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Financement de l’UE (20 M €) : Améliorer l’évaluation de la sécurité TRANslational grâce à la gestion intégrative des connaissances Hor01/09/2017 Programme de recherche et d'innovation de l'UE « Horizon »
Vue d’ensemble
Texte
Améliorer l’évaluation de la sécurité TRANslational grâce à la gestion intégrative des connaissances
Drug safety assessment is a knowledge-intensive process that demands advancement in data handling methods and tools for facilitating data sharing, mining, analysis and predictive modelling. This need is not restricted to any specific type of data and real advancement requires integrating information of different types and from different sources (e.g. publicly available biomedical knowledge, proprietary preclinical and clinical data, evidence from post-marketing studies) for addressing drug safety assessment from a holistic perspective. The eTRANSAFE project will address these needs by developing a powerful data integration infrastructure (Knowledge Hub) and a collection of computational tools (exploitation modules) for making optimal use of these data. The proposed system will be a flexible and expandable framework, built on previous experience and applying state-of-the-art methods and technologies for providing the most advanced solutions for data sharing, interoperability and exploitation. An experienced honest broker will guarantee the confidentiality of any proprietary data. The project will develop in silico tools for data mining, visualisation, and prediction of potential toxicity, with specific attention to the assessment of the preclinical to clinical predictivity and the discovery of safety biomarkers. The CDISC-SEND format will be supported, facilitating the preparation of regulatory-compliant documentation. This infrastructure will be underpinned by development of open standards and guidelines recognised by regulatory agencies and international organisations. The eTRANSAFE consortium brings together 13 organizations that mobilize an unprecedented capacity and resources, uniquely placed to leverage the experience of eTOX and other EU projects and initiatives. The project partners are six prestigious academic institutions, six highly skilled small-medium enterprises (SME) and one European infrastructure (ELIXIR), bringing in this way a perfect balance.
| Abbvie Inc. | 0,00 € |
| Astrazeneca AB | 0,00 € |
| BASF SE | 0,00 € |
| BAYER AG | 0,00 € |
| 0,00 € | |
| Barcelona Supercomputing Center Centro Nacional de Supercomputacion | 0,00 € |
| Certara UK Ltd. | 260 938 € |
| Clarivate Analytics (UK) Ltd. | 0,00 € |
| Danmarks Tekniske Universitet | 0,00 € |
| 1 972 375 € | |
| Eisai CO Ltd. | 0,00 € |
| Erasmus Universitair Medisch Centrum Rotterdam | 1 544 750 € |
| F. HOFFMANN-LA ROCHE AG | 0,00 € |
| FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG e. V. | 451 000 € |
| Fundacio Institut Hospital del Mar D Investigacions Mediques | 1 884 759 € |
| 863 854 € | |
| Institut de Recherches Internationales Servier Iris | 0,00 € |
| Ipsen Innovation SAS | 0,00 € |
| Janssen Pharmaceutica N.V. | 0,00 € |
| Lhasa Ltd. | 2 930 750 € |
| Liverpool John Moores University | 528 875 € |
| MERCK KGaA | 0,00 € |
| MOLECULAR NETWORKS GmbH COMPUTERCHEMIE | 954 125 € |
| Medbioinformatics Solutions SL | 390 000 € |
| NOVARTIS PHARMA AG | 0,00 € |
| Optibrium Ltd. | 531 500 € |
| PDS Computer Software Ltd. | 553 375 € |
| SANOFI-AVENTIS DEUTSCHLAND GmbH | 0,00 € |
| Synapse Research Management Partners SL | 2 853 375 € |
| 1 754 500 € | |
| Universitat Wien | 878 000 € |
| Universiteit Leiden | 1 647 825 € |
https://cordis.europa.eu/project/id/777365
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