Final Report Summary - EURONANOMED II (EUROpean network for transnational collaborative RTD projects in the field of NANOMEDicine)
Executive Summary:
Nanomedicine, the application of nanotechnology to health, is a fast-growing field with a large potential for improving diagnostics and therapeutic solutions in many diseases. The EuroNanoMed II (ENM II) consortium, with 21 partners from 18 countries and regions (Table 1), aimed at fostering the competitiveness of European nanomedicine players through the support of translational research projects enhancing transnational and multidisciplinary collaborations between academia, clinical/public health communities and industry. ENM II was a follow-up of the ERA-NET EuroNanoMed I (ENM I), which launched three joint transnational calls for proposals in three years. The increasing number of submitted proposals in the successive ENM I joint calls and their quality showed the need amongst the nanomedicine scientific community for such a targeted initiative. ENM II was built on the basis of the ENM I accomplishments, and continued to support transnational innovative RTD projects in nanomedicine through the launch of yearly joint calls for proposals. In addition, ENM II aimed to extend the cooperation among its partners through the development of other activities (Figure 1): (i) to foster the participation of young European researchers to ENM II activities; ii) to develop a strategic agenda for ENM II in close cooperation to the ETP Nanomedicine; iii) to create more interactions within the European nanomedicine community and improve communication on nanomedicine to the public; iv) to frame and to address regulatory, safety and ethical issues associated with nanomedicine; v) to monitor the results of the ENM I & ENM II funded research projects and the activities of the ENM II network; and, consequently, vi) to develop a long-term cooperation framework for European nanomedicine research. Therefore, through joint funding of translational nanomedicine projects and its other activities, ENM II has contributed to enhance coordination of research and resources in this field, thereby shaping the European Research Area in nanomedicine.
Project Context and Objectives:
One of the key strategic challenges Europe has to face in the next decades is to provide its ageing population with effective and affordable health care and to assure its wellbeing. To achieve this goal, sustainable efforts in research and innovation are necessary to find new and personalised ways to prevent, manage, treat and cure disease, disability and reduced functionality and for making medicines and treatments available and affordable to all.
One promising tool to meet these challenges that has evolved in the last decade is the use of nanotechnology for medical applications. This new area of research – usually referred to as “nanomedicine” (i.e. the application of nanotechnology to medicine and healthcare. The field takes advantage of the physical, chemical and biological properties of materials at the nanometre scale to be used for diagnosis, treatment and follow-up of diseases)- has been rated among the six most promising Key Enabling Technologies (KET) by the High Level Group on KET in its final report (EU Commission, June 2011). Therefore, nanomedicine 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. Disease areas that are presumed to benefit most from nanomedicine are cancer, cardiovascular diseases, neurological (especially neurodegenerative) diseases, diabetes, inflammatory diseases as well as orthopaedic and other medical conditions needing regenerative medicine. Nanomedicine is a research area at the intersection of different scientific fields. To be successful it has to federate key players from biology, physics, chemistry, medicine and engineering. Furthermore, nanomedicine needs coordinated input from all players along the value chain to effectively move scientific results to innovation: academic scientists, pharmaceutical and medical device companies and clinicians in a translational approach.
Since the early 2000’s, nanotechnologies are a priority for Europe. They have been identified as one of the thematic priority areas for the European Union (Communication from the Commission “Towards a European strategy for nanotechnology” COM 2004-338 final); an action plan for Europe (COM 2005-243 final)) and they are one of the six Key Enabling Technologies to assure Europe’s Industrial Leadership addressed in the draft of the Horizon 2020 framework programme. When EuroNanomed II was submitted in 2012, nanomedicine was expected to be one of the cross-cutting actions “vital in stimulating the interactions between the societal challenges and the enabling and industrial technologies needed to generate major technological breakthroughs”.
Europe has a good starting position in the field of nanomedicine with excellent scientists all over the member states, a large number of innovative SMEs and some leading pharmaceutical companies. The bridge between these players will consolidate and improve the competitiveness of the European industry that will be very important in the worldwide competition in this sector. As these players are usually spread over different member states, a transnational approach is necessary to bring together the most appropriate partners.
Even if European countries invest a substantial amount of money in research and innovation funding, most of the national programmes do not support transnational projects. Pure nationally funded programmes often face difficulties to successfully translate fundamental research in first clinical stages, as in many member states there are too few players in the specific domain of nanomedicine. Therefore, the main goal of the EuroNanoMed II ERA-NET initiative was to go further in supporting transnational research and innovation projects, in order to achieve a critical mass of players translating scientific results from the lab to patient’s bedside. EuroNanoMed complements national and European funding activities as nanomedicine is often not the main focus of the national or European calls for proposals.
The EuroNanoMed II consortium with 21 partners from 18 countries and regions (comprising 18 partners already members of EuroNanoMed I) is a strong, established partnership of relevant member states’ funding bodies, willing to attribute a part of their national funding budget to transnational research and innovation projects in nanomedicine and to make nanomedicine an important contributor to the future European healthcare system and to have a beneficial impact on improved treatment for patients, as well as an economic impact through an improved and cost-effective health care.
EuroNanoMed II project was based on the foundations of EuroNanoMed I, a first ERA-NET on nanomedicine, launched in 2009, and supported by the European Commission under the NMP programme for 3 years. The main goal of ENM I was to build the grounds for a transnational research programme in nanomedicine that responds to the needs identified in the field (ENM I strategic agenda, ETP Nanomedicine). The results of the three JTCs launched in the frame of ENM I showed a real success concerning this goal and EuroNanoMed is now a well-known and recognised initiative. ENM I also carried out other activities intending to accompany the establishment of a common RTD programme in nanomedicine, such as the systematic mapping of the on-going programmes, the establishment of a strategic agenda and the development of actions to address issues on regulatory affairs. In addition, ENM I carried out monitoring and optimisation activities that allowed the consortium to improve the procedures from call to call and to establish an efficient collaboration between agencies based on trust and common understanding. A questionnaire to gather applicant’s feedback showed the positive impact that ENM I had on European researchers, but also helped to identify unmet needs that the consortium intends to fulfil by continuing its collaboration.
Through EuroNanoMed II, the ERA-NET scheme represented a unique opportunity for the ENM consortium to continue its efforts and achieve the long-term goal of fostering the competitiveness of the European nanomedicine players through the joint funding of transnational innovative research projects.
There was indeed an important need for improving the translation of public healthcare nano-research in Europe as pointed out in the white paper of the ETP Nanomedicine . In addition, 2012 was the right time to put some extra efforts in the field of nanomedicine since some highly promising concepts and technologies were currently emerging (e.g. stimuli-responsive polymers, amphiphilic core–shell nanoparticles, molecular targeting approaches for nanocarriers, etc. ). It was therefore essential to support nanomedicine in Europe in order to secure their translation to the clinic and to industry and secure their proof of concept. Hence, based on the experience of EuroNanoMed and in continuation of the first initiative, the main objective of EuroNanoMed II was to foster the competitiveness of European nanomedicine players through the support of projects enhancing translational collaborations between research teams from academia, clinical/public health communities, and industry. EuroNanoMed II aimed to continue its support to transnational RTD projects in nanomedicine through the launch of four joint calls for proposals.
In a nutshell, the main objectives of ENM II initiative were to:
• Fund in common transnational, innovative and translational RTD projects in nanomedicine;
• Launch joint calls for proposals that are in line with the strategic priorities of the ETP Nanomedicine and the NMP expert advisory group;
• Develop a strategic agenda for EuroNanoMed II and for future cooperation, in close cooperation to the ETP Nanomedicine;
• Continue the European coordination of research and programmes in nanomedicine, integrating new members;
• Develop specific actions to foster the participation of young researchers in nanomedicine projects and help them build their research career;
• Create more interactions within the European nanomedicine community through joint calls, review seminars, dissemination of ENM II activities, etc.;
• Keep close relations with the relevant stakeholders (especially the ETP Nanomedicine) and the research community in order to react flexibly to the needs and new developments in nanomedicine research;
• Improve communication on the nanomedicine field towards the general public;
• Go further to identify and address the non-technological innovation barriers in terms of later exploitation and market access for companies in the field of nanomedicine based on the work already achieved in ENM I;
• Frame and address ethical and safety issues in nanomedicine;
• Follow the progress of the EuroNanoMed (I&II)-funded projects and analyse the outcome of the joint calls;
• Monitor the activities of EuroNanoMed II with an aim of continuous improvement;
• Develop a concept for a sustainable cooperation between EuroNanoMed partners after the end of the ERA-NET taking into account the financial and administrative constraints as well as the needs and expectation of the stakeholders.
These objectives were delivered through six work packages (Figure 2), with the following aims:
WP1: Management and strategy
In this work package, a practical infrastructure whose goal was to manage the administrative, technical, financial and strategic aspects of the ERA-NET had to be established. The key aims were to:
• Set up the organisational structures for the network;
• Manage the consortium day-to-day;
• Ensure communication within the network and with the EC;
• Give input and support to the tasks of all the work packages;
• Maintain an active website as a gateway to other stakeholders and the community;
• Produce a strategic agenda to use for all ENM II activities and to set up a future cooperation framework.
WP2: Joint funding activities in nanomedicine
The key aims of this work package were to plan and implement four transnational joint calls for research proposals (one per year), supporting the selection process and the coordination of funding for the successful projects. The first two calls of EuroNanoMed II (2013 & 2014) were planned to be broad and organised around the three sub-topics: targeted drug delivery, diagnostics and regenerative medicine, which are the priorities of the ETP Nanomedicine. Then, based on the strategic agenda of ENM II and input from the External Advisory Board and other experts, the topics of the further joint calls (2015 & 2016) had to be defined. In addition, the procedures regarding the implementation and evaluation of the joint calls (topic selection, preparation, publication, evaluation of proposals, funding decision and national implementation) were to be re-examined and adapted for each call. This best-practice approach aimed at delivering a continuously developing, commonly-agreed framework of call governance and procedures.
Issues linked to the joint calls also needed to be addressed in the frame of this work package. Specific actions regarding young researchers had to be developed to increase the attractiveness of nanomedicine research within the younger generation. These would include networking activities in the review seminars, incentives for outstanding research achievements, as well as measures in the joint calls to encourage their participation. Finally, the follow-up of EuroNanoMed (I&II)-funded projects was planned in this WP2.
WP3: Regulatory Affairs, Ethical and Safety Issues
Research in nanomedicine is generating a bunch of revolutionary new therapeutic and diagnostic solutions that can offer a better therapy and a higher quality of life to patients. Many of these advancements have overcome the classical separation between medical and pharmaceutical products so that classical regulatory frameworks are sometimes inappropriate or even inapplicable to these products. The lack of specific protocols of practices and standard criteria for these brand new nanomedicine products is turning out to be an important imponderable that may considerably hinder industrial R&D and delay market access of innovative products. Therefore, it was essential to establish an EU-wide dialogue on regulatory issues in nanomedicine to facilitate a faster exploitation and market access for companies and to shorten the time from the research to clinical application and to the patient. As these questions were more and more directed at the European level (EMA) it was necessary to consider these issues at a European rather than at a national level. This was critical to avoid any loss of resources and efforts for member states, companies and research/clinical communities and to ensure that new products - supported through the EuroNanoMed calls - could get fast market authorization to finally benefit the patient.
When talking about new drugs and technologies, the safety of end users and patients had necessarily to be considered as well as ethical aspects or social risk perception. These points were fundamental for a new discipline like nanomedicine where a common coordination of safety and ethical issues was still missing.
In the frame of EuroNanoMed I, a fruitful dialogue on regulatory issues involving experts from industry, public research, clinic, regulatory agencies and public authorities had been started and a mapping of relevant nanomedicine related safety issues has been prepared. These two activities needed to be continued and intensified during EuroNanoMed II and completed by training activities on regulatory aspects for EuroNanoMed (I & II)-funded researchers and the consideration of ethical issues.
The objectives of WP3 were:
• To continue and intensify the dialogue between stakeholders from industry, research, clinic, regulatory agencies and public authorities (in close cooperation with the EMA and the ETP Nanomedicine), to identify bottlenecks in existing regulations with respect to the needs of nanomedicine and to propose practical solutions;
• To train and inform EuroNanoMed funded researchers about regulatory issues that should be taken into account in research to facilitate the entry into clinical trials and market access at the end of their project;
• To continue and update the mapping of nanomedicine related safety issues from relevant sources and in cooperation with initiatives like the NanoSafety Cluster or the ERA-NET SIINN, with which there are already many links (partners in common) and regular exchanges are planned;
• To identify and address nanomedicine related ethical issues involving relevant initiatives like the Ethics Resource Center or the European Group of Ethics.
WP4: Communication and Dissemination
While communication activities had already been developed in EuroNanoMed I, the aim of WP4 was to improve the process, informing more systematically the nanomedicine community, the policy makers, and the general public about the ERA-NET activities. This mission was to be carried out in close collaboration with the coordinator and fed from all other ERA-NET activities. During the time course of the project, newsletters and press releases providing information related to the calls launch, results, funded projects, but also related to the other ERA-NET activities (workshops, publications, etc.) were planned to be published on the website and/or disseminated. In parallel, relation with sister and similar initiatives was to be set up to benchmark on common activities. Finally, tools for dissemination towards the larger public had to be developed, such as video clips explaining the three subfields of nanomedicine: targeted delivery systems, diagnostics and regenerative medicine.
WP5: Monitoring and optimisation of activities
The aim of this work package was to analyse and monitor both the EuroNanoMed II activities & the output and added-value of EuroNanoMed (I & II) joint calls. The objective was to provide support for short- and long-term strategic planning activities and to allow the partners to continuously improve ENM II work. It had to be achieved by defining indicators to measure the success of the joint calls and other EuroNanoMed II activities and applying them through a structured monitoring process, which would take into account the expectations of ENM II partners, as well as the views on ENM II joint calls of the involved nanomedicine research community.
WP6: Design of a long-term sustainable cooperation framework for nanomedicine research
The key aim of this work package was to develop a common research funding framework for nanomedicine, which would reach beyond EuroNanoMed II and aiming to sustain and possibly broaden the scale of its activities. The expected outcome was to lead to a self-sustained transnational funding programme with regularly repeated funding initiatives. In collaboration with the partners of ENM II and other interested stakeholders and after benchmarking with similar initiatives, the financial, administrative and legal conditions to develop such a funding framework concept was expected to be explored and a scenario for a long-term sustainable cooperation for research funding in nanomedicine proposed.
In conclusion, the objectives of the proposed Coordinating Action EuroNanoMed II directly corresponded to the FP7 call topic NMP.2012.1.2-3 ERA-NET on nanomedicine: “This ERA-NET aimed at coordinating the research efforts of the participating Member States and Regions in the field of nanomedicine and to implement joint transnational calls for proposals to fund multinational innovative research initiatives in nanomedicine.”
Project Results:
JOINT FUNDING ACTIVITIES IN NANOMEDICINE
Through WP2, EuroNanoMed II aimed at designing and implementing joint transnational calls (JTC) for research projects (one per year). This WP covered all the preparatory work for joint funding activities, such as the selection of the topics, designing the call procedures and documents, encouraging young researchers’ participation, as well as the implementation of the funding activities. It was therefore a WP in which all EuroNanoMed II partners were involved. While the final decision about participation in a JTC followed a variable geometry pattern, discussion and selection of the topic were done by all the ERA-NET partners under the advice of academic, industrial, and clinical experts (External Advisory Board and external experts at large). For each JTC, the partners who committed to participate in the joint call formed a Call Steering Committee (CSC). The CSC took decisions concerning the call procedures, supervised the progress of the call, and made the final funding recommendation to the national/regional funding organisations regarding the proposals to be funded, based on the final ranking list provided by the peer review panel. A call office was set-up from the start as a central helpdesk for activities related to the implementation of the calls. It was responsible for the operational implementation of the calls, until the projects were selected. The Call Office served as contact point for any requests concerning the joint calls, providing information on EuroNanoMed activities, giving advice and information about Joint Calls’ eligibility, deadline, etc. The Call Office also supervised the publication of call texts on the EuroNanoMed II website and in the countries participating in a call and collaborated with the National Contact Points to most efficiently support the applicants. This also implied updating the JTC project submission tool according to the procedures decided for each JTC. Finally, an Expression of interest tool was set up in EuroNanoMed I in order to help the applicants finding partners and building consortia was updated for EuroNanoMed II. The existence of this tool was largely communicated in a timely manner to the scientific community using the communication tools in WP4 (i.e. website, newsletter).
DESIGNING AND IMPLEMENTING JOINT TRANSNATIONAL CALLS
During the period 2012-2016, the ERA-NET EuroNanoMed II has successfully launched 4 joint transnational calls for proposals in the continuation of the 3 calls previously launched under EuroNanoMed I.
The design of the procedures and preparation of the Joint Transnational Calls documents was improved and refined compared to the already established procedures for submitting, evaluating, selecting and funding the proposals. For each call, a Memorandum of Understanding (MoU), a “Joint Transnational Call Governance” document and a call text was prepared. The MoU described the agreement reached by the members of the consortium on the scope of the call, the principles ruling the selection and evaluation procedures (in outline only) and the financial commitments and funding modalities. The “Joint Transnational Call Governance” described the agreed-upon call operative procedures. It included the national or regional funding body partners´ eligibility requirements as an annex. The call text described the rationale of the call, the topic, the eligibility requirements, deadline for submission of an application, the evaluation criteria and process. In addition, for each JTC, a pre-announcement text was published at least a month before the JTC launch to inform the scientific community of the JTC topics, countries/regions involved and the general rules. Finally, templates for the submission of proposals (addressed to applicants) and for the evaluation of proposals (addressed to the external reviewers and panel members) were prepared within this task.
The design of strategic priorities was made with respect to the academic, industrial, and clinical needs. The calls covered the three subfields: targeted drug delivery, diagnostics and regenerative medicine. Building on the experience of EuroNanoMed I, a workshop on defining the scope and topics for JTC2015 and JTC2016 with experts was organised on 19th June 2014 in Tenerife, Spain after the JTC 2014 evaluation meeting / Peer Review Panel (PRP) meeting. The main objective of the workshop had two dimensions: 1- to gather recommendations for improvement of ENM II evaluation procedures, and, 2- to discuss topics that should be covered by ENM II upcoming calls (in 2015 and 2016). PRP members were asked to join the partners for this workshop as external experts. The general consensus during the Workshop was that the open approach that had been used for the ENMI and ENMII calls so far is the optimal way to go. A narrower focus may lead to a drop in the total number of submitted proposals, and the bottom up approach is the right one to contribute to increasing innovation in the field of nanomedicine and is complimentary to current H2020 calls. In addition, most of the discussions were based on the content of the Strategic Research and Innovation Agenda (SRIA) that was prepared by the European Platform on nanomedicine (ETPN) in collaboration with ENM II partners responsible for WP6, and which was used by the European Commission (EC) for the development of the Working Programme 2016-2017.
To encourage the participation of young researchers to EuroNanoMed II funding activities and increased the attractiveness of multidisciplinary and transversal nanomedicine research within the younger generation of scientists, EuroNanoMed II fostered networking of young researchers in the field, to increase exchange of academic information, facilitate technology transfer and provide information about EuroNanoMed funding options for young researchers. This network was initiated by putting in relation the young scientists (PhD students, Postdocs, young PIs) involved in the EuroNanoMed I and II funded projects, using email lists and other means of communication in link with WP4. A “Young scientists” section was created on the ENM website to disseminate information about ENM activities and a mailing list (juniorresearchers@euronanomed2.net) was created to share job offers or information to the young researchers involved in the ENM funded project and was constantly updated. In addition, these young researchers were encouraged to attend the EuroNanoMed II review seminar meetings and present posters of their work (see next section).
On 3rd July 2013, a dedicated workshop for young researchers was organised in Venice, Italy. The results of an online questionnaire sent to 435 researchers (applicants of ENM I calls and EAB members, 114 respondents) were analysed and presented to the EuroNanoMed II partners. The aim of this survey was to check with the interested community of scientists which were the preferred actions towards the following ENM II objectives. The following results were highlighted:
• To encourage the participation of young researchers to EuroNanoMed II funding activities;
• to increase the attractiveness of multidisciplinary and transversal nanomedicine research within the younger generation of scientists.
The results of the survey were used as a basis for discussion about the measures to be taken by ENM II to foster the participation of young researchers. As a result:
• The NSC members agreed on a common definition of “junior researcher”: He/She must have been awarded his/her first PhD or equivalent title, at least 2 and up to 10 years from today (extensions possible in case of career breaks: maternity/paternity leave, long-term illness). 1- The NSC also decided that each ENM II partner was responsible for establishing the equivalent titles of “First PhD” in their own countries; 2- A bulletin board for mobility options on the ENM II website was created. The e-mail distribution list was used as a start to disseminate the information.
• A young researcher won the best poster prize during the review seminar in Oslo, December 2nd, 2014.
Young researchers’ participation in the EuroNanoMed calls was also encouraged through specific measures decided by the CSC members. The decisions on the actions to be chosen to support young researchers took into account the experience of other ERA-NETs (E-Rare-2 JTC2012, etc.) which launched calls that encouraged the participation of young researchers. The possible actions included for example to have a specific track for young PIs in the EuroNanoMed II JTCs or to add eligibility criteria for inclusion of at least one young researcher as a partner in a proposal consortium. Challenges and opportunities within the joint calls that are specific for young scientists were explored. In the JTC2014, 2015 and 2016 call text, the following sentence was added: “active participation of junior researchers in project proposals is encouraged” and the evaluation criteria have been updated accordingly, adding the “participation of junior researchers” in the criterion “quality of the project consortium”. Accordingly, the participation of junior researcher in a proposal was taken into account by the evaluators.
