亚太药物研发领袖峰会2020 | 会讯

为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、探索免疫肿瘤药品开发与战略合作新模式，由上海迪易商务咨询有限公司/Deliver Life Sciences 主办、大费城美中医药协会SAPA-GP 支持筹办的2020亚太药物研发领袖峰会 (‘APRDL 2020’)将如期在上海举行，为国内外专家高端交流、产业与资本对接搭建平台。

会议网站：www.aprdl2020.com

会议时间：2020年4月15-16日

会议地点：上海锦江汤臣洲际酒店

会议规模：

● 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

随着美国和欧洲监管部门最近批准细胞和基因疗法的上市，以及一系列细胞和基因疗法正在向监管审查迈进，人们越来越关注这些复杂的生物疗法的商业生产环节。一直以来，生产制造都是细胞和基因治疗公司面临的最大挑战之一。此次亚太药物研发领袖峰会 (APRDL 2020) 组委会特别针对细胞与基因治疗生产制造工艺邀请到来自全球顶级研究机构、跨国制药公司以及创新生物技术企业共同参与并分享。

Confirmed Speakers

& Hot Topics

The CAR-T PIONEER

PLENARY KEYNOTE SPEECH

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

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.

主题演讲：The CAR-T Cell Revolution -- CAR T-Cell Therapy targeting Leukemia, Lymphoma, and Future Hopes for Solid Tumors

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 )

Dr. Travis Young is the Vice President of Biologics at Calibr, a division of Scripps Research, where he was a member of Calibr’s founding principal investigators. He currently serves as the lead investigator on multiple bench-to-bedside antibody and cellular therapy-based programs. Dr. Young maintains a research group focused in the development of novel therapeutics at the interface between protein engineering and synthetic biology. This research spans multiple disease indications including cancer, autoimmune, metabolic disorders, and infectious disease. His work has been highly awarded and received support from the Wellcome Trust, NIH (National Cancer Institute), Department of Defense, Mesothelioma Research foundation, American Cancer Society, among others, in addition to receiving backing from major pharma groups which supports clinical translation of programs. His work has resulted in numerous publications and patents with ~2000 citations in the past 5 years. He received a BS in biochemistry from Boston College and a PhD in chemical biology from The Scripps Research Institute as an ARCS scholar. At Scripps, his work was foundational for the development of programs in the Calibr pipeline today, including a bispecific antibody for prostate cancer which will enter clinical trials next year. After receiving his PhD, he completed a postdoc at Harvard Medical School with an NIH fellowship, in the department of Biological Chemistry and Molecular Pharmacology.

主题演讲：Controllable CAR-T Cell Therapy

CELL THERAPY BIOPROCESSING & CMC, REGULATORY & QUALITY CONTROL

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

Dr. Wang was trained by Dr. Adolfo García-Sastre and received her Ph.D. in Biomedical Sciences from the Mount Sinai School of Medicine in NYC. She joined Dr. Peter Cresswell’s laboratory in the Department of Immunology at Yale University as a Howard Hughes Medical Institute fellow, and later as a Cancer Research Institute postdoctoral associate. Dr. Wang joined Memorial Sloan Kettering Cancer Center in 2007, and is currently an Associate Lab Member in Department of Molecular Pharmacology, and the Assistant Director of the Michael G Harris Cell Therapy and Cell Engineering Facility. Dr. Wang is in charge of the R&D, process development and manufacturing. She has overseen the successful manufacturing of all the CAR T cell products used in 13 phase I/II clinical trials as well as over 20 batches of cGMP grade viral vectors. She served in the translational science and product development committee in the American Society of Gene and Cell Therapy (ASGCT). She is currently a member for the National Heart, Lung and Blood Institute (NHLBI) independent external panel and a committee member for the Alliance of Regenerate Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL).

主题演讲：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

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 )

Dr. Steve Oh obtained his PhD from Birmingham University, UK (1990) and is the Director of Stem Cell Bioprocessing and Institute Scientist, Stem Cell Group. He holds several industry leadership roles e.g. Past Vice President of International Society of Cell and Gene Therapy (ISCT); Member of International Society of Stem Cell Research (ISSCR); Member of International Stem Cell Banking Initiative (ISCBI); Vice President of Stem Cell Society Singapore (SCSS). He is also an Adjunct Associate Professor at NTU, PhD Supervisor at A*STAR Graduate Academy and has received research funding grants ranging from SGD 10 to 25 million. He has 42 Patents, granted and pending, 107 scientific publications, written the book “Sensational Stem Cell: How to cure medical complications.” and created 2 companies: Veristem and Zenzic Labs.

