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3rd Gene Therapy Potency Assay Summit 2025
2025
Boston, MA, United States
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3rd Gene Therapy Potency Assay Summit 2025
Description
Topics
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 & 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 & 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
Venue
Boston, Massachusetts, United States
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More Details
Prices:
2999-5297 US Dollar
(Estimated)
Exhibition:
No exhibition
Organizer:
Hanson Wade
Website:
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Future Events
3rd Gene Therapy Potency Assay Summit 2025 - 2025, Boston, Massachusetts, United States
(100030)
Past Events
2nd Gene Therapy Potency Assay Summit 2024 - 16-18 Jul 2024, Colonnade Hotel, Boston, Massachusetts, United States
(102680)
Important
Please, check "Gene Therapy Potency Assay Summit" official website for possible changes, before making any traveling arrangements
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Health & Medicine:
Genetics, Healthcare, Medical technology, Pharma
Technology:
Biotechnology
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