Minutes of the Forum

First Annual Conference of the Scientific Panel for Health1: ‘Better research for better health - A holistic

approach to challenges & opportunities’

Forum held in Brussels, January 21, 2016

1 https://ec.europa.eu/programmes/horizon2020/en/h2020-section/scientific-panel-health-sph

First Annual Conference of the Scientific Panel for Health: ‘Better research for better health - A holistic approach to

challenges & opportunities’

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Table of Contents

EXECUTIVE SUMMARY.......................................................................... 3

NOTABLE QUOTES ............................................................................... 6

1. MINUTES...................................................................................... 8

1.1. Opening session..................................................................... 8

1.2. Session 1: Cross-border research: collaboration in Europe and beyond........................................................................... 9

1.3. Address by Rudolf Strohmeier, Deputy Director-General, DG Research and Innovation, European Commission .......................12

1.4. Session 2: Cross-border research: Academia, innovation and health care.....................................................................13

1.5. Session 3: The regulatory framework as a facilitating environment for innovation.....................................................16

1.6. Session 4: A comprehensive biomedical research policy - value-based, health-centred and science-led.............................19

1.7. Closing of conference & final words..........................................22

ACKNOWLEDGMENTS..........................................................................24

ANNEX 1 ATTENDANCE LIST ................................................................25



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EXECUTIVE SUMMARY

The Scientific Panel for Health

The Scientific Panel for Health (SPH)2, in a working document outlined the value of health to European society and the value of research to achieve health and economic prosperity. The SPH identified a number of challenges and opportunities for Europe that demand a new research and innovation framework and strategy. These include the global nature of health and disease; the changing demography and multi-generational population with age-specific needs; the revolution taking place in the understanding of disease and health allowing new preventative and personalized approaches based on causative pathways; the potential of big data for health and the emergence of smart technologies; the growing complexity of the regulatory environment. The document also highlighted European strengths, for example, the EU27’s leading position in a number of research areas; Europe’s organized healthcare systems and ICT potential; high levels of public funding, support and engagement; good public education. The SPH emphasised the need to build on these strengths, to address fragmentation of efforts and engage all stakeholders in a worldwide dialogue, in order to maximise the benefits and impact of biomedical research on health. The document concluded by a call for action to increase cross-border research, cross-border consultation, and ensure that comprehensive policies facilitate health research in Europe. A more long-term mechanism to boost and advance European health research is needed.

The aim of this first SPH conference was to discuss these proposals and provide further input into the working document towards a position paper.

Health research in Europe

This first SPH conference was a clear demonstration of the interest and willingness of the broader health research community to discuss European health research opportunities and work collaboratively to find ways to overcome the challenges faced. With over 400 participants from across all EU Member States, and representing over 200 governmental, non-governmental, and private research organisations, as well as civil society, the resounding message was that there is an active and flourishing health and biomedical research landscape in Europe but that more can be done to ensure a better, and more coordinated, research leading to better health across Europe.

The European Commission reaffirmed health research as a top priority and, as Commissioner Moedas highlighted, “EU policy needs to move quickly” in order to maximise health research impact. Europe needs to create a constructive research environment through close collaboration between stakeholders, through implementing enabling regulatory frameworks, and through facilitating greater innovation and wider investment, to ensure that Europe remains a world-leader in health and biomedical research.

Challenges and solutions to improve collaboration, use of health/research data, interdisciplinarity and facilitation of innovation were major themes of discussion.

Cross-border research: collaboration in Europe and beyond

2 https://ec.europa.eu/programmes/horizon2020/en/h2020-section/scientific-panel-health-sph



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Several examples were shared of successful collaborations across European countries, the European Commission and global organisations, as well as between sectors and disciplines. Reasons for success included having shared aims and objectives, as well as pooled resources. However it was stressed that, currently, undertaking transnational research means facing added legal, technical and organisational barriers, especially for clinical research. The support for research is still very much within national boundaries.

• Cross-border collaboration is vital to overcome the current problems in biomedical research, be it in relation to chronic diseases or infectious diseases. Future cross-border collaborations should build on the successes of current collaborative work, with examples in NordForsk, Cancer Core Europe and EMBL, and EU-level initiatives such as the International Rare Diseases Consortia.

• “Big data” is not a substitute but a supplement to traditional data collection and analysis. To be used to full potential, with proper acquisition, storage, integration and analysis, requires specific training and skills, infrastructure and long-term vision, in cross-border collaboration.

• Funding sources are available, but fragmented. Ensuring that funding is long-term and sustainable is vital. To ensure access to funding, research must be high quality and replicable.

• New ideas will attract private investment and lead to impactful innovations if they provide reliable, robust and in-depth research data. Working from the ground up with new ideas, starting with small and local research successes, moving to wider national research projects and then large scale research/implementation across nations can ensure innovations are well evaluated and lead to improved health outcomes.

Cross-border research: academia, innovation and health care

Differences between academic and industry environments, between areas of research such as public health and basic science, and between patients and scientists were acknowledged. Yet, to address current challenges will require a strategic, long-term focus coupled with a collaborative mind-set across stakeholders. Collaborations across business, academia and industry are needed to bring innovations from idea to market in Europe

• The barriers to working together can be reduced through increased exchange, collaboration and better training and education. Research can be strengthened by having interdisciplinary input and teams, including patients as active partners in health research to achieve greater societal impact.

• Multidisciplinary, multi-stakeholder and cross-border collaboration is required to use patient-level data from national healthcare systems and combine them in and with large-scale EU-level databases. Harmonised imaging and bio-testing platforms and common IT systems are required for storage and analysis, and to ensure data integrity and confidentiality. The proper sharing, linking and usage of reliable, robust and high-quality clinical and health research data is important to improve health, from building understanding of chronic diseases, to improving post-marketing surveillance of products, and responding to global health emergencies.

• Innovative opportunities for Europe to better anticipate, detect, treat and control disease, and improve health, offering exciting prospects for entrepreneurs and investors to seize. However, in order to do so, education and training is needed to build entrepreneurial mindsets and skills.

The regulatory framework as a facilitating environment for innovation



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Successful innovation in health requires a strong enabling research environment to ensure replicability of results, and to ensure product safety and efficacy for patients. The current paths to market approval and the way clinical trials are conducted, are not sustainable anymore because of high costs and high failure attrition rates.

• The regulatory framework needs to be made less complex, more transparent and more flexible – all to enable timely health research without compromising quality and safety.

• EMA aims to provide more support and enable research, not only acting as a gatekeeper; dialogue with all stakeholders, patients.

• Innovative treatments, complex interventions and devices, novel diagnostics and the potential for supportive IT and smart technologies will need creative approaches. Collaboration across different DGs within the EC is essential to address the current fragmentation in regulation.

• Research on effective regulatory models and technical assessments is needed to facilitate approval and patient access to quality interventions.

A comprehensive biomedical research policy - value-based, health- centred and science-led

During the conference it was acknowledged that health research and health outcome inequalities exist across Europe and continued collaboration and innovation must build upon the European value that health is a right for all.

The importance of sharing knowledge, expertise and experiences among stakeholders, including research institutions, the private sector, citizens and patients was highlighted.

To move forward, a comprehensive research policy is needed that involves all stakeholders, engages citizens, and that is patient- and health-centred. It needs to address the major challenges for cross-border collaboration and barriers to innovation that were discussed. The importance of considering the national research strategies of EU Member States in order to develop a coherent European strategy for health research was emphasised.

Many stakeholders are willing to engage in this process. Patient organizations are ready and well poised to participate in the necessary dialogue. The private sector and private funding organizations are partners to inform strategies. The academies of medicine are potential partners and are already working with universities, research institutions and larger organizations such as the WHS. Finally, a strong dialogue is needed between politicians and scientists, in order to develop a plan and act together.

The SPH is a pilot initiative. In order to work towards a European research policy and vision that is value-based, health- and people-centred, and science-led, the SPH will further address and develop, through its working groups, key topics such as education and training, and strategic prioritisation in health research to maximise benefits to society.



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NOTABLE QUOTES

"Europe needs to prepare for the future. I want to hear from you how do we create the right regulatory environment for personalised medicine, how do we bring new digital health technologies into everyday healthcare at little expense, and how do we encourage private sector health companies to invest more in tackling global emerging, chronic and neglected diseases?"

