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Participation in the EU call INFRASTRUCTURE 2012.1.1.5

EATRIS wants to forward the process of integration and to accelerate the building of European translational research infrastructure
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A leap forward in the effectiveness of biomedical research - for better patient outcomes

EATRIS marks official start to developing Europe’s translational research of the future
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Tracers in molecular imaging

Imaging and Tracers

Molecular imaging has become a vital tool in drug discovery and crucial to contain development costs, speed up the process and increase pipeline output, with several benefits:

  • EFFICACY: Used early in the process (Phase I/II) in small, imaging-enabled trials, dead-end compounds can be eliminated before vast trial expenditures are made. Dose-effect relations can be determined more accurately, improving the quality and efficiency of studies and reducing the risk of overdosing.
  • DEVELOPMENT SPEED: Clinical dose finding studies can be performed much more rapidly and the number of volunteers in Phase I can be reduced by up to 80%. This shortens lead times and thus on-patent, in-market time by up to 6-12 months.
  • PERSONALISED MEDICINE: disease delineation and prognostication, followed by confirmation and quantification of selective drug targeting, and finally by early response and outcome monitoring. With molecular imaging, this can be achieved in patient cohorts displaying heterogeneous disease characteristics, identifying cohorts with the highest potential for a therapeutic benefit.
  • MECHANISM OF ACTION: molecular imaging is an essential tool for understanding disease mechanisms, by visualising and allowing quantification of critical disease targets and molecules, drug candidates or diagnostic agents.

The high-end tracer development and (molecular) imaging pipeline comprises the following key components: (1) a target re-validation facility to confirm the status and biological importance of a disease-specific target, (2) a tracer production facility comprising cyclotrons and hot cells for the preparation of PET tracers as well as labs for preparation of other types of disease-specific contrast agents as used in SPECT, MRI and optical imaging (contrast agents collectively called "tracers"), (3) animal facilities using animal models of relevance for studying major as well as orphan human health problems in the field of oncology, neurology, immunology, cardiovascular and infectious diseases, and others (4) labs for tracer metabolite analysis to study metabolism and degradation of tracers, thus facilitating the quantification and interpretation of the imaging signals, (5) preclinical imaging labs comprising PET, SPECT, (ultra high field) MRI, US, optical and hybrid scanners for (quantitative) assessment of tracer kinetics in various biological and pathological models, (6) GMP facilities and hot cells EU certified for tracer production for "human use", (7) clinical trial centers with access to patient cohorts representing major as well as orphan human health problems (8) clinical imaging centers comprising PET, SPECT, (ultra high field) MRI, US, optical and hybrid scanners for optimal and reproducible acquirement of multimodality imaging data, and (9) data analyses centers for optimal and standardized handling, processing and storage of multimodality imaging data, and potential coupling of these data to other sets of data using appropriate ICT infrastructures. Tracer kinetics is analyzed using an array of compartment and non-compartment methods. A key issue is data sharing to facilitate multi-center trials within the EATRIS network. Users may make use of the whole imaging pipeline, or of some defined key elements.