Objectif
The public-private consortium composed of complementary SMEs, academic and clinical centers of excellence and EMEA as partner proposes SAFE-T (Safer And Easter Evidence-based Iranslation) project for the establishment of a biomarker (BM) qualification process and its validation in clinical biomarker studies designed for the translation, performance testing and eventual regulatory qualifIcatIon of drug-Induced organ injury (DILl, DIKI and DIVI) safety BM5. SAFE-T objectives will be achieved through innovative biomarker
approaches employing leading BM technologies.
The consortium will deliver a validated generic qualification process for translational safety BMs that will be released for discussion to gain its acceptance as a reference guideline by stakeholders including EFPIA and health authorities.
BM5 with probable translational utility for DIKI, DILl and DIVI and their assays will be qualified for human applications in an innovative “two step fo,ward” approach. First, Biomarker Proof of Translation (POT) studies will be conducted in human disease models for proving the translational value of the selected candidate BMs. Secondly, Biomarker Proof of Performance (PoP) studies will be conducted for BM performance testing in patients with drug-induced and non-drug-induced pathologies and with common disorders. Integrative Data Analysis will be carried out to demonstrate the performance and the added-translational-value of biomarkers in comparison to current standards.
In addition, the consortium will investigate biologic/mechanistic understanding of DIVI-BMs in severe cardiovascular adverse events (sCVAE) that will allow us predicting drug-induced sCVAE risk by diagnostic kits.
The Consortium will establish a database of human BM profiles and a Biobank for supporting future BM R&D.
Champ scientifique
Appel à propositions
IMI-JU-01-2008
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Régime de financement
JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)Coordinateur
4056 Basel
Suisse
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Participants (25)
72770 Reutlingen
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68330 Huningue
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08022 Barcelona
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1831 Diegem
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Dublin 2 Trinity Technology and Enterprise Centre
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151 85 Sodertaelje
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13353 Berlin
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55218 Ingelheim
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10117 Berlin
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72770 Reutlingen
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RG21 4FA Basingstoke
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75012 Paris
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TW89GS Brentford
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08025 Barcelona
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1000 Bruxelles
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CT13 9NJ Sandwich
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4070 Basel
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64239 Tel Aviv
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94250 GENTILLY
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52074 Aachen
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04109 Leipzig
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L69 7ZX Liverpool
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29016 Malaga
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4 Dublin
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WC2B 4AE London
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