OVERVIEW OF THE FOUR JOINT TRANSNATIONAL CALLS
o 4th Joint Transnational Call for Proposals - JTC2013
The first EuroNanoMed II call (JTC2013) was launched soon after the kick-off meeting of ENM II. On 13th November 2012, the pre-announcement of the 4th Joint Transnational Call for Proposals - JTC2013 was published on the EuroNanoMed website to warn the scientific community of the JTC topics, countries/regions involved and the general rules. The call documents and the procedures for the EuroNanoMed II JTC2013 were based on the call documents developed in the frame of the EuroNanoMed I calls. Only the layout and minor details were modified in the documents. Final versions of the Call Text, Guidelines for applicants and the Proposal application form were published on the EuroNanoMed website on 10th December 2012 at the opening of the call and on the relevant national funding organizations’ websites.
The evaluation procedure established during the last EuroNanoMed I call, in 2011, was used in the JTC2013. This procedure consisted in one-stage submission and evaluation with international peer review involving external experts and a peer review panel (PRP) meeting. Eligible proposals are reviewed through an international peer-reviewed process under the supervision of the Call Steering Committee, according to the criteria established by the call documents of each call. The scientific evaluation was carried out based on reviews of research proposals, and discussed in a peer panel meeting for establishing the ranking list of best proposals during a physical meeting.
The call received 43 proposals. Out of these, 37 were found to be eligible and were evaluated by external reviewers, three members of the final Peer Review Panel (PRP). The PRP members met in Venice, Italy, on July 1st-2nd 2013, to discuss the eligible proposals and, after consideration of the evaluation criteria and their own discussions, the PRP identified the top quality proposals recommended for funding and established a ranking list. Based on this ranking list, the final decision on funding was made by the EuroNanoMed II national/regional funding organizations involved in the call. The funding agencies with budget issues found solutions in order to fund as many projects as possible in the ranking list provided by the PRP members. As a result of these efforts, the Call Steering Committee decided to fund 8 projects for a total amount of about 7 M€. The 8 projects involved 42 partners from 15 countries/regions. They encompassed all three subfields of nanomedicine (as defined by ETPN): diagnostics, targeted delivery systems and regenerative medicine, and covered diverse medical issues such as treatment and monitoring of cancer, bone fractures and allergic reactions.
o 5th Joint Transnational Call for Proposals - JTC2014
On 6th November 2013, the pre-announcement of the 5th Joint Transnational Call for Proposals - JTC2014 was published on the EuroNanoMed II website to warn the scientific community of the JTC topics, countries/regions involved and the general rules. The call documents of the EuroNanoMed II joint transnational call 2014 were updated by a working group established by the NSC during the second NSC meeting held in Venice on 3rd July 2013, which took into consideration the lessons learned session that followed the JTC2013 PRP meeting. The final versions of the Call Text, Guidelines for applicants and the Proposal application form were published on the EuroNanoMed II website on 26th November 2013 at the opening of the call and on the relevant national funding organizations’ websites.
The working group set up in Venice during the second NSC meeting was also in charge of analysing and improving the evaluation procedure used in the JTC2013. According to the suggestions of the working group, the NSC members decided to introduce the following changes in the JTC2014: to assign proposals to 3 reviewers per proposal which are also PRP members and avoid further written evaluation by reviewers who are not part of the PRP and to use the same scale of scoring as in FP7 evaluations.
The call received 51 proposals. Out of these, 49 were found to be eligible and were evaluated by three members of the Peer Review Panel (PRP). The PRP members met in Tenerife, Spain, on June 18th and 19th 2014, to discuss the eligible proposals and, after consideration of the evaluation criteria and their own discussions, the PRP identified the top quality proposals recommended for funding and established a ranking list. Based on this ranking list, the final decision on funding was made by the EuroNanoMed II national/regional funding organizations involved in the call; the funding agencies with budget issues found solutions in order to fund as many projects as possible in the ranking list provided by the PRP members. As a result of these efforts, the Call Steering Committee decided to fund 9 projects for a total amount of about 6,5 M€. The 9 projects involved 52 partners from 15 countries/regions. They encompassed all three subfields of Nanomedicine and covered diverse medical issues such as the diagnosis of emphysema, anticancer and ALS treatments, fast identification of bacterial infections and tissue regeneration.
o 6th Joint Transnational Call for Proposals - JTC2015
On 28th October 2014, the pre-announcement of the 6th Joint Transnational Call for Proposals - JTC2015 was published on the EuroNanoMed II website to warn the scientific community of the JTC topics, countries/regions involved and the general rules. The call documents of the sixth joint transnational call 2015 were updated by a working group established during the fourth NSC meeting held in Tenerife on 20th June 2014. This working group was also in charge of analysing the outcomes of the “Workshop with experts & Improvements for the procedures of the next calls”. Final versions of the Call Text, Guidelines for applicants and the Proposal application form were published on the EuroNanoMed website on 26th November 2014 at the opening of the call and on the relevant national funding organizations’ websites.
According to the suggestions of the working group, the NSC members decided to introduce the following changes in the JTC2015: to establish a score threshold and provide it to the PRP members so that the proposals above a given score can be recommended for funding and proposals below this score cannot be recommended for funding; to establish a ranking list instead of group of projects ranked in blocks.
The call received 66 proposals. Out of these, 62 were found to be eligible and were evaluated by three members of the Peer Review Panel (PRP). The PRP members met in Jerusalem, Israel, on June 23rd and 24th 2015, to discuss 62 eligible proposals and after consideration of the evaluation criteria and their own discussions the PRP identified the top quality proposals recommended for funding and established a ranking list. Based on this ranking list, the final decision on funding was made by the EuroNanoMed II national/regional funding organizations involved in the call; the funding agencies with budget issues found solutions in order to fund as many projects as possible in the ranking list provided by the PRP members. As a result of these efforts, the Call Steering Committee decided to fund 11 projects for a total amount of about 7,5 M€. The 11 projects involved 53 partners from 13 countries/regions. They encompassed all three subfields of Nanomedicine and covered diverse medical issues such as the use of miRNA biomarkers in multiple sclerosis, cancer treatments, heart repair and early diagnosis of Parkinson's disease.
• 7th Joint Transnational Call for Proposals - JTC2016
On 23rd October 2015, the pre-announcement of the 7th Joint Transnational Call for Proposals - JTC2016 was published on the EuroNanoMed II website to warn the scientific community of the JTC topics, countries/regions involved and the general rules. The call documents of the EuroNanoMed II joint transnational call 2014 were updated, taking into consideration the lessons learned session that followed the JTC2015 PRP meeting. The main change was the introduction of the rebuttal stage (i.e. the coordinators of the applications submitted to JTC2016 were provided with the opportunity of commenting the written evaluations before the PRP meeting, so that PRP members could take them into account during the discussions). The final versions of the Call Text, Guidelines for applicants and the Proposal application form will be published on the EuroNanoMed II website on 26th November 2015 at the opening of the call and on the relevant national funding organizations’ websites.
The call received 68 proposals. Out of these, 67 were found to be eligible and each was evaluated by three members of the Peer Review Panel (PRP). The PRP members met in Lisbon, Portugal, on June 23rd and 24th 2016, to discuss the 67 eligible proposals and after consideration of the evaluation criteria and their own discussions the PRP identified the top quality proposals recommended for funding and established a ranking list. Based on this ranking list, the final decision on funding was made by the EuroNanoMed II national/regional funding organizations involved in the call; the funding agencies with budget issues found solutions in order to fund as many projects as possible in the ranking list provided by the PRP members. As a result of these efforts, the Call Steering Committee decided to fund 10 projects for a total amount of about 7,5 M€. The 10 projects involved 50 partners from 12 countries/regions. They encompassed all three subfields of Nanomedicine and covered diverse medical issues such as the use of miRNA biomarkers for the detection and treatment of muscular disease, cancer treatments, nanovaccines for anti-tumour immuno-therapy, nanoparticles for heart ischemia/reperfusion, etc.
Overall, these four joint calls for proposals funded 38 (61 with ENM I) transnational research projects on nanomedicine involving 197 partners (319 with ENM I) from 21 countries/regions participating in the calls and 5 additional non-participating countries, with about 28.4 M€ (53.1 with ENM I) funding from the EuroNanoMed funding agencies and a further 17.6 M€ (36.7 with ENM I) contribution from the research partners participating in the funded projects.
✓ Country of origin of the applicants (figure 3)
Altogether, 1159 partners (1659 with ENM I) from 32 countries participated in these joint calls, in a total of 228 (326 with ENM I) submitted projects. As presented in figure 3, the number of applicants per country has globally grown between 2012 and 2016, as well as the number of submitted proposals (from 43 to 68 respectively).
✓ Overview of the 7 joint calls
The table 2 below summarizes the outcomes of the 7 joint calls for proposals:
✓ Participation of research organizations in translational projects in Nanomedicine
As EuroNanoMed I & II joint calls for proposals aimed at funding translational research projects in Nanomedicine, each consortium had to include teams from at least 2 of the following categories: academia, clinic/public health, industry. The distribution between these three categories among consortia funded in the 7 joint calls is outlined in Figure 4. Noteworthy, 53% of the funded projects included partners from all three categories, indicating the high added value of these collaborations in nanomedicine translational research.
✓ Scientific / technological areas covered by funded projects
The 7 joint calls for proposals were open to projects covering at least one of the three priority topics of the European Technology Platform Nanomedicine: Targeted delivery systems, Diagnostics, Regenerative medicine. The coverage of these three scientific areas among funded projects is presented in figure 5.
FOLLOW-UP AND MONITORING OF THE FUNDED PROJECTS
In addition to the implementation of the calls, the JCS was the first point of contact for the coordinators of funded projects (both from EuroNanoMed I and II), and thus collected the annual and final follow-up progress reports and organised three review seminars, on behalf of the Call Steering Committee.
• A Review seminar for funded projects (JTC 2009, 2010 & 2011) and Training workshop on regulatory affairs for funded partners was held in Düsseldorf, Germany, on January 29th and 30th, 2014. Young researchers involved in EuroNanoMed I funded projects were invited to attend this meeting. Concerning the review seminar for funded projects (JTC2009, 2010 & 2011), all the funded projects, except one, were represented. There were 42 participants, who made 16 oral presentations (JTC2009 and 2010) and displayed 20 posters (JTC2009, 2010 and 2011). Three PRP members also attended the meeting. In mid-March 2014, the Call Office sent to the young researcher and attendees of the Düsseldorf meeting: the contact details of all attendees, the contact details of the Training Workshop’s speakers and the PPT presentations of the Training Workshop’s speakers;
• A Review Seminar for funded projects (JTC 2010, 2011 & 2013) and Training Workshop on ethical issues in nanomedicine were held in Oslo, Norway, on December 2nd-3rd 2014. Young researchers involved in EuroNanoMed I and II funded projects were also invited to attend. Among the 31 participants, 13 were young researchers who presented posters (JTC 2010, 2011 and 2013). A Best Poster award was organized to give a prize to the best poster presentation made by a young researcher. The Poster Prize was an invitation to attend the next European Nanomedicine Conference organized by SFNano (December 2015). The three PRP members who chaired the different sessions of the Review seminar evaluated the posters’ presentations and selected the awardee. During the meeting the contact details of all attendees and of the Training Workshop’s speakers were provided to the young researcher and attendees of the Oslo meeting.
• A Review Seminar for funded projects (JTC 2013, 2014 & 2015) and Training Workshop on regulatory affairs for EuroNanoMed funded researchers were held in Berlin, Germany, on October 26th-27th, 2016. Among the 36 participants, 17 were young researchers and displayed posters. A Best Poster award was organized to give a prize to the best poster presentation made by a young researcher. The Poster Prize was an invitation to attend the next CLINAM Conference (May 2017). Two PRP members, who chaired the different sessions of the Review seminar, evaluated the posters’ presentations with the help of four experts from different funding organisations and selected the awardee. During the meeting the contact details of all attendees and of the Training Workshop’s speakers were provided to the young researcher and attendees of the Berlin meeting.
Through WP5, the monitoring and optimisation of activities was tackled by established indicators for evaluation of the ENM II programme; assessing the achievements of EuroNanoMed programme and its activities; monitoring and evaluating the operational processes underlying EuroNanoMed II activities as well as monitoring of the progress of EuroNanoMed I and II funded research projects. The set of indicators was chosen in two main steps. In a first step, a list of indicators was prepared by the task leaders based on their experience in other similar initiatives. This list consisted in 35 indicators which could be divided in 16 indicators to assess the achievements of ENM II and 19 indicators to monitor the ENM I and II funded research projects. For sake of clarity, the indicators were divided in four different types: networking, input, output and socio-economic impact indicators. In a second step, a Workshop was organised during the NSC2 meeting (Venice, Italy, 4th July 2013). During this Workshop, the indicators were discussed and improved and a final list of indicators, ready for approval by the NSC, was produced. In this section of the final report, we will focus on the indicators related to the monitoring of the ENM funded projects. Indicators related to the assessment of the achievements of ENM II and in particular, the ones related to the socio-economic impact will be considered in the next section (potential impact).
Using the indicators developed, the achievements of the EuroNanoMed (I & II) joint calls were assessed after the 3-year research period of the funded projects. The follow-up project reports of the funded projects and the conclusions from the research review seminars had been thoroughly analysed towards the production of an overall call output report (one per call). The call output reports for the three ENM I joint calls (JTCs 2009, 2010, 2011) and for the first ENM II joint call (JTC2013 call) was produced during the lifespan of the ERA-NET. These call output reports were used as a basis to produce public reports on the joint call results to be disseminated via the EuroNanoMed communication tools in WP4 (i.e. website). These reports were also used as input for planning the joint calls (WP2) as well as towards the development of long-term sustainable European cooperation on nanomedicine research (WP6).
Four deliverables focused on the projects funded under the frame of the Joint Transnational Calls 2009, 2010, 2011 and 2013 (JTC 2009, 2010, 2011 and 2013):
o JTC 2009 call output
A total of 24 projects were submitted to JTC 2009 and 8 projects were finally funded for a success rate of 33%. The total costs of the funded projects were of 16.9 M€ with and allocated funding of 9 M€. About 62% of the projects were identified as “Targeted delivery systems” projects and 38% as “Regenerative medicine” projects. The 8 projects funded under JTC 2009 submitted their final report. These projects involved 40 participants from which 31 fully filled in their reports. A total of 9 out of the 40 participants omitted to reply to some questions or gave incorrect answers mainly linked with budget questions. Therefore, the Progress and Final report templates were updated to reduce error rate in the next reports.
The average duration of a project is 3.5 years (42 months) reflecting that 6 projects were extended of 6 months (data missing for 3 projects). Indeed, the maximum duration of the EuroNanoMed proposals was set to 36 months as an eligibility rule. Consortia were composed of 4 to 6 partners (average of 5 partners) and 60% of the partners were from Academia, 22.5% from SMEs and 17.5% from Clinical organisations.
A total of 66 project meetings were held during the lifetime of the projects. The number of meeting by project is varying from 4 to 15 (average of 8). Consortia or part of consortia which had been funded under JTC 2009 submitted 13 proposals to another European Call. Out of these 13 proposals, 3 were applications to another ENM Call. One consortium did not submit any other proposal when the most prolific submitted 4 applications.
As mentioned above, ENM pays particular attention to the involvement of young researchers in ENM projects. In the 8 projects, 73 young researchers were involved with an average of 9 young researchers per project (from 3 to 15) and of 2 young researchers per participant (from 0 to 6). Regarding the mobility of researchers, all projects led to some mobility, at least via lab visits. Half of the projects led to long term mobility, from a couple of weeks up to 6 months. Globally, project partners were very active in terms of publications: 70 articles, 19 books or book chapters, 13 reviews and 18 articles dedicated to general public. Project partners also had many (147) communication in scientific congress and conferences. In addition, 25 dissertation theses were passed in close relation with the ENM projects but no policy document was published.
o JTC 2010 call output
A total of 33 projects were submitted to JTC 2010 and 8 projects were finally funded for a success rate of 24%. The total costs of the funded projects were of 16 M€ with an allocated funding of 9 M€. A total of 5 projects were characterized as “Targeted delivery systems” projects, 3 as “Diagnostics” projects and 1 as “Regenerative medicine” project. The 8 projects funded under JTC 2010 had submitted their final report. These projects involved 46 partners and all of them adequately replied to the questions which is an improvement compared to the JTC 2009 final reports where 31 out of 40 the participants fully filled in their reports. Thus the update performed in the Progress and Final report templates had been fruitful.
The average duration of a project was 3.5 years and a half (41.2 months) reflecting that 3 projects were extended of 6 months and 2 projects were extended of 12 months.
Consortia were composed of 4 to 7 partners (average of 6 partners). About 61% of the partners were from Academia, 24% from SMEs, 13% from Clinical organizations and 2% from a large company.
Regarding the project budget, on average, the partners used about 92% of the planned budget and 98% of the planned funding. In addition, 37% of the partners used budget from external sources. External sources being defined as budget other than the budget claimed within the frame of the ENM project budget. From these 37%, partners clearly use in priority “in kind” efforts to complete the EuroNanoMed public funding.
A total of 48 project meetings were held during the lifetime of the projects. The number of meetings by project is varying from 4 to 11 (average of 6). Consortia or part of consortia which had been funded under JTC 2010 submitted 11 proposals to another European Call. Only 1 out of these 11 corresponded to an application to another ENM Call. Two consortia did not submit any other proposal when the most prolific submitted 3 applications.
In the 8 projects, 81 young researchers were involved with an average of 10 young researchers per project (from 2 to 23) and of 2 young researchers per participant (from 0 to 8). Regarding the mobility of researchers, all projects lead to some mobility, at least via lab visits. Half of the projects lead to long term mobility, from a couple of weeks up to 6 months.
Project partners were very active in terms of publications: 70 articles, 19 books or book chapters, 13 reviews and 18 articles dedicated to general public. Project partners also had many (147) communications in scientific congress and conferences. In addition, 14 dissertation theses in close relation with the ENM projects were defended.
o JTC 2011 call output
A total of 41 projects were submitted to JTC 2011 and 7 projects were finally funded for a success rate of 17%. The total costs of the funded projects were of 11.1 M€ with an allocated funding of 6.3 M€. One project was characterized as “Targeted delivery systems” project, 2 as “Diagnostics” projects, 2 as “Regenerative medicine” projects, and 2 as “Targeted delivery systems & Diagnostics” projects.
The 7 projects funded under JTC 2011 had submitted their final reports. These projects involved 35 participants.
The average duration of a project was 3 years (37,6 months) reflecting that 3 projects had extended the project duration and 1 project length was only 30 months. Consortia were composed of 3 to 6 partners (average of 5 partners) and 74% of the partners were from Academia, 14% from SMEs and 12% from Clinical.
Regarding the project budget, on average, the partners used about 96% of the planned budget and funding. In addition, 51% of the partners used budget from external sources. External sources being defined as budget other than the budget claimed within the frame of the ENM project budget. From these 51%, partners used mainly “in kind” efforts and other public funding to complete the EuroNanoMed public funding.
A total of 32 project meetings were held during the lifetime of the projects. The number of meetings by project is of 4.6 average, ranging from 5 to 7.
Consortia or part of consortia which had been funded under JTC 2011 submitted only 1 proposal to another European Call.
In the 7 projects, 59 young researchers were involved with an average of 8 young researchers per project (from 3 to 17) and of 2 young researchers per participant (from 0 to 7). Regarding the mobility of researchers, all projects lead to some mobility, at least via lab visits. Two projects lead to long term mobility, from a couple of weeks up to 4 months.
Project partners were very active in terms of publications: 50 articles, 12 books or book chapters, 6 reviews and 5 articles dedicated to general public. Project partners also had many (124) communications in scientific congress and conferences. In addition, 9 dissertation theses in close relation with the ENM projects were defended.
o JTC 2013 call output
Another of the ENM II deliverables focused on the projects funded under the frame of the 2013 Joint Transnational Call (JTC 2013).
A total of 43 projects were submitted to JTC 2013 and 8 projects were finally funded for a success rate of 19%. The total costs of the funded projects were of 11.5 M€ with an allocated funding of 7 M€. Among these projects, 2 were characterised as “Targeted delivery systems” projects, 2 as “Diagnostics” projects, 3 as “Targeted delivery systems & Diagnostics” projects, and 1 as “Targeted delivery systems & Regenerative medicine” project. The 8 projects funded under JTC 2013 involve 42 participants.
It is important to highlight that projects funded under JTC-2013 started in 2014 and that, in consequence, most of them had not finished when we produced the report. Only one project was finished after 24 months and has delivered its final report. Thus, information given hereafter is based on the periodic reports (years 1 and 2). In consequence, data related to individual partners was not available since only data at the consortium level was requested in the periodic reports.
The average duration of a project was 33 months but since projects were not yet finished, an extension (of 6 months) was possible and even probable.
Consortia were composed of 4 to 7 partners (average of 5 partners) and 63% of the partners were from Academia, 23% from SMEs, 12% from Clinical organizations and 2% from large companies.
A total of 27 project meetings were held during the two first years of the projects. The number of meetings by project is varying from 2 to 5 (average of 3).
Consortia or part of consortia which had been funded under JTC 2013 submitted 11 proposals to another European Call. Only 1 out of these 11 corresponded to an application to another ENM Call. Two consortia did not submit any other proposal when the most prolific submitted 4 applications.
