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细胞与基因治疗研发及生产工艺技术论坛2020通知
点击次数:8236 发布日期:2019-11-22  来源:本站 本站原创,转载请注明出处

亚太药物研发领袖峰会 2020 -- ( APRDL 2020 )

 

APRDL 2020亚太药物研发领袖峰会

 
2020年4月15日-16日 | 上海浦东汤臣洲际大酒店(二楼汤臣堂 Grand Thomson Ballroom)

大会官网: 
 
定于2020年4月15-16日上海浦东汤臣洲际大酒店Deliver Life Sciences 主办大费城美中医药协会支持亚太药物研发领袖峰会2020,邀请了500+政府监管机构、行业协会、全球顶级癌症中心、科研院校、临床中心、大型跨国制药公司、创新型生物技术公司、CAR-T 细胞免疫疗法研发企业、新药研发设备平台、细胞和基因治疗服务公司、医药研发服务公司、临床试验研究机构、人工智能以及解决方案提供商、律所、投资以及咨询机构等药物研发领袖及高层代表共同探讨并促进 :

CAR-T细胞疗法及相关联合疗法在血液肿瘤和实体瘤临床研究的最新进展,  中国及亚太 地区CAR-T 与TCR-T 细胞治疗产业发展,再生医疗和细胞治疗产品监管法规政策(欧美与中国,日本,新加坡的对比),   基因编辑技术 ( CRISPR-Cas9 )与 iPSC 技术在细胞治疗产品研发与生产中的运用,CAR-T 细胞的自动化生产与自动化细胞制备,CAR-T细胞与基因治疗产品的工业化与商业化生产,CAR-T 细胞治疗产品的生产工艺与质量控制,CAR-T细胞的早期发现与临床前研究 , 优化CAR 设计结构与转化科学增强CAR-T 细胞治疗的安全性和有效性,研究开发下一代 “ Off-the-Shelf ” CAR-T 细胞治疗产品,上市后药物安全性警戒与风险管理, 推动来源于中国及亚太地区的研发创新, 开放式创新及研发外部合作模式, 药物研发外部合作及加速新药研发策略,免疫肿瘤药品开发与战略合作新模式,同时为国内外专家高端交流,产业与资本对接搭建平台。我们诚挚地邀请您出席本届2020亚太药物研发领袖峰会 (‘APRDL 2020’) [ 英文原版议程 请见 附件 ]

●  APRDL 2020 峰会荣誉主席全球 CAR-T 先驱,Stephan A Grupp教授,医学博士、哲学博士  [ Emily Whitehead-- 艾米莉 主治医师 ]
** University of Pennsylvania Perelman School of Medicine, Children's Hospital of Philadelphia [ 费城儿童医院宾夕法尼亚大学佩雷尔曼医学院 ]
-- Prof. Stephan A. Grupp, Novotny Professor of Paediatrics, Co-Lead, Paediatric Program, Abramson Cancer Centre, University of Pennsylvania Perelman School of Medicine 
Section Chief, Cellular Therapy and Transplant, Division of Oncology, Director, Cancer Immunotherapy Program, Medical Director, Cell and Gene Therapy Lab, Children's Hospital of Philadelphia ( CHOP )
全球顶尖 科研院所 及 生命科学研究机构
** California Institute for Biomedical Research, The Scripps Research Institute (TSRI)( 斯克利普斯研究所 -- 美国最大的,私立非营利性研究机构 )
-- Prof. Travis S. Young, Vice President of Biologics, California Institute for Biomedical Research ( Calibr ), The Scripps Research Institute ( TSRI )
** National Institute of Health Sciences, Japan ( 日本国立健康科学研究中心 NIHS -- 相当于日本的中国科学院 )
-- Prof. Yoji Sato, Head of Division of Cell Based Therapies, National Institute of Health Sciences, Japan
** Bioprocessing Technology Institute, A*STAR, Singapore ( 新加坡科技研究局, 生物工程技术研究院 A*STAR -- 相当于 新加坡的中科院 )
-- Prof. Steve Oh, Institute Professor and Director, Stem Cell Group, Bioprocessing Technology Institute, Agency for Science, Technology and Research, A*STAR, Singapore
** University of Pennsylvania School of Medicine ( 美国宾夕法尼亚大学医学院 )
-- Prof. Yangbing Zhao, Director, T Cell Engineering Laboratory (TCEL), Center for Cellular Immunotherapies, Adjunct Associate Professor, Department of Pathology and Laboratory Medicine, University of Pennsylvania School of Medicine
** Memorial Sloan-Kettering Cancer Center ( 美国纪念斯隆-凯特琳癌症中心 )
-- Prof. Xiu-yan Wang, Assistant Director, Michael G. Harris Cell Therapy and Cell Engineering Facility, Associate Laboratory Member, Department of Molecular Pharmacology, Memorial Sloan Kettering Cancer Center