Carlos Moedas, Commissioner Research, Science and Innovation, European Commission

"Facing global health challenges requires us to act together. The European Commission is working with other funders of health research to align efforts, to be flexible enough to respond to new situations, and to have a firm commitment to improving health across the globe"

Ruxandra Draghia-Akli, Director, Health Directorate, DG Research & Innovation, European Commission

“The Fear of Failure remains a big handicap in Europe. Risk taking and a ‘can-do’ mentality is key for successful entrepreneurship”

Paul Timmers, Director, Digital Society, Trust & Security, DG Connect, European Commission

“A focused and rapid transfer of new Emerging Technologies into Life Sciences will change the face of Health Research and Outcomes”

Frank Luyten, Professor, Head of the Division of Rheumatology, University Hospitals Leuven

“To improve transnational collaboration we need success stories, we need trust to allocate resources and transnational initiatives should build on national initiatives”

Stig Slordahl, CEO of the Central Norway Regional Health Authority

“Public-private partnerships, which also support late stage clinical trials including phase III, such as the IMI initiative, will be very valuable for small and medium-sized companies as they should allow them to develop drugs to market approval, and to decide whether to partner with another company, based on strategic considerations. At AiCuris, we are developing a much-needed resistance-breaking antibiotic against Gram-negative bacteria. For this, the IMI partnership is a great support”

Helga Rüebsamen-Schaeff, founder of AiCuris and current Chair of the Scientific Advisory Board, AiCuris GmbH & Co. KG, Wuppertal, member of the Supervisory

Board of Merck KGaA and the Board of Partners of E. Merck KG



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"Fast-moving, disruptive ICT ever more challenges us to think 'pro-innovation', also in health research"

Frank Luyten, Professor, Head of the Division of Rheumatology, University Hospitals Leuven

“In order to develop more precise, and hence more effective, medical interventions, the diagnostics of the relevant genes causing disease (biomarkers), as well as surveillance of the efficacy of a chosen therapy, must be monitored quantitatively and diagnostic tests must be validated. A closer collaboration between the diagnostic and the drug industry will be necessary if we are to turn medical practice into precision medicine for other areas besides virology, where this goal has already been achieved (e.g. for HIV and hepatitis C)”

Helga Rüebsamen-Schaeff, founder of AiCuris and current Chair of the Scientific Advisory Board, AiCuris GmbH & Co. KG, Wuppertal, member of the Supervisory

Board of Merck KGaA and the Board of Partners of E. Merck KG

“Biomedical technology innovation should not be restricted by regulatory hurdles, but thorough post-marketing technology assessment is needed to prove the benefits for patient care”

Gabriel P. Krestin, Professor and Chairman of the Department of Radiology, Erasmus Medical Centre, Rotterdam



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1. MINUTES

1.1. Opening session

1.1.1. Addressing challenges in EU health research - the Scientific Panel for Health

Ruxandra Draghia-Akli, Director, Directorate for Health, DG Research and Innovation, European Commission, opened the conference by stressing the importance of the Scientific Panel for Health’s (SPH) work in the area of Societal Challenge 1, Health Demographic Change and Well-being.

In a video message, the European Commissioner for Research, Science and Innovation, Carlos Moedas, emphasised that health research is one of his top priorities. Health research is an important part of Horizon 2020, providing the EU with funding at every step of the innovation cycle and supporting cutting edge research. He stressed the importance of making the right policy decisions in the area of health research, in order to facilitate future progress in this area. He also underlined the need for EU policy decisions to respond to the rapid developments in health research. The Commissioner further emphasised the importance of the SPH conference for gathering the ideas and opinions of participants on the health and biomedical research needs for the future, in particular on: how to create the right regulatory environment for personalised medicine; how to bring new digital health technologies into everyday healthcare at little additional expense; and how to encourage private sector health companies to invest more in tackling global emerging chronic and neglected diseases. As a final remark, Commissioner Moedas expressed his willingness to follow up and put into practice the ideas that would emerge from the discussion.

1.1.2. Strengthening European biomedical and health research for better health - Introduction and key messages from the SPH vision paper

Karin Sipido, Professor at KU Leuven, Past-President at the Alliance for Biomedical Research in Europe and Chair of the Scientific Panel for Health (SPH), presented the work of the SPH: its background, composition and mandate. Pr. Sipido highlighted that the SPH has a quite broad mandate: to provide foresight and overall vision and strategy in the area of health and biomedical research; and to identify bottlenecks to innovation and propose solutions.

Within this context, Pr. Sipido explained that the SPH drafted a vision paper, outlining the main challenges and opportunities Europe has in relation to health and biomedical research, and providing a number of recommendations linked to developing a long-term comprehensive research policy. The following points were highlighted:

• Health research is valued because it saves lives;

• Europe faces a number of challenges including: the global nature of health and disease; changing demographic factors; changing definitions and understandings of disease with new insights in the interactions between genes, environment and lifestyle; dealing with ‘Big Data’ for health and the emergence of smart technologies; and the need for a more facilitating regulatory environment which ensures high-quality research;

• European strengths include high impact research; organized health care systems; high levels of public funding, support and engagement; and good public education;

More efforts are needed to build on the EU’s strengths and the successes by addressing fragmentation, increasing transnational research and engaging all stakeholders in a world-wide dialogue to maximise the benefit and impact of health research. As a final point, Pr.



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Sipido introduced the agenda of the day, emphasising that the conference is an opportunity to consult with experts on the above-mentioned issues, which would be further discussed in the four sessions of the day.

1.2. Session 1: Cross-border research: collaboration in Europe and beyond

This session, moderated by Maciej Banach, Professor of Cardiology, Head of Department of Hypertension, Medical University of Łódź and Ildiko Horvath, Professor, Strategic Director, National Koranyi Institute for Pulmonology, examined existing research collaborations: their opportunities, barriers to collaboration and recommendations on future support for such collaborations.

Ulrik Ringborg, Senior Professor of Oncology, Karolinska Institutet, presented the activities of Cancer Core Europe, a consortium of six centres across Europe dedicated to advancing cancer research, through sharing of data and the pooling of each centre’s own resources to fund collaborative research.

Pr. Ringborg provided some background to the work of Cancer Core Europe, highlighting that cancer is an increasing problem, with high mortality rates and an increasing number of cancer patients expected in the next two decades. With present healthcare prevention and research not adequately addressing this, Pr. Ringborg emphasised that an appropriate strategy is lacking and institutional collaboration is needed, as well as an improved interaction between innovation and the healthcare systems. In the case of cancer, comprehensive, collaborative, centres are necessary, where academic research, education and healthcare are integrated and conducted under the same academic leadership. In relation to research gaps in the field of cancer, two were highlighted as important: one between pre-clinical and clinical research and the second between clinical research and adoption into the healthcare system.

In terms of the future work of Cancer Core Europe, Pr. Ringborg presented the long-term objective of expanding the existing consortium in view of creating a virtual European cancer institute with the goal of stimulating cancer innovation and conducting outcome-oriented research by: carrying out joint transnational clinical research; conducting next generation clinical trials; developing personalised cancer medicine; establishing standardised academic diagnostic platforms; and creating large, shared databases. The bottlenecks regarding innovation are not specific for cancer diseases, they are representative for all main chronic diseases.

Roberto Bertollini, Chief Scientist at the WHO Regional Office for Europe and Director of the WHO Representative Office in Brussels, illustrated the WHO’s interest in cross border collaborations, facilitating factors, existing barriers and planned next steps. Dr Bertollini started by highlighting that a number of diseases with potentially international significance are constantly monitored. On this basis, a list of diseases have been defined as research priorities in the near future, including Ebola.

Regarding the lessons learnt from the Ebola crisis, he emphasised the possibility of compressing the decade-long research work related to the discovery of a new drug into a much shorter timeframe if strong collaboration is facilitated between organisations. He specified that it is possible to expedite clinical trials, data sharing, drug testing, and to promote social mobilisation plans that could improve the response to future crises.

Dr Bertollini identified four different dimensions of cross border collaboration:

• Surveillance and early detection. This is the need to anticipate the occurrence of diseases, as well as providing a good response and the proper medical treatment



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when the crises occur. R&D tools therefore need to be developed to detect, treat and control these diseases. Big data can also be useful in this case.

• Anticipatory research. This is the urgent need to develop tools to anticipate the occurrence of diseases that require a prompt public health response. A good practice example was provided in this regard, which used climate data to predict the emergence of malaria epidemics in Southern Africa.

• Responding to crises. The importance of responding to the cultural, social, and anthropological dimensions of crises was highlighted.

• The treatment of disease. Dr. Bertollini emphasised the need to treat new aspects of existing diseases and to experiment with new methods in order to verify their effectiveness.

As a final point, Dr Bertollini emphasised that transparency and sharing research results should be improved, as this could improve the capacity to respond to epidemics.

Valentin Fuster, General Director of the Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, and Director of the Cardiovascular Institute at Mount Sinai Hospital, New York, presented the experience of the Centro Nacional de Investigaciones Cardiovasculares Carlos III, highlighting the importance of promoting cardiovascular health worldwide, of encouraging higher quality research publications, as well as the need for further local funding to address NCDs.

In this regard, Pr. Fuster presented a number of projects and initiatives carried out at local level, all of which achieved successful results, and were subsequently adopted at national level, often by governments. An example was provided of a project carried out in Bogota, Colombia, delivering an education programme to 2000 children. The results were very positive, and the study was published in the American Journal of Medicine. The programme was so successful that it was later adopted at national level, by the government of Colombia and the Spanish government. Other examples of successful projects were presented by Pr. Fuster, include the AMPATH Centres in Kenya, the Global Demonstration Project and the Cardona Integral project carried out in Spain, and the Polypill project, carried out in different countries in Latin America and Europe. Promoting the positive results of these projects helped Pr. Fuster to leverage additional funding, for example, from the American Heart Association.As a general recommendation and final remark, Pr. Fuster emphasised the importance of developing and implementing local level projects to first prove their effectiveness, before replicating the same studies on a larger scale. He argued that once the effectiveness of small-scale projects has been shown, it then becomes easier to secure funding for implementing the same studies across wider geographies, at a much larger scale.

