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Engineering TCR-based Cell Immunotherapy against Cancer and Viral Infection
-- Designing and applying TCR-T cell approaches for immunotherapy against viral infection
-- Developing a novel CAR, Synthetic TCR and Antigen Receptor (STAR), method for cancer immunotherapy
Prof. Xin Lin, Chairman of the Department of Basic Medical Sciences, School of Medicine, Tsinghua University

Developing AAV-based Gene Therapy Products in China, esp. from the Technical Development Front
Dr. Alvin Luk, Chief Executive Officer, Neurophth Therapeutics
Dr. Su Xiao, Chief Technical Operation Officer, Neurophth Therapeutics

CAR T Process Development and in Process and Batch Releasing Assay Development
-- Developing a dependable and consistent CAR T process for a qualified CAR T product
-- Developing the in process control and batch releasing assays to assure the quality of CAR T product
Dr. Xinpo Jiang, Senior Director, Analytical/Process Validation/QC/QA,Legend Biotech

From Manufacturing to Clinical: How Cytiva Accelerate your Cell Therapy Process with Automated, Closed and Scalable Module System
Dr. Yulong Cheng, Product Manager Asia Cell Therapy, Cytiva

Translating and developing novel cell therapy product for fighting against COVID-19
- Emerging Infectious Disease such as SARS, COVID-19 is one of the biggest human threat
- The mechanism of action of cell therapy to treat COVID-19
- The development of MSC product from bench to clinic during the pandemic
- The outcome of clinical study of using MSCs to treat patients with severe COVID-19
Dr. Yu Zhang, Senior Vice President and Chief Scientific Officer, VCANBIO Cell & Gene Engineering

First-in-class Autologous CD7-CAR-T Cells Exhibited Promising Clinical Efficacy for Relapsed and Refractory T-lymphoblastic leukemia/lymphoma
Abstract: CD7 is an attractive therapeutic target for T-lymphoblastic leukemia/lymphoma (T-ALL/LBL). CD19-CAR-T for the treatment of R/R B-cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin's lymphoma (B-NHL) has achieved great success, and therefore greatly promoted the exploration of CAR-T cell therapy to other targets and indications, including T-ALL/T-LBL.However, some big challenges have to be overcome for CD7-CAR-T therapy, including 1) potential contamination by abnormal T cells in CAR-T products; 2) life-threatening T cell hypoplasia; and 3) CAR-T cell fratricide due to CD7 expression on normal T cells.A first-in-class autologous CD7-CAR-T cells were developed by PersonGen and exhibited exciting clinical efficacy and safety in treating R/R T-ALL/LBL.
- Clinical significance of T-ALL/LBL
- Challenges for CD7-CAR-T R&D
- Clinical progress of PersonGen’s CD7-CAR-T
Dr. Lin Yang, Founder and CEO, PersonGen BioTherapeutics

Novel Proceeding about Targeting CD 30 CAR-T Therapy for Lymphoma
Abstract: CAR-T cells therapy has been demonstrated good tolerability and effects in patients with Hodgkin lymphoma (HL) and anaplastic large cell lymphomas (ALCL). However, most studies utilized the second-generation CARs with either CD28 or 4-1BB costimulatory domains resulting in unsatisfactory complete remission rate. Here, we designed a novel third-generation CAR against CD30 and investigated the efficacy and safety on CD30 positive relapsed or refractory lymphoma patients. We found that the anti-CD30 CAR-T cells specifically homing to the tumor with powerful anti-tumor activity in the tumor xenografts. We then conducted a pilot study to evaluate the safety and feasibility of anti-CD30 CAR-T cells which were infused simultaneously in 14 patients with r/r HL and ALCL. The third-generation anti-CD30 CAR-T cells had superior expansion and longer persistence, and the lentiviral copies could be detected after CAR-T infusion for half a year. Of Thirteen patients (92.9%) were successes responded and ten patients (71.4%) achieved complete remission (CR) for 12 months and also four patients remained in CR longer than two years in the patients (4/5) followed over two years. Our results showed that CRS occurred in eleven patients but was mild, only one patient developed CRS over 3 grade, and other 10 patients developed grade 1 or 2 CRS who did not require anti-IL6 therapy. Thus, anti-CD30 CAR-T cells is safety and effective for treating relapsed/ refractory HL and ALCL patients.
Dr. Tony Zhang, Chairman and Chief Executive Officer, Wuhan Bio-Raid Biotechnology

