Join us for the next AAPS Immunogenicity Discussion Group on Wednesday, May 1st at 12pm EDT.
We are excited to host a discussion led by Vibha Jawa exploring current practices around immunogenicity assessment for preclinical, IND-enabling studies: Preclinical Immunogenicity - What Does Fit-For-Purpose Look Like?
Current regulatory guidance focuses on requirements for ADA assays supporting the assessment of immunogenicity during clinical trials. But is rote application of these recommendations to the immunogenicity assessment in the preclinical realm overkill?
- What does a fit-for-purpose approach look like for preclinical immunogenicity assessment?
- Should ADA methods be fully validated or do qualified/non-GLP assays provide meaningful data of adequate quality?
- Does implementation of the full, three-tiered testing paradigm make sense or would a screening assay leveraging S/N ratio allow for sufficient data to empower decisions at this stage of development?
- How should ICH S6 guidance be interpreted and applied in the preclinical setting?
- Do ADA assays need to be implemented in a regulated manner for preclinical assessments?
- Can samples be banked and only analyzed in certain circumstances? If so, what does a sound decision tree look like to trigger any ADA analysis?
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Thanks,
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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