HORIZON EUROPE
Europeo
Specific Challenge:Vaccines and monoclonal Antibodies (mAb) may reduce antimicrobial resistance (AMR). However, individual vaccine developers and manufacturers, as well as organisations developing mAbs and health authorities, acting alone, do not have the resources and the full expertise required to make a realistic and comparable assessment of the use of the different products on the reduction of AMR. This could instead be possible through the development of a mathematical model. For such a model to be representative of the concerns and interests of the various actors (i.e. industry and the public health sector), it should take into account the perspectives of these different actors in order to capture all relevant impacts both in terms of costs and health outcomes.
Please refer to Call topic text.
Scope:The proposal has the following scope:
1) Evaluate the burden of disease of AMR by estimating inpatients’ (acute care hospitals and long-term care facilities) and outpatients’ infection rates in at least 8 EU countries for which suitable data is collected and available, as well as in the US , and the relative attributable risk for morbi...
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Specific Challenge:Vaccines and monoclonal Antibodies (mAb) may reduce antimicrobial resistance (AMR). However, individual vaccine developers and manufacturers, as well as organisations developing mAbs and health authorities, acting alone, do not have the resources and the full expertise required to make a realistic and comparable assessment of the use of the different products on the reduction of AMR. This could instead be possible through the development of a mathematical model. For such a model to be representative of the concerns and interests of the various actors (i.e. industry and the public health sector), it should take into account the perspectives of these different actors in order to capture all relevant impacts both in terms of costs and health outcomes.
Please refer to Call topic text.
Scope:The proposal has the following scope:
1) Evaluate the burden of disease of AMR by estimating inpatients’ (acute care hospitals and long-term care facilities) and outpatients’ infection rates in at least 8 EU countries for which suitable data is collected and available, as well as in the US , and the relative attributable risk for morbidity, mortality and costs.
2) Build a comprehensive AMR model (i.e. model structure, parameters, assumptions) based on an analysis of the strengths and weaknesses of existing models, and a gap analysis.
3) Collecting, gathering, and analysing data from existing databases to feed the model.
4) Develop and test a cost-effectiveness analysis (CEA) to estimate the cost and benefits of covering defined target groups (e.g. 18+, 60+, surgeries) with mAbs and vaccines.
5) Set up a study to test, monitor, evaluate and improve the model.
6) Ensure a public and broad access to the model
Please refer to Call topic text.
Expected Impact:The epidemiological repository that will be obtained by the applicant consortium, besides providing a transparent basis for the BOD estimation, will be made accessible through an internet database to be designed within the project. Any researcher will benefit from using the most comprehensive database on the epidemiology of infectious diseases and resource consumption associated with sensitive and resistant pathogens. Producing a reliable repository with clear description of the methods used to derive the estimates of the BOD and AMR will benefit the credibility of the results of the mathematical model. During the project, the access will be free of charge. The ambition is to favour open access as much as possible.
The results of the mathematical model (publicly available and free of charge) will allow policymakers and healthcare managers to make informed decisions on vaccines and mAb strategies. The impact will include clear direction for EFPIA partners and health care authorities on which research and development strategies should be prioritised to reduce AMR through vaccine and monoclonal antibodies.
Better chance of preserving the efficacy of last-resort antimicrobials. As an example, the European Centre for Disease Prevention and Control has published guidelines for the screening of patients at high risk for Carbapenem Resistant Enerobacteraceae (CRE) and Carbapenemase Producing Enterobacteriaceae (CPE) at the time of admission. The retrospective record review will provide an assessment on their status of implementation and will allow estimation of the resources required to put in place a functional screening and surveillance system for CRE and CPE, as well as other types of resistance.
Testing the sustainability of the study approach by financing a multi-year monitoring and evaluation system in key health units of a few pilot countries. The impact will be a strengthening of the existing AMR surveillance systems, and a verification of the assumptions and parameters underlying the model. For example, an initial model focused on a specific vaccine or mAb might provide an initial base which will be fine-tuned according to real data, and which will be further expanded to other promising mAbs and vaccinations, with further fine-tuning.
Please refer to Call topic text.
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Características del consorcio
:
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 JU 23rd Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call, along with the information below, are given at the end of the Call topics text, in the Call Conditions section.
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... Please read carefully all provisions below before the preparation of your application.
The IMI2 JU 23rd Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call, along with the information below, are given at the end of the Call topics text, in the Call Conditions section.
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):
IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):
Standard evaluation form
Proposal templates are available after entering the submission tool
Proposal template stage 1
Proposal template stage 2
IMI2 Model Grant Agreement
Clinical trial template - The clinical trial template is required only at stage 2! Therefore, in the Proposal Submission Form at stage 1, the answer options to the question "Are clinical studies/trials/investigations included in the work plan of this project?” are disabled.
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.
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
7. Additional documents:
Summary of the most relevant provisions for participating in IMI2 actions
IMI2 Annual Work Plan 2020
IMI JU derogation to H2020 Rules for Participation
Horizon 2020 Rules for Participation
Horizon 2020 Regulation of Establishment
Horizon 2020 Specific Programme
Información adicional de la convocatoria
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