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Contenido archivado el 2024-06-18

SAFER AND FASTER EVIDENCE-BASED TRANSLATION

Objetivo

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.

Ámbito científico (EuroSciVoc)

Programa(s)

Tema(s)

Convocatoria de propuestas

IMI-JU-01-2008
Consulte otros proyectos de esta convocatoria

Régimen de financiación

JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)

Coordinador

NOVARTIS PHARMA AG
Aportación de la UE
Sin datos
Dirección
LICHTSTRASSE 35
4056 Basel
Suiza
Región
Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Stadt
Tipo de actividad
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Enlaces
Coste total
Sin datos

Participantes (25)

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Última actualización: 28 Marzo 2022

Permalink: https://cordis.europa.eu/project/id/115003/es

European Union, 2026