Therapeutic Product Immunogenicity Community

Hi all,

Please join us for the next AAPS Immunogenicity Discussion Group on Wednesday, April 3^rd at 12pm EDT.

We are excited to host Lauren Stevenson for a presentation and discussion exploring A 21^st Century Paradigm - Immunogenicity Assays are Biomarker Assays | Is the 3-tiered Paradigm Fit-For-Purpose?

Over the last several years, industry professionals and regulators have been evaluating signal to noise (S/N) as an alternative approach to titer as a means to measure magnitude of immunogenicity responses to biologic therapeutics.  In parallel, questions have arisen regarding the relative value, or not, of the confirmation tier.

This presentation will focus on a case study from a completed clinical study for an antagonistic mAb therapeutic that compares and contrasts the immunogenicity data set when analyzed using the current 3-tiered paradigm vs using only S/N data from the screening tier where the totality of data is plotted as is typically done for biomarkers. This case demonstrates that S/N provided a clearer, more nuanced understanding of the data set that aligned with overall study conclusions while also avoiding many of the pitfalls encountered with the current paradigm (e.g. cut point challenges, high false positive rates, overly sensitive assays and lack of correlation with clinical outcomes).

Submit your email address below to receive a personal Teams meeting calendar invite:

Submit Email Address

Thanks,
Todd & Rob

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Todd Lester
BioAgilytix | Sr. 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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Sounds really exiting - fingers crossed that I will get an invite to join :-)

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Per Holse Mygind
Director, Clinical Biomarkers & Immunogenicity
Ascendis Pharma
Hellerup
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 03-25-2024 10:30
From: Todd Lester
Subject: AAPS Immunogenicity Discussion Group - April 3rd | 12pm EDT

Hi all,

Please join us for the next AAPS Immunogenicity Discussion Group on Wednesday, April 3^rd at 12pm EDT.

We are excited to host Lauren Stevenson for a presentation and discussion exploring A 21^st Century Paradigm - Immunogenicity Assays are Biomarker Assays | Is the 3-tiered Paradigm Fit-For-Purpose?

Over the last several years, industry professionals and regulators have been evaluating signal to noise (S/N) as an alternative approach to titer as a means to measure magnitude of immunogenicity responses to biologic therapeutics.  In parallel, questions have arisen regarding the relative value, or not, of the confirmation tier.

This presentation will focus on a case study from a completed clinical study for an antagonistic mAb therapeutic that compares and contrasts the immunogenicity data set when analyzed using the current 3-tiered paradigm vs using only S/N data from the screening tier where the totality of data is plotted as is typically done for biomarkers. This case demonstrates that S/N provided a clearer, more nuanced understanding of the data set that aligned with overall study conclusions while also avoiding many of the pitfalls encountered with the current paradigm (e.g. cut point challenges, high false positive rates, overly sensitive assays and lack of correlation with clinical outcomes).

Submit your email address below to receive a personal Teams meeting calendar invite:

Submit Email Address

Thanks,
Todd & Rob

------------------------------
Todd Lester
BioAgilytix | Sr. 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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