Data-Gouv-ML/pcri-informations-sur-les-projets-laureats huggingface dataset:
Inflammatory Bowel Disease CHARACTERization by a multi-modal integrated biomarker study (IBD-CHARACTER)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: United Kingdom,Belgium,Norway,Spain,Sweden,Sweden,Sweden,Spain,Sweden
Call:  (FP7-HEALTH-2012-INNOVATION-1, 2012)
Start date: 2012-12-01
End date: 2017-03-31
Duration (months): 52.0
Total project cost (EUR): 7928060.04
EU funding (EUR): 5989346.0
Participants: 14
Project status: CLOSED

We propose a collaborative effort to advance our understanding of the inflammatory bowel diseases Ulcerative Colitis and Crohn's Disease and to increase diagnostic precision in detection of the diseases in their early manifestation. We will utilize the largest collection of samples so far assembled of treatment naïve patients recently diagnosed with inflammatory bowel disease, a total of 400 patients. The material will be extensively analyzed for DNA methylation status, RNA transcription profile, protein markers and gut microbial content in order to create a molecular snapshot of IBD in its early manifestation. As control group, material from a total of 200 recently by endoscopy diagnosed non-inflammatory but symptomatic patients (symptomatic non-IBD) as well as 200 healthy, age-matched, non-smoking, controls without any known first relatives diagnosed with IBD, will be collected and used. All patients will be diagnosed according to standardized diagnostic criteria’s, characterized using current known clinical markers as well as genotyped for known susceptibility loci. This large, well characterized cohort in conjunction with our proposed massive molecular profiling will yield a list of biomarkers indicative for onset of the disease. Based on the finding within the project assays capable of analyzing panels of relevant protein markers and methods for rapid profiling of gut microbial content relevant for IBD will be developed by participating SME:s, offering large commercial potential. The proposed biomarkers will form a solid ground for development of improved diagnostic assays and be a rich source to mine for novel therapeutic targets.

Keywords: inflammatory bowel disease,dna methylation,proximity extension assay,microbiota,large scale sequencing,biomarker discovery
Methods for Health Technology Assessment of Medical Devices: a European Perspective (MEDTECHTA)

Framework: FP7 — Cooperation
Programme: Health
Destination: Optimising the delivery of healthcare to European citizens
Action type: Collaborative project
Countries involved: Italy,Germany,United Kingdom,United Kingdom,Austria,Slovenia,France
Call:  (FP7-HEALTH-2012-INNOVATION-1, 2012)
Start date: 2013-01-01
End date: 2015-12-31
Duration (months): 36.0
Total project cost (EUR): 2648136.34
EU funding (EUR): 2055134.0
Participants: 7
Project status: CLOSED

Health Technology Assessment (HTA) is widely accepted as a multidisciplinary approach studying the clinical, economic, social and ethical implications of development, diffusion and use of health technologies and its role in policy making is increasingly established in EU countries. However, the currently adopted methodological framework for HTA doesn’t fully encounter the challenges rising from intrinsic differences between different types of health technologies, and in particular medical devices. The general objective of MedtecHTA project is to investigate improvement of HTA methods to allow for more comprehensive evaluation of medical devices by acknowledging complexities rising from their integration into clinical practice. The MedtecHTA project will provide more than 280 person- months of scientific research effort to: (i) explore current differences in methods used for HTA of medical devices in EU countries; (ii) investigate within- and between country variations in utilization of innovative medical devices (e.g implantable devices in cardiology) that have important implications on equity; iii) develop improved methods for satisfying three main pillars of HTA: comparative effectiveness, economic evaluation and organizational impact of medical devices and (iv) investigate uncertainty surrounding the development of new devices and investments in research. The essence of the MedtecHTA research methodology is a cross-disciplinary consortium with outstanding track record in health services research including health economics, healthcare management, health policy and also public health, epidemiology and clinical research. The MedtecHTA is expected to make a substantial contribution to the development of methodologies and practices of HTA for medical devices for a wide range of key stakeholders: policy makers, scientific community, HTA agencies, healthcare providers, medical device industry and patients, which in turn will impact on public health in the Region.