In the only project finished at the time of the analysis, 4 young researchers were involved. Regarding the mobility of researchers, all projects lead to some mobility, at least via lab visits. Two projects lea to long term mobility of at least two weeks.
Project partners were very active in terms of publications: 47 articles, 4 reviews and 4 articles dedicated to general public. Project partners also had 40 communications in scientific congress and conferences. In addition, 6 dissertation theses in close relation with the ENM projects were defended.
REGULATORY AFFAIRS, ETHICAL AND SAFETY ISSUES
To successfully transform innovative research to the market, stakeholders usually have to surmount a number of obstacles. In addition to technical hurdles which are inherent to scientific research, there are “non-technological barriers” that may hinder market access of R&D results. One major non-technological barrier in the healthcare sector is the challenging regulatory framework that makes market approval of new drugs time demanding and costly. This is especially true for nanomedicine, as nanomedical products are often on the borders between medical products and pharmaceuticals and therefore are subjected to different regulatory frameworks. This fact is the source of uncertainties with regard to market accreditation. Regulatory frameworks should be discussed on a European rather than at a national level. In this context, EuroNanoMed offered a unique platform to deliberate regulatory issues that will facilitate the transfer of nanomedicine knowledge from the laboratory to the patient.
Hence, through WP3, EuroNanoMed II aimed at 1- training funded researchers in regulatory issues to be considered during their projects; 2- fostering dialogue among nanomedicine stakeholders from research, industry, agencies & policy makers; and 3- addressing ethical & safety issues that are pivotal for public acceptance of nanomedical products.
TRAINING ON REGULATORY AFFAIRS FOR EURONANOMED FUNDED RESEARCHERS AND ENHANCING EXPERTS DIALOGUE
• On one hand, the aim was to inform and train researchers about regulatory requirements that nano-medical products will have to meet to pass from the research stage towards a later application or a fast entry into clinical trials, and how they should be considered during their research projects. Issues relating to intellectual properties were also addressed.
In order to achieve this, a workshop was organised for researchers from EuroNanoMed (I&II) funded projects. Experts from industry, medical product agencies and notified bodies were invited to give presentations and to participate in round tables. Beyond the training aspect, the workshop also allowed an interaction between the researchers and the experts – especially from regulatory agencies and EMA – to call the experts attention to the researchers’ needs and problems. This workshop on regulatory affairs was organized in Düsseldorf, Germany on 29th January 2014 back to back to one of the review seminars described earlier. As target audience, researchers from all ongoing ENM projects were invited to the workshop, the coordinator (or another senior PI) and one young researcher from every project. Many partners of the ENM II consortium also attended the workshop as well as some members of the ENM II external advisory board (EAB). After an introduction by the ENM coordinator and NSC chair with general information about ENM and upcoming calls and activities, different nanomedicine related topics on regulatory issues were addressed, treating the three subfields of nanomedicine: targeted delivery, diagnostics and molecular imaging and regenerative medicine. In addition, a case study of the successful translation of a nanomedical product was presented as well as presentations about IPR issues and ethical and safety issues in nanomedicine. Lectures on the following topics were hold (speakers in brackets):
o General overview on the regulation of nanomedical products and upcoming new regulations from EMA (Rogério Gaspar, Advisory expert to the EMA);
o Process and general requirements for the approval of nanomedical products (René Thürmer, German Federal Institute for Drugs and Medical Devices);
o Regulation of combination products (Sophie Tabutin, British Standards Institution)
o New Imaging agents – State of the art and regulatory challenges (Philippe Bourrinet, Guerbet),
o Regenerative medicine and stem cell therapies (Volker Scherhammer, apceth)
o Translation of nanomedicine to the clinic – a successful case study (Bernd Mühlenweg, Nanobiotix);
o Intellectual Property Rights Manangement (Carsten Richter, European patent attorney);
o Ethical and Safety Issues in nanomedicine (Adriele Prina-Mello, Trinity College Dublin).
In addition, other initiatives relevant to the field of nanomedicine, translational medicine and clinical research have been invited, to present their activities and services to the ENM researchers.
o European Technology Platform on nanomedicine (ETPN) (presented by Patrick Boisseau, chairman of the ETPN);
o European Clinical Research Infrastructure Network (ECRIN) (presented by Christine Kubiak, ECRIN executive manager);
o European Infrastructure for Translational Medicine (EATRIS) (presented by Anton Ussi, EATRIS head of operations).
The presentations of all speakers have been distributed to the workshop attendees and a report has been produced.
• On the other hand, Following the success of the first training workshop and the good feedback from the attendees, it was decided by the NSC to replace the initially planned “experts’ dialogue” by a second training workshop for funded researchers. This decision was approved by the project officer and the work program was amended accordingly.
The second workshop on regulatory affairs was organized in Berlin, Germany on 26th November 2016, back to back to one of the review seminars described earlier. As target audience, researchers from ongoing ENM projects from JTC-2013, 2014 and 2015 were invited to the workshop, the coordinator (or another senior PI) and one young researcher from every project. Many partners of the ENMII consortium also attended the workshop as well as two invited PRP experts. The workshop was aiming at a) providing the ENM funded researchers with information about regulatory issues and raising their awareness to consider these issues already at an early state in their projects and b) to introduce relevant European initiatives in the field of nanomedicine that could be helpful to researchers to provide information or for potential collaboration.
After an introduction by the ENM coordinator and the WP leader with general information about ENM and the aims of the meeting, in the first part of the workshop different nanomedicine related topics on regulatory issues were addressed, treating the three subfields of nanomedicine: targeted delivery, diagnostics and molecular imaging and regenerative medicine. In addition, a case study of the successful translation of a nanomedical product was presented. Lectures on the following topics have been hold (speakers in brackets):
o Process and general requirements for the approval of nanomedical products (René Thürmer, German Federal Institute for Drugs and Medical Devices)
o New Imaging agents – State of the art and regulatory challenges (Philippe Bourrinet, Guerbet)
o Regulation of combination products (Susanne Hebestreit, i.DRAS GmbH)
o Cell Therapies of the next Generation – Advanced Therapy Medical Products (ATMP) (Suncana Kern, apceth GmbH)
o Translation of nanomedicine to the clinic – a case study (Timm Jessen, Topas Therapeutics GmbH)
In a second part, relevant initiatives in the field of nanomedicine and translation had been invited to present their activities and services to the ENM researchers.
o European Technology Platform on Nanomedicine (ETPN) (presented by Klaus-Michael Weltring, Bioanalytik Münster)
o ENATRANS Project (presented by Nicolas Gouse, Coordinator of ENATRANS)
o European Nanomedicine Characterization Lab (EU-NCL) (presented by Simon Baconnier, CLINATEC)
o GMP Pilot Line: Nanofacturing (presented by Justin Barry, Midatech)
o GMP Pilot Line: NanoPilot (presented by Iradia Loinaz, Cidetec)
Finally, a presentation about Ethical and Safety Issues was given by Cecilie A. Mathiesen (partner 13, RCN) summarizing the main results of the ENMII workshop on Ethical Issues in Oslo, Norway in December 2014 (see below).
The presentations of all speakers were made available as download to the workshop attendees and a report on the workshop was produced.
FRAMING NANOMEDICINE ETHICAL ISSUES
Since the emergence of the nanotechnology field, the ethical issues about nanomaterials have raised concern and have been discussed. As a result, the European Group on Ethics published in 2007 their “Opinion on the ethical aspects on nanomedicine” and, in 2008, the European Commission published the “Code of Conduct for Responsible Nanosciences & Nanotechnologies Research”, as guidance for the responsible development of nanotechnologies. The goal of this task was to explore and frame the ethical issues associated with the nanomedicine field with the aim of better taking ethics into account in defining future activities.
• A report on ethical issues and stakeholders’ attitudes towards the code of conduct in nanomedicine was produced. The report gave a summary of the actual regulatory framework in 2012, taking into consideration the general regulations applicable to nanomaterials and the specific provisions that were planned for the future. The report also addressed hazard assessment of nanomaterials, focusing on the connection between their physicochemical characteristics and the possible mechanisms of toxicity and also addressed relevant ethical questions in nanomedicine like citizens’ perception of risks and benefits of nanomedicine as well as questions of transparency and public participation to scientific discourses. It reviewed ongoing activities in the field of ethics in nanotechnology and summarized existing studies and articles on this topic. This report was used as an input for the discussions during a workshop on ethical issues that was organized in Oslo in December 2014 (see below). As knowledge and regulatory provisions about safety aspects of nanomaterials progress permanently, the statements and conclusions of the report were reviewed in 2016 to get an up-to-date picture of Nanomedicine safety issues. This updated report will also serve as an input for the successor initiative EuroNanoMed III.
• A workshop on ethical issues in nanomedicine was organized in Oslo, Norway on 3rd December 2014. As target audience, researchers from all ongoing ENM projects were invited, the coordinator and one young researcher from every project. All ENM JTC 2010, 2011 & 2013 funded projects except two were represented and most of the partners of the ENM II consortium attended the workshop. The workshop included different lectures on ethical topics given by European ethical experts. Additionally, a practical example was given, wherein a researcher presented his project with main focus on the ethical aspects.
The plenary session of the workshop started with a general presentation of EuroNanoMed II by the coordinator and a presentation of the work package on regulatory, ethical and safety issues in nanomedicine by the work package leader. Then, different ethical topics were addressed by European experts:
o Report on ethical issues and stakeholders attitudes towards the code of conduct (Dr. Ioana Ispas, Advisor Bioethics Genomics & Health, EuroNanoMed partner, MEN, Romania)
o Presentation of the output of EuronanoMed2: mapping of European activities on ethical issues in nanomedicine (ANCS, Romania).
o Occupational peculiarities and hygienic solutions for exposure to engineered nanoparticles (Dr. Raz Dekel, head of occupational medicine, MD MOccH, Head of Occupational Medicine service, Meuhedet HMO, Israel)
o The art of medicine versus technologies of human enhancement: ethical and epistemological considerations (Prof. Jan-Helge Solbakk, Head of Research Centre for Medical Ethics Faculty of Medicine University of Oslo, Norway)
o Ethics of Nanotechnology – Mapping the Terrain, Identifying the Grid (Dr. Gil Siegal, MD, LLB SJD is a surgeon and a health law professor, chairs the Center for Health Law and Bioethics at Ono College, Israel)
o Practical example (Prof. Catharina de Lange Davies, Department of Physics, Norwegian University of Science and Technology, Trondheim, Norway)
o The Project “Multifunctional nanoparticles for drug delivery across the Blood-Brain-Barrier” has been reviewed in terms of working on ethical issues.
These talks were followed by a practical exercise, involving the audience and bringing closer an ethical matrix: the audience was divided in working groups, each consisting of five people. The groups could choose between two projects and analyse three chosen ethical questions and the respective stakeholders, i.e. groups of people or single people affected by the ethical questions. Both projects were represented by a principle investigator to provide additional information if requested. The workshop ended with an open discussion between all participants and speakers.
o Presentation of the "Ethical matrix" exercise (Dr. Ioana Ispas)
o Presentation of two EuroNanoMed2 funded projects: "Gadolymph" and "Nanoasit"
o Discussion on the ethical roadmap, chaired by Dr.Gil Siegal
o Discussion on the role of researchers and funding agencies, chaired by Dr. Klaus-Michael Weltring, chair bioethics group, ETPN.
Most of the presentations were filmed and are available at the ENM website. In addition, based on this workshop, a scientific article was published: Ethical issues in nanomedicine: Tempest in a teapot? Allon I, Ben-Yehudah A, Dekel R, Solbakk JH, Weltring KM, Siegal G. Med Health Care Philos. 2016 Aug 13.The presentations of all speakers were disseminated to the workshop attendees and a report has been written.
FRAMING NANOMEDICINE SAFETY ISSUES
The aim of this task was to provide a periodic update on the relevant nanotoxicology research and regulation initiatives carried on at European level. Several projects -those already started, networked actively in the EU NanoSafety Cluster (www.nanosafetycluster.eu) with other new projects starting later- were supposed to provide information concerning the safety of nanomaterials, the use of validated methods for nano-risk assessment, roadmaps and priorities for future research, integrated and intelligent testing strategies, and the future regulatory framework for engineered nanomaterials. Nanomedicine is one of the key applications of engineered nanomaterials, and all these activities were expected to have a substantial effect on biomedical applications of nanotechnology.
A report was produced to provide a short review of the state of the art concerning safety issues in nanomedicine, updating the last report on this issue provided under ENM I. The report summarised the safety regulatory framework, took into consideration the general regulations applicable to nanomaterials, and the specific provisions that were planned in the future. The report also addressed the knowledge available at the moment concerning hazard assessment of nanomaterials, focusing on the connection between their physicochemical characteristics and the possible mechanisms of toxicity.
Potential Impact:
STRATEGIC IMPACT
EuroNanoMed I gathered the participation of partners from 18 countries and regions and generated the support of 24 RTD projects in nanomedicine through three calls for proposals. ENM I achieved a critical mass of players, arousing translational collaborations between three research communities: academic, industrial and clinical research, with projects covering the three main subfields of nanomedicine, i.e. targeted drug delivery, diagnostics and regenerative medicine. However, the EuroNanoMed I initiative was limited to 3 years only and the majority of the partners consider that the continuation of ENM I with ENM II was of major importance in order to:
• Support more transnational projects to foster the European research community in nanomedicine with the objective of creating a European Research Area in nanomedicine. New calls for proposals will take benefit of the communications already disseminated with regards to the ENM I calls.
• Promote the topics considered as priorities for the NMP unit and for the ETP Nanomedicine, in particular the translational aspects of nanomedicine , .
• Foster the participation of young researchers.
In addition, EuroNanoMed II contributed to EU policies and priorities, such as strengthening the European Research Area, advancing the transition to personalised and targeted medicine, boosting translational and clinical research, and focusing on transferring scientific results towards innovation in healthcare in Europe.
The strategic impact of the ERA-NET EuroNanoMed II can therefore be considered at different levels.
IMPROVE COORDINATION AND REDUCE FRAGMENTATION IN THE FIELDS OF RESEARCH OF NANOMEDICINE
➢ EuroNanoMed II has improved the coordination of national programmes in nanomedicine
In EuroNanoMed I, although only two joint transnational calls were planned to be launched in 2009 and 2010, the consortium decided to launch a third call before the end of the ERA-NET, showing the involvement and the willingness of the partners to coordinate their programmes in nanomedicine. With this second ERA-NET, involving the majority of partners of ENM I plus three new partners, the consortium has improved the coordination of the research programmes already set up during ENM I. ENM II greatly benefited from the tight links between partners and the experience achieved in ENM I.
The coordination of European programmes in nanomedicine has improved through the common work planned in this project:
• Fostering a network of national/regional programme managers working closely together and learning from each other. This builds mutual understanding and trust that have long lasting effects.
• Defining the common procedures, practices and documents for each of the four planned joint transnational calls for proposals;
• Organising the implementation and the follow-up of the funded projects; which required a sustainable work in synergy between the partner funding agencies over many years.
Moreover, the final goal of ENM II was to propose and establish a sustainable cooperation framework after the end of this second ERA-NET. This ambitious goal was achieved through the WP6, which was specifically dedicated to the preparation of this future cooperation towards a common joint programme in nanomedicine. All aspects of a future cooperation were explored with a step by step approach: benchmarking with sister initiatives; gathering the needs and expectations of the partners; identifying the administrative and financial constraints of the partners. The aim was to achieve a realistic cooperation between the funding agencies allowing the support of transnational nanomedicine research after the end of the ERA-NET and hopefully over many years. Finally, the continuation of EuroNanoMed activities became a reality thanks to the support of the EU through a third phase under Horizon 2020 ERA-Net cofund scheme.
➢ EuroNanoMed II has reduced fragmentation in the key fields of research of nanomedicine
The four joint transnational calls for proposals in nanomedicine launched through EuroNanoMed II contributed per se to reduce the fragmentation of the ERA in nanomedicine. The impact of these calls on fragmentation is significant since they were launched in continuation to ENM I. Therefore, they took benefit from the visibility and the success of the calls launched through ENM I. Considering the 18 countries/regions involved in ENM II, the joint calls for proposals allowed the support of partnerships between the majority of the European nanomedicine players, contributing to the construction of the ERA in nanomedicine.
EuroNanoMed II filled in existing gaps in the European landscape and was complementary to existing initiatives. There was a real need of support for the different stages of the value creation chain in medical applications of nanotechnology and specifically through an industry/application/patient driven-approach. As already done in ENM I, ENM II has provided fast allocation of seed funding for innovative ideas and concept, where a limited number of partners is required and with this translational approach. This ERA-NET was therefore highly complementary to FP7 large scale projects funding tools (e.g. EUREKA, Eurostar, IMI) and FP7 programmes (NMP, HEALTH) with a heavier and longer application process and support for larger projects. Moreover, the existing ERA-NETs did not include explicitly nanomedicine as a key target neither had rules that were relevant to nanomedicine projects:
• SIINN dealt with the potential risks of engineered nanomaterials for the environment, human health, and safety. This was very complementary to the ENM II research programme on using nanotechnology for medical applications. Many links had been made with the ERA-NET SIINN since 8 partners were involved in both SIINN and ENM II and the coordinator of ENM II, ANR, was in charge of the work package on joint calls in SIINN.
• EuroTransBio aimed to foster the competitiveness of the European biotechnology industry, which was a border to some specific actions of nanomedicine. However, nanomedicine, or even nanobiotechnology, was not included specifically in their programme. In addition, the constraint for proposals to be coordinated by an SME and to include at least 2 SMEs per project was not applicable to the nanomedicine field which was less mature than biotechnology.
• MANUNET II was strictly focusing on market-oriented enterprise-led R&D projects related to the application and practical use of manufacturing technologies.
With the lessons learned from ENM I, ENM II has gained in efficiency and allowed a more sustainable impact on nanomedicine research. ENM II therefore contributed to the development of innovative therapeutic solutions for the patient and to the competitiveness of the European health industry. The aims of ENM II were thus in line with the European and NMP policy stressing the importance of solid and nationally-funded research efforts allowing cross-border cooperation between the best researchers from public and private sectors .
ACHIEVE CRITICAL MASS AND ENSURE A BETTER USE OF LIMITED RESOURCES IN THE FIELDS OF RESEARCH OF NANOMEDICINE
➢ EuroNanoMed II achieves a critical mass of players and focuses on translational collaborations
To achieve products in nanomedicine, the critical issue is to enable fundamental research to enter into preclinical and first clinical stages. To this aim, it is necessary to facilitate cross-fertilisation between the different players (industry, clinic and academia) and to reach a critical mass of players at the European level. With 21 partners from 18 countries/regions, ENM II covers the major part of the European research community. Moreover, considering the results already achieved in ENM I (i.e. the participation of more than 500 applicants to the three ENM I calls and the increased number of proposals from one call to the next) and the visibility of the ERA-NET, ENM II expects to have a significant impact on the European nanomedicine RTD landscape. In order to facilitate the transfer from research to companies and patients, there is a need to have enough academic teams, clinical teams and companies within research consortia. As such, in ENM I, translational collaborations were required through the calls eligibility criteria. Each consortium had to involve at least two categories of partners among clinical, industrial and academic research teams. ENM II also encouraged translational collaborations and gathered a sufficient number of players of all categories, taking together the 18 countries/regions partnering in the initiative.
➢ A greater impact with EuroNanoMed II joint transnational calls for proposals than the sum of the national ones
National programmes have difficulties to support transnational projects and, in the specific field of nanomedicine, there are often too few players at the national levels to achieve a critical mass. In addition, although nanomedicine has significant implications on the major diseases in Europe, the national calls for proposals are usually focused on specific diseases, making the more methodological field of nanomedicine less prioritised. On the other hand, the EU programmes (FP7 and the future Horizon 2020) have budget limits for each field, and often many good projects cannot be supported. ENM II continued and improved the funding mechanism created by ENM I to support transnational collaborative RTD projects between academia, companies (especially SMEs) and/or clinical/health care settings in nanomedicine, based on actual needs.
The effectiveness and the uniqueness of the ENM II funding programme resulted from the association of three characteristics:
• It was fully dedicated to nanomedicine;
• It was directly funded by national and regional funding organisations;
• It has fostered translational collaborations favouring the development of patient/person-oriented and/or industry-oriented projects.
Under WP6, ENM II specifically put some efforts to update and complement information on national strategies and programmes for nanomedicine. This was the continuation of the monitoring of the ENM II initiative and the starting point for building a long-term sustainable cooperation framework for nanomedicine research in the future. The aim was to gather the needs of EuroNanoMed II partners, as well as other relevant ministries and funding agencies interested in a funding collaboration in nanomedicine, and what they expected for a future cooperation scheme. An expectations’ questionnaire was launched and stakeholders’ needs were discussed in a workshop.
Within the framework of EuroNanoMed I, a survey was performed in early 2009 to gather information on national strategies and programmes and initiatives in nanomedicine among the partners, as well as on funding approaches among nanomedicine players in Europe. This task envisaged the update of the information on national strategies and programmes for nanomedicine on the future of the network collaboration. This survey was updated by: a) sending the original questionnaire to partners that were either new or did not provide answers to the first questionnaire, b) submitting a brief questionnaire to all partners asking for relevant information on recent programmes or initiatives in nanomedicine and changes in their strategy for nanomedicine R&D. The results of both surveys were analysed and presented at the 2nd NSC meeting in Venice, Italy (July 4th 2013). Eighteen organisations out of twenty contacted completed the survey. In addition, UEFISCDI provided access to this online questionnaire to our colleagues from ETPN, so that they could collect this kind of information from partners external to ENM II. UEFISCDI shared with ETPN the information collected by this survey and their analysis. The results of the survey were used to produce the Strategic Research and Innovation Agenda on nanomedicine (see next).