Our research is focused on human adult and pluripotent stem cell bioprocessing. Our team has developed a range of patent families for the manufacture of mesenchymal stem cells, reprogrammed human induced pluripotent stem cells and created neural cells, cardiomyocytes, blood cells, cartilage, bone and retinal pigment epithelial cells at bioreactor scale using a range of microcarrier technologies including biodegradable ones. Most recently, we have achieved a novel method of directed differentiation using CRISPR technology that will accelerate therapeutic applications of stem cells. A complimentary technology that has been developed is the use of microfluidics for separations of cell and particulates.

主题演讲：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.

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

[ Head, Division of Cell-Based Therapeutic Products, National Institute of Health Sciences, Japan ]

Dr. Yoji Sato is Head of Division of Cell-Based Therapeutic Products, National Institute of Health Sciences. Dr. Sato is also an Adjunct Professor of Nagoya City University, a Guest Professor of Osaka University, and an Adjunct Professor of Kyushu University. He received his Ph.D. in Pharmaceutical Science from the University of Tokyo. While a post-doctoral fellow at the University of Cincinnati College of Medicine, he succeeded in establishing a variety of transgenic animal models to elucidate mechanisms of cardiac excitation-contraction coupling and heart failure. Dr. Sato’s current research area is in the field of regulatory science for the quality and safety of advanced cell-based therapeutic products (CTPs). He is currently leading a public-private partnership initiative in Japan for validation of test methods for tumorigenicity assessment of CTPs. He is also serving as Vice Chair of Database Committee, the Japanese Society for Regenerative Medicine, which provides the National Regenerative Medicine Database (NRMD), a nation-wide patient registry system for CTPs, and as a member of Technical Committees, Panel on Science and Technology, Health Science Council, the Japan Ministry of Health Labour and Welfare.

主题演讲：Regulations and Platforms for Ensuring the Quality, Safety and Efficacy of Cell Therapy Products in Japan

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 ]

Sergio presently works as Associate Director RegCMC – Cell and Gene Therapy at Novartis. He is presently RegCMC representative for the development of several gene therapy and gene editing investigational medicinal products at different stage of development.

From 2001 to 2016 he covered the position of Regulatory Affairs Manager in Molmed (Milan), where he lead RegCMC manufacturing, non-clinical and clinical development of more than 15 cell and gene therapy investigational medicinal products through their entire life cycle.

In the position Sergio followed the development and registration of the three major cell and gene therapy products currently approved as well as the world-wide licensing program of Kymriah.

He started his professional life with 1 year post-doctoral research in biochemistry, followed by 15 years of experience at Merck/Serono where he worked in a laboratory focussed on cell bank analytics and characterization.

Formal education includes a MSc in Biology and a PhD in Biotechnology.

主题演讲：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 VicePresident, Technical Operations ]

Dr. Wen Bo Wang is Senior Vice President, Technical Operations at Fate Therapeutics, overseeing the company’s manufacturing strategies for its pipeline of off-the-shelf cell-based cancer immunotherapy candidates and scaling the Company’s induced pluripotent stem cell iPSC platform to support late-stage clinical and commercial operations. She was formerly Senior Vice President Cell Therapy R&D at Fujifilm Cellular Dynamics Inc (FCDI), where she was responsible for developing the cell therapy R&D strategy and the iPSC based pipeline products and led the next generation production technology development efforts. Previously, she was VP Process Sciences, and directed scale up and scale out platform process development for iPSC based iCell products and MyCell products including automation and bioreactor work. Prior to joining FCDI in 2008, Dr. Wang was Group Leader, Process Sciences, at Geron Corporation, Menlo Park, CA working with embryonic stem cell derived cell therapies and dendritic cell cancer vaccine. From 2001 to 2005, Dr Wang held a number of positions at ViaCell, Boston, MA including Associate Scientific Director, ViaCord Human Umbilical Cord Blood Bank (a subdivision of ViaCell). Dr. Wang serves on the board of directors for Standards Coordinating Body and as US expert at the US Technical Advisory Group (US TAG) for ISO TC/276 Biotechnology. Dr. Wang earned a B.S. in Biology from Ocean University of Qingdao, P.R. China and received her Ph.D. in Biology from Newcastle University, United Kingdom. She conducted post-doctoral training in Cryobiology at Biosciences Research Laboratory, USDA/Agricultural Research Service, Fargo, N.D.