** The University of Tokyo & Jichi Medical University ( 日本东京大学, 日本枥木市自治医科大学 )
-- Prof. Keiya Ozawa, Former Director, Center for Gene & Cell Therapy - Professor, Division of Genetic Therapeutics, The Advanced Clinical Research Center, The Institute of Medical Science, The University of Tokyo
Professor Emeritus, Visiting Professor, Division of Immuno-Gene & Cell Therapy (Takara Bio), Senior Adviser, Center for Gene Therapy Research (CGTR), Jichi Medical University, Tochigi, JAPAN
● CAR-T 细胞治疗产品的生产工艺与质量控制 
-- Sergio Fracchia 博士, 全球 RegCMC 总监, Kymriah 全球生产和质量控制负责人, 细胞和基因疗法, 瑞士诺华 [ Global regCMC Director ]
** The Kymriah Story: Challenges, Headaches and Solutions on Manufacturing and Quality Control
-- Wen Bo Wang 博士, 高级副总裁, 技术运营, Fate Therapeutics [ Senior Vice President, Technical Operations ]
** Developing Allogeneic Cancer Immunotherapy with iPSC Technology
-- Yajin ( Jenny ) Ni 博士, 高级总监, 工艺和产品开发, 技术运营, Allogene Therapeutics [ Process & Product Development, Technical Operations ]
** Cell Therapy Bioprocessing and Allogeneic Manufacturing Solutions for Cell Therapy Products
-- Harry Lam 博士, 执行副总裁, 技术运营主管, 上海药明巨诺生物科技有限公司 [ Executive Vice President of Technical Operations ]
**  Cell Therapy Manufacturing Commercialization -- Strategy and Challenges
-- Xiu-Yan Wang 博士, 联席主任, 迈克尔哈里斯细胞疗法和细胞工程实验室, 分子药理学部门主要研究员, 美国纪念斯隆-凯特琳癌症中心 
-- Steve Oh 教授, 研究院教授, 主任, 干细胞治疗工程研究中心, 生物工程技术研究院, 新加坡科技研究局 ( A*STAR )
● 利用CRISPR-Cas iPSC 技术平台在细胞治疗产品生产开发中的创新运用 – 构建更有效的CAR-T 细胞
-- 赵阳宾 教授, 细胞免疫疗法中心, T细胞工程实验室 主任, 美国宾夕法尼亚大学医学院, 科学联合创始人, Tmunity Therapeutics
**  Advancing Cancer Adoptive Immunotherapy with CRISPR/Cas9 Gene Edited T cells
-- Xiu-Yan Wang 博士, 联席主任, 迈克尔哈里斯细胞疗法和细胞工程实验室, 分子药理学部门主要研究员, 美国纪念斯隆-凯特琳癌症中心 
**  CRISPR-Cas and iPSC technologies as new directions for CAR-T cell manufacturing.
-- Steve Oh 教授, 研究院教授, 主任, 干细胞治疗工程研究中心, 生物工程技术研究院, 新加坡科技研究局 ( A*STAR )
** The IPS-SpheresTM Technology Platform for Reprogramming, Expansion of Pluripotent Stem Cells and Differentiation to Cell & Gene Therapies
-- Wen Bo Wang 博士, 高级副总裁, 技术运营, Fate Therapeutics [ Senior Vice President, Technical Operations ]
**  Developing Allogeneic Cancer Immunotherapy with iPSC Technology
● CAR-T 细胞治疗产品 安全及有效性的评价与观点探讨 ( 法规监管,转化科学 )
-- John Rossi 博士, 转换科学总监, 凯特制药, 吉利德科学子公司 [ Director of Translational Sciences, Kite Pharma, A Gilead Company ]
** CAR-T Cell Therapy Translational Insights: Correlates of Toxicity, Safety & Efficacy
-- Yoji Sato教授,  细胞治疗产品部主任兼首席科学家, 日本国立健康科学研究中心
**  Regulations and Platforms for Ensuring the Quality, Safety and Efficacy of Cell Therapy Products in Japan
-- Edward Stewart Geary 博士, 高级副总裁,  全球药物安全总部负责人, 日本卫材株式会社 [ Senior Vice President and Global Safety Officer, Eisai ]
**  Risk Management Plans (RMP) on post-marketing pharmacovigilance
● CAR-T细胞疗法的T细胞 的早期发现与临床前研究
-- Jian-gang Zhang 博士, T-细胞发现与分析主管, 肿瘤细胞疗法研究部, 肿瘤药物研发, 葛兰素史克全球药物研发中心 
[ Head of T Cell Analytics, Oncology Cell Therapy Research Unit, Oncology R&D, GlaxoSmithKline Medicines Research Centre ]
** Discovery Space in T Cell Analytics in Potency and Functionality for CART Cell Therapy
● 中国下一代 “ Off-the-Shelf CAR-T, CAR-NK TCR-T 细胞治疗的产业现状与未来发展