SHARING GOOD PRACTICES IN IMPLEMENTING COMMON RESEARCH PROGRAMMES
ENM II contributed to the improvement and harmonisation of the public policies aiming to support collaborative innovative RTD projects between academics, companies/SMEs and/or hospital/health care settings. During ENM I, a mapping and analysis of the practices existing in participating organisations led to agreeing on best practices that were implemented in the calls. ENM II has updated this mapping and analysis and also benchmarked with similar initiatives (see below). This was very valuable towards improvements in the call procedures and to help identify different schemes for a sustainable cooperation of the ENM II partners after the end of the ERA-NET (WP6, see below). In addition, the lessons learned (WP5) from each call and the continuous systematic exchange of information suggested the best ways for improving existing practices. This iterative process helped in meeting the goal not only to share good practices but to effectively use these practices.
EuroNanoMed II thus contributed to the preparation and use of European standards, with respect to:
• The "systematic" approach for compiling and comparing research programmes (i.e. congruence of terms, standard data formats, software solutions);
• Best practices with regards to programme management and administration as well as innovation issues in R&D funding;
• To define and validate appropriate tools and procedures for the selection of multinational projects and for the monitoring and assessment of multinational procedures;
• To harmonise evaluation practices of public funding bodies in Europe, especially the common use and precise definition of criteria and terms like e.g. “scientific excellence”, technology transfer, market relevance, clinical/public health needs, etc.;
• General agreements and principles for transnational research activities in the long-term (e.g. rules for a contractual and legal framework, models for transnational funding scenarios);
• Consistent IPR arrangements in transnational research funding;
• Dissemination of EMA applicable standards to nanomedicine clinical validation steps within the “nano community”.
A close cooperation with specific European stakeholders was essential to achieving the objectives of ENM II and fostering a long-term cooperation framework for a joint funding programme in nanomedicine. The EuroNanoMed Coordinator and the related WP leaders were in charge to conduct on a regular basis discussions and exchanges with the following networks:
- The European Technology Platform (ETP) on Nanomedicine;
- Other ERA-NETs (e.g. SIINN, EuroTransBio);
- The European Joint Technology Initiative for Innovative Medicine (IMI);
- The CSA NANOMED 2020;
- The CLINAM (network of clinicians working in Nanomedicine).
The collaboration with the ETP Nanomedicine already set up during ENM I was indeed strengthened in ENM II. A representative of the ETP Nanomedicine Executive Board was invited to attend the ENM II NSC meetings. This ETP representative conveyed to ENM II the voice of the platform, meaning the position of the private and public researchers. Vice versa, a representative of the ENM II consortium participated in the Executive Board of the ETP Nanomedicine. Moreover, since some EuroNanoMed NSC members were Mirror group members of the ETP Nanomedicine (Public Authorities representatives at national, regional and European level), they had the possibility to convey their position to the board of the ETP Nanomedicine. The channel of communication between ENM II and the ETP thus functioned in both directions. This collaboration with the ETP Nanomedicine was necessary for the implementation of the different workshops described in this report.
➢ Strategic Agenda for EuroNanoMed II from present to future
Nanomedicine is a rapidly evolving field, and to ensure that the EuroNanoMed II joint activities aim to tackle the unmet clinical needs and the global competitiveness of the European nanomedicine RTD, it is important to monitor the current trends in the field and the unmet clinical needs. This was performed in close collaboration with the European Technology Platform (ETP) Nanomedicine and using the documents they produce as input. The objective was to refresh the ENM I strategic agenda during ENM II.
During the 3rd NSC meeting (31st January 2014) the coming work to reach the objective in conjunction with ETPN plans was presented. As first step, questionnaires developed by the different Working Groups of ETPN (especially the Working Group on Clinical Interface) were distributed to the relevant research groups funded by ENM Joint Transnational Calls. A high-level ETPN meeting took place to discuss, group and filter the inputs received, before defining the next steps towards the establishment of the SRIA. This meeting took place on 24th April 2014 in Brussels and representatives from IMH and SRC (in charge of ENM II SRA) attended this meeting. After this ETPN meeting, it was decided to extend the survey and address all nanomedicine stakeholders in order to validate the first results obtained. ETPN asked ENM II to send an invitation to all ENM II members (both PIs and funded researchers) asking them to contribute to the next Strategic and Innovation Agenda for Nanomedicine in Europe, and to invite all of their industrial/SMEs’ contacts working in the field to contribute as well.
The ETPN online survey towards its Strategic Research and Innovation Agenda (SRIA) was modified and more focused on TRANSLATABLE nanomedicine. The survey was slightly modified accordingly, and the new link sent to ENM researchers was: https://www.surveymonkey.com/s/Towards_ETPN_SRIA_II.
During the ETPN general assembly in San Sebastian (November 2014) the Working Groups presented and discussed propositions, which were consolidated so that a list of technical priorities, clinical applications and roadmap for each sector could be used for the preparation of the SRIA. Some of these priorities were formulated to feed the WP 2016/2017 in H2020, among these, one ERA-NET Cofund (EuroNanoMed III).
At the 5th NSC meeting (December 4th, 2014), SRC presented the state of the art of the SRIA under preparation. The SRIA preparation was delayed due to the preparation of the new status of ETPN, and the preparation of the interphase with other KETs. From September 2015 ENM II has collaborated very actively in the preparation of the final version of the SRIA. A Conference Call with ETPN for better organise the finalisation of the SRIA was organized. The responsibilities of the different chapters and sections were distributed among ENM Coordination Unit, ETPN, SRC and ISCIII. At the ETPN Annual Event in Dublin (12th to 14th October 2015), some ExBo members, ENM coordination unit, WP3 leader (VDI) and WP6 leader (ISCIII) met in order to discuss the first draft texts provided by ENM II.
Hence, questionnaires were disseminated to relevant scientists, opinion-leaders and other stakeholders in the field of nanomedicine. A constant effort was made along the preparation of the document to make it accessible for audiences with very different backgrounds such as technologists, clinicians, patients and the large public as Nanomedicine is a multidisciplinary issue which addresses a large scope of users. The information compiled through these questionnaires was analysed and confronted to other sources of information (ETP Nanomedicine documents), and an updated “European Strategic Research Agenda on Nanomedicine” for ENM II was finally produced in January 2016. This strategic agenda was used as input or reference for all the activities of ENM II: definition of research programmes and call topics in WP2, framing nanomedicine-issues in WP3, dissemination activities in WP4, monitoring activities in WP5.
In Lisbon (June, 2016), the SRIA was presented to the EuroNanoMed partners. Among the recommendations of the SRIA we could highlight the following issues important for the future of ENM (ENM III):
• Detailed recommendations for R&D topics on selected diseases that affect a large number of patients: cardio-vascular diseases, cancer, diabetes, neurodegenerative diseases, infection diseases, osteoarticular pathologies and others
→ Will ENM calls remain open or focused in disease topics? This will need to be discussed during ENM III.
• Focus is set on translation of research results, i.e. the capacity to move the lab proof of concept towards an approved and certified product available for patients on the healthcare market
→ENM III big efforts will be put here. Among other things, ENM III has planned to set up a series of collaborations with the main stakeholders involved in this translation of research results in the field:
Finally, a second update of the strategic agenda was made in the last year of ENM II for planning future sustainable collaboration in this field.
➢ Develop a cost model for maintenance of a collaboration network for RTD funding in nanomedicine
Another important ENM objective with high impact was to develop a cost model for future cooperation among partners after the end of this ERA-NET. A business plan was developed to ensure that cooperation was possible without the EC “glue money”. Based on the needs and expectations of EuroNanoMed II partners and on the analysis and input from other initiatives, a cost model for a common joint management hub was explored. Administrative and legal architecture concepts and financial plans with cost models to share central management costs were discussed. For example, one possibility that was examined was for the partners to jointly fund a Joint Office after the present phase for coordination of the network. Possible financial models and administrative modes of cooperation were explored and discussed in a workshop, with the aim of coming up with a solid business plan. This workshop was held during the 7th NSC meeting (on 9th December 2015, in Grenoble) and focussed on lessons learned from experiences in other ERA-NET Co-Fund (use of EC funding for management, funding gaps in the ranking lists, etc.). Experienced ERA-NET Co-Fund coordinators were invited, and the lessons learned used for the preparation of the ENM III proposal, especially the risk assessment section. The results of the Workshop and main outcomes were part of a report on the cost model for a cooperation joint management hub.
➢ Long-term cooperation framework for continued joint RTD funding in nanomedicine
ENM II finally aimed to build a self-sustained transnational funding programme in nanomedicine with regular funding initiatives, based on the updated EuroNanoMed II strategic agenda. The results of the workshop on financial and administrative models for sustained cooperation, as well as the strategic agenda in nanomedicine were used as input to propose a full scenario for a sustainable network. In addition, during NSC 4 meeting (Tenerife, June 20th, 2014), due to the preparation of the Horizon 2020 Work Programme 2016-2017, all ENM II partners were advised by WP6 leader to contact their national representative of the Programme Committee to express the country interest in including a new topic for an ERA-NET Cofund on Nanomedicine in order to continue EuroNanoMed activities. With the first drafts of the WP some modifications were needed. The Coordination Unit and NSC members prepared a two-pages document intended to help ENM partners to disseminate about ENM activities and our intention to continue our collaboration through the ERA-NET Cofund instrument, which should appear in the H2020 WP for 2016.
Before NSC6 meeting (Jerusalem, June 25th, 2015), the Coordination Unit started to contact new putative partners interested in the next phase of EuroNanoMed (EuroNanoMed III). ENM II partners were asked for their intention to continue the collaboration and invitations to new potential partners were sent. WP6 leader and all partners were asked for contact persons at different funding organizations in Europe and beyond.
A questionnaire was also prepared in order to serve both for gathering partners’ needs and expectations and shaping ENM III proposal. The questionnaire was launched in September 2015 and sent to interested partners in ENM III besides the ENM II partners. They were asked to express their interest in leading specific tasks, WPs or interest in develop activities for the future phase.
After the publication of the draft WP2016/2017 with the inclusion of the topic for an ERA-Net Cofund on nanomedicine, the cooperation framework was assured. This new scenario was not clear at the time of the preparation of ENM II proposal, thus ENM partners decided to slightly change the approach of this task. The envisaged “workshop with policy makers and funding organization representatives of current and prospective partners” was devoted to learn from EuroNanoMed II experiences at the final meeting together with coordinators of funded projects, invited speakers and representatives of funding organisations. A session on lessons learned for future activities was carried out at final meeting in Berlin and interested partners discussed their commitment to the framework for continued collaboration.
The detailed results of the Workshop were compiled in a report on the cooperation framework scenarios.
PROMOTE TRANSNATIONAL COLLABORATIONS AND GENERATE NEW KNOWLEDGE
EuroNanoMed II calls for proposals have made transnational collaboration mandatory, and the added-value of this transnational collaboration, one of the evaluation criteria. For the national players, ENM II has broadened their opportunities to participate in collaborative innovative RTD projects. It has extended the field of partnership to all the 18 countries/regions members of the initiative, exploiting the domains of expertise of public researchers, of clinicians and of private researchers. The access to a very large number of potential partners has stimulated creativity of the different players of the field, generating new knowledge and more knowledge transfer than national projects. The fostering effect of the ENM II transnational joint calls for proposals has improved the quality of submitted proposals by:
- Making it easier to find specific competencies and skills;
- Facilitating European collaborations and synergies;
- Facilitating multidisciplinary approaches, a crucial issue in the field of nanomedicine;
- Generating more robust, ambitious and structured innovative RTD projects.
Finally, EuroNanoMed II has organised three big review seminars for the partners of the EuroNanoMed (I&II) funded projects and young researchers involved in the funded projects, with the participation of high-level invited scientists and European and national representatives. These events brought together the key players in the European nanomedicine research communities and thus further promoted interactions and collaborations at a European level.
As mentioned earlier in the follow-up and monitoring of funded projects section, EuroNanoMed II was assessed with a set of indicators which were identified to monitor both the ENM II programme and the funded research projects of ENM I and ENM II under WP5. The indicators took into account (1) the aims of the ENM II programme (described in this document) and (2) the aims of the calls that had to be addressed by the applicants for joint research projects (described in the published call texts). The selected indicators were used to continuously monitor ENM II activities and performance, and these were confronted with the results about the expectations of the involved partner organisations. Among the 35 identified indicators, 16 indicators were used to assess the achievements of ENM II. The indicators were divided in four different types: networking, input, output and socio-economic impact indicators. Regarding the output and socio-economic impact indicators, from the start of the EuroNanoMed II programme, the network initiated a structured monitoring process of the Consortium activities. It was carried out by the partners themselves, referring to the goals given in the ERA-NET description of work. In a first step, the updated expectations of the EuroNanoMed II partners for the outcomes of the work programme were discussed at the kick-off meeting. Then the expectations of partners were gathered in a short questionnaire which was analysed and presented to all partners. Yearly, these expectations were re-examined to redefine the work programme in a timely manner. A survey to assess research applicants’ feedback regarding ENM II joint transnational calls was also performed. After 2 years, the EuroNanoMed II activities and successes were discussed and compiled in a report. This continuous evaluation process has strengthened the cooperation and integration among partners and facilitated the preparation and definition of future collaboration of partners in nanomedicine (WP6). A final monitoring report was written and delivered.
ENM II partners agreed, among other things, that the main objective of ENM II was to provide national researchers with the opportunity of funding for small to medium-size transnational research consortia, it was considered very important for most of the partners to continue with the European coordination of research and programmes in nanomedicine, integrating new members; finally, a strategic agenda for nanomedicine is considered useful and should be common to all ENM II partners and other stakeholders in the field of Europe or at the international level, and should be in line with ETPN.
Among the 35 identified indicators, 19 indicators were used to monitor the ENM I and II funded research projects. Interestingly, EuroNanoMed II has also led to significant socio-economic impact through the different transnational calls and funded projects. Through JTC 2009, ENM projects led to the creation of 5 new permanent contracts. On average, per project, 3 new fellowships were obtained and 2 fellowships were continued. A total of 23 temporary contracts were created or continued. Globally, on average per participant, 2 positions were mobilized for the research project. A total of 5 patents were submitted during the lifetime of the projects, 2 at the international level and 3 nationally (in Sweden and in Spain). Interestingly, one project led to the creation of a company in Lithuania: the UAB-Ferentis start-up. Through JTC 2010, ENM projects led to the creation of 6 new permanent contracts. On average, per project, 4 new temporary contracts were obtained and 3 were continued after the end of the project. In addition, 13 fellowships directly linked to the project funding were created. Globally, on average per participant, 2 positions were mobilized for the research project. A total of 8 patents were submitted during the lifetime of the projects, 3 at the international level, 2 at the European level and 3 nationally (in Sweden and in Portugal). These patents were coming from 5 different projects. Interestingly, one project led to the creation of a company: The Adjuvatis start-up was created in France. In addition, in the frame of one project, the patented results were transferred to a company founded by the Swedish partners of the project. Through JTC 2011, ENM projects led to the creation of 14 new permanent contracts. On average, per project, 5 new temporary contracts were obtained and 2 were continued after the end of the project. In addition, 14 fellowships directly linked to the project funding were created. Unfortunately, none of the 7 funded projects led to the submission of patents neither to the creation of a company. The economic impact is then limited. Through JTC 2013, as described earlier, only one project was finished at the time we produced the analysis. Hence, most of the socio-economic impacts of the ENM funded projects were not available (employment, new products, creation of firm). Indeed, these indicators are directly linked to the final achievements of the projects. However, 1 patent was submitted by partners 1 and 2 in the only project which was finished.
SPREADING EXCELLENCE, EXPLOITING RESULTS, DISSEMINATING KNOWLEDGE
Based on the knowledge acquired during ENM I and on the experience from partners involved in the other ERA-NETs, the communication of ENM II was greatly efficient, with the WP4 dedicated to communication and dissemination. The leaders of this WP worked with all the ERA-NET partners and with all the other WPs to disseminate the activities and results of ENM II.
The key messages to be disseminated were:
• EuroNanoMed II description, objectives, news, information on the procedures (for benchmarking), information on the joint calls for proposals (announcement of the launch, documents and contacts to apply, etc.), results of the joint calls for proposals;
• Description of the EuroNanoMed II-funded projects and key results from these projects;
• Presentation of the nanomedicine field;
• General information related to nanomedicine events and news.
Different target audiences were identified depending on the messages to be delivered. As already done in ENM I, the main audience targeted was the research community and the policy makers (EC and national). Moreover, in ENM II, some information was also specifically prepared and dedicated to the general public through for example video clips in order to present and explain the nanomedicine field in a comprehensive way. Indeed, the aim was to build an information bridge between research and society in order to increase public awareness to the importance of research in nanomedicine, showing the potential benefit of such research to the patients.
The ENM II website was the main support for dissemination of all ERA-NET data. The website set up for ENM I was updated and improved for ENM II in order to provide all relevant information with a more efficient dissemination process (WP4). This website enabled the consortium to generate an effective flow of information and publicity about the objectives and results of the ERA-NET, the contributions made to European knowledge and scientific excellence, the value of collaboration on a Europe-wide scale, and the benefits to EU citizens in general. The website was divided into three parts: a public part, a communication tool and a restricted area.
• The public part of the website was used for publication of information related to the presentation of EuroNanoMed II, EuroNanoMed II publications, calls for proposals and results, help desk information, events and news, FAQ, etc. The website was regularly updated with details of funded projects including abstract, partners, funding, a link to the project website and publications.
• Contact data base and communication tool: An advanced automatic tool was developed in order to automatically disseminate information published on the website to relevant nanomedicine contacts (in a database). This database included all applicants to the EuroNanoMed calls for proposals and was continuously updated with people subscribing on the website.
• Restricted website area (available for ENM II members only): to facilitate the communication between the ENM II partners. It is composed of both document management and project management software in order to facilitate both the exchange of documents and on-line project management (interactive calendar, information sheets, etc.). Access rights were provided to each Work Package Leaders and Task Leaders for co-ordination activities. The system was technically maintained and information was continuously updated, so that an efficient and timely exchange of information coud be performed.
Regarding the dissemination of results from the ERA-NET, different types of documents were produced with the help of public relation experts to address the different publics targeted: the scientific community and policy makers. These include newsletters and press releases to communicate on the main events of the ERA-NET work, such as announcements and results of joint calls, information on projects funded in the joint calls (summaries and outcomes), and the results of workshops. Furthermore, a brochure presenting the ERA-NET results was prepared for policy makers and used for the WP6 on future cooperation. The documents were disseminated using both printed and internet means. In addition, the ERA-NET and its achievements were presented to the scientific and business communities at nanomedicine conferences and events (e.g. ETP Nanomedicine annual forum, Nanobio Europe conferences, CLINAM conferences, general nanotechnology conferences with a nanomedicine session, etc.) by the coordinator and the WP leaders highly involved in other nanomedicine-related initiatives.
Regarding the introduction of pivotal issues on nanomedicine to the general public, different tools to disseminate information on nanomedicine to the general public were used. Three short video clips were produced related to the three subfields of nanomedicine: targeted drug delivery, diagnostics and regenerative medicine. These are available on the EuroNanoMed II website, as well as on YouTube and Wikipedia. In addition, a Facebook page was launched in February 2013 for EuroNanoMed II to enable the ERA-NET to reach the general public with no geographical limits. The Facebook page includes the outcomes of EuroNanoMed I and II, links to the EuroNanoMed II webpage, press releases and other announcements, and the video clips. In addition, the lectures from the workshop on ethical issues were registered and video clips were produced and published in the same channels.
EuroNanoMed II also enhanced communication with similar initiatives. The aim was to identify initiatives currently involved in implementation of nanotechnology into medicine and to establish contact with them for information, dissemination, and cooperation. The bodies with similar or partially overlapping scope, such as ERA-NETs, networks of excellence, funding organisations and safety and regulatory bodies (e.g. M-ERA.NET ETP Nanomedicine, ERA-NET SIINN, EuMaT, SusChem, JTI IMI, ENIAC, AENEAS, the CSA NANOMED2020 and EMA) were identified by Internet searching and by a short inquiry form sent to ENM II participants. The aim of this survey was to define contact persons in these initiatives and to create a contact list based on the knowledge possessed by the ENM II partners. In order to set up collaborations with similar initiatives, representatives were invited to participate in ENM II meetings. Following the survey, the contact persons in these initiatives were identified and a contact list was created and the list has continuously been updated for communication and dissemination purposes. The participation of ENM II partners to similar initiatives meetings was also encouraged: information concerning meetings organised by similar initiatives was collected and communicated to the ENM II partners. Effective use of resources was achieved by joining forces with other networks and bodies with similar or partially overlapping aims.
The complete list of dissemination activities can be found in the EuroNanoMed dissemination table (template A2).
