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CART-TCR CELL & GENE THERAPY INNOVATORS PLENARY KEYNOTE SPEECH

Genetically Enhanced T Cell Immunotherapies: From Academic Innovation to Industry Translation
Abstract: Since the 1990’s, we have conducted clinical trials of gene modified T cells. Gene editing has created T cells resistant to HIV infection. Chimeric antigen receptor (CAR) T cells targeting CD19 on B cells leukemias and lymphomas have induced durable complete responses in patients who are relapsed or refractory to all other available treatments. New designs for genetically modified T cells include switches and potency enhancements that will be required for targeting solid tumors. In one such approach, multiplex gene editing was accompanied by lentiviral transduction of a T Cell Receptor against the cancer antigen NY-ESO-1. The first use of CRISPR in the US in humans demonstrated that multiplex human genome engineering is safe and feasible. Translation of these technologies from research bench to clinical application requires knowledge of the critical quality attributes of the engineered cell product and acceptable limits. The road forward for wide patient access to engineered cellular therapies depends not only on scientific progress in targeting, gene modification and cellular manipulation methods, but also on meeting automation, engineering, clinical site onboarding, and health policy challenges.
Prof. Bruce Levine , Barbara and Edward Netter Professor in Cancer Gene Therapy, Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania

Clinical Development of CAR T Cell Therapy and Next Generation CAR T cells
Prof. Renier Brentjens, Director, Cellular Therapeutics, Associate Chair, Junior Faculty Development, Department of Medicine, Memorial Sloan-Kettering Cancer Center

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

Driving CAR-T/TCR-T-cell-based Cancer Immunotherapy to Solid Tumors
Abstract : Current CAR/TCR T cell therapies are limited majorly by 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. An efficient T cell adoptive immunotherapy requires to make T cells not only specifically targeting cancers, such as by expressing CAR or TCR, but the T cells need to be further modified to avoid tumor microenvironment (TME) as well, such as introducing a dominant negative TGF-beta receptor, antibodies against inhibitory co-stimulator molecules, cytokines, switch receptors or knocking out inhibitory co-stimulator molecules in the T cells. Furthermore, gene editing technologies greatly facilitate the development of universal CAR T and universal TCR T cells 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 T cell therapy
- Overcoming TME is critically important for T cell therapy to solid tumors
- Gene editing can greatly facilitate the development of cancer immunotherapy
Prof. Yangbing Zhao , President & Chief Scientific Officer, UTC Therapeutics

Maximizing the Therapeutic Potential of CAR-T Cell Therapy Using CRISPR/Cas9 Gene-Editing Technologies
- Challenges and opportunities of CAR-T cell therapy for solid tumors
- Technical progress of CAR-T cell therapy
- CRISPR/Cas9 gene editing system for CAR-T therapy development
- Progress of our universal CAR-T product for solid tumors
Dr. Xiaoyun Shang , Chief Executive Officer, Suzhou T-Maximum Bio-tech

Genetically Modified oHSV with Biomarkers to Enable CAR-T/ADC/BiTE Combination Therapy
Abstract: ImmVira was founded as a biotechnology company focused on genetically modified oncolytic viruses ("OV") as potential cancer therapeutics. The company has developed science, technology and know-how to support ongoing research, development and commercialization of best in class oncolytic viruses on the OvPENS (OV+ Patent, Enabling, Novel & Safe) platform. OvPENS platform comprises of research, patents, gene-recombinant knowhow, manufacturing technology and commercialization analytics to develop next generation OVs that reach drug development targets including Potent, Enabling, Novel and Safe. The OvPENS team also made several novel drug discoveries with the target to enable CAR T-cell, ADC and BiTE effective on solid tumors using an OV based vector-receptor approach
Dr. Grace Zhou, Chairman and Chief Executive Officer, ImmVira