Ruxandra Draghia-Akli, Director, Directorate for Health, DG Research and Innovation, European Commission, highlighted that the essence of EU research programmes is cross-border collaboration. Such collaboration is supported at both European and international levels. She explained that three main models are developed for international collaboration in the Societal Challenge on 'health, demographic change and well-being’: the institutionalised and legally established entities to which several countries are contributing; the programme-level cooperation between funding agencies; and the mutual opening of research programmes. In particular, the programme-level co-operations allow funding agencies to identify and define shared strategic goals. Funding agencies agree to a joint approach, quantitative objectives and shared tasks, costs, data and standards. Dr Draghia-Akli mentioned the examples of the international consortium on rare diseases and the consortium for research preparedness for emerging epidemics. As a last point, Dr Draghia-Akli emphasised that there is a need for good, novel ideas which could address the current health and biomedical research issues and benefit from such funding.

Stig Slordahl, CEO, The Central Norway Regional Health Authority, presented the experience of Nordic cross-border collaboration. He explained that, from previous



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experience, the European Medical Research Councils (EMRC) strengths were in broad connections to scientific institutions across the EU and the close connection and impact on EU funding organisations. He stated that Nordic countries have a number of advantages. This includes strong public healthcare systems; individuals with unique identity numbers (making it easy to follow patients and inhabitants); and a long history of patient and populations registries and biobanks.

Collaboration between Nordic countries was necessary to influence both quality of research and research agenda setting. He specified that the Joint committee of the Nordic Medical Research Councils (NOS-M) works to coordinate and promote Nordic medical research, to monitor progress and facilitate information exchange, while NordForsk, an organisation under the Nordic Council of Ministers, facilitates Nordic research and research infrastructure ‘adding value’ to that conducted within-country. NordForsk provides one third of funding, with countries providing the remaining two thirds; these are placed in a common pot, requiring trust in the process for fund allocation.

Both organisations have identified the Nordic potential for biobank and register based research, but there are legal, technical and organisational hindrances to undertaking this research. An example pilot project run by the Nordic biobank network was also shared. In his final remarks, Dr. Slordahl underlined the lessons learned to improve transnational collaboration: that success stories are needed; that trust is needed to allocate resources; and that transnational initiatives cannot compete, but should build on, national initiatives. He also stated that the final goal would be to have similar collaboration with all EU Member States.

Iain Mattaj, Director General, European Molecular Biology Laboratory (EMBL), presented the European Molecular Biology Laboratory (EMBL), an intergovernmental organisation operating cross-border, which has been collaborating both across countries and disciplines for the past 40 years. He explained that the keys to successful cross-border collaboration include good research infrastructure, interdisciplinary research and sustainable funding. Cross-border collaboration and pooling of resources and expertise help to minimise costs and maximise impact for European countries. Examples were shared of the impact of EMBL’s collaborations and methods developed for the characterisation of new drug targets and development of innovative medicines.

He warned that the declining opportunities for transnational access to research facilities by researchers from across EU countries must be reversed. He stressed that a number of initiatives taking place regarding data resources and management hold potential for clinical research and personalised medicine but that this “Big Data” comes with the challenge of analysis, integration, storage and interlinking with patient data. These challenges can only be tackled by cross-border collaboration. Pr. Mattaj highlighted that the EMBL is one of the largest repositories for biomedical data and a leader in bioinformatics. As such, they will help address challenges around ‘big data’ by contributing to the development of medically relevant data structures. They will do this by: providing, from the data resources that are publicly accessible, reference datasets for clinical research; working internationally to harmonise storage and analysis of medically relevant reference data; and collaborating with national medical data centres to link reference data with patient data (whilst ensuring that confidentiality is maintained). He also shared examples and underlined the importance of making use of interdisciplinary expertise and the necessity of having sustainable funding for long term and high-risk projects.

1.2.1. Public Debate During the public debate, a number of questions were asked to the panel, and are summarised below:



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Questions were raised regarding how issues of confidentiality and privacy, as well as with ‘Big health data’ (for example big data in personalised medicine and the need to develop computational models), could be overcome.

• Pr. Mattaj answered saying that institutes should bring together their own national patient data, while keeping them protected and linking them to the publicly available reference data sets.

• Dr Draghia-Akli mentioned that the Commission is working on open science and will publish a guide, hopefully by the end of 2016.

• Pr. Ringborg explained that a methodology needs to be found to collect the relevant data from healthcare. There is no good system in place at present, with little data available on treatments, and diagnostics not being effectively validated. Good quality data must be collected, and routines to collect them should be developed.

• Pr Fuster stressed that it is important not to get lost in the ‘Big Data’ and to keep the focus on the main health issues.

• Dr. Bertollini commented that the usefulness and potential of ‘Big Data’ needs to be made clear. It could help to monitor people’s behaviour, but pilot projects need to be set up, assessed, and any achievements clearly reported.

A second question from the audience asked what problems were encountered by the speakers in running clinical trials in cross-border initiatives.

Pr. Ringborg answered saying that if there is a decision to collaborate between institutions and the leaders between centres, the differences can be overcome. For example, collaboration in early clinical trials can be difficult because necessary infrastructures, diagnostic platforms and outcomes documentation may be different across centres but Cancer Core Europe overcame these problems by developing a process to harmonise infrastructure, diagnostics and agree selected outcomes across centres before undertaking research.

A few comments were also made by the audience:

• The first comment emphasised that while there is a strong focus on, and funding available for, disease and treatments in Europe, more efforts need to be made in preventative medicine, for example by improving health through behavioural change.

• The second comment was that borders between disciplines should be removed; the tool for doing this is Horizon 2020. Regarding health programmes, there is a need to integrate basic research with clinicians.

• Finally, one of the attendees expressed his concern about the need to improve the education systems in Europe, and in particular, the importance of adopting an interdisciplinary approach.

1.3. Address by Rudolf Strohmeier, Deputy Director-General, DG Research and Innovation, European Commission

Rudolf Strohmeier, Deputy Director-General, DG Research and Innovation, European Commission addressed a message to the participants. He highlighted that health research is an important priority for Horizon 2020 and underlined the Commission’s willingness to address health-related challenges using funding schemes adapted to each step of the innovation cycle, with the clear objective of achieving better health for all. He mentioned several examples of success outcomes of EU-funded research projects, for example the successful therapy using designer immune cells in acute aggressive childhood leukaemia.



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Dr. Strohmeier emphasised that challenges ahead are enormous. He detailed two of them: personalised medicine and global health. He explained that the development of personalised medicine will create a paradigm shift in medical practice, meaning that the regulatory framework, the training of health carers and the health literacy of citizens will need to reflect this paradigm shift. To illustrate the aspect of the regulatory framework, he emphasised the case of the Health Technology Assessment (HTA) for pharmaceuticals, for which a stronger coordination between Member States is necessary to improve patients’ access to medicines.

Concerning global health, Dr. Strohmeier emphasised that health and diseases (communicable and non-communicable diseases) are global issues. There is therefore a need to address them in an adequate way, with the EU at the forefront. He mentioned the strong international dimension of EU-funded research programmes. He closed his speech by emphasising that the challenges of the increasing world population and of massive immigration trends will require a strategic, long-term focus coupled with a collaborative mind-set across stakeholders. The Scientific Panel for Health should support the Commission in providing ideas to address those challenges.

1.4. Session 2: Cross-border research: Academia, innovation and health care

This session, moderated by Ruxandra Draghia-Akli, Director at the Directorate for Health, DG Research and Innovation, European Commission and Michael Manns, Professor and Chairman of Department of Gastroenterology, Hepatology and Endocrinology, at the Hannover Medical School, examined the challenges and opportunities of multidisciplinary and mixed model collaborations.

Tom Otis, Vice Director and Section Head, Synapses and Circuits, at Roche Innovation Center Basel, presented his experience of the interaction and collaboration between industry and academia.

Professor Otis described his experience, first as an academic neuroscientist at the University of California, Los Angeles (UCLA) and then as a Director of the Roche Innovation Centre. Examples of his focus areas of research are: psychiatric illnesses (as schizophrenia), neurodevelopmental disorders (fragile X, Down syndrome…) and neurodegeneration disorders (Alzheimer, Parkinson…). The programmes cut across different areas and involve different actors, including the EU-IMI.

Roche’s focus on rare genetic disorders was driven by two factors: the limited existing knowledge in the scientific community, and the potential for improvements to be made to patients’ medical treatment and therapies. Pr. Otis underlined the complexity of the research, the long term efforts, and the fact that the funding required is substantial, especially given that the results of research are not easily predictable.

Pr. Otis also added that interdisciplinary and cross border research is important in these fields. Reflecting this, Roche is active in many platforms and external consortia, including the EU-IMI initiative, or the Psychiatry Genome Consortium.

Andrzej Rys, Director, Health Systems and products, DG Health and Food safety, at the European Commission, presented the European Reference Networks, a permanent network of highly specialised healthcare providers, which is patient centered and clinically-led, aimed at linking centres of expertise and professionals in different countries to share knowledge, improve quality, safety and access to highly specialised healthcare across the EU for patients with rare or low prevalence, and complex, diseases or conditions.

Regarding the procedure and criteria for applying, he explained that there will be a call for ERNs in March and that Network proposals, if they fulfil the minimum eligibility criteria,



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(scope, involving 10 Members in at least 8 countries independently) would be assessed by an independent assessment body contracted by the EC. The assessment will consider the level of fulfilment of the criteria for Networks and its Members established in the ERN legal base. The final step will be the decision of approval by National Authorities.

As a result, the centres of expertise should be able to provide knowledge and expertise to diagnose, follow up and manage patients; provide evidence of good outcomes; take a multi-disciplinary approach; have the capacity to produce good practice guidelines and to implement outcome measures and quality control; conduct research, teaching and training; and collaborate with other centres of expertise and networks.