List of Websites:
EuroNanoMed Call Office
French National Research Agency,
50 avenue Daumesnil, 75012 Paris, France
Tel : +33(0) 1 78 09 80 44
Mail: calloffice@euronanomed.net
EuroNanoMed Coordinator
Amélie Vergne
Scientific Officer, PhD
Health and Biology Department
Agence Nationale de la Recherche,
50 avenue Daumesnil, 75012 Paris
Tel: +33(0) 1 78 09 80 44
Mail: ENMcoord@anr.fr
For more information, visit the EuroNanoMed web site:
http://www.euronanomed.net/
Nanomedicine, the application of nanotechnology to health, is a fast-growing field with a large potential for improving diagnostics and therapeutic solutions in many diseases. The EuroNanoMed II (ENM II) consortium, with 21 partners from 18 countries and regions (Table 1), aimed at fostering the competitiveness of European nanomedicine players through the support of translational research projects enhancing transnational and multidisciplinary collaborations between academia, clinical/public health communities and industry. ENM II was a follow-up of the ERA-NET EuroNanoMed I (ENM I), which launched three joint transnational calls for proposals in three years. The increasing number of submitted proposals in the successive ENM I joint calls and their quality showed the need amongst the nanomedicine scientific community for such a targeted initiative. ENM II was built on the basis of the ENM I accomplishments, and continued to support transnational innovative RTD projects in nanomedicine through the launch of yearly joint calls for proposals. In addition, ENM II aimed to extend the cooperation among its partners through the development of other activities (Figure 1): (i) to foster the participation of young European researchers to ENM II activities; ii) to develop a strategic agenda for ENM II in close cooperation to the ETP Nanomedicine; iii) to create more interactions within the European nanomedicine community and improve communication on nanomedicine to the public; iv) to frame and to address regulatory, safety and ethical issues associated with nanomedicine; v) to monitor the results of the ENM I & ENM II funded research projects and the activities of the ENM II network; and, consequently, vi) to develop a long-term cooperation framework for European nanomedicine research. Therefore, through joint funding of translational nanomedicine projects and its other activities, ENM II has contributed to enhance coordination of research and resources in this field, thereby shaping the European Research Area in nanomedicine.
Project Context and Objectives:
One of the key strategic challenges Europe has to face in the next decades is to provide its ageing population with effective and affordable health care and to assure its wellbeing. To achieve this goal, sustainable efforts in research and innovation are necessary to find new and personalised ways to prevent, manage, treat and cure disease, disability and reduced functionality and for making medicines and treatments available and affordable to all.
One promising tool to meet these challenges that has evolved in the last decade is the use of nanotechnology for medical applications. This new area of research – usually referred to as “nanomedicine” (i.e. the application of nanotechnology to medicine and healthcare. The field takes advantage of the physical, chemical and biological properties of materials at the nanometre scale to be used for diagnosis, treatment and follow-up of diseases)- has been rated among the six most promising Key Enabling Technologies (KET) by the High Level Group on KET in its final report (EU Commission, June 2011). Therefore, nanomedicine 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. Disease areas that are presumed to benefit most from nanomedicine are cancer, cardiovascular diseases, neurological (especially neurodegenerative) diseases, diabetes, inflammatory diseases as well as orthopaedic and other medical conditions needing regenerative medicine. Nanomedicine is a research area at the intersection of different scientific fields. To be successful it has to federate key players from biology, physics, chemistry, medicine and engineering. Furthermore, nanomedicine needs coordinated input from all players along the value chain to effectively move scientific results to innovation: academic scientists, pharmaceutical and medical device companies and clinicians in a translational approach.
Since the early 2000’s, nanotechnologies are a priority for Europe. They have been identified as one of the thematic priority areas for the European Union (Communication from the Commission “Towards a European strategy for nanotechnology” COM 2004-338 final); an action plan for Europe (COM 2005-243 final)) and they are one of the six Key Enabling Technologies to assure Europe’s Industrial Leadership addressed in the draft of the Horizon 2020 framework programme. When EuroNanomed II was submitted in 2012, nanomedicine was expected to be one of the cross-cutting actions “vital in stimulating the interactions between the societal challenges and the enabling and industrial technologies needed to generate major technological breakthroughs”.
Europe has a good starting position in the field of nanomedicine with excellent scientists all over the member states, a large number of innovative SMEs and some leading pharmaceutical companies. The bridge between these players will consolidate and improve the competitiveness of the European industry that will be very important in the worldwide competition in this sector. As these players are usually spread over different member states, a transnational approach is necessary to bring together the most appropriate partners.
Even if European countries invest a substantial amount of money in research and innovation funding, most of the national programmes do not support transnational projects. Pure nationally funded programmes often face difficulties to successfully translate fundamental research in first clinical stages, as in many member states there are too few players in the specific domain of nanomedicine. Therefore, the main goal of the EuroNanoMed II ERA-NET initiative was to go further in supporting transnational research and innovation projects, in order to achieve a critical mass of players translating scientific results from the lab to patient’s bedside. EuroNanoMed complements national and European funding activities as nanomedicine is often not the main focus of the national or European calls for proposals.
The EuroNanoMed II consortium with 21 partners from 18 countries and regions (comprising 18 partners already members of EuroNanoMed I) is a strong, established partnership of relevant member states’ funding bodies, willing to attribute a part of their national funding budget to transnational research and innovation projects in nanomedicine and to make nanomedicine an important contributor to the future European healthcare system and to have a beneficial impact on improved treatment for patients, as well as an economic impact through an improved and cost-effective health care.
EuroNanoMed II project was based on the foundations of EuroNanoMed I, a first ERA-NET on nanomedicine, launched in 2009, and supported by the European Commission under the NMP programme for 3 years. The main goal of ENM I was to build the grounds for a transnational research programme in nanomedicine that responds to the needs identified in the field (ENM I strategic agenda, ETP Nanomedicine). The results of the three JTCs launched in the frame of ENM I showed a real success concerning this goal and EuroNanoMed is now a well-known and recognised initiative. ENM I also carried out other activities intending to accompany the establishment of a common RTD programme in nanomedicine, such as the systematic mapping of the on-going programmes, the establishment of a strategic agenda and the development of actions to address issues on regulatory affairs. In addition, ENM I carried out monitoring and optimisation activities that allowed the consortium to improve the procedures from call to call and to establish an efficient collaboration between agencies based on trust and common understanding. A questionnaire to gather applicant’s feedback showed the positive impact that ENM I had on European researchers, but also helped to identify unmet needs that the consortium intends to fulfil by continuing its collaboration.
Through EuroNanoMed II, the ERA-NET scheme represented a unique opportunity for the ENM consortium to continue its efforts and achieve the long-term goal of fostering the competitiveness of the European nanomedicine players through the joint funding of transnational innovative research projects.
There was indeed an important need for improving the translation of public healthcare nano-research in Europe as pointed out in the white paper of the ETP Nanomedicine . In addition, 2012 was the right time to put some extra efforts in the field of nanomedicine since some highly promising concepts and technologies were currently emerging (e.g. stimuli-responsive polymers, amphiphilic core–shell nanoparticles, molecular targeting approaches for nanocarriers, etc. ). It was therefore essential to support nanomedicine in Europe in order to secure their translation to the clinic and to industry and secure their proof of concept. Hence, based on the experience of EuroNanoMed and in continuation of the first initiative, the main objective of EuroNanoMed II was to foster the competitiveness of European nanomedicine players through the support of projects enhancing translational collaborations between research teams from academia, clinical/public health communities, and industry. EuroNanoMed II aimed to continue its support to transnational RTD projects in nanomedicine through the launch of four joint calls for proposals.
In a nutshell, the main objectives of ENM II initiative were to:
• Fund in common transnational, innovative and translational RTD projects in nanomedicine;
• Launch joint calls for proposals that are in line with the strategic priorities of the ETP Nanomedicine and the NMP expert advisory group;
• Develop a strategic agenda for EuroNanoMed II and for future cooperation, in close cooperation to the ETP Nanomedicine;
• Continue the European coordination of research and programmes in nanomedicine, integrating new members;
• Develop specific actions to foster the participation of young researchers in nanomedicine projects and help them build their research career;
• Create more interactions within the European nanomedicine community through joint calls, review seminars, dissemination of ENM II activities, etc.;
• Keep close relations with the relevant stakeholders (especially the ETP Nanomedicine) and the research community in order to react flexibly to the needs and new developments in nanomedicine research;
• Improve communication on the nanomedicine field towards the general public;
• Go further to identify and address the non-technological innovation barriers in terms of later exploitation and market access for companies in the field of nanomedicine based on the work already achieved in ENM I;
• Frame and address ethical and safety issues in nanomedicine;
• Follow the progress of the EuroNanoMed (I&II)-funded projects and analyse the outcome of the joint calls;
• Monitor the activities of EuroNanoMed II with an aim of continuous improvement;
• Develop a concept for a sustainable cooperation between EuroNanoMed partners after the end of the ERA-NET taking into account the financial and administrative constraints as well as the needs and expectation of the stakeholders.
These objectives were delivered through six work packages (Figure 2), with the following aims:
WP1: Management and strategy
In this work package, a practical infrastructure whose goal was to manage the administrative, technical, financial and strategic aspects of the ERA-NET had to be established. The key aims were to:
• Set up the organisational structures for the network;
• Manage the consortium day-to-day;
• Ensure communication within the network and with the EC;
• Give input and support to the tasks of all the work packages;
• Maintain an active website as a gateway to other stakeholders and the community;
• Produce a strategic agenda to use for all ENM II activities and to set up a future cooperation framework.
WP2: Joint funding activities in nanomedicine
The key aims of this work package were to plan and implement four transnational joint calls for research proposals (one per year), supporting the selection process and the coordination of funding for the successful projects. The first two calls of EuroNanoMed II (2013 & 2014) were planned to be broad and organised around the three sub-topics: targeted drug delivery, diagnostics and regenerative medicine, which are the priorities of the ETP Nanomedicine. Then, based on the strategic agenda of ENM II and input from the External Advisory Board and other experts, the topics of the further joint calls (2015 & 2016) had to be defined. In addition, the procedures regarding the implementation and evaluation of the joint calls (topic selection, preparation, publication, evaluation of proposals, funding decision and national implementation) were to be re-examined and adapted for each call. This best-practice approach aimed at delivering a continuously developing, commonly-agreed framework of call governance and procedures.
Issues linked to the joint calls also needed to be addressed in the frame of this work package. Specific actions regarding young researchers had to be developed to increase the attractiveness of nanomedicine research within the younger generation. These would include networking activities in the review seminars, incentives for outstanding research achievements, as well as measures in the joint calls to encourage their participation. Finally, the follow-up of EuroNanoMed (I&II)-funded projects was planned in this WP2.
WP3: Regulatory Affairs, Ethical and Safety Issues
Research in nanomedicine is generating a bunch of revolutionary new therapeutic and diagnostic solutions that can offer a better therapy and a higher quality of life to patients. Many of these advancements have overcome the classical separation between medical and pharmaceutical products so that classical regulatory frameworks are sometimes inappropriate or even inapplicable to these products. The lack of specific protocols of practices and standard criteria for these brand new nanomedicine products is turning out to be an important imponderable that may considerably hinder industrial R&D and delay market access of innovative products. Therefore, it was essential to establish an EU-wide dialogue on regulatory issues in nanomedicine to facilitate a faster exploitation and market access for companies and to shorten the time from the research to clinical application and to the patient. As these questions were more and more directed at the European level (EMA) it was necessary to consider these issues at a European rather than at a national level. This was critical to avoid any loss of resources and efforts for member states, companies and research/clinical communities and to ensure that new products - supported through the EuroNanoMed calls - could get fast market authorization to finally benefit the patient.
When talking about new drugs and technologies, the safety of end users and patients had necessarily to be considered as well as ethical aspects or social risk perception. These points were fundamental for a new discipline like nanomedicine where a common coordination of safety and ethical issues was still missing.
In the frame of EuroNanoMed I, a fruitful dialogue on regulatory issues involving experts from industry, public research, clinic, regulatory agencies and public authorities had been started and a mapping of relevant nanomedicine related safety issues has been prepared. These two activities needed to be continued and intensified during EuroNanoMed II and completed by training activities on regulatory aspects for EuroNanoMed (I & II)-funded researchers and the consideration of ethical issues.
The objectives of WP3 were:
• To continue and intensify the dialogue between stakeholders from industry, research, clinic, regulatory agencies and public authorities (in close cooperation with the EMA and the ETP Nanomedicine), to identify bottlenecks in existing regulations with respect to the needs of nanomedicine and to propose practical solutions;
• To train and inform EuroNanoMed funded researchers about regulatory issues that should be taken into account in research to facilitate the entry into clinical trials and market access at the end of their project;
• To continue and update the mapping of nanomedicine related safety issues from relevant sources and in cooperation with initiatives like the NanoSafety Cluster or the ERA-NET SIINN, with which there are already many links (partners in common) and regular exchanges are planned;
• To identify and address nanomedicine related ethical issues involving relevant initiatives like the Ethics Resource Center or the European Group of Ethics.
WP4: Communication and Dissemination
While communication activities had already been developed in EuroNanoMed I, the aim of WP4 was to improve the process, informing more systematically the nanomedicine community, the policy makers, and the general public about the ERA-NET activities. This mission was to be carried out in close collaboration with the coordinator and fed from all other ERA-NET activities. During the time course of the project, newsletters and press releases providing information related to the calls launch, results, funded projects, but also related to the other ERA-NET activities (workshops, publications, etc.) were planned to be published on the website and/or disseminated. In parallel, relation with sister and similar initiatives was to be set up to benchmark on common activities. Finally, tools for dissemination towards the larger public had to be developed, such as video clips explaining the three subfields of nanomedicine: targeted delivery systems, diagnostics and regenerative medicine.
WP5: Monitoring and optimisation of activities
The aim of this work package was to analyse and monitor both the EuroNanoMed II activities & the output and added-value of EuroNanoMed (I & II) joint calls. The objective was to provide support for short- and long-term strategic planning activities and to allow the partners to continuously improve ENM II work. It had to be achieved by defining indicators to measure the success of the joint calls and other EuroNanoMed II activities and applying them through a structured monitoring process, which would take into account the expectations of ENM II partners, as well as the views on ENM II joint calls of the involved nanomedicine research community.
WP6: Design of a long-term sustainable cooperation framework for nanomedicine research
The key aim of this work package was to develop a common research funding framework for nanomedicine, which would reach beyond EuroNanoMed II and aiming to sustain and possibly broaden the scale of its activities. The expected outcome was to lead to a self-sustained transnational funding programme with regularly repeated funding initiatives. In collaboration with the partners of ENM II and other interested stakeholders and after benchmarking with similar initiatives, the financial, administrative and legal conditions to develop such a funding framework concept was expected to be explored and a scenario for a long-term sustainable cooperation for research funding in nanomedicine proposed.
In conclusion, the objectives of the proposed Coordinating Action EuroNanoMed II directly corresponded to the FP7 call topic NMP.2012.1.2-3 ERA-NET on nanomedicine: “This ERA-NET aimed at coordinating the research efforts of the participating Member States and Regions in the field of nanomedicine and to implement joint transnational calls for proposals to fund multinational innovative research initiatives in nanomedicine.”
Project Results:
JOINT FUNDING ACTIVITIES IN NANOMEDICINE
Through WP2, EuroNanoMed II aimed at designing and implementing joint transnational calls (JTC) for research projects (one per year). This WP covered all the preparatory work for joint funding activities, such as the selection of the topics, designing the call procedures and documents, encouraging young researchers’ participation, as well as the implementation of the funding activities. It was therefore a WP in which all EuroNanoMed II partners were involved. While the final decision about participation in a JTC followed a variable geometry pattern, discussion and selection of the topic were done by all the ERA-NET partners under the advice of academic, industrial, and clinical experts (External Advisory Board and external experts at large). For each JTC, the partners who committed to participate in the joint call formed a Call Steering Committee (CSC). The CSC took decisions concerning the call procedures, supervised the progress of the call, and made the final funding recommendation to the national/regional funding organisations regarding the proposals to be funded, based on the final ranking list provided by the peer review panel. A call office was set-up from the start as a central helpdesk for activities related to the implementation of the calls. It was responsible for the operational implementation of the calls, until the projects were selected. The Call Office served as contact point for any requests concerning the joint calls, providing information on EuroNanoMed activities, giving advice and information about Joint Calls’ eligibility, deadline, etc. The Call Office also supervised the publication of call texts on the EuroNanoMed II website and in the countries participating in a call and collaborated with the National Contact Points to most efficiently support the applicants. This also implied updating the JTC project submission tool according to the procedures decided for each JTC. Finally, an Expression of interest tool was set up in EuroNanoMed I in order to help the applicants finding partners and building consortia was updated for EuroNanoMed II. The existence of this tool was largely communicated in a timely manner to the scientific community using the communication tools in WP4 (i.e. website, newsletter).
DESIGNING AND IMPLEMENTING JOINT TRANSNATIONAL CALLS
During the period 2012-2016, the ERA-NET EuroNanoMed II has successfully launched 4 joint transnational calls for proposals in the continuation of the 3 calls previously launched under EuroNanoMed I.
The design of the procedures and preparation of the Joint Transnational Calls documents was improved and refined compared to the already established procedures for submitting, evaluating, selecting and funding the proposals. For each call, a Memorandum of Understanding (MoU), a “Joint Transnational Call Governance” document and a call text was prepared. The MoU described the agreement reached by the members of the consortium on the scope of the call, the principles ruling the selection and evaluation procedures (in outline only) and the financial commitments and funding modalities. The “Joint Transnational Call Governance” described the agreed-upon call operative procedures. It included the national or regional funding body partners´ eligibility requirements as an annex. The call text described the rationale of the call, the topic, the eligibility requirements, deadline for submission of an application, the evaluation criteria and process. In addition, for each JTC, a pre-announcement text was published at least a month before the JTC launch to inform the scientific community of the JTC topics, countries/regions involved and the general rules. Finally, templates for the submission of proposals (addressed to applicants) and for the evaluation of proposals (addressed to the external reviewers and panel members) were prepared within this task.
The design of strategic priorities was made with respect to the academic, industrial, and clinical needs. The calls covered the three subfields: targeted drug delivery, diagnostics and regenerative medicine. Building on the experience of EuroNanoMed I, a workshop on defining the scope and topics for JTC2015 and JTC2016 with experts was organised on 19th June 2014 in Tenerife, Spain after the JTC 2014 evaluation meeting / Peer Review Panel (PRP) meeting. The main objective of the workshop had two dimensions: 1- to gather recommendations for improvement of ENM II evaluation procedures, and, 2- to discuss topics that should be covered by ENM II upcoming calls (in 2015 and 2016). PRP members were asked to join the partners for this workshop as external experts. The general consensus during the Workshop was that the open approach that had been used for the ENMI and ENMII calls so far is the optimal way to go. A narrower focus may lead to a drop in the total number of submitted proposals, and the bottom up approach is the right one to contribute to increasing innovation in the field of nanomedicine and is complimentary to current H2020 calls. In addition, most of the discussions were based on the content of the Strategic Research and Innovation Agenda (SRIA) that was prepared by the European Platform on nanomedicine (ETPN) in collaboration with ENM II partners responsible for WP6, and which was used by the European Commission (EC) for the development of the Working Programme 2016-2017.
To encourage the participation of young researchers to EuroNanoMed II funding activities and increased the attractiveness of multidisciplinary and transversal nanomedicine research within the younger generation of scientists, EuroNanoMed II fostered networking of young researchers in the field, to increase exchange of academic information, facilitate technology transfer and provide information about EuroNanoMed funding options for young researchers. This network was initiated by putting in relation the young scientists (PhD students, Postdocs, young PIs) involved in the EuroNanoMed I and II funded projects, using email lists and other means of communication in link with WP4. A “Young scientists” section was created on the ENM website to disseminate information about ENM activities and a mailing list (juniorresearchers@euronanomed2.net) was created to share job offers or information to the young researchers involved in the ENM funded project and was constantly updated. In addition, these young researchers were encouraged to attend the EuroNanoMed II review seminar meetings and present posters of their work (see next section).
On 3rd July 2013, a dedicated workshop for young researchers was organised in Venice, Italy. The results of an online questionnaire sent to 435 researchers (applicants of ENM I calls and EAB members, 114 respondents) were analysed and presented to the EuroNanoMed II partners. The aim of this survey was to check with the interested community of scientists which were the preferred actions towards the following ENM II objectives. The following results were highlighted:
• To encourage the participation of young researchers to EuroNanoMed II funding activities;
• to increase the attractiveness of multidisciplinary and transversal nanomedicine research within the younger generation of scientists.
The results of the survey were used as a basis for discussion about the measures to be taken by ENM II to foster the participation of young researchers. As a result:
• The NSC members agreed on a common definition of “junior researcher”: He/She must have been awarded his/her first PhD or equivalent title, at least 2 and up to 10 years from today (extensions possible in case of career breaks: maternity/paternity leave, long-term illness). 1- The NSC also decided that each ENM II partner was responsible for establishing the equivalent titles of “First PhD” in their own countries; 2- A bulletin board for mobility options on the ENM II website was created. The e-mail distribution list was used as a start to disseminate the information.
• A young researcher won the best poster prize during the review seminar in Oslo, December 2nd, 2014.
Young researchers’ participation in the EuroNanoMed calls was also encouraged through specific measures decided by the CSC members. The decisions on the actions to be chosen to support young researchers took into account the experience of other ERA-NETs (E-Rare-2 JTC2012, etc.) which launched calls that encouraged the participation of young researchers. The possible actions included for example to have a specific track for young PIs in the EuroNanoMed II JTCs or to add eligibility criteria for inclusion of at least one young researcher as a partner in a proposal consortium. Challenges and opportunities within the joint calls that are specific for young scientists were explored. In the JTC2014, 2015 and 2016 call text, the following sentence was added: “active participation of junior researchers in project proposals is encouraged” and the evaluation criteria have been updated accordingly, adding the “participation of junior researchers” in the criterion “quality of the project consortium”. Accordingly, the participation of junior researcher in a proposal was taken into account by the evaluators.