Leading the innovation of cell therapy by gene editing
-- The new generation of gene editing technology enabling infinite imagination
-- The cell therapy still needs breakthrough for satisfied efficiency
-- Gene editing makes cell therapy different in manufacturing and curative effect
With the revolutionary breakthroughs in gene editing technology, the CRISPR and base editing technology have been widely used in both research and clinical trial. Meanwhile, the adoptive cell transfer (ACT) technology such as CAR-T therapy has been well recognized as the new hope of cancer patients which has tremendous prospect and potential. Whereas, the CAR-T therapy still has some bottlenecks to be broken for further application in cancer especially solid tumor therapy. The classical manufacturing of CAR-T cells based on viral infection which could insert the CAR into the genome of T cells arbitrarily which increase the production cost and malignant transformation risk. And the obstacles in solid tumor therapy has an urgent needing for gene enhanced T cells. Thus, the combination of CAR-T therapy with gene editing are taken for granted. Now gene editing has been used in developing non-viral dependent CAR-T, off-the-shelf universal CAR-T and reinforced CAR-T cells for solid tumor which will widely broaden the patient access to CAR-T cells and benefit more and more cancer patients.
Prof. Liu Mingyao , Chairman & Chief Scientific Officer, Shanghai Bioray Laboratory ; Professor, East China Normal University

Precision TCR Redirected T Cell Immunity Treating Solid Tumors
- The evolution of TCR-T
- XLifeSc 3rd generation TCR-T
- Case studies of TCR-T drug treatment for solid tumors
Prof. Yi Li, President and Chief Scientific Officer, Guangdong Xiangxue Precision Medical Technology

Targeting Ras Mutation with TCR Therapy
Abstract: Ras oncogenes (K/N/HRAS) are frequently mutated in 20% of all human cancers. Globally, approximately 3.4 million new cancer cases are diagnosed annually carrying Ras mutations. There is a large unmet medical need for treating cancers carrying Ras mutations. KRAS mutations account for around 80% of total Ras mutations. Codon 12 and 13 are most frequently mutated in KRAS oncogene. G12D/V/C and G13D represent approximately 90% cases of KRAS mutations. Development of Ras mutation inhibitors has been rarely successful till now. The KRASG12C inhibitor recently developed by Amgen showed promising efficacy in KRASG12C lung cancer. However, no successful drug development targeting other Ras mutations, such as G12V and G13D which accounts for 20-30% of colorectal cancer, has been reported so far.
KRAS mutations are immunogenic and can be recognized by T cell receptors in HLA restricted manner (Steven A. Rosenberg, 2016). Here we report identification of two human TCRs specifically recognizing RasG12V and RasG13D mutations isolated from tumor infiltrating lymphocytes of colorectal cancer patients. Both TCRs show high avidity to RasG12V and RasG13D mutations presented by MHCII alleles widely distributed in human population. Engineered B13.14.1 TCR-T and B8.2.4 TCR-T recognize KRASG12V and KRASG13D presented on APC, result strong INFγ release at low concentrations and potent yet specific cell lysis in multiple tumor cell lines. Furthermore, B13.14.1 TCR-T CD4 cells exhibit potent antitumor activity in a CDX CRC mice model. Our RasG12V and RasG13D targeted TCR-T therapy could hold great potential for treatment of oncogenic Ras-driven cancers.
Dr. Yi Jin, Chief Scientific Officer, Genbase Biotechnology

The Development Progress of IM19 CAR-T Cells in Relapsed or Refractory Non-Hodgkin Lymphoma
Dr. Ting He, Chief Executive Officer, ImmunoChina Pharmaceuticals

