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CART-TCR CELL & GENE THERAPY INNOVATORS PLENARY KEYNOTE SPEECH

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

A Broad Technology Platform for Reprogramming, Expansion of Pluripotent Stem Cells and Differentiation to Cell & Gene Therapies
Abstract: The BTI, at A*STAR has developed a Broad Technology Platform for Reprogramming, Expansion of Pluripotent Stem Cells and Differentiation to Cell Therapies. The IPS-SpheresTM technology is capable of automating the reprogramming of 4 different cell sources: T cells, haematopoietic stem cells, fibroblasts and mesenchymal stem cells into human induced pluripotent stem cells. From each reprogramming campaign, we can select up to 96 wells of clones to characterize and pick the best growing clone that can be cultured in suspension cultures and differentiated to target lineages. Using the microcarrier technology IPS-SpheresTM, BTi has been able to demonstrate production of neuroprogenitors and neurons at 10 million cells/ml. These neurons have been demonstrated to be functional in mouse and rat animal models of Parkinson’s disease with rapid recovery times within 3 to 6 months depending on the cell dose. Secondly, BTI has cardiomyocytes in a completely defined serum free media with 2 small molecules achieving 8 million cells/ml in a suspension bioreactor. Cardiomyocytes have been implanted in pig models of cardiac infarction. Most recently, BTi has manufactured CD34+ haematopoietic progenitors from hiPSC on this platform achieving 2 million cells/ml, these have been further differentiated to universal O negative Rhesus negative RBCs (17 million cells/ml.) and are being tested in animal models of acute anaemia. This platform is broadly available for scale up of pluripotent stem cell therapies to meet the global shortage of cells for therapies.
Prof. Steve Oh, Institute Professor and Director, Stem Cell Group, Bioprocessing Technology Institute, Agency for Science, Technology and Research, A*STAR, Singapore

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

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

Development of Next Generation Safe and Potent NKG2D CAR-T Cell Therapy and Next Generation CAR-T Cells
-- CAR-T development history
-- Safety and potent CART development background and cases show
-- Safety and potent KD-025 CAR-T Cell Therapy Progress
-- The case study of KAEDI next generation CAR-T Cells
Dr. Hongjiu (Paul) Dai, Chief Executive Officer, Nanjing KAEDI Biotech

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

Revolution of CAR-T Cell Therapies: Regulatory and Commercialization Considerations for Yescarta in China
Dr. Richard Wang, Chief Executive Officer, Fosun Kite Biotechnology

Development of Safe and Potent CAR-T Cell Therapy and Anti-CD19 IM19 chimeric antigen receptor (CAR) T cells
Dr. Ting He, Chief Executive Officer, ImmunoChina Pharmaceuticals

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

FasT CAR-T – Breakthrough Technology for Hematological Malignancies
Dr. Wei (William) Cao, Founder, Chairman and Chief Executive Officer, Gracell Biotechnologies

Challenges and Prospects of Allogeneic CAR-T Cell Therapy
Dr. Zhongwei Xu, Chairman and Chief Scientific Officer, Bioceltech Therapeutics

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

Development of Safe and Potent CAR-T Cell Therapy in China targeting Hematological Malignancies and Solid Tumor
Dr. Lei Yu, Chief Executive Officer, Shanghai UniCAR-Therapy Bio-Medicine Technology

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

Mechanisms & Clinical Study of CAR-NK Cell Drugs to Treat Solid Tumors
Abstract: Chimeric antigen receptor T lymphocyte (CAR-T) technology has made remarkable success in the treatment of hematological malignancies. However, its intrinsic character of the technology unlikely leads to a large-scale production of standardized and homogenous cell drugs for cancer treatment. The ATCG Corp. has been pioneered on developing innovative “off-the-shelf” CAR-NK cell drugs for cancer immunotherapy. The ATCG research team, led by Dr. Huashun Li, has been based on natural killer cell line NK-92 as a platform to develop over 15 CAR stably expressing NK cell lines (CAR-NK) to treat different types of solid tumors. The preliminary clinical research studies have shown that ATCG427 CAR-NK therapy yields a remarkable response rate. In investigator initiated clinical study, Robo1 CAR-NK cells could effectively treat the advanced cancers with DCR as high as 76.5%, including but not limited to breast cancer, lung cancer, renal cancer, and pancreatic cancer. In addition, ATCG427 CAR-NK cells not only directly kill target tumor cells but also engage host NK cells and lymphocytes, leading to systemic activation of immunity against tumors. ATCG is a leading enterprise in the fast-growing tumor immunotherapy field .It has laid a solid foundation for the clinical trial of innovative cell drugs
Dr. Huashun Li, President and Chief Executive Officer, Asclepius Technology Company Group ( ATCG Corp )

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

Panel Discussion: Development Next Generation “Off-the-Shelf ” TCR-T Cell Therapy against Solid Malignancies in China
Moderator:
Prof. Xin Lin, Chairman of the Department of Basic Medical Sciences, School of Medicine, Tsinghua University
Panelists:
Dr. Jijun Yuan, Chief Executive Officer, Shanghai Genbase Biotechnology
Dr. Stephen Lim, Chief Executive Officer, LionTCR
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 )