OVERVIEW OF THE FOUR JOINT TRANSNATIONAL CALLS
o 4th Joint Transnational Call for Proposals - JTC2013
The first EuroNanoMed II call (JTC2013) was launched soon after the kick-off meeting of ENM II. On 13th November 2012, the pre-announcement of the 4th Joint Transnational Call for Proposals - JTC2013 was published on the EuroNanoMed website to warn the scientific community of the JTC topics, countries/regions involved and the general rules. The call documents and the procedures for the EuroNanoMed II JTC2013 were based on the call documents developed in the frame of the EuroNanoMed I calls. Only the layout and minor details were modified in the documents. Final versions of the Call Text, Guidelines for applicants and the Proposal application form were published on the EuroNanoMed website on 10th December 2012 at the opening of the call and on the relevant national funding organizations’ websites.
The evaluation procedure established during the last EuroNanoMed I call, in 2011, was used in the JTC2013. This procedure consisted in one-stage submission and evaluation with international peer review involving external experts and a peer review panel (PRP) meeting. Eligible proposals are reviewed through an international peer-reviewed process under the supervision of the Call Steering Committee, according to the criteria established by the call documents of each call. The scientific evaluation was carried out based on reviews of research proposals, and discussed in a peer panel meeting for establishing the ranking list of best proposals during a physical meeting.
The call received 43 proposals. Out of these, 37 were found to be eligible and were evaluated by external reviewers, three members of the final Peer Review Panel (PRP). The PRP members met in Venice, Italy, on July 1st-2nd 2013, to discuss the eligible proposals and, after consideration of the evaluation criteria and their own discussions, the PRP identified the top quality proposals recommended for funding and established a ranking list. Based on this ranking list, the final decision on funding was made by the EuroNanoMed II national/regional funding organizations involved in the call. The funding agencies with budget issues found solutions in order to fund as many projects as possible in the ranking list provided by the PRP members. As a result of these efforts, the Call Steering Committee decided to fund 8 projects for a total amount of about 7 M€. The 8 projects involved 42 partners from 15 countries/regions. They encompassed all three subfields of nanomedicine (as defined by ETPN): diagnostics, targeted delivery systems and regenerative medicine, and covered diverse medical issues such as treatment and monitoring of cancer, bone fractures and allergic reactions.
o 5th Joint Transnational Call for Proposals - JTC2014
On 6th November 2013, the pre-announcement of the 5th Joint Transnational Call for Proposals - JTC2014 was published on the EuroNanoMed II website to warn the scientific community of the JTC topics, countries/regions involved and the general rules. The call documents of the EuroNanoMed II joint transnational call 2014 were updated by a working group established by the NSC during the second NSC meeting held in Venice on 3rd July 2013, which took into consideration the lessons learned session that followed the JTC2013 PRP meeting. The final versions of the Call Text, Guidelines for applicants and the Proposal application form were published on the EuroNanoMed II website on 26th November 2013 at the opening of the call and on the relevant national funding organizations’ websites.
The working group set up in Venice during the second NSC meeting was also in charge of analysing and improving the evaluation procedure used in the JTC2013. According to the suggestions of the working group, the NSC members decided to introduce the following changes in the JTC2014: to assign proposals to 3 reviewers per proposal which are also PRP members and avoid further written evaluation by reviewers who are not part of the PRP and to use the same scale of scoring as in FP7 evaluations.
The call received 51 proposals. Out of these, 49 were found to be eligible and were evaluated by three members of the Peer Review Panel (PRP). The PRP members met in Tenerife, Spain, on June 18th and 19th 2014, to discuss the eligible proposals and, after consideration of the evaluation criteria and their own discussions, the PRP identified the top quality proposals recommended for funding and established a ranking list. Based on this ranking list, the final decision on funding was made by the EuroNanoMed II national/regional funding organizations involved in the call; the funding agencies with budget issues found solutions in order to fund as many projects as possible in the ranking list provided by the PRP members. As a result of these efforts, the Call Steering Committee decided to fund 9 projects for a total amount of about 6,5 M€. The 9 projects involved 52 partners from 15 countries/regions. They encompassed all three subfields of Nanomedicine and covered diverse medical issues such as the diagnosis of emphysema, anticancer and ALS treatments, fast identification of bacterial infections and tissue regeneration.
o 6th Joint Transnational Call for Proposals - JTC2015
On 28th October 2014, the pre-announcement of the 6th Joint Transnational Call for Proposals - JTC2015 was published on the EuroNanoMed II website to warn the scientific community of the JTC topics, countries/regions involved and the general rules. The call documents of the sixth joint transnational call 2015 were updated by a working group established during the fourth NSC meeting held in Tenerife on 20th June 2014. This working group was also in charge of analysing the outcomes of the “Workshop with experts & Improvements for the procedures of the next calls”. Final versions of the Call Text, Guidelines for applicants and the Proposal application form were published on the EuroNanoMed website on 26th November 2014 at the opening of the call and on the relevant national funding organizations’ websites.
According to the suggestions of the working group, the NSC members decided to introduce the following changes in the JTC2015: to establish a score threshold and provide it to the PRP members so that the proposals above a given score can be recommended for funding and proposals below this score cannot be recommended for funding; to establish a ranking list instead of group of projects ranked in blocks.
The call received 66 proposals. Out of these, 62 were found to be eligible and were evaluated by three members of the Peer Review Panel (PRP). The PRP members met in Jerusalem, Israel, on June 23rd and 24th 2015, to discuss 62 eligible proposals and after consideration of the evaluation criteria and their own discussions the PRP identified the top quality proposals recommended for funding and established a ranking list. Based on this ranking list, the final decision on funding was made by the EuroNanoMed II national/regional funding organizations involved in the call; the funding agencies with budget issues found solutions in order to fund as many projects as possible in the ranking list provided by the PRP members. As a result of these efforts, the Call Steering Committee decided to fund 11 projects for a total amount of about 7,5 M€. The 11 projects involved 53 partners from 13 countries/regions. They encompassed all three subfields of Nanomedicine and covered diverse medical issues such as the use of miRNA biomarkers in multiple sclerosis, cancer treatments, heart repair and early diagnosis of Parkinson's disease.
• 7th Joint Transnational Call for Proposals - JTC2016
On 23rd October 2015, the pre-announcement of the 7th Joint Transnational Call for Proposals - JTC2016 was published on the EuroNanoMed II website to warn the scientific community of the JTC topics, countries/regions involved and the general rules. The call documents of the EuroNanoMed II joint transnational call 2014 were updated, taking into consideration the lessons learned session that followed the JTC2015 PRP meeting. The main change was the introduction of the rebuttal stage (i.e. the coordinators of the applications submitted to JTC2016 were provided with the opportunity of commenting the written evaluations before the PRP meeting, so that PRP members could take them into account during the discussions). The final versions of the Call Text, Guidelines for applicants and the Proposal application form will be published on the EuroNanoMed II website on 26th November 2015 at the opening of the call and on the relevant national funding organizations’ websites.
The call received 68 proposals. Out of these, 67 were found to be eligible and each was evaluated by three members of the Peer Review Panel (PRP). The PRP members met in Lisbon, Portugal, on June 23rd and 24th 2016, to discuss the 67 eligible proposals and after consideration of the evaluation criteria and their own discussions the PRP identified the top quality proposals recommended for funding and established a ranking list. Based on this ranking list, the final decision on funding was made by the EuroNanoMed II national/regional funding organizations involved in the call; the funding agencies with budget issues found solutions in order to fund as many projects as possible in the ranking list provided by the PRP members. As a result of these efforts, the Call Steering Committee decided to fund 10 projects for a total amount of about 7,5 M€. The 10 projects involved 50 partners from 12 countries/regions. They encompassed all three subfields of Nanomedicine and covered diverse medical issues such as the use of miRNA biomarkers for the detection and treatment of muscular disease, cancer treatments, nanovaccines for anti-tumour immuno-therapy, nanoparticles for heart ischemia/reperfusion, etc.
Overall, these four joint calls for proposals funded 38 (61 with ENM I) transnational research projects on nanomedicine involving 197 partners (319 with ENM I) from 21 countries/regions participating in the calls and 5 additional non-participating countries, with about 28.4 M€ (53.1 with ENM I) funding from the EuroNanoMed funding agencies and a further 17.6 M€ (36.7 with ENM I) contribution from the research partners participating in the funded projects.
✓ Country of origin of the applicants (figure 3)
Altogether, 1159 partners (1659 with ENM I) from 32 countries participated in these joint calls, in a total of 228 (326 with ENM I) submitted projects. As presented in figure 3, the number of applicants per country has globally grown between 2012 and 2016, as well as the number of submitted proposals (from 43 to 68 respectively).
✓ Overview of the 7 joint calls
The table 2 below summarizes the outcomes of the 7 joint calls for proposals:
✓ Participation of research organizations in translational projects in Nanomedicine
As EuroNanoMed I & II joint calls for proposals aimed at funding translational research projects in Nanomedicine, each consortium had to include teams from at least 2 of the following categories: academia, clinic/public health, industry. The distribution between these three categories among consortia funded in the 7 joint calls is outlined in Figure 4. Noteworthy, 53% of the funded projects included partners from all three categories, indicating the high added value of these collaborations in nanomedicine translational research.
✓ Scientific / technological areas covered by funded projects
The 7 joint calls for proposals were open to projects covering at least one of the three priority topics of the European Technology Platform Nanomedicine: Targeted delivery systems, Diagnostics, Regenerative medicine. The coverage of these three scientific areas among funded projects is presented in figure 5.
FOLLOW-UP AND MONITORING OF THE FUNDED PROJECTS
In addition to the implementation of the calls, the JCS was the first point of contact for the coordinators of funded projects (both from EuroNanoMed I and II), and thus collected the annual and final follow-up progress reports and organised three review seminars, on behalf of the Call Steering Committee.
• A Review seminar for funded projects (JTC 2009, 2010 & 2011) and Training workshop on regulatory affairs for funded partners was held in Düsseldorf, Germany, on January 29th and 30th, 2014. Young researchers involved in EuroNanoMed I funded projects were invited to attend this meeting. Concerning the review seminar for funded projects (JTC2009, 2010 & 2011), all the funded projects, except one, were represented. There were 42 participants, who made 16 oral presentations (JTC2009 and 2010) and displayed 20 posters (JTC2009, 2010 and 2011). Three PRP members also attended the meeting. In mid-March 2014, the Call Office sent to the young researcher and attendees of the Düsseldorf meeting: the contact details of all attendees, the contact details of the Training Workshop’s speakers and the PPT presentations of the Training Workshop’s speakers;
• A Review Seminar for funded projects (JTC 2010, 2011 & 2013) and Training Workshop on ethical issues in nanomedicine were held in Oslo, Norway, on December 2nd-3rd 2014. Young researchers involved in EuroNanoMed I and II funded projects were also invited to attend. Among the 31 participants, 13 were young researchers who presented posters (JTC 2010, 2011 and 2013). A Best Poster award was organized to give a prize to the best poster presentation made by a young researcher. The Poster Prize was an invitation to attend the next European Nanomedicine Conference organized by SFNano (December 2015). The three PRP members who chaired the different sessions of the Review seminar evaluated the posters’ presentations and selected the awardee. During the meeting the contact details of all attendees and of the Training Workshop’s speakers were provided to the young researcher and attendees of the Oslo meeting.
• A Review Seminar for funded projects (JTC 2013, 2014 & 2015) and Training Workshop on regulatory affairs for EuroNanoMed funded researchers were held in Berlin, Germany, on October 26th-27th, 2016. Among the 36 participants, 17 were young researchers and displayed posters. A Best Poster award was organized to give a prize to the best poster presentation made by a young researcher. The Poster Prize was an invitation to attend the next CLINAM Conference (May 2017). Two PRP members, who chaired the different sessions of the Review seminar, evaluated the posters’ presentations with the help of four experts from different funding organisations and selected the awardee. During the meeting the contact details of all attendees and of the Training Workshop’s speakers were provided to the young researcher and attendees of the Berlin meeting.
Through WP5, the monitoring and optimisation of activities was tackled by established indicators for evaluation of the ENM II programme; assessing the achievements of EuroNanoMed programme and its activities; monitoring and evaluating the operational processes underlying EuroNanoMed II activities as well as monitoring of the progress of EuroNanoMed I and II funded research projects. The set of indicators was chosen in two main steps. In a first step, a list of indicators was prepared by the task leaders based on their experience in other similar initiatives. This list consisted in 35 indicators which could be divided in 16 indicators to assess the achievements of ENM II and 19 indicators to monitor the ENM I and II funded research projects. For sake of clarity, the indicators were divided in four different types: networking, input, output and socio-economic impact indicators. In a second step, a Workshop was organised during the NSC2 meeting (Venice, Italy, 4th July 2013). During this Workshop, the indicators were discussed and improved and a final list of indicators, ready for approval by the NSC, was produced. In this section of the final report, we will focus on the indicators related to the monitoring of the ENM funded projects. Indicators related to the assessment of the achievements of ENM II and in particular, the ones related to the socio-economic impact will be considered in the next section (potential impact).
Using the indicators developed, the achievements of the EuroNanoMed (I & II) joint calls were assessed after the 3-year research period of the funded projects. The follow-up project reports of the funded projects and the conclusions from the research review seminars had been thoroughly analysed towards the production of an overall call output report (one per call). The call output reports for the three ENM I joint calls (JTCs 2009, 2010, 2011) and for the first ENM II joint call (JTC2013 call) was produced during the lifespan of the ERA-NET. These call output reports were used as a basis to produce public reports on the joint call results to be disseminated via the EuroNanoMed communication tools in WP4 (i.e. website). These reports were also used as input for planning the joint calls (WP2) as well as towards the development of long-term sustainable European cooperation on nanomedicine research (WP6).
Four deliverables focused on the projects funded under the frame of the Joint Transnational Calls 2009, 2010, 2011 and 2013 (JTC 2009, 2010, 2011 and 2013):
o JTC 2009 call output
A total of 24 projects were submitted to JTC 2009 and 8 projects were finally funded for a success rate of 33%. The total costs of the funded projects were of 16.9 M€ with and allocated funding of 9 M€. About 62% of the projects were identified as “Targeted delivery systems” projects and 38% as “Regenerative medicine” projects. The 8 projects funded under JTC 2009 submitted their final report. These projects involved 40 participants from which 31 fully filled in their reports. A total of 9 out of the 40 participants omitted to reply to some questions or gave incorrect answers mainly linked with budget questions. Therefore, the Progress and Final report templates were updated to reduce error rate in the next reports.
The average duration of a project is 3.5 years (42 months) reflecting that 6 projects were extended of 6 months (data missing for 3 projects). Indeed, the maximum duration of the EuroNanoMed proposals was set to 36 months as an eligibility rule. Consortia were composed of 4 to 6 partners (average of 5 partners) and 60% of the partners were from Academia, 22.5% from SMEs and 17.5% from Clinical organisations.
A total of 66 project meetings were held during the lifetime of the projects. The number of meeting by project is varying from 4 to 15 (average of 8). Consortia or part of consortia which had been funded under JTC 2009 submitted 13 proposals to another European Call. Out of these 13 proposals, 3 were applications to another ENM Call. One consortium did not submit any other proposal when the most prolific submitted 4 applications.
As mentioned above, ENM pays particular attention to the involvement of young researchers in ENM projects. In the 8 projects, 73 young researchers were involved with an average of 9 young researchers per project (from 3 to 15) and of 2 young researchers per participant (from 0 to 6). Regarding the mobility of researchers, all projects led to some mobility, at least via lab visits. Half of the projects led to long term mobility, from a couple of weeks up to 6 months. Globally, project partners were very active in terms of publications: 70 articles, 19 books or book chapters, 13 reviews and 18 articles dedicated to general public. Project partners also had many (147) communication in scientific congress and conferences. In addition, 25 dissertation theses were passed in close relation with the ENM projects but no policy document was published.
o JTC 2010 call output
A total of 33 projects were submitted to JTC 2010 and 8 projects were finally funded for a success rate of 24%. The total costs of the funded projects were of 16 M€ with an allocated funding of 9 M€. A total of 5 projects were characterized as “Targeted delivery systems” projects, 3 as “Diagnostics” projects and 1 as “Regenerative medicine” project. The 8 projects funded under JTC 2010 had submitted their final report. These projects involved 46 partners and all of them adequately replied to the questions which is an improvement compared to the JTC 2009 final reports where 31 out of 40 the participants fully filled in their reports. Thus the update performed in the Progress and Final report templates had been fruitful.
The average duration of a project was 3.5 years and a half (41.2 months) reflecting that 3 projects were extended of 6 months and 2 projects were extended of 12 months.
Consortia were composed of 4 to 7 partners (average of 6 partners). About 61% of the partners were from Academia, 24% from SMEs, 13% from Clinical organizations and 2% from a large company.
Regarding the project budget, on average, the partners used about 92% of the planned budget and 98% of the planned funding. In addition, 37% of the partners used budget from external sources. External sources being defined as budget other than the budget claimed within the frame of the ENM project budget. From these 37%, partners clearly use in priority “in kind” efforts to complete the EuroNanoMed public funding.
A total of 48 project meetings were held during the lifetime of the projects. The number of meetings by project is varying from 4 to 11 (average of 6). Consortia or part of consortia which had been funded under JTC 2010 submitted 11 proposals to another European Call. Only 1 out of these 11 corresponded to an application to another ENM Call. Two consortia did not submit any other proposal when the most prolific submitted 3 applications.
In the 8 projects, 81 young researchers were involved with an average of 10 young researchers per project (from 2 to 23) and of 2 young researchers per participant (from 0 to 8). Regarding the mobility of researchers, all projects lead to some mobility, at least via lab visits. Half of the projects lead to long term mobility, from a couple of weeks up to 6 months.
Project partners were very active in terms of publications: 70 articles, 19 books or book chapters, 13 reviews and 18 articles dedicated to general public. Project partners also had many (147) communications in scientific congress and conferences. In addition, 14 dissertation theses in close relation with the ENM projects were defended.
o JTC 2011 call output
A total of 41 projects were submitted to JTC 2011 and 7 projects were finally funded for a success rate of 17%. The total costs of the funded projects were of 11.1 M€ with an allocated funding of 6.3 M€. One project was characterized as “Targeted delivery systems” project, 2 as “Diagnostics” projects, 2 as “Regenerative medicine” projects, and 2 as “Targeted delivery systems & Diagnostics” projects.
The 7 projects funded under JTC 2011 had submitted their final reports. These projects involved 35 participants.
The average duration of a project was 3 years (37,6 months) reflecting that 3 projects had extended the project duration and 1 project length was only 30 months. Consortia were composed of 3 to 6 partners (average of 5 partners) and 74% of the partners were from Academia, 14% from SMEs and 12% from Clinical.
Regarding the project budget, on average, the partners used about 96% of the planned budget and funding. In addition, 51% of the partners used budget from external sources. External sources being defined as budget other than the budget claimed within the frame of the ENM project budget. From these 51%, partners used mainly “in kind” efforts and other public funding to complete the EuroNanoMed public funding.
A total of 32 project meetings were held during the lifetime of the projects. The number of meetings by project is of 4.6 average, ranging from 5 to 7.
Consortia or part of consortia which had been funded under JTC 2011 submitted only 1 proposal to another European Call.
In the 7 projects, 59 young researchers were involved with an average of 8 young researchers per project (from 3 to 17) and of 2 young researchers per participant (from 0 to 7). Regarding the mobility of researchers, all projects lead to some mobility, at least via lab visits. Two projects lead to long term mobility, from a couple of weeks up to 4 months.
Project partners were very active in terms of publications: 50 articles, 12 books or book chapters, 6 reviews and 5 articles dedicated to general public. Project partners also had many (124) communications in scientific congress and conferences. In addition, 9 dissertation theses in close relation with the ENM projects were defended.
o JTC 2013 call output
Another of the ENM II deliverables focused on the projects funded under the frame of the 2013 Joint Transnational Call (JTC 2013).
A total of 43 projects were submitted to JTC 2013 and 8 projects were finally funded for a success rate of 19%. The total costs of the funded projects were of 11.5 M€ with an allocated funding of 7 M€. Among these projects, 2 were characterised as “Targeted delivery systems” projects, 2 as “Diagnostics” projects, 3 as “Targeted delivery systems & Diagnostics” projects, and 1 as “Targeted delivery systems & Regenerative medicine” project. The 8 projects funded under JTC 2013 involve 42 participants.
It is important to highlight that projects funded under JTC-2013 started in 2014 and that, in consequence, most of them had not finished when we produced the report. Only one project was finished after 24 months and has delivered its final report. Thus, information given hereafter is based on the periodic reports (years 1 and 2). In consequence, data related to individual partners was not available since only data at the consortium level was requested in the periodic reports.
The average duration of a project was 33 months but since projects were not yet finished, an extension (of 6 months) was possible and even probable.
Consortia were composed of 4 to 7 partners (average of 5 partners) and 63% of the partners were from Academia, 23% from SMEs, 12% from Clinical organizations and 2% from large companies.
A total of 27 project meetings were held during the two first years of the projects. The number of meetings by project is varying from 2 to 5 (average of 3).
Consortia or part of consortia which had been funded under JTC 2013 submitted 11 proposals to another European Call. Only 1 out of these 11 corresponded to an application to another ENM Call. Two consortia did not submit any other proposal when the most prolific submitted 4 applications.
