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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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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