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Grant
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-24-2015 | Award Amount: 14.94M | Year: 2016

Pharmacogenomics is the study of genetic variability affecting an individuals response to a drug. Its use allows personalized medicine and reduction in trial and error prescribing leading to more efficacious, safer and cost-effective drug therapy. The U-PGx consortium will investigate a pre-emptive genotyping approach (that is: multiple pharmacogenomic variants are collected prospectively and embedded into the patients electronic record) of a panel of important pharmacogenomic variants as a new model of personalised medicine. To meet this goal we combine existing pharmacogenomics guidelines and novel health IT solutions. Implementation will be conducted at a large scale in seven existing European health care environments and accounts for the diversity in health system organisations and settings. Feasibility, health outcome and cost-effectiveness will be investigated. We will formulate European strategies for improving clinical implementation of pharmacogenomics based on the findings of this project.


Grant
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-26-2014 | Award Amount: 4.59M | Year: 2015

HEARTEN will design, develop and validate an ICT co-operative environment that will enable the HF patients to achieve sustainable behavior change regarding their adherence and compliance, and the ecosystem actors to be engaged and improve the patients HF management. HEARTEN targets all actors related to the management of patients suffering from HF, including healthcare professionals, caregivers (formal/informal), healthcare providers nutritionists, fitness experts and health insurance experts, towards developing a multi-stakeholder patient centered mHealth ecosystem. The target population of HEARTEN are patients with chronic and acute HF, either post-ischemic or with dilated cardiomyopathy, requiring occasionally re-admittance into hospitals. The idea is to develop biosensors that detect and quantify novel breath and saliva HF biomarkers, being identified through analytical techniques. These biomarkers reflect the health status of the patient and identify whether the patient adheres to the administered drugs. The breath biosensor will be integrated into the smartphone while the saliva biosensor will be integrated into the patients cup. Additional sensors for monitoring the ECG, the blood pressure and the physical activity constitute the sensor kit of the patient. The input data are complemented with nutrition information from the patients smartphone, weight monitoring through wireless weight scales as well as the patients profile and information directly added by the caregivers and the healthcare professionals. The multiparametric data are transmitted to the HEARTEN cloud architecture, where a knowledge management system analyses them and delivers critical information at hand. HF patients are empowered in self-management, by using their smartphones and tracking their medical vital signs, while the healthcare professionals and the caregivers can issue warnings, coordinate therapies, improve adherence and intervene before frailty incidences occur.


Grant
Agency: European Commission | Branch: H2020 | Program: IA | Phase: PHC-20-2014 | Award Amount: 4.36M | Year: 2015

As Europes population is ageing, long-term care for elderly citizens will become an increasing cost for society. To manage this transition healthcare policies in the EU and individual Member States are heavily focussed on extending the independent life of the elderly, with the dual aim of increasing their quality of life and reducing the costs of care. Dementia affects more than 6% of people aged 60\ and has a devastating effect on their independence to date, there is no proven intervention to help dementia patients live a fulfilling life for longer. In this project we will build on an innovative patient support tool to develop a mHealth application that is specifically targeted to patients with mild dementia. The tool will help patients to adhere to their treatment and share data with their carers and doctors; carers will use the same application to monitor patients more easily and share their own well-being with doctors. This will slow the patients cognitive and functional decline, avoid carers getting exhausted and reduce costs of emergency care. Our project will comprise two phases: first we will use digital accessibility tools to re-design the existing application for dementia patients. The development will be steered by patients, carers and doctors, through user-centric design: we will collect feedback on each new version of the application until the design is perfectly adapted to the users needs. In the second phase we will pilot the optimised application with 1,100 users (patients \ carers) and 1,100 controls. This will show the clinical and social benefits for patients and carers, as well as financial benefits for the healthcare system. Successful delivery of the pilot will increase patients adherence to treatment (10 %-points), while improving the quality of life of carers and patients. It will save healthcare providers 1,818 / patient / year in care costs and will generate revenue of over 18 million / year for the consortium (Year 5).


Grant
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-15-2015 | Award Amount: 6.34M | Year: 2015

Stroke is the second leading cause of death in the world population. When not fatal, stroke often results in disability, due to motor and cognitive impairments, and secondary health problems affecting not only patients but also their families. Building on emerging preclinical and pilot clinical evidences, RESSTORE will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery and patients quality of life. RESSTORE European multicentre randomised phase IIb will explore, for the first time, the efficacy (functional recovery) and safety of intravenous infusion of allogenic adipose tissue derived mesenchymal stem cells (ADMSCs) in 400 stroke patients. Therapeutic effects of ADMSCs will be assessed and monitored in patients using clinical rating scales, multimodal MRI and novel blood biomarkers. Additionally, the societal value and cost-effectiveness of ADMSCs-based regenerative therapy will be evaluated through health economics and predictive in silico simulations. Complementary ancillary animal studies will support the clinical trial by defining i) if the treatment response can be further enhanced by intensive rehabilitation, ii) the contribution of co-morbidities and iii) the mechanism(s) underlying the therapeutic effect. The European regenerative therapy capacities (France, Spain, Finland, United Kingdom and Czech Republic), developed in RESSTORE will cover the full value chain in the field (large scale GMP cell production, clinical testing, biomarkers discovery, understanding of the restoring mechanisms, modelling, biobanking, economic studies, exploitation and communication plan). RESSTORE will thus surely contribute, together with the workforce trained in the context of the programme, to improve its public and private (SME) competitiveness and increase the attractiveness of Europe as a reference location to develop and clinically assess new innovative therapeutic options for brain diseases.


