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Webinar - On Demand

NAb vs TAb Assays in Gene Therapy Development: Key Considerations for Assessing Immunogenicity

Date: January 17, 2022

Duration: 60 minutes

Gene therapy shows great potential to treat and even cure diseases, with AAV viral vectors being the most common delivery method. However, pre-existing immunity from natural AAV exposure poses a challenge. Thus, developing an assay to evaluate humoral immunogenicity is crucial. With two primary approaches to assess immunogenicity: a neutralizing antibody assay (NAb) or a total antibody assay (TAb), a common question asked by gene therapy developers is “which assay is best?”
 
This webinar will delve into the differences and benefits of each assay type, discuss impacts on regulatory strategies, and offer guidance on assay development best practices for assay development.
 

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Topics covered

  • Importance of immunogenicity assays in gene therapy development
  • Key differences between NAb and TAb assays and considerations in selecting an assay type
  • Regulatory insights surrounding gene therapy immunogenicity evaluations
  • Important design considerations for creating immunogenicity assays
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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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