Final Report Summary - NANOMED2020 (Enabling the European Nanomedicine Area until 2020)
Executive Summary:
Successful translation of research results into medical products has been identified to be one of the major challenges in the innovative area of nanomedicine. Major hurdles were identified between the Proof of Concept (PoC) - TRL4 - and the clinical PoC (TRL7), along technical, regulatory, clinical and business issues. Striving to overcome these bottlenecks, NANOMED2020 partners published in June 2013 the White Paper entitled “Contribution of Nanomedicine to Horizon 2020”, laying hereby the groundwork for the establishment of a Translation Hub to support the creation of a coherent and strong SME based supply chain for innovative nanomedicines as a profitable industrial sector in Europe. To be implemented under Horizon2020, this Translation Hub has been designed as an umbrella for a set of complementary actions and infrastructures encompassing:
- a dedicated Nanomedicine Translation Advisory Board with experienced industrial experts to select, guide and push forward the best translatable concepts,
- a European Nano-Characterisation Laboratory for the full characterisation of nanomaterials intended for medical use before their regulatory submission,
- GMP manufacturing pilot lines to manufacture batches of nanomedical materials for validation in clinical trials,
- a funding instrument dedicated to SMEs and taking into account the specificities of the nanomedical value chain.
Accelerating the nanomedicine development process must go hand in hand with the federation of its community in order to ensure a sustainable and structured nanomedicine landscape. Within NANOMED2020, a series of initiatives were launched in this regard, notably with the release of the European Nanomedicine Map, displaying on a single chart 1,500 actors involved in the field, providing detailed and easily accessible information as well as opportunities for new partnerships. This tool, welcome by the community contributes to reduce the fragmentation of the community.
In addition, NANOMED2020 contributed to two of the main European events in the field of nanomedicine, the European Summit for clinical nanomedicine (CLINAM 2013 - 500 participants) and the ETP Nanomedicine Annual Event 2013 (150 participants), with unprecedented international contacts, notably with the US, collaborations initiated and partnerships and dissemination activities.
Raising awareness of the field in and beyond the community has become one main objective of the project, with attendances and presentations on numerous community events and with promotional and educative material such as a 2-minute animated movie. The first Nanomedicine Award during BIO-Europe 2013, the largest biotech event in Europe provided also NANOMED2020 partners a unique opportunity of showcasing innovative nanomedicines towards the pharmaceutical industry, a crucial stakeholder in the final development steps of products.
Furthermore, the “Nano World Cancer Day” concept has been further developed in NANOMED2020 in 2013 and 2014. This annual pan-European event promoting the applications of nanomedicine against cancer in the framework of the World Cancer Day (Feb 4th) has proved to be a crucial instrument to reach a large public by targeting the press and by multiplying the locations in EU countries (3 countries in 2013, 13 in 2014) addressing thus international, national and local media.
Finally, NANOMED2020 and EuroNanoMed ERA-NET paved the way towards harmonized strategic policies, notably by launching the process to update the Nanomedicine SRIA expected in 2014.
This project involved 7 partners including the ETPN Secretariat, CLINAM, the Institute of Health Carlos III, Bioanalytik-Muenster e.V Nanobiotix SA, the Don Gnocchi Foundation, and SINTEF.
Project Context and Objectives:
Nanotechnology applied to medical applications – usually called Nanomedicine – is one of the most promising out of the six Key Enabling Technologies (KETs), even in terms of expected compound annual rate, individuated in the Final Report from the High-Level Group on KETs (EU Commission, June 2011) and is one of the most important emerging areas of health research expected to achieve earlier and more precise, individual diagnosis, better targeted therapies and better therapy monitoring. Thus, Nanomedicine is understood to be THE enabling instrument for personalised, targeted and regenerative medicine by delivering the next level of new drugs, treatments and implantable devices to clinicians and patients. Beyond that, Nanomedicine provides important new tools to deal with the grand challenge of an ageing population and is thought to be instrumental for improved and cost effective health-care, one crucial factor for making medicines and treatments available and affordable to all. To be able to excel in Nanomedicine and by that to meet the high expectations of society in terms of health-care quality and effectiveness of treatments, Europe needs to federate key players from different academic fields such as biology, physics, chemistry and engineering on one side and physicians and clinicians on the other side with different industries such as pharma or medical device companies. In addition, regulatory agencies at the European and international level have to be involved to bring new innovations to the patient quickly in this highly regulated area. This complexity of stakeholders and the global competition in Nanomedicine require a strong effort at the European level, which needs to be supported by the national and European authorities and funding bodies.
The Nanomedicine community in Europe suffers from fragmentation into many groups of subcritical size, both geographically scattered and / or academic, industry and/or clinical/public health based. These groups do not have enough gravity to exploit the possibilities of nanotechnology in health in its full extent. Their deeper participation of the biomedical and health sectors are critical for creating a comprehensive and inter- and multidisciplinary effort in Nanomedicine and its consequences to foster translation and innovation. Therefore, there is a strong need for supporting activities to form strong partnerships in Nanomedicine in Europe, as well as to exploit the Nanomedicine-related infrastructure in Europe in a focused way.
In the last years, unprecedented efforts of consolidating the area of Nanomedicine research have been undertaken with the major organisations in the Nanomedicine field in Europe joining forces; namely the European Technology Platform on Nanomedicine (ETPN), the European Foundation for Clinical Nanomedicine (CLINAM), the European Medicines Agency (EMA), the European Science Foundation (ESF) and now EuroBioForum. Together with the EuroNanoMed ERA-NET as funding initiative this brought together all relevant stakeholders from industry, academia, clinic and public authorities to define a common view on Nanomedicine. As a first result of the discussions amongst these stakeholders some initial recommendations on how to organise the Nanomedicine community and how to overcome the barriers to Nanomedicine translation were formulated.
Professional support of such activities proposed in this supporting action is of out-most importance to create a competitive environment with respect to quality, time, risk assessment, early translation funding support, etc. within Europe to be competitive with other regions of the world.
Based on the existing body of strategic concepts and information and having a comprehensive partnership covering the whole Nanomedicine value chain at hand, the project partners further elaborated and extended the necessary recommendations.
Obviously, for implementation of the requirements detailed activities and measures had to be defined. Also the rules and conditions under which new collaboration and dissemination structures in new innovative partnerships can be implemented hade to be detailed and worked on. Accordingly, the objectives of this project were:
1. Develop the Nanomedicine community by federating all key stakeholders with ETPN and CLINAM as nucleation points.
2. Together with all stakeholders identify and assess existing research and innovation resources, including Nanomedicine-related infrastructure as well as gaps and needs for successful implementation of nanotechnologies in medicine in close relationship to the clinical and Public Health stakeholders.
3. Harmonise and specify existing strategic research agendas and technical roadmaps.
4. Develop new models for improved translation in Nanomedicine based on identified gaps and needs
5. Establish working groups on today’s societal challenges and major issues
6. Initiate international collaborations in the Nanomedicine area, especially coordinate international / worldwide regulation of Nanomedicine products.
7. Improve dissemination of research results and facilitate translation by cataloguing research results of on-going and past research projects for later use in clinics and industry.
Based on the above objectives the expected output of this supporting action aimed to be a strong, established partnership of relevant stakeholders in identified key areas of Nanomedicine with novel concepts for translation of nanomedical innovations into clinical practice and efficient and transparent communication channels. This made Nanomedicine an important contributor to the future European healthcare system with a beneficial impact on improved treatment for patients in general and societal challenges such as ageing population, in particular, as well as an economic impact through an improved and cost-effective health care.
Overall, NANOMED2020 Coordination and Support Action under the FP7-Health aimed at delivering concrete recommendations to the European Commission to install Nanomedicine as a main European research topic in the next framework program and to push forward the field towards a profitable industrial sector in Europe.
Project Results:
1. Building a sustainable European Nanomedicine Community
Federating and mobilising the nanomedicine field within its community and towards the other stakeholders was of outmost importance by the consortium to efficiently shape the field for Horizon2020, a key outcome of the project. This is why major efforts were spent for WP2 main tasks, structured along the two red lines of Mobilising the Nanomedicine Community and Promoting the field beyond.
1.1. Mobilisation outcomes: Federating and Serving the Nanomedicine Community
1.1.1. Federating the nanomedicine platforms, initiatives and networks
Throughout the project, NANOMED2020 strived for the structuration of the community with ETPN, CLINAM the ERA-Net EuroNanoMed (ENM) and national/regional nanomedicine platform used as nucleation points.
Enhanced collaborations with systemic cross-dissemination of activities and harmonised joint initiatives were notably established, among which the update of the ETPN Strategic Research and Innovation Agenda (SRIA) is still ongoing (release planned at fall 2014).
Active support was provided between these community platforms for the co-organisations of events. Section 2.3. provides further details in this regard.
Moreover, social networks (ENM Facebook page, LinkedIn and Twitter accounts, CLINAM networks) were actively used during the whole project duration for further communication of NANOMED2020 activities and dissemination of project results.
ETPN Newsletters were used to regularly report on NANOMED2020 actions, as well as to ensure an up-to-date and dynamic nanomedicine community. Overall, 4 newsletters were edited throughout the project, had a dedicated NANOMED2020 section and were widely disseminated using various canals (dedicated mailing list, meta-network, national platforms, social networks…): Newsletter 1/2013 (February 26th 2013); Newletter 2/2013 (June 06th 2013); Newsletter 3/2013 (August 30th 2013) and Newsletter 1/2014 (February 17th 2014).
A sustainable meta-network was thus established between the ETPN, ERA-NET and national/regional nanomedicine platforms, which have shown throughout NANOMED2020 initiatives its value in terms of synergies, dissemination and impact. These networks has been solicited for communication & dissemination purposes but also in order to retrieve feedback from the nanomedicine community on a deeper scale. Among such network can notably be listed:
- The ERA-NET EuroNanoMed II
- The French Society of Nanomedicine
- The British Society of Nanomedicine
- NanoMed Spain Platform
- Greek, Polish and Austrian NanoNets.
- SwedNanoTech platform
- NanoMed North platform
- NanoNext NL
- Nanomedicine Czech platform
In addition, NANOMED2020 contributed to the intensified involvement of national public authorities by initiating new contact on national level. As a consequence, the ETPN Mirror Group, gathering representatives from national ministries or innovation agencies could be enlarged from 12 to 18 countries: France, Israel, Italy, Portugal, Finland, Czech Republic and Latvia joined this highly specific network dedicated to make the bridge between the European and national policies, further to provide inputs into the latest nanomedicine initiatives, gaps and needs in their respective country.
1.1.2. Establishment of the European NanoMedicine Map as a reference tool
A key outcome of WP2 and of the overall project towards federating the European nanomedicine community for Horizon 2020 is the establishment of the European Nanomedicine Map, publically available on the ETPN website at: www.etp-nanomedicine.eu/public/nanomedmap/.
The European Nanomedicine Map is displaying on a single chart more than 1,500 actors involved in the field, ranging from research centres and academia to SMEs and industries, from associations and clusters to healthcare providers, public and funding authorities.
Such exhaustive mapping is the result of extensive collaborations over nine months, of surveys consolidations, of online data collection and of literature review. Overall, more than 500 industrial players and SMEs having a direct link or activities in the field of Nanomedicine have been identified, together with nearly a thousand actors conducting research of excellence across Europe in Laboratories or Research Centres.
The intrinsic value of this feature does not only reside in the many dots on the map, but also in the detailed and easily accessible public information about the actors’ research activities, products, areas of activities and specific transversal expertise.
This tool aims therefore to provide new networking opportunities and initiate fruitful partnerships within the community but also to serve as an exploration instrument to any public visitor wishing to discover the nanomedicine landscape and its actors today. The Nanomedicine Map holds the potential to serve as a reference tool for national authorities to assess the state-of-the art activities in the field in order to efficiently prepare the healthcare system for such coming innovations.
Detailed mapping process used: After many contributions from various networks, databases, experts and national platforms, the first results for the Map database listed more than 500 companies active to some extent in the field of nanomedicine. The second phase resulted in a landscape encompassing all research institutes and clusters active in the field, compiling online resources, national and European nanomedicine projects’ partners, and participants to the latest nanomedicine initiatives/events. In parallel, a 10 minutes online questionnaire has been designed and approved to gather additional data and to consolidate the existing and ongoing mapping activity. This first survey conducted under NANOMED2020 is available in Appendix.
Subcontracting: The technical realisation was under the supervision and coordination of VDI/VDE-IT, and was successfully subcontracted to HyperMorgen (www.hypermorgen.com) an SME in Berlin, which core expertise is the identification and monitoring of key factors of change, (collaborative) forecasts and perspectives. HyperMorgen also develops scenarios depicting possible and likely futures and creates design fiction & maps. The physical proximity with the subcontractor allowed several meetings to define specifications, to validate first drafts, to extend the drafts to the whole database, to fine-tune usability, search, …
Release and Communication activities: After significant teasing in key events (including CLINAM, ENF, and ETPN Annual Event 2013), the map was officially released in December 2013 with simultaneous press releases and communication exercises among NANOMED2020 partners. The news was further disseminated by online channels, national platforms and nanomedicine online journals.
Following such official release, the NANOMED2020 consortium strived for a pro-active attitude of all the nanomedicine actors and stakeholders to keep the map up-to-date in order for the community to benefit from the whole potential of such dynamic tool.
An email campaign was also initiated to ensure all organisations shown on the NanoMed Map were aware of such tool. Each organisation was also signified that information displayed on the map is publically available (from the internet) and doesn’t contain personal data. Finally they were informed about the possibility for them to update / or withdraw their entries as the online map is set as a dynamic tool.
By almost the end of the NANOMED2020 Project, the Board came to the conclusion that it would be of great value to also create and distribute an A0-printed map showing the nearly 700 industrial players identified. The first feedback from those receiving such Poster Map were highly positive since it visualises at a glance and without any electronic assistance how large the development of Nanomedicine already is and how the field is structuring itself across the European landscape.
Impact and Sustainability: After wide dissemination and approval, the Nanomedicine map is already seen and used as a reference tool for the community, the public, authorities and policy makers. Such activity initiated similar actions at the national level, with actors keen to assess and federate their resources in the field. The most prominent example is the case of Czech Republic, with an in –depth census and the creation of a dedicated website: http://www.nano-med.cz
The map is a major step towards the creation of a sustainable meta-network for future initiatives and provides unique data for the structuration of the European nanomedicine landscape and for the healthcare system to assess such innovation coming to the market.
The ETPN Secretariat will continue to manage the requests and new entries gathered by the forms available on the NanoMed Map tool after NANOMED2020 ends.
Further actions envisaged: Under the ETPN, it is envisaged to move from a static to a dynamic Map and community, with the creation of catalogue of nanomedicine actors and the assessment of their position along the value chain and development process.
Moreover, the Map was designed to encompass data outside Europe, and an internationalisation of the Map is hence foreseen. First contacts with US organisation are positive in this regard.
1.1.3. Introducing discussion / Working Groups on challenges in Nanomedicine
A specific set of working groups were defined at the start of the project during the kick-off meeting and represented the following areas identified as key to be addressed and discussed for efficient translation of nanomedicine in Europe:
- Toxicology and Characterisation
- Business Opportunities and IPR
- Ethical, Legal ans SAspects (ELSA) and Regulation
- Clinical Interface: connections with clinicians and Public Health organisations
- Education and Training
These key topics and societal challenges were initially addressed not within open workshops but were concretised as ETPN Working Groups in order to ensure sustainability and long-term vision of the engaged discussions. The new ETPN structure, directly resulting from NANOMED2020 vision, has been voted by end 2012 and implemented in June 2013. A Chart of the new ETPN structure can be found at: http://www.etp-nanomedicine.eu/public/about/structure.
Such uptake into the ETPN structure allowed for increased opportunities of cross-disciplinary workshops as dedicated Working Group sessions were organised during the ETPN Annual Event 2013 (see section 1.5 for more information).
In addition, the CLINAM Summit 2013 organised a workshop dedicated to the Ethics and Implications in Nanomedicine. This year, Professor Rafael Capurro was invited for his work on Medicine in the Information and Knowledge Society. This session was a high level philosophical excurse to the relationship between patient and physician in the future world of personalised medicine.
Overall, the newly created Working Groups played a major role in the establishment of the NANOMED2020 White Paper (see WP6 section) by providing a privileged link with the nanomedicine community involved in these strategic areas and specific input.
Regarding the societal challenge of an “Ageing population”, initiatives were taken during NANOMED2020 with the participation of NANOMED2020 members to dedicated workshops such as:
- a workshop on NMP for an Ageing Population organised by the European Commission, July 2013 in Brussels
- a JRC meeting on the Scientific Support to Public Health, November 2013
It has been established that beyond Health, the Ageing dimension will be fully addressed as societal challenge for nanomedicine and therefore taken into account in the updated ETPN SRIA to be released by fall 2014.
1.1.4. European Summit on Clinical Nanomedicine (CLINAM 2013), 23rd-26th June 2013 in Basel
The European Foundation for Clinical Nanomedicine (CLINAM) and the European Technology Platform on Nanomedicine (ETPN) together organised, notably under the aegis of NANOMED2020, the 2013 annual gathering on Clinical Nanomedicine and Targeted Medicine, now an international landmark for actors involved in the field. This years’ focus topic was: “Nanomedicine & Targeted Medicine – the paradigm of precise, highly effective and safe medicine with subtle influence for the benefit of patients and mankind”.
i. Program and highlights of the Summit
Outstanding presentations of high-quality were given throughout the three-day conference, encompassing all possible aspects and scientific areas of today’s nanomedicine state of the art, ranging from the current unmet medical needs to the applications in diagnostics and imaging, scaffolds in regenerative medicine, personalised cancer nanomedicine, impact of the blood bran barrier on drug delivery and targeting, immunology of nanomedicines, …
The full program is available here: www.clinam.org.
Regarding the specific area of translation in Nanomedicine – NANOMED2020 cornerstone, the European Summit 2013 created several sessions that introduced the process of Translation and the key expectations along the value chain.
A crucial session visited by students, young PhD’s as well as founders of start-ups was the session “First Requirements to Get from Research to Drugs” where the pathways of Translation were shown with six interventions: “Ideation as First Step for Translation” “Regulatory Requirements (GMP /GLP / GCP)”, “Business Development Strategy”, “Talking to Members of Venture Capital – how to Get Success”, “Successful Patent Strategies for Nanomedical Research”, and “How to get from a finding to a completed Phase 1”.
Further detailed below are the sessions specifically realised in the framework of NANOMED2020 and in collaboration with the ETPN:
ETPN Brokerage Flash Presentations and CLINAM University Small Speeches
Animated by two partners of the NANOMED2020 consortium, Nicolas Gouze from VDI/VDE-IT and Dr. Ruth Schmid from SINTEF, this session was dedicated to provide networking and partnerships’ opportunities to the nanomedicine community, where participants were given the possibility to present in a 04 minutes time their project (concept of flash presentations). 27 presentations could have been held in the session, giving insights into industrial and academic organisations’ activities and projects ideas.
The University Village also hosted the posters’ area, serving to highlight the research activities in Nanotechnology for Health. An Award was given for the best Poster.
ETPN Policy-industry table:
The round-table intended to initiate fruitful discussion of the ETPN action plan under H2020 towards a better nanomedicine translation in Europe, with the concept developed by ETPN and NANOMED2020 of a Translational Hub as the central element. The role and the interactions between large pharma groups and innovative nanomedicine-SMEs were notably discussed.
NANOMED2020 session:
A session on shaping the European and international Nanomedicine Community, where activities and first results of the NANOMED2020 project were presented and positively received
Regulatory Authorities Session on the Harmonization of Regulatory Matters for drugs and devices:
In a context where joint efforts are needed to accelerate the promise while minimizing the risk of Nanomedicine, the CLINAM Summit 2013 organised a unique session in which regulatory authorities were participating to debate the development of regulations, with a particular focus on harmonization of regulations at the global level. Under the lead of Deputy Director of the DG Research & Innovation of the EC, Dr. Rudolf Strohmeier, participants had the privilege to hear and engage with members from EMA, the FDAs from Japan, USA, Canada and Australia.
The speakers shortly presented their current main activities in the field, highlighting the new methodologies needed for an in depth scientific assessment of benefits and risks of the regulated products. The request for harmonisation was raised concerning the definition of Nanomedicine, drugs and devices, global standards and the scenarios by which regulators could assist in accelerating the translation form research to approved applications.
“Lessons Learned from the US Nanotechnology Characterization Lab (NCL)”:
A six hours characterisation session was organised under the lead of the Director of the Nanotechnology Characterization Laboratory (NCL), National Cancer Institute (USA), Dr Scott McNeil, and 4 further speakers of this Lab on the Lessons Learned by the US-NCL.
As a short version of a one day presentation of the US NCL, this session offered a very concise yet highly focused programme including:
- common challenges in preclinical characterization of nanoparticles, notably nanoparticle-mediated immunostimulation and immunosuppression
- case studies demonstrating the significance of comprehensive physicochemical characterization of engineered nanomaterials prior to their toxicological evaluation
- strengths and limitations of some of specific NCL physicochemical characterization methods for characterising different types of nanomaterials, including strategies for determining appropriate tests for batch-to-batch consistency and surface characterisation
- critical parameters that can influence the success of nanotechnology platforms include in vivo stability, tissue distribution and biocompatibility
- the importance of selecting appropriate preclinical ADME and toxicity models, and the analytical challenges associated with monitoring the in vivo stability of nanotechnology platforms
The presentations were followed up by many questions, debates and statements form European experts.
ii. Outcomes:
The Summit 2013 brought together specialists from 17 countries, reaching the highest audience of nearly 500 participants. NANOMED2020 efficiently contributed to the development of clear goals to create new instruments for translation and to implement them in the near future.
Interestingly, one third of the participants were clinicians, showing the increasing uptake and interest by the medical community and the healthcare system.
Due to NANOMED2020, it was possible to have 20% more speakers and constantly 4 parallel sessions running during the three days of the conference.
iii. Impact:
- Unique forum for the community to propose new ideas and for established research organisations, industries and funding organisations to provide opportunities for further growth of this area.
- Via dedicated sessions, the complex topic of Translation was enlightened in an approach which allowed the participants to see where they stand and discuss related issues with eminent experts in the field following their presentations.
- Reinforcement of a network of strong organisations in Europe striving for the successful translation of nanomedicine
- International Relations and stabilised bonds with other networks and key players of the Nanomedicine Communities in the world.
- High stimulation of the regulatory authorities convinced of the added value to renew their harmonisation Session in 2014 within the CLINAM / ETPN-Summit.
iv. Communication activities:
Significant communications efforts were spent throughout the project to promote the event with a save the date released nearly one year before and frequent update of the preliminary program
Synergies were also used within NANOMED2020 partners for further dissemination, notably via the ETPN as illustrated in the dedicated news:
http://www.etp-nanomedicine.eu/public/news-events/events/events-archive/european-summit-on-clinical-nanomedicine-clinam-2013/
Recording of sessions and online dissemination via NanoMedTV:
Upon proposal from NANOMED2020 consortium, the major Summit sessions and workshops were recorded via the collaboration of Tel-Aviv University which webcast tools already provided significant visibility and impact in previous FP6-FP7 projects such as NANO2LIFE.