Grant
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-18-2015 | Award Amount: 8.19M | Year: 2016

Liver cancer in the paediatric population is rare with an incidence approximately 1-1.5 per million population. The commonest tumour seen in the childhood population is hepatoblastoma (HB), usually seen in young children and infants. Much rarer (about 10% of paediatric liver cancers) is hepatocellular carcinoma (HCC), usually seen in the teenage population and sometimes associated with underlying cirrhotic liver diseases. The ChiLTERN project relates to topic PHC 18 establishing effectiveness of health care interventions in the paediatric population. The ChiLTERN project builds on a unique opportunity to undertake a comprehensive research programme linked to an ambitious global partnership which will see the single largest clinical trial (the Paediatric Hepatic International Tumour Trial - PHITT) ever undertaken in this population of patients, with several randomised questions in six subgroups of patients. ChiLTERN will allow us to move towards an era of personalised therapy in which each patient will receive the correct amount of chemotherapy and will undergo has the best surgical operation (surgical resection or liver transplant). By using both clinical and biological information, we can assign patients more accurately to risk groups based on their survival. Using genetic tests and biomarkers, we will determine those children who may be at risk of developing long term side effects (deafness, heart failure, kidney damage). In addition, biomarkers will allow us to monitor during therapy and detect toxicities early before serious damage is done so that we can adapt treatment and prevent these problems. Finally, we will be using imaging technology tools which will help our surgeons plan liver operations more safely and effectively. Ultimately ChiLTERN will allow us to cure more children with liver cancer, expose fewer children to toxic chemotherapy and ensure their surgery is both effective and safe.


Grant
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-28-2015 | Award Amount: 4.98M | Year: 2016

The main objective of POWER2DM is to develop and validate a personalized self-management support system (SMSS) for T1 and T2 diabetes patients that combines and integrates (1) a decision support system (DSS) based on leading European predictive personalized models for diabetes interlinked with predictive computer models, (2) automated e-coaching functionalities based on Behavioural Change Theories, and (3) real-time Personal Data processing and interpretation. The DSS will be based on the complementary combination of proven predictive models for short term plasma glucose prediction, medium term diabetes progression, and long term risk scoring for diabetes complications. These models will be integrated in adaptive personalized behavior change interventions to increase adherence of the patients to their care program and improve their interaction with health professionals. A cloud-based Data Integration Service, collecting and processing data from personal devices and EHR/PHR in real-time feeds the DSS. The results of the SMSS with respect to clinical parameters, awareness, acceptance and empowerment of the patient to participate in the care process will be evaluated in three studies in NL, DE and ES. The deliverables of the project will increase self-management capabilities and participation of the patient in the care process, resulting in better self-control and management of the disease. This will lead to better glucose management, thereby preventing severe episodes and long-term complications. POWER2DM will reinforce the prevention sector in healthcare by raising the acceptance of SMSS based on DSS that use predictive models fed by data from personal devices. POWER2DM will challenge individuals towards more frequent and long-term use of personal devices for self-monitoring, boosting the development of these devices. POWER2DM will thereby make an essential step forward in empowering the patient, advancing prevention and decreasing disease burden and costs.


Ageing is the major risk factor for idiopathic PARKINSONS DISEASE (PD), the first motor neurodegenerative disorder (in EU 1% in 65\; about 4% in 80\). The most recent conceptualizations of ageing and PD indicate that they share basic mechanisms, e.g. accumulation of senescent cells and propagation phenomena such as inflammaging mirrored in PD by neuro-inflammaging in brain that foster a prion-like spreading of neuronal damage. Thus, to fully understand PD pathogenesis and set up innovative neuro-protective therapies it is mandatory to posit PD within the framework of ageing process. The main goal of PROPAG-AGEING is to identify specific cellular and molecular perturbations deviating from healthy ageing trajectories towards PD. To this aim the project will exploit four large, very informative EXISTING COHORTS where biomaterials are available: i) de novo PD patients (before any therapy) followed longitudinally, including the largest repository of PD patients, i.e. PPMI; ii) centenarians and their offspring (CO) who never showed clinical signs of motor disability; iii) old twins of the Swedish Twin Registry (STR) followed longitudinally for >45 years, assessed for lifestyle and exposure to toxicants, and where incident and prevalent cases of PD discordant twins have been collected, including brains. The most informative sample from these cohorts will be studied in a DISCOVERY PHASE by an integrated set of omics to identify molecular signatures whose results will enter in a VALIDATION PHASE exploiting the four large cohorts, and performing functional in in vitro studies using dopaminergic neurons obtained by PD somatic cells from PD patients and centenarians via iPSC protocol. An added value is that omic data in centenarians and CO are available, and will represent the gold standard of healthy ageing. This approach will allow to identify new molecular profiles for early diagnosis and therapy (identification of druggable targets) of PD and signatures of healthy ageing.


