SAFE-T

The Consortium composed of complementary partners from EFPIA, SMEs, academic and clinical centers of excellence proposes the SAFE-T (Safer And Faster Evidence-based Translation) project for the establishment of a biomarker (BM) qualification strategy and its validation in clinical BM studies for the translation, performance testing and eventual regulatory qualification of safety BMs for drug-induced kidney, liver and vascular injury (DIKI, DILI and DIVI). SAFE-T objectives will be achieved through innovative biomarker qualification approaches.
The Consortium will deliver a validated generic scientific qualification strategy for translational safety BMs that will be released for discussion to gain public acceptance as a reference guide.
BMs with probable translational utility for DIKI, DILI and DIVI will be qualified for human applications, firstly in exploratory Biomarker Proof of Translation (PoT) studies conducted in small groups of healthy volunteers and patients for proving the translational value of the selected candidates. The performance of selected BMs will be validated in confirmatory Biomarker Proof of Performance (PoP) studies in large patient populations with drug- and non-drug-induced pathologies and with common disorders. On data from clinical studies and validated BM assays, Integrative Data Analysis will be carried out to demonstrate the performance and the added translational-value of BMs in comparison to current gold standards.
BMs will be submitted to the EMEA and FDA to gain approval for certain translational and clinical contexts.
In addition, the biologic/mechanistic understanding of DIKI, DILI, and DIVI-BMs will be investigated for supporting the qualification of translational biomarkers.
The Consortium will establish a project database including human BM profiles and a Biobank for supporting future BM R&D.
SAFE-T will communicate the key results and disseminate this knowledge to identified target audiences via workshops, trainings and media.