In terms of research, they should develop research action plans that are part of the DNA of the Networks; promote and support collaborative research and involve patients as active partners in the research. He noted that patient registries and data collection should be incorporated in the Networks and referred to the recently published PARENT project (http://patientregistries.eu/) on building patient registries. Lastly, he stressed that Networks should collaborate with existing infrastructures, including biobanks and laboratories.

Helen Ward, Director of Education for the School of Public Health, Imperial College, UK, and Interim Director at EIT-Health UK-Ireland, shared her experience within the EIT-Health.

EIT-Health is a partnership of over 130 partners, drawn from businesses, universities and public bodies. Members make a financial/in-kind contribution to be part of the EIT, and these resources are then employed with EU-funding as investment funds to provide education and investment in individual projects. EIT-Health has four main objectives:

• Bringing together education, business and research (universities, business, public bodies);

• Promoting entrepreneurship;

• Addressing technology readiness;

• Translating knowledge into products and services - from proof of concept through to market uptake.

One example of this was their creation of “living labs”, where new ‘products’ can be tested in living populations and/or different health systems.

In education, Pr. Ward highlighted the importance of enabling entrepreneurship to flourish, ensuring that students and professionals are able to act innovatively. She underlined that cross-discipline collaboration is not easy, a common agreement and understanding of the priorities of academics and private companies is needed to improve collaboration.

Helga Ruebsamen-Schaeff, founder of AiCuris and current Chair of the Scientific Advisory Board at AiCuris GMBh & Co. KG, Wuppertal; member of the Supervisory Board at Merck KGaA and the Board of Partners at E. Merck KG, and SPH member, shared her experience, spanning from academic research to big pharmaceutical companies and to smaller biotech companies. Pr. Ruebsamen-Schaeff underlined the importance of multidisciplinary research teams and validated diagnostics to detect disease, and to monitor therapeutic success. She highlighted that there are sometimes challenges in working across different disciplines/ between academia and the private sector, and had a number of recommendations to improve these collaborations. These included: clearly defining deliverables at the beginning; patenting; and having standard operating procedures as well as rules on how to remunerate academics and inventors. She also stated that the exchange of people across disciplines/locations would improve innovation and collaboration.



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She has two main suggestions to improve the sustainability of the European biotech landscape. Firstly, more attention needs to be placed on the phase III studies for medicines, which are the pre-requisite for market approval. The Innovative Medicines Initiative (IMI) has been useful in addressing funding for clinical studies, and has helped to get very expensive studies underway by covering half of the costs and dedicating these funds to the academic partners in the IMI consortium concerned. Secondly, tax models and incentives for investors, licensing and patent laws across Europe should be harmonised.


A question was addressed to Pr. Otis and enquired how Roche conducts research and directs resources across different countries.

• Pr. Otis commented that, as a large company, Roche works with smaller pharmaceutical and biotech companies and academia. However, pharmaceutical companies and academia have different drivers, capabilities, resources, and priorities. This can make roles complementary, but can also add challenges to collaboration. He supported the idea of bringing pharmaceutical professionals into universities. This could both improve understanding between partners, and help to transfer skills between sectors, for example, around ensuring the replicability of studies.

• Pr. Ward commented that EIT-Health is bringing stakeholders together, including pharmaceutical professionals, to help shape education programmes and teach innovation skills in universities.

A second question was raised by Pr. Manns, regarding the industry’s and the European Commission’s position on sharing big data for transnational clinical trials.

• Dr. Rys declared that that EC supports the sharing of clinical data, within certain limits.

• Dr. Draghia Akli added that the IMI has a great potential in this regard and she provided the example of the New Meds project where a number of companies decided to combine clinical data. This has shown how clinical trials in the area of schizophrenia can be made shorter and can involve fewer patients. She emphasised that this doesn’t have only a monetary implication, but also allows drugs to arrive faster to patients. She also expressed her conviction that partnerships between academia, companies, SMEs, patients’ organisations and the regulators can produce good results.

A comment was provided by the audience regarding inequalities between research capacities in the Member States, but also the inequalities that exist in health and health outcomes across the EU; underlining the importance of integrating health promotion and prevention into healthcare.

A final question was then raised regarding the existence of different levels of research (at local, national and European level), the complexity deriving from this and how the SPH would address this issue.

Professor Sipido, chair of the SPH, responded that this issue is clearly an interesting point to discuss. The same goes for the issues of inequality in health- another important area to address in the future.



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1.5. Session 3: The regulatory framework as a facilitating environment for innovation

This session was moderated by Bente M. Stalknecht, Professor, Department of Biomedical Sciences, University of Copenhagen and Laurent Degos, Professor of Medicine (Haematology), University Paris VII. It discussed how regulation affects the process from target discovery to patient use, focusing on the path to market approval and use of new technologies.

Françoise Meunier, Director Special Projects, European Organisation for Research and Treatment of Cancer (EORTC) presented her experience in Clinical Trials’ coordination.

Professor Meunier explained that cost containment, or the reduced willingness to spend money on clinical trials, is a major threat for pan-European translational and clinical research. However, few patients (less than 5%) benefit from clinical trials. Participation in clinical trials means higher quality of treatment. In the case of cancer, the incidence of cancer is very high, with one person in three developing cancer; healthcare systems must be ready to deal with this issue.

Pr. Meunier added that clinical research is essential for improving health, but also for healthcare budgets. Regarding this aspect, she made a series of recommendations:

• The way clinical trials are conducted should be adapted both by the pharmaceutical industry and investigators; an increased investment of resources on early clinical trials should be made prior registration; and more population-based studies should also be conducted to evaluate clinical impact.

• Understanding how to improve the path from new medicine approval to wide use among the population is essential.

• The current way of conducting medical trials is not sustainable anymore: they have high costs and companies are facing high attrition rates. Many patients are still treated with inadequate regimens taking into account molecular biology breakthroughs.

• Precision medicine is very complex, as is research in this area, which remains a major challenge at pan-European level.

In relation to EU regulation, Pr. Meunier emphasised that there are many regulations in place and many actors involved at EU level (different DGs), as well as a plethora of different actors at national level, without a real harmonisation process in place. She explained that this makes the development of clinical trials extremely complex and expensive, without improving the quality of science, or the protection of patients. Therefore it is essential to simplify the regulatory system and to harmonise it, in order to benefit patients. Pr. Meunier highlighted the need for infrastructure to promote the participation of hospitals (local investment and coordinated centres) and more qualified staff to conduct clinical trials. She also emphasised that simplification of patients’ information sheets would be beneficial; a harmonisation of insurance rules and coverage would be necessary; and a new partnership model is critical.

Hans-Georg Eichler, Chief Medical Officer, European Medicines Agency (EMA), shared his view on innovative treatments and how to improve the pathway from drug discovery to market approval. Firstly, he explained that the EMA’s role is to protect and promote public health. EMA acts not only as a gatekeeper, but also as an enabler, which includes supporting the development of new and better medicines. There are particular challenges around innovative treatments such as advanced therapies, precision medicine, early disease interceptions, and personalised treatment combinations.



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Regarding what regulators (like the EMA) can do in order to enable useful innovation, Dr.Eichler added that they can provide operational development support to medicine developers through:

• Early dialogue with regulators;

• Dedicated support to priority medicines;

• Dedicated support to SMEs, in order to facilitate their interaction with the EMA;

• Support to academia, through innovation task forces and dedicated interactions.

Regulators should also provide a supportive scientific environment and standards; this could be done through:

• Adapting evidence standards to specific products and feasibility of studies (e.g. for antibiotics);

• Contributing to the progression of regulatory science (e.g. testing novel trial designs, using extrapolation methodologies);

• Developing scientific methods of qualification (i.e. procedures for interacting with the developer of the new methodology), as the EMA has done;

• Exploring adaptive pathways to market (EMA is trying to promote early entry of drugs into the markets, while ensuring that there is sufficient information).

As a last point, Dr Eichler highlighted that regulators can stimulate research in therapeutic areas relevant for public health, and contribute to the development of regulatory science in partnership with other actors..

Paul Timmers, Director, Digital Society, Trust & Security, DG Connect, European Commission presented his view on new technologies that relate to patient data and health and the use of data for research. Regarding ICT & health, he recognised that there is a great potential in many different areas of health (e.g. active and healthy ageing, health ICT, infectious diseases, human biomonitoring, etc.). There is a strong collaboration in place between DG CNECT and DG SANTE in these areas, with the objective of promoting dialogue and finding a common understanding.

Dr Timmers explained that there are high expectations for ICT use in health, for different reasons, most notably: the ageing population; lack of resources in healthcare systems, and increased demand from patients for high quality of care. He added that ICT is sometimes seen as the potential solution to all these problems, but that this will not necessarily always be the case.

He explained that the objectives of regulatory systems are: better disease management, sustainable and effective patient centric systems, and better conditions for developing new products. These objectives are in some way divergent depending on the subjective interpretation of individuals and organisations.

He presented the eHealth action Plan, developed in 2012 by DG CNECT which is ongoing and aims at:

• Increasing patient-centric care;

• Increasing interoperability of e-health services;

• Increasing efficiency;

• Supporting research, development and innovation;

• Ensuring wider deployment and facilitating uptake;



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• Promoting international cooperation.

