CORDIS

There is a global unmet need to cure and prevent diseases for which we currently lack efficient treatments, and which cause suffering and death. The prolonged life expectancy, the higher expectations for improved quality of life and changes in life-style of European citizens, all call for improved, more efficient and affordable health care.

Nanomedicine, the application of nanotechnology to health care, offers numerous promising possibilities to significantly enhance medical diagnosis and therapy. Furthermore, nanomedicine is an important strategic issue for the sustainable competitiveness of Europe. The strategic importance of nanomedicine is being increasingly recognised by governments and industry around the world. Coordinated efforts at the European level are therefore crucial in order to maintain its competitiveness.

The ERA-NET EURONANOMED (ENM) initiative comprises of 24 partners from 18 countries or regions. EURONANOMED aims at fostering the competitiveness of European nanomedicine players through the support of transnational collaboration, translational research and technological development projects with participants from academia, industry and clinical/public health communities.

The European Union (EU) funds the extra costs incurred for the coordination of the joint activities of the national and regional funding organisations. ERA-NET EURONANOMED, launched in January 2009, published a strategic agenda for EURONANOMED activities, stating the EURONANOMED initiative, strategy, organisation and foreseen joint activities.

Originally, the project aimed to publish and handle two joint calls for proposals which were launched in May 2009 and March 2010 respectively, each resulting in eight funded projects. The overall funding of the first call was nine million provided by EURONANOMED funding agencies and the second - EUR 8 million. As a result of their success, it was decided to publish a third call, which was launched in January 2011, resulting in eight projects, funded with eight million. In total, these 24 funded research projects were selected out of the 100 submitted projects involving 500 research teams from 25 countries or regions, encompassing all three subfields of nanomedicine: targeted drug delivery, diagnostics and regenerative medicine.

In parallel, the non-technological innovation barriers were addressed, ranging from the regulatory aspects to concerns about safety in the field of nanomedicine. EURONANOMED offered a unique platform for considering these issues at European level for further industrial exploitation of the research results and access to the market and published two reports on both safety aspects and regulatory questions in nanomedicine.

The high level of the submitted applications and excellent results of EURONANOMED have ensured that it became a valued funding initiative in the field of nanomedicine. In order to continue this successful work and to ensure a durable impact on the research programs involved, a second project proposal: ERA-NET EURONANOMED II, is in preparation. If funded by the European Commission (EC), a new call will be launched already in 2013.

Project context and objectives:

What is a European Research Area Network (ERA-NET)?

The ERA-NET scheme, supported by the EC, aims at developing and improving the coordination of public research programs conducted at national or regional levels in Europe, providing a framework to explore and set up joint activities such as joint calls for transnational proposals. By reducing fragmentation, duplication of efforts and increasing the significant number of participants, the ERA-NET activities strengthen the European Research Area (ERA).

The need

The ERA-NET EURONANOMED aims to bridge the gap between academic research in nanomedicine and industrial or clinical applications in order to shorten the time from bench to bedside.

With an ageing European population and increased demand for improved healthcare, further progress needs to be facilitated. Healthcare expenditure in industrialised countries accounts for 10 % of the gross domestic product (GDP), a figure that is expected to rise. European countries invest a substantial amount of resources into developing the nanotechnology industry. Within this field, nanomedicine, can be an advantage to medicine by its potential to bring about significant progress in diagnosis, prevention and treatment of diseases.

Nanomedicine

According to the Nanomedicine European Technology Platform, nanomedicine is defined as the application of nanotechnology to medicine, health and healthcare. Nanomedicine exploits the improved and often novel physical, chemical and biological properties of materials at the nanometer scale and has the potential to enable early detection and prevention, and to essentially improve diagnosis, treatment and follow-up of diseases.

For example, nanomedicine can improve in-vivo imaging techniques of medical equipment such as magnetic resonance imaging (MRI) scans by means of new contrast agents or facilitate the integration of implants in the body. Nanoparticles can also help drugs to reach their target (e.g. cancer cells) more efficiently.

Over the last few years, Europe has been successful in basic research dedicated to nanotechnologies. However, within the nanomedicine field, concerns remain among the research and technology development (RTD) players as to their capability to move forward effectively from basic knowledge into either industrial or clinical applications, i.e. translational research.

