TOPIC : Cross-cutting KETs for diagnostics at the point-of-care
|Publication date:||14 October 2015|
|Types of action:||RIA Research and Innovation action|
|DeadlineModel: Planned opening date:||single-stage 20 September 2016||Deadline:||19 January 2017 17:00:00|
|Time Zone : (Brussels time)|
Topic DescriptionSpecific 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.
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.
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.
- 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.
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.
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, when comparing ex aequo proposals of different topics, the proposals will be ranked first according to the position in the topic ranked lists
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
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.
- 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
The submission system is planned to be opened on the date stated on the topic header.
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