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Tools and technologies for advanced therapies

Specific challenge: For their successful application, new therapies, such as gene or cell therapies, tissue engineering or regenerative medicine often require technological innovation in the form of development of specific component tools and techniques such as isolation and multiplication of a cell or development of a scaffold, delivery of the therapy to the patient and for following-up the effect of the therapy in the patient.

In particular, achieving therapeutic scale production and GMP standards at reasonable cost is often underestimated. In addition, specific attention needs to be given to aspects such as miniaturisation, automation, biomaterials and scaffold construction while advanced methods and devices for targeted and controlled delivery, and monitoring technology, are needed to bring these innovative treatments to the patient.

Since experience with the new therapies is by definition limited, achieving regulatory compliance for them is another challenge.

Scope: The term advanced therapies encompasses gene therapy, cell therapy, tissue engineering, regenerative medicine and bio-artificial organs. These are biological approaches to therapy which often share common technologies.

Proposals should focus on refining a particular technological step or component needed by the therapeutic approach.

Establishing proof-of-concept for the new technology and carrying out preclinical research may be included if needed.

Regulatory aspects of the new technology should be addressed as appropriate.

The Commission considers that proposals requesting a contribution from the EU of between EUR 4 and 6 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Expected impact:

         Development of tools and technologies enabling establishment of new therapies or patient interventions

         Supporting regulatory compliant new technologies

         Boost the growth and the competitiveness of the European medical technology sector

         Combine new technology developments from different sectors for better, safer and customer friendly products

         Increase the attractiveness of Europe as a hub for innovative medical technologies


Type of action: Research and innovation actions