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ENATRANS Report Summary

Project ID: 646113

Periodic Reporting for period 1 - ENATRANS (Enabling NAnomedicine TRANSlation)

Reporting period: 2015-01-01 to 2016-06-30

Summary of the context and overall objectives of the project

Nanotechnology in medicine 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 bio-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 proof of concept to clinical proof of concept facing a highly regulated area at the international, European and national level. Therefore, each company willing to develop a nano(bio)medical 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 will provide the infrastructure, the network, the 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 the translation of innovative nanomedical products in Europe. Such supportive structures are not available elsewhere in the world and will give Europe a key opportunity to lead the field and a competitive edge in creating jobs and economic wealth in one of the most important future biomedical areas.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Originally planned as an operational measure to provide the nanobiomedical community with an effective access to the Translation Hub as defined by the ETPN, i.e. infrastructure, network, tools and methods to support, advice and follow-up at all stages of the translation process from R&D to clinical trials, ENATRANS became in the context of ESTHER a blue-print action to demonstrate the adequacy of the Translation Hub concept to other KETs aiming at applications for Healthcare. As such, ENATRANS partners constantly pay attention that the measures implemented within the project are suited and transferable for other single technologies or for a combination of technologies.

The Nanomedicine Translation Advisory Board for instance is the central item in the translation hub and the cornerstone activity of ENATRANS (Work Package 4). The success of this concept, with experts in translation providing advice in the first half of ENATRANS to 20 innovation nanomedicine projects out of more than 40 applications , shows firstly that most projects do not have clear translation pathways as they are (very) early-stage and secondly that the challenges they are facing are to a large extend independent from the technology they are developing. Declining the TAB concept to the scope covered by ESTHER would thus require of course some experts with specific technological expertise but above all experts with experience in translation i.e. clinical tests, regulatory, business development, marketing, investment, … The challenge is thus to scale-up the current TAB. MedTech Europe, the alliance of European medical technology industry associations is very interested in this concept and would support the upscaling toward ESTHER. ENATRANS organises its services around the TAB, providing thus a continuum of support & coordination along the Translation Hub.
The “Pre-TAB” aspects are mostly driven by WP2 (Networking & Community Building), WP3 (Access of SMEs to the nano-biomedical ecosystem) and WP7 (Education & Training for SMEs and Academics) which set-up the environment and provide the prerequisite conditions for the community to access the TAB.
Work Package 2 contributed to ENATRANS first period notably with the organisation of the ENATRANS Day in October 2015 in Dublin, a community event with information, networking and brokerage components. Moreover, WP2 aims at structuring of the ecosystem and therefore created and developed the SME² focus group as a peer-to-peer exchange group by and for SMEs, but also further extend the Nanomed Map as a partnersearch tool with high marketing potential. In addition to the 1,750 institutions mapped in Europe, ENATRANS Partners listed a first batch of 135 actors worldwide (mostly in the US) to initiate the internationalisation of this unique tools for the nanomedical community. These concrete tools will be supported in the 2nd half of the project by the already started but not achieved analysis of value-chains and scenario for growth, also in the light of the ESTHER Initiative.
Work Package 3 already achieved its main task to collect, process and provide information about the ecosystem with the provision of an online and printable compendium describing the clinical trials, regulatory and reimbursement processes to be considered when addressing translation and providing the relevant contacts to regulatory agencies in Europe. WP3 reached its target audience through talks and workshops (during ENATRANS Days, CLINAM) and plans together with WP7 to use webinars to enlarge the audience and reach a higher dissemination impact.
Work Package 7 started 6 months after the launch of ENATRANS and is addressing the Nanomedicine ecosystem with several time-perspectives. On the short term, WP7 supports the dissemination of information on the ecosystem collected in WP3 and the coaching-processes for TAB beneficiaries notably by providing the tools for online seminars and the taping of physical sessions. On the mid-term, WP7 acts as an education & training platform and provides tools for nanomedicine stakeholders, independently from their background to enhance their skills in translation, notably with online courses. Finally on the long term WP7 aims at sustaining the nanomedicine approach by educating medicine students with nano-specific modules along their cursus.
The “Post-TAB” activities are covered by Work Packages 5 and 6 whose activities aim at bridging the gap in translation between technology providers and clinics (WP5) and investors / large industry (WP6) and therefore at seamless prolonging the services offered by the TAB.
Work Package 5 established a list of generic unmet clinical needs. Together with the topical working groups of the ETPN, nanomedicine-based solutions have been matched to these needs and presented in the 2016 Version of the Nanomedicine Strategic Research and Innovation Agenda. In addition, WP5 compiled clinical centres with experience in clinical tests with nanotechnologies in a directory accessible for the nanomedicine community.
Work Package 6 builds on cases identified by the TAB as mature enough to be showcased to large industry (pharma, Medtech, diagnostics) or to investors. However the current panel of cases managed by the TAB does not include such mature cases for the moment, constraining WP6 partners to set up further strategies to reach mature projects to be showcased. The Nanomed Awards are part of this strategy, as it provides excellent projects with peer recognition and a platform for promotion. The last edition of the Nanomed Awards in November 2015 rewarded the Canadian SME Celator Pharmaceuticals but also and more surprisingly the company Merck KGaA, confirming the fact that Nanomedicine is becoming recognised by pharma as an enabler for innovation. WP6 also considered how to add value to the TAB and established a concept for a catapultor that should increase the interest of investors in nanomedicine.
Finally Work Package 8 reflects the transversal efforts of the consortium to promote the ENATRANS services to the community and to disseminate results. Starting with a set of material (posters, flyers), WP8 also created the project website and organised the Press event: Nano World Cancer Day 2016.
ENATRANS has established in its first period solid basis to strongly and sustainably impact the nanomedicine community with tailored and coordinated instrument and is fully operational. ENATRANS plays its role of umbrella activity for the Nanomedicine Translation Hub and of central node for contacts with other initiatives in Healthcare.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

