Safer and faster evidence-based translation

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Project Title: Safer and faster evidence-based translation
Project Number: CORDIS-203675
Project web address: Follow on CORDIS
Organization: Novartis Pharma Ag, Switzerland, Basel
Collaborators: University Of Liverpool, GB
Charité Universität Medicine, DE
Universidad De Malaga, ES
Universitaet Leipzig, DE
F. Hoffmann - La Roche Ltd., CH
Pfizer Ltd, GB
Assistance Publique - Hopitaux De Paris, FR
Glaxosmithkline Research And Development Limited, GB
Eli Lilly Company Limited, GB
Astra Zeneca Ab, SE
University College Dublin, National University Of Ireland, Dublin, IE
Universitaetsklinikum Aachen, DE
Naturwissenschaftliches Und Medizinisches Institut An Der Universität Tübingen, DE
Bayer Pharma Ag, DE
Consorci Institut Català De Ciències Cardiovasculars, ES
Edi Experimentelle Diagnostische Immunologie Gmbh, DE
Firalis Sas, FR
Sanofi-Aventis Recherche & Developpement, FR
Ekf Diagnostics Limited, IE
Interface Europe, BE
Amgen Nv, BE
Takeda Development Centre Europe Ltd., GB
Boehriger Ingelheim International Gmbh, DE
Tel Aviv Medical Center, IL
Laboratorios Almirall S.A., ES
Project Description:
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 biomarkerapproaches 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.
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