2019年4月16-17日，CAR-T细胞治疗研发及生产工艺论坛暨亚太药物研发领袖峰会2019在历经一个世纪的时光更迭，愈加雍容华美，尽显国际风范的上海瑞金洲际酒店成功举办。
早年，毛泽东主席，周恩来总理等国家领导人以及其他的国家政府高层都曾在此下榻。解放战争时期，这里曾是中国共产党在上海的第一个重要军事指挥部。
发言嘉宾精彩回顾：
Leaders Fireside Chat: Revolution and Strengthening Collaboration for Future CAR-T Therapies
Moderator:
Dr. Mickey Koh
Director-Stem Transplantation, Consultant Haematologist/Hon Senior Lecturer, St George’s Hospital and Medical School, London, U.K
Panelists:
Dr. Renier Brentjens
Director, ular Therapeutics, Associate Chair, Junior Faculty Development, Department of Medicine,Memorial Sloan-Kettering Cancer Center
Dr. Cheng Liu
Founder and Chief Executive Officer, Eureka Therapeutics
Dr. Eric Smith
Director Translational Development ular Therapeutics Center; Assistant Attending, Myeloma Service,Memorial Sloan-Kettering Cancer Center
Dr. Delara Motlagh
Vice President, Therapy Technologies, Terumo BCT
Dr. John Connolly
Chief Scientific Officer, Tessa Therapeutics Ltd
Dr. Richard Wang
Chief Executive Officer, Fosun Kite Biotechnology
Panel Discussion: Strengthening Collaboration for Development & Commercialization CAR-T Therapy in China
Moderator:
Dr. Hermann Bohnenkamp
Vice President, Business Development APAC, Miltenyi Biotec
Panelists:
Mr. Tony Liu
Chief Executive Officer & Chief Financial Officer, ular Biomedicine Group
Dr. Lei Yu
Chief Executive Officer, UniCAR-Therapy Bio-Medicine Technology
Dr. James Li
Chief Executive Officer, JW Therapeutics
Dr. Lin Yang
Chief Executive Officer, PersonGen BioTherapeutics ( Suzhou )
Dr. Daniel Song
Vice President, HRAIN Biotechnology
Dr. Wendy Li
Chief Medical Officer, Exuma Biotechnology SEZC
Panel Discussion: Key Considerations of Development Next Generation of CAR-TCR Therapy in China
Moderator:
Dr. Jijun Yuan
Chief Executive Officer, Shanghai Genbase Biotechnology
Panelists:
Dr. Ting He
Chief Executive Officer, ImmunoChina Pharmaceuticals
Dr. Jianqiang Li
Chairman and Chief Scientific Officer, Senlang Bio
Dr. Qihong SunVice President & Chief Medical Officer, Asclepius Technology Company Group
Dr. Li Zhou
Vice President of Therapy and Antibody Research, Luye Boston R&D Center
Dr. Renier Brentjens
Director, ular Therapeutics, Associate Chair, Junior Faculty Development, Department of Medicine,Memorial Sloan-Kettering Cancer Center
Keynote：Clinical Development of CAR T Therapy & Next Generation CAR T cells
– Define the concept of CAR T cell therapy for cancer
– Summarize clinical outcomes of CAR T cell trials
– Recognize barriers to CAR T therapy of cancer and highlight novel approaches to overcome these barriers
– Recognize novel CAR T cell designs utilized to optimize anti-cancer efficacy of this novel approach as well as how these armored CAR T cell designs may bridge the gap from liquid to solid tumors
Dr. Eric Smith
Director of Translational Development – ular Therapeutics Center，Memorial Sloan-Kettering Cancer Center
Keynote：Advances in CAR T cell therapy for Multiple Myeloma
– BCMA targeted CAR T cell therapy has dramatic efficacy in heavily pretreated patient population, but relapse is common
– Potential causes of relapse: Antigen escape, anti-CAR immunity, lack of CAR T cell expansion/functional persistence
– Addressing relapse: Targeting additional antigens, human CAR, optimized CAR design
Dr. Mickey Koh
Director-Stem Transplantation, Consultant Haematologist/Hon Senior Lecturer, St George’s Hospital and Medical School
Medical Director, Therapy Facility, Division Director and Consultant Haematologist, Health Sciences Authority, Singapore
Keynote： Based Therapies: Key Considerations for Clinicians, Health Care Systems, International Societies and Regulatory Authorities
– Landscape of cell therapy in Asia
– Initiative for therapy in Singapore
– therapy Trials in Singapore and Asia
– Regulatory convergence
– Unproven therapies
Dr. Pei-Hua (Peggy) Lu
Medical Executive President, Lu Daopei Hospital, Beijing, Lu Daopei Institute of Hematology
