HORIZON EUROPE
Europeo
Scope:Specific challenge: In nanomedicine the scale-up of nanopharmaceuticals production from pre-clinical laboratory scale to the quantity and GMP quality needed for clinical testing is severely hindered by a lack of pilot manufacturing capacity and supply infrastructure. The quantities required for clinical testing studies are modest (e.g. in the order of ten to hundred grams), but such pilot processes do not fit easily into existing manufacturing plants. The lack of a pilot manufacturing supply chain is especially problematic for SMEs and other organisations that do not have the necessary resources to develop the processes in-house.
Scope: Projects shall develop one or more pilot lines and processes for the scaling-up of the production of innovative nanopharmaceuticals to the quantities needed for clinical testing, taking into account the medical regulatory requirements. The pilot lines shall be developed with the appropriate characterisation and quality control processes. Relevant medical regulatory requirements must be taken into account. Projects shall address industrial sustainablity from an economic, environmental and social point of view. The nanopharmaceutic...
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Scope:Specific challenge: In nanomedicine the scale-up of nanopharmaceuticals production from pre-clinical laboratory scale to the quantity and GMP quality needed for clinical testing is severely hindered by a lack of pilot manufacturing capacity and supply infrastructure. The quantities required for clinical testing studies are modest (e.g. in the order of ten to hundred grams), but such pilot processes do not fit easily into existing manufacturing plants. The lack of a pilot manufacturing supply chain is especially problematic for SMEs and other organisations that do not have the necessary resources to develop the processes in-house.
Scope: Projects shall develop one or more pilot lines and processes for the scaling-up of the production of innovative nanopharmaceuticals to the quantities needed for clinical testing, taking into account the medical regulatory requirements. The pilot lines shall be developed with the appropriate characterisation and quality control processes. Relevant medical regulatory requirements must be taken into account. Projects shall address industrial sustainablity from an economic, environmental and social point of view. The nanopharmaceuticals selected for scaling-up shall be translatable and in an advanced stage of pre-clinical development, with positives perspectives to proceed to clinical testing. Clinical testing itself is not part of the project. Scaling-up of nanopharmaceuticals production intended primarily for the therapy of cancer is excluded from the scope of this topic as it is addressed in topic NMP 11.
For this topic, proposals should include an outline of the initial exploitation and business plans, which will be developed further in the proposed project.
Wherever possible, proposers could actively seek synergies, including possibilities for funding, with relevant national / regional research and innovation programmes and/or cumulative funding with European Structural and Investment Funds in connection with smart specialisation strategies. For this purpose the tools provided by the Smart Specialization Platform, Eye@RIS3 may be useful[1]. The initial exploitation and business plans will address such synergies and/or additional funding. Exploitation plans, outline financial arrangements and any follow-up will be developed further during the project. The results of these activities as well as the envisaged further activities in this respect should be described in the final report of the project.
The implementation of this proposal is intended to start at 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 5 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:
Improve GMP nanopharmaceuticals supply for enabling clinical trials, further validating and demonstrating the effectiveness of nanopharmaceuticals for medical therapies;
Leveraging of existing investments in successful pre-clinical nanomedicine research;
Increase of the attractiveness of Europe as a location-of-choice to carry out advanced medical research and product development, due to improved nanopharmaceuticals supply capacity.
Type of action: Research & Innovation Actions
[1] http://s3platform.jrc.ec.europa.eu; the relevant Managing Authorities can be found at http://ec.europa.eu/regional_policy/indexes/in_your_country_en.cfm
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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:
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.
The evaluation criteria are applied as follows:
1. Excellence
• Clarity and importance of the objectives;
• Soundness of the concept, including trans disciplinary considerations;
• Credibility of the proposed approach;
• Readiness of the technology for implementing the pilot;
• Progress beyond the state of the art in production.
2. Impact (**)
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.
The evaluation criteria are applied as follows:
1. Excellence
• Clarity and importance of the objectives;
• Soundness of the concept, including trans disciplinary considerations;
• Credibility of the proposed approach;
• Readiness of the technology for implementing the pilot;
• Progress beyond the state of the art in production.
2. Impact (**)
The extent to which the outputs of the project could contribute at the European and/or International level to:
• The expected impacts listed in the work programme under the relevant topic;
• Soundness of the business cases and business plans and commitment to first exploitation / manufacturing;
• Evidence of the market potential and of the competitive technology advantage that will be gained through the pilot line;
• Potential of creating jobs in Europe;
• Effectiveness of the proposed measures to communicate the project, and disseminate the project results ,including appropriate management of IPR;
• Contribution, where appropriate, to standards and to skills and educational training.
3. Quality and efficiency of the implementation
• Coherence and effectiveness of the work plan, including appropriateness of the allocation of tasks and resources;
• Coverage of the value chain (RTOs, materials, equipment and technology suppliers and end-users);
• Competences, experience and complementarity of the individual participants, as well as of the consortium as a whole;*
• Appropriateness of the management structures and procedures, including risk management.
Operational Capacity (selection criterion)
* As a separate step in the evaluation, expert evaluators must indicate whether the members of the consortium possess at least the minimum competences needed to carry out the proposed work.
**The score for the criterion “impact” will be multiplied by 1.5.
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 one-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 (administrative forms and structure of technical annex)
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.
Información adicional de la convocatoria
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