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.