Innovating Works
NMBP-13-2017
NMBP-13-2017: Cross-cutting KETs for diagnostics at the point-of-care
Specific Challenge:Research and technology development at the interface of key enabling technologies has the potential to provide novel technological Micro-Nano–Bio integrated Systems (MNBS) platforms to enhance the ability to sense, detect, analyse, monitor and act on phenomena from macro (e.g. body, organ, tissues) to nano scale (e.g. molecules, genes). These developments have a high potential for facilitating personalised and preventive healthcare. However, the translation of laboratory proven concepts to the clinical environment involving pre-clinical and clinical testing, prototyping, and small series manufacturing is currently lagging. Business development and market growth are therefore still limited. The challenge is to bring new promising laboratory proven MNBS concepts for addressing priority healthcare needs from the laboratory to the clinic.
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Specific Challenge:Research and technology development at the interface of key enabling technologies has the potential to provide novel technological Micro-Nano–Bio integrated Systems (MNBS) platforms to enhance the ability to sense, detect, analyse, monitor and act on phenomena from macro (e.g. body, organ, tissues) to nano scale (e.g. molecules, genes). These developments have a high potential for facilitating personalised and preventive healthcare. However, the translation of laboratory proven concepts to the clinical environment involving pre-clinical and clinical testing, prototyping, and small series manufacturing is currently lagging. Business development and market growth are therefore still limited. The challenge is to bring new promising laboratory proven MNBS concepts for addressing priority healthcare needs from the laboratory to the clinic.


Scope:The focus is on further development into a clinical setting of novel MNBS platforms, techniques and systems that have already been proven in a laboratory setting (laboratory Proof-of-Concept). These must pertain to one or more of the following:

In vitro/in vivo diagnostics that are deployed a... ver más

Specific Challenge:Research and technology development at the interface of key enabling technologies has the potential to provide novel technological Micro-Nano–Bio integrated Systems (MNBS) platforms to enhance the ability to sense, detect, analyse, monitor and act on phenomena from macro (e.g. body, organ, tissues) to nano scale (e.g. molecules, genes). These developments have a high potential for facilitating personalised and preventive healthcare. However, the translation of laboratory proven concepts to the clinical environment involving pre-clinical and clinical testing, prototyping, and small series manufacturing is currently lagging. Business development and market growth are therefore still limited. The challenge is to bring new promising laboratory proven MNBS concepts for addressing priority healthcare needs from the laboratory to the clinic.


Scope:The focus is on further development into a clinical setting of novel MNBS platforms, techniques and systems that have already been proven in a laboratory setting (laboratory Proof-of-Concept). These must pertain to one or more of the following:

In vitro/in vivo diagnostics that are deployed at the point of care; Therapy monitoring at the point of care. Proposals should pay attention to facilitate clinical data harvesting, e.g. for medical regulatory purposes and/or to enhance epidemiological monitoring of health and disease patterns. As relevant, the proposed activities should address sex and gender specific aspects[1].

Proposals should demonstrate clear compliance with applicable Good Laboratory Practice /Good Clinical Practice /Good Manufacturing Practice, and be consistent with ISO and other regulations (both national and European). The translation from the pre-clinical phase to early clinical testing, including design and pilot manufacturing in appropriate volume for clinical testing (small series), pre-clinical and early clinical testing is a necessary part of the work-up. Attention should be paid to the requirements for Health Technology Assessment (HTA). Standardisation issues have to be taken into account where appropriate.

Activities are expected to commence at Technology Readiness Levels 3/4 and reach 5-6.

A significant participation of SMEs with R&D capacities is encouraged.

The Commission considers that proposals requesting a contribution from the EU between EUR 3 and 5 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:Proposals should address one or more of the following impact criteria and provide metrics to measure and monitor success.

Address priority needs in healthcare diagnostics and / or therapy monitoring, for the benefit of patients; Provide affordable systems with unique features that address specific well identified requirements in healthcare; Progress the development of advanced integrated MNBS based diagnostic health platforms, techniques or systems from the laboratory Proof-of-Concept to the clinical setting; Establish a world-class European competitive industrial R&D and manufacturing competence in Micro-Nano-Bio Systems integration for healthcare diagnostics applications; Strengthening the industrial value chain and progress to marketisation; Early involvement of regulatory bodies and patients in the new developments. Proposals should include a business case and exploitation strategy, as outlined in the Introduction to the LEIT part of this Work Programme.

This topic will be co-funded by LEIT-ICT and LEIT-NMBP within the context of a Cross-KET initiative for Health, for a total budget of EUR 15 000 000.


Cross-cutting Priorities:GenderCross-cutting Key-Enabling Technologies (KETs)


[1]See definition of the 'gender dimension approach' in the introduction of this Work Programme part.

