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 EN COURS 
The vision of EU-ToxRisk is to drive a paradigm shift in toxicology towards an animal-free, mechanism-based integrated approach to chemical safety assessment. The project will unite all relevant disciplines and stakeholders to establish: i) pragmatic, solid read-across procedures incorporating mechanistic and toxicokinetic knowledge; and ii) ab initio hazard and risk assessment strategies of chemi ...
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 43

 TERMINÉ 
COSYN integrates outstanding European academic and three large Pharma to exploit genomic findings for intellectual disability (ID), autism, and schizophrenia. We capitalise on comorbidity, from clinic to cells and synapses, and have access to large existing samples. We focus on rare genetic variants of strong effect in patients with clinical comorbidity. Our aims are: (1) Understand comorbidity by ...
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 14

 TERMINÉ 

Translating neuroimaging findings from research into clinical practice (PSYSCAN)

Date du début: 1 févr. 2014, Date de fin: 31 janv. 2020,

Abstract 9Neuroimaging (NI) has enormous potential to improve the clinical care of patients with psychiatric disorders, but has yet to deliver. The PSYSCAN project will address this issue directly by developing a NI-based tool that will help clinicians resolve key clinical issues in the management of patients with psychotic disorders. Clinicians will use the tool to assess patients with a standard ...
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 24

 TERMINÉ 
Age-related macular degeneration (AMD) is the world’s most important age-related blinding disorder. The current proposal utilises epidemiological data describing clinical phenotype, molecular genetics, lifestyle, nutrition, and in-depth retinal imaging derived from existing longitudinal European epidemiological cohorts and biobanks to provide three major insights needed for long-lasting prevention ...
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 13

 TERMINÉ 

Intelligent Assessment of Pharmaceutical in the Environment (IPIE)

Date du début: 1 janv. 2015, Date de fin: 31 déc. 2018,

Active pharmaceutical ingredients (APIs) can be released to the natural environment during the manufacturing process, following use by patients or when unused medicines are disposed of. As APIs are biologically active compounds concerns have been raised about the potential effects of APIs in the environment on human and environmental health. Over the past 15 years, a substantial amount of work has ...
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 29

 TERMINÉ 

Hepatic and Cardiac Toxicity Systems modelling (HECATOS)

Date du début: 1 oct. 2013, Date de fin: 30 sept. 2018,

HeCaToS aims at developing integrative in silico tools for predicting human liver and heart toxicity. The objective is to develop an integrated modeling framework, by combining advances in computational chemistry and systems toxicology, for modelling toxic perturbations in liver and heart across multiple scales. This framework will include vertical integrations of representations from drug(metabol ...
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 14

 TERMINÉ 

European Medical Information Framework (EMIF)

Date du début: 1 janv. 2013, Date de fin: 31 déc. 2017,

In response to the need to tackle increasingly complex medical research questions, a growing amount of human health data is being collected, either in routine Electronic Healthcare Record (EHR) databases, through research-driven cohort studies, in biobanks or related efforts. However, data sources are typically fragmented and contain information gaps which prevent their full exploitation. EMIF aim ...
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 64

 TERMINÉ 
The QuIC-ConCePT consortium has 2 objectives: 1.(90% of resource, WP2-5) to qualify 3 specific imaging biomarkers (IBs) of tumour cell proliferation, apoptosis, and necrosis, to allow drug developers to demonstrate reliably modulation of these pathologic processes in tumours in patients in realistic trials. Our vision for January 2016 is that drug developers can incorporate these IBs for decision- ...
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 26

 TERMINÉ 

Kinetics for Drug Discovery (K4DD) (K4DD)

Date du début: 1 nov. 2012, Date de fin: 31 oct. 2017,

There is mounting evidence that the often ignored kinetic aspects of the interaction between a drug and its target are highly relevant for clinical success. This ignorance may be one of the reasons for the high attrition rates in drug discovery, as it has been analyzed that many recently marketed drugs had indeed improved kinetic profiles. This hindsight knowledge needs to be converted into data-d ...
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 21

 TERMINÉ 
Since its inception the IMI has funded over 30 public-private partnership projects. Many of these projects are centered upon data intensive translational research and are employing integrative analysis approaches to achieve their goals. Although a common KM platform for IMI projects was envisioned in the original IMI Strategic Research Agenda it has not yet been implemented. The lack of a common p ...
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 17

