Therapeutic Product Immunogenicity Community

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  • 1.  Immunogenicity Discussion Group - Dec 3rd | 12PM EST

    Community Leadership
    Posted 12-01-2025 16:40

    Join us this Wednesday | Dec 3rd | 12pm EST (1800 CET) for the next Immunogenicity Discussion Group.

    We will host @Robert Kubiak to present and discuss his recent publication, Cut Point in Immunogenicity Testing: A Flawed Concept We Can Live Without (https://doi.org/10.1208/s12248-025-01153-3).

    In his latest AAPS commentary, Robert argues that ADA cut points, long regarded as the cornerstone of immunogenicity testing, are fundamentally flawed and actually increase false-negative risk. Robert makes the case for abandoning cut points and tiered strategies altogether, replacing them with a more scientifically defensible, biomarker-like assessment of ADA.

    Link to Teams meeting below.

    Todd & Rob

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    Microsoft Teams Need help?

    Join the meeting now

    Meeting ID: 230 923 966 577

    Passcode: ZyRwNR


    Dial-in by phone

    +1 910-745-0533,,871809719# United States, Fayetteville

    Find a local number

    Phone conference ID: 871 809 719#



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    Todd Lester
    BioAgilytix | Senior Director
    Durham, NC | [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: Immunogenicity Discussion Group - Dec 3rd | 12PM EST

    Community Leadership
    Posted 12-09-2025 06:32

    For those unable to join the presentation by Robert Kubiak on his recent publication 'Cut Point in Immunogenicity Testing: A Flawed Concept We Can Live Without', it is available on demand: here



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    Robert Nelson
    Scientific Officer, Executive Director
    BioAgilytix Laboratories
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer or other entities to which I am affiliated.
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