Closed PHC-12-2014 H2020

Clinical research for the validation of biomarkers and/or diagnostic medical devices

Call text (as on F&T portal)

Scope

Specific challenge: Biomarkers are used in clinical practice to describe both normal and pathological conditions. They can also have a prognostic or a predictive power. They are therefore increasingly used in medicine and many potential biomarkers are proposed every year.

Only a few of them are however validated for use in a clinical research setting. Such validation implies the demonstration of a link to a pertinent clinical endpoint or process, as well as a robust and appropriate analytical method.

The clinical validation of biomarkers will be increasingly important for the development of new diagnostics, and this is a research area where many small European companies are active.

Improved clinical decisions should lead to better health outcomes while contributing to the sustainability of the health care system.

Scope: The SME instrument consists of three separate phases and a coaching and mentoring service for beneficiaries. Participants may apply to phase 1 with a view to applying to phase 2 at a later date, or directly to phase 2.

Proposals submitted to phase 1 shall consist of a draft business plan and feasibility study verifying the technological/practical and economic viability of the clinical validation proposed. These may, for example, comprise risk assessment, market study, user involvement, intellectual property (IP) management, innovation strategy development, partner search, feasibility of concept etc. Proposals may analyse bottlenecks preventing advance of the applicant SME in this area and identify how a phase 2 proposal may contribute to attaining growth or sustainability.

The main outcome of the proposal should be a detailed business plan. Funding for phase 1 will be provided in the form of a lump sum of EUR 50.000 and proposals should have a duration of around 6 months.

In phase 2 proposals should address the specific challenge described, elaborated in the scope section above, and demonstrate high potential in terms of applicant's competitiveness and growth underpinned by a strategic business plan.

Proposals shall be based on a business plan developed either through phase 1 or another means. Particular attention must be paid to IP protection and ownership; applicants should provide evidence of the possibility of commercial exploitation (‘freedom to operate’).

The clinical validation of existing potential biomarkers (not the identification of new ones) is sought. This validation should provide evidence for: high analytical validity; appropriate sensitivity and specificity; clinical validity/ utility. Preference will be given to validation of biomarkers with high potential for short term uptake into clinical practice.

In addition, validation of the clinical performance of new diagnostic devices can be supported, either in combination with the biomarker validation, or against existing standards.

Both in vivo and in vitro potential biomarkers are eligible. Preference will be given to the validation of disease related biomarkers (i.e. diagnostic, susceptibility/risk, monitoring and prognostic biomarkers)

Proposals shall contain a specification for the outcome of the project, including a first commercialisation plan, and criteria for success.

The Commission considers that phase 2 proposals requesting a contribution from the EU of between EUR 1 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. Phase two projects should duly justify their duration making reference to obtaining patient samples, ensuring patient follow up, etc.

In addition, in phase 3, SMEs can benefit from indirect support measures and services as well as access to the financial facilities supported under Access to Risk Finance of this work programme.

Successful beneficiaries will be offered coaching and mentoring support during phase 1 and phase 2. This service will be accessible via the Enterprise Europe Network (EEN) and provided by a dedicated coach through consultation to the beneficiaries. The coaches will be recruited from a database managed by the Commission and on the basis of their business experience and competencies. Throughout the three phases of the instrument, the EEN will complement coaching support by providing access to its innovation and internationalisation services. This may include, for example, depending on the needs of the SME, support in identifying growth potential, developing a growth plan and maximising it through internationalisation; strengthening the leadership and management skills of individuals in the senior management team and developing in-house coaching capacity; developing a marketing strategy or raising external finance.

Expected impact: This should provide:

Increased clinical availability and exploitation of biomarkers for the benefit of the patient.

New diagnostic devices.

Facilitation of entry of improved diagnostics in the clinic and the market.

Support for the implementation of the Commission proposal for a revised in vitro diagnostic devices regulation[1].

Enhancing profitability and growth performance of SMEs by combining and transferring new and existing knowledge into innovative, disruptive and competitive solutions seizing European and global business opportunities.

Contribution to the sustainability of health care systems.

Increased likelihood of market uptake and distribution of resulting innovations tackling the abovementioned specific challenge(s) in a sustainable way.