Keywords: medical devices,comparative effectiveness,economic evaluation,organizational impact,hta
Highlighting EU-funded Health research results via TV media and the internet (HIGHLIGHT)

Framework: FP7 — Cooperation
Programme: Health
Destination: Other Actions across the Health Theme
Action type: Coordination and support actions
Countries involved: Belgium,Italy,France,Germany,Italy
Call:  (FP7-HEALTH-2012-INNOVATION-1, 2012)
Start date: 2012-10-01
End date: 2014-09-30
Duration (months): 24.0
Total project cost (EUR): 1089385.0
EU funding (EUR): 999490.0
Participants: 6
Project status: CLOSED

The strategic objective of HIGHLIGHT is to contribute to the development of public awareness on European Health research in all European countries through the professional use of television media and the internet. The technical objectives of HIGHLIGHT are: • Surf the Health Theme in FP7 to identify most prominent results achieved by individual projects in FP7. • Produce and release a series of 21 high-quality free-of-rights short TV reportages for the general public on the basis of the key results of the research. Project’s audiovisuals will be developed in such a way to be easily adaptable to the needs of a wide spectrum of European TV channels and languages. • Exploit the distribution potential of the Consortium and deliver the TV reportages to 200+ TV programs in Europe, to the news and to the main European broadcasting gateways, targeting all principal TV broadcast media from the 27 EU Member States and beyond. • Produce and release a series of original articles “around the TV reportages” written by professional journalists for the press and on-line media on the basis of the key results of the research. • Translate the released TV reportages in 6 languages and engrave them onto a DVD for public use at conferences, fairs, workshops, etc. The layout of the DVD shall be in line with DG R&I audiovisual communication policy. • Monitor the progress of the project and quantify the overall media impact of the project. On the basis of the above, HIGHLIGHT expects: • To have each of its audiovisual productions took-up and/or broadcast by national European TV stations at least 10 times, for a minimum expected total of 210 take-ups/broadcasts made by public TV stations in Europe and beyond, for a total of several millions viewers. • To have each of its web articles seen, took-up and mirrored at least 35 times, for a minimum expected total of 2,205 referrals on on-line news, specialised magazines, blogs, fora, social networks, etc.

Keywords: science communication,research networking,co-ordination of stakeholders,tv media,internet
Development and clinical trials of a new Software ENgine for the Assessment & Optimization of drug and non-drug Therapy in Older peRsons (SENATOR)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Ireland,Belgium,Spain,Italy,United Kingdom,Iceland,Germany,France,Denmark,Ireland,United Kingdom
Call:  (FP7-HEALTH-2012-INNOVATION-1, 2012)
Start date: 2012-10-01
End date: 2018-06-30
Duration (months): 69.0
Total project cost (EUR): 7805965.07
EU funding (EUR): 5938947.0
Participants: 13
Project status: CLOSED

The European population of older people with multiple chronic diseases (multimorbidity) is increasing steadily in tandem with the rising population of people aged ≥ 65 years. Older multimorbid people are at high risk of polypharmacy (PP), inappropriate prescribing (IP), adverse drug reactions (ADRs) and adverse drug events (ADEs). PP, IP, ADRs and ADEs in turn cause excessive drug costs and excess healthcare utilization; ADRs and ADEs also cause significant mortality. The current rapid rise in drug expenditure relating mostly to drug use by older people across Europe is not economically sustainable. In tandem with the drug therapy problems, there is underuse of non-drug therapies i.e. physiotherapy, occupational therapy, speech & language therapy, nutritional therapy, psychotherapy in the treatment of chronic diseases in this cohort. Optimal management of drug and non-drug therapy in older multimorbid persons usually requires specialist skill, but most doctors who treat older people do not have specialist training in Geriatric Medicine. To address these challenges, we propose to design and build a software engine (SENATOR) with the capacity to optimize therapy and simultaneously minimize ADRs, IP, PP and excessive cost. SENATOR will evaluate drug indications and contraindications, ADR/ADE risk and detect IP using validated criteria. SENATOR will identify cheapest drug brands to minimize cost. SENATOR will also recommend appropriate symptom-focused drug therapy and avoidance of drugs unlikely to be beneficial in frailer older people with low one year life expectancy. In addition, SENATOR will provide specific advice on appropriate non-drug therapies for individual patients. To test SENATOR’s efficacy, we will perform a multicentre RCT involving 1800 older multimorbid patients hospitalized with acute illness under the care of specialists other than geriatricians, using ADR incidence, medication appropriateness and drug/healthcare costs as the main outcome measures.

