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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.

Coordinator

EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL
Net EU contribution
€ 691 479,00
Address
Avenue E. Mounier 83
1200 Brussels
Belgium

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Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Research Organisations
Non-EU contribution
€ 1,37

Participants (27)

BIOXYDYN LIMITED
United Kingdom
Net EU contribution
€ 1 958 392,00
Address
Rutherford House, Pencroft Way
M15 6SZ Manchester

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Region
North West (England) Greater Manchester Manchester
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
UNIVERSITE DIJON BOURGOGNE
France
Net EU contribution
€ 204 864,00
Address
Esplanade Erasme Maison De L Universite
21078 Dijon Cedex

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Region
Bourgogne-Franche-Comté Bourgogne Côte-d’Or
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 156 698,50
Third-party

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.

CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS
France
Net EU contribution
€ 45 136,00
Address
Rue Michel Ange 3
75794 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
CHALMERS TEKNISKA HOGSKOLA AB
Sweden
Net EU contribution
€ 563 003,00
Address
-
412 96 Goteborg

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Region
Södra Sverige Västsverige Västra Götalands län
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 1,50
ACADEMISCH ZIEKENHUIS GRONINGEN
Netherlands
Net EU contribution
€ 1 010 313,00
Address
Hanzeplein 1
9713 GZ Groningen

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Region
Noord-Nederland Groningen Overig Groningen
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIVERSITY OF LEEDS
United Kingdom
Net EU contribution
€ 818 243,00
Address
Woodhouse Lane
LS2 9JT Leeds

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Region
Yorkshire and the Humber West Yorkshire Leeds
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Third-party

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.

THE LEEDS TEACHING HOSPITALS NATIONAL HEALTH SERVICE TRUST
United Kingdom
Net EU contribution
€ 11 094,00
Address
St James's University Hospital, Beckett Street
LS9 7TF Leeds

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Region
Yorkshire and the Humber West Yorkshire Leeds
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,75
LUNDS UNIVERSITET
Sweden
Net EU contribution
€ 716 015,00
Address
Paradisgatan 5c
22100 Lund

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Region
Södra Sverige Sydsverige Skåne län
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
THE UNIVERSITY OF MANCHESTER
United Kingdom
Net EU contribution
€ 1 140 882,25
Address
Oxford Road
M13 9PL Manchester

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Region
North West (England) Greater Manchester Manchester
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 1,00
Third-party

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.

MANCHESTER UNIVERSITY NHS FOUNDATION TRUST
United Kingdom
Net EU contribution
€ 220 139,75
Address
Oxford Road
M13 9WL Manchester

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Region
North West (England) Greater Manchester Manchester
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
STICHTING RADBOUD UNIVERSITEIT

Participation ended

Netherlands
Net EU contribution
€ 0,00
Address
Houtlaan 4
6525 XZ Nijmegen

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Region
Oost-Nederland Gelderland Arnhem/Nijmegen
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
THE UNIVERSITY OF SHEFFIELD
United Kingdom
Net EU contribution
€ 1 564 036,00
Address
Firth Court Western Bank
S10 2TN Sheffield

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Region
Yorkshire and the Humber South Yorkshire Sheffield
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 1,50
Third-party

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.

SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST
United Kingdom
Net EU contribution
€ 313 000,00
Address
Beech Hill Road 8
S10 2SB Sheffield

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Region
Yorkshire and the Humber South Yorkshire Sheffield
Activity type
Research Organisations
Non-EU contribution
€ 0,00
TRULY LABS AB
Sweden
Net EU contribution
€ 792 146,00
Address
Medicon Village
223 81 Lund

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Södra Sverige Sydsverige Skåne län
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,25
ANTAROS MEDICAL AB
Sweden
Net EU contribution
€ 566 025,00
Address
Bioventure Hub Pepparedsleden 1
431 83 Molndal

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Södra Sverige Västsverige Västra Götalands län
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
ABBVIE DEUTSCHLAND GMBH & CO KG
Germany
Net EU contribution
€ 0,00
Address
Mainzer Str. 81
65205 Wiesbaden

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Region
Darmstadt Wiesbaden, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 1 400 000,00
Bayer Pharma AG

Participation ended

Germany
Net EU contribution
€ 0,00
Address
Muellerstrasse 178
13353 Berlin

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Region
Berlin Berlin Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
BRUKER BIOSPIN MRI GMBH
Germany
Net EU contribution
€ 0,00
Address
Rudolf-plank-strasse 23
76275 Ettlingen

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Region
Baden-Württemberg Karlsruhe Karlsruhe, Landkreis
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 508 000,00
GE HEALTHCARE LIMITED
United Kingdom
Net EU contribution
€ 0,00
Address
Amersham Place
HP7 9NA Little Chalfont

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Region
South East (England) Berkshire, Buckinghamshire and Oxfordshire Buckinghamshire CC
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 89 891,00
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.
United Kingdom
Net EU contribution
€ 0,00
Address
Great West Road 980
TW89GS Brentford

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Region
London Outer London — West and North West Hounslow and Richmond upon Thames
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 1 763 130,00
MERCK SHARP & DOHME CORP
United States
Net EU contribution
€ 0,00
Address
One Merck Drive
08889 Whitehouse Station Nj

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 335 600,00
NOVO NORDISK A/S
Denmark
Net EU contribution
€ 0,00
Address
Novo Alle 1
2880 Bagsvaerd

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Region
Danmark Hovedstaden Københavns omegn
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 1 000 000,00
PFIZER LIMITED
United Kingdom
Net EU contribution
€ 0,00
Address
Ramsgate Road
CT13 9NJ Sandwich

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Region
South East (England) Kent East Kent
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 100 000,00
SANOFI-AVENTIS DEUTSCHLAND GMBH
Germany
Net EU contribution
€ 0,00
Address
Bruningstrasse 50
65929 Frankfurt Am Main

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Region
Baden-Württemberg Stuttgart Stuttgart, Stadtkreis
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 660 000,00
BAYER AKTIENGESELLSCHAFT
Germany
Net EU contribution
€ 0,00
Address
Kaiser-wilhelm-allee 1
51373 Leverkusen

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Region
Nordrhein-Westfalen Köln Leverkusen, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 4 711 296,00
STICHTING VUMC
Netherlands
Net EU contribution
€ 75 000,00
Address
De Boelelaan 1117
1081 HV Amsterdam

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Region
West-Nederland Noord-Holland Groot-Amsterdam
Activity type
Research Organisations
Non-EU contribution
€ 0,00
STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM
Netherlands
Net EU contribution
€ 1 310 232,00
Address
Geert Grooteplein 10 Zuid
6525 GA Nijmegen

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Region
Oost-Nederland Gelderland Arnhem/Nijmegen
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00