Data-Gouv-ML/pcri-informations-sur-les-projets-laureats huggingface dataset:
Non-coding RNAs in neurogenic and neuropathic pain mechanisms and their application for risk assessment, patient stratification and personalised pain medicine (NCRNAPAIN)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Austria,Germany,Germany,Germany,Germany,United Kingdom,Czechia,France,Israel,Germany,Denmark
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-10-01
End date: 2017-09-30
Duration (months): 48.0
Total project cost (EUR): 7805150.6
EU funding (EUR): 5988835.0
Participants: 12
Project status: CLOSED

Neuro-immune alterations in the peripheral and central nervous system play a role in the pathophysiology of chronic pain, and non-coding RNAs (ncRNAs) regulate both immune and neuronal processes. Therefore, ncRNAPain proposes that ncRNAs are critically important master switches for chronic pain. ncRNAPain represents a multidisciplinary consortium of clinical partners, molecular and systems-level neuroscientists, bioinformatics and ncRNA experts. In order to gain knowledge on the mechanisms of chronic pain, ncRNAPain will investigate ncRNAs specifically in neurogenic and neuropathic pain, including headache. ncRNAPain will provide novel understanding of ncRNA regulation of processes modulating nociception and endogenous analgesia and of the importance of ncRNAs in circuitries and cognitive, emotional and behavioural components of pain. ncRNAPain will reveal insights into the concerted function of ncRNAs in the control of macromolecular complexes in neurons, glia and immune cells and signals used for neuroimmune communication in the pain pathway. Based on these findings, ncRNAPain will identify and validate specific ncRNAs as new druggable molecular targets for pain prevention and relief. ncRNAPain will identify pain predisposing ncRNA expression patterns and polymorphisms in ncRNAS and/or their binding sites as biomarkers for pain and inter-individual variations in the response to painful stimuli and analgesic drugs. ncRNA-based diagnostic tools will be developed and provided to enable better patient stratification, improved mechanism-based treatment and targeted prevention strategies for high risk individuals. ncRNAPain will provide novel understanding of the induction and maintenance of chronic pain and is committed to translate pre-clinical and clinical results and developments into clinical applications for the benefit of the patients, to improve the patients’ quality of life and reduce the societal burden of chronic pain across Europe.

Keywords: chronic pain neuropathic pain complex regional pain syndrome crps diabetic neuropathy painful neuropathy neuroimmune communication mouse pain model pain pathophysiology pain pathways pain mechanisms
Innovative methodology for small populations research (INSPIRE)

Framework: FP7 — Cooperation
Programme: Health
Destination: Other Actions across the Health Theme
Action type: Collaborative project
Countries involved: United Kingdom,Germany,Austria,France,Germany,Sweden,United Kingdom,United Kingdom
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2014-02-01
End date: 2017-05-31
Duration (months): 40.0
Total project cost (EUR): 2919912.18
EU funding (EUR): 2268504.61
Participants: 8
Project status: CLOSED

The HEALTH.2013.4.2-3 call identifies a need for new or improved statistical methodology for clinical trials for the efficient assessment of safety and/or efficacy of treatment for small population groups. This project brings together international experts in innovative clinical trial design methodology in these specific areas along with key stakeholders including regulatory authorities, industry, clinicians and patient groups to address this need. Our aim is the development novel methodology for the design and analysis of clinical trials in small populations. We will focus on four specific areas where we believe there are particular challenges: (i) early phase dose-finding studies in small populations, (ii) decision-theoretic methods for clinical trials in small populations, (iii) confirmatory trials in small populations and personalised medicines, (iv) use of evidence synthesis in the planning and interpretation of clinical trials in small populations and rare diseases. We will build on recent research advances, of our own and of others in this area. In the rare disease setting, we will focus on Bayesian and decision-theoretic methods that formally enable comparison of the gain in information with the cost, both in economic and opportunity terms, of clinical experimentation, and assess how information from outside the trial can formally be incorporated in the design and decision-making processes. In the personalised medicine setting, we will develop methods that allow evaluation of efficacy in a number of sub-populations simultaneously in a confirmatory clinical trial without any reduction in scientific or statistical rigour.

