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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: 1 hour

The use of gene therapy offers significant promise to treat, and even cure, disease. Viral vectors - primarily AAV - have become the most common method to deliver a gene therapy. A major challenge is pre-existing immunity resulting from natural exposure to AAV.
 
Developing an assay to assess humoral immunogenicity has thus become a crucial step in the clinical development of gene therapies. 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 explore the differences and advantages of each assay type, discuss how assay type selection may impact overall regulatory strategy, and will provide guidance on best practices for assay development.


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

Deb Phippard

Deborah Phippard, Ph.D.
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.

Travis Harrison Roudned

Travis Harrison, Ph.D.
Precision for Medicine

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 an emphasis on diagnostic assays to evaluate immune responses to gene therapies.