ATMP第六屆先進治療產(chǎn)品創(chuàng)新峰會通知

 
2023 會議簡介
近年來，以細(xì)胞基因治療、溶瘤病毒、mRNA為主的先進治療產(chǎn)品研發(fā)熱度居高不下。隨著全球范圍內(nèi)學(xué)術(shù)、醫(yī)療、資本與產(chǎn)業(yè)的積極參與，ATMP相關(guān)在研產(chǎn)品數(shù)量呈現(xiàn)爆發(fā)式增長。與此同時，該領(lǐng)域也面臨著法規(guī)監(jiān)管、工藝開發(fā)、商業(yè)化生產(chǎn)、出海合作、患者可及性等諸多問題與挑戰(zhàn)。為促進來源于中國的高質(zhì)量研發(fā)創(chuàng)新，快速推進先進治療產(chǎn)品的研發(fā)與商業(yè)化進程，探索合作新模式，第六屆先進治療產(chǎn)品創(chuàng)新峰會將于2023年7月6-7日在上海外高橋喜來登酒店舉辦。

會議時間 | 2023年7月6-7日
會議地點 | 上海外高橋喜來登酒店
籌辦單位 | 迪易生命科學(xué)Deliver Life Sciences
 
閉門私享會| 2023年7月6日 下午13: 30 - 18: 00
     

何苗壯
美國國立衛(wèi)生研究院
美國國立癌癥研究所
教授
終身資深研究員
美國醫(yī)學(xué)和生物工程院會士
演講主題: Glypicans as Emerging CAR-T Therapeutic Targets in Solid Tumors
Abstract: The emergence of CAR-T cell therapy has provided renewed hope for many patients with B-cell malignancies. However, while CAR-T cells can safely target and destroy lymphoma and leukemia cells without harming other organs in the body, researchers have struggled to identify tumor-specific proteins that can be used in CAR-T cell therapy to target solid cancers without harming healthy organs in the process. In the past 15 years, we have investigated a family of such proteins called glypicans. Glypican-3 (GPC3) and GPC2 are highly expressed in hepatocellular
carcinoma and neuroblastoma. More recently, we began to validate GPC1 as a target of CAR-T cell therapy in pancreatic cancer. The update about characterizing these glypicans as CAR-T targets in solid tumors will be presented. The engineering of more potent CAR-T cells using nanobody and protein engineering technologies will also be discussed.
 

田志剛
中國工程院院士
歐洲科學(xué)院院士
中國科技大學(xué)學(xué)術(shù)委員會副主任
免疫學(xué)研究所所長
醫(yī)學(xué)中心主任
恩凱賽藥
創(chuàng)始人兼董事長
演講主題: SynNK Cells: Beyond CAR-T Cells
Abstract: Natural killer (NK) cells are the first line against tumor with inherited innate receptors with an array of activating and inhibiting surface molecules to recognize the ligands on tumor and finally to activate NK cells for eliminating tumor. Comparing with “CAR”, an artificial receptor using antibody targeting associated antigen on tumor surface, NK receptors (NKR) and their ligands (NKR-Ls) are more valuable always-standing storehouse of surface targets for NKR as tumor-sensors or NKR-Ls as CARs. Though CAR-T become practical in clinic settings, NKR-NK cells, as effector cells, need pay more attention since advantages of NK cells over T cells, such as NK cells express many naturally-holding anti-tumor receptors in addition to modified CAR/NKR. Importantly, we could not stay at the stage of modification of NK cells only with tumor-sensor CAR or NKR, we need make a more intelligent NK cells with multiple functions to combat complicated “sly” tumor. So, synthetic immunology becomes an ideal tool to produce synthetic NK cells (SynNK) with Logic Gates to precise discriminate tumor from normal tissue, and Basic Circuit to prevent exhaustion, ageing and rejection, and to improve tumor-infiltrating and in situ amplification of NK cells, and so on.

 
回愛民
惠正奇醫(yī)藥 
董事長兼CEO
復(fù)星榮譽全球合伙人
中國生物醫(yī)藥產(chǎn)業(yè)創(chuàng)新與轉(zhuǎn)化聯(lián)盟副會長
演講主題: mRNA: COVID-19 Vaccine and Future
Abstract: mRNA technology has gained popularity over the last decade as a versatile tool for developing novel therapeutics. The recent success of coronavirus disease (COVID-19) mRNA vaccine has unlocked the potential of mRNA technology as a powerful therapeutic platform. Two mRNA vaccines, BNT162b2 (BioNTech) and mRNA-1273 (Moderna TX), have acquired authorization from FDA and other authorities across the world that are currently being used to prevent COVID-19. mRNA vaccines have good efficacy and safety as demonstrated in the various phase III trials and real world studies. Knowledge gained from these trials and versatile therapeutic potential of the mRNA can be applied for the development of vaccine for the infectious diseases, cancer treatment and therapeutics for other diseases. In this presentation, we focus on succesful development experiences of BNT162b2 mRNA vaccine against COVID-19 and an overview on the therapeutic aspect of mRNA technology for other therapeutic areas in future.

 
沈海法
斯微生物 
聯(lián)合創(chuàng)始人
首席技術(shù)官
演講主題: Application of New Technologies in mRNA-based cancer therapeutics
 
 
許田
復(fù)星醫(yī)藥首席
科學(xué)顧問
復(fù)星領(lǐng)智董事長
西湖大學(xué)副校長
演講主題: The Challenge and Opportunity of Gene and Cell Therapy
Abstract: Gene and cell therapy holds great promise for the treatment of a wide range of human diseases from cancer to rare genetic disorders. Recent progress has significantly advanced our ability to overcome the challenges including safety and delivery vehicle. The efforts at GeCell Therapeutics using modified piggyBac transposon and NK cells for cancer therapy and gene therapy of skin disease will be discussed.