-- 实体瘤 & 血液瘤:  刘诚 博士, 优瑞科生物;  Henry Ji 博士,Sorrento Therapeutics;  Li Zhou 博士, 绿叶制药;袁纪军 博士, 吉凯基因; 李华顺 博士 , 阿思科力,      周国庆 博士,鸿易医药;张继帅 博士,深圳普瑞金;王慧 博士,陆道培医院;  
-- 商业化: 刘必佐 先生, 西比曼生物; 王立群 博士, 复星凯特; Harry Lam 博士, 药明巨诺; 杨林 教授, 博生吉医药; 何霆 博士, 艺妙神州; 张宇 博士, 颐昂生物;  
Stephen Lim 博士,  来恩生物,  等等… 
● 促进源于中国及亚太的高质量的新药研发创新 – 生物医药研究创新合作及免疫肿瘤生物新药的临床开发
【 李正卿 博士, 默沙东中国研发中心;陶维康 博士,恒瑞医药;王莉 博士, 礼来中国药物发展和医学事务中心; 顾娟红 女士,  法国益普生集团 亚太新药研发创新中心
金建军 博士, 诺华中国;周辉 博士, 信达生物;罗文 博士, 索元生物医药;周新华 博士, 嘉和生物药业; 朱向阳 博士, 华博和华奥泰生物药业;凌宏 博士,齐鲁制药
边峰 博士,辉瑞制药;  张巍怡 博士, 勃林格殷格翰;吴英捷 女士, 罗氏制药;陈晨 博士 德国默克;  尹鹤群 博士, 复星医药;  党群博士, 石药集团; 万昭奎 博士, 凌科药业
Stefan Glueck 博士, 美国新基医药/百时美施贵宝; Sang Hoon Lee 博士,韩国ABL Bio; Edward Stewart Geary 博士; 日本卫材株式会社 等等… 】
● 资深专利律师 热点 知识产权保护 讨论, Licensing Collaboration, 专利延伸 Patent Extension 以及 专利链接 Patent Linkage 话题
【 李彩辉 女士, 专利总监, 三生国健制药; 杨帆 先生, 中国专利总监, 诺华制药; Frank Zhu, 中国专利副总裁, 罗氏制药 等等…】
● 80+ 国内外知名演讲嘉宾 & 500+ 专业高层参会代表
● 70%+核心市场(主要为 来源于中国及全球的生物医药公司、医院、学术机构)参会者 
● 60%+公司决策层及总监级别以上参会者
● 2天高层峰会+定制化且提前预留安排的一对一交流会议+8小时的合作交流及茶歇午宴+1场鸡尾酒晚宴

部分已确认的峰会演讲嘉宾:

峰会议程和讨论热点:
主旨演讲:来自于美国顶级癌症中心的观点
癌症患者曙光 – “CAR-T革命” -- CAR-T细胞疗法在治疗血液肿瘤, 尤其在B细胞型白血病和淋巴瘤领域的最新运用进展 以及 治疗实体肿瘤未来曙光初现
Topic: The CAR-T Cell Revolution -- CAR T-Cell Therapy targeting Leukemia, Lymphoma, and Future Hopes for Solid Tumors
Stephan Grupp教授, 肿瘤科细胞治疗和移植科主任, 干细胞实验室的医学主任, 主治医师和肿瘤学研究员, 儿科教授, 费城儿童医院 (CHOP), 宾夕法尼亚大学佩雷尔曼医学院,科学顾问委员会成员, 西比曼生物科技集团
Bio: Stephan Grupp, MD PhD, is the Chief of the Cellular Therapy and Transplant Section, Director of the Cancer Immunotherapy Program, and Medical Director of The Cell and Gene Therapy Lab at the Children’s Hospital of Philadelphia (CHOP), as well as the Yetta Dietch Novotny Professor of Pediatrics at the University of Pennsylvania Perelman School of Medicine. Dr. Grupp graduated from the University of Cincinnati after completing the MD/PhD program with a PhD in Immunology.
He completed pediatric residency at the Boston Children’s Hospital, followed by a fellowship in Pediatric Hematology/Oncology at the Dana Farber Cancer Institute and postdoctoral work in Immunology at Harvard University. He then joined the faculty at Harvard University until 1996, when he came to CHOP. His primary area of clinical research is the use of CAR T and other engineered cell therapies in relapsed pediatric cancers. He led all of the pediatric ALL trials of CTL019 (now approved as Kymriah), including the largest and most successful engineered T cell therapy clinical trial conducted to date (1, 2), as well as the global registration trial for CTL019 (3). As a result of this work, he presented the Clinical Perspective at the July 2018 FDA ODAC meeting, at which reviewers voted 10-0 for recommendation of approval for Kymriah in pediatric ALL. His primary laboratory interest is the development of new cell therapy treatments for pediatric cancers. Dr. Grupp is a reviewer for several journals and the author of over 200 peer-reviewed journal articles, as well as numerous abstracts and book chapters.