CART therapy regulation and IND application in China
Chimeric antigen receptor T cell (CART) therapy is a promising therapeutic strategy against cancer and gains extensive attentions from both academia and industry. CART products are living, self-replicating drugs, and thereby bring challenges for both companies and regulatory agencies. So, what are the unique features of CART products from a regulatory perspective? What are the similarities and differences in IND regulation between FDA and NMPA? To what orientation will CART regulation evolve to maximize the safety while maintaining flexibility? Here, the speaker will share his experiences in IND applications in both US and China, illustrate main regulatory principles of CART products in both sides, and discuss the do’s and don’ts in an IND application.
Bullet points:
l Regulatory principles of CART products: from FDA to NMPA
l The do’s and don’ts in IND applications of CART products
l CART cell manufacturing from a regulatory perspective
l The use of correlative sciences in CART IND applications
Dr. Changfeng Zhang, Associate Director, Dept of Cell Therapy, Livzon Biotech

TIL Therapeutics in Solid Tumor: Advantages, Challenges and Development Trends
- The advantages of TIL therapeutics for solid tumor
- The challenges in developing personal TILs drug
- The development trends of TIL therapeutics
Dr. Huajun Jin, Founder, CEO & CTO, Shanghai Gencells Therapeutics

R&D of Gene and Cell Therapy based on Synthetic Biology
Abstract: SyngenTech is a top synthetic biomedical technology company in China. SyngenTech is building a business model of "fast R & D, fast production and fast verification" in cell and gene therapy based on synthetic biology. By building the platform of synthetic AMDP for rational drug design. In 2020, first synthetic gene therapy drug approved for clinical use.
Dr. Yun Jiang, COO, Beijing Syngentech

Manufacturing & Clinical Study of CAR-NK Cell Drugs to Treat Solid Tumors
Dr. Yaqing Zhu, General Manager, CMC, Asclepius Technology Company Group

Developing safe and effective T-cell therapies to treat solid tumors: ARTEMIS T-cell therapy targeting tumor specific antigens with enhanced tumor infiltration
Dr. Cheng Liu, Founder and CEO, Eureka Therapeutics

Building Clinical-grade Stem Cell Library for Developing off-the-shelf Cell Therapy Products in China
- Advance in cell therapy product development in China
- Building different clinical-grade stem cell bank and platform
- Examples of developing allogenic cell therapy products such as MSC for COVID-19
Dr. Yu Zhang, Senior Vice President and Chief Scientific Officer, VCANBIO Cell & Gene Engineering

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

Enhancing AAV Gene Therapy Efficiency
Abstract: AAV gene therapy has proven to be an effective long-term cure and has the potential to be applied to all kinds of diseases. However, drug development is hindered by relatively low efficiency, high side effects, high dose, high price and long manufacture time. For next generation AAV gene therapy, enhancing the efficiency can solve all these problems and should be the first step for every new therapy pipeline. At AAVnerGene, we strive to develop new technologies to enhance AAV gene therapy efficiency from vector design, process development, new capsid screening and gene expression regulation. Our proprietary platform, ATHENA (AAVnerGene’s Tissue-specific, Highly-transductive and Expressive New AAVs), combines library screening with AI-directed rational design to fast and effectively develop new AAV capsids for different target diseases. We are also developing new gene therapy cure for hemophilia A. Our patented FVIII has increased activity up to 40 fold than current FVIII in clinical trial. Combining the improved vector design, gene regulator and new capsid, the new drug will dramatically increase the efficiency and decrease the dose, which will solve the side effects, manufacture and high price problems, and bring affordable new option to the patients.
Dr. Daozhan Yu, President and Chief Executive Officer, AAVnerGene

Bacterial Vector Gene Therapy for Intestine-associated Diseases
Abstract: Gene therapy aims to replace/inactivate the disease-causing gene or to introduce a novel gene into human body to treat diseases. There are several ways of delivering gene therapeutics, including bacterial vector. Bacterial delivery, proposed in the 1990s, was gaining momentum in the last decade, due to the advances in human microbiota and synthetic biology. Recent years, the industry has begun to utilize this approach in drug development. Currently, there are more than 20 biotech companies focusing on using bacterial vector to deliver gene therapeutics. Some early phase clinical trials show promising results. Furthermore, regulatory authorities are integrating this category of therapeutics in the guidelines. We are witnessing the vision-to-clinical-reality of this methodology.
Dr. Bin Xiang, Founder and Chief Executive Officer, CommBio 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