Leveraging of private investment in clinical validation as described above, notably leverage of private co-investor and/or follow-up investments.

Type of action: SME instrument (100% funding)

While all other instances of the use of the SME instrument in Horizon 2020 provide for reimbursement at 70%, the predominance of research type activities in clinical validation necessitate reimbursement at 100% in this case.

[1] Proposal for a regulation of the European Parliament and Council on in vitro diagnostic medical devices COM(2012)541 final

Cross-cutting Priorities:

SME Instrument

News flashes

2016-03-04

Corrigendum relative to the budget available in the fourth cut-off (25-11-2015) of H2020-SMEINST-2-2015 (Phase II).

The Flash Report has been amended and now reads: Available budget: EUR 48.617.590

2016-02-17

List of beneficiaries - SME Instrument Phase II (February 2016)

Interactive map of beneficiaries

Please note that the Flash Report about the results of the fourth cut-off (25-11-2015) of H2020-SMEINST-2-2015 (Phase II) is available in the 'Additional documents' section.

2016-02-04

List of beneficiaries - SME Instrument Phase I (January 2016)

Interactive map of beneficiaries

Please note that the Flash Report about the results of the fourth cut-off (25-11-2015) of H2020-SMEINST-1-2015 (Phase I) is available in the 'Additional documents' section.

2016-02-02

List of beneficiaries - SME Instrument Phase I (January 2016)

Interactive map of beneficiaries

Please note that the Flash Report about the results of the fourth cut-off (25-11-2015) of H2020-SMEINST-1-2015 (Phase I) is available in the 'Additional documents' section.

2015-11-30

The number of received proposals in the November cut-off (H2020-SMEINST-1-2015_25_11_2015) totals 2,056. This figure breaks down as follows:

Topic TotalBG-12-2015-1 35BIOTEC-5b-2015-1 40DRS-17-2015-1 39ICT-37-2015-1 543INSO-10-2015-1 234INSO-9-2015-1 11IT-1-2015-1 158NMP-25-2015-1 196PHC-12-2015-1 218SC5-20-2015-1 211SFS-08-2015-1 121SIE-01-2015-1 202Space-SME-2015-1 48Grand Total 2056The number of received proposals in the November cut-off (H2020-SMEINST-2-2015_25_11_2015) totals 1,090. This figure breaks down as follows:

Evaluation TotalBG-12-2015 16BIOTEC-5b-201521DRS-17-2015 35ICT-37-2015 239INSO-10-2015 62INSO-9-2015 4IT-1-2015 88NMP-25-2015 90PHC-12-2015 246SC5-20-2015 89SFS-08-2015 62SIE-01-2015 122Space-SME-2015-2 16Grand Total 1090

2015-11-20

List of beneficiaries - SME Instrument Phase II (November update)

Interactive map of beneficiaries

Please note, the release on the 18th of November 2015, of the Flash Report about the results of the third cut-off (17-09-2015) of H2020-SMEINST-2-2015 (Phase II).

2015-11-17

Information related to the November cut-off (25/11/2015)In 2016, we will adapt the evaluation and cut-offsrhythm. This shall allow us to inform applicants faster, in particular during summer and at the end of the year. At the same time, we will decouple the evaluation of the phases, which shall lead to a shorter time span for signing grants in Phase 2.During the transition period between November 2015 and February 2016, we will not be able to guarantee information to applicants for immediate resubmission.Thank you for your understanding,

2015-11-16

We regret to inform that with the award of the grants under the September 2015 cut-off the funds for the topic INSO-9 “Mobile e-government applications” are exhausted. It will not be possible to award any further grants under the November cut-off. It is recommended to abstain from submitting any proposal in November for INSO-9 (both Phases).

Any proposal arriving will be evaluated and the potential result will be communicated to the applying company but no grant award will take place. Submitted and evaluated proposals will not be transferred to later cut-off dates. We apologise for any inconvenience this might cause.

In 2016 and 2017 all ICT related activities will be subsumed under the Open Disruptive Innovation Scheme, which will increase its annual budget from 45 M€ to 60 M€.