Dr Timmers illustrated a few examples of disruptive IT for health:

• mHealth apps;

• New medical devices;

• Robotics helping patients;

• Integrated care;

• Virtual physiological human and big data;

• Prevention based upon early risk detection with behavioural and physiological markers;

• Artificial intelligence/smart decision support;

• Emotional computing and new paradigms in user interaction.

Dr Timmers acknowledged that there is fragmentation in the regulatory framework, but that the European Commission does work to limit this. For example, different DGs and units within the EC work in a coordinated way, with new regulations thought through and coordinated between the relevant units before their agreement and implementation.

As a final point, Dr Timmers presented a number of challenges and opportunities in this area:

• Genomics and behavioural data: data protection versus better prevention

• Intelligent buildings, social services and robotics: ethical and safety issues versus quality of life

• Artificial intelligence and emotional computing: behavioural manipulation versus personal prevention coaching

• Remote management of critical conditions: liability aspects versus efficiency and quality of life.

Gabriel Krestin, Professor and Chairman of the Department of Radiology, Erasmus Medical Centre, Rotterdam, shared his experience regarding innovation and its relationship to regulation. Professor Krestin opened his discussion by underlining that there has been a lot of innovation in biomedical imaging and advances in technology in the most recent years (e.g. to screen, detect disease, to stage and monitor treatments, to perform follow-ups, and to guide minimally invasive treatments). The enthusiasm deriving from these new instruments however led to increased utilisation of these technologies at increased costs. However there is little evidence for diagnostic performance of these technologies and the benefits for patient care.

As a result, he emphasised, a step back has to be taken and large studies need to be conducted, aiming at evaluating the benefits for the patients. There has to be a balance, he added, between the diagnostic improvements and the eventual health benefits for the patient. An underlying message is that there is a need for extensive research before the adoption of a new technology. Pr Krestin then encouraged regulators, patients’ organisations, healthcare providers to address this problem. New funding should be available for this, as well as new partnerships between public and private funders, with the aim to plan and evaluate the use of these new technologies. More in general, he added that a post marketing evaluation of these technologies would be needed.

As a final point he concluded that a possible solution could be to retrospectively assess all the data accumulated over the years. In order to do this, storage, access and massive



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computing would be needed, but also a harmonisation of data acquisition rules, protocols, standards, and data processing procedures.


A question was directed to Dr. Eichler, regarding his point of view on the need for more regulation in medical devices. Dr. Eichler answered that this aspect does not fall under the competences of the EMA.

A question was then addressed to Pr. Meunier, regarding the reasons behind the reduction of clinical trials in recent years (as presented during the session), and what strategies could be adopted to avoid further decline. Pr. Meunier responded saying that the data she presented referred to studies being undertaken under the previous Clinical Trials Directive, which now has been revised into a new EU regulation. The main hurdle was not the Directive itself, but its implementation by MS, which was not harmonised; this could be solved, at least partially, by this new EU regulation.

A comment was then addressed at the panel concerning the difficulties encountered by SMEs in bringing innovative technology such as medical devices to the market, given the existing lack of a real single market across Europe.

Pr. Degos answered explaining that the main obstacle for medical devices in Europe is the reimbursement. This is decided at national level, with national insurance systems meaning that the public is often less willing to purchase devices without reimbursement – a key difference between the US and Europe.

Dr. Draghia Akli shared that the EC is now offering loans to SMEs, and that additional mechanisms are being put into place to help commercialise innovations in Europe.

A comment was made that it is a real challenge to have a holistic view of research and regulation across all disciplines, areas and topics of research. The SPH was offered support from the EunetHTA in structuring concepts and linking with the relevant policy-related institutions across Member States.

1.6. Session 4: A comprehensive biomedical research policy - value-based, health-centred and science-led

This session was moderated by Frank Luyten, Professor, Head of the Division of Rheumatology, University Hospitals Leuven & Martin Buxton, Emeritus Professor, Health Economics Professor, Brunel University. It examined the role of the different actors and stakeholders in guiding research policy, the current state of play and future expectations.

A video message was addressed to the audience by Liselotte Højgaard, Chair of the Danish National Research Foundation and AG Health member, who expressed her view on how the research agenda is set and how this process could be improved.

Pr. Højgaard underlined that universities fund and manage more than half of research in health; and that there is a need to collaborate with other actors, also in an interdisciplinary way. Pr. Højgaard then outlined a few key points to be taken into consideration:

• New antibiotics and treatments are needed for existing and infectious diseases;



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• The refugee crisis poses new challenges for healthcare systems;

• Health improvements will be driven by new technologies and their use.

As a final point she suggested the creation of an Open Access Medical House, accessible by all stakeholders working on health, where ideas are shared and advice is provided on coordination and implementation of health research at European level (research strategy and policy, guidelines, HTA, sharing of best practices).

Anders Olauson, President, European Patients' Forum (EPF) presented patients’ views and expectations on health research.

Mr. Olauson underlined the need to have more research in a system that should be guided by the needs of patients. The patients should, he emphasised, be seen as active partners in healthcare and in the research process, not only as users; the involvement of patients should occur at macro, meso and micro levels.

Patients and patient organisations, he added, could contribute to health research, by bringing real life experience and optimising the relevance of research and the societal impact. They could also contribute to advocacy, and promoting the dissemination of results beyond the scientific community. Patients can be involved in all aspects of the research cycle, as information providers, advisers, reviewers, co-researchers or a driving force. The different types of involvement depend on the topic of the research, the methodology used, the skills required, and the stage of research.

He provided the example of the EUPATI, a multi-stakeholder public-private partnership, coordinated by EPF, with the objectives of:

• Developing and disseminating information about medicines and R&D;

• Building competencies and capacity among patients and the public;

• Facilitating patient involvement in R&D.

Mr. Olauson also provided the example of the CHRODIS Joint Action, which aims to promote the exchange of good practices on addressing chronic conditions between European countries and regions, and the EMPATHiE study, aiming at empowering patients in their health management. Findings of this project demonstrated that many stakeholders have a very positive view on EU level action on patient empowerment and its added value. This project has also created an extensive network of organisations and stakeholders, committed to patient empowerment. Mr. Olauson added that the involvement of patients in these kind of initiatives can act as a catalyst and facilitator for further engagement in the future.

As a final point, he concluded that the involvement of patients would have a crucial contribution to the creation and achievement of sustainable, good-quality healthcare systems in the future, in which valuable innovation is embraced. In order to achieve this, patients’ involvement needs to be advanced in a structured, systematic and ethical way, in order to bring maximum value to research outcomes.

Patrick Baeuerle, Managing Director, Cambridge Office, MPM Capital, presented his experience on private funding and venture capital in supporting innovation. He illustrated his role as a private equity investor in bio-health in an American US based venture capital firm, focusing on starting new companies. He emphasised that private equity or venture capital (VC) investment in biotech start-up companies is essential to translate and commercialize breakthrough academic research leading to new therapies for patients. He suggested that, typically, VC firms do not invest in basic research because it takes decades and is often unpredictable. Therefore basic research is much better financed by grant organizations and research institutions. However, VC firms increasingly specialize in building new companies on the basis of breakthrough discoveries that are emerging from basic research.



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He stressed that researchers in the EU should know what will entice VC firms to invest, including:

• Cutting edge, innovative research based on robust, truthful and reproducible scientific data with the possibility of protecting intellectual property(patents);

• In-vitro (cell culture) and in-vivo PoC (animal) data supporting the concept;

• A tangible product candidate (e.g., antibody or small molecule) with supporting data;

• Having more than one product candidate, i.e., a pipeline of products to reduce risks;

• Researchers, institutions and transfer offices that are highly proficient in licensing, patenting, and term sheet negotiations, examples include Harvard/Stanford universities;

• University inventors and founders that know their limitations. Unexperienced management is one of the greatest risks for the success of a start-up company; this risk cannot be compensated by the best research.

He affirmed that basic research in the EU is excellent, with many exciting ideas for new therapies and product ideas. However, most VC funding is still invested in the US, for the following reasons:

• Much longer history and tradition of VC financing in the US;

• More proficient interaction between research institutions and VCs than in EU;

• Private equity tends to also invest into people --not only in science. Serial entrepreneurs are highly favoured, even those that have failed in past – and there are more of these in the US;

• Risk taking and can-do mentality underdeveloped with large pharma top managers in the EU. If at all, they may only engage in start-ups after retirement from industry;

• Lack of understanding in EU of VC business, and of potential huge upside created by VC firms for researchers and their institutions, society and health care.

Dr Baeuerle concluded on a positive note, emphasising that research institutions in the EU can greatly advance the commercialisation of breakthrough research by tapping into the enormous, globally available, private equity funds for dedicated life sciences investments. This will lead to new breakthrough therapies for patients; new workplaces in the biotech industry; extra funding for research institutions, as well as, ultimately, licensing fees and royalties from products developed.

Rudi Balling, Director, Luxembourg Centre for Systems Biomedicine, University of Luxembourg, presented his perspective on research policy and strategic investments in systems biology. He started by highlighting the importance of private funding, but also the role of patients, in setting the priorities for research, as well as the need for patients to have a more prominent role in their own healthcare and wellbeing.

