CGT国际论坛 | 欧洲EMA/日本CiRA/新加坡A*Star等齐聚IGC2024：揭幕CGT全球监管及研发进展与趋势
自2017年起，全球形势下CGT药品产业发展呈加速形式，可视情况下的CGT领域企业药品研发的数量大幅度增加。截止目前，全球已有超过70款CGT产品成功上市，包括体外基因疗法、基于病毒载体的体内基因疗法、以及小核酸药物等。
随着越来越多CGT产品走向产业化，行业也仍面临诸多挑战仍需解决，包括监管审批、投资环境、市场准入和报销等方面。
据此，9月6-7日，IGC2024 第八届免疫基因及细胞治疗大会特设12大专场中的【CGT国际监管与技术前瞻论坛】、【CGT 商业化与BD投融资专场】专场，将特邀EMA欧洲药品管理局、日本京都大学iPS细胞研究所、新加坡科技研究局A*Star、美国爱因斯坦医学院、德国图宾根大学、陆道培医院、信念医药、合源生物、富汇创投、罗氏中国、中国国投、幂方资本、倚锋资本等行业先行者、科研KOL、投资人带来干货分享。
Day1 9月6日
Speaking language: English 演讲语言：英语
9:00 — 9:10
Welcome Speech
9:10 — 9:45
基于iPS细胞疗法：从实验室到临床 KEYNOTE!
iPS cell-based therapies: from bench to bedside
√Current status and perspectives of iPSC-based regenerative therapy and drug discovery in Japan will be presented.
√We are developing iPSC-based regenerative therapies against chronic kidney disease (CKD) including cell therapy and kidney organ reconstruction.
√ We developed iPSC-based disease models for an intractable kidney disorder, autosomal dominant polycystic kidney disease (ADPKD), and identified retinoic acid receptor (RAR) agonists as a novel candidate drug for ADPKD.
Kenji Osafune MD, PhD, Deputy Director/Professor, Center for iPS Cell Research and Application (CiRA), Kyoto University, Japan
9:45 — 10:20
CAR -T 细胞治疗制造的产业化 KEYNOTE!
Industrialization of CAR-T Cell Therapeutic Manufacturing
√Complex manufacturing of CAR T Cell Therapeutics: pDNA, viral vector, autologous T-Cell propagation, T-Cell transfection to CAR T Cell
√Industrialization with stable viral vector producer cells
√Expression of the chimeric antigen by CRISPR technology on the surface of allogenic T Cells
Prof. Dr. Dr. Rolf G. Werner, Honorary Senator and Professor Industrial Biotechnology, University Tübingen, Germany
10:50 — 11:25
新型CAR细胞疗法进展 KEYNOTE!
Novel CAR therapy
•We discovered new functional B7 immune checkpoint molecule HHLA2 and its two functionally opposite receptors including the costimulatory receptor TMIGD2 and the coinhibitory receptor KIR3DL3.
•HHLA2 is widely expressed in a broad spectrum of human cancers, particularly in PD-L1 negative tumors.
•Our novel immune checkpoint inhibitors targeting KIR3DL3 and HHLA2 are currently in two large phase I clinical trials in six US medical centers.
•We have developed a new TMIGD2 Optimized Potent/Persistent (TOP) CAR.
•TOP CAR targeting B7-H3 show superior anti-tumor activity, survival, expansion, and persistence outcomes.
•TOP CAR establish a lower percentage of exhausted cells, less cytokine production, and an increased CD8/CD4 T cell ratio.
Xingxing Zang, Louis Goldstein Swan Professor & Director Albert Einstein College of Medicine, New York（online）
11:25 — 12:00
iPSC衍生的视网膜治疗
iPSC-derived retinal therapy
Xianmin Zeng, Founder & CEO of RxCell Inc, USA; Visiting Professor, National University of Singapore
13:30 — 14:05
Advanced therapies – current regulatory issues and future developments NEW!
√Current landscape of advanced therapy approvals and emerging technologies, including gene editing
√European regulatory pathways, including the PRIME scheme
√The use of patient data in future regulatory landscape
√The role of patients in the regulatory process
Kieran Breen, Vice Chair, Committee for Advanced Therapies of EMA; Head of Research and Innovation, St Andrews Healthcare, United Kingdom（online）
14:05 — 14:40
借助监管政策和技术指导原则 ，为全球基因治疗药物开发降本提速 HOT!
Leveraging regulatory policies and technical guidance principles to reduce costs and accelerate the global development of new gene therapy drugs
Drug development is complex and resource-intensive. Optimizing cost effectiveness without compromising quality is critical for biotech/pharmaceutical companies to maximize resources and accelerate the delivery of innovative therapies. However, orphan drug clinical trials often take longer and are more expensive than trials for non-orphan drugs (Schey et al., 2017). Regulatory guidance principles and innovative trial designs will be discussed to highlight the challenges and opportunities, providing examples of gene therapy/gene editing drug development.
