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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - ENATRANS (Enabling NAnomedicine TRANSlation)

Teaser

Summary

Nanomedicine is a Key Enabling Technology with applications in several medical areas like diagnostics, therapeutics and regenerative medicine. New nanotechnology based inventions aiming for translation into medical products or devices are mostly developed by start-up companies or SMEs. Today they constitute the main actors that drive the development from laboratory to clinical proof of concept, facing a highly regulated area at the international, European and national level. Therefore, each company willing to develop a nanomedical product has to overcome a lot of technical, regulatory, and business issues along the translation process. Many small companies generally spun off from academia, are missing the essential knowledge about these issues and are poorly organised to acquire the necessary information; this results in many missed opportunities for innovation and a globally poor translation in Europe. ENATRANS provided the infrastructure, network, tools and methods to support, advice and follow-up at all stages of the translation process from R&D to clinical trials with the objective to accelerate translation of innovative nanomedical products in Europe. Such supportive structures were not available elsewhere in the world and are now giving Europe a key opportunity to lead the field.

Work performed

ENATRANS succeeded in 3 years in concretising and sustaining a set of concepts to foster translation in the nanomedical sector, to durably impact the European community in this field and to accelerate the availability for the patients of innovative solutions to improve diagnosis, treatment and follow-up of many diseases.
The solid foothold of ENATRANS partners in the European Nanomedicine community and their strong commitment to the action have been critical assets to perform and to reach the right targets as well as to be able to widen the range of stakeholders, reaching far beyond the initial expectations. Furthermore ENATRANS has been the tool-lab for the European initiative ESTHER to test and prove concepts at the (modest) scale of Nanomedicine before deploying them at larger scale.
By setting up, managing and promoting a Translation Advisory Board as a central element of the Translation Hub, ENATRANS could both crystallise the initial interest of TAB experts and convert it into the strong commitment of a team of experts. The TAB has become a tool of reference to advise and guide nanomedicine innovators with the translation of their projects toward the market. The results of the TAB could also convince the MedTech sector of the soundness of this concept and motivate they to use the TAB in the very multi-disciplinary area of advanced medical devices. The TAB is therefore able to maintain its operation after the end of ENATRANS in the framework of the NOBEL CSA.
Further concepts and tools have also been confirmed or validated in the course of the project, in the first instance the compendium for successful translation, the Nanomed Award, the Nano World Cancer Day, the Nanomed Handbook or the Nanomed Map.
Further finding of ENATRANS is the importance of considering translational education and training as a continuous and horizontal task to be mostly interlaced with other elements in the Translation Hub rather than considering it as a separate and independent topic. In the course of the project, the initial concepts for a SME square (SMEÂ²), for the TAB or for the link to investors have had to be reviewed and encountered changes in their processes to better cope with the needs and requirements of the community. The revised process of the TAB for instance has proven to be a success and contacts have been initiated on international level to duplicate the TAB in ecosystems outside Europe.
The cohesion of the partners in the consortium strongly contributed to the coherence and interactions between the different actions and services offered to the European nanomedicine community. ENATRANS has been able to develop a one-stop-shop for translation and to efficiently use European funding to successfully deliver.

Final results

ENATRANS had a visible impact in reinforcing the support to European SMEs and academia as drivers of innovations in nanomedicine, by assisting them in the translation of their bottom-up ideas and by improving their innovation capacity and skills. The project and has implemented a comprehensive set of tools and services building on each otherâ€™s rather than just organising information exchange. With the Translation Advisory Board (TAB) as core offer, ENATRANS was able to fill a gap in support to translation and a team of 12 experts provided specific individual advice to 84 projects from 20 different countries in Europe and associated countries in very different maturity stages. The pipeline of the TAB includes around 20 very promising nanobiomedical projects at different stages of development, some of them poised to eradicate global diseases such as Cancer, Multiple Sclerosis or Pulmonary Infections. Business development support provided by the TAB has contributed to nearly 15 mio â‚¬ in funding rounds; 3 start-ups created; 2 license agreements with industry. It should also be pointed out the impact of the TAB by redirecting 24 projects towards routes with better market prospects and sparing time and money of projects with no possibilities of translation to the market. The TAB had also an important role in educating and developing the field of Nanomedicine by promoting different outreach initiatives to share and disseminate knowledge and insights resulting from its operation widely to all Nanomedicine stakeholders, thus amplifying its impact for those not benefiting directly from the TAB support.
Considering that a majority of projects applying to the TAB were early stage projects, the TAB also served as an interesting tool for early validation of scientific concept and for education of young researchers willing to create businesses.

Europe has a recognised strength in nanomedical research but the research community is generally at the very first step of discovery and usually very far from the market and regulatory constraints. To bridge this gap ENATRANS is setting up and organising training actions where business people, entrepreneurs, and agencies will bring to academics and SMEs their experience on medical and pharmaceutical translation as well as their knowledge about industrial and clinical needs.
By collecting, compiling and publishing in different format key information about translation ENATRANS was able to build a strong knowledge base training and education purposes, extended thus the impact of ENATRANS over time, leading to more efficient use of resources and research. The following action NOBEL will be able to rely on this knowledge base and enlarge it on the same model to other KETs and have a more holistic approach of innovation in Healthcare.
ENATRANS proved to be a central element of the Nanomedicine Translation Hub by initiating common activities and a joint communication strategy as well as facilitating the access to the other items of the Translation Hub. ENATRANS could therefore increase the impact on SMEs by materialising the Hub in a one-stop-shop approach.