 TERMINÉ 

Deciphering inter- and intracellular signalling in schizophrenia (IN-SENS)

Date du début: 1 oct. 2013, Date de fin: 30 sept. 2017,

IN-SENS is an interdisciplinary, cutting-edge European industry-academia collaborative effort for a novel training of scientists in molecular psychiatry with the prospect of discovering the biology of schizophrenia and actively promote drug discovery. Mental illnesses are a major burden to patients, relatives, and public health worldwide. IN-SENS therefore aims to profoundly change the academic-in ...
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 16

 TERMINÉ 

DRIVING RE-INVESTMENT IN R&D AND RESPONSIBLE ANTIBIOTIC USE (DRIVE-AB)

Date du début: 1 oct. 2014, Date de fin: 30 sept. 2017,

Antimicrobial resistance (AMR) is widespread. Its global human and economic burden is tremendous and increasing annually. Yet today only a few pharmaceutical companies retain active antibacterial drug discovery programmes. While the elaboration of antibiotics with novel mechanisms of action is scientifically complex, the chief challenge is diminishing incentives. Pre-market regulatory requirements ...
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 27

 TERMINÉ 
StemBANCC, comprising internationally renowned investigators, is ideally positioned to deliver a unique European biorepository and drug discovery pipeline based upon human induced pluripotent stem cells (hiPSC). This unrivalled opportunity will address the pressing therapeutic need in neurodegeneration, neurodysfunction and diabetes. We have immediate access to richly phenotyped subjects with a we ...
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 38

 TERMINÉ 
Despite the increasing number of macromolecules with potential impact in the treatment of devastating systemic diseases, these therapies have failed to deliver on their expectations because they cannot be administered in the fashion which is most cost efficient and has the highest patient compliance: the oral route. The availability of an oral form of administration could lead to a great improveme ...
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 20

 TERMINÉ 
Despite dramatic advances in molecular and imaging technologies, there are currently no effective pharmacological treatments for the core symptoms of autism spectrum disorder (ASD). Major obstructions to this include a lack of aetiologically-driven or pathophysiologically-accurate animal models; an absence of tests that indicate efficacy; and reliance of clinical trials on DSM/ICD10 categories wh ...
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 29

 TERMINÉ 

European Patients' Academy on Therapeutic Innovation (EUPATI)

Date du début: 1 févr. 2012, Date de fin: 31 janv. 2017,

"The proposed project ""European Patients' Academy on Therapeutic Innovation"" (EUPATI) contributes to IMI’s goal of raising patients’ awareness and participation in pharmaceutical R&D. This patient-led academy will provide scientifically reliable, objective, comprehensive information to patients on pharmaceutical R&D. It will increase the capacity of well-informed patients to be effective advocat ...
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 33

 TERMINÉ 
We propose here an exhaustive analysis of the genome, exome, methylome and transcriptome of primary tumours and metastases from patients with colon carcinoma, based on a combination of deep sequencing and chip based techniques. Dependent on their availability, we shall also perform analyses of tumor stem cells, circulating tumor cells, free tumor DNA in serum and xenografts derived from the same p ...
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 22

 TERMINÉ 

Incorporating real-life clinical data into drug development (GETREAL)

Date du début: 1 oct. 2013, Date de fin: 31 déc. 2016,

When a new medicine reaches the market, it is accompanied by an extensive data package that provides information about the safety and efficacy of the medicine in a clinical trial setting. However, assessing the expected future value of the medicines when used in “real world” clinical practice requires additional information next to traditional (pre-authorisation) clinical trials. Regulatory, HTA ...
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 32

 TERMINÉ 
The eTOX consortium proposes to develop innovative methodological strategies and novel software tools to better predict the toxicological profiles of new molecular entities in early stages of the drug development pipeline. This will be achieved by coordinating the efforts of specialists from academia and SMEs in the wide scope of disciplines that are required to move towards a more reliable modell ...
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 30

 TERMINÉ 
Background:In current drug safety education and training in Europe, an integrative and translational approach is lacking. This shortfall has been identified by EUFEPS. The IMI (‘Strategic Research Agenda’), the FDA and the EMEA have also characterised this fact as a crucial gap in the education and training of scientists evaluating the safety of drug candidates and new medicines. Scope and objecti ...
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 34

