HORIZON EUROPE
Europeo
Specific Challenge:Inflammatory skin diseases affect a significant percentage of our global population. Atopic Dermatitis (AD) affects approximately 10% of children and 3% of adults worldwide. Psoriasis (Pso) affects approximately 2% of our population. These diseases remain poorly understood with limited understanding of their mechanism, endotypes, ontology and co-morbidities, affecting the quality of effective treatments. While there may be aspects of these diseases that overlap, others show little or no similarities e.g. their associated co-morbidities are generally quite distinct with Pso being linked with arthritis, psychiatric disorders, metabolic syndrome and cardiovascular sequelae while AD is associated with rhinitis, asthma, food allergy as well as cardiovascular complications. As a result, there is an immediate need for sophisticated, in-depth investigations of these diseases that address transformative topics. These studies include, but are not limited to, the impact of environmental factors (e.g. via the microbiome) interacting with genomic factors and studies that help elucidate molecular pathways of disease in a comprehensive, patient-driven manner. To this end, the c... ver más
Specific Challenge:Inflammatory skin diseases affect a significant percentage of our global population. Atopic Dermatitis (AD) affects approximately 10% of children and 3% of adults worldwide. Psoriasis (Pso) affects approximately 2% of our population. These diseases remain poorly understood with limited understanding of their mechanism, endotypes, ontology and co-morbidities, affecting the quality of effective treatments. While there may be aspects of these diseases that overlap, others show little or no similarities e.g. their associated co-morbidities are generally quite distinct with Pso being linked with arthritis, psychiatric disorders, metabolic syndrome and cardiovascular sequelae while AD is associated with rhinitis, asthma, food allergy as well as cardiovascular complications. As a result, there is an immediate need for sophisticated, in-depth investigations of these diseases that address transformative topics. These studies include, but are not limited to, the impact of environmental factors (e.g. via the microbiome) interacting with genomic factors and studies that help elucidate molecular pathways of disease in a comprehensive, patient-driven manner. To this end, the challenge is seeking to define the key heterogeneous and homogeneous aspects of AD and Pso, both within each disease and across their shared biology. Such characterisation can include clinical hallmarks, patient epidemiology and reported outcomes, and assessment of molecular signatures.. Expanding our current knowledge to understand unique endotypes of inflammatory skin diseases will help give rise to more precise, targeted treatments that can yield long lasting reductions in disease burden and improved patient quality of life, fulfilling unmet medical needs in patient care.
Scope:The action to be generated from this topic is expected to lead to a step change in our understanding of the molecular mechanism and ontology of the two main inflammatory skin diseases: AD and Pso. Elucidating the molecular pathways of these inflammatory skin conditions over time will give rise to novel and meaningful therapeutic targets for specific patient populations and help address the complex patterns of co-morbidities. In addition, this work will identify biomarkers that will enable robust, efficient and meaningful patient management.
These objectives should be achieved both via a retrospective assessment of Pso and AD patients that can aid in defining key endotypes of disease and the disease commonalities and uniqueness, as well as via access to ongoing prospective studies that will embrace novel approaches and hypotheses relating to defining these. It is expected that reliable access to robustly defined clinical information and specimens will be vital to the overall scope.
Expected Impact:Currently, Pso and AD represent diseases difficult to treat and they significantly impact quality of life and medical health care costs for patients. This topic aims to comprehensively address aspects of disease endotypes, underlying pathobiology, and factors contributing to initiation, exacerbation and severity of disease, as well as response to therapy. Consequently, there are broad impacts relevant to the IMI2 goals that include:
Research and Development (R&D) Process: using a patient-centred approach through comprehensive characterisation of skin disease heterogeneity, it is expected that new understandings into pathobiological processes will be established that should help drive future therapies, as well as stimulate new levels of understandings into skin biology and how it is regulated during homeostasis, disease, and repair.Regulatory Pathways and Health Technology Assessment: establishment of comprehensive disease endophenotyping will improve directed care decisions and future clinical trial design, including biomarkers, quality of life considerations, and patient enrolment suitability.Clinical and healthcare practices: understanding of early life events and environmental influences over disease progression and severity will support improvement in physician recommendations and management of patients. The topic expected impact is to establish, and support access to, a world-leading analysis of skin disease, as comprehensively addressed from the perspectives of AD and Pso. This should be achieved through studying unprecedented patient numbers, a robust depth of data available (e.g. clinical, transcriptomic, response to treatment etc.), state-of-the-art approaches to studying the disease biology and central accessibility for users of the BioResource.
In terms of strengthening the competitiveness and industrial leadership in Europe impact will be significantly enhanced by also including the relevant expertise from the Small- and Medium-sized Enterprises (SMEs).Their involvement might offer a complementary perspective to industry and the academia, and help deliver the long-term impact of the project.
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Características del consorcio
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La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
The IMI2 13th Call for proposals topic text as well as the Call Conditions are available here.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Condtions section, as well as the following information:
1. Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
3. Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full p... Please read carefully all provisions below before the preparation of your application.
The IMI2 13th Call for proposals topic text as well as the Call Conditions are available here.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Condtions section, as well as the following information:
1. Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
3. Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.
Signature of grant agreements: maximum 3 months from the date of informing successful applicants.
5. Proposal templates, evaluation forms and model grant agreements (MGA), clinical trials template:
IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):
Proposal templates are available after entering the submission tool.
Standard evaluation form RIA
IMI2 Model Grant Agreement:
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
Clinical trial template:
The Clinical Trial template is compulsory at stage 2 only !
IMI2 Coordination and Support Action (IMI2-CSA):
Proposal templates are available after entering the submission tool.
Standard evaluation form CSA
IMI2 Model Grant Agreement:
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
Clinical trial template:
The Clinical Trial template is compulsory at stage 2 only !
6. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the H2020 main Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
7. Additional documents:
Summary of the most relevant provisions for participating in IMI2 actions
IMI2 - 2nd Amendment to the Annual Work Plan 2017
IMI2 Regulators Guidance tool for researchers
IMI JU derogation to H2020 Rules for Participation
Horizon 2020 Rules for Participation
Horizon 2020 Regulation of Establishment
Horizon 2020 Specific Programme
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
Información adicional de la convocatoria
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