Supporting innovative SMEs in the healthcare biotechnology sector, Phase 2

Topic Description

The healthcare biotechnology sector offers huge business and commercial opportunities; however it also requires heavy and risky investments which are often lacking in Europe, hampering the development of the industry.

The challenge includes either:

a) Cell technologies in medical applications (all phase 1 and phase 2 deadlines in 2016 and 2017)

Cell technologies include cell manufacturing (culture, multiplication, scale-up and automation), preservation, banking and transport; identification, cell sorting and delivery, imaging, tracking, process and quality control; genetic engineering and gene editing; production of therapeutic biomolecules. The medical applications of cell technologies include diagnostics and biosensors; cell and gene therapy, tissue engineering, bio-artificial organs, haematology, immunotherapy, and vaccine and antibody production; predictive toxicology, synthetic biology, and modelling development and disease processes.

However, the diversity, complexity and variability of living cells pose challenges for bringing safe, reliable, regulatory-compliant and cost-effective products to the market and to the patient. SMEs developing cell-based products and processes have limited financial resources to take the critical steps to move from proof of concept to practical application while at the same time addressing considerations such as scale-up/scale-out, automation, logistics, regulatory pathways and business models.

Particular attention should be given to dialogue with regulators and compliance with safety and regulatory requirements, such as those pertaining to cell procurement, GMP, ethics, clinical trials, ATMPs and medical devices.

The challenge addresses cells from any eukaryotic source though their eventual application must be to human medicine.

Or:

b) Clinical research for the validation of biomarkers and/or diagnostic medical devices (only at the first cut-off date in 2017 and for phase 2 applications - phasing out of the topic PHC-12-2014/2015 introduced in the Work Programme 2014-2015)

Biomarkers are used in clinical practice to indicate both normal and pathological conditions. They are also used for predictive or prognostic purposes. They are being used increasingly in medicine and many potential new biomarkers are proposed every year. However, only a few of these have been validated for clinical use. To achieve validation a robust analytical method is required and a link to a pertinent clinical process or endpoint needs to be demonstrated.

This validation process should provide evidence for high analytical value, appropriate sensitivity and specificity, and clinical validity. Particular attention should be given to validation of biomarkers with potential for rapid uptake into clinical practice. Both in vivo and in vitro potential biomarkers are eligible. Priority is given to the validation of disease-related biomarkers (i.e. diagnostic, susceptibility/risk, monitoring and prognostic biomarkers). Validation of the clinical performance of new diagnostic devices can also be supported, either in combination with the biomarker validation or against existing standards.

The SME instrument consists of three phases, including a coaching and mentoring service for beneficiaries. Participants can apply to phase 1 or directly to phase 2.

In phase 1, a feasibility study shall be developed in order to verify 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^[1],

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. It should outline the specifications of a more elaborate 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 EUR 50.000. Projects should last around 6 months.

In phase 2, innovation projects^[2]

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, 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 elaborate business plan. 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 and criteria for success. They will include an explanation of how the results of the supported project are to be commercialised and of what kind of impact on the company is expected.

The Commission considers that proposals requesting a contribution from the EU of between EUR 0.5 and 2.5 million^[3]

would allow phase 2 to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts (higher or lower). Projects should last between 12 and 24 months.

Phase 3 of the SME Instrument aims to increase the economic impact of the funding provided by the SME Instrument phase 1&2 grants and by the business coaching. Phase 3 is not subsequent to phase 1 and/or 2, but provides specific support to SME instrument beneficiaries during and after phase 1 or 2.

All support under phase 3 of the SME instrument will be accessible through a single, dedicated entry point, which will serve as an information portal and a networking space.

This platform will offer access to two main strands of services:

• Access to markets
• Access to finance

In addition, phase 3 will create opportunities for partnering, networking and training, which are set out in the Dedicated Support Actions at the end of this call.

SME instrument beneficiaries are also offered dedicated business innovation coaching and mentoring support. This service is facilitated by the Enterprise Europe Network and delivered by a dedicated coach through consultation and signposting to the beneficiaries. The coaches are 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.

• 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 innovations^[4] 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).

[1]This is not limited to the costs of acquiring and enforcing European or international IPR titles but could include auditing and risk management schemes to protect IP assets across planned supply and distribution chains and more generally IP valorisation plans to enhance return on investment and lever commercial investment into the relevant project.

[2]In the case of SMEInst-05-2016-2017, research type activities in medical application and clinical validation, including support for clinical studies and trials, will be predominant and will necessitate reimbursement at 100%. The Technology Readiness Levels indication does not apply.

[3]In the case of SMEInst-05-2016-2017, phase 2 proposals can request a contribution from the EU of between EUR 1 and 5 million.

[4]In the case of SMEInst-05-2016-2017, the development of innovative solutions should lead to value creation through the increased use of cell-based products/processes, biomarkers and/or diagnostic medical devices in industrial or clinical settings, and should contribute to technical and regulatory progress in these domains.