Immune Responses to AAV Vectors

A free, public event organized by FDA & ASGCT

January 24-25, 2023
11 a.m. – 3 p.m. (ET) each day

Topics will include, but are not limited to:

  • Appropriateness and utility of a companion diagnostic for assessing pre-existing immunity and requirements for product approval

  • Requirements for immunogenicity testing, including data that should be collected and what may be relied upon from previous applications, and recommendations on clinically meaningful metrics

Speakers & Topics

Jan. 24, 2023

  • Shari Gordon (AskBio)
    Overview of immunogenicity and clinical trials with healthy volunteers

  • J. Fraser Wright (Stanford University)
    Vector process and manufacturing: How does it impact immunogenicity?

  • Manuela Corti (University of Florida)
    Overview of readministration approaches

  • FDA speaker TBD

Jan. 25, 2023

  • Genevieve Laforet (Aspa Therapeutics)
    Complement activation in gene therapy trials

  • Carsten Bonnemann (NINDS/NIH)
    SAEs, complement activation, and anti-dystrophin responses

  • Terry Flotte (UMass Chan Medical School)
    GM2 trial for Tay-Sachs disease

  • Dave Copland (University of Bristol)
    Intraocular AAV inflammation

Please note: Topics will also be of interest to those in the gene therapy regulatory space.


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26th Annual Meeting

May 16-20 | Los Angeles, CA

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