In the past 10 to 15 years the European commission has funded over 100 R&D projects with nearly 500 Mio € in the area of nanomedicine. Many of these projects have produced results with a potential to be translated into innovative diagnostic or therapeutic products. However, up to now academic groups or SMEs willing to turn inventions into innovations spend many months or even years to find and understand information about translation requirements such as characterisation or scale up of their products, regulatory or reimbursement issues or industrial and clinical needs.

By creating a one-stop-shop for information, advice and support dedicated to nanomedical translation in a dynamic network of all relevant stakeholders, ENATRANS will offer a pioneering service to SMEs, start-ups, entrepreneurs and academia from the nano-bio-medical sector lacking critical knowledge and strategic advice on translation.
• With these measures, ENATRANS will have an immediate impact on the reinforcement of the support to European SMEs and academia as drivers of innovations in nanomedicine, by assisting them in the development of their bottom-up ideas, going from pre-clinical proof of concept to late clinical trials.

But ENATRANS will do even more than just organising information exchange. By setting up and providing open access to a Translation Advisory Board (TAB) of industrial experts with recognised track record in translation ENATRANS will overcome a major pitfall in translation which is the lack of project specific individual advice given by people who have successfully mastered the translation process. By providing face-to-face advice along all stages of the translation process the TAB will act as translation catalyser and will thus reduce the risk of failure in translation and maximise the chances of unlocking the European innovation potential in the field.
• By implementing these measures, ENATRANS will have an immediate impact on the improvement of the innovation capacity of the European nano-bio-medical sector – especially at the level of SMEs - by catalysing a more effective translation process from research into industrial marketable products, thus increasing competitiveness, quality and diversity of the Nanomedicine supply chain.

Europe has a recognised strength in nanomedical research (as testified by the publications) 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 will set up and organise 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 designing, developing and offering dedicated training and education activities, ENATRANS will have an immediate and long term impact on the improvement of the short and long term knowledge in the research community of the translation, regulatory and business aspects of new nano-biomedical developments, leading to more efficient use of resources and research.

Besides the availability of relevant information, advice and training the innovation capacity of the sector highly depends on an easy and prepared access to clinical centres and facilities such as a European Characterisation Laboratory and GMP pilot Lines proposed by the ETPN White paper, to funding schemes and private investment opportunities, and to strategic collaborations with large industries.
• By providing such access ENATRANS will have a strong impact on the improvement of capacities of SMEs regarding funding, strategic collaborations, technologies and facilities that are required to facilitate the transfer of scientific knowledge to market or to facilitate clinical studies.

Beyond those impacts listed in the Work Programme, ENATRANS will have a strong impact on the position and attractiveness of Europe in the global nano-bio-medical competition by generating the necessary conditions for the emergence of a coherent and strong SME based supply chain for innovative nanomedicines as a profitable industrial sector. Complemented by additional EU funding for missing facilities for nano-characterisation and scale up of clinical batches, for example, Europe will progress fast in creating a favourable environment for nanomedical developments. No other continent, even the USA, will have the same potential as Europe in a couple of years. Therefore non-EU industries are looking with great interest to Europe, and will consider moving part of their development to Europe, because they will find a well organised environment for their product developments. ENATRANS is designed to play a major role in organising the different elements of this environment and will therefore have a significant impact on
• Re-localising nanomedical industry in Europe with SMEs as backbone
• Increasing the chance to attract non-European nanomedical production to Europe
• Facilitating the emergence of European champions

Overall, Europe has the chance to take a leading position in industrial exploitation of nanomedicine and thereby gain a leading edge in the global competition for high-tech jobs and economic wealth.

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