In the only project finished at the time of the analysis, 4 young researchers were involved. Regarding the mobility of researchers, all projects lead to some mobility, at least via lab visits. Two projects lea to long term mobility of at least two weeks.
Project partners were very active in terms of publications: 47 articles, 4 reviews and 4 articles dedicated to general public. Project partners also had 40 communications in scientific congress and conferences. In addition, 6 dissertation theses in close relation with the ENM projects were defended.
REGULATORY AFFAIRS, ETHICAL AND SAFETY ISSUES
To successfully transform innovative research to the market, stakeholders usually have to surmount a number of obstacles. In addition to technical hurdles which are inherent to scientific research, there are “non-technological barriers” that may hinder market access of R&D results. One major non-technological barrier in the healthcare sector is the challenging regulatory framework that makes market approval of new drugs time demanding and costly. This is especially true for nanomedicine, as nanomedical products are often on the borders between medical products and pharmaceuticals and therefore are subjected to different regulatory frameworks. This fact is the source of uncertainties with regard to market accreditation. Regulatory frameworks should be discussed on a European rather than at a national level. In this context, EuroNanoMed offered a unique platform to deliberate regulatory issues that will facilitate the transfer of nanomedicine knowledge from the laboratory to the patient.
Hence, through WP3, EuroNanoMed II aimed at 1- training funded researchers in regulatory issues to be considered during their projects; 2- fostering dialogue among nanomedicine stakeholders from research, industry, agencies & policy makers; and 3- addressing ethical & safety issues that are pivotal for public acceptance of nanomedical products.
TRAINING ON REGULATORY AFFAIRS FOR EURONANOMED FUNDED RESEARCHERS AND ENHANCING EXPERTS DIALOGUE
• On one hand, the aim was to inform and train researchers about regulatory requirements that nano-medical products will have to meet to pass from the research stage towards a later application or a fast entry into clinical trials, and how they should be considered during their research projects. Issues relating to intellectual properties were also addressed.
In order to achieve this, a workshop was organised for researchers from EuroNanoMed (I&II) funded projects. Experts from industry, medical product agencies and notified bodies were invited to give presentations and to participate in round tables. Beyond the training aspect, the workshop also allowed an interaction between the researchers and the experts – especially from regulatory agencies and EMA – to call the experts attention to the researchers’ needs and problems. This workshop on regulatory affairs was organized in Düsseldorf, Germany on 29th January 2014 back to back to one of the review seminars described earlier. As target audience, researchers from all ongoing ENM projects were invited to the workshop, the coordinator (or another senior PI) and one young researcher from every project. Many partners of the ENM II consortium also attended the workshop as well as some members of the ENM II external advisory board (EAB). After an introduction by the ENM coordinator and NSC chair with general information about ENM and upcoming calls and activities, different nanomedicine related topics on regulatory issues were addressed, treating the three subfields of nanomedicine: targeted delivery, diagnostics and molecular imaging and regenerative medicine. In addition, a case study of the successful translation of a nanomedical product was presented as well as presentations about IPR issues and ethical and safety issues in nanomedicine. Lectures on the following topics were hold (speakers in brackets):
o General overview on the regulation of nanomedical products and upcoming new regulations from EMA (Rogério Gaspar, Advisory expert to the EMA);
o Process and general requirements for the approval of nanomedical products (René Thürmer, German Federal Institute for Drugs and Medical Devices);
o Regulation of combination products (Sophie Tabutin, British Standards Institution)
o New Imaging agents – State of the art and regulatory challenges (Philippe Bourrinet, Guerbet),
o Regenerative medicine and stem cell therapies (Volker Scherhammer, apceth)
o Translation of nanomedicine to the clinic – a successful case study (Bernd Mühlenweg, Nanobiotix);
o Intellectual Property Rights Manangement (Carsten Richter, European patent attorney);
o Ethical and Safety Issues in nanomedicine (Adriele Prina-Mello, Trinity College Dublin).
In addition, other initiatives relevant to the field of nanomedicine, translational medicine and clinical research have been invited, to present their activities and services to the ENM researchers.
o European Technology Platform on nanomedicine (ETPN) (presented by Patrick Boisseau, chairman of the ETPN);
o European Clinical Research Infrastructure Network (ECRIN) (presented by Christine Kubiak, ECRIN executive manager);
o European Infrastructure for Translational Medicine (EATRIS) (presented by Anton Ussi, EATRIS head of operations).
The presentations of all speakers have been distributed to the workshop attendees and a report has been produced.
• On the other hand, Following the success of the first training workshop and the good feedback from the attendees, it was decided by the NSC to replace the initially planned “experts’ dialogue” by a second training workshop for funded researchers. This decision was approved by the project officer and the work program was amended accordingly.
The second workshop on regulatory affairs was organized in Berlin, Germany on 26th November 2016, back to back to one of the review seminars described earlier. As target audience, researchers from ongoing ENM projects from JTC-2013, 2014 and 2015 were invited to the workshop, the coordinator (or another senior PI) and one young researcher from every project. Many partners of the ENMII consortium also attended the workshop as well as two invited PRP experts. The workshop was aiming at a) providing the ENM funded researchers with information about regulatory issues and raising their awareness to consider these issues already at an early state in their projects and b) to introduce relevant European initiatives in the field of nanomedicine that could be helpful to researchers to provide information or for potential collaboration.
After an introduction by the ENM coordinator and the WP leader with general information about ENM and the aims of the meeting, in the first part of the workshop different nanomedicine related topics on regulatory issues were addressed, treating the three subfields of nanomedicine: targeted delivery, diagnostics and molecular imaging and regenerative medicine. In addition, a case study of the successful translation of a nanomedical product was presented. Lectures on the following topics have been hold (speakers in brackets):
o Process and general requirements for the approval of nanomedical products (René Thürmer, German Federal Institute for Drugs and Medical Devices)
o New Imaging agents – State of the art and regulatory challenges (Philippe Bourrinet, Guerbet)
o Regulation of combination products (Susanne Hebestreit, i.DRAS GmbH)
o Cell Therapies of the next Generation – Advanced Therapy Medical Products (ATMP) (Suncana Kern, apceth GmbH)
o Translation of nanomedicine to the clinic – a case study (Timm Jessen, Topas Therapeutics GmbH)
In a second part, relevant initiatives in the field of nanomedicine and translation had been invited to present their activities and services to the ENM researchers.
o European Technology Platform on Nanomedicine (ETPN) (presented by Klaus-Michael Weltring, Bioanalytik Münster)
o ENATRANS Project (presented by Nicolas Gouse, Coordinator of ENATRANS)
o European Nanomedicine Characterization Lab (EU-NCL) (presented by Simon Baconnier, CLINATEC)
o GMP Pilot Line: Nanofacturing (presented by Justin Barry, Midatech)
o GMP Pilot Line: NanoPilot (presented by Iradia Loinaz, Cidetec)
Finally, a presentation about Ethical and Safety Issues was given by Cecilie A. Mathiesen (partner 13, RCN) summarizing the main results of the ENMII workshop on Ethical Issues in Oslo, Norway in December 2014 (see below).
The presentations of all speakers were made available as download to the workshop attendees and a report on the workshop was produced.
FRAMING NANOMEDICINE ETHICAL ISSUES
Since the emergence of the nanotechnology field, the ethical issues about nanomaterials have raised concern and have been discussed. As a result, the European Group on Ethics published in 2007 their “Opinion on the ethical aspects on nanomedicine” and, in 2008, the European Commission published the “Code of Conduct for Responsible Nanosciences & Nanotechnologies Research”, as guidance for the responsible development of nanotechnologies. The goal of this task was to explore and frame the ethical issues associated with the nanomedicine field with the aim of better taking ethics into account in defining future activities.
• A report on ethical issues and stakeholders’ attitudes towards the code of conduct in nanomedicine was produced. The report gave a summary of the actual regulatory framework in 2012, taking into consideration the general regulations applicable to nanomaterials and the specific provisions that were planned for the future. The report also addressed hazard assessment of nanomaterials, focusing on the connection between their physicochemical characteristics and the possible mechanisms of toxicity and also addressed relevant ethical questions in nanomedicine like citizens’ perception of risks and benefits of nanomedicine as well as questions of transparency and public participation to scientific discourses. It reviewed ongoing activities in the field of ethics in nanotechnology and summarized existing studies and articles on this topic. This report was used as an input for the discussions during a workshop on ethical issues that was organized in Oslo in December 2014 (see below). As knowledge and regulatory provisions about safety aspects of nanomaterials progress permanently, the statements and conclusions of the report were reviewed in 2016 to get an up-to-date picture of Nanomedicine safety issues. This updated report will also serve as an input for the successor initiative EuroNanoMed III.
• A workshop on ethical issues in nanomedicine was organized in Oslo, Norway on 3rd December 2014. As target audience, researchers from all ongoing ENM projects were invited, the coordinator and one young researcher from every project. All ENM JTC 2010, 2011 & 2013 funded projects except two were represented and most of the partners of the ENM II consortium attended the workshop. The workshop included different lectures on ethical topics given by European ethical experts. Additionally, a practical example was given, wherein a researcher presented his project with main focus on the ethical aspects.
The plenary session of the workshop started with a general presentation of EuroNanoMed II by the coordinator and a presentation of the work package on regulatory, ethical and safety issues in nanomedicine by the work package leader. Then, different ethical topics were addressed by European experts:
o Report on ethical issues and stakeholders attitudes towards the code of conduct (Dr. Ioana Ispas, Advisor Bioethics Genomics & Health, EuroNanoMed partner, MEN, Romania)
o Presentation of the output of EuronanoMed2: mapping of European activities on ethical issues in nanomedicine (ANCS, Romania).
o Occupational peculiarities and hygienic solutions for exposure to engineered nanoparticles (Dr. Raz Dekel, head of occupational medicine, MD MOccH, Head of Occupational Medicine service, Meuhedet HMO, Israel)
o The art of medicine versus technologies of human enhancement: ethical and epistemological considerations (Prof. Jan-Helge Solbakk, Head of Research Centre for Medical Ethics Faculty of Medicine University of Oslo, Norway)
o Ethics of Nanotechnology – Mapping the Terrain, Identifying the Grid (Dr. Gil Siegal, MD, LLB SJD is a surgeon and a health law professor, chairs the Center for Health Law and Bioethics at Ono College, Israel)
o Practical example (Prof. Catharina de Lange Davies, Department of Physics, Norwegian University of Science and Technology, Trondheim, Norway)
o The Project “Multifunctional nanoparticles for drug delivery across the Blood-Brain-Barrier” has been reviewed in terms of working on ethical issues.
These talks were followed by a practical exercise, involving the audience and bringing closer an ethical matrix: the audience was divided in working groups, each consisting of five people. The groups could choose between two projects and analyse three chosen ethical questions and the respective stakeholders, i.e. groups of people or single people affected by the ethical questions. Both projects were represented by a principle investigator to provide additional information if requested. The workshop ended with an open discussion between all participants and speakers.
o Presentation of the "Ethical matrix" exercise (Dr. Ioana Ispas)
o Presentation of two EuroNanoMed2 funded projects: "Gadolymph" and "Nanoasit"
o Discussion on the ethical roadmap, chaired by Dr.Gil Siegal
o Discussion on the role of researchers and funding agencies, chaired by Dr. Klaus-Michael Weltring, chair bioethics group, ETPN.
Most of the presentations were filmed and are available at the ENM website. In addition, based on this workshop, a scientific article was published: Ethical issues in nanomedicine: Tempest in a teapot? Allon I, Ben-Yehudah A, Dekel R, Solbakk JH, Weltring KM, Siegal G. Med Health Care Philos. 2016 Aug 13.The presentations of all speakers were disseminated to the workshop attendees and a report has been written.
FRAMING NANOMEDICINE SAFETY ISSUES
The aim of this task was to provide a periodic update on the relevant nanotoxicology research and regulation initiatives carried on at European level. Several projects -those already started, networked actively in the EU NanoSafety Cluster (www.nanosafetycluster.eu) with other new projects starting later- were supposed to provide information concerning the safety of nanomaterials, the use of validated methods for nano-risk assessment, roadmaps and priorities for future research, integrated and intelligent testing strategies, and the future regulatory framework for engineered nanomaterials. Nanomedicine is one of the key applications of engineered nanomaterials, and all these activities were expected to have a substantial effect on biomedical applications of nanotechnology.
A report was produced to provide a short review of the state of the art concerning safety issues in nanomedicine, updating the last report on this issue provided under ENM I. The report summarised the safety regulatory framework, took into consideration the general regulations applicable to nanomaterials, and the specific provisions that were planned in the future. The report also addressed the knowledge available at the moment concerning hazard assessment of nanomaterials, focusing on the connection between their physicochemical characteristics and the possible mechanisms of toxicity.
Potential Impact:
STRATEGIC IMPACT
EuroNanoMed I gathered the participation of partners from 18 countries and regions and generated the support of 24 RTD projects in nanomedicine through three calls for proposals. ENM I achieved a critical mass of players, arousing translational collaborations between three research communities: academic, industrial and clinical research, with projects covering the three main subfields of nanomedicine, i.e. targeted drug delivery, diagnostics and regenerative medicine. However, the EuroNanoMed I initiative was limited to 3 years only and the majority of the partners consider that the continuation of ENM I with ENM II was of major importance in order to:
• Support more transnational projects to foster the European research community in nanomedicine with the objective of creating a European Research Area in nanomedicine. New calls for proposals will take benefit of the communications already disseminated with regards to the ENM I calls.
• Promote the topics considered as priorities for the NMP unit and for the ETP Nanomedicine, in particular the translational aspects of nanomedicine , .
• Foster the participation of young researchers.
In addition, EuroNanoMed II contributed to EU policies and priorities, such as strengthening the European Research Area, advancing the transition to personalised and targeted medicine, boosting translational and clinical research, and focusing on transferring scientific results towards innovation in healthcare in Europe.
The strategic impact of the ERA-NET EuroNanoMed II can therefore be considered at different levels.
IMPROVE COORDINATION AND REDUCE FRAGMENTATION IN THE FIELDS OF RESEARCH OF NANOMEDICINE
➢ EuroNanoMed II has improved the coordination of national programmes in nanomedicine
In EuroNanoMed I, although only two joint transnational calls were planned to be launched in 2009 and 2010, the consortium decided to launch a third call before the end of the ERA-NET, showing the involvement and the willingness of the partners to coordinate their programmes in nanomedicine. With this second ERA-NET, involving the majority of partners of ENM I plus three new partners, the consortium has improved the coordination of the research programmes already set up during ENM I. ENM II greatly benefited from the tight links between partners and the experience achieved in ENM I.
The coordination of European programmes in nanomedicine has improved through the common work planned in this project:
• Fostering a network of national/regional programme managers working closely together and learning from each other. This builds mutual understanding and trust that have long lasting effects.
• Defining the common procedures, practices and documents for each of the four planned joint transnational calls for proposals;
• Organising the implementation and the follow-up of the funded projects; which required a sustainable work in synergy between the partner funding agencies over many years.
Moreover, the final goal of ENM II was to propose and establish a sustainable cooperation framework after the end of this second ERA-NET. This ambitious goal was achieved through the WP6, which was specifically dedicated to the preparation of this future cooperation towards a common joint programme in nanomedicine. All aspects of a future cooperation were explored with a step by step approach: benchmarking with sister initiatives; gathering the needs and expectations of the partners; identifying the administrative and financial constraints of the partners. The aim was to achieve a realistic cooperation between the funding agencies allowing the support of transnational nanomedicine research after the end of the ERA-NET and hopefully over many years. Finally, the continuation of EuroNanoMed activities became a reality thanks to the support of the EU through a third phase under Horizon 2020 ERA-Net cofund scheme.
➢ EuroNanoMed II has reduced fragmentation in the key fields of research of nanomedicine
The four joint transnational calls for proposals in nanomedicine launched through EuroNanoMed II contributed per se to reduce the fragmentation of the ERA in nanomedicine. The impact of these calls on fragmentation is significant since they were launched in continuation to ENM I. Therefore, they took benefit from the visibility and the success of the calls launched through ENM I. Considering the 18 countries/regions involved in ENM II, the joint calls for proposals allowed the support of partnerships between the majority of the European nanomedicine players, contributing to the construction of the ERA in nanomedicine.
EuroNanoMed II filled in existing gaps in the European landscape and was complementary to existing initiatives. There was a real need of support for the different stages of the value creation chain in medical applications of nanotechnology and specifically through an industry/application/patient driven-approach. As already done in ENM I, ENM II has provided fast allocation of seed funding for innovative ideas and concept, where a limited number of partners is required and with this translational approach. This ERA-NET was therefore highly complementary to FP7 large scale projects funding tools (e.g. EUREKA, Eurostar, IMI) and FP7 programmes (NMP, HEALTH) with a heavier and longer application process and support for larger projects. Moreover, the existing ERA-NETs did not include explicitly nanomedicine as a key target neither had rules that were relevant to nanomedicine projects:
• SIINN dealt with the potential risks of engineered nanomaterials for the environment, human health, and safety. This was very complementary to the ENM II research programme on using nanotechnology for medical applications. Many links had been made with the ERA-NET SIINN since 8 partners were involved in both SIINN and ENM II and the coordinator of ENM II, ANR, was in charge of the work package on joint calls in SIINN.
• EuroTransBio aimed to foster the competitiveness of the European biotechnology industry, which was a border to some specific actions of nanomedicine. However, nanomedicine, or even nanobiotechnology, was not included specifically in their programme. In addition, the constraint for proposals to be coordinated by an SME and to include at least 2 SMEs per project was not applicable to the nanomedicine field which was less mature than biotechnology.
• MANUNET II was strictly focusing on market-oriented enterprise-led R&D projects related to the application and practical use of manufacturing technologies.
With the lessons learned from ENM I, ENM II has gained in efficiency and allowed a more sustainable impact on nanomedicine research. ENM II therefore contributed to the development of innovative therapeutic solutions for the patient and to the competitiveness of the European health industry. The aims of ENM II were thus in line with the European and NMP policy stressing the importance of solid and nationally-funded research efforts allowing cross-border cooperation between the best researchers from public and private sectors .
ACHIEVE CRITICAL MASS AND ENSURE A BETTER USE OF LIMITED RESOURCES IN THE FIELDS OF RESEARCH OF NANOMEDICINE
➢ EuroNanoMed II achieves a critical mass of players and focuses on translational collaborations
To achieve products in nanomedicine, the critical issue is to enable fundamental research to enter into preclinical and first clinical stages. To this aim, it is necessary to facilitate cross-fertilisation between the different players (industry, clinic and academia) and to reach a critical mass of players at the European level. With 21 partners from 18 countries/regions, ENM II covers the major part of the European research community. Moreover, considering the results already achieved in ENM I (i.e. the participation of more than 500 applicants to the three ENM I calls and the increased number of proposals from one call to the next) and the visibility of the ERA-NET, ENM II expects to have a significant impact on the European nanomedicine RTD landscape. In order to facilitate the transfer from research to companies and patients, there is a need to have enough academic teams, clinical teams and companies within research consortia. As such, in ENM I, translational collaborations were required through the calls eligibility criteria. Each consortium had to involve at least two categories of partners among clinical, industrial and academic research teams. ENM II also encouraged translational collaborations and gathered a sufficient number of players of all categories, taking together the 18 countries/regions partnering in the initiative.
➢ A greater impact with EuroNanoMed II joint transnational calls for proposals than the sum of the national ones
National programmes have difficulties to support transnational projects and, in the specific field of nanomedicine, there are often too few players at the national levels to achieve a critical mass. In addition, although nanomedicine has significant implications on the major diseases in Europe, the national calls for proposals are usually focused on specific diseases, making the more methodological field of nanomedicine less prioritised. On the other hand, the EU programmes (FP7 and the future Horizon 2020) have budget limits for each field, and often many good projects cannot be supported. ENM II continued and improved the funding mechanism created by ENM I to support transnational collaborative RTD projects between academia, companies (especially SMEs) and/or clinical/health care settings in nanomedicine, based on actual needs.
The effectiveness and the uniqueness of the ENM II funding programme resulted from the association of three characteristics:
• It was fully dedicated to nanomedicine;
• It was directly funded by national and regional funding organisations;
• It has fostered translational collaborations favouring the development of patient/person-oriented and/or industry-oriented projects.
Under WP6, ENM II specifically put some efforts to update and complement information on national strategies and programmes for nanomedicine. This was the continuation of the monitoring of the ENM II initiative and the starting point for building a long-term sustainable cooperation framework for nanomedicine research in the future. The aim was to gather the needs of EuroNanoMed II partners, as well as other relevant ministries and funding agencies interested in a funding collaboration in nanomedicine, and what they expected for a future cooperation scheme. An expectations’ questionnaire was launched and stakeholders’ needs were discussed in a workshop.
Within the framework of EuroNanoMed I, a survey was performed in early 2009 to gather information on national strategies and programmes and initiatives in nanomedicine among the partners, as well as on funding approaches among nanomedicine players in Europe. This task envisaged the update of the information on national strategies and programmes for nanomedicine on the future of the network collaboration. This survey was updated by: a) sending the original questionnaire to partners that were either new or did not provide answers to the first questionnaire, b) submitting a brief questionnaire to all partners asking for relevant information on recent programmes or initiatives in nanomedicine and changes in their strategy for nanomedicine R&D. The results of both surveys were analysed and presented at the 2nd NSC meeting in Venice, Italy (July 4th 2013). Eighteen organisations out of twenty contacted completed the survey. In addition, UEFISCDI provided access to this online questionnaire to our colleagues from ETPN, so that they could collect this kind of information from partners external to ENM II. UEFISCDI shared with ETPN the information collected by this survey and their analysis. The results of the survey were used to produce the Strategic Research and Innovation Agenda on nanomedicine (see next).