Pr Balling stated that understandings of health and tools for health research are currently in the dark ages. He presented the need to deal with interconnected and systemic risks and global diseases; in this regard, systems biology and related disciplines should try to understand cascade failures in the pathogenesis of diseases. In order to do this, a good understanding of networks, and of all the factors and components involved, is needed. Related to this, Pr Balling emphasised the importance of the collection of quality data, their accessibility and their secure storage. The storage of research data, he suggested, would provide most benefit for patients if stored within healthcare institutions, as is currently being done with the UK’s 100,000 Genomes project data, which are embedded within the NHS. He stressed that the role of patients should be very significant.



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In terms of the future role of universities and of researchers, he recommended the paper entitled ‘An avalanche is coming’ by the UK Institute for Public Policy Research which states that a major revolution is happening in education, with students setting their learning agenda. He compared this shift to how patients are increasingly making their health decisions, using doctors as coaches and mentors. The future will also bring continuous monitoring of health data, personal curation/cleaning of personalised data, and machine learning.

He also mentioned the importance of data and disease visualisation technologies, in order to facilitate patients’ understanding and awareness regarding disease. He mphasised that more research and innovation is needed to develop effective visualisation technologies, through collaboration with the best partners.

As a final recommendation, regarding education and innovation, Pr. Balling strongly suggested the importance of sharing knowledge, expertise and experiences among research institutions, the private sector, but also with patients.


Comments were made concerning innovations in visualisation technologies and machine learning used in health research. Pr Balling responded that machines are improving but that human intervention is important, with strong input from health experts.

A question was addressed to Dr. Baeuerle concerning the possible reasons why there are not enough good entrepreneurs in Europe - and if it due to a different state of mind compared to the US, or whether there is an absence of immediate necessity to set up new companies.

Dr. Baeuerle answered by specifying that there are very good companies in the EU, however there is less willingness to take risks, and therefore start new companies. He mentioned that the number of existing companies is also smaller, adding that it is probably due to the fact that in the US new possibilities are offered in case of failure, which is not the case generally in Europe.

1.7. Closing of conference & final words The aim of this final session was to present ideas for the future, and capture the main concepts that emerged from the previous sessions, namely: how to ensure that research policy and vision is value-based, health- and people-centred, and science-led.

Ruxandra Draghia-Akli, Director, Directorate for Health, DG Research and Innovation, European Commission, summarised the main points of the discussion as follows:

• Regarding ‘Big Data’, it is necessary to link research data to patients’ clinical data; and to collect reliable, robust and quality data. The replicability and retrospective use of data for post-marketing assessment of technologies also emerged as a crucial aspect.

• Concerning training and education, the collaboration between academics and industry should be improved; at the same time, the development of entrepreneurial scientists within the EU should be fostered.

• With regards to health promotion and prevention, patients should be better empowered to manage their own health, while health research and its results should be better promoted and disseminated.



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• Concerning the regulatory issues, the importance of having a streamlined regulatory framework, adapted to the needs of all actors involved and to new research areas (e.g. personalised medicine) also emerged from the discussion.

• Finally, relating to investment, it is necessary to think about a strategy to attract private investment and to concentrate more on close-to-the-market research; the role and feedback of the SPH in this regard could be prominent.

Detlev Ganten, President of the World Health Summit, and advisor to the SPH, presented his view on the future of health and research in the EU. Pr. Ganten highlighted the need to have a new narrative for Europe, as well as the need for citizens to regain confidence in it and for scientists to have a major responsibility. A holistic view of health is needed, viewing health as one of the most important aspects for individuals and society.

He suggested that Europe needs to break various silos (administrative, scientific, and geographical); this could be done through the work of the SPH, and through collaboration with other EU and international organisations. He recommended close contact and, wherever possible, coordination with other EU advisory groups, e.g. the European Academies of Sciences and the High Level Advisory Group. He also re-emphasised the importance of considering the national research strategies of EU Member States in order to develop a coherent European strategy for health research. As a final remark, Pr. Ganten emphasised the opportunity to consider European Research Strategies in the context of what is done worldwide by bringing European health issues to the World Health Summit, in order to discuss them with other key international organisations.

Professor Sipido thanked the European Commission for its support to the SPH and the organisation of the conference. She also thanked the speakers, the moderators and the participants for their engagement.

Pr. Sipido emphasised the need expressed for urgent action, in order to respond to the revolutions in technology, to seize the potential for innovation and improve healthcare. She highlighted that the current framework for health research is not adapted to address these needs. Existing programmes and initiatives in health research serve as examples of successful models, but she stressed that more is needed, requiring reach-out to Member States and wider stakeholders.

Pr. Sipido explained that SPH is a pilot, a test case, for what is needed as a helicopter organization in health and biomedical research. The SPH will engage more closely, she added, with policy makers and politicians, and extend today’s forum into a wider consultation with stakeholders. A stronger dialogue is needed between politicians and scientists, in order to develop a plan and act together.

As a final point, Pr. Sipido informed that workshops addressing specific barriers to innovation will be held over the coming year. These workshops will focus on the training and education of the next generation workforce; the regulatory environment; and strategic prioritisation in health research.



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ACKNOWLEDGMENTS

The Minutes of this conference were prepared by Alice Bennett, Holly Krelle, Martina Morosi and Christina Dziewanska-Stringer, ICF International.

First Annual Conference of the Scientific Panel for Health: ‘Better research for better health - A holistic approach to challenges & opportunities’

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ANNEX 1 ATTENDANCE LIST

Speakers

BAEUERLE Patrick MPM Capital GERMANY

BALLING Rudi LCSB LUXEMBOURG

BERTOLLINI Roberto World Health Organization BELGIUM

BUXTON Martin Brunel University London UNITED KINGDOM

DE CARLO Giuseppe EFA BELGIUM

DRAGHIA-AKLI Ruxandra European Commission, Director, Health, DG RTD EU

EICHLER Hans-Georg Chief Medical Officer, European Medicines Agency (EMA) UNITED KINGDOM

FUSTER Valentin Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC) SPAIN

GANTEN Detlev World Health Summit GERMANY

HØJGAARD Liselotte Chair Danish National Research Foundation DENMARK

KRESTIN Gabriel Professor and Chairman of the department of Radiology, Erasmus Medical Centre Rotterdam

THE NETHERLANDS

LUYTEN Frank KULeuven BELGIUM

MANNS Michael Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School

GERMANY

MATTAJ Iain William EMBL GERMANY

MEUNIER Françoise EORTC BELGIUM

OLAUSON Anders EPF, European Patient Forum, Agrenska foundation BELGIUM

OTIS Tom F Hoffmann La Roche, Ltd SWITZERLAND

RINGBORG Ulrik Karolinska Institutet SWEDEN

RUEBSAMEN-SCHAEFF Helga AiCuris Anti-infective Cures GmbH GERMANY


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Speakers

RYŚ Andrzej Jan European Commission, Director, Health Systems and products, DG SANTE

EU

SIPIDO Karin KULeuven BELGIUM

SLØRDAHL Stig Arild Helse Midt-Norge RHF NORWAY

STALLKNECHT Bente Merete University of Copenhagen DENMARK

STROHMEIER Rudolf European Commission, Deputy Director-General, DG RTD EU

TIMMERS Paul European Commission, Director, Digital Society, Trust and Security, DG CNECT

EU

WARD Helen Imperial College London UNITED KINGDOM

BAEUERLE Patrick MPM Capital GERMANY

Participants

ADAN Roger UMCU THE NETHERLANDS

AGOSTINHIO Marta eu-life SPAIN

ALMUT Caspary MRC Clinical Sciences Centre UNITED KINGDOM

ALNE Sture Novartis BELGIUM

ANDERSEN Kristin The Research Council of Norway NORWAY

ANDRESEN Inge Aarhus University DENMARK

ANDRZEJCZYK Aneta Medical University of Lodz POLAND

ANTONANZAS Fernando University of La Rioja SPAIN

AREVALO Gonzalo Carlos III National Health Institute SPAIN

ARNALDI Alice Regione Piemonte - Sede di Bruxelles ITALY


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Participants

ARNALTE Roser Fundació Sant Joan de Déu SPAIN

ARNAUD OLIVIER IDRF FRANCE

BALOGH Judit University of Debrecen HUNGARY

BANACH Maciej Instytut Centrum Zdrowia Matki Polki POLAND

BANKS Martin E.B.R BELGIUM

BARACAT Christian GlaxoSmithKline BELGIUM

BARKAUSKAITE Eva Public Health England UNITED KINGDOM

BARRIONUEVO HAFNER Marta Spanish Institute of Health Carlos III SPAIN

BEEM Edvard ZonMw THE NETHERLANDS

BENNETT Alice ICF International UK

BENOOT Adolphe Texaco (ret) BELGIUM

BERNINI Chiara EAPM BELGIUM

BIETRIX Florence European Infrastructure for Translational Medicine (EATRIS) THE NETHERLANDS