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Temáticas Obligatorias del proyecto: Temática principal: Other medical sciences Medical engineering

Características del consorcio

Ámbito Europeo : La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Tipo y tamaño de organizaciones: El diseño de consorcio necesario para la tramitación de esta ayuda necesita de:

Características del Proyecto

Requisitos de diseño: Duración:
Requisitos técnicos: Specific Challenge:Research and technology development at the interface of key enabling technologies has the potential to provide novel technological Micro-Nano–Bio integrated Systems (MNBS) platforms to enhance the ability to sense, detect, analyse, monitor and act on phenomena from macro (e.g. body, organ, tissues) to nano scale (e.g. molecules, genes). These developments have a high potential for facilitating personalised and preventive healthcare. However, the translation of laboratory proven concepts to the clinical environment involving pre-clinical and clinical testing, prototyping, and small series manufacturing is currently lagging. Business development and market growth are therefore still limited. The challenge is to bring new promising laboratory proven MNBS concepts for addressing priority healthcare needs from the laboratory to the clinic. Specific Challenge:Research and technology development at the interface of key enabling technologies has the potential to provide novel technological Micro-Nano–Bio integrated Systems (MNBS) platforms to enhance the ability to sense, detect, analyse, monitor and act on phenomena from macro (e.g. body, organ, tissues) to nano scale (e.g. molecules, genes). These developments have a high potential for facilitating personalised and preventive healthcare. However, the translation of laboratory proven concepts to the clinical environment involving pre-clinical and clinical testing, prototyping, and small series manufacturing is currently lagging. Business development and market growth are therefore still limited. The challenge is to bring new promising laboratory proven MNBS concepts for addressing priority healthcare needs from the laboratory to the clinic.
¿Quieres ejemplos? Puedes consultar aquí los últimos proyectos conocidos financiados por esta línea, sus tecnologías, sus presupuestos y sus compañías.
Capítulos financiables: Los capítulos de gastos financiables para esta línea son:
Personnel costs.
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
Purchase costs.
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
Subcontracting costs.
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
Madurez tecnológica: La tramitación de esta ayuda requiere de un nivel tecnológico mínimo en el proyecto de TRL 5:. Los elementos básicos de la innovación son integrados de manera que la configuración final es similar a su aplicación final, es decir que está listo para ser usado en la simulación de un entorno real. Se mejoran los modelos tanto técnicos como económicos del diseño inicial, se ha identificado adicionalmente aspectos de seguridad, limitaciones ambiéntales y/o regulatorios entre otros. + info.
TRL esperado:

Características de la financiación

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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.
Note also that 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 (follow the links to Australia, Brazil, Canada, China, Hong Kong &Macau, India,  Japan, Republic of Korea, Mexico, Russia, Taiwan).
 
ELIGIBILITY and ADMISSIBILITY CONDITIONS
described in part B and C of the General Annexes of the General Work Programme.
Proposal page limits and layout: Please refer to Part B of the standard proposal template.
 
EVALUATION
3.1  Evaluation criteria and procedure, scoring and threshold:
The criteria, scoring and threshold are described in General Annex H of the work programme.
The following exceptions apply:
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.
The procedure for setting a priority order for proposals with the same score is given in General Annex H of the work programme. The following exceptions apply:
Under 3 (a)
Propo...
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.
Note also that 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 (follow the links to Australia, Brazil, Canada, China, Hong Kong &Macau, India,  Japan, Republic of Korea, Mexico, Russia, Taiwan).
 
ELIGIBILITY and ADMISSIBILITY CONDITIONS
described in part B and C of the General Annexes of the General Work Programme.
Proposal page limits and layout: Please refer to Part B of the standard proposal template.
 
EVALUATION
3.1  Evaluation criteria and procedure, scoring and threshold:
The criteria, scoring and threshold are described in General Annex H of the work programme.
The following exceptions apply:
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.
The procedure for setting a priority order for proposals with the same score is given in General Annex H of the work programme. The following exceptions apply:
Under 3 (a)
Proposals are first ranked in separate lists according to the topics against which they were submitted (‘topic ranked lists’). When comparing ex aequo proposals from different topics, proposals having a higher position in their respective 'topic ranked list' will be considered to have a higher priority in the overall ranked list.
Under 3 (b)
For all topics and types of action, the prioritisation will be done first on the basis of the score for Impact, and then on that for Excellence.
3.2 Submission and evaluation process: Guide to the submission and evaluation process
    
INDICATIVE TIMETABLE for EVALUATION and GRANT AGREEMENT
Information on the outcome of single-stage evaluation: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
 
PROVISIONS, PROPOSAL TEMPLATES and EVALUATION FORMS
for the type of action under this topic
Research and Innovation Action:
Specific provisions and funding rates
Standard proposal template
Standard evaluation form
H2020 General MGA -Multi-Beneficiary
Annotated 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
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.
- 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.
 
ADDITIONAL DOCUMENTS
Legal basis: Horizon 2020 - Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme
H2020 Work Programme 2016-17: Introduction
H2020 Work Programme 2016-17: Introduction to Leadership in enabling and industrial technologies (LEITs)
H2020 Work Programme 2016-17: Nanotechnologies, advanced materials, advanced manufacturing and processing, biotechnology
H2020 Work Programme 2016-17: Cross-cutting activities (Focus Areas)
H2020 Work Programme 2016-17: Dissemination, Exploitation and Evaluation
H2020 Work Programme 2016-17: General Annexes
 
Garantías:
No exige Garantías
No existen condiciones financieras para el beneficiario.

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