Precision Immunotherapy: Development BCMA-Targeted CAR T-Cell Therapy for R/R Multiple Myeloma
-- Global status of BCMA-targeted CAR-T cells
-- Current situation of bispecific CAR-T cells targeting BCMA
-- Characteristics of CT103A, IASO Biotherapeutics’ BCMA-targeted CAR-T cell product
-- Preliminary clinical data of CT103A
Dr. Wen (Maxwell) Wang, Chief Medical Officer, IASO Biotherapeutics

Solid Tumor CAR-T Barriers and Solutions
• Solid tumor quite different from hematologic malignancies
• Tumor microenvironment
• CAR-T design, traditional CAR, novel concept CAR, TCR-like
• Therapy combination
Dr. Enxiu Wang, Chief Executive Officer, Nanjing CART-MED

基于非病毒载体的CAR-T细胞肿瘤治疗 / Non-Viral CAR-T Cell Therapy for Tumor
-- 非病毒载体之于CAR-T肿瘤治疗的价值
-- 非病毒载体CAR-T药物研究
-- 非病毒载体CAR-T实体肿瘤治疗探索
Dr. Sun Yan, Vice President, General Manager, Cell Drug Business Unit, Shanghai Cell Therapy Group

The Latest Advancement in T-cell-based Cancer Immunotherapy
Cancer is a leading cause of death worldwide. Traditional cancer treatments, including surgery, chemotherapy and radiation therapy, have demonstrated very limited efficacy for patients with late-stage disease. Cancer immunotherapy, particularly adoptive cell transfer, has shown great promise in the treatment of patients with late-stage disease, including those who are refractory to standard therapies. Chimeric antigen receptor (CAR)-T cells have achieved great success in treating hematological malignancies, while tumor infiltrating lymphocytes (TIL) and T cell receptor (TCR) -T cell-based immunotherapy have shown encouraging data for solid cancers. In this presentation, I will highlight the latest advancement in T-cell-based cancer immunotherapy based on TIL, TCR-T and CAR-T cells and discuss future directions and challenges in T cell-based cancer immunotherapy.
Dr. Mingjun Wang, Executive President, Shenzhen Institute for Innovation and Translational Medicine

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
Dr. Yu Zhang, Co-Founder and Chief Executive Officer, Aeon Therapeutics

Development of Safe and Potent CD19 CAR-T Cell Therapy in China targeting Hematological Malignancies
Abstract: CD19-targeted chimeric antigen receptor-T (CAR-T) cells with CD28 or 4-1BB (28z CAR-T and BBz CAR-T) have shown great promise to treat relapsed or refractory (r/r) B cell non-Hodgkin’s lymphoma (B-NHL). However, parallel comparison of their clinical outcomes has never been reported. This study investigated their efficacy and adverse events in B-NHL therapy. Six patients with r/r B-NHL were initially enrolled and infused with 28z or BBz CAR-T cells at a dose of 0.75–5x105/kg. These CAR-T cells showed similar antitumor efficacies, with a complete response (CR) rate of 67% within 3 months. BBz CAR-T was well tolerated. However, severe cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome occurred in the 28z CAR-T cohort, resulting in the termination of further evaluation of 28z CAR-T. Three more patients were enrolled to investigate BBz CAR-T cells in-depth at an escalated dose (1-106/kg). All cases achieved CR within 3 months, and only grade 1/2 adverse events occurred. This study suggests that 4-1BB is more beneficial for the clinical performance of CAR-T cells than CD28 in CD19-targeted B-NHL therapy, at least under our manufacturing process.
Dr. Ting He, Chief Executive Officer, ImmunoChina Pharmaceuticals

Novel CAR-T Therapy for T Cell Malignancies
Dr. Lin Yang, Founder and Chairman, PersonGen BioTherapeutics

The Research and Proceedings of CAR-T for Treating the Acute myeloid leukemia (AML)
Dr. Jishuai Zhang, Chief Scientific Officer, The Pregene Biopharma Company

Surface Density of CAR Molecules Modulate the Kinetics of CAR-T Cells In Vivo
Dr. Jianqiang Li, Founder and Chief Scientific Officer, Hebei Senlang Biotech
Adjunct Professor, Second Hospital of Hebei Medical University

