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The 2nd Gene Therapy Potency Assay Summit 2024 covers topics such as: Statistical Analysis of Key Data Packages to Achieve Regulatory Approval, Understanding the Regulators to Reach Clinical Success, Establishing an Optimum Robust Potency Assay Strategy to Avoid Regulatory/Clinical Setbacks, Breaking Boundaries: Setting Gold Standard Regulatory Requirements, Roadmap for Developing Robust Potency Assays for Accelerated Regulatory Approval, Establishing an Optimum Robust Potency Assay Strategy to Avoid Regulatory/Clinical Setbacks, Establishing Strategies to Develop Potency Assays to Ensure Transferability from Pre-Clinical to Clinical, Performing the Potency Matrix, Roadmap for Developing Robust Potency Assays for Accelerated Regulatory Approval, Overcoming Reference Material Restraints, Phase Appropriate Adaptations to The Reference Standard to Ensure Transferability of Potency Assays Through the Product Cycle, Reference Standards in Cell Based Potency Assays, Afternoon Refreshments and Poster Session, Understanding Biological Variability Between Cell-Based Assays and How to Overcome Them, When and How to Use Animal Models as an Alternative to Measuring Potency, Investigating Potency Assays with Unknown MOA’s and the Relevant Biological Function to Accurately Measure Potency, Establishing an Optimum Robust Potency Assay Strategy to Avoid Regulatory/Clinical Setbacks, Breaking Boundaries: Setting Gold Standard Regulatory Requirements, Roadmap for Developing Robust Potency Assays for Accelerated Regulatory Approval, Establishing an Optimum Robust Potency Assay Strategy to Avoid Regulatory/Clinical Setbacks, Establishing Strategies to Develop Potency Assays to Ensure Transferability from Pre-Clinical to Clinical, Performing the Potency Matrix, Roadmap for Developing Robust Potency Assays for Accelerated Regulatory Approval, Overcoming Reference Material Restraints, Phase Appropriate Adaptations to The Reference Standard to Ensure Transferability of Potency Assays Through the Product Cycle, Reference Standards in Cell Based Potency Assays, Afternoon Refreshments and Poster Session, Understanding Biological Variability Between Cell-Based Assays and How to Overcome Them, When and How to Use Animal Models as an Alternative to Measuring Potency, Investigating Potency Assays with Unknown MOA’s and the Relevant Biological Function to Accurately Measure Potency, Improving Cell Based Assays to Produce Repeatable and Reliable Results, The Essential Attributes to Consider During Development, Optimization and Qualification of Cell-Based MoA Potency Assay for AAV Gene Therapy Products, Quantitative, Image-Based Assays for the Functional Evaluation of RNA and Gene Therapies Targeting Muscle Disorders, Cell Line Development Strategies for AAV Potency Assays, Improving Cell Based Assays to Produce Repeatable and Reliable Results, What Does Long Term Programme Management Look Like for Potency as The Life Cycle of Your Product Evolves?, Best Practices, Platform Methods and Automation Tools for Successful mRNA Expression Assays for AAV Gene Therapy, Appropriate Qualification Data to Meet Regulatory Requirements, What Does Long Term Programme Management Look Like for Potency as The Life Cycle of Your Product Evolves?, Understanding Biological Variability Between Cell-Based Assays and How to Overcome Them, Improving accuracy of potency assays to produce reliable results

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