主旨演讲:日本细胞治疗监管法规政策与平台: 确保优质, 安全与有效的细胞治疗产品在日本的开发 
Topic: Regulations and Platforms for Ensuring the Quality, Safety and Efficacy of Cell Therapy Products in Japan
Abstract: There are two tracks for the development of RM/CTs in Japan. The first is that aims at manufacturing and marketing authorization of CTPs under the Pharmaceuticals and Medical Devices Act (PMD Act). This approach involves research and development by a commercial enterprise, followed by a stepwise process consisting of evaluation and approval of the product by the relevant regulatory authorities to confirm its safety, efficacy and quality. It is notable that the PMD Act introduced an independent product category called “regenerative medicine products” (RM products), which include CTPs and gene therapy products, and has a unique process for conditional and time-limited authorization of RM products, which allows approvals with the clinical data likely to predict clinical efficacy, not with the confirmatory trials. The Act requires further safety assurance during the post-marketing phase and additional clinical data for confirmation of the evidence for the second application. The second approach is provision of RM/CTs conducted for non-commercial purposes, according to the Act on the Safety of Regenerative Medicine (ASRM). The ASRM specifies the regulations, to which medical practitioners, review committees, and cell culture/processing facilities have to be compliant, when providing RM/CTs not only in clinical researches but also in other medical practices. For smooth translations of clinical researches on RM products under the ASRM to their commercial development under the PMD Act, several platforms have been established, including a nation-wide database for RM products and a system for the development of human resources, as well as a public-private partnership for validation of test methods for the safety assessment of RM products.
• The Pharmaceuticals and Medical Devices Act (PMD Act)
• The Act on the Safety of Regenerative Medicine (ASRM)
• Platforms to promote R&D of cell therapy products and to ensure their quality, safety and efficacy
Yoji Sato教授,  细胞治疗产品部主任兼首席科学家, 日本国立健康科学研究中心 NIHS ( NIHS日本国立生命科学研究机构, 相当于中国科学院 ) [ Head, Division of Cell-Based Therapeutic Products, National Institute of Health Sciences, Japan ]
CRISPR-Cas and iPSC Technologies -- New Directions of CAR-T Cell Manufacturing:
主旨演讲:高质量临床级的CAR-T细胞生产的最新进展 以及 CRISPR-Cas and iPSC 技术在CAR-T 细胞生产中的运用
Topic: The State of the ART of Manufacturing CAR T Cells and The Latest Advancements
Abstract: The approval of CAR-T cell therapy for ALL and NHL by FDA has led to increased academic and industrial interest for this therapy. The success of this promising therapy relies on reproducible manufacturing of high-quality clinical-grade CAR T cells. We have established a robust modular CAR-T manufacturing platform as well as a clinical grade retroviral vector manufacturing process, which allowed us to manufacture hundreds of CAR-T cell products and support 12 phase I/II CAR-T cell clinical trials successfully at our center. Over the years, we have made improvement of our existing manufacturing platform and tested new manufacturing procedures that supported the products meeting all critical quality attributes. We have generated T cells expressing CARs encoded by gammaretroviral vectors starting from either healthy donors or cryopreserved patient apheresis products using Prodigy. Moreover, the emergence of CRISPR-Cas and iPSC technologies has pointed new directions for CAR-T cell manufacturing.
--  Define the central role of CAR-T cell manufacturing for the clinical applications of CAR-T cell therapies
--  Summarize the current CAR-T cell manufacturing platforms (modular and continuous)
--  MSK experience for CAR-T manufacturing and evolvement of our manufacturing platform
--  Manufacturing of large-scale clinical grade retroviral vectors for CAR-T cell therapy
--  Quality control for clinical grade retroviral vector and CAR-T cell manufacturing
--  New Directions for CAR-T cell manufacturing (TRAC-CAR T, iPSC-derived CAR T)
Xiu-Yan Wang 博士, 联席主任, 迈克尔哈里斯细胞疗法和细胞工程实验室, 分子药理学部门主要研究员, 美国纪念斯隆-凯特琳癌症中心 [ Assistant Director, Michael G. Harris Cell Therapy and Cell Engineering Facility, Associate Laboratory Member, Department of Molecular Pharmacology, Memorial Sloan Kettering Cancer Center ]
主旨演讲:The IPS-SpheresTM 技术和平台 用于多能干细胞的重新编程和扩增并且分化治疗用于细胞与基因疗法
Topic: A Broad Technology Platform for Reprogramming, Expansion of Pluripotent Stem Cells and Differentiation to Cell & Gene Therapies
Abstract: The BTI, at A*STAR has developed a Broad Technology Platform for Reprogramming, Expansion of Pluripotent Stem Cells and Differentiation to Cell Therapies. The IPS-SpheresTM technology is capable of automating the reprogramming of 4 different cell sources: T cells, haematopoietic stem cells, fibroblasts and mesenchymal stem cells into human induced pluripotent stem cells. From each reprogramming campaign, we can select up to 96 wells of clones to characterize and pick the best growing clone that can be cultured in suspension cultures and differentiated to target lineages. 
Using the microcarrier technology IPS-SpheresTM, BTi has been able to demonstrate production of neuroprogenitors and neurons at 10 million cells/ml. These neurons have been demonstrated to be functional in mouse and rat animal models of Parkinson’s disease with rapid recovery times within 3 to 6 months depending on the cell dose. Secondly, BTI has cardiomyocytes in a completely defined serum free media with 2 small molecules achieving 8 million cells/ml in a suspension bioreactor. Cardiomyocytes have been implanted in pig models of cardiac infarction. Most recently, BTi has manufactured CD34+ haematopoietic progenitors from hiPSC on this platform achieving 2 million cells/ml, these have been further differentiated to universal O negative Rhesus negative RBCs (17 million cells/ml.) and are being tested in animal models of acute anaemia. This platform is broadly available for scale up of pluripotent stem cell therapies to meet the global shortage of cells for therapies.
