Moteur de recherche d’entreprises européennes
Financement de l’UE (12 M €) : Biomarqueurs d’imagerie (IB) pour des médicaments plus sûrs : validation des méthodes d’imagerie translationnelle dans l’évaluation de l’innocuité des médicaments … Hor 01/01/2017 Programme de recherche et d'innovation de l'UE « Horizon »
Vue d’ensemble
Texte
Biomarqueurs d’imagerie (IB) pour des médicaments plus sûrs : validation des méthodes d’imagerie translationnelle dans l’évaluation de l’innocuité des médicaments - Sofia réf. : 116106
1.Our consortium has broad, deep experience of drug development and imaging biomarker (IB) validation. We are internationally recognized experts in transporter biology, animal models of lung injury, toxicology, DCEMRI, compartmental modeling, 1H&129Xe lung MR, and labeling of biologicals with PET and fluorescence tags, together with physicians who care for relevant patients. We have an outstanding record of translating IBs: (a) into animals, (b) into man, (c) into tools which drug developers use with confidence in clinical trials of investigational agents, (d) into regulatory drug development and healthcare. We will develop and validate the required IBs and make them commercially available. 2.Building on our previous work with gadoxetate DCEMRI IBs we will develop and standardise, define sensitivity and specificity in rats, and show valid and comparable data multicentre in human volunteers and patients. 3.We believe the search for IBs of Drug Induced Interstitial Lung Disease (DIILD) should start in DIILD patients. Cancer and rheumatology patients receiving, in their standard care, drugs with DIILD liability, and whose physicians withdraw the drug due to suspected DIILD, will be imaged when symptomatic and followed up. From this we will derive IBs of DIILD which predict outcome. We will also develop IBs from 1H/129Xe MRI and PET to further characterise DIILD, and will back-translate and validate all these IBs in rat models. 4.To better assess biodistribution of biologics, we will thoroughly characterise two well-chosen exemplars in rats, pigs and humans: an antibody biologic and a peptide biologic. We will use 89Zr, 18F and 68Ga PET, fluorescence and MALDI imaging. 5.We will follow an imaging biomarker roadmap to establish (a) that the IBs can be deployed robustly in whatever centre they are needed, (b) the relationship of the IB to underlying biology, (c) how well the IB forecasts clinical outcome, and make appropriate arrangements for dissemination.
https://cordis.europa.eu/project/id/116106
Cette annonce se réfère à une date antérieure et ne reflète pas nécessairement l’état actuel.