主题演讲：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

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]

Dr. Ni is Senior Director, Process & Product Development at Allogene Therapeutics, leading the company’s manufacturing process development activities for its pipeline of off-the-shelf CART candidates. During her tenure at Allogeneic Therapeutics and previously at Pfizer from 2015 to now, she has led her team to establish platform allogeneic CART manufacturing processes for enabling pipeline programs quickly advancing to early clinical testing using robust enough 1st generation process and transiting to late stage clinical & commercial manufacturing using more controlled 2nd generation automated & closed process. From 2000 to 2010 she held a senior technical role at VIRxSYS, where she conducted pioneering adaptive T cell therapy development work using lentiviral vector modified autologous CD4 T cells for HIV infection together with Dr. Carl June’s lab at the University of Pennsylvania. Through that work, they were 1st to bring lentiviral vector modified autologous adoptive T cell therapy into the clinic, and 1st to demonstrate feasibility of large scale GMP manufacturing of lentiviral vector and ex vivo expansion of gene-modified T cells in WAVE bioreactor. That work also accumulated a large set of patient safety data for lentiviral vector modified adaptive T cell therapy and laid down the groundwork for lentivector modified autologous CART therapy to be first tested in the clinic by Dr. Carl June’s lab. Dr. Ni earned a M.D. in internal medicine from the Kunming Medical College, P.R. China and received her Ph.D. in virology from the Kyoto University, Japan. She then conducted post-doctoral training in gene delivery at the NIH, USA before embarking on her gene & cell therapy product development career in both small biotech and big pharma.

主题演讲：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 ]

Dr. Harry Lam is currently Executive Vice President, Head of Technical Operations at JW Therapeutics. Previously, he was VP, Head of Biologics Manufacturing at Sanofi; VP, Manufacturing and Technical Operations, Progenitor Cell Therapy (PCT), A Subsidiary of Hitachi Chemical Advanced Therapeutics Solutions; and VP, Manufacturing and Process Development, at Shire Regenerative Medicine.

Prior to Shire, Dr. Lam spent 17 years at Genentech, where he held a variety of positions with increasing responsibilities, including Director of Manufacturing & Technology, Genentech Singapore Pte Ltd; Senior Director, Global Head of Biologics Drug Substance Manufacturing Science & Technology; and Roche Global Head of Contract Manufacturing Operations, Commercial Drug Substance. Prior to joining Genentech, Dr. Lam spent 11 years at Pfizer in the Bioprocess R&D department.

Harry received his B.S. in Chemical Engineering from the University of Birmingham, UK and his Ph.D. in Chemical Engineering from Rensselaer Polytechnic Institute, NY.

主题演讲：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

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 ]

Richard received degrees of B.S of Cell Biology from the University of Science & Technology of China, Ph.D. of Molecular Biology from the University of Maryland, Baltimore and MBA from Xavier University, Cincinnati in the US. He obtained his post-doctoral training at the National Institutes of Health, Baltimore, USA.

Richard now is the CEO of Fosun Kite Biotechnology. Taking a combined approach of internal R&D and external partnering/technology transfer, Fosun Kite is dedicated to the advancement of innovative cell therapy and its industrialization in China to benefit patients.

Richard is very experienced in biopharmaceutical industry. Having spent close to 20 years in R&D and management positions in both the US and China, he has taken senior roles and increasing leadership responsibilities in Procter & Gamble Pharmaceutical, Bristol-Myers Squibb in the US, AstraZeneca Innovation Center and GSK R&D Center in China. Prior to Fosun Kite, Richard was the Chief Operation Officer of Cellular Biomedicine Group (NASDAQ: CBMG), where he was in charge of the company’s immunotherapy pipeline including manufacturing, clinical development and registration, and the stem cell business unit.