Keywords: small population clinical trials,rare diseases,personalised medicine,stratified medicine,statistical methodology,dose-finding,decision-theoretic methods,confirmatory trials,evidence synthesis
Personalised Prognostic Tools for Early Psychosis Management (PRONIA)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Germany,Switzerland,Germany,United Kingdom,Finland,Italy,Australia,Germany,Germany,Germany
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-10-01
End date: 2019-03-31
Duration (months): 66.0
Total project cost (EUR): 9356916.42
EU funding (EUR): 6000000.0
Participants: 18
Project status: CLOSED

Affective and non-affective psychoses have a major negative impact on human society. They account for 6.3% of the global burden of disease and cost €207 billion per year in Europe alone, making them the most expensive brain-related disorders and even more expensive than cardiovascular diseases. This socioeconomic burden is largely caused by two core disease features: onset in adolescence and early adulthood and long-term disabling disease courses. Both factors lead to enduring social and vocational exclusion and contribute to 8-20 times higher suicide rates in affected patients. Reliable and accessible prognostic tools will alleviate this burden by enabling individualised risk prediction, thus facilitating the targeted prevention of psychoses. Thus, we will first use routine brain imaging and complementary data to optimise our candidate biomarkers for the prediction and staging of psychoses and generate a prognostic system that generalises well across mental health services. Secondly, we will implement new multi-modal risk quantification tools to predict mental health-related disability in young help-seekers. The fusion of these tools with clinical knowledge will produce cybernetic prognostic services that accurately identify help-seekers at the highest risk of psychosis, poor functioning and suicide-related mortality. During this project we will secure our intellectual property rights and transform into a European company to commercially exploit these prognostic services through internet-based telemedicine applications. This will provide psychosis risk profiling tools to diverse target groups in the healthcare markets, including care-givers, the pharmaceutical industry and research institutions. By disseminating objective risk quantification, these products will provide firm diagnostic grounds for preventive therapy, improving outcomes and reducing costs. Thus, they will offer a unique selling proposition to the mental health sectors in Europe and beyond.

Keywords: individualised risk quantification,at-risk mental states,early psychosis,staging,machine learning,cybernetic diagnostic applications,prediction of disease,prediction of poor functioning
Hepatic and Cardiac Toxicity Systems modelling (HECATOS)

Framework: FP7 — Cooperation
Programme: Health
Destination: Biotechnology, generic tools and medical technologies for human health
Action type: Collaborative project
Countries involved: Netherlands,Switzerland,Spain,United Kingdom,Ireland,Germany,Germany,Germany,Germany
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-10-01
End date: 2018-09-30
Duration (months): 60.0
Total project cost (EUR): 15927848.6
EU funding (EUR): 11999999.0
Participants: 15
Project status: CLOSED

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(metabolite)-target interactions, through macromolecules/proteins, to (sub-)cellular functionalities and organ physiologies, and even the human whole-body level. In view of the importance of mitochondrial deregulations and of immunological dysfunctions associated with hepatic and cardiac drug-induced injuries, focus will be on these particular Adverse Outcome Pathways. Models will be populated with data from innovative in vitro 3D liver and heart assays challenged with prototypical hepato- or cardiotoxicants; data will be generated by advanced molecular and functional analytical techniques retrieving information on key (sub-)cellular toxic evens. For validating perturbed AOPs in vitro in appropriate human investigations, case studies on patients with liver injuries or cardiomyopathies due to adverse drug effects, will be developed, and biopsies will be subjected to similar analyses. Existing ChEMBL and diXa data infrastructures will be advanced for data gathering, storing and integrated statistical analysis. Model performance in toxicity prediction will be assessed by comparing in silico predictions with experimental results across a multitude of read-out parameters, which in turn will suggest additional experiments for further validating predictions. HeCaToS, organized as a private-public partnership, will generate major socioeconomic impact because it will develop better chemical safety tests leading to safer drugs, but also industrial chemicals, and cosmetics, thereby improving patient and consumer health, and sustaining EU’s industrial competitiveness.

