8:00 am Coffee & Registration

9:00 am Chair’s Opening Remarks

10:15 am Towards Commercialization: Accomplish the Challenges of Autologous Cell and Gene Therapies

Synopsis

  • Control strategies for cell and gene therapies
    • Considerations of a fully automated cell manufacturing process
    • Process transfer and decentralized manufacturing strategies of CAR T cells

10:45 am Morning Refreshments & Networking

12:15 pm Bringing Yescarta® to China

12:45 pm Towards Safer, Effective and Persistent T-Cell Therapies: Development of Antibody-TCR (AbTCR) Expressing T Cells Against Solid and Hematological Malignancies

Synopsis

• Addressing major barriers of current CAR-T: CRS and neurotoxicity risks
• Presenting our solution: ARTEMIS AbTCR T-cell Receptor Platform
• Safety validation of ARTEMIS platform in CD19+ NHL
• Understanding how Eureka built a versatile structure to go after both hem and
solid tumor with ARTEMIS Plus
• Safety and efficacy validation in AFP+ HCC and CD19 programs are achieved
• Exploring future directions

1:15 pm Lunch & Networking

2:45 pm Selection of an Optimal Antibody as the Targeting Moiety of CAR-T Cells

Synopsis

• Immunogenicity of the antibody in the CAR-T cells
• Specificity of the antibody in the CAR-T cells
• Tonic signaling related to the antibody structure

2:45 pm PANEL: Regulatory Requirements for Successful CAR-TCR Submission and Approval

Synopsis

Regulatory policy for cell and gene therapies
• Guidelines for gene edited approaches
• Safety and toxicity considerations
• IND submission vs. clinical study
• Regulations and guidelines for GMP compliant
manufacturing
• Safety and toxicity perspectives
• Manufacturing standards across different geographies
and regions
• Setting up a GMP facility and ensuring it complies with
regulations
• Perspectives on allogeneic vs. autologous

Research & Development

2.45pm Selection of an Optimal Antibody as the
Targeting Moiety of CAR-T Cells

• Immunogenicity of the antibody in the CAR-T cells
• Specificity of the antibody in the CAR-T cells
• Tonic signaling related to the antibody structure

Zonghai Li, CEO & CSO, CARsgen Therapeutics

 


3.15pm TCR-T Cell-based Immunotherapy for Solid
Cancers
• Analyzing recent advances in clinical trials using TCR-T
cells
• Overcoming challenges in TCR-T cell-based cancer
immunotherapy
• Exploring future directions and focuses including
neoantigen based therapies
Mingjun Wang, Vice President, Shenzhen Innovation
Immunotechnology

Mingjun Wang, Vice President, Shenzhen Innovation
Immunotechnology

 

Manufacturing & Commercialization

2.45pm Developing and Commercializing of CAR-T/TCR-T Product for Solid Tumors Using Automatic Manufacturing Process

 Comparison of CQA&CPP between CAR-T/TCR-T products for hematological and solid tumors
• Differences between using manual and automatic process during CAR-T/TCR-T products manufacture for solid tumors
• Developing a CAR-T/TCR-T product by using close, automatic manufacturing system
• Key considerations of setting down business model to commercialize CAR-T/TCR-T products manufacture for solid tumors in China: CMC, logistics, price and reimbursement

Yu Zhang, Co-Founder & CEO, Aeon Therapeutics

 

 


2.45pm PANEL: Regulatory Requirements for Successful
CAR-TCR Submission and Approval
• Discussing regulatory policy for cell and gene therapies
• Reviewing guidelines for gene edited approaches
• Safety and toxicity considerations
• IND submission vs. clinical study
• Assessing regulations and guidelines for GMP compliant
manufacturing
• Safety and toxicity perspectives
• Understanding manufacturing standards across different geographies
and regions
• Setting up a GMP facility and ensuring it complies with
regulations
• Perspectives on allogeneic vs. autologous

3:45 pm Afternoon Refreshments & Poster Session

4:45 pm

Research & Development

4.45pm A Step Toward Standardization with the
nCounter® CAR-T Characterization Panel

• NanoString has partnered with 8 leading CAR-T
development centers to produce a new gene expression
panel for the molecular characterization of CAR-T cells
• Using a 780-gene expression panel measuring T-cell
activation, metabolism, exhaustion, and TCR receptor
diversity with optional customization for measuring
transgene expression
• Leveraging the robustness, ease of workflow and rapid
time to results of the nCounter® platform, NanoString
aims to provide a standardized set of biomarker
discovery tools to both enable and advance the field

Erin Piazza, Bioinformatics Scientist, NanoString
Technologies

Manufacturing & Commercialization

4.45 pm Viral Vector Engineering Approaches and
Technologies

• Learn about quality control and replication competent
Retrovirus/Lentivirus Testing
• Follow up and monitoring of patients for RCR/RCL
testing
• Ensuring quality assurance of viral vectors
• Understanding the ability and kinetics of potential
RCR/RCL
• Replication in cellular products

Yu Lei, CEO, Shanghai Unicar-Therapy Bio-medicine
Technology Co

5:15 pm Screening CAR T Cells for Target Specificity Using Human Cell Microarray Technology

Synopsis

Optimisation of the human cell microarray technology for off-target screening of
whole engineered CAR T cells, in addition to antibodies and ScFvs
• An efficient approach for specificity screening of novel cell therapies to support
safety assessment and provide key data prior to IND submissions

5:45 pm Competition and Challenges in the Space of BCMA Targeted Immunotherapy

  • Frank Fan CSO, Nanjing Legend Biotechnology

Synopsis

• Overview of clinical stage immunotherapies targeting BCMA
• Evaluating the advantages and disadvantages of autologous BCMA-CAR-T
technology in development
• Discussing challenges encountered and potential solutions

6:15 pm Chairman’s Closing Remarks

7:30 pm Close of Day 1