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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... see more

31/12/2024

EORTC

23M€

Project Budget: 23M€

Project leader

EUROPEAN ORGANISATION FOR RESEARCH AND TREATM... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

PARTICIPATION DEPralty Sin fecha límite de participación.

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Financing granted El organismo H2020 notifico la concesión del proyecto The day 2024-12-31

IMI2-2015-07-01: VALIDATION OF TRANSLATIONAL IMAGING... Specific Challenge:The development of imaging biomarkers both for the pre-clinic and the clinic has...

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Cerrada does 9 years

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Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

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No hay información privada compartida para este proyecto. Habla con el coordinador.

30 Participantes

EORTC

691.48K€ | Leader

TRIA RAILWAY RyD

65.63K€ | participant

CNRS

N.D. | participant

GEHC

89.89K€ | participant

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Project duration: 93 months Date Start: 2017-03-10
End date: 2024-12-31

Project leader

EUROPEAN ORGANISATION FOR RESEARCH AND TREATM... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Project Budget 23M€

participation deadline Sin fecha límite de participación.

Project description 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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