What can Flow Cytometry Do for CAR-T
• Flow cytometry can be helpful in CAR-T design and tocicity prediction
• Identify the quality of immune cells
• MRD detection after CAR-T
• Immune surveillance
• Cytokines by ELISA, detect more cytokines by FCM
Dr. Hui Wang, Deputy Director, Clinical Diagnostic Dept, Director, Flow Cytometry Lab , Lu Daopei Medical Group; Director, CEO, CMO, Synarc Research Laboratory (Beijing) Ltd

Precision TCR Redirected T Cell Immunity Treating Solid Tumour
• The Evolution of TCR-T
• XLifeSc 3rd Generation TCR-T
• Case Studies of TCR-T Drug Treatment for Solid Tumors
Dr. Yi Li, President and Chief Scientific Officer, Guangdong Xiangxue Life Sciences, Principal Investigator of Center for Infection & Immunity, Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences, Principal Investigator, State Key Laboratory of Respiratory Disease

Progress on TCR-T Development and Solid Tumor Treatment
-- Recent progress on TCR-T product development
-- Clinical practice on TCR-T treating solid tumors
Dr. Yi Zhu, China Business Head, T-Cure Bioscience

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.
Dr. Pete Gagnon, Chief Scientific Officer, BIA Separations

Panel Discussion: Development Next Generation “Off-the-Shelf ” TCR-T Cell Therapy against Solid Malignancies in China
Prof. Xin Lin, Chairman of the Department of Basic Medical Sciences, School of Medicine, Tsinghua University
Dr. Jijun Yuan, Chief Executive Officer, Shanghai Genbase Biotechnology
Dr. Christy Ma, Chief Strategy Officer, SCG Cell Therapy Dr. Li Zhou, Vice President of Cell Therapy and Antibody Research, Luye Boston R&D LLC
Dr. Yi Li, President and Chief Scientific Officer, Guangdong Xiangxue Life Sciences, Principal Investigator of Center for Infection & Immunity, Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences, Principal Investigator, State Key Laboratory of Respiratory Disease
Dr. Yanyan Han, R&D Director, HRYZ Biotech, SYZ Cell Therapy ( Inviting )


Towards Commercialization – Accomplish the Challenges of Cell and Gene Therapies
• Review how manufacturing processes can affect quality attributes of living drug products
• Considerations ofChina Business Heading process in the context of process transfer
• Assess industry collaboration strategies
Dr. Hermann Bohnenkamp, Vice President, Business Development APAC, Miltenyi Biotec
Dr. Silvio Weber, Head of the Industrial Process Development Team, Miltenyi Biotec

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.
Dr. Lin Yang, Founder, Chairman and Chief Scientific Officer, PersonGen BioTherapeutics
Chairman & CEO, PersonGen-Anke Cellular Therapeutics

Panel Discussion: 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;
Dr. Yajin ( Jenny ) Ni, Senior Director, Process and Product Development, Technical Operations, Allogene Therapeutics
Dr. Wong Tee Wee, Director of Operations, LionTCR

Dr. Weidong Cui, Chief Technology Officer, Fosun Kite Biotechnology ( Inviting )
Dr. Che-Hung Yeh, Senior Vice President and Chief Quality Officer, JW Therapeutics( Inviting )

Strengthening Collaboration for Development & Commercialization CAR-T Cell Therapy in China
Dr. Hermann Bohnenkamp, Vice President, Business Development APAC, Miltenyi Biotec
Mr. Tony Liu, Chief Executive Officer & Chief Financial Officer, Cellular Biomedicine Group
Dr. Lyu Lulu, Chief Executive Officer, Juventas Cell Therapy
Dr. Guoqing Li, General Manager, HRAIN Biotechnology
Dr. Yan Sun, Vice President, Shanghai Cell Therapy Group and Shanghai Baize Medical Laboratory
Dr. Tongcun Zhang, Founder and Chief Executive Officer, Wuhan Bio-Raid Biotechnology
Dr. Cheng Qian, Director of Center of Biotherapy, Southwest Hospital, Third Military Medical University, Chief Executive Officer, Chongqing Precision Biotech( Inviting )


CBMG Commercialization Strategies for Cell and Gene Therapies in China
Mr. Tony (Bizuo) Liu, Chief Executive Officer & Chief Financial Officer, Cellular BioMedicine Group
( Confirming )