Platform for Identification and Optimization of TCR for Shared Tumor Antigens in Large-Scale
Dr. Xingwang Xie, Founder & Chief Executive Officer, Corregene Biotechnology

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

Genetic modulation of RNA splicing for human genetic diseases
Abstract: RNA splicing is a critical step to generate mature RNA, and alternative splicing (AS) is the primary mechanism for mammalian cells to diversify their proteomes. Aberrant splicing impairs many biological processes and has been implicated in an increasing number of diseases. Previously, we have developed a genetic approach to efficiently modulate various forms of RNA splicing in their native chromatin context. Based on a CRISPR-guided cytidine deaminase (i.e. Targeted AID-mediated mutagenesis, TAM), our approach precisely edits universal cis-regulatory elements of splicing to either suppress or promote inclusion of an exon, enabling both gain- and loss-of-function analysis using the same platform. Duchenne muscular dystrophy (DMD) is caused by loss of dystrophin protein, which is characterized by progressive degeneration of cardiac and skeletal muscles, leading to mortality in adolescence or young adult. In this meeting, I will present our recent study showing that a single-dose administration of AAV9-based CRISPR/Cas9-AID (eTAM) instituted over 50% targeted exon skipping in the Dmd mRNA and restored up to 90% dystrophin in the heart in a murine model of DMD. As a result, early ventricular remodeling was prevented and cardiac and skeletal muscle functions were improved, leading to an increased lifespan of the DmdE4* mice. Our study demonstrates the feasibility and efficacy of using an enhanced TAM to institute exon skipping in vivo for therapeutic application(s).
Dr. Xing Chang, Investigator, School of Life Sciences, Westlake University

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
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. 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

The Significance, Prospect, Risk Control of Fully Automated CAR T Cell Manufacturing
摘要(Summaries)
1.免疫治疗的进展正在改善许多晚期恶性肿瘤患者的预后
2.CAR-T细胞能有现在的成就,归功于多学科的成功融合
3.高质量的临床级CAR-T细胞产品的可重复制造是CAR-T技术能够广泛应用的先决条件
4.CAR-T细胞产品制备中的全过程质控是必须具备的条件
5.全封闭、自动化的CAR-T细胞制备,成为该治疗模式广泛应用和最终商业化的优先选择
Dr. Min Wang, Chief Technology Officer, PersonGen BioTherapeutics

The impact of Closed Systems on Cell and Gene therapy scalability
- Review the scalability challenges associated with therapy development
- How closed systems positively impact scalability
- How to choose the right partner in creating closed systems
Dr. Pamela Yin, Application Development Manager of China Region, Colder Products Company

Cell & Gene Therapy Manufacturing from Concept to Patient
Abstract: The field of cell and gene therapy is transforming the way patients diagnosed with cancers or genetic diseases can be treated. These novel drug candidates provide drastically improved patient outcomes and, in some cases, can be curative. However, manufacturing of such medicines pose complex new challenges. Today, the cost of production still represents a major hurdle for clinical translation and commercialization of these potentially ground-breaking therapies. New technologies are needed to enable robust and cost-efficient manufacturing of high-quality medicines. While the therapeutic opportunities for patients are exciting, the stakes for patients and drug developers are high.
During this presentation we review:
- The key challenges of bringing a cell/gene therapy to market
- Establishing a roadmap from early stages to commercialization
- Platform technologies to achieve commercial viability
Dr. Hartmut Tintrup, Global Head of Business Development & Partnering, Cell & Gene Technologies Business Unit, Lonza