 
劉明耀
邦耀生物
董事長
演講主題: Research Progress of Gene Editing Technology in Cell Therapy
- Introduction to gene editing technology and CAR-T technology
- Development and preclinical evaluation of non-viral site-specific integrated CAR-T technology
- Clinical treatment of non-viral site-specific integration of CAR-T cells
 
 
施霖宇
輝大基因聯(lián)合創(chuàng)始人
兼首席科學(xué)官
演講主題: Development of Gene editing Tools for Treating Rare Diseases 
 
 
陳功 
暨南大學(xué)大腦修復(fù)
中心主任 
NeuExcell 神曦集團
創(chuàng)始人, 首席科學(xué)家
演講主題: 運用神經(jīng)再生型基因療法治療退行性疾病
 
 
周靜敏
鯨奇生物
聯(lián)合創(chuàng)始人
兼首席執(zhí)行官
演講主題: Treatment of neurodegenerative diseases with AAV and its CMC
Abstract: In situ cell reprogramming offers the hope of a regenerative therapeutic approach to numerous neurodegenerative diseases. Using AAVs to deliver reprogramming factors to glial cells can result in the transdifferentiation of these cells into neurons and the replenishment of specific neuronal cell populations lost in a given disorder. In a chemically induced non-human primate model of PD, treatment with AAV-GM101 has led to improved motor behavior, increased dopamine concentration in the CSF, and enhanced dopamine signal within the striatum as measured by PET-CT. To achieve such significant improvement, the quality of AAV is critical, we’ll also discuss the chemistry, manufacturing and controls (CMC) of AAV.

 
郭曉寧
紐福斯首席醫(yī)學(xué)官 
演講主題: Development Experiences of AAV Gene Therapy for Ophthalmic Diseases
- History of ophthalmic gene therapy
- Development and clinical trial design of gene therapy for LHON
- Prospects for gene therapy for ophthalmic diseases
 
 
趙新平
中因科技
首席科學(xué)官
演講主題: Gene Therapy for BCD- 眼科基因治療藥物的研發(fā)方向 
Abstract: This presentation briefly describes the history and current status of gene therapy with particular focus on ophthalmology and introduces the overall strategy of Chinagene for developing gene therapy drugs for ocular diseases. One of the Chinagene’s pipelines, ZVS101e is designed to treat BCD patients and has shown excellent safety and efficacy profile in both preclinical studies and clinical trials. The presentation discusses the current trend and future direction of gene therapy. A wave of consolidation and MA is anticipated in the gene therapy industry. Possible solutions to address challenges in R&D of gene therapy drugs are also reviewed and proposed.

 
王海峰
無錫科金生物
創(chuàng)始人, 首席執(zhí)行官
演講主題: Development of innovative Ex Vivo Gene Editing gene cell therapy technology

 
馬一介
北海康成
全球商務(wù)拓展和戰(zhàn)略
合作主管
高級總監(jiān)
演講主題: R&D and Business Strategy for Translational Innovation in Gene Therapy – A CANbridge’s Perspectives
Abstract: One of the major trends in modern medicine is the increasing role of industry partnerships in driving innovation. Academia has traditionally been the main driving force of breakthroughs and innovations in medical sciences in the past. However, due to the open-ended, explorative nature of academic research, the lack of commercial perspectives, and the complex, capital-heavy process of drug development, academia alone cannot meet the growing demand for better healthcare solutions. Therefore, industry partnerships have emerged as a way to drive innovation in modern medicine by providing access to capital, expertise, infrastructure, and markets that are essential for translating research into bedside applications to benefit patients. CANbridge is an innovation-driven biopharma committed to developing transformative therapies for patients. We will share our story and result-oriented strategy of gene therapy innovation and discuss challenges along the way.
 
 
王永忠
銳正基因
董事長, 首席執(zhí)行官
演講主題: 開發(fā)全球Best-in-class 的體內(nèi)基因編輯產(chǎn)品

 
牟曉盾
正序生物
首席執(zhí)行官
演講主題: 應(yīng)用創(chuàng)新型變形式堿基編輯技術(shù) (tBE) 開發(fā)同類最好 (Best-in-Class) 基因編輯藥物
演講摘要: 基因編輯技術(shù)在細(xì)胞和基因治療領(lǐng)域的應(yīng)用發(fā)展迅速，目前全球范圍內(nèi)有幾項通過in vivo或ex vivo編輯方式針對不同的適應(yīng)癥的治療性應(yīng)用已經(jīng)進入臨床研究甚至BLA階段，然而他們目前使用的基因編輯工具仍然存在導(dǎo)致染色體異常、脫靶等安全風(fēng)險。 
- 正序生物自主研發(fā)的創(chuàng)新型變形式堿基編輯器tBE（transformer Base Editor）可實現(xiàn)較高的安全控制，與CRISPR/Cas9 和傳統(tǒng)的堿基編輯器相比，tBE不會造成DNA雙鏈斷裂，具有更高的靶向編輯效率而且不會造成脫靶突變，具有更低的細(xì)胞毒性，這些安全性和有效性上的優(yōu)勢使其有望成為同類最好的堿基編輯工具。
- 正序生物首條管線CS-101針對β-地中海貧血癥和鐮刀型貧血癥，以tBE技術(shù)通過ex vivo的方式精準(zhǔn)編輯患者造血干細(xì)胞，在臨床前研究實驗中實現(xiàn)了高效靶向編輯效率的同時，也消除了脫靶突變的風(fēng)險。CS-101即將進入臨床階段，有很大潛力成為治療β-地中海貧血癥和鐮狀細(xì)胞病的best-in-class基因編輯藥物。
- tBE系統(tǒng)也適用于AAV、LNP等體內(nèi)遞送方式。采用經(jīng)商業(yè)驗證過的LNP或AAV將tBE系統(tǒng)遞送至小鼠肝臟中，實現(xiàn)了高效的靶向編輯效率，同時無脫靶突變。此次我們會介紹關(guān)于tBE系統(tǒng)的更多信息和管線進展。


何春艷
新芽基因
創(chuàng)始人兼首席執(zhí)行官
演講主題: Non-clinical Studies of the Base Editor Drug for DMD Disease
 
