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Project team’s safety target assessment identified kidney toxicity as substantial liability in infectious kidney target indication with concurrent known drug-associated lysosomal accumulation in kidney tubules.
SABER inquiry via nonclinical safety team reps & coordinated discussion with drug safety team rep.
Kidney scientific sub-team provided a tailored translational strategy outside of the Kidney biomarker Regulatory qualification to use two subsets of kidney biomarkers to distinguish PD and safety effects in the kidney, as well as provided the technical, operational and analytical guidance to enable successful integration and evaluation:
Strategy: Tailored safety and PD kidney biomarker strategy, nonclinical to clinical, based on known biomarker biology and non-published data from PSTC
Assay: Leveraged and built on PSTC assay development and validation for nonclinical rat and dog assays; used Virtual Lab’s preferred partnership with Pac Bio for clinical assays as aligned with global procurement
Operations: Supported nonclinical outsourcing and clinical biomarker operations to smoothly integrate and operationalize the strategy into the protocol
Data Solution: Biostats provided unique approach to support the hypothesis; Virtual lab worked with Dev Sci informatics to integrate kidney biomarker data into SADR and QUASAR.
Use new approach to distinguish and monitor GLP studies to enable clinical PD & Safety biomarker strategy
Immediately relevant strategy to peripherally available LNA platform and other teams with similar drug disposition/tox profile
Know your biomarker biology relative to the pathophysiology of drug disposition and toxicity
Early alignment of nonclinical and clinical drug safety is required for successful implementation of novel safety strategies
Regulatory qualifications provide foundational knowledge but are not directly applicable to each situation of acute kidney injury
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