Keywords: systems toxicology,chemoinformatics,multiscale modeling,case studies,in vitro 3d assays,omics,functional endpoints
Innovation Partnership for a Roadmap on Vaccines in Europe (IPROVE)

Framework: FP7 — Cooperation
Programme: Health
Destination: Other Actions across the Health Theme
Action type: Coordination and support actions
Countries involved: Belgium,Germany,Italy,Netherlands,Netherlands
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-12-01
End date: 2016-03-31
Duration (months): 28.0
Total project cost (EUR): 670419.4
EU funding (EUR): 496367.0
Participants: 5
Project status: CLOSED

Under the leadership of the major Europe-based vaccine industry players, IPROVE (Innovation Partnership for a Roadmap on Vaccines in Europe) will produce a comprehensive roadmap on the future of vaccine R&D, production and delivery in the EU. IPROVE aims to drive current EU research efforts towards the establishment of a clear vision of the priority innovations and technologies necessary to address infectious and non-infectious threats of importance not only to global public health, but also to today’s key EU health challenges (e.g. ageing population, healthcare-associated infections, high chronic disease incidence, low levels of prevention awareness, and suboptimal use of existing cost-effective vaccines across the lifespan). The roadmap will explore how the wealth of expertise available across academia, industry, SMEs, public health institutes, and regulatory bodies can be pooled and leveraged to overcome fragmentation and removal of bottlenecks to the timely translation of breakthrough research into innovative vaccines. The project will look at the entire innovation chain, from discovery to delivery, including interventions necessary to improve education curricula, perception and awareness. IPROVE proposes to achieve its goal using a consultation-based stakeholder collaborative process bringing together the key public and private players in the vaccine field in Europe and beyond. This will contribute to understanding the scientific, political and economic potential to be tapped in order to favour a more structured vaccine innovation agenda. The roadmap is expected to inform strategic decisions on the priorities for future vaccine investment at EU and MS level. The exercise is considered key to secure that the EU is capable of tackling changing medical needs and strained healthcare system budgets. Strengthening the EU’s vaccine research base will also protect and grow the EU’s economic competitiveness in this area, where Europe has traditionally maintained a position of leadership.

Keywords: vaccine vaccinology vaccination r&d production future roadmap eu industry competitiveness innovation health cooperation technology translational research partnerships consultation diseases prevention
Development of very promising humanized therapeutic mAbs efficiently neutralizing a novel immunosuppressive pathway involved in a wide range of cancers (TUMADOR)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: France,France,Finland,Switzerland,United States,France,Germany
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-09-01
End date: 2018-02-28
Duration (months): 54.0
Total project cost (EUR): 7748471.12
EU funding (EUR): 5978890.0
Participants: 8
Project status: CLOSED

