HORIZON EUROPE
Europeo
Scope:Specific challenge: Promising pre-clinical nano-medicine proof-of-concepts have been developed for the therapy of cancer, but their translation into clinical therapies remains a major challenge. An important bottleneck is up-scaling under Good Manufacturing Practice (GMP) conditions for the production of the nanomedicines from the pre-clinical laboratory scale to the quantity needed for clinical testing.
Scope: The aim is to translate promising novel nano-technology enabled therapies for cancer with pre-clinical proof-of-concept, from a pre-clinical lab stage up to Phase I clinical testing. The project shall start from an established pre-clinical proof-of-concept, with relevant efficacy and toxicity data. The project shall be focused on the translation process, so that ultimately new effective therapies can be introduced to the European healthcare market. An important aspect is the development of a pilot line for scaling-up the production of the nanomedicines and the quality control, taking into account GMP and medical regulatory requirements. Projects may include the later stages of pre-clinical testing and Phase 1 clinical testing, but the latter is not a requi...
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Scope:Specific challenge: Promising pre-clinical nano-medicine proof-of-concepts have been developed for the therapy of cancer, but their translation into clinical therapies remains a major challenge. An important bottleneck is up-scaling under Good Manufacturing Practice (GMP) conditions for the production of the nanomedicines from the pre-clinical laboratory scale to the quantity needed for clinical testing.
Scope: The aim is to translate promising novel nano-technology enabled therapies for cancer with pre-clinical proof-of-concept, from a pre-clinical lab stage up to Phase I clinical testing. The project shall start from an established pre-clinical proof-of-concept, with relevant efficacy and toxicity data. The project shall be focused on the translation process, so that ultimately new effective therapies can be introduced to the European healthcare market. An important aspect is the development of a pilot line for scaling-up the production of the nanomedicines and the quality control, taking into account GMP and medical regulatory requirements. Projects may include the later stages of pre-clinical testing and Phase 1 clinical testing, but the latter is not a requirement. Nanopharmaceuticals may be manufactured with either a top-down or a bottom-up approach, using for example self-assembling technology. Applicants must describe, according to industrial criteria, how the various barriers for advancing their new therapy to clinical application will be overcome, including technical, IPR, competitive, commercial and regulatory criteria, with efficacy and toxicity. Attention must be paid to clinical trial design and the foreseen research and commercial path to market introduction has to be well outlined.
For this topic, proposals should include an outline of the initial exploitation and business plans, which will be developed further in the proposed project.
The research is to be implemented from TRL 4/5 and target TRL 6/7. Implemented as cross-KET activities.
The Commission considers that proposals requesting a contribution from the EU between EUR 6 and 9 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:
Potential major improvement in clinical cancer therapy, thereby providing enhanced quality of life for patients (taking gender and other diversities into account).
Potential reduced direct and indirect healthcare costs linked to the disease and its treatment.
Accelerated introduction of new nanotechnology enabled cancer therapy, through robust manufacturing and quality control procedures for new nanotechnology enabled drugs.
Type of action: Research & Innovation Actions
Cross-cutting Priorities:Gender
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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
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:
For single-stage and second-stage evaluations, the threshold for the criteria Excellence and Impact will be 4. The overall threshold, applying to the sum of the three individual scores, will be 12.
In case of equal overall scores in the ranked list, the priority order of proposals will be established in accordance with part H of the General Annexes, except that proposals will be ranked on the basis of individual scores for the Impact criterion before the Excellence criterion.
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 inform... 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:
For single-stage and second-stage evaluations, the threshold for the criteria Excellence and Impact will be 4. The overall threshold, applying to the sum of the three individual scores, will be 12.
In case of equal overall scores in the ranked list, the priority order of proposals will be established in accordance with part H of the General Annexes, except that proposals will be ranked on the basis of individual scores for the Impact criterion before the Excellence criterion.
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
Standard proposal template
Standard evaluation form
Annotated Model Grant Agreement
Additional provisions:
Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.
Financial support to Third Parties – where a topic description foresees financial support to Third Parties, these provisions apply.
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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