EURONANOMED

Funding organisations across Europe identified the need for a European initiative to coordinate research efforts and funding programs in nanomedicine. The ERA-NET EURONANOMED, supported by the EC for a three year period and coordinated by the CEA (France), was launched in January 2009. This initiative attracted the participation of as many as 24 research funding organisations (programme owners and managers) from 15 EU Member States and Associate Countries, as well as from three regions in Europe: Basque Region (Spain), France, Germany, Hungary, Iceland, Israel, Latvia, Lithuania, Poland, Portugal, Romania, Spain, Sweden, Switzerland, the Netherlands, Turkey, Veneto Region (Italy), and Walloon Region (Belgium).

EURONANOMED aims at fostering the competitiveness of European nanomedicine contributors through the support of transnational collaborative and multidisciplinary RTD projects with participants from academia, clinical / public health communities, and industry, particularly small and medium-sized enterprises.

EURONANOMED developed coordinated European-wide programs based on three joint transnational calls for proposals in nanomedicine. Identifying obstacles and barriers to joint activities and raising solutions to overcome the barriers were important strategic issues for the success of the transnational program. In addition EURONANOMED contributed to the identification and analysis of legal and safety aspects in the field of nanomedicine.

The ERA-NET EURONANOMED aspires to bridge the gap between academic research in nanomedicine and industrial or clinical applications in order to shorten the time from bench to bedside.

Project results:

Results

EURONANOMED joint calls

EURONANOMED launched three joint transnational calls for proposals (JTC) in nanomedicine in 2009, 2010 and 2011: the two original ones were planned in the initial strategic agenda of the ERA-NET while the third one was decided upon during the period of the ERA-NET, due to the prompt call launching process and the positive feedback from the participants.

The topics of the three calls covered the strategic priorities identified by the European Technology Platform on Nanomedicine: diagnostics, targeted delivery and regenerative medicine.

The aim of the calls was to support translational research proposals in the field of nanomedicine, encouraging transnational collaborations (at least three different countries) between researchers from academia, clinical sector and industry (with partners from at least two out of the three categories).

The evaluation of the projects was carried out based on external reviews from international experts and discussions by a joint peer review panel of international experts in order to establish the ranking list of best proposals.

The final budget of each funded project partner was negotiated and provided for by the relevant funding agency.

Results

In total, the three JTCs generated the submission of almost 100 proposals (with an increased number of projects from one call to another) involving 500 research teams from 25 countries or regions (including EURONANOMED and non EURONANOMED countries / regions covering almost the whole European research community.

EURONANOMED strategic agenda:

A strategic agenda for EURONANOMED activities was published in 2009. The main aim of this document was to present the:

-EURONANOMED initiative, its strategy, organisation and foreseen joint activities;
-obstacles and barriers between the national funding programs participating in EURONANOMED to joint research activities;
-current trends in nanomedicine;
-global state of nanomedicine.

Summary:

There is a global unmet need to cure and prevent diseases for which we currently lack efficient treatment modalities, and which causes suffering and a shortened life expectancy. The ageing population, the high expectations for improved life quality and the changing life style of European citizens also call for improved, more efficient and affordable health care. Nanomedicine, the application of nanotechnology in health care, offers numerous promising possibilities to significantly improve medical diagnosis and therapy, ultimately leading to a higher quality of life. Furthermore, nanomedicine is an important strategic issue for the sustainable competitiveness of Europe. The global competition in the field is very strong and the strategic importance of nanomedicine is being increasingly recognised by industry and governments around the world.

Coordinated efforts at the European level are thus crucial to stay competitive.

The EURONANOMED ERA-NET initiative comprises 24 partners from 18 countries or regions. EURONANOMED aims at fostering the competitiveness of European nanomedicine players through the support of transnational collaborative and multidisciplinary research and technological development projects with participants from academia, industry and clinical/public health communities.

The EU funds the extra costs incurred for the coordination of the joint activities of the national and regional funding organisations.

For the complete paper please visit this link: http://www.EURONANOMED.net/files/Strategic_Agenda_for_EURONANOMED.pdf

The 24 funded projects encompassed all three subfields of nanomedicine i.e. diagnostics, targeted delivery and regenerative medicine, covering diverse medical issues such as cancer; inflammatory diseases; cardiovascular diseases; Alzheimer's disease; infectious diseases as well as tissue regeneration of several organs, such as eyes, ears, spinal cords or bones.

