Imaging biomarkers (ibs) for safer drugs: validation of translational imaging methods in drug safety assessment (ib4sd-tristan)

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Project Title: Imaging biomarkers (ibs) for safer drugs: validation of translational imaging methods in drug safety assessment (ib4sd-tristan)
Project Number: CORDIS-209469
Project web address: Follow on CORDIS
 
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.
 
Project Terms:
topic corda chronic toxicity pharmacology pharmacogenomics drug discovery and design drug therapy safety pharmacology pharmaceutical development translational medicine radiology nuclear medicine and medical imaging biomarkers acute toxicity
Project Title: Imaging biomarkers (ibs) for safer drugs: validation of translational imaging methods in drug safety assessment (ib4sd-tristan)
Project Number: CORDIS-209469
Project web address: Follow on CORDIS
Organization: European Organisation For Research And Treatment Of Cancer Aisbl, Belgium, Brussels
Collaborators: University Of Leeds, GB
University Of Sheffield, GB
University Of Manchester, GB
Stichting Katholieke Universiteit, NL
Bayer Ag, DE
Université De Bourgogne, FR
Novo-Nordisk A/S, DK
Pfizer Ltd, GB
Glaxosmithkline Research And Development Limited, GB
Chalmers Tekniska Hoegskola Ab, SE
Sanofi-Aventis Deutschland Gmbh, DE
Ge Healthcare Limited, GB
Abbvie Deutschland Gmbh & Co. Kg, DE
Merck Sharp And Dohme, Corp., US
Lunds Universitet, SE
Academisch Ziekenhuis Groningen, NL
Antaros Medical Ab, SE
Bioxydyn Limited, GB
Truly Labs Ab, SE
Bruker Biospin Mri Gmbh, DE
 
Project Categories:
Natural Sciences
 
Other Information:
Fiscal Year: 2017
Project Start Date: 1 January 2016
Project End Date: 31 December 2021
Project program: H2020-EU.3.1.
 
Project Funding Information:
Year Funding Organization Total Funding, $
2017 European Research Council $27,395,669
Project Title: Imaging biomarkers (ibs) for safer drugs: validation of translational imaging methods in drug safety assessment (ib4sd-tristan)
Project Number: CORDIS-209469
Project web address: Follow on CORDIS
 
Title FY Funding
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Project Title: Imaging biomarkers (ibs) for safer drugs: validation of translational imaging methods in drug safety assessment (ib4sd-tristan)
Project Number: CORDIS-209469
Project web address: Follow on CORDIS
 
Project Title Organization FY Funding
Project Title: Imaging biomarkers (ibs) for safer drugs: validation of translational imaging methods in drug safety assessment (ib4sd-tristan)
Project Number: CORDIS-209469
Project web address: Follow on CORDIS
 
Title Journal Year Country Rel
Project Title: Imaging biomarkers (ibs) for safer drugs: validation of translational imaging methods in drug safety assessment (ib4sd-tristan)
Project Number: CORDIS-209469
Project web address: Follow on CORDIS
 
Title Year
Project Title: Imaging biomarkers (ibs) for safer drugs: validation of translational imaging methods in drug safety assessment (ib4sd-tristan)
Project Number: CORDIS-209469
Project web address: Follow on CORDIS
 
Title Phase Year