Keywords: elderly,optimization,pharmacotherapy,non-drug therapy,iatrogenic injury,adverse drug reaction prevention,inappropriate prescribing prevention,drug cost reduction,randomized controlled trial
Apoptosis Modelling for Treatment Decisions in Colorectal Cancer (APO-DECIDE)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Ireland,United Kingdom,France,Israel,Germany
Call:  (FP7-HEALTH-2012-INNOVATION-1, 2012)
Start date: 2012-11-01
End date: 2014-10-31
Duration (months): 24.0
Total project cost (EUR): 3896336.0
EU funding (EUR): 2999482.0
Participants: 7
Project status: CLOSED

With the arrival of new colorectal cancer (CRC) therapeutics targeting specific cell signalling pathways, such as anti-EGFR therapy, personalised cancer treatment is at the door step of clinical practise. This progress in drug development contrasts strikingly with current clinical practice, where decision making depends largely on clinical factors such as tumour staging and age of patient, with the success of such treatments being largely unpredictable. 5-FU-based chemotherapy represents the main stay of CRC therapy. DNA damaging agents such as 5-FU and anti-EGFR therapy seek to induce tumour regression through induction of apoptosis or sensitization to apoptosis. Dysfunctional apoptosis is well recognized as a key contributing factor in chemotherapy resistance. The aim of the APODECIDE consortium is to develop systems medicine tools that predict treatment responses in CRC patients to 5-FU-based chemotherapy and anti-EGFR therapy, based on a systems analysis of apoptosis and EGFR signalling pathways. Based on previous clinical proof-of-concept studies that demonstrated the unique potential of such approaches in predicting tumour resistance, the APO-DECIDE consortium aims to deliver new clinical decision making tools that enable personalised medicine approaches and ‘smart’ clinical trials design in the future. The SMEs will benefit from the project through the development of systems-based combinatorial biomarkers adapted to formalin fixed paraffin-embedded material, the routine material used in clinical histopathology, hence providing a unique opportunity for marketing and exploitation. SMEs and their academic partners will also develop computational whole body models reflecting drug pharmacodynamics and pharmacokinetics in patient cohorts, providing a unique market niche in the field clinical oncology.

Keywords: colorectal cancer,personalized oncology,systems modeling,quantitative pathology,biomarkers,virtual trial
Adapting Breast Cancer Screening Strategy Using Personalised Risk Estimation (ASSURE)

Framework: FP7 — Cooperation
Programme: Health
Destination: Biotechnology, generic tools and medical technologies for human health
Action type: Collaborative project
Countries involved: Netherlands,Germany,Germany,Germany,United Kingdom,Spain,Netherlands,Belgium,United Kingdom,Denmark
Call:  (FP7-HEALTH-2012-INNOVATION-1, 2012)
Start date: 2012-12-01
End date: 2015-11-30
Duration (months): 36.0
Total project cost (EUR): 7235026.6
EU funding (EUR): 5608543.5
Participants: 10
Project status: CLOSED

