IB4SD-TRISTAN
Financiado
Imaging Biomarkers IBs for Safer Drugs Validation of Translational Imaging Me...
Imaging Biomarkers IBs for Safer Drugs Validation of Translational Imaging Methods in Drug Safety Assessment Sofia ref. 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, compartment...
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.
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Duración del proyecto: 93 meses
Fecha Inicio: 2017-03-10
Fecha Fin: 2024-12-31
Fecha Fin: 2024-12-31
Línea de financiación: concedida
El organismo H2020 notifico la concesión del proyecto el día 2017-03-10
Línea de financiación objetivo
El proyecto se financió a través de la siguiente ayuda:
Presupuesto
El presupuesto total del proyecto asciende a
23M€
Líder del proyecto
EUROPEAN ORGANISATION FOR RESEARCH AND TREATM...
No se ha especificado una descripción o un objeto social para esta compañía.
Perfil tecnológico
TRL
4-5
Perfil tecnológico
TRL
4-5
65.63K€ |
Participante
N.D. |
Participante
89.89K€ |
Participante