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Imaging Biomarkers (IBs) for Safer Drugs: Validation of Translational Imaging Methods in Drug Safety Assessment - Sofia ref.: 116106

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.

Call for proposal

H2020-JTI-IMI2-2015-07-two-stage
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Funding Scheme

IMI2-RIA - Research and Innovation action

Coordinator

EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL
Address
Avenue E. Mounier 83
1200 Brussels
Belgium
Activity type
Research Organisations
EU contribution
€ 1 180 901

Participants (21)

BIOXYDYN LIMITED
United Kingdom
EU contribution
€ 1 958 392
Address
Rutherford House, Pencroft Way
M15 6SZ Manchester
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITE DIJON BOURGOGNE
France
EU contribution
€ 250 000
Address
Esplanade Erasme Maison De L Universite
21078 Dijon Cedex
Activity type
Higher or Secondary Education Establishments
CHALMERS TEKNISKA HOEGSKOLA AB
Sweden
EU contribution
€ 563 003
Address
-
41296 Goeteborg
Activity type
Higher or Secondary Education Establishments
ACADEMISCH ZIEKENHUIS GRONINGEN
Netherlands
EU contribution
€ 1 010 313
Address
Hanzeplein 1
9713 GZ Groningen
Activity type
Higher or Secondary Education Establishments
UNIVERSITY OF LEEDS
United Kingdom
EU contribution
€ 829 337
Address
Woodhouse Lane
LS2 9JT Leeds
Activity type
Higher or Secondary Education Establishments
LUNDS UNIVERSITET
Sweden
EU contribution
€ 716 015
Address
Paradisgatan 5C
22100 Lund
Activity type
Higher or Secondary Education Establishments
THE UNIVERSITY OF MANCHESTER
United Kingdom
EU contribution
€ 1 361 022
Address
Oxford Road
M13 9PL Manchester
Activity type
Higher or Secondary Education Establishments
STICHTING KATHOLIEKE UNIVERSITEIT
Netherlands
EU contribution
€ 1 310 232
Address
Geert Grooteplein Noord 9
6525 EZ Nijmegen
Activity type
Higher or Secondary Education Establishments
THE UNIVERSITY OF SHEFFIELD
United Kingdom
EU contribution
€ 1 462 614
Address
Firth Court Western Bank
S10 2TN Sheffield
Activity type
Higher or Secondary Education Establishments
TRULY LABS AB
Sweden
EU contribution
€ 792 146
Address
Medicon Village
223 81 Lund
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ANTAROS MEDICAL AB
Sweden
EU contribution
€ 566 025
Address
Bioventure Hub Pepparedsleden 1
431 83 Molndal
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ABBVIE DEUTSCHLAND GMBH & CO KG
Germany
EU contribution
€ 0
Address
Mainzer Str. 81
65205 Wiesbaden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Bayer Pharma AG

Participation ended

Germany
EU contribution
€ 0
Address
Muellerstrasse 178
13353 Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BRUKER BIOSPIN MRI GMBH
Germany
EU contribution
€ 0
Address
Rudolf-plank-strasse 23
76275 Ettlingen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
GE HEALTHCARE LIMITED
United Kingdom
EU contribution
€ 0
Address
Amersham Place
HP7 9NA Little Chalfont
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.
United Kingdom
EU contribution
€ 0
Address
Great West Road 980
TW89GS Brentford
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
MERCK SHARP & DOHME CORP
United States
EU contribution
€ 0
Address
One Merck Drive
08889 Whitehouse Station Nj
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
NOVO NORDISK A/S
Denmark
EU contribution
€ 0
Address
Novo Alle 1
2880 Bagsvaerd
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
PFIZER LIMITED
United Kingdom
EU contribution
€ 0
Address
Ramsgate Road
CT13 9NJ Sandwich
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SANOFI-AVENTIS DEUTSCHLAND GMBH
Germany
EU contribution
€ 0
Address
Bruningstrasse 50
65929 Frankfurt Am Main
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BAYER AKTIENGESELLSCHAFT
Germany
EU contribution
€ 0
Address
Kaiser-wilhelm-allee 1
51373 Leverkusen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)