Keynote：CD19 CAR-T Treatment for R/R B-cell ALL
– Summarize the development of CAR T cell therapy for hematological malignancies
– Display clinical outcomes of CD19 CAR T treatment in R/R B-cell ALL including a large cohort of high-risk subgroups in our center
– Compare the effects of CD19+CD22 to CD 19 CAR T for R/R B-cell ALL patients
– Explain the benefits from bridging into transplant after CAR-T for B-cell ALL patients
Dr. John Connolly
Senior Principal Investigator and Director for Translational Immunology, Institute of Molecular and ular Biology (IMCB), A*STAR Singapore; Chief Scientific Officer, Tessa Therapeutics Ltd
Keynote：Virus Specific T s as Platform for Solid Tumor Immunotherapy
The ability to simultaneously monitor changes in multiple immune parameters holds great discriminatory and instructive power for the purpose of biomarker validation and mechanistic target discovery. In the case of Virus Specific T cell therapy for solid tumors, an examination of the systemic, cellular and local immune environment during the course of treatment has yielded a series of predictive biomarkers correlating with immunogenicity, response to therapy and overall survival on trial. An analysis of antigen specific T-cells have identified anti-viral responses with positive prognostic value. Differences in the immunosuppressive state of the patient’s activated regulatory T-cells (Tregs) and the expansion or contraction of the myeloid-derived suppressor cell (MDSC) compartment, point to a mechanism of action for the therapy.
Dr. Cheng Liu
Founder and Chief Executive Officer, Eureka Therapeutics
Keynote：Towards safer, more effective and persistent T-cell therapies: Development of antibody-TCR (AbTCR) expressing T cells against solid and hematological malignancies
– Major barriers of current CAR-T – CRS and neurotoxicity risks
– ARTEMIS AbTCR T-cell Receptor Platform intro
– Safety validation of ARTEMIS platform in CD19+ NHL
– Eureka built a versatile structure to go after solid tumor by using a TCRm antibody on ARTEMIS platform
– Safety and efficacy validation in AFP+ HCC is achieved
– Future directions to expand the ARTEMIS platform
Dr. Zonghai Li
Founder, CEO and CSO, CARSgen Therapeutics
Keynote：Development of next-generation of CAR T cells
– Problems of current CAR-T cell therapeutics in clinic
– Innovative safety switch for CAR-T cells
– Next-generation of CAR-T cells with increased antitumor activities
Dr. James Li
Chief Executive Officer and Co-Founder, JW Therapeutics
Keynote：Revolution of CAR-T Therapies and Innovation in China
Dr. Wei (William) Cao
Founder, Chairman and CEO, Gracell Biotechnologies
Keynote：FasT CAR-T – Breakthrough Technology For Hematological Malignancies
Chimeric antigen receptor T cell (CAR-T) therapy has been a success in treating acute lymphoblastic leukemia (ALL) and non-Hodgkin’s lymphoma (NHL). However, the therapeutic potential can still be further improved. In addition, long manufacturing time and high cost of CAR-T product limit the wider applications of CAR-T therapy. We have developed a new manufacturing platform, FasT CAR-T, in that the manufacturing time is shortened to one day (plus 7 days for releasing tests per regulatory requirement) as compared to the conventional CAR-T manufacturing time of 9-14 days plus 7 days. Hence the FasT CAR-T’s vein-to-vein time is shortened by an average of 12 days, which is critical for patients with rapidly progressing disease. More importantly, CD19-directed FasT CAR-T has been shown to have superior expansion capability, younger and less exhausted phenotype, and higher potency in eliminating B-ALL and NHL both in vitro and in vivo. First-in-human clinical study is ongoing and the early results show that FasT CAR-T is safe, and significantly more potent than the conventionally-manufactured CAR-T.