BLANC Julien Aix-Marseille University FRANCE

BLANCO Ana The Medical Research Institute of the Hospital La Fe SPAIN

BONDAS Terese Elisabet University of Nordland NORWAY

BORGE Anne Inger Helmen University of Oslo NORWAY

BORGERMANS Liesbeth Vrije Universiteit Brussel BELGIUM

BOTTARELLI Valentina EURORDIS BELGIUM

BOYKO Nadiya Uzhhorod National University UKRAINE

BREHM Judith HealthRegion CologneBonn GERMANY

BROES Stefanie KULeuven/EORTC BELGIUM


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Participants

BROLIS Elena FIPRA BELGIUM

BROWN Rebecca Southampton University UNITED KINGDOM

BULTO Olivier Brussels Diplomatic BELGIUM

BUS Milan Hungarian development center HUNGARY

CALADO Patrícia FCT PORTUGAL

CAMILO Joana UCP - CREATING HEALTH PORTUGAL

CAPITAINE Laura European Association for the Study of the Liver BELGIUM

CAREY Emma UK Research Office UNITED KINGDOM

CASADEI Barbara European Society of Cardiology FRANCE

CASTELLARO Mirta MIVS BELGIUM

CELIS Julio E. Danish Cancer Society DENMARK

CHABOUD Corentin BIOASTER FRANCE

CHALLINOR ép. REES Vanessa Alzheimer Europe LUXEMBOURG

CHARALAMBIDOU Georgia PhD student, University of Manchester CYPRUS

CHARPENTIER Bernard FEAM BELGIUM

CHENG Hui-Wen Taipei Representative Office in the European Union and Belgium TAIWAN

CHILIDIS Konstantinos University of Oslo/Faculty of Medicine NORWAY

CHIOTAN Cristina EuroHealthNet BELGIUM

CHIUCCHIUINI Antonella Takeda Pharmaceuticals International AG SWITZERLAND

CHRISTOFORIDI Kalliopi Anna European Cancer Patient Coalition BELGIUM

CLAEYS Audrey European Biopharmaceutical Enterprises BELGIUM

CLARKE Patricia Health Research Board Ireland IRELAND


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Participants

COCQUEREZ Armande Inserm-CLORA FRANCE

COLLEN Sarah NHS European Office UNITED KINGDOM

COLVER Anders European Commission DG RTD EU

CREFF Nicolas Interface Europe BELGIUM

CUPERS Philippe European Commission DG RTD EU

DALLINGA-THIE G.M. EAS THE NETHERLANDS

D'AMARIO Rosanna European Commission DG RTD EU

DAMON Céline Aix Marseille Université FRANCE

DAVIES Berwyn Welsh Higher Education Brussels UNITED KINGDOM

DE ANGELI Paolo Chiesi Farmaceutici S.p.A. ITALY

DE HAAS Fleur European Hematology Association (EHA) THE NETHERLANDS

DE SUTTER Petra ESHRE BELGIUM

DEGOS Laurent University Paris VII FRANCE

DEL BRENNA Giulia European Commission DG RTD CAB EU

DELIS Robert British Medical Association UNITED KINGDOM

DELPIRE Veronique Words&Science BELGIUM

DESTREBECQ Frédéric European Brain Council BELGIUM

DI GIACOMO Dina University of l'Aquila ITALY

DICKSON Suzanne University of Gothenburg SWEDEN

DINKLA-RITTER Anna Katrin Hannover Medical School GERMANY

DONNELLY Kathryn Nord University NORWAY

DOUO Myriam HOPE BELGIUM


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Participants

DRAGAN Raluca Turkish Research and Business Organizations BELGIUM

DRATWA Jim European Commission DG RTD EU

DREW James EU Reporter BELGIUM

DUDEK Monika European Commission DG RTD EU

DUFFY Ciaran Enterprise Ireland IRELAND

DUGGAN-WALLS Kay Health Research Board IRELAND

DUYVENÉ DE WIT Thom European Hematology Association (EHA) THE NETHERLANDS

DZIEWANSKA-STRINGER Christina ICF International BELGIUM

EIBE GUIJARRO Carmen PharmaMar S.A. SPAIN

EKLUND Malin Swedish Research Council SWEDEN

ELMEIER Wilfried Alliance for bio medical research AUSTRIA

FAURE Bénédicte Interel BELGIUM

FAUVEL Anne-Charlotte European Infrastructure for Translational Medicine (EATRIS) THE NETHERLANDS

FERRO José European Commission EU

FILIPE Joao European Commission EU

FOTIADIS Stavros University of Birmingham UNITED KINGDOM

FRESENBORG Jana Sophie HealthRegion CologneBonn GERMANY

GAL Diane KUL Leuven BELGIUM

GARAGNANI Paolo Università di Bologna ITALY

GAROS Casper Philips Healthcare THE NETHERLANDS

GAY Steffen Dept Rheum USZ Zurich SWITZERLAND

GIBBS Alexander Europa Bio FRANCE


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Participants

GLASMACHER Birgit Leibniz Universitaet Hannover, EAMBES GERMANY

GOMEZ QUINTANILLA Marta CDTI SPAIN

GOMEZ RECIO Silvia Coventry University UNITED KINGDOM

GRABITZ Peter WHO Office at the EU BELGIUM

GRACIANI DIAZ Ricardo Universitat de Barcelona SPAIN

GUILLÉN-NAVARRO Encarna Consejería de Sanidad-Región de Murcia SPAIN

GUNDEL Silke Helmholtz Association of German Research Centres e.V. GERMANY

GUNN Magda Innovative Medicines Initiative BELGIUM

HAABERG Siri Norwegian Institute of Public Health NORWAY

HAAR Sören EACON BELGIUM

HANNIGAN Bernadette Public Health England UNITED KINGDOM

HANSEN Gesa European Commission DG RTD EU

HAUTANIEMI Antti Academy of Finland FINLAND

HAWROT Tadeusz European Brain Council BELGIUM

HEAD Michael University of Southampton UNITED KINGDOM

HEFTBERGER Peter European Research Council Executive Agency BELGIUM

HEINE Renaud PA Europe BELGIUM

HENNEY Adriano Virtual Physiological Human Institute for Biomedical Research UNITED KINGDOM

HENRIQUES Luisa PermRep PT PORTUGAL

HINES Philip European Policy Centre BELGIUM

HOLLIDAY Phillip White Rose University Consortium UNITED KINGDOM

HORGAN Denis European Alliance for Personalised Medicine BELGIUM


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Participants

HORVATH Ildiko National Koranyi Institute for Pulmonogy HUNGARY

HRADSKY Anne Charlotte DSW BELGIUM

HUERTAS Lucía Region of Murcia SPAIN

IAKOVIDIS Ilias European Commission DG CNECT EU

ISHIWA Aki Region Emilia-Romagna ITALY

JACSON Samantha Nord - Pas de Calais - Picardie Region FRANCE

JAGERSMA Christian University Medical Center Utrecht THE NETHERLANDS

JARUSEVICIENE Lina Hospital of Lithuanian University of Health Sciences LITHUANIA

JEAN-BAPTISTE Marine European Public Health Alliance FRANCE

JO Jeongdai KIC-EUROPE SOUTH KOREA

JOOS Angelika Merck Sharp &Dohme (Europe), Inc. BELGIUM

JOOS Guy European Respiratory Society (ERS) BELGIUM

JULIENNE Anne-Claire Servier FRANCE

KAIAFA Maria IVAA-International Federation of Anthroposophic Medical Associations BELGIUM

KAMEL Nadia European Respiratory Society SWITZERLAND

KARCZA Mariann European Commission DG RTD EU

KARLSEN Tom Hemming European Association for the Study of the Liver NORWAY

KEARNEY Anne European Federation of Allergy and Airways Diseases Patients Associations BELGIUM

KENNEDY James Rohde Public Policy IRELAND

KENTNER Susan German Cancer Research Center (DKFZ) GERMANY

KERSTIËNS Barbara European Commission DG RTD EU

KOK Menno Erasmus MC THE NETHERLANDS


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Participants

KOKKONEN Kari Kymenlakso University of Applied Sciences FINLAND

KOTECKA Katarzyna Adam Mickiewicz University POLAND

KRAKOWIAK Magda Łódzkie Region POLAND

KRELL Andreas EU liaison office of the German Research Organisations BELGIUM

KRELLE Holly ICF UNITED KINGDOM

KRISTENSEN Finn Børlum Danish Health Authority, EUnetHTA Secretariat DENMARK

KRYGER Kim Danish Agency for Science , technology and Innovation DENMARK

KUITTINEN Saara Finnish Liaison Office for EU R&D FINLAND

KURUCZ Andrej Représentation permanente de la Slovaquie SLOVAKIA

KUSS Katharina Spanish Foundation for International Cooperation, Health and Social Affairs SPAIN

LAHOUTTE Tony ESMI European Society For Molecular Imaging BELGIUM

LANGE Peter Langeconsult GERMANY

LANZENBERGER Monika European Commission DG CNECT EU

LASCHENA Alberta KREAB BELGIUM

LASITHITAKI Lina IVAA-International Federation of Anthroposophic Medical Associations BELGIUM