2015-11-05

List of beneficiaries - SME Instrument Phase I (October update)

Interactive map of beneficiaries

Please note, the release on the 5th of November 2015, of the Flash Report about the results of the third cut-off (17-09-2015) of H2020-SMEINST-1-2015 (Phase I).

2015-10-02

Please note that since June 18th, a revised version of form (Technical Annex Section 4-5) for Phase II of the SME Instrument is available in the submission set and should be followed by applicants.

A new table referring to subcontracting tasks is to be found on page 31 of the proposal template (SME Instrument Phase 2- Part A and B forms).

2015-09-28

The number of received proposals in theSeptember cut-off (H2020-SMEINST-2-2015_17_09_2015) totals 960. This figure breaks down as follows:

Topic TotalICT-37-2015 260NMP-25-2015 113PHC-12-2015 111SIE-01-2015 103IT-1-2015 93SC5-20-2015 87INSO-10-2015 52SFS-08-2015 46DRS-17-2015 29Space-SME-2015-2 25BG-12-2015 16BIOTEC-5b-2015 16INSO-9-2015 9Grand Total 960

2015-09-22

The number of received proposals in theSeptember cut-off (H2020-SMEINST-1-2015_17_09_2015) totals 1873. This figure breaks down as follows:

Topic TotalICT-37-2015-1 442SIE-01-2015-1 207NMP-25-2015-1 203SC5-20-2015-1 193INSO-10-2015-1 177IT-1-2015-1 163PHC-12-2015-1 152SFS-08-2015-1 123Space-SME-2015-1 52DRS-17-2015-1 47INSO-9-2015-1 43BIOTEC-5b-2015-1 41BG-12-2015-1 30Grand Total 1873

2015-09-02

List of beneficiaries - SME Instrument Phase II (September update)

Interactive map of beneficiaries

2015-08-27

Please note, the release on the 18th ofAugust 2015, of the Flash Report about the results of the second cut-off (17-06-2015) of H2020-SMEINST-2-2015.

2015-07-29

List of beneficiaries - SME Instrument Phase I (July update)

Interactive map of beneficiaries

2015-07-29

Please note, the release on the 24th ofJuly 2015, of the Flash Report about the results of thesecond cut-off (17-06-2015) of H2020-SMEINST-1-2015.

2015-06-24

The number of proposals received in the June cut-off (H2020-SMEINST-2-2015_17_06_2015) totals 961. This figure breaks down as follows:

Topic TotalBG-12-2015 14BIOTEC-5b-2015 22DRS-17-2015 30ICT-37-2015 293INSO-10-2015 32INSO-9-2015 8IT-1-2015 86NMP-25-2015 95PHC-12-2015 130SC5-20-2015 91SFS-08-2015 42SIE-01-2015103Space-SME-2015-2 15Grand Total 961

2015-06-24

The number of received proposals in the June cut-off (H2020-SMEINST-1-2015_17_06_2015)totals 2029. This figurebreaks down as follows:

Topic TotalBG-12-2015-1 15BIOTEC-5b-2015-1 40DRS-17-2015-1 42ICT-37-2015-1 530INSO-10-2015-1 175INSO-9-2015-1 42IT-1-2015-1 178NMP-25-2015-1 234PHC-12-2015-1 178SC5-20-2015-1 216SFS-08-2015-1 127SIE-01-2015-1 206Space-SME-2015-1 46Grand Total 2029

2015-06-02

Please note, the release on the2nd ofJune 2015, of the Flash Report about the results of the first cut-off (18-03-2015) of H2020-SMEINST-2-2015.

2015-05-08

Please note, the release on the 8th ofMay 2015, of the Flash Report about the results of the first cut-off (18-03-2015) of H2020-SMEINST-1-2015.

2015-04-15

List of beneficiaries - SME Instrument Phase 1 (April update)

Interactive map of beneficiaries

2015-04-15

List of beneficiaries - SME Instrument Phase 2 (April update)

Interactive map of beneficiaries

2015-03-26

The number of proposals received in relation to the first 2015 cut-off of Phase 1,totals 1,569.