SHARING GOOD PRACTICES IN IMPLEMENTING COMMON RESEARCH PROGRAMMES
ENM II contributed to the improvement and harmonisation of the public policies aiming to support collaborative innovative RTD projects between academics, companies/SMEs and/or hospital/health care settings. During ENM I, a mapping and analysis of the practices existing in participating organisations led to agreeing on best practices that were implemented in the calls. ENM II has updated this mapping and analysis and also benchmarked with similar initiatives (see below). This was very valuable towards improvements in the call procedures and to help identify different schemes for a sustainable cooperation of the ENM II partners after the end of the ERA-NET (WP6, see below). In addition, the lessons learned (WP5) from each call and the continuous systematic exchange of information suggested the best ways for improving existing practices. This iterative process helped in meeting the goal not only to share good practices but to effectively use these practices.
EuroNanoMed II thus contributed to the preparation and use of European standards, with respect to:
• The "systematic" approach for compiling and comparing research programmes (i.e. congruence of terms, standard data formats, software solutions);
• Best practices with regards to programme management and administration as well as innovation issues in R&D funding;
• To define and validate appropriate tools and procedures for the selection of multinational projects and for the monitoring and assessment of multinational procedures;
• To harmonise evaluation practices of public funding bodies in Europe, especially the common use and precise definition of criteria and terms like e.g. “scientific excellence”, technology transfer, market relevance, clinical/public health needs, etc.;
• General agreements and principles for transnational research activities in the long-term (e.g. rules for a contractual and legal framework, models for transnational funding scenarios);
• Consistent IPR arrangements in transnational research funding;
• Dissemination of EMA applicable standards to nanomedicine clinical validation steps within the “nano community”.
A close cooperation with specific European stakeholders was essential to achieving the objectives of ENM II and fostering a long-term cooperation framework for a joint funding programme in nanomedicine. The EuroNanoMed Coordinator and the related WP leaders were in charge to conduct on a regular basis discussions and exchanges with the following networks:
- The European Technology Platform (ETP) on Nanomedicine;
- Other ERA-NETs (e.g. SIINN, EuroTransBio);
- The European Joint Technology Initiative for Innovative Medicine (IMI);
- The CSA NANOMED 2020;
- The CLINAM (network of clinicians working in Nanomedicine).
The collaboration with the ETP Nanomedicine already set up during ENM I was indeed strengthened in ENM II. A representative of the ETP Nanomedicine Executive Board was invited to attend the ENM II NSC meetings. This ETP representative conveyed to ENM II the voice of the platform, meaning the position of the private and public researchers. Vice versa, a representative of the ENM II consortium participated in the Executive Board of the ETP Nanomedicine. Moreover, since some EuroNanoMed NSC members were Mirror group members of the ETP Nanomedicine (Public Authorities representatives at national, regional and European level), they had the possibility to convey their position to the board of the ETP Nanomedicine. The channel of communication between ENM II and the ETP thus functioned in both directions. This collaboration with the ETP Nanomedicine was necessary for the implementation of the different workshops described in this report.
➢ Strategic Agenda for EuroNanoMed II from present to future
Nanomedicine is a rapidly evolving field, and to ensure that the EuroNanoMed II joint activities aim to tackle the unmet clinical needs and the global competitiveness of the European nanomedicine RTD, it is important to monitor the current trends in the field and the unmet clinical needs. This was performed in close collaboration with the European Technology Platform (ETP) Nanomedicine and using the documents they produce as input. The objective was to refresh the ENM I strategic agenda during ENM II.
During the 3rd NSC meeting (31st January 2014) the coming work to reach the objective in conjunction with ETPN plans was presented. As first step, questionnaires developed by the different Working Groups of ETPN (especially the Working Group on Clinical Interface) were distributed to the relevant research groups funded by ENM Joint Transnational Calls. A high-level ETPN meeting took place to discuss, group and filter the inputs received, before defining the next steps towards the establishment of the SRIA. This meeting took place on 24th April 2014 in Brussels and representatives from IMH and SRC (in charge of ENM II SRA) attended this meeting. After this ETPN meeting, it was decided to extend the survey and address all nanomedicine stakeholders in order to validate the first results obtained. ETPN asked ENM II to send an invitation to all ENM II members (both PIs and funded researchers) asking them to contribute to the next Strategic and Innovation Agenda for Nanomedicine in Europe, and to invite all of their industrial/SMEs’ contacts working in the field to contribute as well.
The ETPN online survey towards its Strategic Research and Innovation Agenda (SRIA) was modified and more focused on TRANSLATABLE nanomedicine. The survey was slightly modified accordingly, and the new link sent to ENM researchers was: https://www.surveymonkey.com/s/Towards_ETPN_SRIA_II.
During the ETPN general assembly in San Sebastian (November 2014) the Working Groups presented and discussed propositions, which were consolidated so that a list of technical priorities, clinical applications and roadmap for each sector could be used for the preparation of the SRIA. Some of these priorities were formulated to feed the WP 2016/2017 in H2020, among these, one ERA-NET Cofund (EuroNanoMed III).
At the 5th NSC meeting (December 4th, 2014), SRC presented the state of the art of the SRIA under preparation. The SRIA preparation was delayed due to the preparation of the new status of ETPN, and the preparation of the interphase with other KETs. From September 2015 ENM II has collaborated very actively in the preparation of the final version of the SRIA. A Conference Call with ETPN for better organise the finalisation of the SRIA was organized. The responsibilities of the different chapters and sections were distributed among ENM Coordination Unit, ETPN, SRC and ISCIII. At the ETPN Annual Event in Dublin (12th to 14th October 2015), some ExBo members, ENM coordination unit, WP3 leader (VDI) and WP6 leader (ISCIII) met in order to discuss the first draft texts provided by ENM II.
Hence, questionnaires were disseminated to relevant scientists, opinion-leaders and other stakeholders in the field of nanomedicine. A constant effort was made along the preparation of the document to make it accessible for audiences with very different backgrounds such as technologists, clinicians, patients and the large public as Nanomedicine is a multidisciplinary issue which addresses a large scope of users. The information compiled through these questionnaires was analysed and confronted to other sources of information (ETP Nanomedicine documents), and an updated “European Strategic Research Agenda on Nanomedicine” for ENM II was finally produced in January 2016. This strategic agenda was used as input or reference for all the activities of ENM II: definition of research programmes and call topics in WP2, framing nanomedicine-issues in WP3, dissemination activities in WP4, monitoring activities in WP5.
In Lisbon (June, 2016), the SRIA was presented to the EuroNanoMed partners. Among the recommendations of the SRIA we could highlight the following issues important for the future of ENM (ENM III):
• Detailed recommendations for R&D topics on selected diseases that affect a large number of patients: cardio-vascular diseases, cancer, diabetes, neurodegenerative diseases, infection diseases, osteoarticular pathologies and others
→ Will ENM calls remain open or focused in disease topics? This will need to be discussed during ENM III.
• Focus is set on translation of research results, i.e. the capacity to move the lab proof of concept towards an approved and certified product available for patients on the healthcare market
→ENM III big efforts will be put here. Among other things, ENM III has planned to set up a series of collaborations with the main stakeholders involved in this translation of research results in the field:
Finally, a second update of the strategic agenda was made in the last year of ENM II for planning future sustainable collaboration in this field.
➢ Develop a cost model for maintenance of a collaboration network for RTD funding in nanomedicine
Another important ENM objective with high impact was to develop a cost model for future cooperation among partners after the end of this ERA-NET. A business plan was developed to ensure that cooperation was possible without the EC “glue money”. Based on the needs and expectations of EuroNanoMed II partners and on the analysis and input from other initiatives, a cost model for a common joint management hub was explored. Administrative and legal architecture concepts and financial plans with cost models to share central management costs were discussed. For example, one possibility that was examined was for the partners to jointly fund a Joint Office after the present phase for coordination of the network. Possible financial models and administrative modes of cooperation were explored and discussed in a workshop, with the aim of coming up with a solid business plan. This workshop was held during the 7th NSC meeting (on 9th December 2015, in Grenoble) and focussed on lessons learned from experiences in other ERA-NET Co-Fund (use of EC funding for management, funding gaps in the ranking lists, etc.). Experienced ERA-NET Co-Fund coordinators were invited, and the lessons learned used for the preparation of the ENM III proposal, especially the risk assessment section. The results of the Workshop and main outcomes were part of a report on the cost model for a cooperation joint management hub.
➢ Long-term cooperation framework for continued joint RTD funding in nanomedicine
ENM II finally aimed to build a self-sustained transnational funding programme in nanomedicine with regular funding initiatives, based on the updated EuroNanoMed II strategic agenda. The results of the workshop on financial and administrative models for sustained cooperation, as well as the strategic agenda in nanomedicine were used as input to propose a full scenario for a sustainable network. In addition, during NSC 4 meeting (Tenerife, June 20th, 2014), due to the preparation of the Horizon 2020 Work Programme 2016-2017, all ENM II partners were advised by WP6 leader to contact their national representative of the Programme Committee to express the country interest in including a new topic for an ERA-NET Cofund on Nanomedicine in order to continue EuroNanoMed activities. With the first drafts of the WP some modifications were needed. The Coordination Unit and NSC members prepared a two-pages document intended to help ENM partners to disseminate about ENM activities and our intention to continue our collaboration through the ERA-NET Cofund instrument, which should appear in the H2020 WP for 2016.
Before NSC6 meeting (Jerusalem, June 25th, 2015), the Coordination Unit started to contact new putative partners interested in the next phase of EuroNanoMed (EuroNanoMed III). ENM II partners were asked for their intention to continue the collaboration and invitations to new potential partners were sent. WP6 leader and all partners were asked for contact persons at different funding organizations in Europe and beyond.
A questionnaire was also prepared in order to serve both for gathering partners’ needs and expectations and shaping ENM III proposal. The questionnaire was launched in September 2015 and sent to interested partners in ENM III besides the ENM II partners. They were asked to express their interest in leading specific tasks, WPs or interest in develop activities for the future phase.
After the publication of the draft WP2016/2017 with the inclusion of the topic for an ERA-Net Cofund on nanomedicine, the cooperation framework was assured. This new scenario was not clear at the time of the preparation of ENM II proposal, thus ENM partners decided to slightly change the approach of this task. The envisaged “workshop with policy makers and funding organization representatives of current and prospective partners” was devoted to learn from EuroNanoMed II experiences at the final meeting together with coordinators of funded projects, invited speakers and representatives of funding organisations. A session on lessons learned for future activities was carried out at final meeting in Berlin and interested partners discussed their commitment to the framework for continued collaboration.
The detailed results of the Workshop were compiled in a report on the cooperation framework scenarios.
PROMOTE TRANSNATIONAL COLLABORATIONS AND GENERATE NEW KNOWLEDGE
EuroNanoMed II calls for proposals have made transnational collaboration mandatory, and the added-value of this transnational collaboration, one of the evaluation criteria. For the national players, ENM II has broadened their opportunities to participate in collaborative innovative RTD projects. It has extended the field of partnership to all the 18 countries/regions members of the initiative, exploiting the domains of expertise of public researchers, of clinicians and of private researchers. The access to a very large number of potential partners has stimulated creativity of the different players of the field, generating new knowledge and more knowledge transfer than national projects. The fostering effect of the ENM II transnational joint calls for proposals has improved the quality of submitted proposals by:
- Making it easier to find specific competencies and skills;
- Facilitating European collaborations and synergies;
- Facilitating multidisciplinary approaches, a crucial issue in the field of nanomedicine;
- Generating more robust, ambitious and structured innovative RTD projects.
Finally, EuroNanoMed II has organised three big review seminars for the partners of the EuroNanoMed (I&II) funded projects and young researchers involved in the funded projects, with the participation of high-level invited scientists and European and national representatives. These events brought together the key players in the European nanomedicine research communities and thus further promoted interactions and collaborations at a European level.
As mentioned earlier in the follow-up and monitoring of funded projects section, EuroNanoMed II was assessed with a set of indicators which were identified to monitor both the ENM II programme and the funded research projects of ENM I and ENM II under WP5. The indicators took into account (1) the aims of the ENM II programme (described in this document) and (2) the aims of the calls that had to be addressed by the applicants for joint research projects (described in the published call texts). The selected indicators were used to continuously monitor ENM II activities and performance, and these were confronted with the results about the expectations of the involved partner organisations. Among the 35 identified indicators, 16 indicators were used to assess the achievements of ENM II. The indicators were divided in four different types: networking, input, output and socio-economic impact indicators. Regarding the output and socio-economic impact indicators, from the start of the EuroNanoMed II programme, the network initiated a structured monitoring process of the Consortium activities. It was carried out by the partners themselves, referring to the goals given in the ERA-NET description of work. In a first step, the updated expectations of the EuroNanoMed II partners for the outcomes of the work programme were discussed at the kick-off meeting. Then the expectations of partners were gathered in a short questionnaire which was analysed and presented to all partners. Yearly, these expectations were re-examined to redefine the work programme in a timely manner. A survey to assess research applicants’ feedback regarding ENM II joint transnational calls was also performed. After 2 years, the EuroNanoMed II activities and successes were discussed and compiled in a report. This continuous evaluation process has strengthened the cooperation and integration among partners and facilitated the preparation and definition of future collaboration of partners in nanomedicine (WP6). A final monitoring report was written and delivered.
ENM II partners agreed, among other things, that the main objective of ENM II was to provide national researchers with the opportunity of funding for small to medium-size transnational research consortia, it was considered very important for most of the partners to continue with the European coordination of research and programmes in nanomedicine, integrating new members; finally, a strategic agenda for nanomedicine is considered useful and should be common to all ENM II partners and other stakeholders in the field of Europe or at the international level, and should be in line with ETPN.
Among the 35 identified indicators, 19 indicators were used to monitor the ENM I and II funded research projects. Interestingly, EuroNanoMed II has also led to significant socio-economic impact through the different transnational calls and funded projects. Through JTC 2009, ENM projects led to the creation of 5 new permanent contracts. On average, per project, 3 new fellowships were obtained and 2 fellowships were continued. A total of 23 temporary contracts were created or continued. Globally, on average per participant, 2 positions were mobilized for the research project. A total of 5 patents were submitted during the lifetime of the projects, 2 at the international level and 3 nationally (in Sweden and in Spain). Interestingly, one project led to the creation of a company in Lithuania: the UAB-Ferentis start-up. Through JTC 2010, ENM projects led to the creation of 6 new permanent contracts. On average, per project, 4 new temporary contracts were obtained and 3 were continued after the end of the project. In addition, 13 fellowships directly linked to the project funding were created. Globally, on average per participant, 2 positions were mobilized for the research project. A total of 8 patents were submitted during the lifetime of the projects, 3 at the international level, 2 at the European level and 3 nationally (in Sweden and in Portugal). These patents were coming from 5 different projects. Interestingly, one project led to the creation of a company: The Adjuvatis start-up was created in France. In addition, in the frame of one project, the patented results were transferred to a company founded by the Swedish partners of the project. Through JTC 2011, ENM projects led to the creation of 14 new permanent contracts. On average, per project, 5 new temporary contracts were obtained and 2 were continued after the end of the project. In addition, 14 fellowships directly linked to the project funding were created. Unfortunately, none of the 7 funded projects led to the submission of patents neither to the creation of a company. The economic impact is then limited. Through JTC 2013, as described earlier, only one project was finished at the time we produced the analysis. Hence, most of the socio-economic impacts of the ENM funded projects were not available (employment, new products, creation of firm). Indeed, these indicators are directly linked to the final achievements of the projects. However, 1 patent was submitted by partners 1 and 2 in the only project which was finished.
SPREADING EXCELLENCE, EXPLOITING RESULTS, DISSEMINATING KNOWLEDGE
Based on the knowledge acquired during ENM I and on the experience from partners involved in the other ERA-NETs, the communication of ENM II was greatly efficient, with the WP4 dedicated to communication and dissemination. The leaders of this WP worked with all the ERA-NET partners and with all the other WPs to disseminate the activities and results of ENM II.
The key messages to be disseminated were:
• EuroNanoMed II description, objectives, news, information on the procedures (for benchmarking), information on the joint calls for proposals (announcement of the launch, documents and contacts to apply, etc.), results of the joint calls for proposals;
• Description of the EuroNanoMed II-funded projects and key results from these projects;
• Presentation of the nanomedicine field;
• General information related to nanomedicine events and news.
Different target audiences were identified depending on the messages to be delivered. As already done in ENM I, the main audience targeted was the research community and the policy makers (EC and national). Moreover, in ENM II, some information was also specifically prepared and dedicated to the general public through for example video clips in order to present and explain the nanomedicine field in a comprehensive way. Indeed, the aim was to build an information bridge between research and society in order to increase public awareness to the importance of research in nanomedicine, showing the potential benefit of such research to the patients.
The ENM II website was the main support for dissemination of all ERA-NET data. The website set up for ENM I was updated and improved for ENM II in order to provide all relevant information with a more efficient dissemination process (WP4). This website enabled the consortium to generate an effective flow of information and publicity about the objectives and results of the ERA-NET, the contributions made to European knowledge and scientific excellence, the value of collaboration on a Europe-wide scale, and the benefits to EU citizens in general. The website was divided into three parts: a public part, a communication tool and a restricted area.
• The public part of the website was used for publication of information related to the presentation of EuroNanoMed II, EuroNanoMed II publications, calls for proposals and results, help desk information, events and news, FAQ, etc. The website was regularly updated with details of funded projects including abstract, partners, funding, a link to the project website and publications.
• Contact data base and communication tool: An advanced automatic tool was developed in order to automatically disseminate information published on the website to relevant nanomedicine contacts (in a database). This database included all applicants to the EuroNanoMed calls for proposals and was continuously updated with people subscribing on the website.
• Restricted website area (available for ENM II members only): to facilitate the communication between the ENM II partners. It is composed of both document management and project management software in order to facilitate both the exchange of documents and on-line project management (interactive calendar, information sheets, etc.). Access rights were provided to each Work Package Leaders and Task Leaders for co-ordination activities. The system was technically maintained and information was continuously updated, so that an efficient and timely exchange of information coud be performed.
Regarding the dissemination of results from the ERA-NET, different types of documents were produced with the help of public relation experts to address the different publics targeted: the scientific community and policy makers. These include newsletters and press releases to communicate on the main events of the ERA-NET work, such as announcements and results of joint calls, information on projects funded in the joint calls (summaries and outcomes), and the results of workshops. Furthermore, a brochure presenting the ERA-NET results was prepared for policy makers and used for the WP6 on future cooperation. The documents were disseminated using both printed and internet means. In addition, the ERA-NET and its achievements were presented to the scientific and business communities at nanomedicine conferences and events (e.g. ETP Nanomedicine annual forum, Nanobio Europe conferences, CLINAM conferences, general nanotechnology conferences with a nanomedicine session, etc.) by the coordinator and the WP leaders highly involved in other nanomedicine-related initiatives.
Regarding the introduction of pivotal issues on nanomedicine to the general public, different tools to disseminate information on nanomedicine to the general public were used. Three short video clips were produced related to the three subfields of nanomedicine: targeted drug delivery, diagnostics and regenerative medicine. These are available on the EuroNanoMed II website, as well as on YouTube and Wikipedia. In addition, a Facebook page was launched in February 2013 for EuroNanoMed II to enable the ERA-NET to reach the general public with no geographical limits. The Facebook page includes the outcomes of EuroNanoMed I and II, links to the EuroNanoMed II webpage, press releases and other announcements, and the video clips. In addition, the lectures from the workshop on ethical issues were registered and video clips were produced and published in the same channels.
EuroNanoMed II also enhanced communication with similar initiatives. The aim was to identify initiatives currently involved in implementation of nanotechnology into medicine and to establish contact with them for information, dissemination, and cooperation. The bodies with similar or partially overlapping scope, such as ERA-NETs, networks of excellence, funding organisations and safety and regulatory bodies (e.g. M-ERA.NET ETP Nanomedicine, ERA-NET SIINN, EuMaT, SusChem, JTI IMI, ENIAC, AENEAS, the CSA NANOMED2020 and EMA) were identified by Internet searching and by a short inquiry form sent to ENM II participants. The aim of this survey was to define contact persons in these initiatives and to create a contact list based on the knowledge possessed by the ENM II partners. In order to set up collaborations with similar initiatives, representatives were invited to participate in ENM II meetings. Following the survey, the contact persons in these initiatives were identified and a contact list was created and the list has continuously been updated for communication and dissemination purposes. The participation of ENM II partners to similar initiatives meetings was also encouraged: information concerning meetings organised by similar initiatives was collected and communicated to the ENM II partners. Effective use of resources was achieved by joining forces with other networks and bodies with similar or partially overlapping aims.
The complete list of dissemination activities can be found in the EuroNanoMed dissemination table (template A2).
List of Websites:
EuroNanoMed Call Office
French National Research Agency,
50 avenue Daumesnil, 75012 Paris, France
Tel : +33(0) 1 78 09 80 44
Mail: calloffice@euronanomed.net
EuroNanoMed Coordinator
Amélie Vergne
Scientific Officer, PhD
Health and Biology Department
Agence Nationale de la Recherche,
50 avenue Daumesnil, 75012 Paris
Tel: +33(0) 1 78 09 80 44
Mail: ENMcoord@anr.fr
For more information, visit the EuroNanoMed web site:
http://www.euronanomed.net/