These projects generated transnational collaborations with research teams from academia, clinical and industry. In over half of the projects, the three categories of research teams worked together. This cross-fertilisation between the different partners (industry, clinical and academia) is a key point to enable basic research to enter into preclinical and first clinical stages in order to maximise the potential number of nanomedicine products to reach the market.

Through the three JTCs of years 2009, 2010 and 2011, EURONANOMED funded 24 transnational research projects on nanomedicine involving 126 partners from 19 countries / regions (EURONANOMED and non EURONANOMED), with EUR 25 million funding from the Member States and regions and a further EUR 21 million funding from the participating project partners. EURONANOMED generated a huge leverage effect for nanomedicine, considering the EC budget dedicated to the coordination of the ERA-NET (EUR 1.33 million) compared to the budget dedicated to nanomedicine research through the funded projects (EUR 46 million).

Three categories

First joint call

In May 2009, the first joint call for proposals was launched with the participation of 19 EURONANOMED funding agencies (from 17 countries / regions). Twenty four applications were submitted from 117 research groups. The proposals involved the majority of partners from the participating countries, but also from non participating countries such as Denmark and Italy. Finally, eight projects involving 40 research groups from 14 countries / regions were funded with EUR 9 million provided by EURONANOMED funding agencies.

Second joint call

The second JTC was launched by ERA-NET EURONANOMED in March 2010 with the participation of 17 EURONANOMED funding agencies from 16 countries / regions. A total of 33 projects were submitted, involving 178 applicant groups from 19 EU Members States and Associated Countries / regions. Finally, eight projects involving 46 partners from 10 countries / regions were funded with EUR 8 million provided by EURONANOMED funding agencies.

Third joint call

An additional call was planned and the third JTC was launched in January 2011, with the participation of 14 EURONANOMED funding agencies. There were 41applications involving 207 groups from 20 EU Members States and Associated Countries / regions (EURONANOMED and non EURONANOMED countries / regions). Finally, eight projects, involving 40 partners from 11 countries were funded with EUR 8 million provided by EURONANOMED funding agencies.

Country

More detailed information about the funded projects can be found in the ENM website: http://www.EURONANOMED.net/

Non-technological innovation barriers: Safety and regulatory issues in nanomedicine

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.

Two reports that addressed these issues were published by EURONANOMED:

1. a synthetic report summarising the main information regarding safety aspects in nanomedicine is available on the website: http://www.EURONANOMED.net/files/D2-WPD_wrap%20up%20safety%20issues%2031052010-FINAL.pdf
2. a report presenting the conclusions of an expert workshop 'Non-technological innovation barriers' dedicated to regulatory questions in molecular imaging. The field of molecular Imaging was chosen as an exemplary subfield of nanomedicine due to its importance to both therapeutic and preventive medicine and, accordingly, its impact on therapy costs and reimbursement. The workshop aimed to define common interests between clinicians, producers of medical devices and imaging agents as well as regulatory agencies. It also set out to establish a fruitful cooperation in finding rapid and practicable solutions for regulatory problems and achieving a reasonable regulatory framework for imaging agents. Twenty five international experts from industry, public research, clinical and medical product agencies attended the workshop. The report summarising the main issues and recommendations raised by the experts is available on the website: http://www.EURONANOMED.net/files/EURONANOMED_Workshop_Non-Technological_Innovation_Barriers.pdf

Main meetings and workshops

Two experts' workshops were dedicated to the definition of the scientific topics for the EURONANOMED joint transnational calls for proposals:

External advisory board workshop for EURONANOMED call topics 2009, March 2009, Brussels, Belgium:

Members of the EURONANOMED external advisory board were invited to discuss and make recommendations on the topics of the first EURONANOMED transnational call for proposals. The EAB is composed of six high-level experts in nanomedicine from academia, industry and clinics, covering the three main areas of nanomedicine, drug delivery, diagnostics and regenerative medicine. The EAB is involved in the strategic activities and priorities of EURONANOMED in order to help in delineating topics for the JTCs. During this meeting, EURONANOMED objectives and work packages were presented and the comments and advice from the EAB were taken into account for writing the call text while keeping the topics as broad as possible to attract more applicants.