 
姜儒鴻
ASC Therapeutics
聯(lián)合創(chuàng)始人
兼首席執(zhí)行官
演講主題: Development of AAV-based gene and gene editing therapeutic products for Hemophilia A
Abstract: Hemophilia A is a X-link monogenic disease with a blood clotting factor VIII (FVIII) deficiency caused by a FVIII gene mutation and resulted in prolonged bleeding. With ~400,000 patients worldwide, the hemophilia market is expected to surpass $14B by 2023. Compared with current prophylactic treatments with frequent infusion of recombinant FVIII protein or alternative drugs, gene therapy approach represents an opportunity to address the underlying cause of disease and potentially cure Hemophilia A. ASC therapeutics, a leading gene & cell therapy platform in the US and China, has developed two pipelines (ASC-618 and ASC-518 ) for gene therapy of Hemophilia A.
- ASC-618 is the second generation FVIII transgene targeted to liver and with shorter transgene size, longer sustainability, lower immunogenicity and smaller AAV vector injection volume, FDA Phase I/II clinical trials ongoing
- ASC-518 is a novel genome editing therapy for hemophilia A and precisely inserts FVIII transgene into a safe-harbor locus in the genome with sustainable FVIII expression even with hepatocyte proliferation. ASC-518 can potentially cures in broad patient population including pediatric patients


Bose Kalampanayil
紐福斯生物科技
首席技術(shù)官 
演講主題: Neurophth's,“Center of Excellence" in Gene Therapy Development, Manufacturing and Analytical Testing Capabilities with a Diverse Platform, including AAV-based Gene Replacement Therapy Product for Leber's Hereditary Optic Neuropathy
- Global development and manufacturing of Adeno-Associated Virus serotype 2 (AAV2) containing human mitochondrial ND4 gene (NR082) to meet international regulatory requirements 
- NR082 has granted orphan drug designation (ODD) from China NMPA, EMA and US FDA. In addition, the NR082 program has completed Phase 1/2 and Phase 3 clinical trials in China and initiated Phase 1/2 trial in USA
- Chemistry Manufacturing and Controls (CMC) for gene therapies is one of the biggest hurdles for achieving global regulatory approval. Here we present the risks, challenges and lessons learned for Scale Up of Plasmid and AAV manufacturing processes
- We highlight many components of QbD, which are used to assess the process and minimize risks, from quality target product profile (QTPP) to Process Validation and PPQ Batches, as preparation for late-state development and BLA-enabling activities
- Discuss Neurophth’s, “Center of Excellence” in Gene Therapy Development, Manufacturing and Analytical Testing Capabilities with the state-of-the-art facility, equipped to handle the complexity of a diverse gene therapy pipelines
 

Ales Štrancar
BIA Separations
創(chuàng)始人兼首席執(zhí)行官
演講主題: 制造更安全的AAV載體 
Manufacturing of safer AAV vectors
- Recent clinical trials revealed the immune response to AAV vectors might be a bottleneck in AAV gene therapy
- One of the key reasons for the immune response is AAV purity. Improved manufacturing, especially purification process, is therefore mandatory for safer gene therapy
- In addition to hc proteins and hc DNA, removal of empty and partial AAV capsids, infectious viruses and endotoxin will be presented in this paper

 
張春
吉恒基因創(chuàng)始人
中國科學(xué)院蘇州
生物醫(yī)學(xué)工程技術(shù)
研究所研究員
演講主題: What is holding back the development of AAV gene therapy?
Abstract: AAV gene therapy has become the hope to cure many human diseases, especially genetic disorders. However, the development of AAV gene therapy is facing many challenges which prevent success of the AAV gene therapy. Before these challenges are solved, very little progress can be made. Some challenges include:
- rAAV vector quality
- rAAV vector gene expression efficiency
- rAAV vector integration issues
- rAAV packaging for large genes
- rAAV vector for gene editing
Suzhou genehealth biotechnology company focuses on research to address these challenges. Significant breakthroughs have been made and innovative rAAV technologies have been developed. Some of these challenges have been solved which would greatly facilitate the success of AAV gene therapy.
 
 
申華瓊
紐歐申醫(yī)藥 
創(chuàng)始人兼首席執(zhí)行官
演講主題: Building a CNS global biotech with innovative and accelerated pipeline for unmet needs
 

張艷君
中吉智藥生物技術(shù)
研發(fā)總監(jiān)
演講主題: 慢病毒載體造血干細(xì)胞基因治療
HSPC Gene Therapy with Lentiviral Vector
 

方日國
博雅輯因研發(fā)副總裁
干細(xì)胞平臺
演講主題待更新
 
 
呂璐璐
首席執(zhí)行官
合源生物
演講主題: Innovative R&D and the Commercialization Road of CAR-T Cell Therapy for the Treatment of B-Cell Acute Lymphoblastic Leukemia
- Epidemiology, Treatment, and Great Umet Clinical Needs of B-ALL CAR-T Cell Therapy for the Treatment of B-Cell Acut
Lymphoblastic Leukemia in global scale
- The Innovative R&D Road of Inaticabtagene Autoleucel Injection (CNCT19), a Chinese CAR-T Cell Therapy Product
 
 
姚樹元
安諾瓴路
首席執(zhí)行官
演講主題: An Industry Perspective on Cell Therapy CMC
演講要點
- CMC Capacity Building of Cell Therapy
- Product Development of Cell Therapy
 

王永增
合源生物
首席技術(shù)官
演講主題: Challenges and Approaches of Comparability Study in Autologous CAR-T Cell Therapy
Abstract: Autologous CAR-T cell therapy is featured with personal, living drug in vitro and in vivo, sterile, and complex characteristics, nevertheless, as drug, changes in materials, process, equipment, method, and sometimes manufacturing site are unavoidable along product development, it is challenging to assess the risks of such changes, even more so to rationalize comparability of pre- and post-change. This presentation focuses on explore the approaches of comparability study in autologous CAR-T cell therapy. The key points include: 
- Types of changes
- Risk assessment of changes
- Quality attribute study
- Analytical comparability study
- Non-clinical study
- Clinical bridging
- Regulatory consultation

 
李明明
Cytiva
亞洲項目合作負(fù)責(zé)人
演講主題: Cytiva助力細(xì)胞治療產(chǎn)業(yè)化
 
 
金夷
精繕科技 
首席執(zhí)行官
演講主題: Non-viral vector based gene delivery system for the next generation gene and cell therapy
Abstract: We have developed a proprietary non-viral based gene writing technology (casPB-ActinG) for treatment of rare genetic disease and cancer immune cell therapy. casPB-ACTinG offers remarkable advantages in multiple aspects for cell and gene therapies: 1) precise insertion of transgenes into specific sites on genome with high efficiency 2) Large cargo capacity (>10 kb) to carry multiple functional or regulatory elements for various purposes in a single step engineering 3) simultaneously knockout genes at the insertion sites 4) No immunogenicity issues; 5) Remarkable cost benefits. We apply our technology platforms to Recessive Dystrophic Epidermolysis Bullosa (RDEB), a rare genetic disorder with no cures available and achieved efficacy in mice models. In addition, the nonviral based genetic engineering of NK cells also enables multiplexed engineering of NK cells to enable best-in-class immuno-cell therapy.
 