This high quality material is now available on YouTube and delivers opportunities to disseminate state of the art knowledge and to show how the European Nanomedical Scene is developing.
v. Future perspectives and sustainability:
Following the successful collaboration between ETPN and CLINAM under NANOMED2020, the CLINAM /ETPN Summit 2014 will include an important feedback-session that will highlight the best achieved results of NANOMED2020. For the upcoming Summit in June 2014, 70 new speakers and many novel sessions are already planned, made possible via the increasing impact and continuous efforts of ETPN and CLINAM networks.
In addition, the Regulatory session of 2013 was for the panel participants of such quality that they decided to meet again in 2014 for a follow-up and continuation of the dialogue.
Further internationalisation engagement is also envisaged beyond NANOMED2020, with dedicated satellite workshops in other continents. CLINAM already received for instance invitations from Singapore and from Australia to create a European Clinical Nanomedicine Session.
1.1.5. ETP Nanomedicine Annual Event 2013:
The ETPN, together with the NANOMED2020 consortium and associated partners, organised the 2013 ETPN Annual Event on 1st and 2nd of October 2013 at MINATEC in Grenoble, France.
The ETPN event was locally organised by CEA-Leti, a leading French research and technology organisation focused on nanotechnologies and their applications in healthcare.
The two-day conference gathered all European stakeholders involved in the nanomedicine field, ranging from leading industrial and academic experts to national authorities and European Commission (EC) representatives, with the aims to:
- Strengthen the nanomedicine community by providing participants with networking sessions and the opportunity to visit state-of-the art facilities on site,
- establish the ETPN’s new action plan with a strong focus on strengthening industry engagement and extending the platform’s community as nanomedical R&D is expected to progress in the coming years from the pre-clinical to the clinical testing stage,
- provide further insights on the consortium’s recommendations for the efficient development of nanomedicine under the upcoming Horizon2020 Research Framework Programme,
- Set future milestones for the implementation of the White Paper’s concepts elaborated by the NANOMED2020 European consortium to drive innovation across Europe in nanomedicine (see WP6 main results for further information on the White Paper),
- Report and build on NANOMED2020 results,
- Shed light on the local nanomedicine resources, initiatives and actors.
i. Program highlights:
On October 1st, following keynote openings from high-level representatives of the French government (video message from the French Minister for Research) and the EC (Christos Tokamanis, Unit G4, DG RTD), selected experts and leading industry specialists introduced the latest issues evolving around the nanomedicine ecosystem and value chain, providing state-of-the art knowledge to the community on the issues to be addressed to successfully translate research into innovative products towards the market. In this context, the first results and future perspectives of NANOMED2020 were presented and positively received.
The event also strived to reinforce the nanomedicine community with new forces, with a session composed of small speeches by industries and SMEs.
Before the ETPN General Assembly closing the first day, the French society of Nanomedicine was successfully launched.
The second day was dedicated to on-site visits and parallel workshops addressing the technical, economic and societal challenges of the nanomedicine ecosystem. Each workshop was articulated around an ETPN Working Group, mainly:
- Diagnostics and Imaging, Therapeutics and Drug Delivery, Regenerative Medicine
- Business opportunities and IPR, Toxicology and Characterisation, ELSA, Clinical Interface.
The full Program of the ETPN 2013 Annual Event is available here: www.etp-nanomedicine.eu/public/news-events/events/past-etpn-events/etp-nanomedicine-general-assembly-2013/Final%20Programme%20ETP%20Nanomedicine%20General%20Assembly%202013.pdf
ii. Communication and dissemination activities:
- A dedicated page was created on the ETPN website
- Increased visibility was also sought across European dissemination channels such as Pan-European Network: http://www.paneuropeannetworks.com/science-technology/etpn-to-hold-nanomed-conference
- Simultaneous press releases were organised among the project partners with the theme: «Nanomed Line on the Horizon» (http://www-leti.cea.fr/en/layout/set/print/content/view/full/1934)
iii. Impact and outcomes:
- More than 150 participants attended the ETPN 2013 Event, making it the most attended annual meeting of the platform.
- Significant partnerships opportunities were provided, notably thanks to the Small speeches session.
- Successful launch of the French nanomedicine platform and of the new ETPN Working Groups, where participants were provided with key opportunities to engage with each other and share their vision on the latest context and challenges to be addressed today. Each Working Group session led to the establishment of a dedicated action plan to be monitored by the ETPN Executive Board and to be implemented beyond the end of NANOMED2020.
1.2. Communication and Dissemination outcomes: Promoting the field and its actors beyond the nanomedicine community
1.2.1. Communication through dedicated channels
a) Video materials
Urgent actions are needed to leverage nanomedicine acceptance as public perception on nanotechnologies is often mitigated due to the image and risks conveyed by the media.
In order to reflect today’s communication pathways, NANOMED2020 consortium decided to create a short animated movie with the aims to have a very simple, pleasant and easily understandable video for the general public explaining in broad terms what is nanomedicine, its main applications in healthcare and its development (clinical trials) and regulation specificities. A cartoon mode was chosen to stimulate public interest while delivering a highly accurate message. The script of the Movie can be found in Appendix.
Subcontracting: The technical realisation of the movie was subcontracted to Flikli, a highly experienced company in animated videos. The technical realisation of the movie was under the joint supervision and coordination of VDI/VDE-IT and Nanobiotix.
Dissemination: The realisation of the Movie ended in January 2014 and was disseminated via internet. NANOMED2020 used the opportunity of the Nano World Cancer Day to increase the impact of this feature and to present it also to the press. The movie is available at: https://www.youtube.com/watch?v=2VcNpl8-PRI
Further dissemination activities were conducted using social networks (Facebook, LinkedIn, and Twitter), attended events and nanomedicine platforms.
Impact: Around 1500 views were registered by the end of March 2014 on YouTube and the movie received a large approval from the NANOMED2020 consortium and nanomedicine community. The movie can be found on websites from nanomedicine actors who found in it a useful element in their own communication strategy to explain to the general public what they are doing.
Further perspectives and sustainability: Further actions are envisaged, using this movie to raise interest of TV stations for further nanomedicine reports. As proven successful, the concept may be further pushed with similar movies explaining specific nanomedicine applications or benefits in regards to a major disease.
In addition, a candidature was submitted as NANOMED2020 consortium for the REACH OUT! contest, a science communication competition organized by E-MRS under the STIMULATE European Project (“Stimulating the public attitude towards advanced materials”), that seeks to recognise actions of public outreach activity in the field of nanomaterials in the EU between the 1st of January 2013 and the 27th of April 2014.
Enriching the NanoMedTV web platform:
NanoMed TV is an online web platform created in 2010 by the ETPN. All opportunities were taken to keep such online tool alive during the project, notably with the upload of all video related results: the animated movie described above, the CLINAM Summit and ETPN Annual Event 2013, as well as the introductory movie of the Nano World Cancer Day 2014.
b) Press Articles
Throughout the project, the NANOMED2020 consortium engaged significant efforts in promoting the field of nanomedicine and communicating around its potential and applications through the press.
A first article was edited in the European Journal of Nanomedicine soon after the launch of the project to raise awareness on the activities and expectations from NANOMED2020. The article is available online at:
http://www.degruyter.com/view/j/ejnm.2012.4.issue-2-4/ejnm-2012-0015/ejnm-2012-0015.xml
In addition, a sustainable collaboration with the International Innovation Publication has been initiated with a dedicated Nanomedicine series of articles as The Last Word of their issues. International Innovation is a leading global dissemination resource for the wider scientific, technology and research communities, with discrete publications covering Climate, Energy, Environment, Food & Agriculture, Healthcare, Nanotechnology and US Research:
http://www.research-europe.com/index.php/international-innovation/
After an introductory article explaining the field of nanomedicine, the following articles written were focusing either on strategic concepts and activities (White Paper infrastructures, NanoMedMap and NanoMedAward initiatives…) or on dedicated applications of nanomedicine against a major disease. The collaboration started in the second half of 2013.Overall 7 articles were written during the project duration, thereof 3 were directly related to NANOMED2020 activities and results and 4 about increasing awareness in Nanomedicine for specific applications (cancer, atherosclerosis, diabetes, ophtalmology):
- “Future Medicines-Nanotools” (ETPN Secretariat):
www.research-europe.com/index.php/2013/07/future-medicines-nanotools
- “Big Plans-NanoVation” (ETPN Secretariat):
www.etp-nanomedicine.eu/public/press-documents/press-documents/publications/etp-member-publications/International%20Innovation%20second%20article.pdf
- “Federating an outstanding European community in nanomedicine” (ETPN Secretariat)
www.etp-nanomedicine.eu/public/press-documents/press-articles/Federating%20an%20Outstanding%20Community%202.pdf
Future perspectives and sustainability: The Nanomedicine series of articles is expected to continue after the end of NANOMED2020 Project and will be ensured by the ETPN Secretariat. Topics on regenerative medicine and antimicrobial resistance are notably envisaged.
As ETPN owns the rights on all the contents, these articles are foreseen to be further exploited as education materials towards the nanomedicine community but also the general public. The creation of a section dedicated to understanding nanomedicine on the ETPN website is a start, and a catalogue of short articles should be published for dissemination at events when enough materials will be produced.
1.2.2. Engaging stakeholders involved in the nanomedical ecosystem
a) Nanomedicine showcases: launching the first Nanomedicine Award
The NANOMED2020 consortium launched in 2013 the first Nanomedicine Award (http://nanomedicine-award.com/). Open to all stakeholders across the globe, the Award aims at recognising and promoting the best innovative nanomedicine-based solutions that have the potential to open new ways in the treatment of diseases and to bring new diagnostic and therapeutic approaches to address unmet medical needs.
i. Procedure and eligibility criteria:
Applications were welcomed from all categories of stakeholders across the globe and were not limited to Europe. There were no restrictions regarding the stage of development neither: projects could be either a concept or a preclinical or clinical application in nanotherapeutics, diagnostic or regenerative medicine.
ii. Jury and evaluation criteria:
Applications were reviewed and assessed by a panel of highly-qualified pharma industry specialists with experience in R&D and commercial roles:
• Laurent Levy, Nanobiotix;
• Neil Desai, Celgene;
• Mike Eaton, consultant;
• Patrick Tricoli, Sanofi;
• Karen Zinkevich-Peotti, Ipsen
• Thorsten Melcher, Johnson & Johnson Innovation.
The applications were evaluated against the following criteria:
• clear unmet medical needs addressed
• no feasibility without nanotechnologies
• clear distinction from the “standard approaches” with new chemical entities / small molecules and biologics
• clear defined market or market potential
• affiliation in one of the categories (1) nanotherapy in regenerative medicine or (2) nanodiagnostic or nanotherapy in general
iii. Process:
A: Call for Proposals (6th June 2013 - 7th September 2013)
B: Evaluation of Proposals (September 2013)
C: Notification sent to finalists (first week of October 2013)
D: Finalist Selection (middle of October 2013)
E: Award Ceremony and presentation of the winning projects during the Nanomedicine panel discussion at BioEurope 2013 in Vienna (4th to 6th November 2013)
iv. Prize:
Initially, the winners of the first Nanomedicine Award were expected to receive the following benefits:
FIRST PLACE
1. Full ticket incl. Partnering for BioEurope 2013
2. 5 minutes presentation of the winning project during the Nanomedicine Panel Discussion that will take place during BioEurope
3. 15 minutes presentation of the winning project during the CLINAM conference 2014 (www.clinam.org) in Basel, Switzerland
4. 1 year of free membership at ETPN (either for the winning company or the winning scientist)
5. 2 days consulting action by the members of the ETPN translational advisory board
SECOND PLACE
6. Full ticket incl. Partnering for BioEurope 2013
7. 5 minutes presentation of the winning project during the Nanomedicine Panel Discussion that will take place during BioEurope
8. 15 minutes presentation of the winning project during the CLINAM conference 2014 (www.clinam.org) in Basel, Switzerland
In the end, due to the excellence of projects submitted, the Jury decided to award two First Prizes.
v. Outcomes and Award Winners:
10 applications were initially expected for the initiative to be considered as successfully launched. Overall, 23 exceptional projects coming mostly from Europe –but also USA and Australia- applied to the first edition.
70% of the candidatures came from academia, 30% from industries and SMEs. Although all applications areas were represented, the field of therapeutics represented 74% of the candidatures, and 69% of all applications were in a stage of a preclinical phase of development:
The winners out of the 23 exceptional applications were officially announced during a Nanomedicine Panel session at BIO-Europe 2013 (4th November 2013 in Vienna), the largest biotech event in Europe, providing a unique opportunity to attract the attention of the pharmaceutical industry, a crucial stakeholder in the final development steps of products (see section 2.3 for further information regarding the Nanomedicine Panel Session).
The Award and the Nanomedicine Panel Session was officially supported by EBD Group, the leading partnering firm for the global life science industry and organiser of Bio-Europe®. For instance, to ensure a significant presence of nanomedicine actors to such event and Panel session, a negotiation with EBD Group led to a 200€ ticket reduction for ETPN members and NANOMED2020 partners.
The nanodiagnostic Award winning company, Endomagnetics Ltd, is developing advanced magnetic sensing technology to increase access to the standard of care in breast cancer staging by providing an alternative approach to locating sentinel lymph nodes.
In the regenerative medicine category, the candidate Linköping University was awarded for the European Project entitled Integrative nano-Composites And Regeneration of the Eye (I-CARE), a regenerative medicine‐based treatment for Corneal Herpes Simplex Keratitis (HSK), that simultaneously treat the disease while regenerating the damaged cornea.
vi. Communication and dissemination:
A dedicated website has been created to leverage the communication impact and to serve as the single entry point for the nanomedicine community wishing to candidate for the Award (online application form): http://nanomedicine-award.com/
The website was regularly updated, notably with the results of the winners’ announcement.
In order to ensure high visibility of the Award initiative throughout the entire process, three press releases were also disseminated:
1. to announce the launch of the Award applications
2. to increase interest about the winners’ announcement a few days before Bio-Europe 2013:
3. to announce the winners following the official ceremony during the NanoMedicine Panel Session:
This last press release was also used for the Award winners’ own communication actions and press releases.
vii. Impact
- Promising proof of the community federated during the establishment of the Nanomedicine Map.
- A major opportunity to concretely show the outstanding R&D in the area as well as the potential of nanomedicine in providing innovative solutions to currently unmet medical needs.
- Showcase and awareness towards the pharmaceutical industry, a crucial stakeholder in the final development of products for the benefit of the patients.
- Promoting acknowledgement of excellence and new opportunities to the Award winners via the Prize.
- Creation of a brand and a reference: the “Nanomedicine Award”.
viii. Future perspectives and sustainability
Following the success and visibility of the first edition, it is envisaged that the Nanomedicine Award will be conducted on a regular basis, every one or two years.
The concept should remain the same, with the organisation of the Award Ceremony during a large conference beyond the nanomedicine community in order to raise awareness about the field and engage further synergies with other stakeholders of the ecosystem such as pharmaceutical, diagnostic or imaging large industries.
Events such as Bio-Europe, BIO US, Medica, CRS or ECR Vienna are notably envisaged.
The future NanoMedicine Award editions will be under the responsibility and coordination of the ETPN.
b) Pan-European initiatives: Nano World Cancer Days 2013 and 2014
The Concept: The Nano World Cancer Day (NWCD) has been set up as a pan-European initiative with simultaneous press conferences occurring in the framework of the World Cancer Day. This event has been initiated by NANOMED2020 and used the European network of members of the ETPN. VDI/VDE-IT and Nanobiotix had a strong coordination role in the organisation of the events.
Beneficiating from the media coverage of the World Cancer Day, these press conferences were a unique chance to raise awareness and improve knowledge about the field of nanomedicine and its range of applications against cancer, from diagnostic to therapeutic perspectives: Where is the research? What are the new methods of diagnosis and treatments in development? What are the first results and benefits? What are the products used every day?
Targeting the generalist and scientific media (press, radio, TV, website, blog…) at a regional, national and international level, the format of these conferences was 1h30 of presentations during a convivial breakfast atmosphere to ensure journalists feel at ease to raise any possible questions.
As each event aimed to gather different categories of stakeholders in the field to explain nanomedicine from different horizons (including Cancer institutes, representatives of the Nanomedicine community, oncologists and clinicians, industries and academia, patients’ organisations…), the Nano World Cancer Days have been also seen as a key opportunity to shed the light on the local and national resources, initiatives and actors actively involved in the field of nanomedicine.
The events have been designed to take place 1 day (or a few days) before the official World Cancer Day (every year on Feb 4th) to ensure significant attendance of journalists and to leave the opportunity for articles to be published for the WCD.
The local organisers received extensive support and overall coordination from the ETPN with all the necessary documents (including press invitations, press release, press kit...) and benefit from further communication and dissemination channels and visibility.
Nano World Cancer Day 2013 – 1st Edition:
Entitled “Small tools for a big cause: How nanomedicine contributes to better cancer diagnostic and therapy”, the multi-sites concept of the NWCD took a highly positive start in Germany, France and Portugal thanks to the collaboration between the ETP Nanomedicine Secretariat, Nanobiotix and the International Iberian Nanotechnology Laboratory (INL).
The Nano World Cancer Day 2013 took place on 1st February 2013, with events taking place in parallel across Europe in Berlin, Paris and Braga. Renowned speakers shown how nanomedicine can play an important role serves as a key enabling technology in the fight against cancer, from early diagnostics and selective treatments to in-depth imaging, improved drug delivery and inherent therapeutics.
Nano World Cancer Day 2013 resulted in significant media outcomes, with high visibility in the press (both regional and national), radio and TV interviews, and uptake by online resources database (NanoTech-now, News-medical.net NanoPaprika).
In Paris, 13 journalists attended the press breakfast at the Mini-Palais and 6 journalists took part or received the press kit in the event held in Berlin.
A full description of the NWCD 2013 together with a detailed report of the media outcomes is available on the dedicated NWCD website section at: www.nanoworldcancerday.eu/previous-editions/2013
Nano World Cancer Day 2014 – 2nd Edition:
For the second edition of the Nano World Cancer Day, thirteen countries gave their engagement to set up a national event on January 31st (or exceptionally on January 30th), highlighting the importance of nanomedicine research for cancer on the European level: in Austria, Czech Republic, Finland, France, Germany, Greece, Italy, Ireland, Luxembourg, Netherlands, Norway, Portugal, United Kingdom.
Building on the success of last year, Nano World Cancer Day 2014 focused on the theme “Nanomedicine for Cancer-Did you know?” and on shedding light on the four following aspects:
1. Cancer today: what is at stake
2. Nanomedicine for cancer: what it is and how it works
3. Nanomedicine is already a reality for patients
4. Yes, we can make it happen faster
This is a result of the NANOMED2020 consortium policy to reinforce links and synergies with the UICC (the organization behind the WCD), as these themes are directly linked to the official World Cancer Day 2014 communication campaign: “Debunking the Myths” around four specific dimensions.
Full information regarding each event program, speakers and media outcomes is available on the dedicated weblinks above or via the official Nano World Cancer Day webpage: www.nanoworldcancerday.eu
Across the 13 countries, two type of event’s format emerged, either a small conference dedicated to journalists or the extension to a much larger initiative open to public and the community, reaching up to 300 people in some places (Athens).
The wide coverage obtained would not have been possible without such European dimension and the common engagement across member states, highlighting the value of such pan-European event which gave birth to several side interviews (TV or radio), recording of events, and press articles across the involved countries.
Dedicated communication actions:
For the 2013 edition:
1. Simultaneous Press Release by all the local organisers and the ETPN to announce the Nano World Cancer Day 2013
For the 2014 edition:
2. Dissemination via European channels
3. Simultaneous Press Release(s) as for 2013: a non-exhaustive list is given below as an example
4. Creation of a dedicated LinkedIn Group and Twitter hashtag to facilitate communication and information flow between all the local organisers.
5. Dedicated Flyer distributed during the ETPN Annual Event 2013
6. Dedicated website, including insights and outcomes of the first edition
7. Introductory Movie to federate the different nodes and give more impact to the supervision of the ETPN and the support of the European Commission.
8. Increased visibility and collaboration with the official World Cancer Day organisation: Use of WCD logo and inspiration from 2014 WCD themes (turning myths into reality); Insertion in the WCD Map of events.
Impact:
- Creation of sustainable brand: “Nano World Cancer Day”
- Nodes and media coverage across all Europe in 2014 from 03 to 13 countries involved
- Federating and shedding the light on nanomedicine actors and resources within each key European countries
- Highly valuable resources for education and training materials on nanomedicine and cancer
- Proof-of-concept for further similar initiatives focusing on key other diseases under international context.
- Deep involvement of NANOMED2020 partners in the local nodes in both editions
Further perspectives and sustainability: NWCD is a concept likely to be declined in the near future to other diseases where nanomedicine can significantly contribute by providing innovative solutions and products. Neurodegenerative or cardiovascular diseases, diabetes or HIV are some of the envisaged directions. Increased and formal collaboration with the World Cancer Day-UICC is also envisaged for the next years.
1.2.3. Communication through active participations in Events, workshops and meetings
EuroNanoForum 2013, Dublin (June 18th-20th): Presentation of the field of Nanomedicine and raising awareness of the newly released White Paper; Speakers and delegates at the Healthcare and Advances on Bionanotechnology sessions, in addition to a dedicated Nanomedicine Workshop: www.etp-nanomedicine.eu/public/news-events/events/events-archive/euronanoforum-2013
10th International Conference on Nanosciences and Nanotechnologies- NN13, Thessaloniki (July 09th-12th): Presentation of NANOMED2020 activities and results during a Nanomedicine Workshop; Networking and building synergies with the Greek nanomedicine platform (NanoNet).
MNBS & EPOSS annual event 2013, Cork (September 24th-26th): Presentation of ETPN and NANOMED2020 activities and results (speech and A0-poster)
Nordic Life Science Days 2013, Stockholm (October 14th-15th): Presentation of ETPN and NANOMED2020 activities and results during a Nanomedicine Session; Networking and building synergies with the Swedish nanomedicine members (SwedNanoTech platform)
ETPN Day at NanoFar Autumn School 2013, Santiago de Compostela (October 24th): Launch of the Working Group on Education and Training
BioEurope 2013 and Nanomedicine Panel Session (November 4th-06th): Announcement of the Nanomedicine Award winners; Build bridges with large industries for partnerships opportunities; Showcase and awareness of nanomedicine to the biotech and pharmaceutical industry with a Nanomedicine Panel Session addressing key topics:
• How has “nano” contributed to the pipeline of pharma companies thus far
• What is the outlook for the established nano-principles
• Examples of the „next in class from nano“ – nanotherapeutics with projects in Regenerative Medicine and in Oncology
• Why is pharma not taking such approaches on board?
