Proposals should focus on the development of new multifunctional biomaterials, as part of eventual Medical Devices[[ As defined by Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to Active Implantable Medical Devices (90/385/EEC) (OJ L 189, 20.7.1990 p. 17) (as amended), Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices (OJ L 169, 12.7.1993 p. 1) (as amended) and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices (OJ L 331, 7.12.1998 p. 1) (as amended) and with the relevant Implementing Measures and all succeeding measures.]] or Advanced Therapies[[ As defined by Regulation (EC) No 1394/2007 on advanced therapy medicinal products (gene therapy, stem cell therapy and tissue engineering)]], so that they can function as effective eventual therapeutic interventions. They can include biocompatible and biodegradable biomaterials as part of minimally invasive treatments and theragnostic materials. Funding for the development of new drug candidates for these conditions or for any form of clinical trial will not be considered.
The development of new integrated experimental and computational approaches aimed to describe interface processes and their determinants should be considered as key step for the design of safe and performing biomaterials. Experimental protocols should be planned taking due account of current good laboratory practice (GLP) and ISO guidelines. Manufacturing processes will need to be addressed, including up scaling, good manufacturing practice (GMP), process analytical technology (PAT), technology transfer and regulatory work in respect of relevant regulations as appropriate[[As defined by Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to Active Implantable Medical Devices (90/385/EEC) (OJ L 189, 20.7.1990 p. 17) (as amended), Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices (OJ L 169, 12.7.1993 p. 1) (as amended) and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices (OJ L 331, 7.12.1998 p. 1) (as amended) and with the relevant Implementing Measures and all succeeding measures.]][[As defined by Regulation (EC) No 1394/2007 on advanced therapy medicinal products (gene therapy, stem cell therapy and tissue engineering)]]. At least one type of tissue engineering construct should be delivered at the end of the research project together with a proof of concept of its therapeutic potential and preclinical validation.
In order to ensure relevance and impacts of the research efforts, the active participation of industrial partners and clinicians represents an added value to the proposals and this will be reflected in the evaluation under the criterion “Impact”. A multidisciplinary approach is preferred; taking into account both surgical, minimally invasive and pharmacological approaches, as well as prevention and rehabilitation strategies, including robotics if necessary. The expected results should improve the quality of life of the affected population and their careers. They should be measurable even for optimising research costs of the enterprises and for reducing time-to-market of new products. The project should include training and dissemination activities. As relevant, the proposed activities should address sex and gender specific aspects[[See definition of the 'gender dimension approach' in the introduction of this Work Programme part.]].
The implementation of this topic is intended to start at TRL 3 and target TRL 5.
This topic is particularly suitable for SMEs.
The Commission considers that proposals requesting a contribution from the EU between EUR 5 and 8 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.
The aim of this topic is to develop innovative approaches for biomaterials for health that are easily transferable from industry to the clinic and based on new methodologies directed to the improvement of the treatment and prognosis of demyelination disorders (one specific disorder to be chosen), where regrowth and regeneration of affected areas of the nervous system is the key to successful therapy. These disorders are often of chronic duration and associated with increasing levels of disability. In the European Union, at least 1 000 000 people are affected with these disorders and many more times than that world-wide. They are often diagnosed between the ages of 20 and 40 when families and careers are developing and can represent the most common cause of disability affecting young adults, thereby having a strong economic impact for society in terms of healthcare costs.
- Innovative bio/nano-materials for the treatment of patients with demyelination disorders of the Central Nervous System, improving their quality of life due to minimally invasive action and/or longer duration of implants and devices;
- reduced direct and indirect costs linked to these diseases and their treatment;
- enhance competitiveness of the biomaterials and biomedical industries in the EU, in particular through technology transfer effects on biotechnology companies, with particular regard to SMEs and new forms of cooperation between academia, research centres and the private sectors. Such effects should be balanced to match sustainability principles and values, and to enforce competitiveness in terms of reducing time-to-market and trial costs for European industries;
- Dissemination of results, contributing to increase social awareness about more efficient and less costly therapies – based upon innovative approaches and broader accessibility – with improved patient compliance.
Proposals should include a business case and exploitation strategy, as outlined in the Introduction to the LEIT part of this Work Programme.