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EU funding (€12M): Imaging Biomarkers (IBs) for Safer Drugs: Validation of Translational Imaging Methods in Drug Safety Assessment - Sofia ref.: 116106 Hor1 Jan 2017 EU Research and Innovation programme "Horizon"
Overview
Text
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, 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.
Funded Companies:
| Company name | Funding amount |
| ABBVIE DEUTSCHLAND GmbH & Co. KG | €0.00 |
| Academisch Ziekenhuis Groningen | €1,010,313 |
| Antaros Medical AB | €566,025 |
| BAYER AG | €0.00 |
| BRUKER BIOSPIN MRI GmbH | €0.00 |
| Bayer Pharma AG | €0.00 |
| Bioxydyn Ltd. | €1,958,392 |
| Centre National de la Recherche Scientifique Cnrs | €0.00 |
| Chalmers Tekniska Hogskola AB | €563,003 |
| European Organisation for Research AND Treatment OF Cancer Aisbl | €691,479 |
| GE Healthcare Ltd. | €0.00 |
| €0.00 | |
| Lunds Universitet | €716,015 |
| Manchester University NHS Foundation Trust | €0.00 |
| €0.00 | |
| Novo Nordisk A/S | €0.00 |
| Pfizer Ltd. | €0.00 |
| SANOFI-AVENTIS DEUTSCHLAND GmbH | €0.00 |
| €0.00 | |
| Stichting Amsterdam UMC | €75,000 |
| Stichting Radboud Universitair Medisch Centrum | €1,310,232 |
| €0.00 | |
| €0.00 | |
| The University of Manchester | €1,361,022 |
| €1,877,036 | |
| Truly Labs AB | €792,146 |
| Universite Dijon Bourgogne | €250,000 |
| University of Leeds | €829,337 |
Source: https://cordis.europa.eu/project/id/116106
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