Studies have demonstrated the importance of CD73 in the spread of cancer. Overexpressed in numerous cancer types, this enzyme leads to the production of high amounts of extracellular Adenosine, creating an immunosuppressive microenvironment, and contributing to tumor proliferation and dissemination. Neutralizing its activity represents a highly potent and innovative therapy. Following on the recent success of mAbs targeting immune checkpoint (PD1, CTLA4), TumAdoR aims to discover, characterize and produce humanized anti-hCD73 mAbs that will be assessed for their efficacy and safety in relevant mouse preclinical tumor models. It will result in the development of anti-CD73 drug candidates that will strengthen the immune system, stop cancer cell progression and prevent relapse through restoration of immune memory. TumAdoR aims at paving the way to first-in-human clinical trials of potent mAb candidates, and validating a new cancer immunotherapy, suitable for a wide range of cancers. More precisely, TumAdoR will: •Reinforce knowledge about CD73 role as an immune checkpoint target •Correlate CD73 expression with clinical outcome and validate the tumor patients most likely to benefit from CD73 blockade •Discover and develop mAbs neutralizing hCD73 •Develop relevant preclinical tumor models to validate the in vivo efficacy and safety of anti-CD73 mAbs candidate(s) •Develop and standardize tools to assess CD73 expression, and monitor immune parameters in patients TumAdoR addresses topic 1 by developing antibodies neutralizing CD73, and topic 3 by fighting against immune evasion in tumor host microenvironment. The high-level consortium including 3 SMEs possesses all the scientific and clinical expertises, industrial competences, biological and enzymatic assays, biological and clinical resources, and preclinical models to discover and produce mAbs, and investigate the functions of CD73, and the therapeutic impact of its neutralization.

Keywords: cancer,immunotherapy,treatment efficacy,assays,monoclonal antibodies,tumor-host microenvironment
Multivessel versus culprit lesion only percutaneous revascularization in patients with acute myocardial infarction complicated by cardiogenic shock (CULPRIT-SHOCK)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Germany,Germany,Netherlands,Lithuania,France,Slovenia,Poland,Sweden,United Kingdom,Germany,Germany,Italy,Belgium,Austria,Switzerland,Italy,United Kingdom
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-09-01
End date: 2018-08-31
Duration (months): 60.0
Total project cost (EUR): 7844658.7
EU funding (EUR): 5999145.0
Participants: 24
Project status: CLOSED

Cardiogenic shock (CS) complicating acute myocardial infarction (AMI) represents a major European health care concern with mortality rates between 40-70%. Approximately 70-80% of these patients present with multivessel disease defined as coronary lesions in more than one vessel. The clinician is faced with the decision to either 1) intervene only on the culprit lesion acutely responsible for the initiation of cardiogenic shock, or 2) treat additional lesions considered hemodynamically significant but not acutely triggering the CS cascade as well. Current guidelines recommend percutaneous coronary intervention of all critical lesions. However, due to a lack of randomized trials, these recommendations are solely based on registry data and pathophysiological considerations. Aim of the randomized CULPRIT-SHOCK trial is therefore to compare a) immediate multivessel PCI versus b) culprit lesion only PCI in patients with AMI complicated by CS. A total of 706 CS patients will be randomized in several European countries. The primary endpoint will be 30-day all-cause mortality and/or severe renal failure requiring renal replacement therapy. CULPRIT-SHOCK will therefore determine the optimal percutaneous revascularization strategy in patients with AMI and multivessel disease complicated by CS. In addition, a comprehensive array of efficacy, safety and socio-economic parameters for the chosen population will be assessed. Multiple secondary endpoints and several substudies (microcirculation, biomarkers, angiography) will serve to further understand the presumed differential effects of the 2 treatment arms and to understand the underlying pathophysiology and prognostic markers. From these parameters a multivariable regression model and a risk score for the prediction of clinical prognosis and a cost-effectiveness model in AMI and CS will be developed. Furthermore, CULPRIT-SHOCK will obtain data on CS patients not meeting inclusion criteria by instituting a separate registry.

Keywords: myocardial infarction,cardiogenic shock,revascularization,outcome
Nano Engineering for Cross Tolerance: new approach for bioengineered, vascularised, chimeric islet transplantation in non-immunosuppressed hosts. (NEXT)

Framework: FP7 — Cooperation
Programme: Health
Destination: Biotechnology, generic tools and medical technologies for human health
Action type: Collaborative project
Countries involved: United Kingdom,Italy,Switzerland,United Kingdom,Italy,Luxembourg
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-10-01
End date: 2017-09-30
Duration (months): 48.0
Total project cost (EUR): 6103494.53
EU funding (EUR): 4741726.4
Participants: 6
Project status: CLOSED

