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Webinar - On Demand

Future-proofing Gene Therapy Assays: Validation Strategies for Long-Term Success

Date: April 2, 2025

Duration: 60 minutes

In this webinar, industry experts from Precision for Medicine will provide insights on developing gene therapy immunogenicity assays focused on regulatory compliance, minimizing rework, and selecting the right assay approach.

Learn best practices for immunogenicity assay validation, cost-effective strategies, and future-proof assay designs. Compare neutralizing antibody (NAb) and total antibody (TAb) assays and their effects on timelines, costs, and clinical outcomes. Whether you're in early development or optimizing later-phase trials, this session ensures your assays meet global standards, are robust, compliant, and scalable.

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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
Key Strategies for Future-Proofing Gene Therapy Assay Validation 2

Speakers

  • Travis Harrison

    Travis Harrison, PhD

    Travis Harrison, is a vice president of Diagnostic Development at Precision for Medicine. He brings more than 20 years of Bioanalytical assay experience to the precision team with expertise in ligand-binding and cell-based assays. Travis has experience supporting clinical and nonclinical studies for a broad range of indications, with and emphasis on diagnostic assays to evaluate immune responses to gene therapies.

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  • Deb Phippard

    Deb Phippard, PhD

    Deb Phippard, Chief Scientific Officer at Precision for Medicine. Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy.

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