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IB4SD-TRISTAN SIGNED

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

Total Cost €

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EC-Contrib. €

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Partnership

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 IB4SD-TRISTAN project word cloud

Explore the words cloud of the IB4SD-TRISTAN project. It provides you a very rough idea of what is the project "IB4SD-TRISTAN" about.

data    suspected    followed    lung    outstanding    sensitivity    rheumatology    dcemri    labeling    disease    building    investigational    multicentre    biodistribution    liability    care    translating    record    validation    biologics    predict    fluorescence    chosen    robustly    68ga       physicians    thoroughly    characterise    developers    peptide    89zr    relationship    biomarker    appropriate    valid    transporter    symptomatic    deep    animal    mr    cancer    tags    imaging    18f    start    humans    exemplars    drug    back    clinical    toxicology    drugs    search    human    compartmental    underlying    injury    broad    patients    derive    outcome    biology    imaged    129xe    healthcare    tools    regulatory    models    antibody    pet    diild    trials    receiving    follow    rats    ibs    experts    whatever    roadmap    confidence    mri    man    rat    arrangements    specificity    translate    biologic    biologicals    volunteers    gadoxetate    validate    believe    internationally    1h    centre    pigs    ib    agents    standard    forecasts    standardise    withdraw    animals    maldi    interstitial    commercially    modeling   

Project "IB4SD-TRISTAN" data sheet

The following table provides information about the project.

Coordinator
EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL 

Organization address
address: Avenue E. Mounier 83
city: Brussels
postcode: 1200
website: www.eortc.be

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Belgium [BE]
 Project website https://www.imi-tristan.eu
 Total cost 22˙641˙050 €
 EC max contribution 12˙000˙000 € (53%)
 Programme 1. H2020-EU.3.1.7. (Innovative Medicines Initiative 2 (IMI2))
 Code Call H2020-JTI-IMI2-2015-07-two-stage
 Funding Scheme IMI2-RIA
 Starting year 2017
 Duration (year-month-day) from 2017-01-01   to  2021-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL BE (Brussels) coordinator 1˙241˙601.00
2    BIOXYDYN LIMITED UK (MANCHESTER) participant 1˙991˙627.00
3    UNIVERSITY OF LEEDS UK (LEEDS) participant 1˙367˙686.00
4    THE UNIVERSITY OF MANCHESTER UK (MANCHESTER) participant 1˙361˙022.00
5    STICHTING KATHOLIEKE UNIVERSITEIT NL (NIJMEGEN) participant 1˙310˙232.00
6    ACADEMISCH ZIEKENHUIS GRONINGEN NL (GRONINGEN) participant 1˙099˙795.00
7    THE UNIVERSITY OF SHEFFIELD UK (SHEFFIELD) participant 994˙512.00
8    TRULY LABS AB SE (LUND) participant 644˙712.00
9    LUNDS UNIVERSITET SE (LUND) participant 609˙785.00
10    ANTAROS MEDICAL AB SE (MOLNDAL) participant 566˙025.00
11    CHALMERS TEKNISKA HOEGSKOLA AB SE (GOETEBORG) participant 563˙003.00
12    UNIVERSITE DIJON BOURGOGNE FR (DIJON CEDEX) participant 250˙000.00
13    ABBVIE DEUTSCHLAND GMBH & CO KG DE (WIESBADEN) participant 0.00
14    Bayer Pharma AG DE (Berlin) participant 0.00
15    BRUKER BIOSPIN MRI GMBH DE (ETTLINGEN) participant 0.00
16    GE HEALTHCARE LIMITED UK (LITTLE CHALFONT) participant 0.00
17    GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD. UK (BRENTFORD) participant 0.00
18    MERCK SHARP & DOHME CORP US (WHITEHOUSE STATION NJ) participant 0.00
19    NOVO NORDISK A/S DK (BAGSVAERD) participant 0.00
20    PFIZER LIMITED UK (SANDWICH) participant 0.00
21    SANOFI-AVENTIS DEUTSCHLAND GMBH DE (FRANKFURT AM MAIN) participant 0.00

Map

 Project 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.

 Deliverables

List of deliverables.
Free-breathing 3D acquisition protocol for pre-clinical MRI Websites, patent fillings, videos etc. 2020-04-24 02:25:35
Manuscript on the progression of bleomycin induced inflammation and fibrosis in rats imaged by MRI/CT Documents, reports 2020-04-24 02:25:35
Manuscript on novel 89Zr chelates for protein labeling Documents, reports 2020-04-24 02:25:35
Manuscript for phantom imaging reproducibility Documents, reports 2020-04-24 02:25:35
Manuscript for reviews on ILD imaging in humans Documents, reports 2020-04-24 02:25:35
Free-breathing 3D acquisition protocol for clinical MRI Websites, patent fillings, videos etc. 2020-04-24 02:25:35
Gadoxetate imaging model software Websites, patent fillings, videos etc. 2020-04-24 02:25:35
Manuscript for a review on current 89Zr chelates for protein labeling Documents, reports 2020-04-24 02:25:34
Review 1 for liver transporter assessment by imaging Documents, reports 2020-04-24 02:25:34
Phantom QC for clinical MRI scanner stability over time Websites, patent fillings, videos etc. 2020-04-24 02:25:34
optimized data acquisition of 129 Xe MRI Websites, patent fillings, videos etc. 2020-04-24 02:25:34
Workplan for pre-clinical BSEP-probe evaluation Documents, reports 2020-04-24 02:25:34
Phantom QC for rat MRI scanner stability over time Websites, patent fillings, videos etc. 2020-04-24 02:25:34
Open-access website for validation SOP download Websites, patent fillings, videos etc. 2020-04-24 02:25:34

Take a look to the deliverables list in detail:  detailed list of IB4SD-TRISTAN deliverables.

 Publications

year authors and title journal last update
List of publications.
2017 Sandra Heskamp, René Raavé, Otto Boerman, Mark Rijpkema, Victor Goncalves, Franck Denat
89 Zr-Immuno-Positron Emission Tomography in Oncology: State-of-the-Art 89 Zr Radiochemistry
published pages: 2211-2223, ISSN: 1043-1802, DOI: 10.1021/acs.bioconjchem.7b00325
Bioconjugate Chemistry 28/9 2020-04-24
2018 Sarah Skeoch, Nicholas Weatherley, Andrew Swift, Alexander Oldroyd, Christopher Johns, Conal Hayton, Alessandro Giollo, James Wild, John Waterton, Maya Buch, Kim Linton, Ian Bruce, Colm Leonard, Stephen Bianchi, Nazia Chaudhuri
Drug-Induced Interstitial Lung Disease: A Systematic Review
published pages: 356, ISSN: 2077-0383, DOI: 10.3390/jcm7100356
Journal of Clinical Medicine 7/10 2020-04-24

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