- Open Innovation Test Beds (OITB) should upgrade or develop nano-pharmaceutical materials production facilities and make available to industry and interested parties, including SMEs, services for the design and development of production processes, characterisation and quality control of nano-pharmaceuticals;
- The OITB should provide GMP certified batches of nano-pharmaceuticals suitable for late pre-clinical and clinical testing and in accordance with European regulatory requirements for medicines;
- The OITB need to provide guidance for late pre-clinical and clinical testing, which itself could be done outside the OITB, benefitting from already existing infrastructures, and/or within the same OITB;
- Open access at fair conditions and cost as well as outreach and dissemination across Europe, based on a distinct methodology;
- The users / clients of the OITB will typically be SME's and laboratories with innovative proofs-of-concept and IPR for developing novel nano-pharmaceuticals and demonstration of the scalability of the production process of the technology.
Proposals submitted under this topic are encouraged to include actions designed to facilitate cooperation, across Europe, with other projects; to enhance user involvement; and to ensure the accessibility and reusability of data produced in the course of the project.
Proposals should therefore include a business case and exploitation strategy, as outlined in the LEIT Introduction in this Work Programme. In particular, they should demonstrate the likelihood of an additional turnover of at least 4 times the requested EU funding, within 5 years of the end of the grant.
Activities should start at TRL 4 and achieve TRL 7 at the end of the project.
The Commission considers that proposals requesting a contribution from the EU between EUR 7 and 15 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.
Laboratories across Europe and the world develop novel promising laboratory proof-of-concepts for nano-pharmaceuticals. These proofs-of-concept show strong potential for providing more effective and safer therapies and diagnostic procedures (e.g. medical imaging) for a wide range of diseases. For example, nano-pharmaceuticals may improve bio-availability, reduce toxicity and side effects and allow more targeted and controlled delivery of drugs to affected organs, tissues and cells. At the same time they may also include components that act as contrast agent for medical imaging. A major challenge is to produce the novel nano-pharmaceuticals to GMP (Good Manufacturing Practice) quality, maximising bioavailability and stability and in sufficient quantity for late pre-clinical and clinical testing. To this end the production of the nano-pharmaceuticals needs to be scaled-up from a small laboratory scale in the milligram range to a larger scale. A high level of GMP quality needs to be ensured, for example in terms of particle size and sterility (where appropriate), as required by the regulations for medicines.
The OITB should improve the European infrastructure and competence in nano-pharmaceutical process development, characterisation, quality control and pilot production, while taking into account the medical regulatory requirements. Proposals must address all the following impact criteria:
- Realise open and upgraded facilities at the EU level for the development, characterisation, quality control and production of nano-pharmaceuticals, easily accessible to users across different regions of Europe;
- Improved availability and flexibility of nano-pharmaceuticals supply with GMP quality for late pre-clinical and clinical trials, meeting medical regulatory requirements;
- Increase of the attractiveness of Europe as a location-of-choice to carry out advanced medical and nano-pharmaceutical research and product development, due to improved nano-pharmaceuticals supply capacity and availability of a rich eco-system of related suppliers of products and services;
- Contribution to demonstrating the effectiveness of nano-pharmaceuticals for medical therapies and / or diagnostic procedures (e.g. medical imaging);
- Improvement of user’s knowledge on medical and pharmaceutical regulatory aspects, especially of academics and SMEs;
Relevant indicators and metrics, with baseline values, should be clearly stated in the proposal.