Precision Immunotherapy: CAR T-Cell Therapy for Multiple Myeloma -- The Development Story of LCAR-B38M
Abstract: Legend Biotech has successfully developed a proprietary multi-specific CAR-T platform which differentiate the company from all other CAR-T companies in the world. The innovative CAR-T technology platform applied Camelid single domain antibodies as antigen binding domain in the CAR design and it demonstrated significant clinical benefit in terms of safety and efficacy. Multiple Myeloma had been largely considered an incurable cancer in the field of hematologic malignancy. Dr Fan’s group not only proved that BCMA molecule is one of the best CAR-T target for treating multiple myeloma, but also designed an innovative bi-epitope targeting CAR-T modality in which myeloma cell surface BCMA molecule be captured by the CAR-T cells at two different epitopes simultaneously, thus effectively prevent the cancer cell from escape. The LCAR-B38M CAR-T cells had been proven to be the best-in-class therapy for multiple myeloma via an investigator initiated clinical trial conducted in China. The innovative product became the first cell therapy product obtained the first ever IND certificate for CAR-T cell product in China. Johnson & Johnson has entered into a worldwide collaboration and license agreement with Legend Biotech to co-develop the world market of the product.
Dr. Frank Fan, Co-Founder and Chief Scientific Officer, Legend Biotech ( Confirming )

Building a Cell Therapy Platform Company Develop Best-in-Class Products
-- Huge Unmet Medical Drives New Therapy
-- Introduction of JW Therapeutics
-- JW Pipelines & Developing a best in class product
Dr. James Li, Chief Executive Officer and Co-Founder, JW Therapeutics ( Confirming )

Development of Next Generation of CAR T Cells ( CAR-GPC3 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. Zonghai Li, Chief Executive Officer and Chief Scientific Officer, CARSgen Therapeutics ( Confirming )

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. Xiao Lei, Chairman and Chief Scientific Officer, Innovative Cellular Therapeutics ( Confirming )


The CAR-T Cell Revolution -- CAR T-Cell Therapy targeting Leukemia, Lymphoma, and Future Hopes for Solid Tumors
Prof. Stephan A. Grupp, Novotny Professor of Paediatrics, Co-Lead, Paediatric Program, Abramson Cancer Centre, University of Pennsylvania Perelman School of Medicine
Section Chief, Cellular Therapy and Transplant, Division of Oncology, Director, Cancer Immunotherapy Program, Medical Director, Cell and Gene Therapy Lab, Children's Hospital of Philadelphia
Member of Scientific Advisory Board, Cellular Biomedicine Group ( Confirming )

Advancing Cancer Adoptive Immunotherapy with CRISPR/Cas9 Gene Edited T cells
Abstract: Despite impressive clinical efficacy of T cells engineered to express chimeric antigen receptors (CAR) for some cancers, the current applications of CAR T cell therapy, especially for treating solid tumors, are limited by some major challenges, such as the lack of cancer specific targets and the interference of tumor microenvironment (TME). Strategies to identify safe targets as well as safe ways to target some validated tumor associated antigens that are not only widely overexpressed on solid tumors, but also expressed at lower physiologic levels on the normal tissues. An efficient T cell adoptive immunotherapy requires to make T cells specifically target cancers, such as by expressing CAR or TCR, the T cells need to be further modified to avoid tumor microenvironment (TME), such as introducing a dominant negative TGF-beta receptor, PD1-CD28 switch receptor, or knocking out PD1 in the T cells using CRISPR/CAS9. Furthermore, CRISPR/CAS9 gene editing technology greatly facilitates the development of universal CAR T and universal TCR T as the off-the-shelf T cell products to treat cancers, which holds great promise in advancing the field of cancer immunotherapy.
• Safely targeting cancers is utmost important for developing an effective CART therapy
• Successfully overcoming TME is required for an effective CART therapy
• CRISPR/CAS9 can greatly facilitates the development of cancer immunotherapy
Dr. Yangbing Zhao, Director, T Cell Engineering Laboratory (TCEL), Center for Cellular Immunotherapies, Adjunct Associate Professor, Department of Pathology and Laboratory Medicine, University of Pennsylvania School of Medicine, Scientific Co-Founder, Tmunity Therapeutics ( Confirming )

