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.
The scope and funding available under the current rounds of the EU’s SME Instrument – are outlined below. Unusually for EU proposals, single company bids from for-profit SMEs are allowed, alongside consortia bids. There is a wealth of support available in the UK to support your company or organisation put forward an application. KTN can introduce you to the right people at the right point in time and discuss your outline idea for a proposal. For example, the UK-wide The Enterprise Europe Network can support on finding partners across the EU through their extensive network. There are also those supporting with specific information and on applications through the National Contact points. For this particular sector, KTN hosts a portal on the medicines manufacturing innovation landscape that highlights the sector activity in the UK.
KTN contacts: email@example.com; firstname.lastname@example.org; email@example.com
Areas being funded under the EU SME instrument are 1) Cell technologies in medical applications and 2) Clinical research for the validation of biomarkers and/or diagnostic medical devices.
The Specific Challenge for cell technologies in medical applications includes:
· 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
Scope and Levels of funding available:
The SME instrument consists of three phases, phase 3 includes a coaching and mentoring service for beneficiaries. Participants can apply to phase 1 or directly to phase 2.
In phase 1, Funding will be provided in the form of a lump sum of EUR 50.000. Projects should last around 6 months.
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, 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.
In phase 2, projects of the scale of between EUR 0.5 and 2.5 million and should last between 12 and 24 months.
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, Technology Readiness Levels of 6 or above (or similar for non-technological innovations) are envisaged;
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.
Further details here
SME-1 SME instrument phase 1 Closing dates
04 February 2016
03 May 2016
07 September 2016
09 November 2016
15 February 2017
03 May 2017
06 September 2017
08 November 2017
SME-2 SME instrument phase 2 Closing dates
03 February 2016
14 April 2016
15 June 2016
13 October 2016
18 January 2017
06 April 2017
01 June 2017
18 October 2017