Dr. Ting He
Chief Executive Officer, ImmunoChina Pharmaceuticals
Keynote：Development of CAR-T Targeting Hematological Malignancies
Dr. Lin Yang
Chief Executive Officer, PersonGen BioTherapeutics ( Suzhou )
Keynote：Automated Manufacturing of Chimeric Antigen Receptor T s
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 cellderived 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.
Dr. Jishuai Zhang
Chief Scientific Officer, The Shenzhen Pregene Biopharma Company, Ltd
Keynote：The development of CART targeting BCMA using the single domain antibody as the antigen recognition domain
– The introduction for single-domain antibodies
– The development and clinical effect of CART targeting BCMA using the single domain antibody as the antigen recognition domain.
Dr. Xiao Lei
Chairman, Chief Scientific Officer, Innovative ular Therapeutics
Keynote：The preliminary results of the first-in-class dnPD1“Armored” CAR-T proof of concept clinical study in r/r NHL patient
– An introduction of the dominant negative PD1 platform technology
– The pre-clinical data of ICTCAR014
– Preliminary clinical data of ICTCAR014
Dr. Yu Zhang
Co-Founder and Chief Executive Officer, Aeon Therapeutics
Keynote：Key Considerations in Developing Anti-AFP (TCR-mimic) Artemis T product for HCC in China
– Major Challenges for CAR-T therapy in solid tumors, especially in HCC
– Developing investigator-initiated clinical study of using anti-AFP Artemis T cell to treat patients with HCC in China
– Key considerations in translating and developing anti-AFP Artemis T cell product for IND and commercialization in China
Dr. Jianqiang Li
Chairman and Chief Scientific Officer, Senlang Bio
Keynote：Development of Combined CAR-T s in Therapy against Solid Tumors
Dr. Qihong Sun
Vice President & Chief Medical Officer, Asclepius Technology Company Group
Keynote：In Situ Vaccination of Monoclonal CAR-NK s Activates Systemic Immunity against Tumors
This presentation will be introduced from three aspects: Seamless large scale production of CAR-NK, Activation of systemic immunity, and in Situ vaccination to treat solid tumors. We has been focused on developing innovative “off-the-shelf” CAR-NK cell drugs for cancer immunotherapy. The R&D team at ATCG, led by Drs. 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 and partly persistent remission in the treatment of over 80% solid tumors including but not limited to breast cancer, lung cancer, renal cancer, and pancreatic cancer. ATCG has been well positioned in the fast growing tumor immunotherapy field with the proprietary CAR-NK technology.
Dr. Jie (Kathryn) Liu
Principal Scientist, Fosun Kite Biotechnology
Keynote：Translational Data Supporting Development of Yescarta® and Mechanisms of Resistance to CD19 CAR T Therapy
新技术、新平台的应用介绍
Dr. Hermann Bohnenkamp
Vice President, Business Development APAC, Miltenyi Biotec
Keynote：Towards Commercialization – Accomplish the Challenges of Autologous and Gene Therapies
– Control strategies for cell and gene therapies
– Considerations of a fully automated cell manufacturing process
– Process transfer and decentralized manufacturing strategies of CAR T cells
Dr. Delara Motlagh
Vice President, Therapy Technologies, Terumo BCT
Keynote：From Compelling to Propelling: The Drive to Accelerate and Gene Therapies to Market– Global progress and momentum in the cell and gene therapy market
– Needs and challenges for various stakeholders on the path to commercialization
– Collaboration to drive standardization in the industry
Dr. Philip G. Vanek
General Manager, and Gene Therapy Strategy, GE Healthcare
Keynote：Industrializing & Gene Therapies: Managing Complexity Across the Ecosystem
– and gene therapies hold tremendous clinical promise but are complex and costly
– Dealing with patient heterogeneity and treatment histories complicates manufacturing
– The supply chain has many steps, but new technologies are emerging to improve efficacy and manufacturing efficiency
– Data collection, analytics, and automation will help scale manufacturing of cell and gene therapies
Mr. Shen Liang
Manager of Platform Development Specialists, Sartorius Stedim (Shanghai) Trading Co. Ltd
Keynote：Platform Technology to Scale Up CAR-T to Commercial Manufacturing
– QbD implementation in CAR-T on process development and process characterization
– Single use technologies for closure system and risk mitigation
– Single use technologies quality risk management
– Technologies for data management, in-process control and release testing
Dr. Neil Kayal
Global Bio-Pharma Manager – and Gene Therapy Commercialization, Beckman Coulter
Keynote：Evolution in the Manufacturing of ular Therapies – Lessons Learned and Current Solutions
Immunotherapy is a powerful treatment that harnesses the body’s immune system in the fight against cancer. With optimized cell therapy, the result is an expanded population of T cells primed to recognize and eradicate malignant tumor cells that would otherwise escape immune detection.