Such Panel session received extensive interest and media outcomes, with the relay of the statement that "Five years from now every pharma will have a nano program": www.partnering360.com/insight/showroom/id/428
Future perspectives:
Several events are already planned where the consortium will actively contribute through the dynamics installed within NANOMED2020:
- BioNanoMed 2014 Congress (March 26th-28th, Vienna )
- Nanomedicine in Scotland (March 26-27th, Edinburgh):
- Industrial Technologies 2014 (April 09th-11th,Athens)
- NanoMedNorth 1st seminar (May 16th, Stockholm)
- NanoBio Europe 2014
2. International Relations
2.1. Launching the basis for an international network
2.1.1. Key nanomedicine initiatives and further nanomedicine actors
The internationalisation process in any field of science is best done by having experts in other countries and continents to start out the exchange for larger groups. CLINAM has:
• created excellent relations to the Regulatory authorities on all continents,
• shaped contacts to the WHO (in Africa for Regulatory matters, in Geneva for Roll Back Malaria),
• shaped contacts to the United Nations office (regarding ethical matters),
• shaped contacts to the international established Nanomedicine Networks in Japan, USA, China. Australia and South Africa as well to other Networks realizing important research Projects in Europe and overseas.
A crucial role is in the hands of the International Society for Nanomedicine (ISNM) which is presently in its 3rd year of activities. The ISNM has as statutes the goal to establish a global networking and information exchange platform for Nanomedicine and Targeted Medicine. During the Summit 2013 a two hours ISNM meeting was fruitful to discuss the future cooperation.
Within NANOMED2020, CLINAM has investigated high-level and renowned groups worldwide that they had not contacted before. New contacts were established with top centres in targeted nano-based Drug Delivery and Nanomedical treatments, mainly in:
- the USA: BIND Therapeutics, Harvard medical school, the Alliance for NanoHealth, Carolina Institute for Nanomedicine, Methodist Hospital Research Institute…
- China: Shanghai Jiao Tong University, City University of Hong Kong
- Russia: Russian State Medical University, Institute for Holistic Medical Sciences, Nanyang Technological University
- India: Christian Medical College
- Singapore: Singapore National Eye Centre
- Australia: University of Queensland, University of New South Wales, Children’s Cancer Institute for Medical Research, Lowy Cancer Research Centre, Australian Centre for NanoMedicine
Furthermore, NANOMED2020 allowed the initiation of fruitful exchanges with worldwide international structures such as:
- WHO in Africa: delegate for the Regulatory session from Africa for the Summit 2014. We have established also manifold contacts to the Roll Back Malaria Initiative of the WHO.
- United Nations: Ethics-Reasoning for a session at the Summit 2014; Ultimate goal of this attempt is to bring via political debate Nanomedicine for large population into a fruitful and positive debate. A further contact is established regarding a CLINAM Event on rare diseases in Africa: Poverty-related diseases shall be the focus of Africa's first Nanomedicine Workshop. The application of Nanomedicine for infectious diseases of poverty shall be treated. The event is planned for the Spring 2015.
- Organisation for Economic Co-operation and Development (OECD): 2 contacts to the OECD have been realised. contacted the medical committee and invited 2 representatives from the committee for Regulatory Frameworks for Nanotechnology in Foods and Medical Products.
- All FDAs across the world: Within the internationalisation of the CLINAM / ETPN-Summit it was a challenge to get all members from continents to the roundtable of Regulatory Matters in Nanomedicine. This acquisition procedure brought excellent lasting contacts to diverse members of the international Regulatory members. It will be for the future of great help to have now direct, sustainable and personal related contacts.
European and International Key Projects, Calls and Announcements
• Evaluation of the Regenerative Medicine & Nanomedicine Initiative Canadian Institutes of Health Research, Ottawa, Ontario Canada http://www.cihr-irsc.gc.ca/e/47302.html
• The Human Brain Project, Lausanne Involving 23 institutions in Europe, 8 related to nanomedical approaches
• European Flagship Initiatives http://cordis.europa.eu/fp7/ict/programme/fet/flagship/
• EuroNanoMed II Joint Transnational Call for Proposals (2014) for “European Innovative Research & Technological Development Projects in Nanomedicine”
• Towards Personalized Medicine
• Insight into all current initiatives and key players in Personalized Medicine in Europe
The list of important initiatives is long and we have chosen here only a few but most promising fields in which Nanomedicine will be of great importance. All here cited projects are under investigating by CLINAM and most of them include at least one NANOMED2020 partner, facilitating thus the link to these initiatives. The selections shows how important the issue of Nanomedicine is relating practically all fields of tomorrow’s technologies to investigate the human being in order to achieve a better diagnosis and therapy with a more innocuous effect.
Structuring and strengthening the ecosystem
• ETP Nanomedicine
• IMI – Innovative Medicines Initiative
• FP7 NANOMED ROUND TABLE (Nanomedicine ethical, regulatory, social and economic environment - Project reference: 218732)
• Nano2life
Structuring and filling in the pipeline of nanomedical products
• Current & future FP7 and Horizon 2020 collaborative research projects in the nano-bio-medical sector
• FP7 EuroNanoBio (EUROpean scale infrastructure in NANOBIOtechnology - Project reference: 231654)
2.1.2. Bi-Continental meetings
2 bi-continental meetings have been organised in the framework of the European Summit for Clinical Nanomedicine 2013 in Basel:
• CLINAM Sunday / ISNM (23/06/2013)
• EU-US cooperation at CLINAM Summit and beyond
2.2. Insights into long-term cooperation frameworks
A Memorandum of Understanding with Nanomedicine platforms inside and outside Europe (US, Argentina, Australia, Russia) has been drafted. The contacts with these platforms have been established.
The Organisation for Economic Co-operation and Development (OECD) has published last year a recommendation that its member companies apply the existing international and national chemical regulatory frameworks or other management systems, adapted to take into account the specific properties of manufactured nanomaterials. The OECD also recommends that member countries make data relevant to the safety of nanomaterials available to the public.
A topic discussed in NANOMED2020 has also been the need for alignment of Europe and its international activities, for instance through the harmonisation of regulation and standards in the field with the implication at CLINAM Summit of regulation authorities worldwide.
Both CLINAM and ETPN, the two major networks in Europe, seek to assist to the furthering of Nanomedicine to the benefit of the patient but also to facilitate that - when Nanomedicine goes to market – this will happen also within and from Europe to the world. After the period of the “knowledge-Society” it should now follow for Europe a simultaneous renewed period of “Action in the Projects” since otherwise Europe could lose best knowledge driven results to countries where technology can be built significantly cheaper.
NANOMED2020 initiated a particular and concrete translational cooperation with the US-NCL in order to provide Europe with a similar infrastructure coping with the high quality standards defined by the US counterpart. These aspects are of particular interest for future recommendations to the EC and have been further developed in the context of the White Paper (WP6) and its implementation under Horizon2020. Further meetings and investigations are already planned to leverage all possible levels of synergies and collaborations.
Impact and Sustainability:
The successful establishment of such extended international network will set the basis for the internationalisation of the Nanomedicine Map described above in WP2.
All players in the field of clinical researches from the Global Nanomedical Community have been invited to be in Basel at the Summit in June 2014. Having them in the international interdisciplinary scientific community will be of mutual benefit and enable to European Participants good contacts in the other continents.
3. Coordinating the update of strategic research roadmap(s) relating to Nanomedicine
The Nanomedicine Strategic Research and Innovation Agenda (SRIA), for which the ETP Nanomedicine is responsible, is seen of outmost importance by the consortium and the nanomedicine community as it describes the vision of ETPN for the future development of nanomedicine and lists the main research priorities that should be implemented by the European Commission, the Member States and their funding agencies until 2020 and beyond.
The SRIA is envisaged not only as the critical update of the last ETPN Roadmaps published in 2009 but also as the integration and merging of INNOVATION dimensions into strategic and technological inputs. The next generation of roadmaps will hence be structured along the value chain development, where TRANSLATION and TRL are becoming major elements to evaluate the maturity and potential of technologies while deeper engagement of late-stage stakeholders are becoming centrally important to ensure R&D projects are meeting industrial requests and clinical needs.
In this context, the SRIA document will answer the following expectations:
- Provide a state-of-the art overview of the technologies to be funded to structure the field and efficiently answer today’s challenges and unmet medical needs.
- Establish the latest nanomedicine portfolio – pipeline to present the products already commercialised or under clinical development reaching the market in the next years. This will allow to prepare the healthcare system for upcoming innovations while increasing the market penetration of nanomedicine products.
- Link the ongoing research with clinical needs through their potential applications to provide a navigation tool for all stakeholders looking at one or the other end of the value chain.
- Provide guidance on translation to accelerate developments and re-orient non-translatable projects.
- Propose dedicated implementation measures and means-instruments under H2020
A collaboration with the EuroNanoMed ERA-NET has been undertaken to avoid duplication and optimise resources. The elaboration of single common SRA has been agreed to leverage synergies and future uptake by national and European policies as well as to maximise the impact of such strategic document.
3.1. Structuring the SRIA:
Such official document aims to address a large audience – public authorities, decision-makers, academic and industrial players as well as clinicians - even beyond Europe, and will cover all possible areas of application of nanotechnology in healthcare.
This document has been compiled through the collaborative work of many stakeholders involved in the ETP Nanomedicine and is the outcome of an in-depth discussion process that took place in the platform. This document shall thus reflect the general state of the discussion within the Nanomedicine community and the importance of an efficient translatable development process in nanomedicine.
The three technological areas addressed, Nano-diagnostics, Nanopharmaceutics and Regenerative Medicine are represented by the three scientific areas of the ETPN. Horizontal considerations with specific focus on establishing a novel environment for nanomedicine are present in the last sections of the SRIA.
3.2. Introducing Innovation to the Nanomedicine Research Agenda
The Strategic Research Agendas (SRAs) defined by the Nanomedicine community and in particular the ETP Nanomedicine over the last half decade were mainly based on technology push and clinical demand. The R&D projects implemented under these research priorities in FP6 and FP7 have successfully delivered a lot of new nanomedicines but few products on the market so far. In consequence the next level of the strategic development of the ETPN is to emphasise the introduction of “Innovation” into the Agenda by improving the translation of nanotechnology R&D into medical applications. This is a Grand Challenge that has been at the core of the ETP since its formation in 2004.
Innovation applied to Nanomedicine for example means enabling personalised medicine through stratification of patients by nano-based diagnostic tests (companion tests for instance) or imaging agents, which are new and different approaches to current medical practice. Another example could be the combination of a diagnostic tests and a therapy within one type of nanoparticle thus making some clinical protocols simpler. However, for such an innovation to reach the patient, close and well informed interactions between all actors in the nanomedicine research and development chain (academic, industrial, public and private partners) are mandatory, including special structures to actively manage communication and collaboration between all stakeholders, including regulatory bodies to effectively translate and commercialise ideas.
Horizontal aspects will also be considered to elaborate the innovation section of the SRIA and the Horital Working Groups as set-up in WP 2 will be asked to contribute, notably through the involvement of industrial actors to ensure that recommended technologies will be taken into consideration by large industries for further development and uptake once developed.
One crucial task will be thus to assess the maturity of technologies and the clusterisation of current products and R&D portfolios to diversify the pipeline and to cover all medical needs.
The White Paper “contribution of Nanomedicine to Horizon 2020” produced by NANOMED2020 will be considered as a main input for the Innovation section of the future SRIA.
In parallel, in order to maximise European resources, synergies and cooperations with existing initiatives should also be investigated further such as with EATRIS or ECRIN, and the European Technology Platforms NanoFutures, Photonics'21 and EPoSS.
3.3. Update of 2009 Nanomedicine Roadmaps
The Nanomedicine SRIA to be released in 2014 will rely to large extent on the update of previous strategic documents elaborated by the Nanomedicine community: Vision Paper (2005), SRA (2006) or Roadmaps in Nanomedicine – Towards 2020 (2009). The 2009 Roadmaps serve thus as reference, given that the time perspective covered by this document is in line with the one that the SRIA will cover (Horizon 2020). The update will be articulated around following issues:
a. Product Pipeline, state of the art research and market expectations: Strategic research priorities by key medical diseases and where nanotechnology is expected to have a high impact will be considered and prioritised as they strongly reduce patient’s quality of life and impose a high socio-economic burden on society.
b. Considerations by area of applications
c. Bringing nanomedicine research into marketable products: Tools and measures to support innovation will be drafted to foster deployment opportunities for nanomedicine with following criteria: business opportunities, focus on SMEs, increase dialogue and uptake at interfaces across the value chain.
As a matter of fact, the future SRIA will consider the value chain in its integrity and propose recommendation at all stages following this scheme: enabling | translating | Leveraging | Implementing.
3.4. Creating a cross-disciplinary repository via workshops and online initiatives
NANOMED2020 initiated a series of activities in order to provide a framework to the knowledge management in the SRIA process, to identify relevant sources for input to the SRIA as well as to collect first information. This knowledge management system relies essentially on a repository gathering all contributions collected. Such repository was further completed by the following initiatives launched within NANOMED2020 and sources of valuable perspectives:
- First contacts, initiation of a collaboration with the French Observatory for Micro and NanoTechnologies (OMNT), a joint unit between the CEA and the CNRS to detect weak signals in nanotechnologies that could have a high impact on medicine on the long term
- Inputs into NanoFutures roadmaps
- Attendance of the cross-ETP workshop organised by the European Commission (Dec 19th 2013)
- Working Group Meetings during the ETPN Annual Events 2012 and 2013 defining the criteria for aggregation and consolidation of information to be implemented
- 2009 Roadmaps Tables
- Collaboration with Bionest Partners who released in 2013 a study on nanomedicine along these criteria:
- mapping of UK, France, Germany and USA
- Product pipeline and market segmentation
- Pharmaceutical perspectives
- Translational issues
- Societal and regulatory study
- The final key milestone for the creation of a full repository of technical data and inputs was the design of an online questionnaire
3.5. Future perspectives – implementation of the process towards the SRIA
NANOMED2020 aimed at providing the preliminary work for the Nanomedicine SRIA. In consequence, this document although not fully consolidated at the end of NANOMED2020, highly benefited from NANOMED2020 contribution as the consortium spent significant time and efforts in the last month of the project to sustainably launch the final steps of the SRA section.
Such planning aims to ensure a release of the document on time for recommendations to the 2016-2020 national policies and European work programmes, while leveraging as many synergies as possible within nanomedicine platforms and coming events to ensure a transparent and wide visibility of the document for giving the opportunity to all actors to provide their inputs into such strategic vision for the future of nanomedicine.
In addition, the White Paper will successfully represent the translational implementation-action plan of the Innovation concepts outlined in the SRIA.
4 Compiling recommendations for identified gaps and barriers based on state of the art
In order to identify the gaps and needs and accelerating the development of innovative nanomedicine products along the value chain, different activities were launched to gather complementary collections of inputs, mainly with online surveys and synergistic collaborations with other national or EU initiatives.
NANOMED2020 actions were structured along the two following objectives:
- Analysing the state of the art, gaps and needs in Europe regarding nanomedicine resources, infrastructures, governance and initiatives.
- Analysing the gaps and barriers along the value chain, notably between stakeholders’ key interfaces.
4.1. Analysing the state of the art, gaps and needs in Europe regarding nanomedicine resources, infrastructures, governance and initiatives.
a) Collaboration with the EuroNanoMed ERA-NET
An overview of funding sources for nanomedicine R&D in Europe was gained in co-operation with the ERA-NET EuroNanoMed II (ENM II). ENM II performed a survey in 2013 on national research and development programs (R&D) which support projects on nanomedicine among its 20 partners, whereof 18 answered. ENM II shared the results with NANOMED2020. With the reinforcement of the ETPN Mirror Group during the project, the ENM II survey was extended to 7 additional countries by the NANOMED2020 project team. The overall analysis as well as the list of all countries included in this survey and the questions are given in Appendices.
Summary of results and conclusions:
Overall, a total of 25 participants from 22 countries answered the survey, which is a substantial number, allowing us to consider these results as representative for Europe. The survey has been mostly answered by national funding agencies, whereof a majority was both owners and managers of R&D programs. None of the countries have dedicated strategies for nanomedicine. 28% of the countries have legal regulations hindering them in participating in joint transnational calls.
The funding for nanomedicine at national level is mostly through general programs, not in programs dedicated exclusively to nanomedicine. The amounts vary from a few 100k€ to several M€. It is positive to recognise that 60-70% of the countries support SMEs and large industry. Such a scattered and scarce funding of a highly multidisciplinary area, as nanomedicine seems suboptimal. There is a need for mobilizing larger amounts of funding, both on the national, but even more on the pan-European level.
The main conclusion is, that based on the facts, that there are no national R&D programs dedicated exclusively to nanomedicine, that no country has a national strategy for nanomedicine and that the fundings are relatively scattered and scarce, the need for a pan-European strategy and pan-European funding programs and initiative is given. Both the ETPN and ENM II have important roles to play and are justified.
b) Governance and infrastructures state of the art
During summer 2013, a survey was conducted to gather complementary information on nanomedicine governance and infrastructures in Europe, in order to assess potential gaps and needs for recommendations to be made under H2020 and input to the SRIA update planned by the ETPN in 2014. The survey targeted the organisations which fund nanomedicine R&D and decision makers on regulatory aspects in the European countries. The survey questions and complete analysis are given in Appendices.
Summary of results and conclusions:
Nine countries answered the survey, Estonia, Finland, Italy, Norway, Poland, Portugal, Turkey and Ukraine. None of the leading European countries responded. The results have therefore to be interpreted with care and are not considered as representative for Europe. It is obvious from the survey results that the answers mostly are given by the organisations managing the R&D programs and the funding money, but not by the organisations providing the funding.
Based on the results, the need for European infrastructure, available for scientists, SME and industry in countries without such infrastructure, is of high importance. Also, improvement of governance structure, both on pan-European and national levels, to allow for improved collaboration of academia with clinicians and industry and among various scientific fields, should be addressed further in the future. The findings in the survey underpin the needs and recommendations described in the White Paper of the ETPN. Translational research has to be improved by:
- Improved collaboration of academia with clinicians and industry
- Access to European infrastructure for characterisation, clinical trials and GMP scale-up production.
4.2. Analysing the gaps and barriers along the value chain
a) Analysing the product pipeline
In order to position the nanomedicine stakeholders along the value chain, NANOMED2020 paved the way with a first survey in March 2013. Reaching over 150 participants, the answers received significantly contributed to the establishment of the Map database as well as of the consolidation of the nanomedicine product pipeline that will be included in the next ETPN Strategic Research and Innovation Agenda.
The latter activity was further conducted in close collaboration with Bionest Partners, who published in Feb 2014 the latest exhaustive study on the field of nanomedicine and the positioning of Europe in comparison with US and Asia environments and markets.
The full study is available at:
www.etp-nanomedicine.eu/public/press-documents/publications/public-documents/bionest-partners-2014-nanomedicine-study-leem/Rapport%20final%20version%20definitive.pdf
In addition, NANOMED2020 identified several online papers that will provide further insights into the nanomedicine product and R&D portfolios, with a high interest for the study conducted by Michael L. Etheridge and al. entitled “The big picture of nanomedicine: the state of investigational and approved nanomedicine products“ (Nanomedicine: Nanotechnology, Biology, and Medicine, May 2012): www.nanomedjournal.com/article/S1549-9634(12)00288-2/abstract
b) Optimising the nanomedicine value chain by improving the knowledge at the key interfaces between stakeholders
We can consider that the value chain for the development of nanomedical products is quite similar to the one for other medical products meaning that bringing nanomedicine from research to the market needs to go through successive milestones (research concept, preclinical development, early and late clinical development, market) and transfer between different categories of stakeholders (academia, SMEs, pharma/diagnostics industry, end-users).
The interfaces between each category of stakeholders and the uptake of the development are crucial for a successful translation, and require a good understanding of late stage stakeholders expectations and requirements in order to plan the product development accordingly.
This is always a challenging proposition, even for industry who understand the severe restrictions of a heavily regulated sector, but in the case of non–industrial researchers it is exacerbated by a lack of knowledge of the drug development process. Knowing both the barriers and opportunities for commercialisation are hence very important even at a basic research stage, and overcoming these barriers would significantly challenge the status-quo for many academics and SMEs.
In this context, a checklist has been drafted by NanoMed2020 consortium during a dedicated workshop in March 2013 and reflects the key elements to provide or thoughts to have at this point for successful development towards the next milestone of the value chain.
In addition, NANOMED2020 designed a second online survey in the last months of the project (from January to March 2014), with the aim to gather key insights into the nanomedicine development process in order to identify the main barriers and needs along each step of the value chain, from idea and research all the way to market and commercialisation.
Focusing on each relevant category of stakeholders, the data provided a major opportunity to assess the interplay between the different stakeholders involved and the main differences of perspectives at the key interfaces.
Finally, this survey provided all participants with the possibility to comment and endorse the milestones and checklists established so far by the NANOMED2020 consortium.
The survey questions and detailed analysis are available in the Appendices.
Summary of survey results and conclusions:
Open during one month for contributions by the nanomedicine community, the survey gathered 75 answers amongst which 56 coming from 22 EU countries (75%) were relevant and provided useful inputs. This lower number of answers compared to other surveys conducted under NANOMED2020 is due to the high-level expertise requested for contributions. With 75% of academic inputs, answers have to be carefully balanced with industrial perspectives.
With 33% of participants assessing the financial category as a main barrier to move forward at each stage of development (basic research, preclinical, early and late clinical stages), funding is the most highlighted issue, for both academia and industrial actors, followed by Clinical Transferability, Scientific issues, Skills and people at the early stages (Basic research and Preclinical).
Regarding early clinical development, Manufacturing, Characterisation and Business issues were much more highlighted and Regulation was shown to be the cornerstone for late clinical development (phase III).
These main outcomes reinforce the strategic positioning of the White Paper along the three major barriers:
- Missing relevant knowledge in the field of oncology and in market access at the early stage of the project; then, it took a long time to acquire the necessary knowledge,
- Difficulty to find appropriate funding to finance the proof of concept in order to further raise investment from venture capitalists; this has slowed down the development of the product,
- Difficulty to acquire the appropriate knowledge on clinical trials and to identify a competent Clinical Research Organisation to develop the specific preclinical studies required before going to the First in Man trials; this has highlighted the need to develop new relevant methods and assays.
With different trends in the answers provided by academia and SMEs-industries, the survey highlighted the urgent need to provide common criteria and dialogue to all stakeholders to harmonize the value chain and the actors’ expectations.
However, when asked to comment on the overall checklist drafted by the NANOMED2020 consortium, 87% of academic participants and 92% of industrials/SMEs partly or completely agree with the milestones provided.
On average, it can be noticed that 70% of participants rated each White Paper concepts as “Highly Relevant”, showing the coherence and consistence of the provided recommendations for Horizon2020.
4.3. Further Recommendations and perspectives
With the realisation of the Nanomedicine Map and its illustration in a AO-poster format gathering all listed industrial actors, NANOMED2020 has shown the existence of a “Nanomedicine Valley” where most SMEs and large companies active in the field are present and structured. Such “Nanomedicine Valley” has the shape of a bi-crescent going from the Nordic regions and UK down to Northern Italy and Spain, as outlined in the graph below, with the exception of the Paris region industrial cluster.