Treating Solid Tumours with TCR-mimic Antibody Redirected ARTEMISTM T-cells
• While CAR-T has seen initial success in treating hematological malignancies, solid tumor remains an unsolved problem
• Utilizing TCR-mimic antibody redirected T-cells, our novel T-cell therapy targets solid tumor cells with high affinity and specificity
• In combination with our tumor-infiltration technology, ARTEMISTM T-cells incorporate the best features of CAR and TCR T-cell therapies while overcoming their limitations
• Our lead drug candidate is currently in US PhI /II trial while other assets are validated by multiple academic and pharma partnerships
Dr. Cheng Liu, Founder and Chief Executive Officer, Eureka Therapeutics ( Confirming )

Development Next-Generation off-the-shelf CAR-T Cell Therapy
Dr. Henry Ji, Chairman and Chief Executive Officer, Sorrento Therapeutics ( Confirming )

The State of the ART of Manufacturing CAR T Cells and The Latest Advancements
Abstract: The approval of CAR-T cell therapy for ALL and NHL by FDA has led to increased academic and industrial interest for this therapy. The success of this promising therapy relies on reproducible manufacturing of high-quality clinical-grade CAR T cells. We have established a robust modular CAR-T manufacturing platform as well as a clinical grade retroviral vector manufacturing process, which allowed us to manufacture hundreds of CAR-T cell products and support 12 phase I/II CAR-T cell clinical trials successfully at our center. Over the years, we have made improvement of our existing manufacturing platform and tested new manufacturing procedures that supported the products meeting all critical quality attributes. We have generated T cells expressing CARs encoded by gammaretroviral vectors starting from either healthy donors or cryopreserved patient apheresis products using Prodigy. Moreover, the emergence of CRISPR-Cas and iPSC technologies has pointed new directions for CAR-T cell manufacturing.
-- Define the central role of CAR-T cell manufacturing for the clinical applications of CAR-T cell therapies
-- Summarize the current CAR-T cell manufacturing platforms (modular and continuous)
-- MSK experience for CAR-T manufacturing and evolvement of our manufacturing platform
-- Manufacturing of large-scale clinical grade retroviral vectors for CAR-T cell therapy
-- Quality control for clinical grade retroviral vector and CAR-T cell manufacturing
-- New Directions for CAR-T cell manufacturing (TRAC-CAR T, iPSC-derived CAR T)
Dr. Xiu-Yan Wang, Assistant Director, Michael G. Harris Cell Therapy and Cell Engineering Facility, Associate Laboratory Member, Department of Molecular Pharmacology, Memorial Sloan-Kettering Cancer Center ( Confirming )


Development and Commercialization of Globally Innovative Medicines in China
-- The benefits and challenges of developing globally innovative medicines in China
-- The benefits and challenges of having multiple global partners
-- What the future will bring to the pharmaceutical industry in China
Dr. Kerry L. Blanchard, Chief Executive Officer, Everest Medicines

Exploration of Epigenetic Modulation as a New Anti-cancer Treatment
-- Relapse, metastasis and drug resistance still a great challenge facing in today’s therapeutic treatment
-- Epigenetic aberrations in cancer development is a key process to target on the above-mentioned challenges
-- Scientific effort to develop a novel epigenetic modulator as a new cancer treatment from blood cancer to solid tumors
Dr. Xian-Ping Lu, Chairman & CEO, Chipscreen Biosciences Co. Ltd., Shenzhen, China

Advancing siRNA Therapeutics for Enhancing Antitumor Activity of Immune Checkpoint Inhibitor
Abstract: Using a proprietary and optimized polypeptide nanoparticle-based delivery technology, we have developed the novel anti-fibrosis and anti-cancer therapeutics with siRNAs targeting both TGFβ1 and Cox-2 simultaneously (STP705), resulting in human fibroblasts apoptosis. STP705 was initially used for local treatments for skin hypertrophic scar and non-melanoma skin cancer. STP707 (a systemic formulation of STP705) was further advanced for treatment of liver fibrosis and cholangiocarcinoma, both of these indications have received Orphan drug designations by US FDA. Using a mouse syngeneic model of hepatocellular carcinoma, we tested a therapeutic potential of antitumor activity with a combination of STP707 and PD-L1 mAb. After multiple IV administrations twice a week, both single agent of STP707 and the combination treatments resulted in strong antitumor activity, more potent than those treated with Sorafenib and PD-L1 alone. Those antitumor activity were further supported by significant increase of CD8+ and CD4+ T cell infiltrations into the tumor tissue. I will discuss the unique advantage of our Polypeptide Nanoparticle (PNP) technology platform for safe and efficient siRNA delivery, and our strategy for advancing multiple clinical studies ongoing in both USA and China.
Dr. Patrick Y. Lu, President & Chief Executive Officer, Sirnaomics