Grant
Agency: European Commission | Branch: H2020 | Program: PCP | Phase: SC1-PM-12-2016 | Award Amount: 4.66M | Year: 2017

Patient Empowerment Individualized tackling of unnecessary stress, in particular when related to healthcare procedures, promises to enhance the autonomy and quality of life of many people and yield a significant contribution to self-empowerment, thus relieving careers and related persons from personal assistance. Not at least, also a considerable economic relief (see Impact). This is the topic the STARS consortium is determined to deal with. Of course, as will be shown, the objective is complex and ambitious and has to meet challenges from smart vital signs measuring to wireless real-time transfer of large data amounts to big data management. Nevertheless, concerning the expectable positive impact there is a large potential of revenue for the efforts. And, regarding present technological progress, it seems absolutely feasible to face this challenge when doing this inby a concerted, multidisciplinary, cross-linked effort. To achieve the aim, our proposal addresses an advanced, eHealth based concept for tailored avoidance and/or reduction of healthcare related stress, beginning as early as in the preclinical phase, proceeding during their hospitalisation until the end of the aftercare period. I.a. it can be expected that, recovery time will be shortened, harmful side-effects of sedating drugs will be prevented and costs will be reduced, which in sum will be an important contribution to a cost-effective healthcare system in the next decades.


Grant
Agency: European Commission | Branch: H2020 | Program: COFUND-PCP | Phase: PHC-27-2015 | Award Amount: 2.70M | Year: 2016

RELIEF aims to link European health procurers in order to create the innovative and sustainable solutions that will improve chronic pain control/relieve through ITC self-management techniques. Chronic pain diseases is costing to healthcare systems annually over 300bn in Europe; 1.5%-3% of GDP (gross domestic product). Chronic pain entails a significant direct cost to healthcare systems. Consultations with healthcare professionals confirm that Chronic pain associated costs are the largest share in healthcare system costs. Inappropriate and ineffective management and treatment generates repetitive visits to primary care physicians, and referrals to specialists. This has been identified as important drivers of avoidable healthcare costs. However, while direct costs are high, it has been estimated that nine-tenths of the burden of pain may fall on the broader society. Even small increases in the effectiveness of pain management reap large economic rewards. More than half of patients with acute or chronic pain are not well treated even though the existing therapeutic options have confirmed effective results. There is a clear heterogeneity in the treatments and also in the results. eHealth solutions must achieve greater comparability between systems, patients and protocols, so as to reach more effective and efficient procedures. At present, there is a wide range of high-tech devices aimed at treating pain in its many facets and complexity. But it is still necessary to cover the gap between Research and Commercialization of new products and devices, as outlined during the Pain Technology Transfer Forum, held in Madrid in July 2014. RELIEF will foster and accelerate the access to market for innovative solutions, while respecting the public procurement directives. The project will contribute to boost innovative tools that empower the patient to self-manage current and future pains.


Grant
Agency: European Commission | Branch: H2020 | Program: IA | Phase: ICT-28-2015 | Award Amount: 2.70M | Year: 2016

The overall aim of LIQBIOPSENS project is the further development and validation in real settings of a novel diagnostic platform for the early and fast detection of ctDNA and their KRAS and BRAF mutations associated to colorectal cancer through blood samples. The main features of LIQBIOPSENS are: reliability (detection rates vary from 95100 %), low-cost (40-50 per sample analysis), sensitivity (in the zM range), multiplexing capabilities (analysis of 27 KRAS and BRAF mutations simultaneously), short analysis time (30-60 min.), user-friendly interface and flexibility. Solution proposed by the LIQBIOPSENS project relies on the multidisciplinary integration of different Key Enabled Technologies: microelectronics, microfluidics, nanomaterials and genomics. In particular, LIQBIOPSENS platform is based on the integration of two novel complementary technologies. On the one hand, the revolutionary DGL technology property of DestiNA Genomics Ltd, capable of delivering faster, more error-free detection of nucleic acids and their mutations than current enzyme-based detection systems, making false positive results a thing of the past. On the other hand, a novel high resolution acoustic wave microsensor technology property of AWSensors, that allows an accurate, inexpensive, label-free, direct and real time transduction method to quantitatively evaluate the results of the application of the above mentioned DGL technique.

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