張紅兵
優(yōu)瑞科
研發(fā)副總裁
演講主題: Overcoming the Challenge of T-cell Immunotherapy in Solid Tumors
Abstract: CAR T-cell therapy has been highly successful in treating hematological malignancies, and as a result, there is growing interest in testing this technology for solid tumors. However, the biology of solid tumors is more complex than that of hematological malignancies. There are two major obstacles in T cell immunotherapy for solid tumors: difficulty of engineered T cell-infiltration into solid tumors, and availability of ideal target antigens. At Eureka Therapeutics, we have developed proprietary technologies to address these challenges. Our ARTEMIS technology demonstrated enhanced T-cell infiltration into solid tumors, and our T Cell Receptor-mimic antibody (TCRm) platform broadens the range of cancer specific antigens that can be targeted, including those that are normally expressed intracellularly. We will present an update on our case studies using these technologies to treat liver cancer (HCC)

 
趙陽兵
優(yōu)替濟生
創(chuàng)始人兼首席科學(xué)官
演講主題: Challenges and Solutions for CAR-T Treatment of Solid Tumors
Abstract: Despite impressive clinical efficacy of T cells engineered to express chimeric antigen receptors (CAR) for some hematological 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 safe cancer specific targets, highly heterogeneities of the tumors and the tumor microenvironment (TME).  To make breakthrough in treating solid tumors, strategies to solve all these challenges are required. We have developed a (CAR or TCR) T cell engineering strategy by incorporating a LACO-Stim molecule for the aim of enhancing engineered T cells’ abilities to counteract with TEM and, at the same time, orchestrating both innate and adaptive immunities against tumors of the patients. This synergistic combination effective CART therapy with tumor vaccine has been proved in pre-clinical syngeneic mouse tumor models and early clinical trials.

 
周鵬輝
泛恩生物
創(chuàng)始人兼首席技術(shù)官
演講主題: Challenges and Opportunities in T Cell Therapy for Solid Tumors
摘要: CAR-T療法在血液腫瘤治療中取得的進展及療效證實了免疫細(xì)胞治療腫瘤的可行性。然而，目前的CAR-T和TCR-T等細(xì)胞療法在實體腫瘤中的臨床療效并不理想，其中，實體腫瘤免疫抑制微環(huán)境、可用抗原靶點稀缺、細(xì)胞體外制備工藝與成本都是影響治療的重要阻礙，針對上述關(guān)鍵挑戰(zhàn)，我們從細(xì)胞免疫機理出發(fā)，進行了多基因組合改造腫瘤微環(huán)境、鑒定與分離自體抗腫瘤T細(xì)胞及TCR/CAR 體內(nèi)靶向遞送等關(guān)鍵核心技術(shù)突破，研制了“逆轉(zhuǎn)腫瘤微環(huán)境的TCR-T”療法，目前，正在開展臨床試驗，初步研究表明療效顯著提升，安全性較好，可以預(yù)見，未來TCR-T療法將為實體腫瘤治療帶來希望。


李懿
瑅安生物
創(chuàng)始人兼首席科學(xué)官
演講主題: The Application of Human Professional Antigen Receptors for the Development of Cell Therapy
 
 
何霆
藝妙神州
創(chuàng)始人兼首席執(zhí)行官
演講主題: Phase I Study of a BCMA-Directed CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma Manufactured with the InstanCART platform
Abstract: Although Chimeric antigen receptor (CAR)-T cell therapy has achieved effective efficacy in patients with multiple myeloma (MM), the lack of durable response and high cost are still main directions of improvement of CAR-T cell therapy. The traditional process of autologous CAR-T cells needs to be expanded and cultured in vitro for a long time (9-14 days). Here, we developed an efficient BCMA-targeting CAR-T cell production process called InstanCART platform, which can be produced within 3 days. We evaluated the clinical safety and efficacy of the InstanCART cells in the treatment of relapsed/refractory MM (RRMM) in a Phase I clinical trials. Initial data from this Phase I study demonstrate that low doses of BCMA CAR-T cells manufactured by InstanCART production processes have encouraging clinical activity and a manageable safety profile in patients with RRMM. InstanCART cells expand rapidly in vivo, persist at relatively high levels for prolonged periods, and demonstrate better efficacy.

 
鄒勇
馴鹿生物
CMC副總裁 
演講主題 藥品全生命周期下的CMC 
MAH制度全面實施后，藥品上市許可持有人須對藥物研發(fā)、臨床研究、生產(chǎn)銷售、不良反應(yīng)等全生命周期負(fù)責(zé)，而CMC是藥品生命周期里的非常關(guān)鍵的一環(huán)。從藥品全生命周期的角度如何看待和開展CMC工作，使其能夠更好地為藥品全生命周期服務(wù)，確保安全、有效的藥物得以實現(xiàn)。

 
楊黎明
廣東瑞順生物技術(shù)
董事長兼首席科學(xué)官
演講主題: The off-the-shelf Allogeneic DNT Cells in Immunotherapy
 

胡適
海軍軍醫(yī)大學(xué)
基礎(chǔ)醫(yī)學(xué)院副教授
演講主題: Progress of Therapeutic Engineered CAR-T Cell-derived Extracellular Vesicle
Abstract: Engineered T cells have attracted substantial attention in recent years as an emerging therapy for hematological and non-hematological malignancies. Despite the rapid and robust clinical responses, unexpected toxicity, such as cytokine release syndrome, still remains a major concern in this therapy. Moreover, the intrinsic ability of tumors to evade immune responses could lead to treatment failure especially in patients with solid tumors. These obstacles together highlight a need to improve current Engineered T therapy. Exosomes are small extracellular vesicles secreted by almost all cell types and have the capability of trafficking cargos to mediate many physiological，pathophysiological processes. Therefore, researchers have been trying to utilize exosomes as highly effective carriers to deliver various therapeutic agents to target cells. We reported that Engineered immune cells release extracellular vesicles with the stimulation of antigens, mostly in the form of exosomes that carry synthetic receptors on their surface. These exosomes express a high level of cytotoxic molecules and therefore inhibit tumor growth in an antigen-specific manner. Besides, exosomes do not express programmed cell death protein 1 (PD1), and thus could circumvent the immunosuppressive mechanism caused by tumor cells. More importantly, the administration of exosomes exhibited lower risk compared with engineered T therapy in a preclinical in vivo model of cytokine release syndrome. All these advantages of engineered immune cell derived exosomes suggest that they may be promising therapeutic agents against tumors.
 