Expert workshop for EURONANOMED call topics, 7 - 9 February 2010, Reykjavik, Iceland:

This expert workshop involved an analysis of the evolving field of nanomedicine. The aim was to ensure that the scope of the EURONANOMED calls are kept in line with the academic, industrial, health, and clinical needs, along with the developments in nanomedicine during the time frame of the EURONANOMED ERA-NET. The workshop brought together 16 scientists with industrial, academic or clinical backgrounds, including the EAB members. Four selected nanomedicine topics were discussed in group sessions: diagnostics; drug delivery; regenerative medicine and clinical / industry needs, in order to give insights into possible strategic priorities concerning actions, training or research in the field. The aim of this analysis was to map strengths and weaknesses of the European Community in nanomedicine, pointing out the relevant areas to be addressed in the second EURONANOMED call for proposals to be launched in 2010.

Non technological innovation barriers in the field of molecular imaging, 14 - 15 December 2009, Düsseldorf, Germany:

The main objective of the workshop was to enable - on an European level – a well built dialogue between clinicians, producers of medical devices and imaging agents together with regulatory organisations, in order to address regulatory issues in nanomedicine, in particular in the field of molecular imaging. Twenty five international experts attended the workshop.

During the two day workshop, the experts identified a number of bottle-necks in existing regulations and formulated recommendations as to how to refine the existing guidelines to improve and accelerate the approval of imaging agents.

A report summarising the main issues and recommendations raised by the experts is available on the EURONANOMED website at: http://www.EURONANOMED.net/files/EURONANOMED_Workshop_Non-Technological_Innovation_Barriers.pdf

Midterm review meeting of the projects funded in 2009, 15 - 16 November 2011, Bern, Switzerland.

This meeting was the first midterm review meeting of EURONANOMED aimed at reviewing the projects funded in 2009 through the first EURONANOMED joint transnational call for proposals. The coordinators of the eight projects funded in 2009 presented the objectives, first results and any difficulties encountered in their projects. A poster session was also organised, providing the 12 young researchers with an opportunity to present, in more detail, specific parts of their projects. In order to foster communication between researchers, the coordinators of the eight projects funded in 2010 were also invited to participate in this meeting with a brief presentation of their projects. A total of 60 people attended the meeting, including researchers involved in the funded projects, representatives of the EURONANOMED funding agencies, a representative of the EC and three expert members of the EURONANOMED peer review panel.

The oral presentations and the poster exhibition enabled the PRP members to receive feedback on their funding recommendations.

Papers to review are:

Strategic Agenda for EURONANOMED
http://www.EURONANOMED.net/files/Strategic_Agenda_for_EURONANOMED.pdf

Nontechnological Innovation Barriers
http://www.EURONANOMED.net/files/EURONANOMED_Workshop_Non-Technological_Innovation_Barriers.pdf

Safety Issues in Nanomedicine
http://www.EURONANOMED.net/files/D2-WPD_wrap%20up%20safety%20issues%2031052010-FINAL.pdf

Potential impact:

Facilitating cross-fertilisation between the different actors in nanomedicine was one of EURONANOMED's prime objectives, aiming to accelerate the flow of information from research laboratories to end products for patients and to bridge the gap between life-enhancing / life-saving research and patient care. In addition, developing networks among the different research communities (academic, industry and clinical) will create synergies and improve the competitiveness of the European industry, which is very important in the worldwide competition in the field. This will increase efforts towards achieving preclinical and clinical validations, which will shorten time to market of innovative products and the time for patients waiting to benefit from such advancements.

In line with Europe's vision of promoting a better standard of living and the opportunity of healthy ageing globally, this ERA-NET will directly benefit all EU Member States involved, Europe's neighbors (some of which are members of the consortium), and the world at large.

In a survey among all ENM applicants it was found that 98 % of the EURONANOMED applicants (out of 144 respondents) considered joint calls in nanomedicine were very useful for the research community. EURONANOMED was considered as a 'perfect complement to FP7 NMP calls' and 'very important to improve translational research'.