Such crescent hence provides geographic input for future targeted networking and translational support actions that could benefit to nanomedicine emerging industry.
Further actions are also envisaged within the ETPN and potential future European projects to leverage the first steps taken under NANOMED2020, including:
- Providing the nanomedicine community with a useful tool to quickly understand the requirements to move along the value chain as well as the expectations –often different- of the late stage stakeholders in this regard. This is needed to provide a set of common criteria and a consistent dialogue to facilitate uptake of projects, accelerate translation and decrease the risk of non-translatable projects to the earliest stage possible. Such tool could come as a complement to the recommended actions of the Translation Advisor Board outlined in the White Paper, for desk-based self-assessment and additional education and training perspectives. The format of an article/check list is envisaged. With nanomedicine technologies evolving to higher TRLs, these issues will become increasingly important as funders will start to fund very expensive clinical stages where industrial uptake has to be ensured not to lose massive amounts of investments.
- Mapping of the pipeline of technologies products and FP7 and H2020 projects portfolio. Based on existing studies (ex: Bionest) and NANOMED2020 results, the objective is to provide an analysis and clusterisation of technologies, products and research results in order to identify hot and white spots in the nanomedical pipeline and formulate recommendations to optimise the coverage of research priorities, unmet clinical needs and grand societal challenges.
- Mapping of the nanomedicine stakeholders along the value chain to visualise where is the nanomedicine development in its different application areas (diagnostics, imaging, therapeutics, regenerative medicine).
5. Developing concepts for implementation of future partnerships and strategies
After extensive consultations and dialogue with industrial federations to assess the possibilities of integrating a PPP on Health, the consortium took the decision to publish a White paper stating its vision for the field until 2020, while keeping high contacts with these federations for future possibilities.
The White Paper is available in Appendix or on the ETPN website at: www.etp-nanomedicine.eu/etpn-white-paper-2013
Entitled “Contribution of Nanomedicine to Horizon2020”, the White paper introduces four main recommendations and concrete concepts to foster innovation in Nanomedicine and support the European sector:
1. Nanomedicine Translation Advisory Board with experienced industrial experts to select, guide and push forward the best translatable concepts,
2. European Nano-Characterisation Laboratory for physical, chemical and biological characterisation of nanomaterials intended for medical use,
3. GMP manufacturing pilot lines for clinical batches to assist both academia and SMEs to develop nanomedical materials for validation in clinical trials, before transfer to dedicated manufacturing organisations,
4. NanoMed SME instrument as a new SBIR-like funding model for discovery projects and innovative SMEs.
Process:
The White paper is the result of intensive consultations with the community (notably via ETPN members and Annual Event 2012), national authorities and the EC to deeply understand the state-of-the art, gaps and needs, where and how the consortium could respond to such challenges, and to gather continuous feedback. For instance, 11 meetings were organised with the European Commission to meet different DGs and exchange on different horizons:
23rd Nov 2012: Meeting DG Connect, A. Lymberis (MNBS)
23rd Nov 2012: Meeting DG RTD, J. Suominen, H. Frima (NMP)
13th Dec 2012: Meeting DG RTD, R. Strohmeier
23rd Jan 2013: Meeting DG RTD, R. Strohmeier
8th Feb 2013: Meeting DG RTD, H. Von Bose (Industrial technologies)
8th Feb 2013: Meeting DG RTD, A. Hoeveler (Health)
14th Feb 2013: Meeting DG RTD, C. Tokamanis, H. Frima (NMP)
15th Feb 2013: Meeting DG Enterprise
21th Feb 2013: Meeting DG ERA, P. Froissard, M. Douka
13th Mar 2013: Meeting ETPN Executive Board in Paris
10th Sep 2013: Meeting DG RTD, C. Tokamanis, H. Frima (NMP), T. Ingemansson (Health)
A dedicated online endorsement form was established following the release of the document to leverage the visibility and impact of such strategic paper, and to ensure the envisaged concepts were well received by the community:
www.etp-nanomedicine.eu/public/special-issues/nanomedicine-white-paper-2013-endorsement
In the end, all forms submitted were in favour of the concepts outlined, amongst which 40% came from non-ETPN members, showing the very wide awareness and interest of the overall community in this regard. Supporters even included national authorities such as the German Ministry for Health, supporting this strategic positioning for the field in a written letter to Bioanalytik-muenster.
Communication activities:
Dedicated factsheets for each key concept outlined in the White paper were created for easier and targeted communication across events.
Dissemination and communication around the White Paper concepts was a key objective in all main events attended by the consortium and listed in WP2 with dedicated sessions at ENF, CLINAM and ETPN Annual Event 2013.
Further articles following interviews with the ETPN secretariat were published, for example under horizon2020projects: “Nanomedicine-Open Innovation”
http://horizon2020projects.com/il-nanotechnology-interviews/nanomedicine-open-innovation
Impact:
- Large dissemination incl. several DGs in the EC
- High interest from the European Commission and Member States
- Reference Document for the European community and beyond, answering unmet needs to accelerate the development and translation of excellent research into innovative nanomedicine products
- Nano-concepts for a macro-impact on EU economy: With 500+ SMEs that could directly benefit from these concepts and nearly 250 “nano”-products used or tested in humans worldwide representing a $130.9 billion market by 2016, nanomedicine and the concept of a dedicated Translation Hub is meant to have a real impact on the European economy.
It can be outlined that NANOMED2020 succeeded in providing key recommendations for the field under H2020, as the concept of a Translation Hub is concretely outlined for implementation under Horizon 2020 First Calls:
- NMP 8 – 2014: Scale-up of nanopharmaceuticals production (GMP Pilot Lines)
- NMP 9 – 2014: Networking of SMEs in the nano-biomedical sector (Translation Advisory Board)
- INFRAIA-1-2014/2015: Integrating and opening existing national and regional research infrastructures of European interest (EU-NCL)
The SME-Instrument established by the EC for Horizon 2020 is also well aligned with the recommendations from the nanomedicine community.
Future perspectives:
Further meetings with industrial associations and regulatory authorities such as EFPIA, COCIR and EMA are envisaged to initiate long-term strategies with large industries and to efficiently structure the ecosystem amongst its stakeholders.
Potential Impact:
1. Potential impact
With the overall objectives to federate the nanomedicine community, structure the European landscape and provide recommendations for nanomedicine under Horizon 2020, NANOMED2020 had significant and sustainable impact in the following dimensions:
• Preparing strong partnerships
• Pushing forward nanomedicine as a key area of health research
• Societal and economic returns
• Increasing awareness on Nanomedicine
• Impact beyond Europe
Overall, NANOMED2020 did succeed in preparing the field of nanomedicine for the next horizon, with the large endorsement of the White Paper concepts by the community and their successful implementation into Horizon 2020 first calls:
• GMP Pilot Lines -> NMP 8 – 2014: Scale-up of nanopharmaceuticals production
• Translation Advisory Board -> NMP 9 – 2014: Networking of SMEs in the nano-biomedical sector
• EU-NCL -> INFRAIA-1-2014/2015: Integrating and opening existing national and regional research infrastructures of European interest
With regard to the establishment of a Translation Advisory Board in the near future, the expected impact should:
• Support European SMEs and academia as drivers of innovations nanomedicine
• Improve the innovation capacity of the nano-biomedical sector by catalysing a more effective translation process from research into industrial marketable products.
• Improve the 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
• Improve the capacities of SME networks regarding technologies and facilities that are required to facilitate the transfer of scientific knowledge to market or to facilitate clinical studies.
a) Preparing strong partnerships
For nanomedical products, the Societal Challenges pillar of Horizon 2020 provides a route to the market, consisting in building up Public Private Partnerships for specific applicative areas. As described previously, such link to the private sector, especially to large companies (pharmaceutical, diagnostic/imaging), is a crucial step in the nanomedicine value chain for R&D actors such as academia and SMEs. It defines whether a novel enabling nanotechnology developed for medical application can meet the patients’ and markets’ needs, becoming thus an innovative medical technology.
Currently the nanomedicine community is mostly composed of academic institutions and SMEs conducting research, pre-clinical development and clinical trials in phase I. Their goal is generally to transfer their products to large companies for final clinical validation, regulatory approval and commercialisation, because they don’t have generally the resources and time to commercialise their innovations in a regulated sector.
NANOMED2020 strived hence for the leveraging of nanomedical technologies and for their implementation in medical products through the optimisation of the interface with large pharmaceutical and diagnostic companies. An intensive and continuous feedback from end-users / stakeholders close to the market is also essential to drive research and development and to define Strategic Research Priorities in an efficient way. Therefore, although the nanomedicine community cannot apply for its own PPP model yet it can actively contribute to future PPPs on Health by:
• Suggesting research topics for the SRA of established PPPs, in particular related to Health,
• Showcasing nanomedical technologies with high translational capacity to large companies,
• Participating in R&D consortia for PPP calls for projects.
With a nanomedicine area characterised by a wide fragmentation and dispersion of its stakeholders; NANOMED2020 paved the way for the harmonisation and federation of nanomedicine initiatives and networks across Europe.
Not only the synergies between the ETPN, CLINAM and the EuroNanoMed ERA-NET increased notably through joint-events and collaboration for the next European Strategic and Innovation Agenda, but it is also expected that the contacts established while building the European nanomedicine map will be sustained. Official partnerships between the ETPN secretariat and all national platforms across Europe are for example already initiated, notably with the British Society of Nanomedicine, the French Society of Nanomedicine, NanoMed Spain, Greek, Austrian and Polish NanoNets, SwedNanoTech, NanoMedNorth, Nanomedicine CZ.
b) Pushing forward nanomedicine as a key area of health research
Nanotechnology is one of the six Key Enabling Technologies (KETs) that has a significant impact on many different medical developments in the three main areas: Therapeutics, Diagnostics/Imaging and Regenerative Medicine. Accordingly, the mapping of nanotechnology research in these areas to diseases is an important milestone to ensure that nano-enabled medical products answer unmet medical needs. Significant steps have been achieved in this regard under NANOMED2020, with the inclusion of the targeted medical diseases in the Nanomed Map actors’ information. Moreover and as a result of discussions within NANOMED2020, the ETPN integrated in its structure among others a dedicated Work Package on Clinical Interface to ensure long term impact of the dialogue and bridges with clinics and healthcare providers, led by the NANOMED2020 partner Fondazione Don Gnocchi.
Matching nanomedicine R&D portfolio and potential applications with today’s unmet medical needs will be at the heart of the definition of Strategic Research Priorities in the field in the coming months in order to fill in the pipeline with innovative products and solutions having a high impact on the healthcare and societal challenges.
All therapeutic areas will potentially benefit from nanomedicine. Specific priorities should be identified jointly by industry and the EC, to be filled by dedicated calls for proposals.
On a similar basis, contacts with large industrial federations such as EFPIA, the European Federation of Pharmaceutical Industries and Associations, have been initiated in order to align the projects of nanomedicine SMEs with the pharmaceutical industrial products requirements.
As Nanomedicine fits naturally with the Key Enabling Technologies (KETs) defined by the European Commission, along with micro- and nano-electronics (including semiconductors), advanced materials, biotechnology, photonics, and advanced manufacturing technologies, inherent interactions exist between these sectors and could be mutually beneficial in terms of research innovation.
This is why the ETPN secretariat will continuously monitor for opportunities in Horizon 2020, push forward synergies and initiate cross-KETs collaborations in order to enhance and enlarge the tools and possibilities for nanomedicine technologies.
A specific collaboration has been already initiated in this regard between Nanomedicine and the MNBS (Micro-Nano-Bio-Systems) and NANOMED2020 participated in the MNBS cluster workshop 2013 in Cork to identify real opportunities for diagnostic innovations and new roads to deal with major societal challenges.
Finally, the release of the ETPN SRIA by fall 2014 will provide high-level and in depth recommendations to guide the future nanomedicine policies until 2020 and beyond. This official document addresses a large audience, even beyond Europe, and will cover a large spectrum of possible areas of application for nanotechnologies in healthcare. Such an agenda is of outmost importance as it describes the vision of ETPN for the future development of nanomedicine and lists all research priorities that should be implemented and funded by the European Commission and the Member States.
c) Important societal and economic returns
With a growing market expected to reach up to 130 billion US$ in 2016 according to the latest study conducted by Bionest Partners (see graph below), it is without doubt that nanomedicine is a fast expanding domain that can and will provide high economic return.
With 49 products currently on the market incorporating nanoparticles, and four times that many now moving through the pipeline with half of those already in Phase II or Phase III trials, nanomedicine is becoming a concrete market segment. However, more is to be done to translate such promises into key innovative medical products onto the market.
In this context, the NANOMED2020 Translation Hub concept and related strategies aim at speeding up the translation of research and development into the Nanomedicine market to enable a fast offer of many novel products that can effectively improve the health of patients suffering from health disorders and illnesses and result in an economically sound and competitive European industry.
With 500+ SMEs identified via the Nanomedicine Map that could directly benefit from these concepts in Europe and 39% of EMA objections of a new product review linked to quality problems related to manufacturing process validation or specifications’ setting (EMA’s SME office annual report 2012), nanomedicine and the concept of a dedicated Translation Hub is meant to have a real impact on the European economy.
In designing and establishing the EU-NCL and the GMP pilot lines, NANOMED2020 will have a direct impact on jobs, healthcare and global value for Europe. By initiating an innovative and competitive healthcare supply chain of SMEs (and even academics) in the field of nanomedicine, NANOMED2020 paved the way for a new environment needed make the concept of Open Innovation successful in and profitable to Europe.
The concept of GMP pilot lines established under NANOMED2020 Translation Hub will provide a unique opportunity to keep production jobs in Europe and reindustrialise the healthcare system. Indeed, much has changed in the last decade, with pharmaceutical companies moving to a global Open Innovation model. With revenues under pressure and a willingness to reduce risks, lower costs and raise innovation standards, R&D staff in Europe’s research centres have been cut off and outsourced outside Europe.
With the implementation of the EU-NCL, it is envisaged that perceived regulatory hurdles will decrease for an increasingly-global pharmaceutical industry, thanks to complementary regulatory framework between the FDA and EMA. This, in return, could increase investment in this area from international pharmaceutical companies, which is a necessary step toward widespread commercialisation of nanotech therapies and diagnostics.
Bridging US-FDA and EMA on nanomedicine evaluation and approval procedures will reduce trade and regulatory barriers between EU and US, as discussed nowadays.
Societal expectation for better healthcare is also huge: scenarios describing the diagnosing of pathologies before clinical symptoms appear, treating them with low doses of drugs and generating few or even no side effects in a custom tailored therapy are commonly discussed and foreseen as the next golden state of care.
Nanomedicine has clearly some answers and contributions to pave the way to realise such scenarios towards personalised, predictive and preventive medicine.
To answer current and future societal challenges, addressing societal and ethical issues in a broad responsible research and innovation concept shall not be an option but must be explicitly taken into account in future proposals.
The ETPN will find ways under Horizon 2020 to initiate sustainable and dedicated actions in this regard as a continuity of NANOMED2020, including:
• Improved public perception of nanomedicine and making the public aware of the benefits of nanomedicine,
• Greater public involvement in nanomedicine directives and more public consultation and dialogue (such as in EPSRC "nanotechnology to medicine and healthcare grand challenge programme“),
• Clear regulatory guidelines for nanomedicines,
• Increased information about ethical issues in nanomedicine education programmes of schools and Universities,
• Inclusion of societal experts and representatives in the selection of projects (in the TAB in particular),
• Encouraged dialogue between and inside related laboratories and between all stakeholders for a responsible innovation. An ethical nanomedicine chart could be pushed forward.
d) Increasing awareness on Nanomedicine
Dissemination of NANOMED2020 activities and key results:
A majority of NANOMED2020 outcomes were dedicated to the support, coordination and federation of the nanomedicine community. The consortium spent thus a lot of efforts in efficiently communicating around its activities, targeting a large dissemination as key element for the success of the project results.
Dedicated press releases and websites were hence put in place to cover specific activities such as the launch of the NanoMed Award and the Nano World Cancer Days, whereas the release of the Nanomedicine Map and NANOMED2020 White paper were disseminated through presentations and direct contacts at large conferences across Europe.
The full list of such dissemination activities is available under section A2.1.
Dissemination of nanomedicine outside the nanomedicine community:
Urgent actions are needed to leverage nanomedicine acceptance as public perception on nanotechnologies is often mitigated due to the image and risks conveyed by the media. NANOMED2020 contributed to prepare the future of health research and innovation by increase awareness on innovative nanotechnologies for medical applications. NANOMED2020 opted for a short (two minutes) and animated movie disseminated via internet (YouTube: https://www.youtube.com/watch?v=2VcNpl8-PRI) social networks (Facebook, LinkedIn, Twitter), events and nanomedicine platforms, to explain in broad terms to the public what is nanomedicine. A cartoon mode was chosen to stimulate public interest while delivering a highly accurate message.
In parallel, efficient translation of nanomedicine to the market also requires increased awareness and synergies with late-stage stakeholders in the value chain, mainly large industries. NANOMED2020 initiated nanomedicine showcases at large biotech and pharma conferences to meet this objective, with the announcement of the first Nanomedicine Award during BioEurope 2013.
e) Impact beyond Europe
Installing a EU-US NCL transnational cooperation:
The aim of the proposed EU-US collaboration under NANOMED2020 is to develop EU-NCL as a mirror organisation to NCL, based on the NCL’s model of operations. EU-NCL would serve the European scientific and start-up communities in characterising nanomaterials developed for medical applications. The EU-NCL is a key component of the Translation Hub proposed by NANOMED2020 in Horizon 2020 and will hence benefit from the five years‘experience of the US-NCL.
Moreover, such cooperation will have a sustainable impact on support the harmonisation of standards between the US and the EU, thus helping transatlantic trade of nanomedicine products and accelerating the introduction of nanomedicines.
The EU-US proposal for cooperation can possibly be implemented under the framework of the existing EU-US cooperation on nanotechnology, in considering the nano-characterisation of medical nanomaterials as a new cooperation topic. This will lead to a faster and safer translation of nanomedicine to the market, and a harmonisation of the nano-characterisation on both US and EU sides, as a preamble to coherent regulatory approval of nanomedicine on both sides.
Federating a worldwide nanomedicine community:
With the federation of resources between CLINAM, ETPN and NANOMED2020 partners, the CLINAM/ETPN Summit 2013 has become a major annual meeting in Europe for international contacts and cooperation, reaching 500 participants at this last edition. Many projects have been shaped at this occasion during dedicated networking sessions. The creation of two FP7 Projects are an example of such impact beyond Europe: the Project “NanoAthero” (www.Nanoathero.eu) developing nanomedicine for target-specific imaging and treatment of atherothrombosis (development and initial clinical feasibility) and the Project “Discognosis” for Point-of-Care diagnosis of malaria and tropical diseases on a CD-like operating platform (http://www.discognosis.eu/).
On a sustainable basis, these international contacts outside Europe encompassing clinically researching members of the Global Nanomedical Community have been all invited to the next CLINAM Summit in June 2014 to join forces again and enable European Participants to reach good contacts in the other continents.
A crucial role has also been put in the hands of the International Society for Nanomedicine (ISNM) which is presently in its 3rd year of activities. The ISNM has the goal to establish a global networking and information exchange platform for Nanomedicine and Targeted Medicine. With a two hours ISNM meeting during CLINAM 2013 Summit, ISNM beneficiated of increased visibility and partnerships opportunities via NANOMED2020 to paved the way for future international cooperation.
The ETPN also initiated through the project the emergence of collaborations with nanomedicine networks outside Europe, with draft Memorandum of Understanding between ETPN and corresponding platforms in Australia, Argentina and Russia, with the aim to leverage synergies and resources across the communities and R&D projects.
2. Main dissemination activities
Dissemination activities were an intrinsic part of the project and were conducted and structured along the two main directions below:
• Dissemination of NANOMED2020 activities and key results
• Dissemination of nanomedicine outside the nanomedicine community
3. Dissemination material
If printed materials where occasionally used when relevant (e.g. printed copies of White Paper, NANOMED2020 flyer and A0-poster for example), most of the dissemination activities were done via the internet to cover the widest audience possible in a very short period (NANOMED2020 had a duration of 18 months).
The NANOMED2020 (www.nanomed2020.eu) and ETPN (www.etp-nanomedicine.eu) websites were the main portals to the project. They contained the project description, consortium members, events, results and offer functionality for giving feedback as well as links to other related initiatives, most notably coming from the ETPN, CLINAM as well as national platforms.
In addition, in order to address a broader audience other means like Web 2.0 communication channels were used. Dissemination of project activities and key outcomes were often disseminated by EuroNanoMed Facebook page and ETPN LinkedIN and Twitter accounts.
YouTube was also sought to efficiently reach the general public. The nanomedicine animated video together with the recordings of CLINAM 2013 were notably broadcasted via the dedicated Nanomedicine channel NanoMedTV (https://www.youtube.com/user/nanomedTV).
Further dissemination channels were recommended to be implemented beyond NANOMED2020, with the creation of a Wiki-like platform for online collaborative editing and intuitive tool for the public to understand the field of nanomedicine and its numerous applications in healthcare.
Nevertheless, it was seen as of crucial importance to perform a more personalised dissemination towards key actors in strategic industrial, societal, legal and academic fields on a national, EU and international level. This was realised by using key events across Europe as the privileged link towards the nanomedicine community but also national and European authorities. For example, the White Paper wide-spread impact and visibility is notably due to significant presence and communication efforts during dedicated sessions or workshops at EuroNanoForum, CLINAM Summit, ETPN Annual Event and national nanomedicine events.
Finally, Press Releases were often used as many of the initiatives launched within the project were novel and required intensive communication efforts to be visible and be launched on a sustainable basis.
4. Exploitation of results
In order to successfully exploit NANOMED2020 results, the White Paper – the cornerstone of the project outcomes and long-term impact - was written at the middle of the project (June 2013) to provide a key milestone for further exploitation and officially state the NANOMED2020 vision and recommendations resulting from the activities launched until then.
In addition, intense communication was organised along specific target groups (nanomedicine community, national networks and initiatives, industrial stakeholders, general public and EC) to gather as many feedback and additional inputs as possible to preliminary results and leverage impact of the final outcomes.
All initiatives launched under NANOMED2020 were designed from the start on a renewable and sustainable basis for long-term exploitation of the results achieved: NanoMed Award and the Nano World Cancer Day are for example concepts likely to be conducted every one or two years under the supervision of the ETPN now that the brand name has been established, and the dedicated websites were thought to host the next editions to ensure traceability and optimisation of resources. Moreover, the Nano World Cancer Day and the Nanomedicine Animated Movie are concepts likely to be declined in the near future respectively to other medical diseases or specific applications of nanomedicine in areas such as diagnostic, imaging, therapy or regenerative medicine.
List of Websites:
The project's public website address is www.nanomed2020.eu. The coordinator's contact is Mr. Nicolas Gouze, VDI/VDE-IT, Steinplatz 1 10623 Berlin, email: nicolas.gouze@vdivde-it.de tel.: +49 30 310078 209.