LE CHALONY Catherine CEA FRANCE

LE CORVEC Anaïs Asserta Global HealthCare Solutions SPAIN

LENZ Yanina Robert Koch Institute GERMANY

LEROY Josiane Civil society BELGIUM

LESAUSKAITE Vaiva Lithuanian University of Health Sciences LITHUANIA

LEVALLOIS Heloise IPSEN PHARMA FRANCE

LIAO Jiunn-Der Taipei Representative Office in the European Union TAIWAN


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Participants

LINNENBANK Andreas EAMBES THE NETHERLANDS

LINSSEN Vivian R. F. IMNRC-NewPOL Network BELGIUM

LISBOA Paulo Liverpool John Moores University UNITED KINGDOM

LÓPEZ CORTÉS Ignacio José MICOF Valencia SPAIN

MAAS Jeroen Amsterdam Economic Board THE NETHERLANDS

MACHALSKA Magdalena COCIR BELGIUM

MAGUIRE Peg European Institute of Womens Health IRELAND

MALACHE Jacques International PRESS Agency BELGIUM

MANCIN Stefano MIVS BELGIUM

MANGAN Aoife European Commission DG RTD EU

MARÍN GARCÍA Beatriz Centre Balears Europa SPAIN

MARTIN Stephan European Society of Cardiology FRANCE

MARTINEZ-LOZANO Beatriz Ministry of Health-Región de Murcia SPAIN

MARTÍNEZ-ZALDÍVAR MORENO

Cristina Oficina de Proyectos Internacionales (Universidad de Granada) SPAIN

MASI Veronique NOVARTIS BELGIUM

MATOSEVIC Tihana London School of Economics UNITED KINGDOM

MAZUREK Cezary Poznan Supercomputing and Networking Center POLAND

MCLAUGHLIN Clare Australian Embassy and Mission to the EU AUSTRALIA

MEERT Theo Janssen Pharmaceutica NV BELGIUM

MEISCH Françoise Luxinnovation LUXEMBOURG

MELZER Ross SciencelBusiness BELGIUM

MENDEZ ZORRILLA Amaia University of Deusto SPAIN


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Participants

MEREDITH Dora Innovate UK UNITED KINGDOM

MERTENS Rony Internationale and European Press Federation Ingolstadt GERMANY

MEZZASALMA Riccardo EuropaBio BELGIUM

MIFSUD Janet University of Malta MALTA

MILANO Martina moverim BELGIUM

MIRANOVIC Vesna Clinical Center of Montenegro MONTENEGRO

MONTANTE Sabrina Università Cattolica del Sacro Cuore ITALY

MONTEIRO FERRERA Guilherme GSK BELGIUM

MOONEN Chrit University Medical Center Utrecht THE NETHERLANDS

MORAVCOVA Jana International Federation for Spina Bifida and Hydrocephalus BELGIUM

MOROSI Martina ICF International BELGIUM

MOTA Jorge CIAFEL-FADEUP PORTUGAL

MULLIGAN Bernard European Commission DG RTD EU

MUNNA Antonella Alma Mater Studiorum - Università di Bologna ITALY

MURPHY Dan EFA/Asthma UK UNITED KINGDOM

MUSCH Greet FAMHP BELGIUM

NEBB Hide University of Oslo NORWAY

NEMEC Vojtech Kreab BELGIUM

NIEDERKOFLER, MA Sonja EANM European Association of Nuclear Medicine AUSTRIA

NIKOLOGIANNI Maria Permanent Mission of Greece to the EU GREECE

OERTEL Wolfgang EAN European Academy of Neurology GERMANY

O'MORAIN Colm BioMedical Alliance for Health Research in Europe IRELAND


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Participants

OUSLAND Asbjørn Rune Oslo University Hospital NORWAY

OVERLAET Willem COCIR / Toshiba Medical Systems THE NETHERLANDS

OZKAN Mine Sanem Ministry of Health of Turkey TURKEY

OZKAN Oguz The Scientific and Technological Research Council of Turkey TURKEY

PAGANONI Marco Université de Milan Italy

PALKONEN Susanna EFA/EPF FINLAND

PAOLETTI Anne DGRI FRANCE

PAPADOPOULOU Ellas European Commission DG RTD EU

PATTUS Franc CNRS FRANCE

PAVALKIS Dainius Lithuanian university of Health sciences LITHUANIA

PENNINGTON Stephen University College Dublin IRELAND

PETERSEN Anne creoDK DENMARK

POLENZANI Lorenzo Angelini ITALY

POLLOZHANI Aziz National Institute of Public Health FORMER YUGOSLAV REPUBLIC OF MACEDONIA

PRITCHARD Stuart Wellcome Trust UNITED KINGDOM

PUNDZIENE Asta Kaunas University of Technology LITUANIA

PYTKO Anna IPPT PAN - NCP PL POLAND

RACHEL Msetfi University of Limerick IRELAND

RAE Logan Takeda Pharmaceuticals International SWITZERLAND

REINCKE Wilfried Radboud University Nijmegen THE NETHERLANDS

RICCIARDI Gualtiero Istituto Superiore di Sanita' ITALY

RICHEZ Jean-Michel SUEZ Environment BELGIUM


26/05/2016 Page 37 of 40

Participants

RIERA MADURELL Teresa Universitat Illes Balears SPAIN

RIESE Hans Heinz Instituto de Salud Carlos III SPAIN

RIJKERS Tonnie Netherlands Enterprise Agency (RVO.nl) THE NETHERLANDS

RODRÍGUEZ Cristina CIBER SPAIN

ROGERS Heather University of Deusto SPAIN

ROMAIN Séverine European Commission DG RTD EU

RONFINI Pier-francesco Prodgetto "rete ircss/di per leuropa" ITALY

ROUX Jean Louis EURORDIS BELGIUM

SADALLAH Fatiha Innovative Medicines Initiative BELGIUM

SALMONSON Tomas Medical Products Agency SWEDEN

SANDNES Camilla Lien Oslo University Hospital NORWAY

SANNE Jean-Luc European Commission DG RTD EU

SCHAART Dennis Delft University of Technology THE NETHERLANDS

SCHMALTZ Cornelius European Commission DG RTD EU

SCHOBER Karen Weber Shandwick BELGIUM

SCULIER Jean-Paul ERS & ULB BELGIUM

SELEIRO Eduardo International Agency for Research on Cancer FRANCE

SERI Marco University of Bologna ITALY

SIGUTINA Maria ITMO University - St. Petersburg BELGIUM

SIMULESCU Maria Loredana The Alliance For Biomedical Research in Europe BELGIUM

SIPIDO Eveline EAN European Academy of Neurology BELGIUM

SITNIK Monia Johnson & Johnson BELGIUM


26/05/2016 Page 38 of 40

Participants

SIVAN Virginie CEA FRANCE

SJØLIE Berit Mosseng University of Nordland NORWAY

SMIRNOVA Masha European Public Health Alliance BELGIUM

SMITH Ulf University of Gothenburg SWEDEN

SOGNER Ingrid University of Oslo NORWAY

SOMERS Hilde European Commission DG RTD EU

SPEK Wouter EuroBioForum Foundation THE NETHERLANDS

SPORTELLI Giancarlo Università di Pisa ITALY

STALLINGS Raymond Royal College of Surgeons in Ireland IRELAND

STAMBOLSKY Dmitry Lomonosov Moscow State University RUSSIA

STARBORG Maria Joint Programming of Antibiotic Resistance/Swedish Research Council SWEDEN

STAVROU Andri Universite Libre de Bruxelles BELGIUM

STEINER-LANGE Sabine DLR-Project Management Agency GERMANY

STIEGLER Theresa-Sophie Cambre associates/ULG Brussels AUSTRIA

SZCZEPANSKA Anna EFPIA BELGIUM

SZOCSKA Miklos Semmelweis University HUNGARY

TAMMINEN Tuula University of Tampere FINLAND

TARNAWSKA Katarzyna Polish Science Contact Agency POLAND

TAVERNIER Stefaan Vrije Universiteit Brussels BELGIUM

TEMINO DE DIOS Paloma EU-EYE BELGIUM

TERRÓN PUIG Maria Centre Balears Europa SPAIN

TORRES Federico EULAR BELGIUM


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Participants

TROTTIER Andre Roche SWITZERLAND

UHRENFELDT Lisbeth Aalborg University DENMARK

VAN BATENBURG Okker EuroBioForum Foundation THE NETHERLANDS

VAN CAMPENHOUT Jelle Departement economie, wetenschap & innovatie BELGIUM

VAN DE VELDE Lubumbe Johanniter International BELGIUM

VAN DE VOORDE Jeannine AIG BELGIUM

VAN DE WERF Frans European Society of Cardiology BELGIUM

VAN DEN BERG Maria Heleen Netherlands Enterprise Agency THE NETHERLANDS

VAN DEN BIESEN Jan Philips THE NETHERLANDS

VAN DER LINDEN Anne-Marie ESMI European Society For Molecular Imaging BELGIUM

VAN EIMEREN Mischa European Association for the Study of Diabetes GERMANY

VAN HAELST Sarah IMPULSE.BRUSSELS BELGIUM

VAN HOOTEGEM Philippe United European Gastroenterology BELGIUM

VAN KOOTEN Karin Mens in het Midden THE NETHERLANDS

VAN VILSTEREN Carmen TU/e THE NETHERLANDS

VANCROMBRUGGE Thierry fod justitie BELGIUM

VERMEIJ Rolf University of Twente THE NETHERLANDS

VERNANT Cécile DSW BELGIUM

VEYS Bart Eindhoven University of Technology THE NETHERLANDS

VLAD Amalia-Irina European Commission DG CNECT EU

VODUSEK David B. EAN - European Academy of Neurology SLOVENIA

VOLLESTAD Nina University of Oslo NORWAY


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Participants

VRAZELOVA Michaela Representation of the Olomouc Region to the EU CZECH REPUBLIC

VRIJHOEF Hubertus Maastricht University Medical Center THE NETHERLANDS

VUIJK Gosse Neth-ER THE NETHERLANDS

WAHLFORS Jarmo Academy of Finland FINLAND

WARD Brian European Respiratory Society BELGIUM

WARDY Marie organisation privée (traductrice) BELGIUM

WHYTE Jacqueline Science Europe BELGIUM

ZAFFARONI Lenny University of Milano - Bicocca ITALY

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