Steve Oh 教授, 研究院教授, 主任, 干细胞治疗工程研究中心, 生物工程技术研究院, 新加坡科技研究局 ( A*STAR ) [ Institute Professor and Director, Stem Cell Group, Bioprocessing Technology Institute, Agency for Science, Technology and Research, A*STAR, Singapore ]
主旨演讲:运用iPSC技术来开发 同种异体癌症免疫疗法 以及 细胞培养规模放大面临的挑战
Topic: Developing Allogeneic Cancer Immunotherapy with iPSC Technology
-- Fate is pioneering a revolutionary approach to cell therapy -- we use renewable master induced pluripotent stem cell (iPSC) lines generated from our proprietary iPSC platform to derive cell therapy product candidates that can be delivered off-the-shelf for the treatment of a large number of patients.
-- Our cell therapy product candidate pipeline is comprised of immuno-oncology programs, including off-the-shelf NK- and T-cell product candidates derived from master iPSC lines.
-- Discuss challenges in cell culture scale up for allogeneic cell therapies with iPSC technology
Wen Bo Wang 博士, 高级副总裁, 技术运营, Fate Therapeutics [ Senior Vice President, Technical Operations, Fate Therapeutics ]
Cell Therapy CMC and Manufacturing; Bioprocessing and Quality Control
主旨演讲:Kymriah (tisagenlecleucel) 在生产与质量控制过程中面临的挑战和解决方案

Topic: The Kymriah Story: Challenges, Headaches and Solutions on Manufacturing and Quality Control
Sergio Fracchia 博士, 全球 RegCMC 总监, Kymriah 全球生产和质量控制负责人, 细胞和基因疗法, 瑞士诺华 [ Global regCMC Director Cell and Gene Therapy, Novartis ]
主旨演讲:细胞疗法商业化生产战略与挑战 
Topic: Cell Therapy Manufacturing Commercialization -- Strategy and Challenges
-- Unique Manufacturing Challenges for Autologous Cell Therapy
-- IND to Commercial: A Paradigm Shift
-- Development By Design
-- Quality By Design
-- Cell Therapy COGs Optimization
-- IND to Commercial: Scale-out Challenge
-- Cell Therapy Technology Road Map Vision
-- Current Weakness in the Technology Landscape
-- Final Thoughts
Harry Lam 博士, 执行副总裁, 技术运营主管, 上海药明巨诺生物科技有限公司 [ Executive Vice President of Technical Operations, JW Therapeutics ]
主旨演讲: 颐昂生物 开发FIC & FIH CAR-T 细胞治疗产品的经验
Topic: The Aeon experience of translating and developing a FIC&FIH CAR-T product in China
-- The Regulatory of Cell & Gene product in China: Poc or IND
-- Key CMC strategy: manual & automatic system in PoC and IND
-- the Aeon experience in fast translating FIC&FIH product in China
张宇 博士, 联合创始人 兼 首席执行官, 颐昂生物 [ Co-Founder and Chief Executive Officer, Aeon Therapeutics ]
主旨演讲:CAR-T细胞自动化生产 
Topic:  Automated Manufacturing of Chimeric Antigen Receptor T Cells
Abstract: The chimeric antigen receptor gene-modified T cells (CAR-T cells) technology has been proven clinically successful since 2010, especially targeting CD19 molecules in the treatment of refractory, relapsed B cell-derived malignancies in which the clinical efficacy has never been achieved by traditional tumor therapy strategies, and become the most attractive area in cancer immunotherapy. However, CAR-T cell technology has been experiencing huge challenges, including the expensive preparation and quality control costs for CAR-T cells and lacking clinically verified automated and closed technology. In another word, current mainstream technology hugely relies on highly skillful personnel that increases risk of contamination and production failure, and brings uncertainty for its industrialization. In this presentation, Dr. Yang will analyze the development trend based on his team’s effort in this area, and summarize how applying automated platform to CAR-T cell manufacturing will prompt CAR-T cell technology industrialization and lead to clinical success.