Cancer Immunotherapy: Opportunity and Challenge
Abstract: Therapy with immune checkpoint inhibitors has revolutionized cancer therapy. Multiple checkpoint inhibitors, including anti-PD1/PD-L1 or anti-CTLA-4 antibodies, have been approved for patients with advanced cancer. However, all currently approved checkpoint inhibitors when used as single-agent therapy only result in modest clinical improvement in patients with advanced disease. In this presentation, I will discuss the following topics:
-- Opportunities and challenges of immune checkpoint inhibitors for cancer treatment
-- Basic principles of cancer immune checkpoint inhibitor combination therapies and their potential clinical applications
-- Future for cancer immunotherapies
Dr. Ruirong Yuan, President, CMO and Board Director, Adlai Nortye Biopharma

Future Cancer Immunotherapy Revolution
-- Immunotherapy Revolution: The discovery and development of immune checkpoint inhibitors has revolutionized the cancer treatment
-- Current Challenges in immunotherapy: biomarker identification, efficacy, and drug resistance
-- Next-Generation Immuno-oncology agents: New approaches to remove obstacles to immune function
Dr. Steve Chin, Chief Medical Officer, Elpiscience Biopharma

Novel Business Model and Biomarker Platform for Developing First-in-Class Drugs Globally with Targeted Precision Medicine
-- Novel and proprietary biomarker platform to advance drug development, including re-evaluating medicines that have failed in general patient populations by stratifying the responders for the original indication
-- Identifying biomarkers correlated with patients' responses to drug candidates retrospectively, Denovo enables the design and execution of follow-on clinical trials in targeted patient populations while optimizing efficacy, safety and tolerability
-- Denovo currently has five late stage drugs in its pipeline: DB102 for DLBCL and GBM, DB103 for schizophrenia, DB104 for depression, DB105 for Alzheimer’s Disease, and DB106 for acute myeloid leukemia (AML).
Dr. Wen Luo, Chief Executive Officer and Chief Scientific Officer, Denovo BioPharma

Cancer immunotherapy: How can we do it better
-- Overview of cancer immunotherapy development
-- Major challenges for current cancer immunotherapy
-- Discussion on the strategies for addressing these challenges and further advancing cancer immunotherapy R&D
Dr. Weikang Tao, Corp Vice President and CEO of R&D Centers, Jiangsu Hengrui Medicine

Small Molecule, Big Impact – Targeting Synthetic lethality for Anticancer Therapy
Dr. Jun Bao, President and Chief Executive Officer, IMPACT Therapeutics

Challenges and Opportunities of NASH drug discovery
-- Challenges of NASH drug discovery
-- Opportunities of next wave NASH drug discovery
-- Emerging NASH treatment strategy
Dr. Jingye Zhou, Chief Executive Officer and Co-Founder, Eccogene

Challenges and opportunities of global bio-Therapeutic industry: New time with great opportunity in different arenas
Dr. Joe Zhou, President and Chief Scientist, Genor Biopharma, Visiting Professor, Peking University

Accelerating Drug Development in China – How best to address important unmet needs in China with an integrated local development strategy and Innovative Collaboration Model
-- The benefits and challenges of developing globally innovative medicines in China
-- The benefits and challenges of having multiple global partners
-- What the future will bring to the pharmaceutical industry in China
Dr. Xiang Yang Zhu, Chief Executive Officer, Huaota Biopharm and Huabo Biopharm
Dr. Zhengqing Li, Vice President & Head of MSD China R&D, Merck Research Laboratories
Dr. Li Wang, Senior Vice President and Head of Lilly China Drug Development & Medical Affairs Center (LCDDMAC), Eli Lilly
Dr. Maggie Gu, Vice President, Head of R&D Innovation Hub, Therapeutic Area Oncology & Rare Diseases, IPSEN

Dr. Hui Zhou, Vice President, Head of Oncology Strategy and Medical Sciences, Innovent Bio