Successful translation of research results into medical products has been identified to be one of the major challenges in the innovative area of nanomedicine. Major hurdles were identified between the Proof of Concept (PoC) - TRL4 - and the clinical PoC (TRL7), along technical, regulatory, clinical and business issues. Striving to overcome these bottlenecks, NANOMED2020 partners published in June 2013 the White Paper entitled “Contribution of Nanomedicine to Horizon 2020”, laying hereby the groundwork for the establishment of a Translation Hub to support the creation of a coherent and strong SME based supply chain for innovative nanomedicines as a profitable industrial sector in Europe. To be implemented under Horizon2020, this Translation Hub has been designed as an umbrella for a set of complementary actions and infrastructures encompassing:
- a dedicated Nanomedicine Translation Advisory Board with experienced industrial experts to select, guide and push forward the best translatable concepts,
- a European Nano-Characterisation Laboratory for the full characterisation of nanomaterials intended for medical use before their regulatory submission,
- GMP manufacturing pilot lines to manufacture batches of nanomedical materials for validation in clinical trials,
- a funding instrument dedicated to SMEs and taking into account the specificities of the nanomedical value chain.
Accelerating the nanomedicine development process must go hand in hand with the federation of its community in order to ensure a sustainable and structured nanomedicine landscape. Within NANOMED2020, a series of initiatives were launched in this regard, notably with the release of the European Nanomedicine Map, displaying on a single chart 1,500 actors involved in the field, providing detailed and easily accessible information as well as opportunities for new partnerships. This tool, welcome by the community contributes to reduce the fragmentation of the community.
In addition, NANOMED2020 contributed to two of the main European events in the field of nanomedicine, the European Summit for clinical nanomedicine (CLINAM 2013 - 500 participants) and the ETP Nanomedicine Annual Event 2013 (150 participants), with unprecedented international contacts, notably with the US, collaborations initiated and partnerships and dissemination activities.
Raising awareness of the field in and beyond the community has become one main objective of the project, with attendances and presentations on numerous community events and with promotional and educative material such as a 2-minute animated movie. The first Nanomedicine Award during BIO-Europe 2013, the largest biotech event in Europe provided also NANOMED2020 partners a unique opportunity of showcasing innovative nanomedicines towards the pharmaceutical industry, a crucial stakeholder in the final development steps of products.
Furthermore, the “Nano World Cancer Day” concept has been further developed in NANOMED2020 in 2013 and 2014. This annual pan-European event promoting the applications of nanomedicine against cancer in the framework of the World Cancer Day (Feb 4th) has proved to be a crucial instrument to reach a large public by targeting the press and by multiplying the locations in EU countries (3 countries in 2013, 13 in 2014) addressing thus international, national and local media.
Finally, NANOMED2020 and EuroNanoMed ERA-NET paved the way towards harmonized strategic policies, notably by launching the process to update the Nanomedicine SRIA expected in 2014.
This project involved 7 partners including the ETPN Secretariat, CLINAM, the Institute of Health Carlos III, Bioanalytik-Muenster e.V Nanobiotix SA, the Don Gnocchi Foundation, and SINTEF.
Project Context and Objectives:
Nanotechnology applied to medical applications – usually called Nanomedicine – is one of the most promising out of the six Key Enabling Technologies (KETs), even in terms of expected compound annual rate, individuated in the Final Report from the High-Level Group on KETs (EU Commission, June 2011) and is one of the most important emerging areas of health research expected to achieve earlier and more precise, individual diagnosis, better targeted therapies and better therapy monitoring. Thus, Nanomedicine is understood to be THE enabling instrument for personalised, targeted and regenerative medicine by delivering the next level of new drugs, treatments and implantable devices to clinicians and patients. Beyond that, Nanomedicine provides important new tools to deal with the grand challenge of an ageing population and is thought to be instrumental for improved and cost effective health-care, one crucial factor for making medicines and treatments available and affordable to all. To be able to excel in Nanomedicine and by that to meet the high expectations of society in terms of health-care quality and effectiveness of treatments, Europe needs to federate key players from different academic fields such as biology, physics, chemistry and engineering on one side and physicians and clinicians on the other side with different industries such as pharma or medical device companies. In addition, regulatory agencies at the European and international level have to be involved to bring new innovations to the patient quickly in this highly regulated area. This complexity of stakeholders and the global competition in Nanomedicine require a strong effort at the European level, which needs to be supported by the national and European authorities and funding bodies.
The Nanomedicine community in Europe suffers from fragmentation into many groups of subcritical size, both geographically scattered and / or academic, industry and/or clinical/public health based. These groups do not have enough gravity to exploit the possibilities of nanotechnology in health in its full extent. Their deeper participation of the biomedical and health sectors are critical for creating a comprehensive and inter- and multidisciplinary effort in Nanomedicine and its consequences to foster translation and innovation. Therefore, there is a strong need for supporting activities to form strong partnerships in Nanomedicine in Europe, as well as to exploit the Nanomedicine-related infrastructure in Europe in a focused way.
In the last years, unprecedented efforts of consolidating the area of Nanomedicine research have been undertaken with the major organisations in the Nanomedicine field in Europe joining forces; namely the European Technology Platform on Nanomedicine (ETPN), the European Foundation for Clinical Nanomedicine (CLINAM), the European Medicines Agency (EMA), the European Science Foundation (ESF) and now EuroBioForum. Together with the EuroNanoMed ERA-NET as funding initiative this brought together all relevant stakeholders from industry, academia, clinic and public authorities to define a common view on Nanomedicine. As a first result of the discussions amongst these stakeholders some initial recommendations on how to organise the Nanomedicine community and how to overcome the barriers to Nanomedicine translation were formulated.
Professional support of such activities proposed in this supporting action is of out-most importance to create a competitive environment with respect to quality, time, risk assessment, early translation funding support, etc. within Europe to be competitive with other regions of the world.
Based on the existing body of strategic concepts and information and having a comprehensive partnership covering the whole Nanomedicine value chain at hand, the project partners further elaborated and extended the necessary recommendations.
Obviously, for implementation of the requirements detailed activities and measures had to be defined. Also the rules and conditions under which new collaboration and dissemination structures in new innovative partnerships can be implemented hade to be detailed and worked on. Accordingly, the objectives of this project were:
1. Develop the Nanomedicine community by federating all key stakeholders with ETPN and CLINAM as nucleation points.
2. Together with all stakeholders identify and assess existing research and innovation resources, including Nanomedicine-related infrastructure as well as gaps and needs for successful implementation of nanotechnologies in medicine in close relationship to the clinical and Public Health stakeholders.
3. Harmonise and specify existing strategic research agendas and technical roadmaps.
4. Develop new models for improved translation in Nanomedicine based on identified gaps and needs
5. Establish working groups on today’s societal challenges and major issues
6. Initiate international collaborations in the Nanomedicine area, especially coordinate international / worldwide regulation of Nanomedicine products.
7. Improve dissemination of research results and facilitate translation by cataloguing research results of on-going and past research projects for later use in clinics and industry.
Based on the above objectives the expected output of this supporting action aimed to be a strong, established partnership of relevant stakeholders in identified key areas of Nanomedicine with novel concepts for translation of nanomedical innovations into clinical practice and efficient and transparent communication channels. This made Nanomedicine an important contributor to the future European healthcare system with a beneficial impact on improved treatment for patients in general and societal challenges such as ageing population, in particular, as well as an economic impact through an improved and cost-effective health care.
Overall, NANOMED2020 Coordination and Support Action under the FP7-Health aimed at delivering concrete recommendations to the European Commission to install Nanomedicine as a main European research topic in the next framework program and to push forward the field towards a profitable industrial sector in Europe.
Project Results:
1. Building a sustainable European Nanomedicine Community
Federating and mobilising the nanomedicine field within its community and towards the other stakeholders was of outmost importance by the consortium to efficiently shape the field for Horizon2020, a key outcome of the project. This is why major efforts were spent for WP2 main tasks, structured along the two red lines of Mobilising the Nanomedicine Community and Promoting the field beyond.
1.1. Mobilisation outcomes: Federating and Serving the Nanomedicine Community
1.1.1. Federating the nanomedicine platforms, initiatives and networks
Throughout the project, NANOMED2020 strived for the structuration of the community with ETPN, CLINAM the ERA-Net EuroNanoMed (ENM) and national/regional nanomedicine platform used as nucleation points.
Enhanced collaborations with systemic cross-dissemination of activities and harmonised joint initiatives were notably established, among which the update of the ETPN Strategic Research and Innovation Agenda (SRIA) is still ongoing (release planned at fall 2014).
Active support was provided between these community platforms for the co-organisations of events. Section 2.3. provides further details in this regard.
Moreover, social networks (ENM Facebook page, LinkedIn and Twitter accounts, CLINAM networks) were actively used during the whole project duration for further communication of NANOMED2020 activities and dissemination of project results.
ETPN Newsletters were used to regularly report on NANOMED2020 actions, as well as to ensure an up-to-date and dynamic nanomedicine community. Overall, 4 newsletters were edited throughout the project, had a dedicated NANOMED2020 section and were widely disseminated using various canals (dedicated mailing list, meta-network, national platforms, social networks…): Newsletter 1/2013 (February 26th 2013); Newletter 2/2013 (June 06th 2013); Newsletter 3/2013 (August 30th 2013) and Newsletter 1/2014 (February 17th 2014).
A sustainable meta-network was thus established between the ETPN, ERA-NET and national/regional nanomedicine platforms, which have shown throughout NANOMED2020 initiatives its value in terms of synergies, dissemination and impact. These networks has been solicited for communication & dissemination purposes but also in order to retrieve feedback from the nanomedicine community on a deeper scale. Among such network can notably be listed:
- The ERA-NET EuroNanoMed II
- The French Society of Nanomedicine
- The British Society of Nanomedicine
- NanoMed Spain Platform
- Greek, Polish and Austrian NanoNets.
- SwedNanoTech platform
- NanoMed North platform
- NanoNext NL
- Nanomedicine Czech platform
In addition, NANOMED2020 contributed to the intensified involvement of national public authorities by initiating new contact on national level. As a consequence, the ETPN Mirror Group, gathering representatives from national ministries or innovation agencies could be enlarged from 12 to 18 countries: France, Israel, Italy, Portugal, Finland, Czech Republic and Latvia joined this highly specific network dedicated to make the bridge between the European and national policies, further to provide inputs into the latest nanomedicine initiatives, gaps and needs in their respective country.
1.1.2. Establishment of the European NanoMedicine Map as a reference tool
A key outcome of WP2 and of the overall project towards federating the European nanomedicine community for Horizon 2020 is the establishment of the European Nanomedicine Map, publically available on the ETPN website at: www.etp-nanomedicine.eu/public/nanomedmap/.
The European Nanomedicine Map is displaying on a single chart more than 1,500 actors involved in the field, ranging from research centres and academia to SMEs and industries, from associations and clusters to healthcare providers, public and funding authorities.
Such exhaustive mapping is the result of extensive collaborations over nine months, of surveys consolidations, of online data collection and of literature review. Overall, more than 500 industrial players and SMEs having a direct link or activities in the field of Nanomedicine have been identified, together with nearly a thousand actors conducting research of excellence across Europe in Laboratories or Research Centres.
The intrinsic value of this feature does not only reside in the many dots on the map, but also in the detailed and easily accessible public information about the actors’ research activities, products, areas of activities and specific transversal expertise.
This tool aims therefore to provide new networking opportunities and initiate fruitful partnerships within the community but also to serve as an exploration instrument to any public visitor wishing to discover the nanomedicine landscape and its actors today. The Nanomedicine Map holds the potential to serve as a reference tool for national authorities to assess the state-of-the art activities in the field in order to efficiently prepare the healthcare system for such coming innovations.
Detailed mapping process used: After many contributions from various networks, databases, experts and national platforms, the first results for the Map database listed more than 500 companies active to some extent in the field of nanomedicine. The second phase resulted in a landscape encompassing all research institutes and clusters active in the field, compiling online resources, national and European nanomedicine projects’ partners, and participants to the latest nanomedicine initiatives/events. In parallel, a 10 minutes online questionnaire has been designed and approved to gather additional data and to consolidate the existing and ongoing mapping activity. This first survey conducted under NANOMED2020 is available in Appendix.
Subcontracting: The technical realisation was under the supervision and coordination of VDI/VDE-IT, and was successfully subcontracted to HyperMorgen (www.hypermorgen.com) an SME in Berlin, which core expertise is the identification and monitoring of key factors of change, (collaborative) forecasts and perspectives. HyperMorgen also develops scenarios depicting possible and likely futures and creates design fiction & maps. The physical proximity with the subcontractor allowed several meetings to define specifications, to validate first drafts, to extend the drafts to the whole database, to fine-tune usability, search, …
Release and Communication activities: After significant teasing in key events (including CLINAM, ENF, and ETPN Annual Event 2013), the map was officially released in December 2013 with simultaneous press releases and communication exercises among NANOMED2020 partners. The news was further disseminated by online channels, national platforms and nanomedicine online journals.
Following such official release, the NANOMED2020 consortium strived for a pro-active attitude of all the nanomedicine actors and stakeholders to keep the map up-to-date in order for the community to benefit from the whole potential of such dynamic tool.
An email campaign was also initiated to ensure all organisations shown on the NanoMed Map were aware of such tool. Each organisation was also signified that information displayed on the map is publically available (from the internet) and doesn’t contain personal data. Finally they were informed about the possibility for them to update / or withdraw their entries as the online map is set as a dynamic tool.
By almost the end of the NANOMED2020 Project, the Board came to the conclusion that it would be of great value to also create and distribute an A0-printed map showing the nearly 700 industrial players identified. The first feedback from those receiving such Poster Map were highly positive since it visualises at a glance and without any electronic assistance how large the development of Nanomedicine already is and how the field is structuring itself across the European landscape.
Impact and Sustainability: After wide dissemination and approval, the Nanomedicine map is already seen and used as a reference tool for the community, the public, authorities and policy makers. Such activity initiated similar actions at the national level, with actors keen to assess and federate their resources in the field. The most prominent example is the case of Czech Republic, with an in –depth census and the creation of a dedicated website: http://www.nano-med.cz
The map is a major step towards the creation of a sustainable meta-network for future initiatives and provides unique data for the structuration of the European nanomedicine landscape and for the healthcare system to assess such innovation coming to the market.
The ETPN Secretariat will continue to manage the requests and new entries gathered by the forms available on the NanoMed Map tool after NANOMED2020 ends.
Further actions envisaged: Under the ETPN, it is envisaged to move from a static to a dynamic Map and community, with the creation of catalogue of nanomedicine actors and the assessment of their position along the value chain and development process.
Moreover, the Map was designed to encompass data outside Europe, and an internationalisation of the Map is hence foreseen. First contacts with US organisation are positive in this regard.
1.1.3. Introducing discussion / Working Groups on challenges in Nanomedicine
A specific set of working groups were defined at the start of the project during the kick-off meeting and represented the following areas identified as key to be addressed and discussed for efficient translation of nanomedicine in Europe:
- Toxicology and Characterisation
- Business Opportunities and IPR
- Ethical, Legal ans SAspects (ELSA) and Regulation
- Clinical Interface: connections with clinicians and Public Health organisations
- Education and Training
These key topics and societal challenges were initially addressed not within open workshops but were concretised as ETPN Working Groups in order to ensure sustainability and long-term vision of the engaged discussions. The new ETPN structure, directly resulting from NANOMED2020 vision, has been voted by end 2012 and implemented in June 2013. A Chart of the new ETPN structure can be found at: http://www.etp-nanomedicine.eu/public/about/structure.
Such uptake into the ETPN structure allowed for increased opportunities of cross-disciplinary workshops as dedicated Working Group sessions were organised during the ETPN Annual Event 2013 (see section 1.5 for more information).
In addition, the CLINAM Summit 2013 organised a workshop dedicated to the Ethics and Implications in Nanomedicine. This year, Professor Rafael Capurro was invited for his work on Medicine in the Information and Knowledge Society. This session was a high level philosophical excurse to the relationship between patient and physician in the future world of personalised medicine.
Overall, the newly created Working Groups played a major role in the establishment of the NANOMED2020 White Paper (see WP6 section) by providing a privileged link with the nanomedicine community involved in these strategic areas and specific input.
Regarding the societal challenge of an “Ageing population”, initiatives were taken during NANOMED2020 with the participation of NANOMED2020 members to dedicated workshops such as:
- a workshop on NMP for an Ageing Population organised by the European Commission, July 2013 in Brussels
- a JRC meeting on the Scientific Support to Public Health, November 2013
It has been established that beyond Health, the Ageing dimension will be fully addressed as societal challenge for nanomedicine and therefore taken into account in the updated ETPN SRIA to be released by fall 2014.
1.1.4. European Summit on Clinical Nanomedicine (CLINAM 2013), 23rd-26th June 2013 in Basel
The European Foundation for Clinical Nanomedicine (CLINAM) and the European Technology Platform on Nanomedicine (ETPN) together organised, notably under the aegis of NANOMED2020, the 2013 annual gathering on Clinical Nanomedicine and Targeted Medicine, now an international landmark for actors involved in the field. This years’ focus topic was: “Nanomedicine & Targeted Medicine – the paradigm of precise, highly effective and safe medicine with subtle influence for the benefit of patients and mankind”.
i. Program and highlights of the Summit
Outstanding presentations of high-quality were given throughout the three-day conference, encompassing all possible aspects and scientific areas of today’s nanomedicine state of the art, ranging from the current unmet medical needs to the applications in diagnostics and imaging, scaffolds in regenerative medicine, personalised cancer nanomedicine, impact of the blood bran barrier on drug delivery and targeting, immunology of nanomedicines, …
The full program is available here: www.clinam.org.
Regarding the specific area of translation in Nanomedicine – NANOMED2020 cornerstone, the European Summit 2013 created several sessions that introduced the process of Translation and the key expectations along the value chain.
A crucial session visited by students, young PhD’s as well as founders of start-ups was the session “First Requirements to Get from Research to Drugs” where the pathways of Translation were shown with six interventions: “Ideation as First Step for Translation” “Regulatory Requirements (GMP /GLP / GCP)”, “Business Development Strategy”, “Talking to Members of Venture Capital – how to Get Success”, “Successful Patent Strategies for Nanomedical Research”, and “How to get from a finding to a completed Phase 1”.
Further detailed below are the sessions specifically realised in the framework of NANOMED2020 and in collaboration with the ETPN:
ETPN Brokerage Flash Presentations and CLINAM University Small Speeches
Animated by two partners of the NANOMED2020 consortium, Nicolas Gouze from VDI/VDE-IT and Dr. Ruth Schmid from SINTEF, this session was dedicated to provide networking and partnerships’ opportunities to the nanomedicine community, where participants were given the possibility to present in a 04 minutes time their project (concept of flash presentations). 27 presentations could have been held in the session, giving insights into industrial and academic organisations’ activities and projects ideas.
The University Village also hosted the posters’ area, serving to highlight the research activities in Nanotechnology for Health. An Award was given for the best Poster.
ETPN Policy-industry table:
The round-table intended to initiate fruitful discussion of the ETPN action plan under H2020 towards a better nanomedicine translation in Europe, with the concept developed by ETPN and NANOMED2020 of a Translational Hub as the central element. The role and the interactions between large pharma groups and innovative nanomedicine-SMEs were notably discussed.
NANOMED2020 session:
A session on shaping the European and international Nanomedicine Community, where activities and first results of the NANOMED2020 project were presented and positively received
Regulatory Authorities Session on the Harmonization of Regulatory Matters for drugs and devices:
In a context where joint efforts are needed to accelerate the promise while minimizing the risk of Nanomedicine, the CLINAM Summit 2013 organised a unique session in which regulatory authorities were participating to debate the development of regulations, with a particular focus on harmonization of regulations at the global level. Under the lead of Deputy Director of the DG Research & Innovation of the EC, Dr. Rudolf Strohmeier, participants had the privilege to hear and engage with members from EMA, the FDAs from Japan, USA, Canada and Australia.
The speakers shortly presented their current main activities in the field, highlighting the new methodologies needed for an in depth scientific assessment of benefits and risks of the regulated products. The request for harmonisation was raised concerning the definition of Nanomedicine, drugs and devices, global standards and the scenarios by which regulators could assist in accelerating the translation form research to approved applications.
“Lessons Learned from the US Nanotechnology Characterization Lab (NCL)”:
A six hours characterisation session was organised under the lead of the Director of the Nanotechnology Characterization Laboratory (NCL), National Cancer Institute (USA), Dr Scott McNeil, and 4 further speakers of this Lab on the Lessons Learned by the US-NCL.
As a short version of a one day presentation of the US NCL, this session offered a very concise yet highly focused programme including:
- common challenges in preclinical characterization of nanoparticles, notably nanoparticle-mediated immunostimulation and immunosuppression
- case studies demonstrating the significance of comprehensive physicochemical characterization of engineered nanomaterials prior to their toxicological evaluation
- strengths and limitations of some of specific NCL physicochemical characterization methods for characterising different types of nanomaterials, including strategies for determining appropriate tests for batch-to-batch consistency and surface characterisation
- critical parameters that can influence the success of nanotechnology platforms include in vivo stability, tissue distribution and biocompatibility
- the importance of selecting appropriate preclinical ADME and toxicity models, and the analytical challenges associated with monitoring the in vivo stability of nanotechnology platforms
The presentations were followed up by many questions, debates and statements form European experts.
ii. Outcomes:
The Summit 2013 brought together specialists from 17 countries, reaching the highest audience of nearly 500 participants. NANOMED2020 efficiently contributed to the development of clear goals to create new instruments for translation and to implement them in the near future.
Interestingly, one third of the participants were clinicians, showing the increasing uptake and interest by the medical community and the healthcare system.
Due to NANOMED2020, it was possible to have 20% more speakers and constantly 4 parallel sessions running during the three days of the conference.
iii. Impact:
- Unique forum for the community to propose new ideas and for established research organisations, industries and funding organisations to provide opportunities for further growth of this area.
- Via dedicated sessions, the complex topic of Translation was enlightened in an approach which allowed the participants to see where they stand and discuss related issues with eminent experts in the field following their presentations.
- Reinforcement of a network of strong organisations in Europe striving for the successful translation of nanomedicine
- International Relations and stabilised bonds with other networks and key players of the Nanomedicine Communities in the world.
- High stimulation of the regulatory authorities convinced of the added value to renew their harmonisation Session in 2014 within the CLINAM / ETPN-Summit.
iv. Communication activities:
Significant communications efforts were spent throughout the project to promote the event with a save the date released nearly one year before and frequent update of the preliminary program
Synergies were also used within NANOMED2020 partners for further dissemination, notably via the ETPN as illustrated in the dedicated news:
http://www.etp-nanomedicine.eu/public/news-events/events/events-archive/european-summit-on-clinical-nanomedicine-clinam-2013/
Recording of sessions and online dissemination via NanoMedTV:
Upon proposal from NANOMED2020 consortium, the major Summit sessions and workshops were recorded via the collaboration of Tel-Aviv University which webcast tools already provided significant visibility and impact in previous FP6-FP7 projects such as NANO2LIFE.