杨林 博士, 首席执行官, 博生吉医药科技(苏州)有限公司 [ Chief Executive Officer, PersonGen BioTherapeutics (Suzhou) ]
Commercialization Strategies for Cell and Gene Therapies in China
主旨演讲:YESCARTA (axicabtagene ciloleucel) 在中国开发的法规和商业化进展
Topic: Revolution of CAR-T Cell Therapies – Regulatory and Commercialization Considerations for Yescarta in China 
王立群 博士, 首席执行官, 复星凯特生物科技有限公司 [ Chief Executive Officer, Fosun Kite Biotechnology ]
主旨演讲:西比曼生物在细胞和基因疗法领域的中国和全球商业化战略 
Topic: CBMG Commercialization Strategies for Cell and Gene Therapies; Particularly in China
-- What China can bring to advancing the manufacture process in novel therapy modalities 
-- Manufacturing capabilities: addressing the “ Achilles heel “ of cell therapy 
-- The importance of strategic collaborations to improve manufacturing
刘必佐 先生, 首席执行官 兼 首席财务官, 西比曼生物科技集团 [ Chief Executive Officer & Chief Financial Officer, Cellular Biomedicine Group ]
Discovery Space of T-Cells for CAR-T Cell Therapy
主旨演讲:细胞早期发现: T细胞分析在CAR-T细胞疗法中效力和功能性方面的最新发现
Topic: Discovery Space in T Cell Analytics in Potency and Functionality for CART Cell Therapy
Abstract: The interest in cell therapy with CAR-T and TCR-T in the scientific community has increased exponentially in the last decade and the therapeutic utility is further exemplified by the approval of the two CD19 therapies in haematological malignancies. For the hundreds of CAR-T/TCR-T modalities in clinical development, a successful discovery platform coupled with robust and reproducible foundational assays deciphering the potency and polyfunctionality is pivotal to accelerate the success. To support the fill and flow of discovery programmes and to expedite them to clinical development we have developed a number of assays covering CAR-T/TCR-T characterisation, potency estimation, polyfunctionality assessment and molecular biology techniques. T cell signalling and metabolic profiling are also integral part of our in vitro strategy for selecting a T cell modality with better persistence and metabolic profile to overcome the suppressive tumor microenvironment.
-- Define the critical role of building assay capability for potency and polyfunctionality of T cells in discovery; selection of simple yet conclusive assays for CAR-T discovery
-- T cell characterisation, potency estimation and polyfunctionality include cytotoxicity, signalling and molecular biology in selecting the most suitable candidate
-- Capability building to interrogate T cell’s ability in overcoming the suppressive tumour microenvironment
-- Assay alignment and harmonisation in a diverse and fast-moving research environment
-- Future perspectives
Jian-gang Zhang 博士, T-细胞发现与分析主管, 肿瘤细胞疗法研究部, 肿瘤药物研发, 葛兰素史克全球药物研发中心 [ Head of T Cell Analytics, Oncology Cell Therapy Research Unit, Oncology R&D, GlaxoSmithKline Medicines Research Centre ]
主旨演讲:CRISPR/Cas9 基因编辑的T细胞 运用于 新兴的癌症细胞疗法过继性免疫治疗
Topic: Advancing Cancer Adoptive Immunotherapy with CRISPR/Cas9 Gene Edited T cells
Abstract: Despite impressive clinical efficacy of T cells engineered to express chimeric antigen receptors (CAR) for some cancers, the current applications of CAR T cell therapy, especially for treating solid tumors, are limited by some major challenges, such as the lack of cancer specific targets and the interference of tumor microenvironment (TME). Strategies  to identify safe targets as well as safe ways to target some validated tumor associated antigens that are not only widely overexpressed on solid tumors, but also expressed at lower physiologic levels on the normal tissues. An efficient T cell adoptive immunotherapy requires to make T cells specifically target cancers, such as by expressing CAR or TCR, the T cells need to be further modified to avoid tumor microenvironment (TME), such as introducing a dominant negative TGF-beta receptor, PD1-CD28 switch receptor,  or knocking out PD1 in the T cells using CRISPR/CAS9. Furthermore, CRISPR/CAS9 gene editing technology greatly facilitates the development of universal CAR T and universal TCR T  as the off-the-shelf T cell products to treat cancers, which holds great promise in advancing the field of cancer immunotherapy.
• Safely targeting cancers is utmost important for developing an effective CART therapy
• Successfully overcoming TME is required for an effective CART therapy
• CRISPR/CAS9 can greatly facilitates the development of cancer immunotherapy
赵阳宾 教授, 细胞免疫疗法中心, T细胞工程实验室 主任, 美国宾夕法尼亚大学医学院, 科学联合创始人, Tmunity Therapeutics [ Director, T Cell Engineering Laboratory (TCEL), Center for Cellular Immunotherapies, Adjunct Associate Professor, Department of Pathology and Laboratory Medicine, University of Pennsylvania School of Medicine, Scientific Co-Founder, Tmunity Therapeutics ]
The State of the ART of Chinese Cell Therapy: Development Next Generation “ Off-the-Shelf “ CAR-T/TCR-T/CAR-NK Cell Therapy:
主旨演讲:开发安全且有效的CAR-T 细胞疗法