 
韓研妍
恒瑞源正
首席科學(xué)家
演講主題: An HLA-class II restricted HPV18 E7 specific TCR cloned from a long-term surviving cervical cancer patient induces tumor remission in murine model
Abstract: T cell receptor (TCR)-engineered T cell therapy is a promising approach for the treatment of solid malignancy, with multiple clinical trials reporting impressive responses using affinity-matured TCRs. However, artificially mutated TCRs can increase the risk of off-target toxicities due to unexpected cross-reactions, which limits the overall safety of this approach. To tackle this challenge, we have developed a novel strategy for cloning tumor-specific endogenous therapeutic TCRs from long-term surviving patients who have responded to immunotherapy. Specifically, we have identified a TCR (10F04) that is specific to human papillomavirus type 18 (HPV18) E7 and restricted to human leukocyte antigen (HLA) class II molecular from the peripheral blood of a patient with HPV-positive metastatic cervical cancer who received multiple antigens stimulating cellular therapy (MASCT) and exhibited sustained T-cell immunological responses. Upon transduction into human T cells, the 10F04 TCR demonstrated robust antitumor activity in both in vitro and in vivo models. Notably, the TCR effectively redirected both CD4 and CD8 T cells to specifically recognize tumor cells and induced multiple cytokine secretion along with durable antitumor activity. Importantly, no cross-reactivity was detected. As a result, this TCR is currently being investigated in a clinical trial for treating HPV18-positive cancers. Our approach of cloning tumor-specific and safe endogenous therapeutic TCRs from long-term surviving patients offers a promising strategy for developing safe and effective TCR-engineered T T-cell therapies for solid tumors. These findings provide important insights into the potential of HLA class II-restricted TCR-T therapy as a novel cancer treatment modality.
 
 
李華順
阿思科力
董事長
演講主題: The Development Progress of CAR-NK Cell Therapy
Abstract: The remarkable success of CD19 CAR-T in the treatment of B lymphocytic leukemia and lymphoma promotes Ascle Therapeutics to explore other cell types to treat solid tumors.  Natural killer cells is a major type of innate cells that bridge innate immunity to acquired immunity to defend broad spectrum of pathogenic microbes and function as central commanding cells to initiate systemic activation of immune system to eliminate transformed or senescent cells.  Ascle team has been using natural killer cell line NK-92 as a platform to tap into its potential as cancer killer carrier and has developed several lines of products.  One of the CAR-NK products has successfully treated late-stage cancer patients with a remarkable 80% disease control rate.  In addition, selected naval cord blook NK cells and mRNA enabling CAR-NK cells have dramatically reduced or eliminated the tumor load in animal model.  Ascle Therapeutics is well on the way to bring the products to the market for cancer patients with innovative technologies.
 

孫艷
上海細(xì)胞治療集團
共同創(chuàng)始人
集團首席運營官
上海細(xì)胞治療集團
藥物技術(shù)有限公司總裁
演講主題: Practical exploration of nanobody armed CAR-T in breakthrough of solid tumor immunotherapy
Abstract: With the launch of several kinds of chimeric antigen-receptor (CAR) -T cells both domestically and internationally, outstanding values of CAR-T cells have largely verified in treatment of hematological carcinomas. However, treatment with CAR-T cells alone in solid tumor faces great challenges with poor efficacy. Given that lack of tumor specific antigen, high heterogeneity and immunosuppressive microenvironment in solid tumors, we explore a unique nanobody armored CAR-T cell (NAC) which elicits the dual anti-tumor effect of targeting tumor antigen and changing immunosuppressive tumor microenvironment for solid tumor therapy. Autocrine PD1 nanobody-targeting mesothelin NAC has recently been approved by the National Food and Drug Administration for phase I/II clinical trials. Previous IIT studies have shown that the NAC cells achieve a therapeutic breakthrough in the target population with advanced solid tumors. While NAC targets tumors to produce killing effects, PD-1 nanobodies are continuously secreted locally in tumors to relieve immunosuppression. On the one hand, nanobodies protect CAR-T from tumor microenvironment immunosuppression and maintain tumor killing effect, on the other hand, relieve the immunosuppression of tumor-infiltrating T cells (TILs) in vivo, promote TIL to develop anti-tumor immune response extended to different tumor-associated antigens, overcome the obstacles caused by tumor heterogeneity and immunosuppressive microenvironment, and further improve the long-lasting efficacy and safety of CAR-T cells.
 
 
李志遠
普米斯生物技術(shù)
功能生物學(xué)
與細(xì)胞治療總監(jiān)
演講主題: Leading the Innovation of Developing Next Generation Cell Therapy Products against Solid Tumor via CAB-T Cell Therapy Platform
Abstract: In the past decade, immunotherapy has achieved unprecedented success in providing the complete remission rate of hematological tumors. Since 2017, 6 CAR-T products targeting CD19 or BCMA have been successfully marketed and approved for the treatment of hematological malignancies. However, unlike tumor infiltrated lymphocytes (TIL) therapy and TCR-T cell therapy, which have been proved for their effectiveness for treating solid tumors, CAR-T therapy has not yet demonstrated significant clinical efficacy, and there is still an unmet need to develop an HLA independent cellular therapeutic regimen for treating solid tumors with good clinical efficacy and manageable clinical side effects. Biotheus’ CAB-T is a novel cell therapy platform combining the advantages of CAR-T and using T cells as an anti-CD3 T cell engager delivery source. Here, we will present a comprehensive overview of our CAB-T programs with proof of safety and efficacy in multiple in vivo efficacy studies and investigator initiated trials (IIT).

