Objective
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.
Fields of science
Not validated
Not validated
- medical and health sciencesbasic medicinepharmacology and pharmacydrug discovery
- medical and health sciencesbasic medicinepharmacology and pharmacydrug safety
- medical and health sciencesclinical medicinerheumatology
- medical and health sciencesclinical medicineoncology
- medical and health sciencesbasic medicinetoxicology
Programme(s)
Topic(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
1200 Bruxelles / Brussel
Belgium
See on map
Participants (27)
M1 4DZ MANCHESTER
See on map
21078 Dijon Cedex
See on map
Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
75794 Paris
See on map
412 96 Goteborg
See on map
9713 GZ Groningen
See on map
LS2 9JT Leeds
See on map
Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
LS9 7TF LEEDS
See on map
22100 Lund
See on map
M13 9PL Manchester
See on map
Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
M13 9WL Manchester
See on map
Participation ended
6525 XZ Nijmegen
See on map
S10 2TN Sheffield
See on map
Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
S10 2SB Sheffield
See on map
223 81 Lund
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
431 53 MOLNDAL
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
65205 Wiesbaden
See on map
Participation ended
13353 Berlin
See on map
76275 Ettlingen
See on map
HP8 4SP CHALFONT ST GILES
See on map
WC1A 1DG LONDON
See on map
08889 Whitehouse Station Nj
See on map
2880 Bagsvaerd
See on map
CT13 9NJ Sandwich
See on map
65929 Frankfurt Am Main
See on map
51373 Leverkusen
See on map
1081 HV Amsterdam
See on map
6525 GA Nijmegen
See on map