HORIZON EUROPE
Europeo
Scope:Specific challenge: For their successful application, new therapies, such as gene or cell therapies, tissue engineering or regenerative medicine often require technological innovation in the form of development of specific component tools and techniques such as isolation and multiplication of a cell or development of a scaffold, delivery of the therapy to the patient and for following-up the effect of the therapy in the patient.
In particular, achieving therapeutic scale production and GMP standards at reasonable cost is often underestimated. In addition, specific attention needs to be given to aspects such as miniaturisation, automation, biomaterials and scaffold construction while advanced methods and devices for targeted and controlled delivery, and monitoring technology, are needed to bring these innovative treatments to the patient.
Since experience with the new therapies is by definition limited, achieving regulatory compliance for them is another challenge.
Scope: The term advanced therapies encompasses gene therapy, cell therapy, tissue engineering, regenerative medicine and bio-artificial organs. These are biological approaches...
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Scope:Specific challenge: For their successful application, new therapies, such as gene or cell therapies, tissue engineering or regenerative medicine often require technological innovation in the form of development of specific component tools and techniques such as isolation and multiplication of a cell or development of a scaffold, delivery of the therapy to the patient and for following-up the effect of the therapy in the patient.
In particular, achieving therapeutic scale production and GMP standards at reasonable cost is often underestimated. In addition, specific attention needs to be given to aspects such as miniaturisation, automation, biomaterials and scaffold construction while advanced methods and devices for targeted and controlled delivery, and monitoring technology, are needed to bring these innovative treatments to the patient.
Since experience with the new therapies is by definition limited, achieving regulatory compliance for them is another challenge.
Scope: The term advanced therapies encompasses gene therapy, cell therapy, tissue engineering, regenerative medicine and bio-artificial organs. These are biological approaches to therapy which often share common technologies.
Proposals should focus on refining a particular technological step or component needed by the therapeutic approach.
Establishing proof-of-concept for the new technology and carrying out preclinical research may be included if needed.
Regulatory aspects of the new technology should be addressed as appropriate.
The Commission considers that proposals requesting a contribution from the EU of between EUR 4 and 6 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:
Development of tools and technologies enabling establishment of new therapies or patient interventions
Supporting regulatory compliant new technologies
Boost the growth and the competitiveness of the European medical technology sector
Combine new technology developments from different sectors for better, safer and customer friendly products
Increase the attractiveness of Europe as a hub for innovative medical technologies
Type of action: Research and innovation actions
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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
List of countries and applicable rules for funding: described in part A of the General Annexes of the General Work Programme.
Eligibility and admissibility conditions: described in part B and C of the General Annexes of the General Work Programme
Evaluation
3.1 Evaluation criteria and procedure, scoring and threshold: described in part H of the General Annexes of the General Work Programme, with the following exceptions
The thresholds for each criterion at stage 1 (of a two stage process) will be 4 and 4. The cumulative threshold will be 8.5.
The thresholds for each criterion at stage 2 (of a two stage process) will be 4, 4 and 3. The cumulative threshold will be 12.
If a proposal fails to achieve the threshold for a criterion at any stage, the evaluation of the proposal will be stopped.
The median of individual evaluator scores may be used at stage 1 to determine the consensus score and when appropriate, the resulting consensus report may comprise elements of these individual reports, or standard phrases representative thereof.
The page limit for stage 1 proposals is 7 pages (including the title page).
3.2 Guide to the submission and evaluation process
Proposal page limits and layout: Please refer to Part B of the standard proposal template.
Indicative tim... Please read carefully all provisions below before the preparation of your application.
List of countries and applicable rules for funding: described in part A of the General Annexes of the General Work Programme.
Eligibility and admissibility conditions: described in part B and C of the General Annexes of the General Work Programme
Evaluation
3.1 Evaluation criteria and procedure, scoring and threshold: described in part H of the General Annexes of the General Work Programme, with the following exceptions
The thresholds for each criterion at stage 1 (of a two stage process) will be 4 and 4. The cumulative threshold will be 8.5.
The thresholds for each criterion at stage 2 (of a two stage process) will be 4, 4 and 3. The cumulative threshold will be 12.
If a proposal fails to achieve the threshold for a criterion at any stage, the evaluation of the proposal will be stopped.
The median of individual evaluator scores may be used at stage 1 to determine the consensus score and when appropriate, the resulting consensus report may comprise elements of these individual reports, or standard phrases representative thereof.
The page limit for stage 1 proposals is 7 pages (including the title page).
3.2 Guide to the submission and evaluation process
Proposal page limits and layout: Please refer to Part B of the standard proposal template.
Indicative timetable for evaluation and grant agreement:
Information on the outcome of two-stage evaluation: maximum 5 months from the final date for submission.
Signature of grant agreements: maximum 3 months from the date of informing successful applicants.
Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:
Research and Innovation Action:
Specific provisions and funding rates
Annotated Model Grant Agreement
For information, a pdf. template of the evaluation form for this topic is available on the call page under call documents. In addition, to be consulted on the same page a specific template for essential information for clinical trials/studies/investigations is available.
Additional provisions:
Horizon 2020 budget flexibility
Classified information
Open access must be granted to all scientific publications resulting from Horizon 2020 actions, and proposals must refer to measures envisaged. 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.
Información adicional de la convocatoria
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