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International Regulatory for New Drugs Forum
Agendas
9:00 - 12:00
国际创新药监管论坛
International Regulatory for New Drugs Forum
Moderator
何如意 , 荣昌生物首席医学官、国投创新首席科学家、原CDE首席科学家
HE Ruyi , CMO of RemeGen, CMO of SDIC, Former Chief Scientist of CDE
9:00 - 9:25
主旨报告1
Keynote Speech 1
基于QTsome的核酸药物研发和临床转化
QTsome-based Nucleic Acid Drug Development and Clinical Translation
赵孝斌 海昶生物创始人兼总裁
ZHAO Xiaobin , Founder & Chairman, Zhejiang Haichang Biotech
9:25 - 9:50
主旨报告2
Keynote Speech 2
药物伴随诊断的出海机会和挑战
Marketing Companion Diagnostics Overseas - Opportunities and Challenges
胡云富 泛生子首席医疗官
HU Yunfu , CMO of Genetron Health
9:50 - 10:15
主旨报告3
Keynote Speech 3
中国创新药出海同步临床的策略及考量
Strategies and Considerations to Conduct Simultaneous MRCT in U.S. and China for Chinese Innovative Drugs
操先华 锐得麦医药联合创始人及董事长
Walt CAO , Co-Founder & President of D2V Clinical
10:15 - 10:40
主旨报告4
Keynote Speech 4
创新药出海的主要因素分析和路径选择
Discussion of Major Factors and Pathways for Domestic Biotech Going to Overseas
肖申 思路迪医药首席医学官
XIAO Shen , Chief Medical Officer of 3D Medicines
10:40 - 11:05
主旨报告5
Keynote Speech 5
利培酮缓释微球注射剂Rykindo美国获批案例分享
Case Sharing of Innovative Drug Rykindo® Approved in the U.S.
孙志刚 绿叶制药集团高级副总裁
SUN Zhigang , Group Senior Vice President, Luye Pharma Group Co., Ltd.
11:05 - 12:00
讨论
Panel
国际药物监管策略助力中国药企出海
International Drug Regulatory Strategies Help Chinese Pharmaceutical Companies to Go Overseas
Moderator
陈少羽, 安诺波特律师事务所管理合伙人
CHEN Shaoyu, Managing Partner of Arnold & Porter LLP Shanghai Office
Panelists
杜涛,深圳埃格林医药董事长
DU Tao,Chairman of Shenzhen Evergreen Therapeutics
李宁,上海君实生物首席执行官
LI Ning,CEO of Shanghai Junshi Biosciences
胡云富,泛生子首席医疗官
HU Yunfu,CMO of Genetron Health
肖申,思路迪医药首席医学官
XIAO Shen,Chief Medical Officer of 3D Medicines
胡育志,FDA律师,前FDA资深政策顾问
HU Yuzhi, Former Senior Consultant of FDA