The Innovative Medicines Initiative (IMI), a unique partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA), recently announced that the QuIC-ConCePT (Quantitative Imaging in Cancer: Connecting Cellular Processes with Therapy) consortium has been awarded a grant to study imaging biomarkers (IBs) for anticancer drug development.

QuIC-ConCePT is coordinated by AstraZeneca and managed by the EORTC. A major objective of QuIC-ConCePT is to qualify IBs of tumor cell proliferation, apoptosis, and necrosis that will allow drug developers to reliably demonstrate the modulation of these pathologic processes in tumors in patients in cancer clinical trials.

It is envisioned that by 2016, drug developers will be able to incorporate these IBs in Phase I trials of investigational therapies and be confident that the IBs are technically valid, that a measured change in the IBs faithfully reflects the desired change in the underlying tumor pathology, and that the IBs can be readily deployed in multiple cancer centers in a robust, consistent, ethical, and cost-effective way acceptable to the patients.

Biomarkers of tumor cell proliferation and necrosis will be developed from 3′-deoxy-3′-[18F] fluorothymidine (FLT) positron emission tomography (PET) and apparent self-diffusion coefficient (ADC) of water protons measured by magnetic resonance imaging (MRI), respectively. Recognizing that the science around apoptosis tracers is less secure, studies will initially focus on the novel isatin-5 sulfonamide PET tracer [18F]ICMT-11 (ICMT-11), but the work plan allows additional or alternative apoptosis tracers to be utilized in later years.

A more exploratory objective of QuIC-ConCePT includes a portfolio of highly innovative approaches to devise, evaluate, and introduce IBs of invasion and metastasis.

Overall, QuIC-ConCePT will be delivered using a creative and comprehensive portfolio of animal, human, image analysis, and regulatory work. The project plans to deliver image acquisition and analysis protocols which are technically valid, standardized, and suitable for multicenter use. The plan is to evaluate these IBs, assess their reproducibility, effects of intervention, timing, dose-response, and imaging-histopathology correlation in animals and patients.

Platforms for data acquisition, analysis, and dissemination will be standardized and integrated across the consortium in order to support this project, and an approach based on data collection, transfer, and archiving mechanisms jointly developed by two of the QuIC-ConCePT partners, the EORTC and Keosys, will be adopted.

The IMI aims to support faster discovery and development of better medicines for patients and enhance Europe’s competitiveness by ensuring a dynamic European biopharmaceutical sector. QuIC-ConCePT has been given a unique opportunity to deliver tools which will markedly improve drug development and benefit cancer patients not only in Europe but worldwide.

QuIC-ConCePT participants include:

EFPIA Partners
AstraZeneca (Coordinator)
Eli Lilly (Lilly), Germany
Merck Serono
Sanofi Aventis

Academic Partners
EORTC (Managing Entity)
Cancer Research UK
Manchester Cancer Research Centre
European Institute for Molecular Imaging at the Westfälische Wilhelms-Universität Münster
Radboud University Nijmegen Medical Center
Université Paris Diderot
Stichting Maastricht Radiation Oncology “Maastro Clinic”
VUmc Amsterdam
Guys and St. Thomas NHS Trust
Universitair Ziekenhuis Antwerpen
The Institute of Cancer Research – Royal Cancer Hospital
Erasmus Universitair Medisch Centrum Rotterdam
Imperial College London
Eidgenössische Technische Hochschule Zürich

SME Partners

John Bean

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