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0606 | 基因/细胞产品的质量控制及临床开发法规考量

时间: 05 月 23 日 10:30 - 12:00
内容介绍:

分会场主持人

张海洲 医学博士

博际生物医药科技(杭州)有限公司首席执行官


作为一种重要的治疗手段,细胞/基因治疗逐步成为各国研发的一个热点。但由于这类产品本身的独特特点,其研发和生产与传统的药物有不少区别。如何保证这类产品的生产质量和控制其临床试验的风险,是各国药物研发公司和监管机构面临的共同挑战。本分会场围绕上述

挑战,邀请来自于监管机构和国内外领先企业的讲演嘉宾共同分享和讨论他们实战中应对这些挑战的策略和思考。


新法规环境下CAR-T产品开发的考量

刘蕾

诺华全球研发部(中国)临床研发医学副总监


细胞治疗产品的临床前安全性评价

耿兴超 博士

中国食品药品检定研究院国家药物安全评价监测中心研究员


CAR-T工艺与分析方法的挑战

蒋忻坡 博士

南京传奇生物有限公司工艺/方法分析高级总监


日程嘉宾
2019 DIA中国年会/ 2019 DIA China Annual Meeting
张海洲
Ph.D., MD., DABT CEO, BJ Bioscience Inc.
Dr. Zhang is the CEO of BJ Bioscience Inc., which is a biotech company with a focus on discovering and developing innovative biologics for unmet medical needs. Prior to joining BJ Bioscience, Dr. Zhang served quite a number of organizations including CFDA, Covance, Boehringer Ingelheim, and Roche with increased roles and responsibilities from scientist to vice president during his more than 20 years of professional career in pharmaceutical R&D. Dr. Zhang is a pharmaceutical industry veteran trained in the United States and China. He received his Ph.D. in Toxicology from Indiana University and is a certified toxicologist by American Board of Toxicology. He also has medical degrees from Beijing Medical University.
2019 DIA中国年会/ 2019 DIA China Annual Meeting
刘蕾
诺华全球研发部(中国)临床研发医学副总监
Lei Liu, Associate Clinical Development Medical Director in Novartis Global Development Department China, TA head for hematology products. Lei is a certified hematology physician and received her medical degree for Oncology from Peking University Health Science Center. She received her medical training at Beijing Jishuitan Hospital, specializing in hematology. Lei has more than 7 years of pharmaceutical industry experience in Oncology. She served as Medical Affairs Manager, Clinical Development Lead, Associate Clinical Development Medical Director in Novartis where she leads the clinical drug development for several compounds in China.
2019 DIA中国年会/ 2019 DIA China Annual Meeting
耿兴超
中国食品药品检定研究院国家药物安全评价监测中心副主任
耿兴超,博士/研究员,现任中国食品药品检定研究院国家药物安全评价监测中心副主任,兼任中国药学会药物安全评价专业委员会主任委员、国家药品注册审评药理毒理专家咨询委员会专家等。先后于北京大学医学部获药理学学士和硕士学位,第四军医大学获得生化与分子生物学博士学位。自2004年在中检院安评所从事药物安全性评价研究工作,先后承担完成了100余项国内外新药临床前安全性评价研究。主持和参加了国家科技部重大新药创制专项、北京市科技新星等15项课题的研究。研究成果曾获国家科学技术奖一等奖。工作期间,先后赴英国Huntingdon life Sciences公司、美国FDA 国家毒理研究中心(NCTR)、美国健康与环境科学研究所(HESI)、美国环保署(EPA)、环境卫生科学研究院(NIEHS)等进修学习。发表学术论文50余篇,参编专著5部。