主持人

胡蓓 医学博士

北京协和医院临床药理中心临床药理学教授


王在琪 博士

InxMed首席执行官


从临床前向临床开发过渡的考量

刘萍 博士

北京领初医药科技有限公司总经理


非临床的安全项目支持高校的临床开发

解建勋 博士

罗氏上海创新中心药物科学部负责人


专家讨论

特邀讨论嘉宾

孔燕 博士

北京大学肿瘤医院肾癌黑色素瘤内科转化医学专家


清水俊雄 医学博士

日本国家癌症中心医院(NCCH)试验治疗部早期药物开发主任医师


日程嘉宾
2019 DIA中国年会/ 2019 DIA China Annual Meeting
胡蓓
教授,北京协和医院临床药理中心
胡蓓教授1982年毕业于北京医科大学获医学学士学位,1989年毕业于中国协和医科大学获医学博士学位。1991年至1994年在美国国立卫生研究院(NIH)福格地奖学金的资助下,在美国华盛顿大学药物化学系从事博士后研究3年。 目前担任北京协和医院临床药理中心临床药理学教授,I期临床研究室主任,从事临床药理学的教学和研究20年,至今已经发表文章70余篇。主要研究方向包括:新药的早期临床研究及定量药理学研究。
2019 DIA中国年会/ 2019 DIA China Annual Meeting
刘萍
北京领初医药科技有限公司总经理
自2018年6月担任北京领初医药科技有限公司总经理,带领团队为创新药公司提供产品在其全生命周期中所涉及的临床药理学服务,从首次人体试验到向监管部门提交新药申报资料及批准 16年临床药理学相关工作经验,丰富的新药临床开发经验(参与60+项 I/II/III期研究)。曾任辉瑞(中国)临床药理部负责人(2016/7-2018/5), 辉瑞(美国)全球临床药理部项目负责人(支持抗感染,炎症和呼吸系统领域的新药项目,2003/6-2016/7) 擅长创新药的早期临床开发,临床药理学策略制定,早期临床试验设计及报告,群体药代动力学/药效动力学(PK/PD)研究,建模与模拟,NDA申报中临床药理学的撰写等 熟悉欧美及中国药政管理部门的法规要求,在支持新药递交/批准,与世界各地监管机构互动方面,经验丰富。发表SCI文章30+篇 2002年12月获美国佛罗里达大学药剂学博士,1999年获加拿大纽芬兰纪念大学药剂学硕士,1993年获北京医科大学药剂学学士
2019 DIA中国年会/ 2019 DIA China Annual Meeting
清水俊雄
日本国家癌症中心医院(NCCH)试验治疗部早期药物开发主任医师
Dr. Toshio Shimizu is a Head of Physicians at Department of Experimental Therapeutics (Oncology Early Phase 1 Drug Development Unit), National Cancer Center Hospital, Tokyo Japan. Dr. Shimizu's research interests include the Early Phase 1 Drug Development and clinical pharmacology/trials for the development of new anticancer agents as well as molecular genetic targets for cancer therapy. Dr. Shimizu is a Board Certified Senior Member of the Medical Oncology by Japanese Society of Medical Oncology (JSMO) and a Fellow of the Japanese Society of Internal Medicine (FJSIM). Dr. Shimizu is an alumnus of Department of Medical Oncology, Faculty of Medicine, Kindai University in Osaka, Japan where he graduated and thereafter, performed his residency in internal medicine and fellowship/staff physician/Assistant Professor in Medical Oncology. He then performed a more advanced clinical fellowship in early phase 1 drug development at START (South Texas Accelerated Research Therapeutics) in San Antonio, Texas, United States which operates one of the world’s largest Phase 1 cancer research programs supervised by Anthony W. Tolcher, M.D., FRCPC. He is currently the principal investigator/co-investigator of over 40 early phase clinical trials of novel anticancer agents including many immuno-oncology trials for patients with advanced cancer. He has been a member of the Joint Scientific Committee Review Member for Phase 1 trials in Hong Kong, The Consortium on Harmonization of Institutional Requirements for Clinical Research (CHAIR) and serves as a scientific reviewer for phase 1 trials in HKSAR (Hong Kong Special Administrative Region of the People’s Republic of China). Dr. Shimizu has authored and co-authored over 50 peer-reviewed publications of original cancer research in internationally respected scientific journals including the Clinical Cancer Research. Dr. Shimizu is also the recipient of the ASCO 2011 Merit Award (Oral Presentation at Clinical Science Symposium) at American Society of Clinical Oncology (ASCO) 47th Annual Meeting, Chicago, IL, USA, June 2011. Since September 2017, the Asian Oncology Early Phase 1 Consortium (AsiaOne) has been formed across key early phase new drug development institutions (phase 1 centers) in Japan, China (HKSAR), Korea, Taiwan and Singapore. Dr. Shimizu is one of the core investigator who is currently leading AsiaOne platform.