Session I:Innovation Translation:Policy Guidance and Scientific Pactice
主持人 Moderator
唐柯, CPE源峰董事总经理,长生医疗董事长
TANG Ke, Managing Director, CPE
14:00 - 14:25
主题报告1
Keynote Speech 1
ICH E6R3 及国际监管新规对中国创新药早期临床试验的影响与应对
Impact and Response of ICH E6R3 and New International Regulatory Rules on Early Clinical Trials of Innovative Drugs in China
罗飞, 松禾资本创始合伙人
LUO Fei, Founding Partner, Greenpine Capital
14:25 - 14:50
主题报告2
Keynote Speech 2
监管科学视角下的研究者发起临床研究与前沿治疗创新(以细胞基因治疗为例)
Investigator-Initiated Clinical Research and Cutting-Edge Therapeutic Innovation from a Regulatory Science Perspective (Taking Cell Gene Therapy as an Example)
樊毅超, 阿斯利康战略合作与业务发展部执行总监, 阿斯利康中金资本执行董事
FAN Yichao, Executive Director, AstraZeneca Business Development、AZ-CICC fund
14:50 - 15:15
主题报告3
Keynote Speech 3
罕见病创新药的医疗和社会价值
The Medical and Social Value of Innovative Drugs for Rare Diseases
张盈, 合麟资本创始合伙人
Linda ZHANG, Founding Partner, Innokylin Capital
15:15 - 17:00
第二阶段:临床开发:前沿突破与协同创新
Session II:Clinical R&D:Frontier Breakthroughs and Collaborative Innovation
主持人 Moderator
霍勇, 中国药促会心血管专委会资深主委,北京大学第一医院心内科首席专家
HUO Yong, Eminent Chairman of PhIRDA Clinical Research on Cardiovascular Drugs Specialty Committee,
Chief Cardiologist Department of Cardiology Peking University First Hospital
15:15 - 15:40
主题报告4
Keynote Speech 4
新政下创新药I期试验和仿制药BE试验的临床实施
Clinical Implementation of Phase I Trials for Innovative Drugs and BE Trials for Generic drugs under the New Policy
陈佳伶, 凯西医药全球业务拓展中国区负责人
Irene Chen, Head of Global Business Development, China;Chiesi
15:40 - 16:05
主题报告5
Keynote Speech 5
研究型医院如何助力创新性临床研究
How Research Hospitals Support Innovative Clinical Research
赵群, 苏州工业园区元禾原点创业投资管理有限公司合伙人
ZHAO Qun, Partner, SIP Oriza Seed Fund Management Co., LTD.
16:05 - 17:00
主题讨论
Panel
先进技术赋能早期转化临床——机遇、挑战与监管协同
Advanced Technologies Empower Early Translational Clinical Practice: Opportunities, Challenges, and Regulatory Collaboration