– Commercialization of manufacturing- preparing a CAR Garage,lessons learned and how does it impact the patient
– Automated functional testing- fully integrated unit operations taking the art out of science!
Dr Jacqueline Barry
Chief Clinical Officer, The & Gene Therapy Catapult
Keynote：CAR-T Approval and Adoption Considerations
Dr. James Brady
Vice President of Technical Applications and Customer Support，MaxCyte
Keynote：Advancing ular Therapies with a cGMP-Compliant Non-viral Engineering Platform
The field of cellular therapy has advanced rapidly in recent years due to the emergence of precision tools for genome modification. Chimeric antigen receptors and CRISPR/Cas9 gene editing reagents are enabling researchers and clinicians to target T cells and NK cells to diseased tissues and to engineer phenotypic changes that were unimagined only a few years ago. Although cell and gene therapies have been approved by the FDA, it remains imperative that researchers consider early in development whether their cell engineering method meets the stringent demands of clinical use – – namely the ability to safely and reproducibly modify human primary or stem cells with high efficiency, low cytotoxicity, and at the scale required to treat patients. MaxCyte’s ExPERT platform, a non-viral cell engineering technology designed to fulfill these demands, has an established record of rapidly advancing cell- and gene-based therapies to the clinic. This presentation will highlight the high efficiency, high viability, fully scalable engineering of a variety of primary hematopoietic cells, stem cells and hiPSCs as well as their real-world application in pre-clinical disease modeling and IND-enabling studies for the therapeutic correction of monogenic disease mutations such as Xlinked chronic granulomatous disease (X-CGD) and sickle cell disease (SCD).
Mr. Max Wang
Director, China Operations, PMP, Werum IT Solutions
Keynote：A Practical Strategy for a & Gene Digitized Supply Chain
The anticipated explosive growth and critical supply chain requirements of the & Gene sector cannot be fully supported by traditional pharmaceutical and bio-tech solutions. There is enough learning coming from the commercial pioneers to paint a practical vision for the digitized supply chain
– Key solution learnings from the first wave of sector commercialization
– The impediments to scale solved by digitization
– Identification of key components of comprehensive solution architecture
– Leveraging commercial solutions vs filling the white spaces
– Translating the strategy to successful solution deployments
Dr. Kai Zhu
Vice President and Co-Founder, Help Stem Innovation Ltd
Keynote：Next Generation Drug Screening based on Novel iPSC-derived Cardiomyocyte Platform
Mr. Christopher Griffith
Partner, Green, Griffith & Borg-Breen LLP
Keynote：Key Considerations of US IP Law relating to Pharma and Biologics
Panel Discussion: Key Considerations of IP Patent Relating to Pharma & Biologicals Development
Moderator:
Mr. Christopher Griffith
Partner, Green, Griffith & Borg-Breen LLP
Panelists:
Mr. Alex Liu
Head of Intellectual Property Rights, Bayer (China) Limited
Mr. Kent Yang
Head of Patents China, Novartis Pharmaceuticals (China)
Mr. Weibin Wang
Senior Partner, Shanghai Beshining Law Office
Ms. Caihui Li
IP Director, 3S Pharmaceutical Group
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