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TOPIC : Cross-cutting KETs for diagnostics at the point-of-care

Topic identifier: NMBP-13-2017
Publication date: 14 October 2015

Types of action: RIA Research and Innovation action
DeadlineModel:
Opening date:
single-stage
20 September 2016
Deadline: 19 January 2017 17:00:00

Time Zone : (Brussels time)
  Horizon 2020 H2020 website
Pillar: Industrial Leadership
Work Programme Year: H2020-2016-2017
Topic Updates
  • 11 January 2017 10:28

    Switzerland as associated country

    From 1 January 2017 Switzerland is associated to the whole Horizon 2020 programme instead of the previous partial association.

    This applies to all the grant agreements signed on 1 January 2017 and afterwards.

    For more information please see the relevant Note on the Participant Portal.

Topic Description
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:

  1. In vitro/in vivo diagnostics that are deployed at the point of care;
  2. 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:

Gender
Cross-cutting Key-Enabling Technologies (KETs)

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

Topic conditions and documents

Please read carefully all provisions below before the preparation of your application.
 

  1. 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, IndiaJapan, Republic of Korea, Mexico, Russia, Taiwan).
     
  2. 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.


     
  3. 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
        

  4. 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.
     
  5. 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
  6. 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.

     
  7. 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.

     
  8. 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

 

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