This high quality material is now available on YouTube and delivers opportunities to disseminate state of the art knowledge and to show how the European Nanomedical Scene is developing.
v. Future perspectives and sustainability:
Following the successful collaboration between ETPN and CLINAM under NANOMED2020, the CLINAM /ETPN Summit 2014 will include an important feedback-session that will highlight the best achieved results of NANOMED2020. For the upcoming Summit in June 2014, 70 new speakers and many novel sessions are already planned, made possible via the increasing impact and continuous efforts of ETPN and CLINAM networks.
In addition, the Regulatory session of 2013 was for the panel participants of such quality that they decided to meet again in 2014 for a follow-up and continuation of the dialogue.
Further internationalisation engagement is also envisaged beyond NANOMED2020, with dedicated satellite workshops in other continents. CLINAM already received for instance invitations from Singapore and from Australia to create a European Clinical Nanomedicine Session.
1.1.5. ETP Nanomedicine Annual Event 2013:
The ETPN, together with the NANOMED2020 consortium and associated partners, organised the 2013 ETPN Annual Event on 1st and 2nd of October 2013 at MINATEC in Grenoble, France.
The ETPN event was locally organised by CEA-Leti, a leading French research and technology organisation focused on nanotechnologies and their applications in healthcare.
The two-day conference gathered all European stakeholders involved in the nanomedicine field, ranging from leading industrial and academic experts to national authorities and European Commission (EC) representatives, with the aims to:
- Strengthen the nanomedicine community by providing participants with networking sessions and the opportunity to visit state-of-the art facilities on site,
- establish the ETPN’s new action plan with a strong focus on strengthening industry engagement and extending the platform’s community as nanomedical R&D is expected to progress in the coming years from the pre-clinical to the clinical testing stage,
- provide further insights on the consortium’s recommendations for the efficient development of nanomedicine under the upcoming Horizon2020 Research Framework Programme,
- Set future milestones for the implementation of the White Paper’s concepts elaborated by the NANOMED2020 European consortium to drive innovation across Europe in nanomedicine (see WP6 main results for further information on the White Paper),
- Report and build on NANOMED2020 results,
- Shed light on the local nanomedicine resources, initiatives and actors.
i. Program highlights:
On October 1st, following keynote openings from high-level representatives of the French government (video message from the French Minister for Research) and the EC (Christos Tokamanis, Unit G4, DG RTD), selected experts and leading industry specialists introduced the latest issues evolving around the nanomedicine ecosystem and value chain, providing state-of-the art knowledge to the community on the issues to be addressed to successfully translate research into innovative products towards the market. In this context, the first results and future perspectives of NANOMED2020 were presented and positively received.
The event also strived to reinforce the nanomedicine community with new forces, with a session composed of small speeches by industries and SMEs.
Before the ETPN General Assembly closing the first day, the French society of Nanomedicine was successfully launched.
The second day was dedicated to on-site visits and parallel workshops addressing the technical, economic and societal challenges of the nanomedicine ecosystem. Each workshop was articulated around an ETPN Working Group, mainly:
- Diagnostics and Imaging, Therapeutics and Drug Delivery, Regenerative Medicine
- Business opportunities and IPR, Toxicology and Characterisation, ELSA, Clinical Interface.
The full Program of the ETPN 2013 Annual Event is available here: www.etp-nanomedicine.eu/public/news-events/events/past-etpn-events/etp-nanomedicine-general-assembly-2013/Final%20Programme%20ETP%20Nanomedicine%20General%20Assembly%202013.pdf
ii. Communication and dissemination activities:
- A dedicated page was created on the ETPN website
- Increased visibility was also sought across European dissemination channels such as Pan-European Network: http://www.paneuropeannetworks.com/science-technology/etpn-to-hold-nanomed-conference
- Simultaneous press releases were organised among the project partners with the theme: «Nanomed Line on the Horizon» (http://www-leti.cea.fr/en/layout/set/print/content/view/full/1934)
iii. Impact and outcomes:
- More than 150 participants attended the ETPN 2013 Event, making it the most attended annual meeting of the platform.
- Significant partnerships opportunities were provided, notably thanks to the Small speeches session.
- Successful launch of the French nanomedicine platform and of the new ETPN Working Groups, where participants were provided with key opportunities to engage with each other and share their vision on the latest context and challenges to be addressed today. Each Working Group session led to the establishment of a dedicated action plan to be monitored by the ETPN Executive Board and to be implemented beyond the end of NANOMED2020.
1.2. Communication and Dissemination outcomes: Promoting the field and its actors beyond the nanomedicine community
1.2.1. Communication through dedicated channels
a) Video materials
Urgent actions are needed to leverage nanomedicine acceptance as public perception on nanotechnologies is often mitigated due to the image and risks conveyed by the media.
In order to reflect today’s communication pathways, NANOMED2020 consortium decided to create a short animated movie with the aims to have a very simple, pleasant and easily understandable video for the general public explaining in broad terms what is nanomedicine, its main applications in healthcare and its development (clinical trials) and regulation specificities. A cartoon mode was chosen to stimulate public interest while delivering a highly accurate message. The script of the Movie can be found in Appendix.
Subcontracting: The technical realisation of the movie was subcontracted to Flikli, a highly experienced company in animated videos. The technical realisation of the movie was under the joint supervision and coordination of VDI/VDE-IT and Nanobiotix.
Dissemination: The realisation of the Movie ended in January 2014 and was disseminated via internet. NANOMED2020 used the opportunity of the Nano World Cancer Day to increase the impact of this feature and to present it also to the press. The movie is available at: https://www.youtube.com/watch?v=2VcNpl8-PRI
Further dissemination activities were conducted using social networks (Facebook, LinkedIn, and Twitter), attended events and nanomedicine platforms.
Impact: Around 1500 views were registered by the end of March 2014 on YouTube and the movie received a large approval from the NANOMED2020 consortium and nanomedicine community. The movie can be found on websites from nanomedicine actors who found in it a useful element in their own communication strategy to explain to the general public what they are doing.
Further perspectives and sustainability: Further actions are envisaged, using this movie to raise interest of TV stations for further nanomedicine reports. As proven successful, the concept may be further pushed with similar movies explaining specific nanomedicine applications or benefits in regards to a major disease.
In addition, a candidature was submitted as NANOMED2020 consortium for the REACH OUT! contest, a science communication competition organized by E-MRS under the STIMULATE European Project (“Stimulating the public attitude towards advanced materials”), that seeks to recognise actions of public outreach activity in the field of nanomaterials in the EU between the 1st of January 2013 and the 27th of April 2014.
Enriching the NanoMedTV web platform:
NanoMed TV is an online web platform created in 2010 by the ETPN. All opportunities were taken to keep such online tool alive during the project, notably with the upload of all video related results: the animated movie described above, the CLINAM Summit and ETPN Annual Event 2013, as well as the introductory movie of the Nano World Cancer Day 2014.
b) Press Articles
Throughout the project, the NANOMED2020 consortium engaged significant efforts in promoting the field of nanomedicine and communicating around its potential and applications through the press.
A first article was edited in the European Journal of Nanomedicine soon after the launch of the project to raise awareness on the activities and expectations from NANOMED2020. The article is available online at:
http://www.degruyter.com/view/j/ejnm.2012.4.issue-2-4/ejnm-2012-0015/ejnm-2012-0015.xml
In addition, a sustainable collaboration with the International Innovation Publication has been initiated with a dedicated Nanomedicine series of articles as The Last Word of their issues. International Innovation is a leading global dissemination resource for the wider scientific, technology and research communities, with discrete publications covering Climate, Energy, Environment, Food & Agriculture, Healthcare, Nanotechnology and US Research:
http://www.research-europe.com/index.php/international-innovation/
After an introductory article explaining the field of nanomedicine, the following articles written were focusing either on strategic concepts and activities (White Paper infrastructures, NanoMedMap and NanoMedAward initiatives…) or on dedicated applications of nanomedicine against a major disease. The collaboration started in the second half of 2013.Overall 7 articles were written during the project duration, thereof 3 were directly related to NANOMED2020 activities and results and 4 about increasing awareness in Nanomedicine for specific applications (cancer, atherosclerosis, diabetes, ophtalmology):
- “Future Medicines-Nanotools” (ETPN Secretariat):
www.research-europe.com/index.php/2013/07/future-medicines-nanotools
- “Big Plans-NanoVation” (ETPN Secretariat):
www.etp-nanomedicine.eu/public/press-documents/press-documents/publications/etp-member-publications/International%20Innovation%20second%20article.pdf
- “Federating an outstanding European community in nanomedicine” (ETPN Secretariat)
www.etp-nanomedicine.eu/public/press-documents/press-articles/Federating%20an%20Outstanding%20Community%202.pdf
Future perspectives and sustainability: The Nanomedicine series of articles is expected to continue after the end of NANOMED2020 Project and will be ensured by the ETPN Secretariat. Topics on regenerative medicine and antimicrobial resistance are notably envisaged.
As ETPN owns the rights on all the contents, these articles are foreseen to be further exploited as education materials towards the nanomedicine community but also the general public. The creation of a section dedicated to understanding nanomedicine on the ETPN website is a start, and a catalogue of short articles should be published for dissemination at events when enough materials will be produced.
1.2.2. Engaging stakeholders involved in the nanomedical ecosystem
a) Nanomedicine showcases: launching the first Nanomedicine Award
The NANOMED2020 consortium launched in 2013 the first Nanomedicine Award (http://nanomedicine-award.com/). Open to all stakeholders across the globe, the Award aims at recognising and promoting the best innovative nanomedicine-based solutions that have the potential to open new ways in the treatment of diseases and to bring new diagnostic and therapeutic approaches to address unmet medical needs.
i. Procedure and eligibility criteria:
Applications were welcomed from all categories of stakeholders across the globe and were not limited to Europe. There were no restrictions regarding the stage of development neither: projects could be either a concept or a preclinical or clinical application in nanotherapeutics, diagnostic or regenerative medicine.
ii. Jury and evaluation criteria:
Applications were reviewed and assessed by a panel of highly-qualified pharma industry specialists with experience in R&D and commercial roles:
• Laurent Levy, Nanobiotix;
• Neil Desai, Celgene;
• Mike Eaton, consultant;
• Patrick Tricoli, Sanofi;
• Karen Zinkevich-Peotti, Ipsen
• Thorsten Melcher, Johnson & Johnson Innovation.
The applications were evaluated against the following criteria:
• clear unmet medical needs addressed
• no feasibility without nanotechnologies
• clear distinction from the “standard approaches” with new chemical entities / small molecules and biologics
• clear defined market or market potential
• affiliation in one of the categories (1) nanotherapy in regenerative medicine or (2) nanodiagnostic or nanotherapy in general
iii. Process:
A: Call for Proposals (6th June 2013 - 7th September 2013)
B: Evaluation of Proposals (September 2013)
C: Notification sent to finalists (first week of October 2013)
D: Finalist Selection (middle of October 2013)
E: Award Ceremony and presentation of the winning projects during the Nanomedicine panel discussion at BioEurope 2013 in Vienna (4th to 6th November 2013)
iv. Prize:
Initially, the winners of the first Nanomedicine Award were expected to receive the following benefits:
FIRST PLACE
1. Full ticket incl. Partnering for BioEurope 2013
2. 5 minutes presentation of the winning project during the Nanomedicine Panel Discussion that will take place during BioEurope
3. 15 minutes presentation of the winning project during the CLINAM conference 2014 (www.clinam.org) in Basel, Switzerland
4. 1 year of free membership at ETPN (either for the winning company or the winning scientist)
5. 2 days consulting action by the members of the ETPN translational advisory board
SECOND PLACE
6. Full ticket incl. Partnering for BioEurope 2013
7. 5 minutes presentation of the winning project during the Nanomedicine Panel Discussion that will take place during BioEurope
8. 15 minutes presentation of the winning project during the CLINAM conference 2014 (www.clinam.org) in Basel, Switzerland
In the end, due to the excellence of projects submitted, the Jury decided to award two First Prizes.
v. Outcomes and Award Winners:
10 applications were initially expected for the initiative to be considered as successfully launched. Overall, 23 exceptional projects coming mostly from Europe –but also USA and Australia- applied to the first edition.
70% of the candidatures came from academia, 30% from industries and SMEs. Although all applications areas were represented, the field of therapeutics represented 74% of the candidatures, and 69% of all applications were in a stage of a preclinical phase of development:
The winners out of the 23 exceptional applications were officially announced during a Nanomedicine Panel session at BIO-Europe 2013 (4th November 2013 in Vienna), the largest biotech event in Europe, providing a unique opportunity to attract the attention of the pharmaceutical industry, a crucial stakeholder in the final development steps of products (see section 2.3 for further information regarding the Nanomedicine Panel Session).
The Award and the Nanomedicine Panel Session was officially supported by EBD Group, the leading partnering firm for the global life science industry and organiser of Bio-Europe®. For instance, to ensure a significant presence of nanomedicine actors to such event and Panel session, a negotiation with EBD Group led to a 200€ ticket reduction for ETPN members and NANOMED2020 partners.
The nanodiagnostic Award winning company, Endomagnetics Ltd, is developing advanced magnetic sensing technology to increase access to the standard of care in breast cancer staging by providing an alternative approach to locating sentinel lymph nodes.
In the regenerative medicine category, the candidate Linköping University was awarded for the European Project entitled Integrative nano-Composites And Regeneration of the Eye (I-CARE), a regenerative medicine‐based treatment for Corneal Herpes Simplex Keratitis (HSK), that simultaneously treat the disease while regenerating the damaged cornea.
vi. Communication and dissemination:
A dedicated website has been created to leverage the communication impact and to serve as the single entry point for the nanomedicine community wishing to candidate for the Award (online application form): http://nanomedicine-award.com/
The website was regularly updated, notably with the results of the winners’ announcement.
In order to ensure high visibility of the Award initiative throughout the entire process, three press releases were also disseminated:
1. to announce the launch of the Award applications
2. to increase interest about the winners’ announcement a few days before Bio-Europe 2013:
3. to announce the winners following the official ceremony during the NanoMedicine Panel Session:
This last press release was also used for the Award winners’ own communication actions and press releases.
vii. Impact
- Promising proof of the community federated during the establishment of the Nanomedicine Map.
- A major opportunity to concretely show the outstanding R&D in the area as well as the potential of nanomedicine in providing innovative solutions to currently unmet medical needs.
- Showcase and awareness towards the pharmaceutical industry, a crucial stakeholder in the final development of products for the benefit of the patients.
- Promoting acknowledgement of excellence and new opportunities to the Award winners via the Prize.
- Creation of a brand and a reference: the “Nanomedicine Award”.
viii. Future perspectives and sustainability
Following the success and visibility of the first edition, it is envisaged that the Nanomedicine Award will be conducted on a regular basis, every one or two years.
The concept should remain the same, with the organisation of the Award Ceremony during a large conference beyond the nanomedicine community in order to raise awareness about the field and engage further synergies with other stakeholders of the ecosystem such as pharmaceutical, diagnostic or imaging large industries.
Events such as Bio-Europe, BIO US, Medica, CRS or ECR Vienna are notably envisaged.
The future NanoMedicine Award editions will be under the responsibility and coordination of the ETPN.
b) Pan-European initiatives: Nano World Cancer Days 2013 and 2014
The Concept: The Nano World Cancer Day (NWCD) has been set up as a pan-European initiative with simultaneous press conferences occurring in the framework of the World Cancer Day. This event has been initiated by NANOMED2020 and used the European network of members of the ETPN. VDI/VDE-IT and Nanobiotix had a strong coordination role in the organisation of the events.
Beneficiating from the media coverage of the World Cancer Day, these press conferences were a unique chance to raise awareness and improve knowledge about the field of nanomedicine and its range of applications against cancer, from diagnostic to therapeutic perspectives: Where is the research? What are the new methods of diagnosis and treatments in development? What are the first results and benefits? What are the products used every day?
Targeting the generalist and scientific media (press, radio, TV, website, blog…) at a regional, national and international level, the format of these conferences was 1h30 of presentations during a convivial breakfast atmosphere to ensure journalists feel at ease to raise any possible questions.
As each event aimed to gather different categories of stakeholders in the field to explain nanomedicine from different horizons (including Cancer institutes, representatives of the Nanomedicine community, oncologists and clinicians, industries and academia, patients’ organisations…), the Nano World Cancer Days have been also seen as a key opportunity to shed the light on the local and national resources, initiatives and actors actively involved in the field of nanomedicine.
The events have been designed to take place 1 day (or a few days) before the official World Cancer Day (every year on Feb 4th) to ensure significant attendance of journalists and to leave the opportunity for articles to be published for the WCD.
The local organisers received extensive support and overall coordination from the ETPN with all the necessary documents (including press invitations, press release, press kit...) and benefit from further communication and dissemination channels and visibility.
Nano World Cancer Day 2013 – 1st Edition:
Entitled “Small tools for a big cause: How nanomedicine contributes to better cancer diagnostic and therapy”, the multi-sites concept of the NWCD took a highly positive start in Germany, France and Portugal thanks to the collaboration between the ETP Nanomedicine Secretariat, Nanobiotix and the International Iberian Nanotechnology Laboratory (INL).
The Nano World Cancer Day 2013 took place on 1st February 2013, with events taking place in parallel across Europe in Berlin, Paris and Braga. Renowned speakers shown how nanomedicine can play an important role serves as a key enabling technology in the fight against cancer, from early diagnostics and selective treatments to in-depth imaging, improved drug delivery and inherent therapeutics.
Nano World Cancer Day 2013 resulted in significant media outcomes, with high visibility in the press (both regional and national), radio and TV interviews, and uptake by online resources database (NanoTech-now, News-medical.net NanoPaprika).
In Paris, 13 journalists attended the press breakfast at the Mini-Palais and 6 journalists took part or received the press kit in the event held in Berlin.
A full description of the NWCD 2013 together with a detailed report of the media outcomes is available on the dedicated NWCD website section at: www.nanoworldcancerday.eu/previous-editions/2013
Nano World Cancer Day 2014 – 2nd Edition:
For the second edition of the Nano World Cancer Day, thirteen countries gave their engagement to set up a national event on January 31st (or exceptionally on January 30th), highlighting the importance of nanomedicine research for cancer on the European level: in Austria, Czech Republic, Finland, France, Germany, Greece, Italy, Ireland, Luxembourg, Netherlands, Norway, Portugal, United Kingdom.
Building on the success of last year, Nano World Cancer Day 2014 focused on the theme “Nanomedicine for Cancer-Did you know?” and on shedding light on the four following aspects:
1. Cancer today: what is at stake
2. Nanomedicine for cancer: what it is and how it works
3. Nanomedicine is already a reality for patients
4. Yes, we can make it happen faster
This is a result of the NANOMED2020 consortium policy to reinforce links and synergies with the UICC (the organization behind the WCD), as these themes are directly linked to the official World Cancer Day 2014 communication campaign: “Debunking the Myths” around four specific dimensions.
Full information regarding each event program, speakers and media outcomes is available on the dedicated weblinks above or via the official Nano World Cancer Day webpage: www.nanoworldcancerday.eu
Across the 13 countries, two type of event’s format emerged, either a small conference dedicated to journalists or the extension to a much larger initiative open to public and the community, reaching up to 300 people in some places (Athens).
The wide coverage obtained would not have been possible without such European dimension and the common engagement across member states, highlighting the value of such pan-European event which gave birth to several side interviews (TV or radio), recording of events, and press articles across the involved countries.
Dedicated communication actions:
For the 2013 edition:
1. Simultaneous Press Release by all the local organisers and the ETPN to announce the Nano World Cancer Day 2013
For the 2014 edition:
2. Dissemination via European channels
3. Simultaneous Press Release(s) as for 2013: a non-exhaustive list is given below as an example
4. Creation of a dedicated LinkedIn Group and Twitter hashtag to facilitate communication and information flow between all the local organisers.
5. Dedicated Flyer distributed during the ETPN Annual Event 2013
6. Dedicated website, including insights and outcomes of the first edition
7. Introductory Movie to federate the different nodes and give more impact to the supervision of the ETPN and the support of the European Commission.
8. Increased visibility and collaboration with the official World Cancer Day organisation: Use of WCD logo and inspiration from 2014 WCD themes (turning myths into reality); Insertion in the WCD Map of events.
Impact:
- Creation of sustainable brand: “Nano World Cancer Day”
- Nodes and media coverage across all Europe in 2014 from 03 to 13 countries involved
- Federating and shedding the light on nanomedicine actors and resources within each key European countries
- Highly valuable resources for education and training materials on nanomedicine and cancer
- Proof-of-concept for further similar initiatives focusing on key other diseases under international context.
- Deep involvement of NANOMED2020 partners in the local nodes in both editions
Further perspectives and sustainability: NWCD is a concept likely to be declined in the near future to other diseases where nanomedicine can significantly contribute by providing innovative solutions and products. Neurodegenerative or cardiovascular diseases, diabetes or HIV are some of the envisaged directions. Increased and formal collaboration with the World Cancer Day-UICC is also envisaged for the next years.
1.2.3. Communication through active participations in Events, workshops and meetings
EuroNanoForum 2013, Dublin (June 18th-20th): Presentation of the field of Nanomedicine and raising awareness of the newly released White Paper; Speakers and delegates at the Healthcare and Advances on Bionanotechnology sessions, in addition to a dedicated Nanomedicine Workshop: www.etp-nanomedicine.eu/public/news-events/events/events-archive/euronanoforum-2013
10th International Conference on Nanosciences and Nanotechnologies- NN13, Thessaloniki (July 09th-12th): Presentation of NANOMED2020 activities and results during a Nanomedicine Workshop; Networking and building synergies with the Greek nanomedicine platform (NanoNet).
MNBS & EPOSS annual event 2013, Cork (September 24th-26th): Presentation of ETPN and NANOMED2020 activities and results (speech and A0-poster)
Nordic Life Science Days 2013, Stockholm (October 14th-15th): Presentation of ETPN and NANOMED2020 activities and results during a Nanomedicine Session; Networking and building synergies with the Swedish nanomedicine members (SwedNanoTech platform)
ETPN Day at NanoFar Autumn School 2013, Santiago de Compostela (October 24th): Launch of the Working Group on Education and Training
BioEurope 2013 and Nanomedicine Panel Session (November 4th-06th): Announcement of the Nanomedicine Award winners; Build bridges with large industries for partnerships opportunities; Showcase and awareness of nanomedicine to the biotech and pharmaceutical industry with a Nanomedicine Panel Session addressing key topics:
• How has “nano” contributed to the pipeline of pharma companies thus far
• What is the outlook for the established nano-principles
• Examples of the „next in class from nano“ – nanotherapeutics with projects in Regenerative Medicine and in Oncology
• Why is pharma not taking such approaches on board?
