Qualification of Drug Induced Organ Injury Biomarkers -
Firalis SAS, with several of its members, co-authored a paper outlining a generic qualification strategy for drug induced organ injury biomarkers. The paper was published in the peer reviewed journal Drug Discovery Today (Vol. 16 No 13&14/24) “A generic operational strategy to qualify translational safety biomarkers”. These safety biomarkers are intended to accelerate drug development by providing to the pharmaceutical industry tools to assess the effect of drug candidates on the liver, the kidneys and the vasculature. This strategy, established by the team of experts collaborating within the SAFET consortium, outlines a method to generate sufficient preclinical and clinical evidence for the qualification of translational safety biomarkers.
The SAFE-T consortium is a large public/private consortium funded by the European Commission Innovative Medicines Initiative (IMI). Firalis, the initiator of the public consortium, is playing a central role in this project by participating in the design of the scientific strategy, the execution of clinical studies, the development of biomarker assays and the analysis of biomarker data.
“Firalis’ position among this team of international experts testifies its expertise in biomarker qualification and highlights its place as a leading actor in this highly competitive and dynamic field.” commented Dr. Béatrice Molac, director of regulatory affairs at Firalis.
With this publication, the SAFE-T consortium targets a larger scientific community and expects to trigger a valuable exchange with key opinion leaders and other stakeholders on the proposed strategy...
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...About FIRALIS SAS
Firalis is a privately owned life sciences biotechnology company, creating novel values via biomarker discovery, development and regulatory qualification; to establish an internal portfolio of biomarker-based diagnostic methods and provide customer-tailored biomarker solutions. Firalis is active in the field of cardiovascular, inflammatory and autoimmune diseases... FIRALIS' Press Release -