Dissemination activities

Press conference:

April 23rd 2009:

A press conference hosted by the Veneto Region Offices in Brussels was organised in order to promote the launch of the first EURONANOMED JTC. Mr Gianlorenzo Martini, Director of Veneto Region Brussels Office opened the press conference. The speakers were:
- Mr Christos Tokamanis, Head of Unit, Operational Unit Nanosciences and Nanotechnologies, European Commission - DG RTD: 'Nanosciences in the European Research Area: What are the Challenges for the future?';
- Karin Forsberg Nilsson, EURONANOMED NSC Chair, Deputy Secretary General Scientific Council for Medicine, Swedish Research Council: 'The EURONANOMED project: an asset for the development of nanomedicine in Europe'

Presentations and posters

-European Technology Platform on Nanomedicine (ETPN) General Assembly, May 2009, Münster, Germany

Presentation: 'EURONANOMED: launch of the first JTC' Pierre-Noël Lirsac, Coordinator of EURONANOMED, CEA, France.

-Proposers' Day and Partnering Event on Nanomedicine, 12 April 2010, Berlin, Germany.

The European Technology Platform on Nanomedicine organised a proposers' day and partnering event targeting nanomedicine research in the perspective of several relevant European calls in 2010, namely, FP7 and EURONANOMED ERA-NET.

Presentation: 'EURONANOMED: Launch of the Second JTC' Olaf Rotthaus, EURONANOMED NSC chair, VDI, Germany
http://www.etp-nanomedicine.eu/public/press-documents/press-articles/successful-proposers2019-day-and-partnering-event-on-nanomedicinein-berlin

-European Technology Platform on Nanomedicine General Assembly, October 2010, Milan, Italy

Presentation: 'European funding instrument in nanomedicine: EURONANOMED' Virginie Sivan, Coordinator of EURONANOMED, CEA, France
http://www.dailymotion.com/video/xg4e3y_virginie-sivan-european-fundinginstrument-in-nanomedicine_tech

-European research area (ERA) - Platform Meeting of ERA-NETs related to ERA-IB and the KBBE, November 2010, Dresden, Germany

The aim of this meeting was to exchange information and experiences with different ERA-NETs with regard to the general organisation of ERA-NETs, the joint activities and the follow up of the funded projects. The possibilities of sustainable joint multinational research activity were also discussed.

-NanotechItaly, November 2010, Venice, Italy

Poster: 'For your transnational projects in nanomedicine, think EURONANOMED' EURONANOMED Call Office, Veneto Nanotech, Italy
http://www.nanotechitaly.it/

-European Technology Platform on Nanomedicine General Assembly, October 2011, Barcelona, Spain

Poster: 'EURONANOMED Funding of transnational research projects in Nanomedicine' Virginie Sivan, Coordinator of EURONANOMED, CEA, France
http://www.etp-nanomedicine.eu/public/news-events/events/etpnanomedicine-general-assembly-annual-forum-2011

Press releases:

- 24 April 2009: EURONANOMED: Launch of the first ERA-NET Call for Proposals in the field of Nanomedicine
- 29 October 2009: EURONANOMED Promotes European Collaborations and Innovations in Nanomedicine
http://www.EURONANOMED.net/files/press%20release%20EURONANOMED.pdf

-9 November 2010: ERA-NET EURONANOMED Allocates EUR 8 Million to European Transnational Research Projects in Nanomedicine
http://www.EURONANOMED.net/index.php?option=com_content&view=category&layout=blog&id=4

- 2 November 2011: EURONANOMED Allocates EUR 8 Million to European Transnational Research Projects in Nanomedicine
http://www.EURONANOMED.net/files/EURONANOMED%20press%20release%20JTC2-results-VFx.pdf

Other publications:

-ENM newsletter number 1
http://www.EURONANOMED.net/files/Newsletter%20EURONANOMED.pdf

-ENM newsletter number 2
http://www.EURONANOMED.net/files/Newsletter%20EURONANOMED%202011.pdf

-'For your Transnational Projects in Nanomedicine, think EURONANOMED!'

- European research review journal, November 2009, page 15
http://viewer.zmags.com/publication/cc5cc0b9#/cc5cc0b9/14

- 'EURONANOMED', ERA-NET - Networking the European Research Area Series II, EC publication, May 2010, page 13
http://cordis.europa.eu/fp7/coordination/library_en.html