2015-03-26

List of beneficiaries - SME Instrument Phase 1 (March update)

Interactive map of beneficiaries

2015-03-26

List of beneficiaries - SME Instrument Phase 2 (March update)

Interactive map of beneficiaries

2015-03-26

The number of proposals received in relation to the first 2015 cut-off of Phase 2, totals 614.

2015-01-20

The number of proposals received in relation to thethird cut-off of Phase1 is 2,363.

2015-01-20

The number of proposals received in relation to thesecond cut-off of Phase 2 is 629 for an average requested grant value of EUR1,658,318.

2015-01-08

List of beneficiaries - SME Instrument Phase 1

Interactive map of beneficiaries

2015-01-08

List of beneficiaries - SME Instrument Phase 2

Interactive map of beneficiaries

2015-01-05

Please note, the release on the 5th ofJanuary 15, of the FlashReport about the results of thefirst cut-off (09-10-2014) of H2020-SMEINST-2-2014.

2014-12-18

The submission session is now available for: BG-12-2015-1(SME-1), BIOTEC-5b-2015-1(SME-1), DRS-17-2015-1(SME-1), ICT-37-2015-1(SME-1), INSO-10-2015-1(SME-1), INSO-9-2015-1(SME-1), IT-1-2015-1(SME-1), NMP-25-2015-1(SME-1), PHC-12-2015-1(SME-1), SC5-20-2015-1(SME-1), SFS-08-2015-1(SME-1), SIE-01-2015-1(SME-1), Space-SME-2015-1(SME-1)

2014-12-18

The submission session is now available for: BG-12-2015(SME-2), BIOTEC-5b-2015(SME-2), DRS-17-2015(SME-2), ICT-37-2015(SME-2), INSO-10-2015(SME-2), INSO-9-2015(SME-2), IT-1-2015(SME-2), NMP-25-2015(SME-2), PHC-12-2015(SME-2), SC5-20-2015(SME-2), SFS-08-2015(SME-2), SIE-01-2015(SME-2), Space-SME-2015-2(SME-2)

2014-12-18

2014-12-08

Please note, the release on the 8th of December 14, of the Flash Info about the results of the second cut-off (24-09-2014) of H2020-SMEINST-1-2014.

The number of proposals submittedin relation to thesecond cut-off (24-09-2014) of H2020-SMEINST-1-2014 is 1,944.

• List of the first beneficiaries of the SME instrument

• Interactive map of the first beneficiaries

Please note the release of the Flash Info on the 28th of August 14.

2014-12-02

The number of proposals submittedin relation to thesecond cut-off (24-09-2014) of H2020-SMEINST-1-2014 is 1,944.

• List of the first beneficiaries of the SME instrument

• Interactive map of the first beneficiaries

Please note the release of the Flash Info on the 28th of August 14.

2014-10-10

The number of proposals received in relation to the first cut-off of Phase 2 is 580.

2014-10-03

The number of proposals submittedin relation to thesecond cut-off (24-09-2014) of H2020-SMEINST-1-2014 is 1,944.

• List of the first beneficiaries of the SME instrument

• Interactive map of the first beneficiaries

Please note the release of the Flash Info on the 28th of August 2014.

2014-09-18

Please note the release of the Flash Info on the 28th ofAugust 2014.

• List of the first beneficiaries of the SME instrument

• Interactive map of the first beneficiaries

2014-09-17

Please note the release of the Flash Info on the 28th ofAugust 2014.

Names and map of the first SME beneficiaries under Phase I of the SME Instrument now available:

• List of the first beneficiaries of the SME instrument

• Interactive map of the first beneficiaries

2014-08-28

Please note the release of the Flash Info on the 28th ofAugust 2014.

