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A KOL recommended for an investigator to use miR122 to monitor for early DILI in an investigator sponsored trial; an approach with which the Safety Science Leader for the BP40091 team did not agree.
SABER provided the then unpublished internal data generated by POC work with the Anti-CSF1R/PDL1 team demonstrating miR122is not a reliable safety biomarker.
Liver scientific sub-team provided the data to demonstrate that miR122 is not a reliable biomarker to be used as a safety biomarker to monitor for BP40091-related DILI.
Strategy: Scientific rationale not to use the KOL recommended safety biomarker.
Assay: Virtual lab worked with the SA investigative toxicology group to develop and validate the method to measure and normalize miRs.
Operations: Not required for BP40091 team.
Data Solution: Biostats supported normalization approach.
Team was able to convince the investigator in question to NOT require miR122 measurements in the investigator sponsored trial.
PSTC and TransBioLine consortia no longer pursue miR122 as a safety biomarker for regulatory qualification.
Promising safety biomarkers must demonstrate little intra- and inter-individual variation.
Despite promising external data on safety biomarkers, we must still pressure test consortia and industry perspectives.
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