Activities

The SAFE-T project started on 15 June 2009 and lasts for 5 years. The Consortium has established a scientific strategy to qualify biomarkers for implementation into clinical studies during drug research and development, and to gain regulatory qualification of safety biomarkers for drug-induced kidney, liver and vascular injury (indicated with abbreviations DIKI, DILI and DIVI). The main underlying activities are:

• Definition of clinical qualification processes for safety biomarkers
• Identification of new clinical biomarkers as compared to current standards and criteria of DIKI, DILI & DIVI
• Different assay validation levels for exploratory phase (fit for purpose method) and confirmatory phase (multiplexed and GLP-validated)
• Setting up a common database and biosample repository to be able to build up on any new data set upcoming in the future and to investigate further biomarker candidates
• Establishing baseline values of biomarkers and their variability in healthy subjects and various patient populations
• Run protocols to measure the performance of these biomarkers against current standards in clinical studies and hospital units with expected drug-induced injuries and in patients with relevant diseases
• Qualification of appropriate biomarkers for regulatory decision making in clinical contexts together with heath authorities
• Gaining mechanistic understanding when needed via pre-clinical studies

The work of the project is carried out in 9 work packages as indicated in below with the expected results marked in yellow on the right