High-titer and scalable viral vector manufacturing through complete suspension LV and AAV production systems
Abstract: Recombinant lentivirus (LV) and adeno-associated virus (AAV) are critical components of cell and gene therapies, which show great promise for treatment of diseases from genetic disorders to cancer. There are increasing needs for high titer and scalable viral vector processes from research and development to manufacturing.
Thermo Fisher Scientific offers innovative complete suspension systems, LV-MAX and AAV-MAX, to support high-titer and scalable viral vector manufacturing.
Below are discussion points of LV-MAX and AAV-MAX systems
• Integrated components and processes in two systems
• High-title performance and scalable consistency
• Research-grade and GMP options
• Update of other GMP supports in cell and gene therapy workflow
Dr. Eddie Sun, Strategy Alliance Manager, GC & JP, Thermo Fisher Scientific

Parallel GMP Manufacturing to Develop Gene Therapies in Both the US and China
Dr. Jimmy Zhang, Founder, Chairman and CEO, AccuGen Group

Off-the-shelf” human blood manufacturing from pluripotent stem cells to mitigate donor blood shortages from infectious diseases
Abstract: Globally an estimated 112.5 million units of blood are collected for transfusion applications from blood donors. Unfortunately, since the COVID-19 pandemic, many nations like Singapore have had extreme depletion of bloodstocks, and loss of healthy donors. Alternatives to donated blood must be found to solve an escalating shortage of blood.
Continual advancements in the fields of lineage differentiation, bioprocessing and scale-up culture have brought closer the reality of using hiPSCs-differentiated cells for therapeutic applications and regenerative medicine. One such potential is the use of hiPSCs to generate O –ve universal RBCs for transfusion applications. However, unlike most cell therapies, generating RBCs for clinical application poses unique bioprocessing and manufacturing challenges. The need to generate 2 trillion RBCs for each transfusion unit of blood (equivalent to 300 ml of donated blood) requires the development of ultra-high density cultures of cells.
We demonstrate significant progress in solving the manufacturing challenge by:-
1. Implementing efficient reprogramming of hiPSC in suspension microcarrier cultures at the start of the process. Screening hundreds of clones and selecting dozens with both features of high expansion capability (greater than 10-fold) and differentiation to early hematopoietic lineage, positive for CD34 and CD43 markers (above 70%).
2. Initiating of the mesoderm differentiation in suspension culture and selection of clones with at least 20-fold expansion and production of T-bra and KDR +ve cells (>20% expression)
3. Simplifying differentiation with implementation of designs of experiments to use small molecules and reduced cytokine cocktails towards the erythroblast lineage. Screening a second stage for high expandability to erythroblasts, > 20,000 fold or more; while decreasing cost of goods by 10 fold.
4. Applying high intensity culture methods using ultrasound to concentrate erythroblast expansion to achieve greater than 25 million cells/ml in controlled bioreactor cultures.
5. Applying shortened, simplified enucleation protocol with inactivated OP9 co-cultures and screened plasma sources to drive enucleations rates up by 10 fold or more from 6% to 65%.
6. Characterisation of oxygen binding curves, haemaglobin expression, membrane fluidity and SEM images.
We present solutions to developing a bioreactor scalable-process for generating high-density cultures of functional O-ve universal RBCs from hiPSCs.
* Prof. Steve Oh, Institute Professor and Director, Stem Cell Group, Bioprocessing Technology Institute, A*STAR

Cell Therapy Bio-manufacturing and Cell Processing
Prof. Mickey Koh, Director Stem Cell Transplantation, St George's Hospital and Medical School, London, UK, Medical Director, Health Sciences Authority, Singapore

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;
Panelists:
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
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 )

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

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
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. 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,Qilu 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

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
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;

全球首创新药多扎格列艾汀的研发途径和产业化发展方向
From R&D to Commercialization: A First-In-Class GKA Dorzagliatin story