Panel Discussion: New Modalities Research Opportunities and Innovative Collaboration Model in China
Dr. Hequn Yin, Chief Scientific Officer,Qilu Pharma
Dr. Xiayang Qiu, Founder and Chief Executive Officer, Regor Therapeutics, Group Vice President & President of Innovative Drug Research, Qilu Pharmaceuticals
Dr. Zhao-Kui (ZK) Wan, Founder & Chief Executive Officer, Lynk Pharmaceuticals
Dr. Weiyi Zhang, Director, External Innovation China, Research Beyond Borders, Boehringer Ingelheim
Dr. Feng Bian, Senior Director & Asia Emerging Science Lead (Shanghai), Emerging Science & Innovation (ES&I), Pfizer Worldwide R&D,Pfizer
Dr. Jenny Yang, Vice President, Head of Search and Evaluation, Novo Nordisk China Research Center
Dr. Qun (Max) Dang, Corporate Vice President, President, CEO, CSPC, CSPC Shanghai Research Institute, InnovStone Therapeutics

Strategy and Technology Investment for Innovative Medicines
-- Innovative medicines in China: progresses and gaps
-- Lead identification technologies and structure-based drug design
-- Computer-Accelerate Rational Discovery (CARD) and Artificial Intelligence
Dr. Xiayang Qiu, Founder and CEO, Qilu Regor Therapeutics

Collaborating for Innovative Growth-Pfizer R&D Strategy, Partnering Model and Asia Discovery Labs
Dr. Feng Bian, Senior Director & Asia Emerging Science Lead (Shanghai), Asia Discovery Labs, Emerging Science & Innovation (ES&I), Pfizer Worldwide Research & Development, Pfizer

The External Innovation Strategies from CSPC Pharma
Dr. Qun (Max) Dang, Corporate VP, CSPC, Director, CSPC Shanghai New Drug Research Institute, Chief Executive Officer, InnovStone Pharmaceuticals

Growth in Quality of Innovation – A Perspective about Innovative Drug Discovery and Development in China
Abstract: This presentation will highlight the key components underlying the vibrant innovation ecosystem of drug discovery and development in China. Specifically, examples of the drug discovery and development projects at MNC’s Innovation Center Shanghai will be used to showcase how MNCs in China move first-in-class/best-in-class potential programs forward through internal innovation and external collaboration. External collaboration strategy and efforts in China will be summarized at a high level:
l Ecosystem fosters drug discovery and development in China
l Challenges & opportunities in innovative drug discovery and development in China
l Innovative drug discovery and development highlights
l External collaboration in China
Roche Innovation Center Shanghai
Johnson & Johnson Innovation Center Shanghai
Merck Innovation Hub

Pharma IP Patent Panel:
IP Enforcement; Regulatory Data Protection, Licensing Collaboration, Strategies for IP Monetization, Patent Linkage and Patent Term Extension in New Era of Drug Discovery and Development

Ms. Caihui Li, IP Director,3S Bio
Mr. Frank Zhu, Vice President of Patent China, Roche Group Patents
Mr. Kent Yang, Head of Patents China,Novartis

新药研发到商业化生产: 原料药工艺开发; CMC的挑战和策略; MAH实践;

郭明 博士, 总裁兼首席运营官, 联合创始人, 亚盛医药集团

商业化制剂设计, 研发与中试放大, 技术及法规要求

吴振平 博士, 高级副总裁( 药物科学 ), 和黄医药

- 结合实际生产中的案例介绍了相应的分离解决策略
- CMC的挑战和策略, 处方工艺设计
单波 博士, 副总裁, 药物开发和生产 ( CMC ) , 德琪(浙江)医药科技有限公司

Innovative Drug CMC Challenges: Time, Cost & Risk Control
章世杰 博士,首席技术官, 药石科技

CMC的挑战和策略, 处方工艺设计
胡新辉 博士, 副总裁, 药物开发与生产 ( CMC ), 云顶新耀

原辅料物化特性对合理的产品设计, 开发与中试放大的影响
Deepak Hegde 博士, 首席技术官, 亿腾景昂药业

原料药的开发, 质量控制 及未来发展趋势
Dhileep Krishnamurthy博士, 首席科学官, 浙江新和成股份有限公司

周伟澄 教授, 创新药物与制药工艺国家重点实验室主任,上海市抗感染药物重点实验室主任,上海交通大学兼职教授,《中国医药工业杂志》总编辑

Considerations and Approaches to speed up CMC development to match the new clinical paradigms for Oncology studies
张世英 博士, 副总裁, 药物开发与生产( CMC ), 迪哲医药