 
張同存
波睿達
董事長兼首席執(zhí)行官
演講主題: CD30 CAR-T cell therapy for relapsed/refractory CD30+ lymphoma patients
Abstract: CD30 is a membrane protein that is constitutively overexpressed on all stages of cells in classical Hodgkin lymphoma (HL) and anaplastic large-cell lymphoma (ALCL) with minimal/negligible expression on normal cells, rendering its an ideal target for CAR-T cell therapy to treat relapsed/refractory HL/ALCL patients. Thus, we designed a new third-generation anti-CD30 CAR, and conducted a pilot study of 15 r/r HL/ACLC patients to test the efficacy and safety of CD30 CAR-T cell therapy, resulting in 93.3% ORR, 86.6% CR, and none CRS/ICNAS/CRES over grade 3. Thereby, a Phase I registered clinical trial was carried out in a classic 3 + 3 dose escalation manner to further validate the safety and efficacy of CD30 CAR-T cell therapy. Expectedly, 100% ORR and 83.3% CR were observed in median/high doses, while none Grade ≥ 3 CRS was found in all 9 patients. Taken together, these clinical studies demonstrated CD30 CAR-T cell therapy as a safe and effective treatment for relapsed/refractory CD30+ lymphoma patients.
 

張宇
中源藥業(yè)
首席執(zhí)行官
演講主題: Key Considerations during Cell Therapy Product Development
- Advances of cell therapy products worldwide
- Cell therapy products: a pearl on the crown in pharmaceuticals industry
- Key considerations in CTP development
- Cell resource selection
- CMC in IND vs in BLA/NDA
- IIT study vs IND trial
- License-out vs in-house development
 

張長風(fēng)
上藥生物
注冊總監(jiān)
演講主題: Regulatory Trends in Investigator-Initiated Trials (IITs) of Cell and Gene Therapies
Abstract: Investigator-initiated trials (IITs) are of importance in cell and gene therapies.  However, few regulatory guidelines are available compared with those for IND trials. Recently, a draft guidance document applying to the IIT trials of somatic cell products was issued by the National Health Commission.  Here the speaker will review the newly issued draft guidance and related active or draft guidance documents dated 2019 and 2015 for cell products, and illustrate the emerging regulatory trends in IIT trials. Finally, recommendations for potential IIT sponsors will be discussed.
- Key points in the newly issued draft guidance document
- The emerging regulatory trends in IIT trials of cell products
- The relationship between IIT and IND trials from a regulatory perspective
- The dos and don’ts for potential IIT sponsors

 
陸佩華
陸道培醫(yī)院醫(yī)療
執(zhí)行院長
北京陸道培血液病
研究院院長
演講主題: The advances and challenges of CD7 CAR-T Therapy in treating T-cell malignancies
Abstract: While the use of CAR-T therapy in treating T-cell malignancies is still in the early-stage of clinical trials. It exhibits substantial potential and possibly offering long-term remission for patients with refractory/relapsed (R/R) T-cell malignancies, who generally have very limited effective treatment options. A phase I/II clinical trial was conducted and enrolled pediatric and adult patients with R/R T-ALL/LBL. Here we analyzed 60 heavily pretreated R/R T-cell ALL/LBL patients with longer follow-up, including those with EMD and a history of all-HSCT. Our NS7CAR-T therapy demonstrated great efficacy with promising long-term outcomes along with tolerable safety in treatment patients with R/R T-cell malignancies who otherwise have limited treatment options and a very poor prognosis.
UCAR-T using gene-editing techniques has attracted significant attention due to its prompt availability for patients. To date, there are only a few clinical case reports of universal CAR-T therapy for T-cell malignancies. Here, T-ALL and T-LBL in a phase I clinical trial. Out phase I trial showed that allogeneic “off-the-shelf“ RD 13-01 product was safe and dose dependently effective in treating patients with heavily pretreated T-ALL/LBL, including those with EMD and prior allo-HSCT, those who already failed autologous CD7 CAR-T Therapy, and who could not manufacture autologous CAR-T from the patient’s own PB due to high blasts in PB and those with rapid disease progression. Long-term observation and more patients are needed to further evaluate the safety and efficacy of CD7 UCAR-T cells.

 
楊林
博生吉創(chuàng)始人
董事長兼CEO 
演講主題: PersonGen Potential First-in-class CAR-T for Unmet Clinical Needs
A number of CAR-T cell drugs have been approved for marketing around the world, and most of them have achieved beautiful commercial sales data. But these marketed CAR-T products focus on B-cell-derived malignancies. The research and development of CAR-T cell drugs for T-cell-derived malignant tumors faces many technical and clinical obstacles, and its development is relatively lagging behind. Through innovative research and development, PersonGen successfully developed the world's first CAR-T product for malignant T cell tumors, and achieved excellent performance in clinical trials.
- Innovative CAR-T target and indications
- T cell derived malignancies
- Fully automated manufacturing process

 
孫敏敏
易慕峰創(chuàng)始人
首席執(zhí)行官
演講主題: Empower CAR-T Cells to Treat Solid Tumors
CAR-T therapies have been validated in hematologic malignancies, but not approved for treatment of solid tumors. Immunofoco, a cutting-edge CAR-T company, is dedicated to addressing unmet clinical needs by advancing breakthroughs in CAR-T therapy for treating solid tumors and have adopted firstly the strategy of “curing the solid tumors by treating them as hematologic malignancies”.
- Pipeline and preliminary clinical progress
- Innovative CAR-T technology platforms
- The prospect of CAR-T industry

 
黃可
濟因生物
首席執(zhí)行官
演講主題:  In vivo CAR-T - The Next Generation of Universal Cell Therapy
Personalized CAR-T cell therapies have provided great promise in treating leukemia and even some types of solid tumor, while the high costs of traditional CAR-T manufacture limited their clinical applications and commercialization. So far, novel strategies have emerged in the generating off-the-shelf/universal cell therapies, including UCAR-T, PB/UCB CAR-NK, iPS CAR-NK and in vivo CAR-T. Compared to the UCAR-T and CAR-NKs, the in vivo CAR-T simplified the immune cell manufacture by directly generating CAR-T in vivo, and meanwhile harnessing the persistence of autologous T cells in patients. We have developed a VivoExpress system to precisely and efficiently deliver the CAR payload into the non-divided T cells to generate the in vivo CAR-T. These cells could efficiently eliminate the target tumor cells in vitro and in vivo. While the costs of in vivo CAR-T could be less than 1/10 of the traditional CAR-T. In the presentation, we will give an overview on the current progresses, challenges and potential benefits of in vivo CAR-T.

