Future-proofing gene therapy assays: Validation strategies for long-term success
In this webinar, industry experts from Precision for Medicine will provide actionable insights into developing gene therapy immunogenicity assays, with a focus on ensuring regulatory compliance at the various trial stages, minimizing rework, and selecting the right assay approach. Our discussion will highlight best practices for assay validation, strategies to balance assay costs with regulatory requirements before you know if the therapy is efficacious, and approaches to future-proofing assay design.
We will explore the key considerations in selecting and validating immunogenicity assays, with a comparison of neutralizing antibody (NAb) and total antibody (TAb) assays and how their selection impacts timelines, costs, regulatory strategy and clinical outcomes. Whether you are working on early assay development or optimizing assays for later-phase trials, this session offers the insights you need to ensure your assays are validated to the applicable regulatory standards, fit for use around the globe, robust, compliant, and scalable.
Topics Covered:
- Understanding the regulatory landscape: key considerations for assay development
- How to understand whether an IDE (Investigational Device Exemption) is required for assays used in your gene therapy trial
- Comparative advantages of NAb and TAb assays
- Best practices for assay validation — Practical strategies to ensure gene therapy immunogenicity assays are robust, reproducible, and compliant
- Future-proofing your assay strategy — Balancing the need for a cost-effective assay to use in a Phase I that can be pivoted to support a later Phase study or post market testing without significant rework
Register now to secure your spot!