2014-07-25

The submission session is now available for: BG-12-2014-1(SME-1), BIOTEC-5a-2014-1(SME-1), DRS-17-2014-1(SME-1), ICT-37-2014-1(SME-1), IT-1-2014-1(SME-1), NMP-25-2014-1(SME-1), PHC-12-2014-1(SME-1), SC5-20-2014-1(SME-1), SFS-08-2014-1(SME-1), SIE-01-2014-1(SME-1), Space-SME-2014-1(SME-1)

2014-07-25

The submission session is now available for: BG-12-2014(SME-2), BIOTEC-5a-2014(SME-2), DRS-17-2014(SME-2), ICT-37-2014(SME-2), IT-1-2014(SME-2), NMP-25-2014(SME-2), PHC-12-2014(SME-2), SC5-20-2014(SME-2), SFS-08-2014(SME-2), SIE-01-2014(SME-2), Space-SME-2014-2(SME-2)

2014-03-03

call topic details

Call status: Closed
Opening date: 2014-03-03 (12 years ago)
Closing date: 2014-10-09 (12 years ago)
Procedure: multiple cut-off

Budget: 220,897,600
Expected grants: not specified

News flashes

This call topic has been appended 46 times by the EC with news.

2016-03-04
corrigendum relative to the budget avail...
2016-02-17
list of beneficiaries - sme instrument p...
2016-02-04
list of beneficiaries - sme instrument p...
2016-02-02
list of beneficiaries - sme instrument p...
2015-11-30
the number of received proposals in the...
2015-11-20
list of beneficiaries - sme instrument p...
2015-11-17
information related to the november cut-...
2015-11-16
we regret to inform that with the award...
2015-11-05
list of beneficiaries - sme instrument p...
2015-10-02
please note that since june 18th, a revi...
2015-09-28
the number of received proposals in thes...
2015-09-22
the number of received proposals in thes...
2015-09-02
list of beneficiaries - sme instrument p...
2015-08-27
please note, the release on the 18th ofa...
2015-07-29
list of beneficiaries - sme instrument p...
2015-07-29
please note, the release on the 24th ofj...
2015-06-24
the number of proposals received in the...
2015-06-24
the number of received proposals in the...
2015-06-02
please note, the release on the2nd ofjun...
2015-05-08
please note, the release on the 8th ofma...
2015-04-15
list of beneficiaries - sme instrument p...
2015-04-15
list of beneficiaries - sme instrument p...
2015-03-26
the number of proposals received in rela...
2015-03-26
list of beneficiaries - sme instrument p...
2015-03-26
list of beneficiaries - sme instrument p...
2015-03-26
the number of proposals received in rela...
2015-01-20
the number of proposals received in rela...
2015-01-20
the number of proposals received in rela...
2015-01-08
list of beneficiaries - sme instrument p...
2015-01-08
list of beneficiaries - sme instrument p...
2015-01-05
please note, the release on the 5th ofja...
2014-12-18
the submission session is now available...
2014-12-18
the submission session is now available...
2014-12-18
the submission session is now available...
2014-12-18
the submission session is now available...
2014-12-08
please note, the release on the 8th of d...
2014-12-02
the number of proposals submittedin rela...
2014-10-10
the number of proposals received in rela...
2014-10-03
the number of proposals submittedin rela...
2014-09-18
please note the release of the flash inf...
2014-09-17
please note the release of the flash inf...
2014-08-28
please note the release of the flash inf...
2014-07-25
the submission session is now available...
2014-07-25
the submission session is now available...
2014-03-03
the submission session is now available...
2014-03-03
the submission session is now available...

Call

H2020-SMEInst-2014-2015

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Call published · 30 Sep 2024 (2 years ago)

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Today

Work programme published

11 Oct 2013 · est.

Call opens

03 Mar 2014

Call closes

09 Oct 2014

Outcome expected

09 Mar 2015 · est.

Grant agreement signed

09 Jun 2015 · est.

Call published

30 Sep 2024

Preparation Open for submission Evaluation Grant preparation Not yet reached

Work programme published Estimated

11 Oct 2013 · 13 years ago

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Call opens

03 Mar 2014 · 12 years ago

Submissions can be made from this date.
Call closes

09 Oct 2014 · 12 years ago

Deadline to submit a proposal.
Outcome expected Estimated

09 Mar 2015 · 11 years ago

The maximum time to inform applicants of the evaluation outcome is five months after the call closes.
Grant agreement signed Estimated

09 Jun 2015 · 11 years ago

The maximum time to sign the grant agreement is three months after applicants are informed of the outcome.
Call published

30 Sep 2024 · 2 years ago

This topic was first published in TopicTree.
Today · 15 Oct 2026

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