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

Topic identifier: PHC-12-2014
Publication date: 11 December 2013

Types of action: SME-2 SME instrument phase 2
DeadlineModel:
Opening date:
multiple cut-off
03 March 2014
Cut-off dates: 09 October 2014 17:00:00
17 December 2014 17:00:00

Time Zone : (Brussels time)
  Horizon 2020
Topic Description
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

Topic conditions and documents

Please note that the budget figure in the main heading refers to the overall budget available for phase 2 actions in 2014. The indicative budgets, including the breakdown of the budget according to the different phases of the SME Instrument, is provided in the H2020 Work Programme parts for the Societal Challenges and for the Leadership in Enabling and Industrial Technologies (LEITS). Please refer to "call 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. For the SME Instrument only applications from SMEs established in EU Members States or countries associated to Horizon 2020.
     
  2. Eligibility and admissibility conditions: described in part B and C of the General Annexes of the General Work Programme, with the following exceptions: A proposal for phase 2 shall include a first commercialisation plan.

    Specific eligibility conditions of SME Instrument:
    • At least one SME. For-profit SMEs’ means micro-, small- and medium-sized enterprises, as defined in Commission Recommendation 2003/361/EC, that are not 'non-profit legal entities' as defined in the Rules for Participation and Dissemination (‘legal entity which by its legal form is non-profit-making or which has a legal or statutory obligation not to distribute profits to its shareholders or individual members’)
    • Only applications from for-profit SMEs established in EU Member States or countries associated to Horizon 2020.
    • No concurrent submission or implementation with another phase 1 or phase 2 project.
     
  3. 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: Proposals will be evaluated individually when they arrive. They will be ranked after the respective cut-off dates.
    The criterion Impact will be evaluated first, then Excellence and Implementation. If the proposal fails to achieve the threshold for a criterion, the evaluation of the proposal will be stopped.
    For phase 2 the threshold for the criterion Impact will be 4. The overall threshold, applying to the sum of the three individual scores, will be 12.
    The final consensus score of a proposal will be the median of the individual scores of the individual evaluators; and the consensus report will comprise a collation of the individual reports, or extracts from them. Where appropriate, a Panel Review will be organised remotely.
    Applicants can provide during the electronic proposal submission up to three names of persons that should not act as an evaluator in the evaluation of their proposal for potential competitive reasons.

    3.2 Guide to the submission and evaluation process

    3.3 Specific arrangements for the evaluation of Call ID: H2020-SMEINST-2-2014:

    • The median of the individual scores will be taken as the consensus score.
    • The consensus report will comprise a collation of the individual reports, or extracts from them.
     
  4. Proposal page limits and layout: Sections 1, 2 and 3 should not be longer than 30 pages. All tables in these sections must be included within this limit. The minimum font size allowed is 11 points. The page size is A4, and all margins (top, bottom, left, right) should be at least 15 mm (not including any footers or headers).
     
  5. Indicative timetable for evaluation and grant agreement:
    Information on the outcome of phase 2 of the SME Instrument within four months after the corresponding cut-off date. Signature of grant agreements two months from the date of informing successful applicants in phase 2.
     
  6. Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:


    SME instrument (phase 2):

    Specific provisions and funding rates
    Standard proposal template SME-PHASE2
    Standard evaluation form
    H2020 General MGA -Multi
    H2020 General MGA-Mono
     
  7. Additional provisions:

    Horizon 2020 budget flexibility

    Classified information

    Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply. The TRL of proposals submitted under the SME instrument shall be minimum 6. 

    Commission Decision C(2014) 1393 authorising the use of unit costs for clinical trials, studies or investigations

     

    Essential information to be provided for proposals including clinical trials / studies / investigations - This information only concerns you if your proposal contains a clinical trial/study/investigation! - see call documents tab on H2020-SMEINST-2-2014 main page

 

  1. 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

  • Commission Decision C(2014) 1393 - use of unit costs for actions requiring the conduct of clinical studies en
  • Essential information to be provided for proposals including clinical trials / studies / investigations en
  • Legal basis - Framework Programme H2020 en
  • Legal basis - Specific Programme H2020 en
  • WP H2020 - 1. Introduction en
  • WP H2020 - 5. Introduction to Leadership in enabling and industrial technologies (LEITs) en
  • WP H2020 - 5i. Information and communication technologies (ICT) en
  • WP H2020 - 5ii. Nanotechnologies, advanced materials, advanced manufacturing and processing, biotechnology en
  • WP H2020 - 5iii. Space en
  • WP H2020 - 7. Innovation in SMEs en
  • WP H2020 - 8. Health, demographic change and wellbeing en
  • WP H2020 - 9. Food security, sustainable agriculture and forestry, marine and maritime and inland water research and the bioeconomy en
  • WP H2020 - 10. Secure, clean and efficient energy en
  • WP H2020 - 11. Smart, green and integrated transport en
  • WP H2020 - 12. Climate action, environment, resource efficiency and raw materials en
  • WP H2020 - 13. Europe in a changing world - inclusive, innovative and reflective societies en
  • WP H2020 - 14. Secure societies - protecting freedom and security of Europe and its citizens en
  • WP H2020 - 19. General Annexes en
  • List of beneficiaries - SME Instrument Phase II (February 2016 update) en
  • Flash Call Info (25-11-2015 cut-off - Phase II) en
  • Flash Call Info (17-09-2015 cut-off - Phase II) en
  • Flash Call Info (17-06-2015 cut-off - Phase II) en
  • Flash Call Info (18-03-2015 cut-off - Phase II) en
  • List of beneficiaries - SME Instrument Phase I (January 2016 update) en
  • Flash Call Info (25-11-2015 cut-off - Phase I) en
  • Flash Call Info (17-09-2015 cut-off - Phase I) en
  • Flash Call Info (17-06-2015 cut-off - Phase I) en
  • Flash Call Info (18-03-2015 cut-off - Phase I) en
  • Frequently Asked Questions - Open Disruptive Innovation Scheme en
  • Frequently Asked Questions - SME Instrument en
  • Flash_Report SME Instrument phase 1 - 24-09-14_EN en
  • flash report SME Instrument phase 1 - 17-12-2014_Final_EN en
  • flash report SME Instrument phase 2 - 09-10-14_EN en
  • flash report SME Instrument phase 2 - 17-12-14_Final_EN en
  • Flash Info (18-06-2014 cut-off) en

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