主题演讲：Revolution of CAR-T Cell Therapies – Regulatory and Commercialization Considerations for Yescarta 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 ]

Dr. Zhang Yu is the president and CEO of Aeon Therapeutics Inc., a joint-venture biotech company established by Eureka Therapeutics Inc. and Vcanbio Cell&Gene Engineering Co.,Ltd. Prior to found Aeon, Dr. Zhang acted as assistant president and senior strategic planning expert in Vcanbio. Dr. Zhang received his B.S. in Bioengineering and M.S. in Biomedical Engineering from Beihang University, and Ph.D. in Stem Cell and Regenerative Medicine from Heinrich-Heine-Universität Düsseldorf in Germany. Before the industrial career, he worked in Rhine Forum, University of Applied Sciences Bonn-Rhein-Sieg, and was a visiting scholar in German Aerospace Center and University of Palermo. He is a member of German Society of Stem Cell, Chinese Society of Cell Biology, and reviewer of several journals, e.g. Current Stem Cell Research&Therapy. Dr. Zhang was the winner of “131 talent plan”and “Tianjin Green Card Plan”.

主题演讲：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

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 ]

Mr. Liu formerly served as the Corporate Vice President at Alibaba Group responsible for Alibaba’s overseas investments. Since joining Alibaba in 2009, Tony held various positions including Corporate Vice President at B2B corporate investment, corporate finance, and General Manager for the B2C global e-commerce platform. He was also Chief Financial Officer for HiChina, a subsidiary of Alibaba, a leading internet infrastructure service provider.

Prior to joining Alibaba, Tony spent 19 years at Microsoft Corporation where he served in a variety of finance leadership roles. He was the General Manager of Corporate Strategy looking after Microsoft’s China investment strategy and corporate strategic planning process. Tony was a key leader in the Microsoft corporate finance department during the 1990s as the Corporate Accounting Director. He was well recognized within Microsoft for driving an efficient worldwide finance consolidation, reporting, internal management accounting policy process, and showcased Microsoft’s best practices to many Fortune 500 companies in the U.S.

Mr. Liu obtained his Washington State CPA certificate in 1992. He had been serving as an Independent Director and Chairman of the Audit Committee for CBMG since March 2013 and was appointed as Chief Financial Officer in January 2014. He was appointed as Chief Executive Officer of the Company in February 2016.

主题演讲：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

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) ]

Dr. Lin Yang is currently a Distinguished Professor at the Cyrus Tang Hematology Center of Soochow University, China, and an adjunct professor of Department of Lymphoma and Myeloma at the MD Anderson Cancer Center, USA. Dr. Yang is the founder/chairman/chief scientific officer of PersonGen BioTherapeutics (Suzhou) Co., Ltd., and Chairman/CEO of PersonGen-Anke Cellular Therapeutics Co., Ltd. Dr. Yang received many awards, including Innovation and Entrepreneurship Talent of Jiangsu Province, Six Peak Talent of Jiangsu Province, Gusu Innovation and Entrepreneur Leading Talent, Pioneer of Suzhou Industrial Park Technology, Nanjing “321” Technology Leaders, Second Prize of China Innovation and Entrepreneurship Competition, and many other honorary titles and awards. He has published more than 70 research articles in recognized peer reviewed journals, such as Cancer Cell, Cancer Research, Oncogene, JBC, and Cancer Science, etc., which were all funded by international, national and provincial foundations.As a principle investigator, Dr. Yang plays a major role in the immunotherapy of CAR-T cells and CAR-NK cells of China, and has obtained impressive achievements in the industrialization and clinical trials of CAR-T cell therapy. Among them, several clinical trials are the first-in human projects performed globally, including CAR-T cell therapy for T-cell acute lymphoblastic leukemia, and 4th generation CAR-T cell therapy for solid tumors. Led by Dr. Yang, PersonGen-Anke’s CD19-CAR-T product has been submitted to Chinese FDA and is being under the evaluation process which is expected an approval from CFDA within next few months.

主题演讲：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.