Topic: Development of safe and potent CAR-T therapy
何霆 博士, 首席执行官, 北京艺妙神州医药科技有限公司 [ Chief Executive Officer, ImmunoChina Pharmaceuticals ]
主旨演讲:将ARTEMISTM T 细胞 TCR模拟抗体结合 治疗实体瘤
Topic: Treating Solid Tumours with TCR-mimic Antibody Redirected ARTEMISTM T-cells
• While CAR-T has seen initial success in treating hematological malignancies, solid tumor remains an unsolved problem
• Utilizing TCR-mimic antibody redirected T-cells, our novel T-cell therapy targets solid tumor cells with high affinity and specificity
• In combination with our tumor-infiltration technology, ARTEMISTM T-cells incorporate the best features of CAR and TCR T-cell therapies while overcoming their limitations
• Our lead drug candidate is currently in US PhI /II trial while other assets are validated by multiple academic and pharma partnerships
刘诚 博士, 创始人兼首席执行官, 优瑞科生物技术公司[ Founder and Chief Executive Officer, Eureka Therapeutics ]
主旨演讲:开发下一代 “ Off-the-Shelf ” CAR-T 细胞疗法
Topic: Development Next-generation off-the-shelf CAR-T cell therapy
Henry Ji 博士, 总裁兼首席执行官, Sorrento Therapeutics [ President and Chief Executive Officer, Sorrento Therapeutics ]
主旨演讲:开发下一代 “ off the shelf ” CAR-NK细胞药物治疗实体瘤的临床进展
Topic: Mechanisms & Clinical Study of CAR-NK Cell Drugs to Treat Solid Tumours
Abstract: Chimeric antigen receptor T lymphocyte (CAR-T) technology has made remarkable success in the treatment of hematological malignancies. However, its intrinsic character of the technology unlikely leads to a large-scale production of standardized and homogenous cell drugs for cancer treatment. The ATCG Corp. has been pioneered on developing innovative “off-the-shelf” CAR-NK cell drugs for cancer immunotherapy. The ATCG research team, led by Dr. Huashun Li, has been based on natural killer cell line NK-92 as a platform to develop over 15 CAR stably expressing NK cell lines (CAR-NK) to treat different types of solid tumors. The preliminary clinical research studies have shown that ATCG427 CAR-NK therapy yields a remarkable response rate. In investigator initiated clinical study, Robo1 CAR-NK cells could effectively treat the advanced cancers with DCR as high as 76.5%, including but not limited to breast cancer, lung cancer, renal cancer, and pancreatic cancer. In addition, ATCG427 CAR-NK cells not only directly kill target tumor cells but also engage host NK cells and lymphocytes, leading to systemic activation of immunity against tumors. ATCG is a leading enterprise in the fast-growing tumor immunotherapy field .It has laid a solid foundation for the clinical trial of innovative cell drugs.
李华顺 博士, 总裁兼首席执行官, 阿思科力 [ President and Chief Executive Officer, Asclepius Technology Company Group ]
主旨演讲:针对T细胞恶性肿瘤的最新CAR-T细胞疗法
Topic: Novel CAR-T Therapy for T Cell Malignancies
杨林 博士, 首席执行官, 博生吉医药科技(苏州)有限公司 [ Chief Executive Officer, PersonGen BioTherapeutics (Suzhou) ]
主旨演讲: CAR-T 细胞疗法针对急性髓细胞性白血病的最新研究进展
Topic: The Research and Proceedings of CAR-T for Treating the AML
张继帅 博士, 首席科学官, 深圳普瑞金生物 [ Chief Scientific Officer, The Pregene Biopharma Company ]
主旨演讲: 利用流式细胞术 CAR-T 细胞的鉴定与研究
王慧 博士, 临床诊断部 副主任, 流式细胞实验室 主任, 陆道培疫疗集团
** CAR-T Cell Therapy Translational Insights: Safety and Efficacy: 
主旨演讲:CAR-T 细胞疗法转化研究的观点毒性关联确保有效性和安全
Topic: CAR-T Cell Therapy Translational Insights: Correlates of Toxicity, Safety & Efficacy
-- Product related 
-- Tumour microenvironment related 
-- Loss of Target
John Rossi 博士, 转换科学总监, 凯特制药, 吉利德科学子公司 [ Director of Translational Sciences, Kite Pharma, A Gilead Company ]
主旨演讲:亚太药物警戒与风险管理策略
Topic: Risk Management Plans in Asia
• Overview of the status of Risk Management Plans (RMP) in Asia including their structure, organization, and positioning within pharmaceutical regulatory regime
• Comparison of experience with RMP in Asia compared to the US and EU
• Strategies for managing the creation and maintenance of RMP’s in Asia
• Impact of the RMP on post-marketing pharmacovigilance
Edward Stewart Geary 博士, 高级副总裁, 全球药物安全负责人, 总监, 全球药物安全总部, 日本卫材株式会社 [ Senior Vice President and Global Safety Officer, Eisai ]
** Open Innovation Model -- Strengthening Pharma R&D Collaboration and Partnership:
主旨演讲:辉瑞亚太研发战略及创新合作模式
Topic: Collaborating for Innovative Growth-Pfizer R&D Strategy, Partnering Model and Asia Discovery Labs
边锋 博士, 资深总监,辉瑞亚洲研发实验室, 辉瑞全球研发  [ Senior Director & Asia Emerging Science Lead (Shanghai), Asia Discovery Labs, Emerging Science & Innovation, Pfizer Worldwide Research & Development, Pfizer ]
主旨演讲:开放式创新战略创造全球合作机遇
Topic: Open Innovation Strategy to Build Global Opportunity: ABL Bio as New Trend Leader
• Importance of open innovation
• Major reasons for open innovation strategy in competitive landscape
• Early discovery collaborations between small biotech startups, academic labs, and large corporations, between two large corporations to form joint venture partnerships, between startups and venture capital firms.
