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Webinar - On Demand

Strategies for Immunogenicity Assays in AAV Gene Therapy: Development to CDx Approval

Date: December 7, 2023

Duration: 1 hour

Immunogenicity can pose a challenge in the assessment of both the efficacy and safety of gene therapies that use adeno-associated virus (AAV) vectors. Gene therapy developers encounter a multitude of challenges, from choosing the right immunogenicity assay in the lab to regulatory approval by governing bodies. However, proven strategies can mitigate risks, reduce costs, and pave a smoother path to contemporaneous approval of Rx and companion diagnostics (CDx). In this webinar, Precision will map out a path for successful gene therapy development, CDx development, and commercialization.


Topics covered:

  • Recommended best practices throughout the development lifecycle for a gene therapy CDx
     
  • Tools for successful CDx partner assessment and selection
     
  • Regulatory requirements of an immunogenicity clinical trial assay, based on intended use (e.g. enrollment or stratification) in US and EU
     
  • Registration requirements and timelines for a CDx, including premarket approvals (PMAs)

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Speakers

Deb Phippard

Deb Phippard PhD
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.

Kennon Daniels

Kennon Daniels PhD
Precision for Medicine

Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms.

Travis Harrison Roudned

Travis Harrison PhD
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.