Alvin Luk, HuidaGene Therapeutics, Co-founder, CEO, and Head of Medical
15:10 — 15:45
治疗实体瘤的同种异体NK细胞生产的机遇与挑战 HOT!
Opportunities and Challenges in Manufacturing of Allogeneic Natural Killer (NK) Cells for Immunotherapy targeting Solid Tumors
√Development of feeder cells to support expansion of NK cells bearing high anti-tumor efficacy
√Optimization of feeder-free process for production of functionally potent NK cells
√CAR engineering of NK cells for immunotherapy against solid tumors
A/Prof Andy Tan, Principal Scientist and Group Leader, Bioprocessing Technology Institute (BTI) , Agency for Science, Technology and Research, Singapore (A*STAR)
15:45 — 16:20
兼具降低CRS风险及适应多平台的CD19 CAR-T细胞生产工艺
Cross-Platform Adaptability of a synchronized CD19 CAR T-Cell Manufacturing Process with Reduced CRS Risk
M.H. U. Turabe Fazil, Head of Research & Development, Biocell Innovations Pte Ltd
CGT 商业化与BD投融资专场 HOT!
16:00 — 16:40
圆桌讨论：CGT商业化与商业保险支付现状与趋势
主持人：刘博锋，陆道培医院国际中心，主任
谢祖全，信念医药，商务管理副总裁
蒋璐，暖哇科技，带病体保险部总经理
张卓敏，北京圆心惠保科技有限公司，医药创新总监
合源生物
更多嘉宾确认中
16:40 — 17:20
圆桌讨论：CGT投融资与BD合作环境与趋势
主持人：余永平，鋆昊资本医疗基金合伙人，清华校友总会生命科学与医疗健康专委会秘书长
邓灵泉，幂方健康基金合伙人
薛园，北京生命园创投基金合伙人
赵敏熙，中国国投高新产业投资有限公司，医药医械副总裁
周勤勇，倚峰资本，董事总经理
孟凡勇，富汇创投，执行董事
Kyle Chen, Director Business Development, Roche China, Pharma Partnering
17:20 — 17:40
中国CGT行业研发趋势分析
√中国CGT行业发展背景
√中国CGT疗法研发现状
√热门赛道研发趋势分析
√CGT面临的挑战与改造策略
王韵依，医药魔方 新药数据部，高级数据分析师
17:40 — 18:00
公众视角的免疫基因及细胞治疗洞察
√公众平台上免疫基因及细胞治疗相关数据分享
√大众对免疫基因及细胞治疗的认知及关注
√免疫基因及细胞治疗专业内容的传播洞察
李梁，微博泛生活运营部总经理
Day1 9月6日
CGT 商业化与BD投融资专场 HOT!
16:20 — 16:40
圆桌讨论：CGT商业化与商业保险支付现状与趋势
主持人：刘博锋，陆道培医院国际中心，主任
谢祖全，信念医药，商务管理副总裁
蒋璐，暖哇科技，带病体保险部总经理
张卓敏，北京圆心惠保科技有限公司，医药创新总监
齐渊元，复星凯特生物科技有限公司，首席商务官
合源生物
更多嘉宾确认中
16:40 — 17:20
圆桌讨论：CGT投融资与BD合作环境与趋势
主持人：余永平，鋆昊资本医疗基金合伙人，清华校友总会生命科学与医疗健康专委会秘书长
邓灵泉，幂方健康基金合伙人
薛园，北京生命园创投基金合伙人
赵敏熙，中国国投高新产业投资有限公司，医药医械副总裁
周勤勇，倚峰资本，董事总经理
孟凡勇，富汇创投，执行董事
Kyle Chen, Director Business Development, Roche China, Pharma Partnering
17:20 — 17:40
中国CGT行业研发趋势分析
√中国CGT行业发展背景
√中国CGT疗法研发现状
√热门赛道研发趋势分析
√CGT面临的挑战与改造策略
王韵依，医药魔方 新药数据部，高级数据分析师
17:40 — 18:00
公众视角的免疫基因及细胞治疗洞察
√公众平台上免疫基因及细胞治疗相关数据分享
√大众对免疫基因及细胞治疗的认知及关注
√免疫基因及细胞治疗专业内容的传播洞察
李梁，微博泛生活运营部总经理
8月19日迎来第七个中国医师节，是医者，也是生命的守护者，更是时代的先锋者。据此，IGC组委特别推出【医师节免费参会票】，向所有医者致敬！
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