Such Panel session received extensive interest and media outcomes, with the relay of the statement that "Five years from now every pharma will have a nano program": www.partnering360.com/insight/showroom/id/428
Future perspectives:
Several events are already planned where the consortium will actively contribute through the dynamics installed within NANOMED2020:
- BioNanoMed 2014 Congress (March 26th-28th, Vienna )
- Nanomedicine in Scotland (March 26-27th, Edinburgh):
- Industrial Technologies 2014 (April 09th-11th,Athens)
- NanoMedNorth 1st seminar (May 16th, Stockholm)
- NanoBio Europe 2014
2. International Relations
2.1. Launching the basis for an international network
2.1.1. Key nanomedicine initiatives and further nanomedicine actors
The internationalisation process in any field of science is best done by having experts in other countries and continents to start out the exchange for larger groups. CLINAM has:
• created excellent relations to the Regulatory authorities on all continents,
• shaped contacts to the WHO (in Africa for Regulatory matters, in Geneva for Roll Back Malaria),
• shaped contacts to the United Nations office (regarding ethical matters),
• shaped contacts to the international established Nanomedicine Networks in Japan, USA, China. Australia and South Africa as well to other Networks realizing important research Projects in Europe and overseas.
A crucial role is in the hands of the International Society for Nanomedicine (ISNM) which is presently in its 3rd year of activities. The ISNM has as statutes the goal to establish a global networking and information exchange platform for Nanomedicine and Targeted Medicine. During the Summit 2013 a two hours ISNM meeting was fruitful to discuss the future cooperation.
Within NANOMED2020, CLINAM has investigated high-level and renowned groups worldwide that they had not contacted before. New contacts were established with top centres in targeted nano-based Drug Delivery and Nanomedical treatments, mainly in:
- the USA: BIND Therapeutics, Harvard medical school, the Alliance for NanoHealth, Carolina Institute for Nanomedicine, Methodist Hospital Research Institute…
- China: Shanghai Jiao Tong University, City University of Hong Kong
- Russia: Russian State Medical University, Institute for Holistic Medical Sciences, Nanyang Technological University
- India: Christian Medical College
- Singapore: Singapore National Eye Centre
- Australia: University of Queensland, University of New South Wales, Children’s Cancer Institute for Medical Research, Lowy Cancer Research Centre, Australian Centre for NanoMedicine
Furthermore, NANOMED2020 allowed the initiation of fruitful exchanges with worldwide international structures such as:
- WHO in Africa: delegate for the Regulatory session from Africa for the Summit 2014. We have established also manifold contacts to the Roll Back Malaria Initiative of the WHO.
- United Nations: Ethics-Reasoning for a session at the Summit 2014; Ultimate goal of this attempt is to bring via political debate Nanomedicine for large population into a fruitful and positive debate. A further contact is established regarding a CLINAM Event on rare diseases in Africa: Poverty-related diseases shall be the focus of Africa's first Nanomedicine Workshop. The application of Nanomedicine for infectious diseases of poverty shall be treated. The event is planned for the Spring 2015.
- Organisation for Economic Co-operation and Development (OECD): 2 contacts to the OECD have been realised. contacted the medical committee and invited 2 representatives from the committee for Regulatory Frameworks for Nanotechnology in Foods and Medical Products.
- All FDAs across the world: Within the internationalisation of the CLINAM / ETPN-Summit it was a challenge to get all members from continents to the roundtable of Regulatory Matters in Nanomedicine. This acquisition procedure brought excellent lasting contacts to diverse members of the international Regulatory members. It will be for the future of great help to have now direct, sustainable and personal related contacts.
European and International Key Projects, Calls and Announcements
• Evaluation of the Regenerative Medicine & Nanomedicine Initiative Canadian Institutes of Health Research, Ottawa, Ontario Canada http://www.cihr-irsc.gc.ca/e/47302.html
• The Human Brain Project, Lausanne Involving 23 institutions in Europe, 8 related to nanomedical approaches
• European Flagship Initiatives http://cordis.europa.eu/fp7/ict/programme/fet/flagship/
• EuroNanoMed II Joint Transnational Call for Proposals (2014) for “European Innovative Research & Technological Development Projects in Nanomedicine”
• Towards Personalized Medicine
• Insight into all current initiatives and key players in Personalized Medicine in Europe
The list of important initiatives is long and we have chosen here only a few but most promising fields in which Nanomedicine will be of great importance. All here cited projects are under investigating by CLINAM and most of them include at least one NANOMED2020 partner, facilitating thus the link to these initiatives. The selections shows how important the issue of Nanomedicine is relating practically all fields of tomorrow’s technologies to investigate the human being in order to achieve a better diagnosis and therapy with a more innocuous effect.
Structuring and strengthening the ecosystem
• ETP Nanomedicine
• IMI – Innovative Medicines Initiative
• FP7 NANOMED ROUND TABLE (Nanomedicine ethical, regulatory, social and economic environment - Project reference: 218732)
• Nano2life
Structuring and filling in the pipeline of nanomedical products
• Current & future FP7 and Horizon 2020 collaborative research projects in the nano-bio-medical sector
• FP7 EuroNanoBio (EUROpean scale infrastructure in NANOBIOtechnology - Project reference: 231654)
2.1.2. Bi-Continental meetings
2 bi-continental meetings have been organised in the framework of the European Summit for Clinical Nanomedicine 2013 in Basel:
• CLINAM Sunday / ISNM (23/06/2013)
• EU-US cooperation at CLINAM Summit and beyond
2.2. Insights into long-term cooperation frameworks
A Memorandum of Understanding with Nanomedicine platforms inside and outside Europe (US, Argentina, Australia, Russia) has been drafted. The contacts with these platforms have been established.
The Organisation for Economic Co-operation and Development (OECD) has published last year a recommendation that its member companies apply the existing international and national chemical regulatory frameworks or other management systems, adapted to take into account the specific properties of manufactured nanomaterials. The OECD also recommends that member countries make data relevant to the safety of nanomaterials available to the public.
A topic discussed in NANOMED2020 has also been the need for alignment of Europe and its international activities, for instance through the harmonisation of regulation and standards in the field with the implication at CLINAM Summit of regulation authorities worldwide.
Both CLINAM and ETPN, the two major networks in Europe, seek to assist to the furthering of Nanomedicine to the benefit of the patient but also to facilitate that - when Nanomedicine goes to market – this will happen also within and from Europe to the world. After the period of the “knowledge-Society” it should now follow for Europe a simultaneous renewed period of “Action in the Projects” since otherwise Europe could lose best knowledge driven results to countries where technology can be built significantly cheaper.
NANOMED2020 initiated a particular and concrete translational cooperation with the US-NCL in order to provide Europe with a similar infrastructure coping with the high quality standards defined by the US counterpart. These aspects are of particular interest for future recommendations to the EC and have been further developed in the context of the White Paper (WP6) and its implementation under Horizon2020. Further meetings and investigations are already planned to leverage all possible levels of synergies and collaborations.
Impact and Sustainability:
The successful establishment of such extended international network will set the basis for the internationalisation of the Nanomedicine Map described above in WP2.
All players in the field of clinical researches from the Global Nanomedical Community have been invited to be in Basel at the Summit in June 2014. Having them in the international interdisciplinary scientific community will be of mutual benefit and enable to European Participants good contacts in the other continents.
3. Coordinating the update of strategic research roadmap(s) relating to Nanomedicine
The Nanomedicine Strategic Research and Innovation Agenda (SRIA), for which the ETP Nanomedicine is responsible, is seen of outmost importance by the consortium and the nanomedicine community as it describes the vision of ETPN for the future development of nanomedicine and lists the main research priorities that should be implemented by the European Commission, the Member States and their funding agencies until 2020 and beyond.
The SRIA is envisaged not only as the critical update of the last ETPN Roadmaps published in 2009 but also as the integration and merging of INNOVATION dimensions into strategic and technological inputs. The next generation of roadmaps will hence be structured along the value chain development, where TRANSLATION and TRL are becoming major elements to evaluate the maturity and potential of technologies while deeper engagement of late-stage stakeholders are becoming centrally important to ensure R&D projects are meeting industrial requests and clinical needs.
In this context, the SRIA document will answer the following expectations:
- Provide a state-of-the art overview of the technologies to be funded to structure the field and efficiently answer today’s challenges and unmet medical needs.
- Establish the latest nanomedicine portfolio – pipeline to present the products already commercialised or under clinical development reaching the market in the next years. This will allow to prepare the healthcare system for upcoming innovations while increasing the market penetration of nanomedicine products.
- Link the ongoing research with clinical needs through their potential applications to provide a navigation tool for all stakeholders looking at one or the other end of the value chain.
- Provide guidance on translation to accelerate developments and re-orient non-translatable projects.
- Propose dedicated implementation measures and means-instruments under H2020
A collaboration with the EuroNanoMed ERA-NET has been undertaken to avoid duplication and optimise resources. The elaboration of single common SRA has been agreed to leverage synergies and future uptake by national and European policies as well as to maximise the impact of such strategic document.
3.1. Structuring the SRIA:
Such official document aims to address a large audience – public authorities, decision-makers, academic and industrial players as well as clinicians - even beyond Europe, and will cover all possible areas of application of nanotechnology in healthcare.
This document has been compiled through the collaborative work of many stakeholders involved in the ETP Nanomedicine and is the outcome of an in-depth discussion process that took place in the platform. This document shall thus reflect the general state of the discussion within the Nanomedicine community and the importance of an efficient translatable development process in nanomedicine.
The three technological areas addressed, Nano-diagnostics, Nanopharmaceutics and Regenerative Medicine are represented by the three scientific areas of the ETPN. Horizontal considerations with specific focus on establishing a novel environment for nanomedicine are present in the last sections of the SRIA.
3.2. Introducing Innovation to the Nanomedicine Research Agenda
The Strategic Research Agendas (SRAs) defined by the Nanomedicine community and in particular the ETP Nanomedicine over the last half decade were mainly based on technology push and clinical demand. The R&D projects implemented under these research priorities in FP6 and FP7 have successfully delivered a lot of new nanomedicines but few products on the market so far. In consequence the next level of the strategic development of the ETPN is to emphasise the introduction of “Innovation” into the Agenda by improving the translation of nanotechnology R&D into medical applications. This is a Grand Challenge that has been at the core of the ETP since its formation in 2004.
Innovation applied to Nanomedicine for example means enabling personalised medicine through stratification of patients by nano-based diagnostic tests (companion tests for instance) or imaging agents, which are new and different approaches to current medical practice. Another example could be the combination of a diagnostic tests and a therapy within one type of nanoparticle thus making some clinical protocols simpler. However, for such an innovation to reach the patient, close and well informed interactions between all actors in the nanomedicine research and development chain (academic, industrial, public and private partners) are mandatory, including special structures to actively manage communication and collaboration between all stakeholders, including regulatory bodies to effectively translate and commercialise ideas.
Horizontal aspects will also be considered to elaborate the innovation section of the SRIA and the Horital Working Groups as set-up in WP 2 will be asked to contribute, notably through the involvement of industrial actors to ensure that recommended technologies will be taken into consideration by large industries for further development and uptake once developed.
One crucial task will be thus to assess the maturity of technologies and the clusterisation of current products and R&D portfolios to diversify the pipeline and to cover all medical needs.
The White Paper “contribution of Nanomedicine to Horizon 2020” produced by NANOMED2020 will be considered as a main input for the Innovation section of the future SRIA.
In parallel, in order to maximise European resources, synergies and cooperations with existing initiatives should also be investigated further such as with EATRIS or ECRIN, and the European Technology Platforms NanoFutures, Photonics'21 and EPoSS.
3.3. Update of 2009 Nanomedicine Roadmaps
The Nanomedicine SRIA to be released in 2014 will rely to large extent on the update of previous strategic documents elaborated by the Nanomedicine community: Vision Paper (2005), SRA (2006) or Roadmaps in Nanomedicine – Towards 2020 (2009). The 2009 Roadmaps serve thus as reference, given that the time perspective covered by this document is in line with the one that the SRIA will cover (Horizon 2020). The update will be articulated around following issues:
a. Product Pipeline, state of the art research and market expectations: Strategic research priorities by key medical diseases and where nanotechnology is expected to have a high impact will be considered and prioritised as they strongly reduce patient’s quality of life and impose a high socio-economic burden on society.
b. Considerations by area of applications
c. Bringing nanomedicine research into marketable products: Tools and measures to support innovation will be drafted to foster deployment opportunities for nanomedicine with following criteria: business opportunities, focus on SMEs, increase dialogue and uptake at interfaces across the value chain.
As a matter of fact, the future SRIA will consider the value chain in its integrity and propose recommendation at all stages following this scheme: enabling | translating | Leveraging | Implementing.
3.4. Creating a cross-disciplinary repository via workshops and online initiatives
NANOMED2020 initiated a series of activities in order to provide a framework to the knowledge management in the SRIA process, to identify relevant sources for input to the SRIA as well as to collect first information. This knowledge management system relies essentially on a repository gathering all contributions collected. Such repository was further completed by the following initiatives launched within NANOMED2020 and sources of valuable perspectives:
- First contacts, initiation of a collaboration with the French Observatory for Micro and NanoTechnologies (OMNT), a joint unit between the CEA and the CNRS to detect weak signals in nanotechnologies that could have a high impact on medicine on the long term
- Inputs into NanoFutures roadmaps
- Attendance of the cross-ETP workshop organised by the European Commission (Dec 19th 2013)
- Working Group Meetings during the ETPN Annual Events 2012 and 2013 defining the criteria for aggregation and consolidation of information to be implemented
- 2009 Roadmaps Tables
- Collaboration with Bionest Partners who released in 2013 a study on nanomedicine along these criteria:
- mapping of UK, France, Germany and USA
- Product pipeline and market segmentation
- Pharmaceutical perspectives
- Translational issues
- Societal and regulatory study
- The final key milestone for the creation of a full repository of technical data and inputs was the design of an online questionnaire
3.5. Future perspectives – implementation of the process towards the SRIA
NANOMED2020 aimed at providing the preliminary work for the Nanomedicine SRIA. In consequence, this document although not fully consolidated at the end of NANOMED2020, highly benefited from NANOMED2020 contribution as the consortium spent significant time and efforts in the last month of the project to sustainably launch the final steps of the SRA section.
Such planning aims to ensure a release of the document on time for recommendations to the 2016-2020 national policies and European work programmes, while leveraging as many synergies as possible within nanomedicine platforms and coming events to ensure a transparent and wide visibility of the document for giving the opportunity to all actors to provide their inputs into such strategic vision for the future of nanomedicine.
In addition, the White Paper will successfully represent the translational implementation-action plan of the Innovation concepts outlined in the SRIA.
4 Compiling recommendations for identified gaps and barriers based on state of the art
In order to identify the gaps and needs and accelerating the development of innovative nanomedicine products along the value chain, different activities were launched to gather complementary collections of inputs, mainly with online surveys and synergistic collaborations with other national or EU initiatives.
NANOMED2020 actions were structured along the two following objectives:
- Analysing the state of the art, gaps and needs in Europe regarding nanomedicine resources, infrastructures, governance and initiatives.
- Analysing the gaps and barriers along the value chain, notably between stakeholders’ key interfaces.
4.1. Analysing the state of the art, gaps and needs in Europe regarding nanomedicine resources, infrastructures, governance and initiatives.
a) Collaboration with the EuroNanoMed ERA-NET
An overview of funding sources for nanomedicine R&D in Europe was gained in co-operation with the ERA-NET EuroNanoMed II (ENM II). ENM II performed a survey in 2013 on national research and development programs (R&D) which support projects on nanomedicine among its 20 partners, whereof 18 answered. ENM II shared the results with NANOMED2020. With the reinforcement of the ETPN Mirror Group during the project, the ENM II survey was extended to 7 additional countries by the NANOMED2020 project team. The overall analysis as well as the list of all countries included in this survey and the questions are given in Appendices.
Summary of results and conclusions:
Overall, a total of 25 participants from 22 countries answered the survey, which is a substantial number, allowing us to consider these results as representative for Europe. The survey has been mostly answered by national funding agencies, whereof a majority was both owners and managers of R&D programs. None of the countries have dedicated strategies for nanomedicine. 28% of the countries have legal regulations hindering them in participating in joint transnational calls.
The funding for nanomedicine at national level is mostly through general programs, not in programs dedicated exclusively to nanomedicine. The amounts vary from a few 100k€ to several M€. It is positive to recognise that 60-70% of the countries support SMEs and large industry. Such a scattered and scarce funding of a highly multidisciplinary area, as nanomedicine seems suboptimal. There is a need for mobilizing larger amounts of funding, both on the national, but even more on the pan-European level.
The main conclusion is, that based on the facts, that there are no national R&D programs dedicated exclusively to nanomedicine, that no country has a national strategy for nanomedicine and that the fundings are relatively scattered and scarce, the need for a pan-European strategy and pan-European funding programs and initiative is given. Both the ETPN and ENM II have important roles to play and are justified.
b) Governance and infrastructures state of the art
During summer 2013, a survey was conducted to gather complementary information on nanomedicine governance and infrastructures in Europe, in order to assess potential gaps and needs for recommendations to be made under H2020 and input to the SRIA update planned by the ETPN in 2014. The survey targeted the organisations which fund nanomedicine R&D and decision makers on regulatory aspects in the European countries. The survey questions and complete analysis are given in Appendices.
Summary of results and conclusions:
Nine countries answered the survey, Estonia, Finland, Italy, Norway, Poland, Portugal, Turkey and Ukraine. None of the leading European countries responded. The results have therefore to be interpreted with care and are not considered as representative for Europe. It is obvious from the survey results that the answers mostly are given by the organisations managing the R&D programs and the funding money, but not by the organisations providing the funding.
Based on the results, the need for European infrastructure, available for scientists, SME and industry in countries without such infrastructure, is of high importance. Also, improvement of governance structure, both on pan-European and national levels, to allow for improved collaboration of academia with clinicians and industry and among various scientific fields, should be addressed further in the future. The findings in the survey underpin the needs and recommendations described in the White Paper of the ETPN. Translational research has to be improved by:
- Improved collaboration of academia with clinicians and industry
- Access to European infrastructure for characterisation, clinical trials and GMP scale-up production.
4.2. Analysing the gaps and barriers along the value chain
a) Analysing the product pipeline
In order to position the nanomedicine stakeholders along the value chain, NANOMED2020 paved the way with a first survey in March 2013. Reaching over 150 participants, the answers received significantly contributed to the establishment of the Map database as well as of the consolidation of the nanomedicine product pipeline that will be included in the next ETPN Strategic Research and Innovation Agenda.
The latter activity was further conducted in close collaboration with Bionest Partners, who published in Feb 2014 the latest exhaustive study on the field of nanomedicine and the positioning of Europe in comparison with US and Asia environments and markets.
The full study is available at:
www.etp-nanomedicine.eu/public/press-documents/publications/public-documents/bionest-partners-2014-nanomedicine-study-leem/Rapport%20final%20version%20definitive.pdf
In addition, NANOMED2020 identified several online papers that will provide further insights into the nanomedicine product and R&D portfolios, with a high interest for the study conducted by Michael L. Etheridge and al. entitled “The big picture of nanomedicine: the state of investigational and approved nanomedicine products“ (Nanomedicine: Nanotechnology, Biology, and Medicine, May 2012): www.nanomedjournal.com/article/S1549-9634(12)00288-2/abstract
b) Optimising the nanomedicine value chain by improving the knowledge at the key interfaces between stakeholders
We can consider that the value chain for the development of nanomedical products is quite similar to the one for other medical products meaning that bringing nanomedicine from research to the market needs to go through successive milestones (research concept, preclinical development, early and late clinical development, market) and transfer between different categories of stakeholders (academia, SMEs, pharma/diagnostics industry, end-users).
The interfaces between each category of stakeholders and the uptake of the development are crucial for a successful translation, and require a good understanding of late stage stakeholders expectations and requirements in order to plan the product development accordingly.
This is always a challenging proposition, even for industry who understand the severe restrictions of a heavily regulated sector, but in the case of non–industrial researchers it is exacerbated by a lack of knowledge of the drug development process. Knowing both the barriers and opportunities for commercialisation are hence very important even at a basic research stage, and overcoming these barriers would significantly challenge the status-quo for many academics and SMEs.
In this context, a checklist has been drafted by NanoMed2020 consortium during a dedicated workshop in March 2013 and reflects the key elements to provide or thoughts to have at this point for successful development towards the next milestone of the value chain.
In addition, NANOMED2020 designed a second online survey in the last months of the project (from January to March 2014), with the aim to gather key insights into the nanomedicine development process in order to identify the main barriers and needs along each step of the value chain, from idea and research all the way to market and commercialisation.
Focusing on each relevant category of stakeholders, the data provided a major opportunity to assess the interplay between the different stakeholders involved and the main differences of perspectives at the key interfaces.
Finally, this survey provided all participants with the possibility to comment and endorse the milestones and checklists established so far by the NANOMED2020 consortium.
The survey questions and detailed analysis are available in the Appendices.
Summary of survey results and conclusions:
Open during one month for contributions by the nanomedicine community, the survey gathered 75 answers amongst which 56 coming from 22 EU countries (75%) were relevant and provided useful inputs. This lower number of answers compared to other surveys conducted under NANOMED2020 is due to the high-level expertise requested for contributions. With 75% of academic inputs, answers have to be carefully balanced with industrial perspectives.
With 33% of participants assessing the financial category as a main barrier to move forward at each stage of development (basic research, preclinical, early and late clinical stages), funding is the most highlighted issue, for both academia and industrial actors, followed by Clinical Transferability, Scientific issues, Skills and people at the early stages (Basic research and Preclinical).
Regarding early clinical development, Manufacturing, Characterisation and Business issues were much more highlighted and Regulation was shown to be the cornerstone for late clinical development (phase III).
These main outcomes reinforce the strategic positioning of the White Paper along the three major barriers:
- Missing relevant knowledge in the field of oncology and in market access at the early stage of the project; then, it took a long time to acquire the necessary knowledge,
- Difficulty to find appropriate funding to finance the proof of concept in order to further raise investment from venture capitalists; this has slowed down the development of the product,
- Difficulty to acquire the appropriate knowledge on clinical trials and to identify a competent Clinical Research Organisation to develop the specific preclinical studies required before going to the First in Man trials; this has highlighted the need to develop new relevant methods and assays.
With different trends in the answers provided by academia and SMEs-industries, the survey highlighted the urgent need to provide common criteria and dialogue to all stakeholders to harmonize the value chain and the actors’ expectations.
However, when asked to comment on the overall checklist drafted by the NANOMED2020 consortium, 87% of academic participants and 92% of industrials/SMEs partly or completely agree with the milestones provided.
On average, it can be noticed that 70% of participants rated each White Paper concepts as “Highly Relevant”, showing the coherence and consistence of the provided recommendations for Horizon2020.
4.3. Further Recommendations and perspectives
With the realisation of the Nanomedicine Map and its illustration in a AO-poster format gathering all listed industrial actors, NANOMED2020 has shown the existence of a “Nanomedicine Valley” where most SMEs and large companies active in the field are present and structured. Such “Nanomedicine Valley” has the shape of a bi-crescent going from the Nordic regions and UK down to Northern Italy and Spain, as outlined in the graph below, with the exception of the Paris region industrial cluster.