While early detection of breast cancer by screening appears effective, many women derive little or no benefit from screening, due to the way it is currently organized: as a one-size-fits all approach irrespective of personalised risk factors. It is known, however, that some women are at a much higher risk of getting the disease than others, and that mammography is unsuitable for cancer detection in women with dense breasts. The aim of this project is to develop personalised methods to tailor breast cancer screening to the individual needs of the woman. We will propose methods to stratify women at the highest risk to MRI; those with intermediate risk and/or dense breasts to follow-on ultrasound. A risk model will be developed that includes both breast cancer risk and the risk of missing cancers in mammograms. In this model, breast density plays a key role, as one of the largest known risk factors and the factor making mammograms ineffective. Two SMEs focusing on breast density are involved, where academic partners bring unique databases with over 80,000 screening mammograms and associated risk profiles. These are essential for model development, and subsequently for the development of products that benefit all women. Personalised screening is only economically feasible if it is based upon cost-effective strategies. While current methods in breast MRI imaging and breast ultrasound are promising, more efficient protocols must be developed to use these modalities routinely in screening. With leading SMEs and clinical partners, screening procedures will be optimized by developing automated image analysis tools to guide workflow and quality assurance. More efficient MRI protocols will be investigated to reduce time and cost, while the use of novel MRI imaging sequences without intravenous contrast will be explored. Cost-effectiveness of the stratification models will be assessed by combining the risk model with cost and effectiveness of alternative screening strategies.

Keywords: breast cancer,screening,radiology,breast density,image analysis,mammography,breast cancer risk
First Targeted Therapy to FIGHT Hemophagocytic Lymphohistiocytosis (HLH): A novel approach to HLH (FIGHT-HLH)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Switzerland,United Kingdom,Italy,Belgium
Call:  (FP7-HEALTH-2012-INNOVATION-1, 2012)
Start date: 2012-07-01
End date: 2017-07-31
Duration (months): 61.0
Total project cost (EUR): 11241261.6
EU funding (EUR): 5946261.8
Participants: 6
Project status: CLOSED

Hemophagocytic lymphohistiocytosis (HLH) is a rare, devastating disease characterized by uncontrolled immune response that primarily affects young infants and children. HLH is usually fatal if untreated. Even when treated, the overall survival rate is still as low as 60-70%. No drug has been formally developed for the treatment of this disease and current treatment methods require the use of drugs which have not formally been developed for this indication which have an unfavourable safety profile. The cytokine interferon-gamma (IFNγ) was shown to play a key pathological role in the disease. It has been demonstrated that neutralization of IFNγ with a monoclonal antibody (mAb) reverts the disease and rescues animals from death in murine models of primary HLH. In patients, evidence points towards a correlation between levels of IFNγ and disease activity. In order to target IFNγ in patients with HLH, NovImmune generated and characterized a fully human mAb, NI-0501, that neutralizes the biological activity of human IFNγ. This consortium proposes an adaptive clinical trial with a pilot and a pivotal phase to provide the necessary data for Market Access Authorization for NI-0501 in HLH. The pilot phase will enroll only patients well-known to have a primary form of HLH and who relapsed after having responded to an initial treatment while the pivotal phase will open the recruitment to newly diagnosed HLH patients. The transition between the pilot and the pivotal phase will be governed by strict pre-defined transition rules and will only occur if a favorable benefit-risk profile has been demonstrated. During the course of the pilot phase the consortium will attempt to generate the necessary information to justify the inclusion in the pivotal phase of a broad range of HLH patient (secondary forms of the disease), for which the pivotal role of IFNγ will have been demonstrated thanks to the research activities of members of the consortium.

