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

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

Address

Avenue E. Mounier 83
1200 Brussels

Belgium

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 241 601

Participants (20)

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BIOXYDYN LIMITED

United Kingdom

EU Contribution

€ 1 991 627

UNIVERSITE DE BOURGOGNE

France

EU Contribution

€ 250 000

CHALMERS TEKNISKA HOEGSKOLA AB

Sweden

EU Contribution

€ 563 003

ACADEMISCH ZIEKENHUIS GRONINGEN

Netherlands

EU Contribution

€ 1 099 795

UNIVERSITY OF LEEDS

United Kingdom

EU Contribution

€ 1 367 686

LUNDS UNIVERSITET

Sweden

EU Contribution

€ 609 785

THE UNIVERSITY OF MANCHESTER

United Kingdom

EU Contribution

€ 1 361 022

STICHTING KATHOLIEKE UNIVERSITEIT

Netherlands

EU Contribution

€ 1 310 232

THE UNIVERSITY OF SHEFFIELD

United Kingdom

EU Contribution

€ 994 512

TRULY LABS AB

Sweden

EU Contribution

€ 644 712

ANTAROS MEDICAL AB

Sweden

EU Contribution

€ 566 025

ABBVIE DEUTSCHLAND GMBH & CO KG

Germany

Bayer Pharma AG

Germany

BRUKER BIOSPIN MRI GMBH

Germany

GE HEALTHCARE LIMITED

United Kingdom

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.

United Kingdom

MERCK SHARP & DOHME CORP

United States

NOVO NORDISK A/S

Denmark

PFIZER LIMITED

United Kingdom

SANOFI-AVENTIS DEUTSCHLAND GMBH

Germany

Project information

Grant agreement ID: 116106

Status

Ongoing project

  • Start date

    1 January 2017

  • End date

    31 December 2021

Funded under:

H2020-EU.3.1.

  • Overall budget:

    € 22 641 050

  • EU contribution

    € 12 000 000

Coordinated by:

EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL

Belgium