杜争鸣 博士, 高级副总裁, 药学部首席总监 ( CMC ), 百济神州

MAH制度赋能新药研发, CMC的挑战和策略
佘劲 博士, 药物研发生产部副总裁 ( CMC ), 华领医药

小组讨论: MAH制度赋能新药研发
吴振平 博士, 高级副总裁 ( 药物科学 ), 和黄医药
郭玉申 博士, 药学副总裁 ( CMC ), 亚虹医药
杜争鸣 博士, 高级副总裁, 药学部首席总监 ( CMC ), 百济神州
冯涛 博士, 副总裁, 药物开发与生产( CMC ), 来凯医药

促进源于中国的创新: 汇聚中国制药产业 “源动力”-- 我国原料药产业发展现状与趋势
吴振平 博士, 资深副总裁, 药学和生产负责人, 和记黄埔医药
佘劲 博士, 药物研发生产部副总裁 ( CMC ), 华领医药
杜争鸣 博士, 高级副总裁, 药学部首席总监 ( CMC ), 百济神州
Deepak Hegde 博士, 首席技术官, 亿腾景昂药业
Dhileep Krishnamurthy博士, 首席科学官, 浙江新和成股份有限公司

质谱分析法; 基因毒性和元素杂质控制; 创新制剂设计与开发; 注射剂一致性评价; 溶出度试验技术

Application of multi-stage mass spectrometry (MSn) in solving challenging problems in pharmaceutical industry: from rapid structure elucidation, drug degradation mechanism studies, to detection of genotoxic impurities
Abstract: This presentation will cover two aspects of multi-stage mass spectrometry (MSn) application: the first one covers the utilization of LC-MSn in conjunction with mechanism-based stress studies for rapid elucidation of degradant structures and drug degradation mechanisms. The second aspect covers the application of MSn in the detection and quantification of genotoxic impurities. The particular challenges, such as sensitivity and specificity (e.g., sample matrix interference) at sub-ppm levels of these impurities, will be presented and discussed.
李敏 博士, 副总裁, 分析领域首席科学家, 浙江华海药业有限公司

【 基因毒性杂质和元素杂质控制策略与分析方法】
- 中国药监局要有独立思考。不要被欧美药监局牵着鼻子走。
- 研发和控制过度就是过犹不及,现今我国的杂质理念已步入误区。
- “水至清则无鱼”的道理同样适用于药物研发和质控。
谢沐风, 资深专家, 副主任药师, 上海市食品药品检验所

本人发言题目:我国注射剂目前存在问题 和 临床疗效与原研药的差距
- 目前问题主要体现在注射用粉末剂型,其他液体类注射剂质量与原研药无差距。
- 强烈呼吁“切勿将注射剂一致性评价变成杂质研究的航空母舰”。
- 注射用粉末剂型关键性药学评价指标与目前质量现状。
谢沐风, 资深专家, 副主任药师, 上海市食品药品检验所

- 知晓原研药好在哪儿、才能把仿制药仿到位。
- 如何将BE试验成功率提升至90%以上?
- BE试验是金标准吗?仿制药的最高境界是什么?
谢沐风, 资深专家, 副主任药师, 上海市食品药品检验所

开发口服固体缓控释制剂案例分析 及 口服固体制剂开发关键技术: 口服固体制剂溶出度试验技术探讨-溶出度和溶出曲线
雷继峰 博士, 董事, 青岛百洋制药有限公司 创始人兼首席执行官, 上海安必生制药技术有限公司

王晓飞 博士, 药物制剂部总监, 上海欧米尼医药科技有限公司, 副秘书长, IDDA

李又欣 博士, 全球研发总裁, 科技部“长效缓控释及靶向技术国家重点实验室”主任, 绿叶制药集团

陈洪 博士, 副总经理, 研发中心总经理, 成都苑东生物制药股份有限公司
任毅 博士, 董事长兼首席执行官, 上海众强药业
王志云 博士, 制剂专家 ( 确认中 )

胡楠 博士,LC-MS资深应用工程师,安捷伦

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