Such crescent hence provides geographic input for future targeted networking and translational support actions that could benefit to nanomedicine emerging industry.
Further actions are also envisaged within the ETPN and potential future European projects to leverage the first steps taken under NANOMED2020, including:
- Providing the nanomedicine community with a useful tool to quickly understand the requirements to move along the value chain as well as the expectations –often different- of the late stage stakeholders in this regard. This is needed to provide a set of common criteria and a consistent dialogue to facilitate uptake of projects, accelerate translation and decrease the risk of non-translatable projects to the earliest stage possible. Such tool could come as a complement to the recommended actions of the Translation Advisor Board outlined in the White Paper, for desk-based self-assessment and additional education and training perspectives. The format of an article/check list is envisaged. With nanomedicine technologies evolving to higher TRLs, these issues will become increasingly important as funders will start to fund very expensive clinical stages where industrial uptake has to be ensured not to lose massive amounts of investments.
- Mapping of the pipeline of technologies products and FP7 and H2020 projects portfolio. Based on existing studies (ex: Bionest) and NANOMED2020 results, the objective is to provide an analysis and clusterisation of technologies, products and research results in order to identify hot and white spots in the nanomedical pipeline and formulate recommendations to optimise the coverage of research priorities, unmet clinical needs and grand societal challenges.
- Mapping of the nanomedicine stakeholders along the value chain to visualise where is the nanomedicine development in its different application areas (diagnostics, imaging, therapeutics, regenerative medicine).
5. Developing concepts for implementation of future partnerships and strategies
After extensive consultations and dialogue with industrial federations to assess the possibilities of integrating a PPP on Health, the consortium took the decision to publish a White paper stating its vision for the field until 2020, while keeping high contacts with these federations for future possibilities.
The White Paper is available in Appendix or on the ETPN website at: www.etp-nanomedicine.eu/etpn-white-paper-2013
Entitled “Contribution of Nanomedicine to Horizon2020”, the White paper introduces four main recommendations and concrete concepts to foster innovation in Nanomedicine and support the European sector:
1. Nanomedicine Translation Advisory Board with experienced industrial experts to select, guide and push forward the best translatable concepts,
2. European Nano-Characterisation Laboratory for physical, chemical and biological characterisation of nanomaterials intended for medical use,
3. GMP manufacturing pilot lines for clinical batches to assist both academia and SMEs to develop nanomedical materials for validation in clinical trials, before transfer to dedicated manufacturing organisations,
4. NanoMed SME instrument as a new SBIR-like funding model for discovery projects and innovative SMEs.
Process:
The White paper is the result of intensive consultations with the community (notably via ETPN members and Annual Event 2012), national authorities and the EC to deeply understand the state-of-the art, gaps and needs, where and how the consortium could respond to such challenges, and to gather continuous feedback. For instance, 11 meetings were organised with the European Commission to meet different DGs and exchange on different horizons:
23rd Nov 2012: Meeting DG Connect, A. Lymberis (MNBS)
23rd Nov 2012: Meeting DG RTD, J. Suominen, H. Frima (NMP)
13th Dec 2012: Meeting DG RTD, R. Strohmeier
23rd Jan 2013: Meeting DG RTD, R. Strohmeier
8th Feb 2013: Meeting DG RTD, H. Von Bose (Industrial technologies)
8th Feb 2013: Meeting DG RTD, A. Hoeveler (Health)
14th Feb 2013: Meeting DG RTD, C. Tokamanis, H. Frima (NMP)
15th Feb 2013: Meeting DG Enterprise
21th Feb 2013: Meeting DG ERA, P. Froissard, M. Douka
13th Mar 2013: Meeting ETPN Executive Board in Paris
10th Sep 2013: Meeting DG RTD, C. Tokamanis, H. Frima (NMP), T. Ingemansson (Health)
A dedicated online endorsement form was established following the release of the document to leverage the visibility and impact of such strategic paper, and to ensure the envisaged concepts were well received by the community:
www.etp-nanomedicine.eu/public/special-issues/nanomedicine-white-paper-2013-endorsement
In the end, all forms submitted were in favour of the concepts outlined, amongst which 40% came from non-ETPN members, showing the very wide awareness and interest of the overall community in this regard. Supporters even included national authorities such as the German Ministry for Health, supporting this strategic positioning for the field in a written letter to Bioanalytik-muenster.
Communication activities:
Dedicated factsheets for each key concept outlined in the White paper were created for easier and targeted communication across events.
Dissemination and communication around the White Paper concepts was a key objective in all main events attended by the consortium and listed in WP2 with dedicated sessions at ENF, CLINAM and ETPN Annual Event 2013.
Further articles following interviews with the ETPN secretariat were published, for example under horizon2020projects: “Nanomedicine-Open Innovation”
http://horizon2020projects.com/il-nanotechnology-interviews/nanomedicine-open-innovation
Impact:
- Large dissemination incl. several DGs in the EC
- High interest from the European Commission and Member States
- Reference Document for the European community and beyond, answering unmet needs to accelerate the development and translation of excellent research into innovative nanomedicine products
- Nano-concepts for a macro-impact on EU economy: With 500+ SMEs that could directly benefit from these concepts and nearly 250 “nano”-products used or tested in humans worldwide representing a $130.9 billion market by 2016, nanomedicine and the concept of a dedicated Translation Hub is meant to have a real impact on the European economy.
It can be outlined that NANOMED2020 succeeded in providing key recommendations for the field under H2020, as the concept of a Translation Hub is concretely outlined for implementation under Horizon 2020 First Calls:
- NMP 8 – 2014: Scale-up of nanopharmaceuticals production (GMP Pilot Lines)
- NMP 9 – 2014: Networking of SMEs in the nano-biomedical sector (Translation Advisory Board)
- INFRAIA-1-2014/2015: Integrating and opening existing national and regional research infrastructures of European interest (EU-NCL)
The SME-Instrument established by the EC for Horizon 2020 is also well aligned with the recommendations from the nanomedicine community.
Future perspectives:
Further meetings with industrial associations and regulatory authorities such as EFPIA, COCIR and EMA are envisaged to initiate long-term strategies with large industries and to efficiently structure the ecosystem amongst its stakeholders.
Potential Impact:
1. Potential impact
With the overall objectives to federate the nanomedicine community, structure the European landscape and provide recommendations for nanomedicine under Horizon 2020, NANOMED2020 had significant and sustainable impact in the following dimensions:
• Preparing strong partnerships
• Pushing forward nanomedicine as a key area of health research
• Societal and economic returns
• Increasing awareness on Nanomedicine
• Impact beyond Europe
Overall, NANOMED2020 did succeed in preparing the field of nanomedicine for the next horizon, with the large endorsement of the White Paper concepts by the community and their successful implementation into Horizon 2020 first calls:
• GMP Pilot Lines -> NMP 8 – 2014: Scale-up of nanopharmaceuticals production
• Translation Advisory Board -> NMP 9 – 2014: Networking of SMEs in the nano-biomedical sector
• EU-NCL -> INFRAIA-1-2014/2015: Integrating and opening existing national and regional research infrastructures of European interest
With regard to the establishment of a Translation Advisory Board in the near future, the expected impact should:
• Support European SMEs and academia as drivers of innovations nanomedicine
• Improve the innovation capacity of the nano-biomedical sector by catalysing a more effective translation process from research into industrial marketable products.
• Improve the 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
• Improve the capacities of SME networks regarding technologies and facilities that are required to facilitate the transfer of scientific knowledge to market or to facilitate clinical studies.
a) Preparing strong partnerships
For nanomedical products, the Societal Challenges pillar of Horizon 2020 provides a route to the market, consisting in building up Public Private Partnerships for specific applicative areas. As described previously, such link to the private sector, especially to large companies (pharmaceutical, diagnostic/imaging), is a crucial step in the nanomedicine value chain for R&D actors such as academia and SMEs. It defines whether a novel enabling nanotechnology developed for medical application can meet the patients’ and markets’ needs, becoming thus an innovative medical technology.
Currently the nanomedicine community is mostly composed of academic institutions and SMEs conducting research, pre-clinical development and clinical trials in phase I. Their goal is generally to transfer their products to large companies for final clinical validation, regulatory approval and commercialisation, because they don’t have generally the resources and time to commercialise their innovations in a regulated sector.
NANOMED2020 strived hence for the leveraging of nanomedical technologies and for their implementation in medical products through the optimisation of the interface with large pharmaceutical and diagnostic companies. An intensive and continuous feedback from end-users / stakeholders close to the market is also essential to drive research and development and to define Strategic Research Priorities in an efficient way. Therefore, although the nanomedicine community cannot apply for its own PPP model yet it can actively contribute to future PPPs on Health by:
• Suggesting research topics for the SRA of established PPPs, in particular related to Health,
• Showcasing nanomedical technologies with high translational capacity to large companies,
• Participating in R&D consortia for PPP calls for projects.
With a nanomedicine area characterised by a wide fragmentation and dispersion of its stakeholders; NANOMED2020 paved the way for the harmonisation and federation of nanomedicine initiatives and networks across Europe.
Not only the synergies between the ETPN, CLINAM and the EuroNanoMed ERA-NET increased notably through joint-events and collaboration for the next European Strategic and Innovation Agenda, but it is also expected that the contacts established while building the European nanomedicine map will be sustained. Official partnerships between the ETPN secretariat and all national platforms across Europe are for example already initiated, notably with the British Society of Nanomedicine, the French Society of Nanomedicine, NanoMed Spain, Greek, Austrian and Polish NanoNets, SwedNanoTech, NanoMedNorth, Nanomedicine CZ.
b) Pushing forward nanomedicine as a key area of health research
Nanotechnology is one of the six Key Enabling Technologies (KETs) that has a significant impact on many different medical developments in the three main areas: Therapeutics, Diagnostics/Imaging and Regenerative Medicine. Accordingly, the mapping of nanotechnology research in these areas to diseases is an important milestone to ensure that nano-enabled medical products answer unmet medical needs. Significant steps have been achieved in this regard under NANOMED2020, with the inclusion of the targeted medical diseases in the Nanomed Map actors’ information. Moreover and as a result of discussions within NANOMED2020, the ETPN integrated in its structure among others a dedicated Work Package on Clinical Interface to ensure long term impact of the dialogue and bridges with clinics and healthcare providers, led by the NANOMED2020 partner Fondazione Don Gnocchi.
Matching nanomedicine R&D portfolio and potential applications with today’s unmet medical needs will be at the heart of the definition of Strategic Research Priorities in the field in the coming months in order to fill in the pipeline with innovative products and solutions having a high impact on the healthcare and societal challenges.
All therapeutic areas will potentially benefit from nanomedicine. Specific priorities should be identified jointly by industry and the EC, to be filled by dedicated calls for proposals.
On a similar basis, contacts with large industrial federations such as EFPIA, the European Federation of Pharmaceutical Industries and Associations, have been initiated in order to align the projects of nanomedicine SMEs with the pharmaceutical industrial products requirements.
As Nanomedicine fits naturally with the Key Enabling Technologies (KETs) defined by the European Commission, along with micro- and nano-electronics (including semiconductors), advanced materials, biotechnology, photonics, and advanced manufacturing technologies, inherent interactions exist between these sectors and could be mutually beneficial in terms of research innovation.
This is why the ETPN secretariat will continuously monitor for opportunities in Horizon 2020, push forward synergies and initiate cross-KETs collaborations in order to enhance and enlarge the tools and possibilities for nanomedicine technologies.
A specific collaboration has been already initiated in this regard between Nanomedicine and the MNBS (Micro-Nano-Bio-Systems) and NANOMED2020 participated in the MNBS cluster workshop 2013 in Cork to identify real opportunities for diagnostic innovations and new roads to deal with major societal challenges.
Finally, the release of the ETPN SRIA by fall 2014 will provide high-level and in depth recommendations to guide the future nanomedicine policies until 2020 and beyond. This official document addresses a large audience, even beyond Europe, and will cover a large spectrum of possible areas of application for nanotechnologies in healthcare. Such an agenda is of outmost importance as it describes the vision of ETPN for the future development of nanomedicine and lists all research priorities that should be implemented and funded by the European Commission and the Member States.
c) Important societal and economic returns
With a growing market expected to reach up to 130 billion US$ in 2016 according to the latest study conducted by Bionest Partners (see graph below), it is without doubt that nanomedicine is a fast expanding domain that can and will provide high economic return.
With 49 products currently on the market incorporating nanoparticles, and four times that many now moving through the pipeline with half of those already in Phase II or Phase III trials, nanomedicine is becoming a concrete market segment. However, more is to be done to translate such promises into key innovative medical products onto the market.
In this context, the NANOMED2020 Translation Hub concept and related strategies aim at speeding up the translation of research and development into the Nanomedicine market to enable a fast offer of many novel products that can effectively improve the health of patients suffering from health disorders and illnesses and result in an economically sound and competitive European industry.
With 500+ SMEs identified via the Nanomedicine Map that could directly benefit from these concepts in Europe and 39% of EMA objections of a new product review linked to quality problems related to manufacturing process validation or specifications’ setting (EMA’s SME office annual report 2012), nanomedicine and the concept of a dedicated Translation Hub is meant to have a real impact on the European economy.
In designing and establishing the EU-NCL and the GMP pilot lines, NANOMED2020 will have a direct impact on jobs, healthcare and global value for Europe. By initiating an innovative and competitive healthcare supply chain of SMEs (and even academics) in the field of nanomedicine, NANOMED2020 paved the way for a new environment needed make the concept of Open Innovation successful in and profitable to Europe.
The concept of GMP pilot lines established under NANOMED2020 Translation Hub will provide a unique opportunity to keep production jobs in Europe and reindustrialise the healthcare system. Indeed, much has changed in the last decade, with pharmaceutical companies moving to a global Open Innovation model. With revenues under pressure and a willingness to reduce risks, lower costs and raise innovation standards, R&D staff in Europe’s research centres have been cut off and outsourced outside Europe.
With the implementation of the EU-NCL, it is envisaged that perceived regulatory hurdles will decrease for an increasingly-global pharmaceutical industry, thanks to complementary regulatory framework between the FDA and EMA. This, in return, could increase investment in this area from international pharmaceutical companies, which is a necessary step toward widespread commercialisation of nanotech therapies and diagnostics.
Bridging US-FDA and EMA on nanomedicine evaluation and approval procedures will reduce trade and regulatory barriers between EU and US, as discussed nowadays.
Societal expectation for better healthcare is also huge: scenarios describing the diagnosing of pathologies before clinical symptoms appear, treating them with low doses of drugs and generating few or even no side effects in a custom tailored therapy are commonly discussed and foreseen as the next golden state of care.
Nanomedicine has clearly some answers and contributions to pave the way to realise such scenarios towards personalised, predictive and preventive medicine.
To answer current and future societal challenges, addressing societal and ethical issues in a broad responsible research and innovation concept shall not be an option but must be explicitly taken into account in future proposals.
The ETPN will find ways under Horizon 2020 to initiate sustainable and dedicated actions in this regard as a continuity of NANOMED2020, including:
• Improved public perception of nanomedicine and making the public aware of the benefits of nanomedicine,
• Greater public involvement in nanomedicine directives and more public consultation and dialogue (such as in EPSRC "nanotechnology to medicine and healthcare grand challenge programme“),
• Clear regulatory guidelines for nanomedicines,
• Increased information about ethical issues in nanomedicine education programmes of schools and Universities,
• Inclusion of societal experts and representatives in the selection of projects (in the TAB in particular),
• Encouraged dialogue between and inside related laboratories and between all stakeholders for a responsible innovation. An ethical nanomedicine chart could be pushed forward.
d) Increasing awareness on Nanomedicine
Dissemination of NANOMED2020 activities and key results:
A majority of NANOMED2020 outcomes were dedicated to the support, coordination and federation of the nanomedicine community. The consortium spent thus a lot of efforts in efficiently communicating around its activities, targeting a large dissemination as key element for the success of the project results.
Dedicated press releases and websites were hence put in place to cover specific activities such as the launch of the NanoMed Award and the Nano World Cancer Days, whereas the release of the Nanomedicine Map and NANOMED2020 White paper were disseminated through presentations and direct contacts at large conferences across Europe.
The full list of such dissemination activities is available under section A2.1.
Dissemination of nanomedicine outside the nanomedicine community:
Urgent actions are needed to leverage nanomedicine acceptance as public perception on nanotechnologies is often mitigated due to the image and risks conveyed by the media. NANOMED2020 contributed to prepare the future of health research and innovation by increase awareness on innovative nanotechnologies for medical applications. NANOMED2020 opted for a short (two minutes) and animated movie disseminated via internet (YouTube: https://www.youtube.com/watch?v=2VcNpl8-PRI) social networks (Facebook, LinkedIn, Twitter), events and nanomedicine platforms, to explain in broad terms to the public what is nanomedicine. A cartoon mode was chosen to stimulate public interest while delivering a highly accurate message.
In parallel, efficient translation of nanomedicine to the market also requires increased awareness and synergies with late-stage stakeholders in the value chain, mainly large industries. NANOMED2020 initiated nanomedicine showcases at large biotech and pharma conferences to meet this objective, with the announcement of the first Nanomedicine Award during BioEurope 2013.
e) Impact beyond Europe
Installing a EU-US NCL transnational cooperation:
The aim of the proposed EU-US collaboration under NANOMED2020 is to develop EU-NCL as a mirror organisation to NCL, based on the NCL’s model of operations. EU-NCL would serve the European scientific and start-up communities in characterising nanomaterials developed for medical applications. The EU-NCL is a key component of the Translation Hub proposed by NANOMED2020 in Horizon 2020 and will hence benefit from the five years‘experience of the US-NCL.
Moreover, such cooperation will have a sustainable impact on support the harmonisation of standards between the US and the EU, thus helping transatlantic trade of nanomedicine products and accelerating the introduction of nanomedicines.
The EU-US proposal for cooperation can possibly be implemented under the framework of the existing EU-US cooperation on nanotechnology, in considering the nano-characterisation of medical nanomaterials as a new cooperation topic. This will lead to a faster and safer translation of nanomedicine to the market, and a harmonisation of the nano-characterisation on both US and EU sides, as a preamble to coherent regulatory approval of nanomedicine on both sides.
Federating a worldwide nanomedicine community:
With the federation of resources between CLINAM, ETPN and NANOMED2020 partners, the CLINAM/ETPN Summit 2013 has become a major annual meeting in Europe for international contacts and cooperation, reaching 500 participants at this last edition. Many projects have been shaped at this occasion during dedicated networking sessions. The creation of two FP7 Projects are an example of such impact beyond Europe: the Project “NanoAthero” (www.Nanoathero.eu) developing nanomedicine for target-specific imaging and treatment of atherothrombosis (development and initial clinical feasibility) and the Project “Discognosis” for Point-of-Care diagnosis of malaria and tropical diseases on a CD-like operating platform (http://www.discognosis.eu/).
On a sustainable basis, these international contacts outside Europe encompassing clinically researching members of the Global Nanomedical Community have been all invited to the next CLINAM Summit in June 2014 to join forces again and enable European Participants to reach good contacts in the other continents.
A crucial role has also been put in the hands of the International Society for Nanomedicine (ISNM) which is presently in its 3rd year of activities. The ISNM has the goal to establish a global networking and information exchange platform for Nanomedicine and Targeted Medicine. With a two hours ISNM meeting during CLINAM 2013 Summit, ISNM beneficiated of increased visibility and partnerships opportunities via NANOMED2020 to paved the way for future international cooperation.
The ETPN also initiated through the project the emergence of collaborations with nanomedicine networks outside Europe, with draft Memorandum of Understanding between ETPN and corresponding platforms in Australia, Argentina and Russia, with the aim to leverage synergies and resources across the communities and R&D projects.
2. Main dissemination activities
Dissemination activities were an intrinsic part of the project and were conducted and structured along the two main directions below:
• Dissemination of NANOMED2020 activities and key results
• Dissemination of nanomedicine outside the nanomedicine community
3. Dissemination material
If printed materials where occasionally used when relevant (e.g. printed copies of White Paper, NANOMED2020 flyer and A0-poster for example), most of the dissemination activities were done via the internet to cover the widest audience possible in a very short period (NANOMED2020 had a duration of 18 months).
The NANOMED2020 (www.nanomed2020.eu) and ETPN (www.etp-nanomedicine.eu) websites were the main portals to the project. They contained the project description, consortium members, events, results and offer functionality for giving feedback as well as links to other related initiatives, most notably coming from the ETPN, CLINAM as well as national platforms.
In addition, in order to address a broader audience other means like Web 2.0 communication channels were used. Dissemination of project activities and key outcomes were often disseminated by EuroNanoMed Facebook page and ETPN LinkedIN and Twitter accounts.
YouTube was also sought to efficiently reach the general public. The nanomedicine animated video together with the recordings of CLINAM 2013 were notably broadcasted via the dedicated Nanomedicine channel NanoMedTV (https://www.youtube.com/user/nanomedTV).
Further dissemination channels were recommended to be implemented beyond NANOMED2020, with the creation of a Wiki-like platform for online collaborative editing and intuitive tool for the public to understand the field of nanomedicine and its numerous applications in healthcare.
Nevertheless, it was seen as of crucial importance to perform a more personalised dissemination towards key actors in strategic industrial, societal, legal and academic fields on a national, EU and international level. This was realised by using key events across Europe as the privileged link towards the nanomedicine community but also national and European authorities. For example, the White Paper wide-spread impact and visibility is notably due to significant presence and communication efforts during dedicated sessions or workshops at EuroNanoForum, CLINAM Summit, ETPN Annual Event and national nanomedicine events.
Finally, Press Releases were often used as many of the initiatives launched within the project were novel and required intensive communication efforts to be visible and be launched on a sustainable basis.
4. Exploitation of results
In order to successfully exploit NANOMED2020 results, the White Paper – the cornerstone of the project outcomes and long-term impact - was written at the middle of the project (June 2013) to provide a key milestone for further exploitation and officially state the NANOMED2020 vision and recommendations resulting from the activities launched until then.
In addition, intense communication was organised along specific target groups (nanomedicine community, national networks and initiatives, industrial stakeholders, general public and EC) to gather as many feedback and additional inputs as possible to preliminary results and leverage impact of the final outcomes.
All initiatives launched under NANOMED2020 were designed from the start on a renewable and sustainable basis for long-term exploitation of the results achieved: NanoMed Award and the Nano World Cancer Day are for example concepts likely to be conducted every one or two years under the supervision of the ETPN now that the brand name has been established, and the dedicated websites were thought to host the next editions to ensure traceability and optimisation of resources. Moreover, the Nano World Cancer Day and the Nanomedicine Animated Movie are concepts likely to be declined in the near future respectively to other medical diseases or specific applications of nanomedicine in areas such as diagnostic, imaging, therapy or regenerative medicine.
List of Websites:
The project's public website address is www.nanomed2020.eu. The coordinator's contact is Mr. Nicolas Gouze, VDI/VDE-IT, Steinplatz 1 10623 Berlin, email: nicolas.gouze@vdivde-it.de tel.: +49 30 310078 209.
