Cel
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.
Dziedzina nauki
Zaproszenie do składania wniosków
IMI-JU-01-2008
Zobacz inne projekty w ramach tego zaproszenia
System finansowania
JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)Koordynator
4056 Basel
Szwajcaria
Zobacz na mapie
Uczestnicy (25)
72770 Reutlingen
Zobacz na mapie
68330 Huningue
Zobacz na mapie
08022 Barcelona
Zobacz na mapie
1831 Diegem
Zobacz na mapie
Dublin 2 Trinity Technology and Enterprise Centre
Zobacz na mapie
151 85 Sodertaelje
Zobacz na mapie
13353 Berlin
Zobacz na mapie
55218 Ingelheim
Zobacz na mapie
10117 Berlin
Zobacz na mapie
72770 Reutlingen
Zobacz na mapie
RG21 4FA Basingstoke
Zobacz na mapie
75012 Paris
Zobacz na mapie
TW89GS Brentford
Zobacz na mapie
08025 Barcelona
Zobacz na mapie
1000 Bruxelles
Zobacz na mapie
CT13 9NJ Sandwich
Zobacz na mapie
4070 Basel
Zobacz na mapie
64239 Tel Aviv
Zobacz na mapie
94250 GENTILLY
Zobacz na mapie
52074 Aachen
Zobacz na mapie
04109 Leipzig
Zobacz na mapie
L69 7ZX Liverpool
Zobacz na mapie
29016 Malaga
Zobacz na mapie
4 Dublin
Zobacz na mapie
WC2B 4AE London
Zobacz na mapie