An Immunogenicity Veteran Shares His Experiences

Robert Kubiak’s professional journey has taken him from the University of Illinois at Chicago to the labs at Johns Hopkins to his current role with MedImmune.  The next stop for Robert will be the 15^th Annual Immunogenicity for Biotherapeutics where he’ll be leading a workshop on the Fundamentals of Immunogenicity Assessment. 

Robert will be sharing his experiences in his current role acting as head of a research group focusing on validation of bioanlytical methods.  In addition, he’s worked on development and validation of immunoassays at Tandem Labs, PPD and Meso Scale Discovery as well.  You’ll find some of those experiences cited in the work below:

-   Correlation of screening and confirmatory results in tiered immunogenicity testing by solution-phase bridging assays, Journal of Pharmaceutical and Biomedical Analysis

Commented by Coleman, D., Hendricks, R., et al, in 2013 Letter to the Editor “Regarding confirmatory immunogenicity assays” J. Pharm. Biomed. Analysis

Kubiak et al. present experimental and theoretical evidence that correlation of the screening and confirmatory results may be a general feature of the tiered approach when the same test platform is used for both screening and confirmatory assays. Presence of such correlation suggests that one of the tiers is redundant and that a single tier (e.g. screening only) can potentially yield the same results as the two-tiered assay.

-   Is The Tiered Immunogenicity of Biologics the Adequate Approach in Prenatal Development?, FutureScience

Following the arguments by Kubiak et al., Sauerborn proposes replacing the current tiered approach to immunogenicity testing with risk-based approach that follows fit-for-purpose strategy.

-   Challenges in keeping pace with immunogenicity advances throughout the clinical development of a biological therapeutic, FutureScience

     Authors of this paper argue that many immunogenicity assays tend to yield screening and confirmatory cut point values that are not reflective of biological variability in the study population. Such cut points, while mathematically correct, tend to result in high number of confirmed positive classifications in drug-naïve populations.

Don’t miss your chance to hear from Robert at IIR’s Immunogenicity for Biotherapeutics event. Join us October 20 – 22 in Boston, MA. Download the agenda to see the list of industry leaders presenting at this year’s event.

SAVE $100. Register here and use code XP1938BLOG

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