 TERMINÉ 

European Medicines Research Training Network (EMTRAIN)

Date du début: 1 oct. 2009, Date de fin: 30 sept. 2016,

EMTRAIN is an essential element for the success of the IMI Education & Training (E&T) Call Topics in Europe (current and future). It will establish a pan-European platform of excellence for education and training covering the whole life-cycle of medicines from basic research through clinical development to pharmaco-vigilance. It will underpin the successful delivery of the current and future IMI-f ...
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 32

 TERMINÉ 

Drug Disease Model Resources (DDMORE)

Date du début: 1 mars 2011, Date de fin: 31 août 2016,

Model based-drug development (MBDD) is accepted as a vital approach in understanding patient risk/benefit and attrition. At the core of MBDD lies Modelling and Simulation (M&S), a technology providing the basis for informed, quantitative decision-making.M&S facilitates the continuous integration of available information related to a drug or disease into constantly-evolving mathematical models capa ...
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 28

 TERMINÉ 

European programme in Pharmacovigilance and Pharmacoepidemiology (EU2P)

Date du début: 1 sept. 2009, Date de fin: 30 juin 2016,

The Eu2P training network in Pharmacovigilance and Pharmacoepidemiology will meet the needs of industry,regulatory authorities and academia at the European level. It will give access to a harmonised training programme that gathers complementary specialized and eminent European partners. The Eu2P consortium consists of course providers with aproven record including the University of Bordeaux (Eu2P ...
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 24

 TERMINÉ 
Traditional preclinical discovery methods, particularly for target validation, poorly predict drug efficacy, causing a high attrition rate in costly late-stage clinical trials. The PREDECT consortium will focus on complex but transferable, next generation in vitro and in vivo models for breast, prostate and lung cancers. Models will be investigated for their improved potential to validate novel th ...
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 23

 TERMINÉ 

Electronic Health Record systems for Clinical Research (EHR4CR)

Date du début: 1 mars 2011, Date de fin: 29 févr. 2016,

Current medical needs, the growth of targeted therapies and personalized medicines, and escalating R&D costs result in formidable cost pressures on healthcare systems and the pharmaceutical industry. Clinical research is also growing in complexity, labour intensity and cost. There is a growing realization that the development and integration of Electronic Health Record systems (EHRs) for medical ...
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 37

 TERMINÉ 
PHARMA-COG aims to develop a new integrated model to accelerate the development of drug cindidates for MS, PKD and AD. The innovation relies on a 'multidimensional matrix' approach, integrating all available and renewed inputs (biomarkers/animal, human models/physiological and pharmcological challenges, Phase 0/1/1b to reduce the attrition rate, to allow an early and pertinent GO/NOGO decision bef ...
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 38

 TERMINÉ 
Diabetes mellitus is a lifelong, incapacitating disease affecting multiple organs. Worldwide prevalence figures estimate that there will be 246 million diabetic patients in 2007 and 380 million in 2025. Presently, diabetes can neither be prevented nor cured and the disease is associated with devastating chronic complications including coronary heart disease and stroke (macrovascular disease) as we ...
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 27

 TERMINÉ 
In the understanding of the initiation and development of several diseases revolutionary changes are currently taking place. Cancer and brain diseases are examples of medical fields where new technologies are finding their way into research and applications, radically altering the way the diseases are being diagnosed and treated. Especially methods that yield information on molecular and cellular ...
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 10

 TERMINÉ 
An absolute or relative loss of beta-cell mass and function underlie the development of type I and type 2 diabetes.Preventing beta-cell demise or restoring their number and function is a major therapeutic goal. However,development of novel diagnostic and prognostic tools, and of novel therapeutic modalities, is hampered by the limited knowledge of the molecular pathways that control beta-cell demi ...
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 23

 TERMINÉ 

Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED)

Date du début: 1 oct. 2009, Date de fin: 30 sept. 2015,

RationaleThe inability of pre-clinical studies to predict clinical efficacy is a major bottleneck in drug development. In severe asthma this bottleneck results from: a lack of useful and validated biomarkers, underperforming pre-clinical models, inadequate and incomplete sub-phenotyping, and insufficient disease understanding.HypothesisThe use of biomarker profiles comprised of various types of hi ...
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 42