Yajin (Jenny) Ni

俞 磊

张 宇

Stephen Lim

何 霆

Li Zhou

Yajin ( Jenny ) Ni 博士

高级总监, 工艺和产品开发, 技术运营, Allogene Therapeutics

俞磊 博士

首席执行官, 上海优卡迪生物医药科技

张宇 博士

联合创始人兼首席执行官, 颐昂生物

Stephen Lim 博士

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

Li Zhou 博士

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: Establishing a Robust, Scalable, Automated, Functionally-closed Manufacturing Process to Support a Pipeline of Emerging CAR-T Cell Immunotherapy

-- Overcome the viral vector supply bottleneck for the clinical development timeline

-- Overcome the equipment capacity limitation for implementing a robust automated & closed processing

-- How to manufacturing a large batch of allogeneic CAR T drug product with homogeneity and a robust post thaw recovery

-- Overcome the starting cell source limitation & variation, how to secure an unlimited, identical, clean cells (free of human viruse infection) for allogeneic CAR T product manufacturing;

Stephan Grupp

赵阳宾

Yoji Sato

Travis Young

Sergio Fracchia

John Rossi

Cheng Liu

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

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 )

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

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

圆桌讨论: Global CAR-T Pioneers Fireside Chat: Revolution and Strengthening Academia-Industry Collaboration for Development Next Generation CAR T-Cell Therapies

Corporate Sponsors

Hermann Bohnenkamp

Silvio Weber

Hermann Bohnenkamp 博士

VP Business Development APAC

Miltenyi Biotec

As Vice President of Business Development APAC at Miltenyi Biotec, Hermann is responsible for Miltenyi’s strategic collaborations with Biotech and Pharma in Cell and Gene Therapy (CGT) in Asia. Joining Miltenyi Biotec in 2009, he was instrumental in building Miltenyi’s cell and gene therapy business as Business Area Manager, including the release of key ancillary materials and the T Cell Transduction Prodigy platform. In 2016 he led Miltenyi’s Australian business as Managing Director. Before joining Miltenyi, Hermann was responsible for the project management for early drug and monoclonal antibody development at MediGene Immunotherapies, Munich. He holds a doctoral degree from the University of Bonn and the Helmholtz Research Center Juelich for studies on bioprocess development of DCs and ACT in solid tumor indications. He continued similar studies at King’s College London (Guy’s Hospital) with Cancer Research UK.

Silvio Weber 博士Head of the Industrial Process Development Team

Miltenyi Biotec

As the Head of the Industrial Process Development Team at Miltenyi Biotec, Silvio is responsible to provide automated Cell and Gene Therapy procedures on the CliniMACS Prodigy for industrial customers. Silvio has more than 10 years of R&D experience in various fields of cell biology, including Immunology, Regenerative Medicine and Pharmacology. After joining Miltenyi, Silvio has been coordinating custom-tailored development of automated processes for T-cell mediated Immunotherapy, Stem Cell Engineering and other innovative Cell and Gene Therapy approaches using the Miltenyi Biotec CliniMACS Prodigy platform. Silvio holds a Diploma degree in Biochemistry from the University of Bielefeld and a Doctoral degree in Biochemistry from the University of Kiel.

主题演讲：Towards commercialization – accomplish the challenges of cell and gene therapies

-- Review how manufacturing processes can affect quality attributes of living drug products

-- Considerations of a fully automated cell manufacturing process in the context of process transfer

-- Assess industry collaboration strategies

Pete Gagnon 博士

CSO, BIA Separations

Pete Gagnon is a widely respected global authority in the field of downstream processing. He is the author or more than 100 scientific publications and inventor on more than 100 awarded patents in the United States, Europe, and Asia. His expertise covers purification of monoclonal antibodies, virus particles, extra-cellular vesicles, plasmid DNA, and mRNA. He is currently Chief Scientific Officer at BIA Separations, a European manufacturer of specialized chromatography media for purification of gene therapy products.

主题演讲：A Cornerstone Industrial Purification Platform for Exosomes

Abstract: Exosome-based therapies are already in advanced clinical trials as many new applications beckon. This highlights a need for a simple effective purification platform that maximizes probability for clinical success and hastens the path to market. This presentation will share detailed case studies with extensive analytical support, illustrating a broadly applicable platform approach for purifying exosomes from all cell culture sources. Removal of host cell DNA, host proteins, virus, and endotoxins will be discussed.

Exosomes are quickly evolving as next-generation candidates for regenerative therapy but manufacturing technology lags behind.

-- The antibody industry demonstrated the value of a platform approach to purification. A similar approach is needed for exosomes.

-- This presentation will describe a scalable platform that can be used as a cornerstone to purify exosomes from all cell cultures.

-- It particularly focuses on removal of chromatin since chromatin interferes with both purification efficiency and product quality.

-- New high throughput analytical methods combining multi-angle light scattering and immunofluorescence will also be presented.

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