 
周國慶
榮瑞醫(yī)藥
創(chuàng)始人
演講主題: Oncolytic Virus Vaccine Drives Combination Immunotherapy 


陳銳
厚無生物
研發(fā)副總裁
演講主題: Strategies for Developing Next Generation TIL Therapy
 
 
王文博
立凌生物
創(chuàng)始人兼首席執(zhí)行官
演講主題: From Antibodies to T Cell Receptors: the Next Wave of Innovative Biologics
Abstract: Antibodies as the core component of humoral immunity have been employed to develop novel biologics including cellular immunotherapy, mAbs and its derivatives for almost 50 years. As the counterpart of antibodies, TCRs as the most important functional molecules of cellullar immunity are also developed for novel therapeutic modalities including TCR-T cell therapy, TCR bispecifics, etc.. Because of unique features of TCRs, challenges and opportunities both exist in the way for successfully developing commercialized TCR based therapies. Nevertheless, what can be foreseen is that successful stories and failure examples will be recorded and people who are leading this area will be remembered in the history of drug development.


高曉飛
西湖生物
創(chuàng)始人兼總裁 
西湖大學(xué)
生命科學(xué)學(xué)院PI
演講主題: Overcoming Immunotherapy Resistance by Therapeutic Red Blood Cells
 
 
高基民
溫州醫(yī)科大學(xué)教授
演講主題: Pilot Trials of Armored Nectin4/NKG2DL/FAP-targeted Hi-TCR-T in the Treatment of Solid Tumors
Abstract: Our armored HLA independent (Hi)-TCR-T integrates the features of TCR-T and the fourth generation CAR-T such as multi-targeting and immune regulatory factors-secreting. The Hi-TCR-T can effectively reprogram an intact TCR complex to recognize tumor surface antigens and thus induce more efficient anti-tumor responses and cause little cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) compared with classic CAR-T. The armored Hi-TCR-T cells recognize highly expressed surface antigens on tumor cells, activating all of the subunits of the complete TCR machinery to generate a broad and controlled response allowing for more potent tumor cell killing, faster migration to the tumor, and longer persistence so as to have a superior therapeutic index relative to CAR-T cells. Currently, our clinical trials are being carried out to treat hematological and solid malignancies with preliminary studies showing that the armored Hi-TCR-T outperformed CAR-T with increased anti-tumor efficacy and reduced toxicity. For example, We have been carrying out the first-in-class clinical trial of Nectin4/NKG2DL/FAP-targeted Hi-TCR-T cells secreting IL7 and CCL21 for therapy of relapsed/refractory advanced solid tumors such as non-small-cell lung cancer and liver cancer with impressive efficacy with only fever in absence of CRS and ICANS.
 

王漢明
武漢濱會生物科技
副總裁
演講主題: Intratumoral OH2, an oncolytic herpes simplex virus 2, in patients with advanced solid tumors as a breakthrough therapy designation
Abstract: OH2 is a genetically engineered oncolytic herpes simplex virus type 2, designed to selectively amplify in tumor cells and express granulocyte-macrophage colony-stimulating factor to enhance antitumor immune responses by Binhui Biopharma
- OH2 injection has received five INDs and one orphan drug designation from China NMPA and US FDA since 2018 for cancer monotherapy and combination therapy, currently has been entered a pivotal phase III study in melanoma
- OH2 is the first and the only oncolytic herpes simplex virus type 2 that has entered clinical trials in the world till today, also the first CDE-approved oncolytic virus candidate therapy to receive a breakthrough therapy designation
- Intratumoral injection of OH2 was well tolerated with a favorable safety profile, and demonstrated durable antitumor activity in patients with Advanced/Metastatic Solid Tumors such as melanoma, glioblastoma (GBM), soft tissue sarcoma, metastatic esophageal and colorectal cancer
 

張驥
杭州云心質(zhì)力
COO, 聯(lián)合創(chuàng)始人
演講主題待更新
 
  
蔣云
清華工研院
細(xì)胞與基因治療
創(chuàng)新中心負(fù)責(zé)人
演講主題: Analysis and Research Examples of the Development of Nucleic Acid Drug Industry


趙春林
安龍生物創(chuàng)始人
演講主題: 安龍生物在核酸藥物開發(fā)的探索
 
 
張鴻聲
雅科生物董事長
兼首席執(zhí)行官 
演講主題: Developing Cancer Treatment with CAR-T Cell Therapies: A Biotechnology Research Company’s Perspective
Abstract: CAR-T cell therapy is a revolutionary new pillar in cancer treatment. Although treatment with CAR-T cells has produced remarkable clinical responses with certain subsets of B cell leukemia or lymphoma, many challenges limit the therapeutic efficacy of CAR-T cells in solid tumors and hematological malignancies. Barriers to effective CAR-T cell therapy include severe life-threatening toxicities, modest anti-tumor activity, antigen escape, restricted trafficking, and limited tumor infiltration. In addition, the host and tumor microenvironment interactions with CAR-T cells critically alter CAR-T cell function. Furthermore, a complex workforce is required to develop and implement these treatments. In order to overcome these significant challenges, innovative strategies and approaches to engineer more powerful CAR-T cells with improved anti-tumor activity and decreased toxicity are necessary. In this presentation, we will discuss our company’s strategy for developing CAR-T cell therapies and present the results from clinical trials in the treatment of hematological malignancies, such as leukemia, lymphoma, and multiple myeloma. We will also present our recent endeavor in developing advanced CD7 CAR-T technology that overcomes fratricide for the treatment of T-cell leukemia and lymphoma. This technology was recognized as one of the ten greatest advances in Chinese Hematology in 2021.

