Biomedical Engineering Reference
In-Depth Information
again evaluated by an independent scientifi c committee before it can be
approved.
The fi rst call was launched in 2008 and 15 of the 18 call topics resulted in
consortia projects that made it all the way through to approval. Most consortia
are led by a coordinator from the EFPIA with a deputy coordinator from
academia, although this is not always the case, with PROTECT being led by
the European Medicines Agency (EMA). These 15 consortia involve some 395
teams across Europe and cover the effi cacy, safety, and education and training
themes of the IMI. In terms of effi cacy there are projects in diabetes, asthma,
chronic obstructive pulmonary disease (COPD), cognitive disorders, schizo-
phrenia, and pain.
Safety Projects
• Non - genotoxic carcinogenesis (MARCAR) aims to provide validated
reliable early biomarkers for the prediction of cancer development.
• Expert systems for
in silico
toxicity prediction (eTOX) will develop a
pharmaceutical toxicity database and
in silico
expert systems for the
computational prediction of drug secondary pharmacology and direct
drug - induced toxicity.
• Qualifi cation of translational safety biomarkers (SAFE-T) aims to
develop new specifi c and sensitive safety biomarkers and their respective
assays for human samples to improve predictivity between nonclinical
and early clinical studies.
• Strengthening the monitoring of the benefi t/risk of medicines (PROTECT)
will develop new methodologies in pharmacovigilance and pharmaco-
epidemiology. It is important that these safety projects communicate
regularly with other similar projects both within Europe and without
and where possible avoid duplication of effort. For example, the clinical
IMI projects are complementary to those of the Predictive Safety Testing
Consortium (PSTC), which is focusing on preclinical safety and
toxicity.
Effi cacy Projects
• Islet cell research (IMIDIA) will gain a better understanding of
β
- cell
function and survival.
• The aim of surrogate markers for vascular endpoints (SUMMIT) is to
validate agency acceptable surrogate markers for micro- and macrovas-
cular diabetic complications, thereby enhancing the effi ciency of drug
development studies and shorten clinical trials.
• In pain research, EUROPAIN aims to improve the understanding of
pathways and mechanisms mediating different kinds of pain and develop
markers for patient stratifi cation and quantitative pain assessment for
effi cient testing of new analgesics. This is desperately needed in light of
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