• Strategic partnership is key factor to create a win-win deal and to increase the probability discovery to drug approval in the long term.
• ABL Bio, South Korean biotechnology company developing antibody therapeutics for immuno-oncology and neurodegenerative disease.
• ABL Bio’s strategy building for global opportunity
Sang Hoon Lee 博士, 创始人兼首席执行官, 韩国 ABL 生物 [ Founder and Chief Executive Officer, ABL Bio, Korea ]
主旨演讲:石药集团研发战略及外部创新合作模式
Topic: The External Innovation Strategies from CSPC Pharma
党群 博士, 副总裁, 上海研发中心新药研究院院长, 石药集团 
[ Corporate Vice President, CSPC, Director, CSPC Shanghai New Drug Research Institute, Chief Executive Officer, InnovStone Pharmaceuticals ]
主旨演讲:全球生物药研发的挑战与机会:新时代新机遇新方向
Topic: Challenges and opportunities of global bio-Therapeutic industry: New time with great opportunity in different arenas
周新华  博士, 总裁, 首席科学家, 嘉和生物药业有限公司 [ President and Chief Scientist, Genor BioPharma, Visiting Professor, Peking University ]
主旨演讲:未来癌症免疫研究的研发变革
Topic: Revolution in Future Cancer Immunotherapy
陶维康 博士,  副总经理兼研发中心首席执行官,  恒瑞医药 [ Vice President and CEO of the R&D Centers, Jiangsu Hengrui Medicine ]
* The Interactive Panel Discussion(s):
圆桌讨论:  加强 “法规单位学术机构工业企业的合作开发下一代的细胞和基因疗法产品
Global CAR-T Pioneers Fireside Chat: Revolution and Strengthening Academia-Industry Collaboration for Development Next Generation CAR T-Cell Therapies
Moderator: 
Stephan Grupp教授
肿瘤科细胞治疗和移植科主任, 干细胞实验室的医学主任, 主治医师和肿瘤学研究员, 儿科教授, 费城儿童医院 (CHOP), 宾夕法尼亚大学佩雷尔曼医学院
科学顾问委员会成员, 西比曼生物科技集团
赵阳宾 教授
细胞免疫疗法中心, T细胞工程实验室 主任, 美国宾夕法尼亚大学医学院
Yoji Sato教授
细胞治疗产品部主任兼首席科学家, 日本国立健康科学研究中心 NIHS ( NIHS日本国立生命科学研究机构, 相当于中国科学院 )
Travis Young 教授
生物制品部副总裁, 美国California Institute for Biomedical Research ( Calibr ), 美国The Scripps Research Institute ( TSRI )
John Rossi 博士
转换科学总监, 凯特制药, 吉利德科学子公司
刘诚 博士
创始人兼首席执行官, 优瑞科生物技术公司
小组讨论细胞治疗生产工艺与技术创新
Panel Discussion: Establishing a Robust, Scalable, Automated, Functionally-closed Manufacturing Process to Support a Pipeline of Emerging CAR-T Cell Immunotherapy
Panelists:
Dr. Yajin ( Jenny ) Ni
高级总监, 工艺和产品开发, 技术运营, Allogene Therapeutics [ Senior Director, Process and Product Development, Technical Operations, Allogene Therapeutics ]
张宇 博士
联合创始人兼首席执行官, 颐昂生物  
Dr. Stephen Lim
首席执行官, 来恩生物医药
何霆 博士
首席执行官, 北京艺妙神州医药科技有限公司
Dr. Li Zhou
细胞疗法和抗体研究 副总裁, 绿叶制药波士顿研发中心
小组讨论促进源于中国的创新 – 中国未来癌症免疫肿瘤药品开发及临床研究战略
Panel Discussion: Promoting China Innovation – Revolution in Future Cancer Immunotherapies in China:
Panelists:
李正卿 博士, 全球副总裁, 总经理, 默沙东研发 (中国) 有限公司, 默沙东实验室
-- Vice President and Head of MSD China R&D, Merck Research Laboratories
王莉 博士, 高级副总裁,药物发展和医学事务中心负责人, 礼来中国
-- Senior Vice President and Head of Lilly China Drug Development & Medical Affairs Center (LCDDMAC), Eli Lilly
顾娟红 女士, 副总裁, 研发创新中心总监, 肿瘤治疗与罕见病治疗总监, 法国益普生集团
-- Vice President, Head of R&D Innovation Hub, Therapeutic Area Oncology / Rare Diseases, IPSEN
金建军 博士, 临床开发总监, 诺华 中国 
-- Head of Clinical Development, Novartis, China
周辉 博士, 副总裁, 医学科学与战略肿瘤部, 信达生物制药集团
-- Vice President, Medical Science and Strategy Oncology, Innovent Bio

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联系方式
联系人:Kevin Tan
联系电话:+86 21 6172 6970 / +86 1364 1961 545  
Email: kevin.tan@deliver-consulting.com  
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