Navigating Cell Therapy Discovery and Development
Monday, April 24, 2023
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Chapters
Introduction
Disruptions in Development of Cell and Gene Therapies
A Complex, Fragmented Development Network
Integrated CGT Development Platform
Interdependencies in Cell and Gene Therapies
Remove the Need for Multiple Vendors
Major Factors that can Influence Progress
Key Questions to Answer for Selecting Cellular Starting Material
Key Questions to Answer in the Discovery Phase
Key Questions to Answer in the Safety Phase
Cellular Starting Materials-Arif Khan, Senior Scientist Lead
Industry Challenges
Key Considerations Around Starting Material
Material Variability From the Source
Source Material Characterization
Impact of Donor Variability on Final Product Efficacy
Tumor Antigen-Specific CD8+ T Cells
In Vitro and In Vivo Pharmacology and Safety assessment - Gemma Moiset, Group Leader Advanced Modalities
Remove the Need for Multiple Vendors
In Vitro Pharmacology and Safety Assessment
Lead Selection
Example: Binding Avidity of HER2 CAR-T cells
In Vitro Efficacy and Specificity
Co-Culture Assay Principles
Example: Efficacy of HER2 CAR-T Cells
Example: Efficacy of HER2 CAR-T cells in a 3D Tumor Model
In Vitro Safety Assessment
In Vitro Off-Target and On-Target/Off-Tumor Investigation
Example: Safety Assessment of HER2 CAR-T Cells
Example: Safety Assessment of HER2 CAR-T Cells
In Vivo Pharmacology
Example: Antitumoral Activity of HER2 CAR-T Cells
Animal Models - Steven Bronson, Scientific Product Manager
Immunodeficient Animal Models and Cell Therapies
Nude Mouse
SCID Mouse
SRG Rat
The NCG is a Triple Immunodeficient Mouse that can be Humanized
Humanized Mice and Cancer Therapy
Humanization Overview
PBMC Humanization Overview
HuCD34 NCG as a Tool for Cellular Therapy
HuCD34 NCG Checkpoint Inhibitor A549 Lung Cancer Tumor Engraftment Study
HuCD34 NCG Checkpoint Inhibitor A549 Lung Cancer Tumor Engraftment Study
Future of Humanized Mouse Research: Next Generation Models Expand the Scope of Humanized Research
Moving to the Clinic - Nicholas Ostrout, Senior Director, CGT Scientific Services
Your Trusted Partner from Research and Development to Commercialization (CRDMTO)
Cell and Gene Therapies
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Outcomes
Our mission is to create healthier lives
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