HORIZON EUROPE
Europeo
Scope:Specific challenge: A considerable amount of knowledge has been generated by biomedical research in recent years, yet most of the 6000-8000 rare diseases are lacking therapies despite many diseases being life-threatening or chronically debilitating.
Specific problems posed in therapy development for rare diseases include the small and dispersed patient populations[1] and the nature of the therapies proposed which are often highly specialised and novel requiring the advice of regulatory authorities during development. In addition the limited market for such therapies provides a low commercial return.
Scope: Proposals may address one or more of the following: development of new or improved therapeutic approaches, for repurposing of existing therapies, as well as for preclinical research, animal model development and good manufacturing practice (GMP) production.
Proposed treatments to be developed may range from small molecule to gene or cell therapy.
Clinical trials shall only be supported in cases where "orphan designation" has been given by the European Commission and where the proposed clinical t...
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Scope:Specific challenge: A considerable amount of knowledge has been generated by biomedical research in recent years, yet most of the 6000-8000 rare diseases are lacking therapies despite many diseases being life-threatening or chronically debilitating.
Specific problems posed in therapy development for rare diseases include the small and dispersed patient populations[1] and the nature of the therapies proposed which are often highly specialised and novel requiring the advice of regulatory authorities during development. In addition the limited market for such therapies provides a low commercial return.
Scope: Proposals may address one or more of the following: development of new or improved therapeutic approaches, for repurposing of existing therapies, as well as for preclinical research, animal model development and good manufacturing practice (GMP) production.
Proposed treatments to be developed may range from small molecule to gene or cell therapy.
Clinical trials shall only be supported in cases where "orphan designation" has been given by the European Commission and where the proposed clinical trial design takes into account recommendations from protocol assistance given by the European Medicines Agency and where a clear patient recruitment strategy is presented. The orphan medicinal product must have been granted the EU orphan designation[2] at the latest on the date of the Stage 2 call closure. A concise feasibility assessment justified by available published and preliminary results and supporting data shall also be provided. Considerations of effectiveness / potential clinical benefit should be integrated in the application if relevant.
Selected proposals should contribute to the objectives of, and follow the guidelines and policies of the International Rare Diseases Research Consortium, IRDiRC[3].
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: This should provide:
Advancing the development of new therapeutic options for patients living with rare diseases. In line with the Union’s strategy for international cooperation in research and innovation[4], proposals should contribute towards IRDiRC objectives. Type of action: Research and innovation actions
[1] http://ec.europa.eu/health/files/eudralex/vol-1/reg_2000_141/reg_2000_141_en.pdf
[2] The European register of designated Orphan Medicinal Products is available from http://ec.europa.eu/health/documents/community-register/html/alforphreg.htm
[3] www.irdirc.org
[4] COM(2012)497
Cross-cutting Priorities:International cooperation
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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, with the following exception:
Clinical trials shall only be supported in cases where "orphan designation" has been given. The orphan medicinal product must have been granted the EU orphan designation* at the latest on the date of the call closure (of stage 2).
*The European register of designated Orphan Medicinal Products is available from http://ec.europa.eu/health/documents/community-register/html/alforphreg.htm
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 determ... 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, with the following exception:
Clinical trials shall only be supported in cases where "orphan designation" has been given. The orphan medicinal product must have been granted the EU orphan designation* at the latest on the date of the call closure (of stage 2).
*The European register of designated Orphan Medicinal Products is available from http://ec.europa.eu/health/documents/community-register/html/alforphreg.htm
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.
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