Diabetes is caused by insufficient or lack of insulin secretion by the specialized B cells of the pancreas and, if not treated adequately evolves into in complications which alter patients integrity and wellness. Treatment is based on lifetime drugs administration for blood glucose control or parenteral infusion of insulin to better control glucose levels and glycosylation of hemoglobin. Artificial pancreases are in development but still dependent by external energy sources and need permanent transcutaneous access to release the hormone. Pancreatic whole organ transplantation is a major intervention requiring selected recipient and matched cadaveric donor which keep numbers down. Islet of Langerhans transplantation is a non-invasive method for the treatment of type 1 diabetes but several questions remain and several issues have to be addressed in order to improve the method since islet engraftment is clearly suboptimal, as a result of pro-apoptotic and pro-inflammatory stimuli sustained during islet isolation and at the site of implantation, the long-term islet graft function drops to 15% with time, and the current systemic immunosuppressive regimen has several drawbacks in terms of side effects. Solution should be find to increase transplantation efficiency with an higher number of islet, eventually from animals, induce tolerance toward the graft, avoiding systemic, lifetime immunosuppression and, lowering a specific inflammatory reaction and enhancing graft micro vasculogenesis to improve islet nesting. NEXT provides a 360° solution to the pitfalls of current methodology for pancreatic islet transplantation: i) Nano technologies, to engineer donor cell surfaces in order to derange recognition and suppress their rejection; ii) Advanced tissue engineering methods, to assemble bio synthetic islet, enriched by chimeric microvasculature; iii) Innovative double immune-suppressive strategy by graft - bound immunosuppressive nano peptides and shielded by self- vasculature

Keywords: pancreatic islet transplantation,adverse immune reactions,immune-shielded pancreatic islets
Introducing diagnostic applications of ‘3Gb-testing’ in human genetics (3GB-TEST)

Framework: FP7 — Cooperation
Programme: Health
Destination: Other Actions across the Health Theme
Action type: Coordination and support actions
Countries involved: Netherlands,Belgium,United Kingdom,Netherlands,France,Greece,United Kingdom,United Kingdom
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-09-01
End date: 2015-08-31
Duration (months): 24.0
Total project cost (EUR): 553889.0
EU funding (EUR): 499668.0
Participants: 11
Project status: CLOSED

The landscape of genetic testing is rapidly changing. Soon, whole genome sequence analysis (3Gb-testing) will be an effective and financially viable alternative to targeted gene analysis. New technologies that allow efficient sequencing of a whole human genome in a diagnostic setting will have an enormous impact on diagnostic centres replacing many existing molecular and cytogenetic tests. Patients deserve to benefit from our vastly growing knowledge on functional genomics. 3Gb-testing is the ideal method to bring these benefits to the public. However, it is critical to avoid mistakes with respect to ethics, quality, over or mis-interpretation of data. It is essential that our society is prepared for the change once it is implemented. Hence, current gaps in our knowledge have to be identified and research has to be initiated to bridge these gaps. The 3Gb-TEST project will bring stakeholders together and ensure they are informed with respect to the desirable and undesirable developments. The clinical utility and cost effectiveness of whole genome sequencing needs to be determined as part of a robust health technology assessment process (HTA). Interpretation of sequence data in terms of clinical relevance will pose a challenge to both laboratory and clinical geneticists. Substantial investments may be required and the logistic restructuring of genetic services will need to be addressed. This project aims to prepare Europe for innovations in molecular testing. Quality assessment schemes, HTA and guidelines have to be in place. Healthcare professionals must be aware of the impending change and potential impact on practice. The Consortium will inform the healthcare community and make recommendations to the European Commission, the European Society of Human Genetics, and national organizations relevant to this field. A key output will be a validated roadmap for the implementation of diagnostic genome sequencing in Europe.

Keywords: whole genome test,diagnostic application,next generation sequencing,clinical application,guidelines,quality assessment