 
李斌
余㵑學(xué)者
上海交大特聘教授 
上海市免疫學(xué)研究所
科研副所長
生命科學(xué)學(xué)院PI
演講主題: Functional Stability of FOXP3+ Treg subsets and their clinical applications
 

方宏亮
晨泰醫(yī)藥
首席開發(fā)官
演講主題: NK Cell Therapy against Solid Tumor: Memory NK Cells against Cancer
Abstract: Autologous CAR-Ts are great, But many challenges remain. Natural Killer (NK) cells are the most common type of naturally allogeneic immune cells, and more recently, use of NK cells that naturally exclude a typical TCR and can be used off-the-shelf. NK Cells achieved Similar Initial Efficacy in BCL to that Observed with Autologous CAR-Ts and appeared to have Improved Safety. Achieving activity in solid tumors would be transformational for NK Cells and the cellular therapeutic space more broadly. Memory-Like Nk cells was identified in 2009, which showed long-lived, super-charged NK cells with enhanced ability to kill cancer cells. Cellular therapeutics have yet to reach their full potential in solid tumors. However, Wu-NK cells have several compelling features: (1) Increases cytotoxicity capacity by engaging ADCC; (2) Increased trafficking, penetration and persistence in TME through sequential dosing-coating of tumor with Ab prior to NK cell administration; (3) Potential decrease T cell rejection due to impaired T cell function in TME; (4) May salvage CPI failure as well as synergize with CPI. We view signals of activity in solid tumors as potentially transformative for the space.
 
 
胡璧梁
楚天思為康 
首席科學(xué)家
演講主題: Automatic equipment in transforming the process of CART production
Abstract: Chimeric antigen receptor T cells (CART) have been proved a powerful weapon to treat cancers. Extensive efforts are focused on improving the efficacy of CART in solid tumors. Phase I trial of IL18 secreting CART targeting CD19 showed remarkable clinical effects in patients with relapse from previous CART therapy, supporting the notion that IL18 may serve as an important tool to enhance CART potency in solid tumor. Meanwhile, the complicated process of autologous CART production is labor intensive and costly. Various approaches are being explored to optimize the clinical translation of universal CAR armored immune cell therapies, such as universal CART and iPS derived CAR-NK.  Alternatively, the process of CART production can be significantly accelerated by utilizing automatic equipment. The presentation will discuss how Truking Gene CART series achieve a streamline process of CART production:
- Automatic processing of patient blood samples to obtain PBMC
- Automatic isolation of T cells by magnetic beads simultaneously activating purified T cells
- One step continuous expansion of CART cells
- Automatic formulation of CART final product
The Truking gene CART series operate with sterile, closed and single use consumables to avoid microbe and cross contamination. The automated streamline process not only minimizes the risk of human errors during production, but also helps pharmaceutical companies to expand the manufacturing capacity for treating more patients.  
 
 
崔昕暉
索尼（中國）生命科學(xué)
高級應(yīng)用專家
演講主題: A Full Closed And GMP-Level Cell Isolation System to Empower Next Generation Cell & Gene Therapy - Sony CGX10 Cell Isolation System
Abstact: The Sony CGX10 cell isolation system is innovative flow cytometry sorting platform specifically designed for cell and gene therapy manufacturing processes. The patented hydrodynamic design realizes gentle processing of cells in microfluidics chip, with five following advantages: "Closed system, GMP-ready, simple operation, high cell viability, and reliable data". Sony CGX10 can isolate target cells with multi-parameter labelling, regulate the composition of subsets in cell therapy products, and shorten manufacturing time to obtain various specific CAR-X products for patients, helping biomedical companies empower the next generation of CGT therapies development and help break through existing bottlenecks to achieve the best results.

 
陳麗娟
躍賽生物
首席運營官
演講主題: Clinical Considerations for Stem Cell therapy in CNS indications
- Commercial prospects for stem cell therapy in CNS indication
- Challenges in clinical development of stem cell therapy
- Addressing challenges and acceleration strategies
 
 
丁平
康德賽醫(yī)療 
創(chuàng)始人兼首席執(zhí)行官
演講主題: mRNA編輯的細(xì)胞藥物開發(fā)
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會議演講,內(nèi)容及合作
譚經(jīng)理 Kevin Tan   
項目經(jīng)理
電話: 136-4196-1545
郵箱:  kevin.tan@deliver-consulting.com
 
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徐經(jīng)理 David Xu
郵箱: david.xu@deliver-consulting.com
電話: 137-7629-3901微信同
 
媒體合作
Michelle Wang
郵箱: michelle.wang@deliver-consulting.com
 
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迪易生命科學(xué)是一家專注并服務(wù)于中國及亞太制藥與生物科技領(lǐng)域的信息資訊及會議運營單位。我們著眼于最新的法規(guī)要求、產(chǎn)業(yè)發(fā)展趨勢、科學(xué)發(fā)現(xiàn)及技術(shù)更新，通過與領(lǐng)先的國際行業(yè)協(xié)會、政府監(jiān)管單位、學(xué)術(shù)及生物制藥產(chǎn)業(yè)界的關(guān)鍵意見領(lǐng)袖及顧問建立長期及緊密的合作及聯(lián)系。我們策劃并推廣專業(yè)性的會議、論壇、公共培訓(xùn)及相關(guān)資訊服務(wù)，主要涵蓋了藥物的早期發(fā)現(xiàn)、臨床研究、生物標(biāo)志物與伴隨診斷、抗體藥物、核酸藥物與疫苗制品、細(xì)胞與基因治療產(chǎn)品、生物工藝開發(fā)等。
 
Deliver Life Sciences is a specialty producer and organizer of the conference, workshop, training together with tailored solutions to serve the growing biomedical industry in Asia. Through looking into the current trends of regulation, scientific findings and cutting-edge technology and work with leading associations, regulatory agency, industry and academia KOLs, we translate, formulate and promote our offerings from basic medicinal research, discovery to development till commercialization. Our current programs cover Drug Discovery, Clinical Development, Antibody Therapeutics, Biomarkers and Companion Diagnostics, RNA Therapeutics and Vaccines, Cell and Gene Therapies, BioProcess Development.