Industrial Leadership


Grants focused on companies, mainly SMEs, for the development of technologies and innovations, especially Key Enabling Technologies (KET), access to Risk Finance, and Bottom-Up Projects market oriented with New SME instrument.
Topic / Target >PHC-12-2015 Clinical research for the validation of biomarkers and/or diagnostic medical devices


DESCRIPTION


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. 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.

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.

 

H2020-SMEINST-1-2015
Start date: 18/12/2014
End date: 16/12/2015
Total budget
for this call: 26,557,000
CALL H2020-SMEINST-2-2015
Start date: 18/12/2014
End date: 16/12/2015
Total budget
for this call: 233,701,600
(SMEI) H2020-SMEINST-2-2015 SME instrument

(SMEI) H2020-SMEINST-1-2015 SME instrument

FINANCING
INSTRUMENTS
TOPIC INCLUDED IN...
SME Instrument

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

In phase 1, a feasibility study shall be developed verifying the technological /practical as well as economic viability of an innovation idea/concept with considerable novelty to the industry sector in which it is presented (new products, processes, design, services and technologies or new market applications of existing technologies). The activities could, for example, comprise risk assessment, market study, user involvement, Intellectual Property (IP) management, innovation strategy development, partner search, feasibility of concept and the like to establish a solid high-potential innovation project aligned to the enterprise strategy and with a European dimension. Bottlenecks in the ability to increase profitability of the enterprise through innovation shall be detected and analysed during phase 1 and addressed during phase 2 to increase the return in investment in innovation activities. The proposal should contain an initial business plan based on the proposed idea/concept.
The proposal should give the specifications of the elaborated business plan, which is to be the outcome of the project and the criteria for success.
Funding will be provided in the form of a lump sum of € 50.000. Projects should last around 6 months.

In phase 2, innovation projects will be supported that address the specific challenges identified and that demonstrate high potential in terms of company competitiveness and growth underpinned by a strategic business plan. Activities should focus on innovation activities such as demonstration, testing, prototyping, piloting, scaling-up, miniaturisation, design, market replication and the like aiming to bring an innovation idea (product, process, service etc.) to industrial readiness and maturity for market introduction, but may also include some research. For technological innovation a Technology Readiness Levels of 6 or above (or similar for non-technological innovations) are envisaged; please see part G of the General Annexes.
Proposals shall be based on an elaborated business plan either developed through phase 1 or another means. Particular attention must be paid to IP protection and ownership; applicants will have to present convincing measures to ensure the possibility of commercial exploitation ("freedom to operate").
Proposals shall contain a specification for the outcome of the project, including a first commercialisation plan, and criteria for success.
The Commission considers that proposals requesting a contribution from the EU of between € 0.5 and 2.5 million would allow phase 2 to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts. Projects should last between 12 and 24 months.

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 and delivered by a dedicated coach through consultation and signposting to the beneficiaries. The coaches will be recruited from a central database managed by the Commission and have all fulfilled stringent criteria with regards to business experience and competencies. Throughout the three phases of the instrument, the Network will complement the coaching support by providing access to its innovation and internationalisation service offering. This could include, for example, depending on the need 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.

Transition from one phase to the next will be seamless, provided that the SME project has proven to be worth further funding during a previous phase. There is no obligation for applicants to sequentially cover all three phases. At the same time each phase will be open to all SMEs.

Expected Impact:
* 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.
* Market uptake and distribution of innovations12 tackling the specific challenges in a sustainable way.
* Increase of private investment in innovation, notably leverage of private co-investor and/or follow-up investments.
* The expected impacts should be clearly described in qualitative and quantitative terms (e.g. on turnover, employment, market seize, IP management, sales, return on investment and profit).
Innovation in small and medium-sized enterprises

The specific objective of this programme is to stimulate growth by means of increasing the levels of innovation in SMEs, covering their different innovation needs over the whole innovation cycle for all types of innovation, thereby creating more fast-growing, internationally active SMEs
OTHER TOPICS ARE:
 SME-SPACE-1-2014 SME instrument
 SME-SPACE-1-2015 SME instrument


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