 TERMINÉ 

SAFER AND FASTER EVIDENCE-BASED TRANSLATION (SAFE-T)

Date du début: 15 juin 2009, Date de fin: 14 juin 2015,

The public-private consortium composed of complementary SMEs, academic and clinical centers of excellence and EMEA as partner proposes SAFE-T (Safer And Easter Evidence-based Iranslation) project for the establishment of a biomarker (BM) qualification process and its validation in clinical biomarker studies designed for the translation, performance testing and eventual regulatory qualifIcatIon of ...
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 26

 TERMINÉ 
Pre-approval clinical trials cannot possibly ensure that a drug will not have disastrous side effects once it arrives on the market. Post-approval safety data gathering was put in place to address this problem, but as implemented, it has not proven to be as effective as hoped. This is due to the fact that, current post market safety studies largely depend on the submission of spontaneous case repo ...
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 10

 TERMINÉ 
Recent pharmacovigilance (PV) issues have led to questions regarding the ability of the current PV system to meet the global needs. Controversies around the assessment of spontaneous reports and conflicting results from pharmacoepidemiology studies may lead to delay in, or inappropriate, regulatory decisions. The PROTECT consortium, consisting of 20 core partners lead by the European Medicines Age ...
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 36

 TERMINÉ 

Novel Methods leading to New Medications in Depression and Schizophrenia (NEWMEDS)

Date du début: 1 sept. 2009, Date de fin: 28 févr. 2015,

Despite dramatic advances in molecular and imaging technologies and nearly 1 5,000 articles on schizophrenia and depression (S&D) there are few novel treatments. We think this is because of three major “bottle-necks”: a lack of etiologically-driven or pathophysiologically-accurate animal models; a lack of tests that provide indication of efficacy in healthy volunteers; and the reliance of clinical ...
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 20

 TERMINÉ 
Individualisation of cancer therapy based on standardized biomarker assays is one of the most demanding challenges in cancer medicine. In the RESPONSIFY consortium, we will integrate information on response prediction from different breast cancer types and methodologies into biomarker tests for targeted therapies in the clinical routine setting. Those tests will be developed for commercialisation ...
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 14

 TERMINÉ 
Inhibition of angiogenesis, the formation of new blood vessels from pre-existing vasculature, is a well established therapeutic strategy against cancer. Inhibitors of angiogenesis have been developed to block tumour growth and metastasis, and a number of these inhibitors are now clinically approved. However, contrary to initial expectations, angiogenesis inhibitors can cause a range of toxicities ...
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 11

 TERMINÉ 
"To maintain homeostasis of the central nervous system (CNS) the blood-brain barrier (BBB) prevents the free transcellular passage of hydrophilic molecules from the blood into the CNS. Because of this, the BBB is now recognised as the major obstacle to the treatment of most neurological disorders, as it hinders the delivery of many potentially important therapeutic and diagnostic substances to the ...
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 8

 TERMINÉ 

Pharmaceutical Medicine Training Programme (PHARMATRAIN)

Date du début: 1 mai 2009, Date de fin: 30 avr. 2014,

"The proposed Pharmaceutical Medicine Training Programme provides a comprehensive solution for the complex needs of integrated drug development for all professionals involved, incl. physicians, pharmaceutical scientists,biologists, biometricians, health economists, and safety and regulatory scientists from universities, regulatory agencies, large, middle-sized and small pharmaceutical enterprises, ...
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 52

 TERMINÉ 
eHealth Innovation TN will develop consensus among stakeholders and recommendations to-wards making innovative integrated, and therefore interoperable eHealth services operational and deployed at large scale in Europe.The focus will be to analyse, achieve consensus on and deliver a detailed summary report on how to achieve in the medium-term more patient/person-centred health services for an agein ...
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 22

 TERMINÉ 

Embryonic Stem cell-based Novel Alternative Testing Strategies (ESNATS)

Date du début: 1 avr. 2008, Date de fin: 30 sept. 2013,

"ESNATS aims at developing a novel toxicity test platform based on embryonic stem cells (ESC), especially human ESC (hESC), to accelerate drug development, reduce R&D costs and propose a powerful alternative to animal tests (3 Rs). ESNATS will address current drug-testing shortcomings: - testing takes place late in the development cycle - animal test systems bear the risk of non-prediction due to ...
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