陈力 博士,董事长、首席执行官、创始人、首席科学官,华领医药技术(上海)有限公司

从新药研发到商业化生产—原料药工艺研发漫谈
摘要: 从呋喹替尼, 索凡替尼到赛沃替尼, 从RSM的确定与管理到原料药工艺的验证与商业化生产, 试论工艺研发的难点与痛点, 分享漫长研发过程中的经验与教训.
刘波 博士, 副总裁, 药学部, 和记黄埔医药(上海)有限公司

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

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

药物研发中的质量研究与分析方法的建立
- Stability indicating impurity method development and case study
- Polymorph study and requirement for XRPD method sensitivity
- The missing items in particle size method development and the risks for product development
- Dissolution discriminating capability - how much we need
- GTI method implementation – consideration and challenges
Dr. Yang Gao, Head of Suzhou Analytical Research and Development, BeiGene

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

创新药CMC挑战:时间、成本及风险控制
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

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

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

Development of anti-RSV drug ziresovir: en route to market -- Disease background: RSV is one of the most common viruses with no approved effective therapy
-- History of ziresovir and its competitors: from nucleoside analog to fusion protein inhibitors
-- Clinical development of ziresovir
-- Formulation consideration for pediatric use
-- MAH: preparation for commercialization
袁海卿 博士, 首席科学官, 爱科百发

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:
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

Pathways and considerations for 505(b)(2) development of inhaled drug products 改良吸入药物研发思路及考量
The presentation will focus on the following perspectives of inhaled drug products:
- Advantages and clinical applications
- Regulatory pathways for registration and approval
- Strategy and case studies for 505(b)(2) product development
- Future trend of inhaled products
Dr. Shuguang Hou, Chairman and Chief Executive Officer, Sichuan Purity Pharmaceutical

眼科505(b)2药物的研发
- 505(b)2新药开发的法律基础
- 眼科505(b)2新药开发的特点
- 案例分享
欧阳晖 博士, 资深研发副总裁, 广州因明生物

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

* How to comply the latest FDA requirements to control Nitrosamine genotoxic impurities?如何满足FDA的最新要求来控制亚硝胺的遗传毒性杂质?
- N-Nitrosodimethylamine crisis has extended to all medications亚硝基二甲胺危机扩散到所有的药品
- FDA Latest regulatory requirements to evaluate and control Nitrosamine FDA评估和控制亚硝酸胺最新法规
- Are you ready to comply: a practical approach strategy for API and finished product manufacturers 你准备好了吗?原料和制剂厂家的具体实施策略
陈洪博士, 副总经理, 研究院院长, 成都苑东生物制药股份有限公司

基于QbD的API杂质谱研究
u 杂质谱的定义
u 基因毒杂质
u 杂质谱一般研究方法
u 案例分析
l 伊曲康唑
l 利奈唑胺
l 右美托咪定
l 琥珀酸曲格列汀
l Iclaprim
周伟澄 教授, 上海医药工业研究院研究员,博士研究生导师,《中国医药工业杂志》总编辑。上海交通大学药学院兼职教授,复旦大学药学院博士生导师

为您打开一扇窗-- 溶出度技术在日本的应用
- 日本独树一帜的溶出度技术由来历史和对我国的借鉴。
- 溶出度技术对原研药的杀伤力和在仿制药研发中举足轻重的作用。
- 阐述原研制剂规律性溶出曲线→ 指引仿制制剂的开发 → 力促BE试验一次性成功。

发达国家向非发达国家发射的“数枚烟雾弹-- 揭开基因毒性杂质真面目
- 宏观解读药物临床不良反应与杂质无关、更与基因毒性杂质无关。
- 冷静看待《ICH指导原则》,做到有所取舍,而非全盘接受、照搬照抄。
- 列举数个烟雾弹实例,揭开发达国家设置的技术陷阱与专业误导
谢沐风, 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 )

安捷伦杂质分析方案及多维液相色谱-质谱联用技术的应用
胡楠 博士,LC-MS资深应用工程师,安捷伦

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