HORIZON EUROPE
Europeo
Specific Challenge:The development of medical devices and pharmaceutical products are associated with high costs. A new pharmaceutical product and its introduction into the market is estimated to cost today over 2 billion EUR, from which nearly 75% is spent at the late stages of the drug development process in the various phases of the clinical trials.
As biomedical knowledge increases and bioinformatics capability likewise grows, there is hope that greater predictive power may be obtained from individualised computer simulations used in in-silico medicine research, such as predictive toxicology and pharmacokinetics.
The adoption of individualised computer models and simulations to develop and assess drugs and devices , their translation into the clinic and penetration on the market of ICT solutions, depend on the trust of users (healthcare professionals and patients), the industry and investors and the competent authorities and regulatory bodies. The users need proofs of validation in the real clinical contexts.
The specific challenge of this call is accelerating the uptake of individualised computer simulations in the regulatory evaluation...
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Specific Challenge:The development of medical devices and pharmaceutical products are associated with high costs. A new pharmaceutical product and its introduction into the market is estimated to cost today over 2 billion EUR, from which nearly 75% is spent at the late stages of the drug development process in the various phases of the clinical trials.
As biomedical knowledge increases and bioinformatics capability likewise grows, there is hope that greater predictive power may be obtained from individualised computer simulations used in in-silico medicine research, such as predictive toxicology and pharmacokinetics.
The adoption of individualised computer models and simulations to develop and assess drugs and devices , their translation into the clinic and penetration on the market of ICT solutions, depend on the trust of users (healthcare professionals and patients), the industry and investors and the competent authorities and regulatory bodies. The users need proofs of validation in the real clinical contexts.
The specific challenge of this call is accelerating the uptake of individualised computer simulations in the regulatory evaluation of medicines and/or medical devices to become closer to the market., Applicants will provide proofs of validation of computer modelling solutions that gain the trust of regulatory bodies for innovation, in order to, in collaboration with academic and industrial experts, develop the framework of standards, protocols and shared resources required to evaluate the safety and the efficacy of medical devices and/or medicines at the end of the drug development process.
Scope:Proposals will develop innovative scientific and technological computer modelling solutions for testing medicines and/or medical devices. The proposed computer modelling solutions will be the result of a multidisciplinary effort (e.g. within the fields of computational modelling, chemo/bio-informatics, systems biology, pharmacology, -omics (genomics, epigenomics, metabolomics), tissue mechanics, biology, pharmaceutics, medicine, physiology, toxicology, social science aspects such as gender) and should also explore and inform of the reasons for failure should the drug or medical device be found not efficient or safe and will suggest improvements. To help adopt such in-silico methods, measures for validation (human trials, animal studies, in vivo and in vitro validation, including the use of biobanks if appropriate) of the in-silico results should be included in the proposed projects. The benefit for human health, environment and animal welfare should be analysed and quantified. Engagement with regulators and consideration of the regulatory framework issues for computer simulations are highly recommended. Participation of SMEs is encouraged.
The Commission considers that proposals requesting a contribution from the EU of between EUR 6 and 8 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.
Expected Impact:The proposal should provide appropriate indicators to measure its progress and specific impact in the following areas by contributing to:
Accelerating the adoption of computer simulations for testing medicines and/or medical devices, their translation into the clinic and the market.Increasing the trust of users (healthcare professionals and patients), investors and stakeholders at industry and academia to adopt computer simulations for testing medicines or medical devices as a substitution or complement of current clinical trials when appropriate.Contributing to redesigning current drug clinical trials by integrating in-silico methods for testing medicines or medical devices and creating a unique, digitised, personalised testing environment.Engagement with regulators and consideration of the regulatory framework for computer modelling solutions.Contributing to reducing the size and the duration of the human clinical trials and/or contributing to significantly reducing animal testing in clinical trials. Contributing to increased efficacy and patient safety in clinical trials.Contributing to reducing development costs and/or shorter time-to-market for new drugs or new medical devices. Contributing to setting standards for computer modelling solutions for testing.Contributing to the European Cloud Initiative, notably by providing open, reusable data and in silico models for clinical trials.
Cross-cutting Priorities:Socio-economic science and humanitiesOpen ScienceGender
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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
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects. See the information in the Online Manual.
2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
3. Evaluation:
Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
Submission and evaluation processes are described in the Online Manual.
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
Information on the outcome of evaluation (two-stage call):
For stage 1: maximum 3 months from the deadline for submission.
For stage 2: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
1. Eligible countries: described in Annex A of the Work Programme.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects. See the information in the Online Manual.
2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
3. Evaluation:
Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
Submission and evaluation processes are described in the Online Manual.
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
Information on the outcome of evaluation (two-stage call):
For stage 1: maximum 3 months from the deadline for submission.
For stage 2: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
Research and Innovation Action:
Specific provisions and funding rates
Standard proposal template
Specific evaluation form
General MGA - Multi-Beneficiary
Annotated Grant Agreement
6. Additional provisions:
Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply
Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.
8. Additional documents:
1. Introduction WP 2018-20
2-Health, demographic change and well-being WP 2018-20
3.Dissemination, Exploitation and Evaluation WP 2018-20
4.Cross-cutting activities WP 2018-20
General annexes to the Work Programme 2018-2020
Legal basis: Horizon 2020 Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme
7. 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 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.
Información adicional de la convocatoria
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