Keywords: hemophagocytic lymphohistiocytosis,hlh,anti-interferon gamma monoclonal antibodies,ni-0501
Multimodular biomarker analysis workflow for diagnosis, prognosis and monitoring of drug treatment response in bladder cancer (DIPROMON)

Framework: FP7 — Cooperation
Programme: Health
Destination: Biotechnology, generic tools and medical technologies for human health
Action type: Collaborative project
Countries involved: United Kingdom,Austria,France,Germany,Austria
Call:  (FP7-HEALTH-2012-INNOVATION-1, 2012)
Start date: 2012-11-01
End date: 2016-10-31
Duration (months): 48.0
Total project cost (EUR): 4596144.2
EU funding (EUR): 3492216.5
Participants: 6
Project status: CLOSED

With the advent of Omics technologies capable of profiling substantial fractions of molecular entities from the genome down to the metabolome level a significant boost in understanding disease pathophysiology, consequently providing tailored diagnostics and therapy, was expected. With impressive results for selected diseases, cancer still sees significant shortcomings. One reason for this clinical situation is certainly the apparent heterogeneity of cancers, manifesting in clinical presentation and outcome, but also on the personalized molecular level. Within DIPROMON we selected bladder cancer as a prototypical example for the need of personalization efforts in therapy, and we plan of using this clinically highly challenging disease phenotype for establishing a general workflow for enabling personalization strategies towards rational decision on tailoring therapeutic interventions for defined patient groups. DIPROMON on its basis follows a computational Systems Biology approach for delineating statistical rules for patient segmentation, resting on patient-specific biomarker profiles interpreted in tight integration with patient-specific clinical data. DIPROMON will establish a workflow including quality control aspects for i) selecting biomarker panels for given clinical phenotypes, ii) providing modular instrumentation for measuring the profiles in a clinical setting, and iii) deriving statistics-driven rules for patient segmentation regarding optimal therapy. DIPROMON will finally validate the concept in bladder cancer.

Keywords: systems biology,biomarker,integration,stratification,bladder cancer
Next Generation Sequencing platform for targeted Personalized Therapy of Leukemia (NGS-PTL)

Framework: FP7 — Cooperation
Programme: Health
Destination: Biotechnology, generic tools and medical technologies for human health
Action type: Collaborative project
Countries involved: Italy,Italy,Germany,Belgium,Czechia,Spain,Germany,Switzerland
Call:  (FP7-HEALTH-2012-INNOVATION-1, 2012)
Start date: 2012-11-01
End date: 2015-10-31
Duration (months): 36.0
Total project cost (EUR): 7623351.88
EU funding (EUR): 5870815.0
Participants: 10
Project status: CLOSED

Hematological diseases are highly heterogeneous malignancies in the matter of the molecular mechanisms related to their development and progression. A considerable heterogeneity can be further observed within the same hematological disease at the inter-individual level, being reflected by different clinical outcomes and responses to treatment in different patients. Nowadays, the advent of high-throughput next generation sequencing (NGS) technologies that are revolutionizing genomics and transcriptomics by providing a single base resolution tool for a unified deep analysis of diseases complexity allows a fast and cost-efficient fine-scale assessment of the genetic variability hidden within cohorts of patients affected by the same leukemia. That being so, by potentially highlighting inter-individual differences that may play a role in the differential success of diverse therapeutic interventions, they promise to be crucial for selecting the most appropriate medical treatments. This project aims at developing a European Hematological/NGS platform of scientists for improving outcomes for therapeutic interventions on acute and chronic leukemias and at developing strategies to personalize treatments and tailor therapies to different stratified groups of leukemia patients, with the goal of optimizing their efficacy and safety through a deeper and deeper understanding of the influence of genetic alterations on leukemias pathogenesis and treatment response (i.e. “personalized therapy”). Moreover, the final aim will be the identification of novel prognostic biomarkers for acute and chronic leukemias, as well as of molecular biomarkers and/or genome-wide profiles for the assessment of minimal residual disease. The originality of this project is to perform systematic deep whole exome/transcriptome studies on well-clinically-characterized leukemia patients, by exploiting NGS technologies able to quickly produce data with a good cost-effectiveness and an unprecedented resolution.

Keywords: next generation sequencing technologies leukemia personalized therapy patient startification biomarkers