CELL & GENE THERAPY BIOPROCESSING & MANUFACTURING COMMERCIALIZATION

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

Cell Therapy Manufacturing Commercialization -- Strategy and Challenges
-- Unique Manufacturing Challenges for Autologous Cell Therapy
-- IND to Commercial: A Paradigm Shift
-- Development By Design
-- Quality By Design
-- Cell Therapy COGs Optimization
-- IND to Commercial: Scale-out Challenge
-- Cell Therapy Technology Road Map Vision
-- Current Weakness in the Technology Landscape
-- Final Thoughts
Dr. Harry Lam, Executive Vice President of Technical Operations, JW Therapeutics

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;
Moderator:
Prof. Steve Oh Institute Professor and Director, Stem Cell Group, Bioprocessing Technology Institute, Agency for Science, Technology and Research, A*STAR, Singapore
Panelists:
Dr. Yajin ( Jenny ) Ni, Senior Director, Process and Product Development, Technical Operations, Allogene Therapeutics
Dr. Wong Tee Wee, Director of Operations, LionTCR
Dr. Xuejun Yu, Chairman and Chief Executive Officer, HuaDao CAR-T Cell
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
Moderator:
Dr. Hermann Bohnenkamp, Vice President, Business Development APAC, Miltenyi Biotec
Panelists:
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 )

CART-TCR CELL & GENE THERAPY INNOVATORS ( CONFIRMING )

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 )

GLOBAL CAR-T PIONEERS PLENARY KEYNOTE SPEECH ( 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 )

Developing Allogeneic Cancer Immunotherapy with iPSC Technology
-- Fate is pioneering a revolutionary approach to cell therapy -- we use renewable master induced pluripotent stem cell (iPSC) lines generated from our proprietary iPSC platform to derive cell therapy product candidates that can be delivered off-the-shelf for the treatment of a large number of patients.
-- Our cell therapy product candidate pipeline is comprised of immuno-oncology programs, including off-the-shelf NK- and T-cell product candidates derived from master iPSC lines.
-- Discuss challenges in cell culture scale up for allogeneic cell therapies with iPSC technology
Dr. Wen Bo Wang, Senior Vice President, Technical Operations, Fate 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 )

FUTURE CANCER IMMUNOTHERAPY REVOLUTION & DRUG DEVELOPMENT

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

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 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
Moderator:
Dr. Xiang Yang Zhu, Chief Executive Officer, Huaota Biopharm and Huabo Biopharm
Panelists:
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. Jianjun ( James ) Jin, Head of Clinical Development, China, Novartis
Dr. Hui Zhou, Vice President, Head of Oncology Strategy and Medical Sciences, Innovent Bio

STRENGTHENING PHARMA R&D COLLABORATION AND PARTNERSHIP IN CHINA

Panel Discussion: New Modalities Research Opportunities and Innovative Collaboration Model in China
Moderator:
Dr. Hequn Yin, Chief Scientific Officer,FOSUN Pharma
Panelists:
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

Computer-accelerate rational discovery (CARD) --计算机加速药物创新的策略和愿景
Dr. Xiayang Qiu, Founder and Chief Executive Officer, Regor Therapeutics, Group Vice President & President of Innovative Drug Research, Qilu Pharmaceuticals

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
Panelists:
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

Panelists:
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;

早期临床用药生产及原料药及制剂药学研究
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
呋喹替尼--从新药研发到商业化生产

吴振平 博士, 高级副总裁( 药物科学 ), 和黄医药

原料药工业生产中的杂质控制与系统研究
- 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

新药创新中的原料药工艺开发
陈曦 博士, 常务副总裁, 药物开发和生产 ( CMC ), 北京盛诺基医药科技股份有限公司

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
, 资深副总裁, 药物开发和生产 ( CMC ), 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

原料药工艺合成及工艺路线优化
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

临床药品的生产放大及技术转移
张世英 博士, 副总裁, 药物开发与生产( CMC ), 迪哲医药

从新药研发到商业化生产-产业化项目以及MAH实践
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
主持人:
吴振平 博士, 高级副总裁 ( 药物科学 ), 和黄医药
小组讨论成员:
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
小组讨论成员:
陈曦 博士, 常务副总裁, 药物开发和生产 ( CMC ), 北京盛诺基医药公司
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, 资深副总裁, 药物开发和生产 ( CMC ), 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】
谢沐风观点:
- 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

【注射剂一致性评价&焦点问题】
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
大纲:
- 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

【口服固体制剂开发思路与策略】
本人发言题目:对于口服固体制剂仿制药研发美日差异、中国应各取所长
大纲
- 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

吸入制剂颗粒处理工艺及制剂特性相关颗粒性质评价
目前用于吸入制剂的颗粒正在由简单微粉化向特殊颗粒工程处理、定制化处理方向发展。基于目前颗粒的微观和宏观评价研究,将颗粒的微观、宏观评价技术与其用在吸入制剂中表现出的制剂特性相关联,是吸入制剂进一步发展需要解决的关键问题
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

长效和靶向微球制剂工业开发及质量控制
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

注射剂一致性评价开发以及制剂处方工艺开发及临床评价关键技术以及相关焦点问题探讨
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 )

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