EU Funding for Health Horizon 2020
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1 EU Funding for Health Horizon 2020 Kay Duggan-Walls National Contact Point UCD 4 February 2016
2 Horizon 2020 Horizon 2020 is the biggest EU Research and Innovation programme ever 80 billion of funding available over 7 years (2014 to 2020) It promises more breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market.
3 Health Demographic Change and well-being challenge Budget 7.4 billion Main Goal: Better Health for all Translating science to benefit citizens Improve health and well being outcomes Support a competitive health & care sector Test and demonstrate new health & care models, approaches and tools Promote healthy and active ageing Promote EU as a global leader in the health area
4 Ireland s Participation in Horizon 2020 Jan 2014 May ,182 applicants 445 applicants successful success rate 13.98% [EU average 13.8%] Total funding million - broadly in line with national target 1.25 billion 1.54% of total Horizon 2020 budget target 1.56% Drawdown FP7-625 million over 7 years ( 68.3 million in first year)
5 Areas of largest funding Ireland Jan 2014 May Information & Communications technologies ( 40.8M up from 27.5M) 2. European Research Council ( 25.9M) 3. Marie Sklodowska-Curie Actions ( 25.6M) 4. Health ( 23.1M - up from 15.5M) 5. Nanotechnologies ( 19.8M) Nanotechnologies, Advanced materials, Biotechnology, Advanced manufacturing and processing) 6. Agri-Food ( 11.1M)
6 Compare performance to Ireland s peers i.e. Ireland, Finland and Denmark higher financial drawdown Adjust by population, Ireland & Finland roughly equivalent, Denmark higher UK significantly lower as is case for any of large MS
7 Health Results 2014/ ,229, % of the available health budget. A total of 23 projects including 4 R&I coordinators & 5 SME Instrument funded a large increase in the number of applications from Irish coordinators 56 Irish coordinator applicants during By comparison, in FP7 the highest number in any one year was 14 (2012) 69 Irish coordinator applicants during the entire seven-year lifetime of FP ,642, % of available budget 25% increase in applications to the first stage of the two-stage call compared to the 2014 two-stage call 10 projects including two R&I coordinators and two SME coordinator have been funded. Total 30,871,937
8 Health Successes 2014 Coordinators Two-stage Tim O Brien, NUI Galway (Coordinator) Nephstrom, Novel Stromal Cell Therapy for Diabetic Kidney Disease ICT Single-stage Kieran Moran, School of Health Sciences, DCU (Coordinator), PATHway, Technology enabled behavioural change as a pathway towards better self-management of CVD Dympna Casey, School of Nursing, NUI Galway (Coordinator), MARIO, 'Managing active and healthy aging with use of caring service robots Single-stage Frank Barry, REMEDI Galway, (Coordinator), ADIPOA2, Clinical trial of autologous adipose-derived mesenchymal stromal cells (ASC) in the treatment of mild to moderate osteoarthritis (regerenative medicine) 2015 Coordinators Mary Murphy, REMEDI, NUI Galway, Development of closed, scalable and AUTOmated robotic systems for therapeutic STEM cell manufacturing: aseptic systems from Donor-to-Patient John Dinsmore (ICT for Health call), School of Nursing and Midwifery,TCD. Integrated Technology Ecosystem for ProACTive Patient Centred Care. IBM Ireland & Phillips UK are partners
9 Ireland s success in the SME instrument Ireland Top 5 position, No 1 in first call - highest success rate of 20%, with 10 of the 50 submitted project being funded at phase 1 Successes in Health Phase Vitalograph, BlueBridge Technologies, Inform Bio Phase 2 Radisens Diagnostics 4.5 million Biosensia 0.6 million 2015 Phase 2: Oncomark 2.7 million PMD Solutions 4.26 million
10 Ireland s success in the SME instrument Ireland Top 5 position, No 1 in first call - highest success rate of 20%, with 10 of the 50 submitted project being funded at phase 1 Successes in Health Phase Vitalograph, BlueBridge Technologies, Inform Bio Phase 2 Radisens Diagnostics 4.5 million Biosensia 0.6 million 2015 Phase 2: Oncomark 2.7 million PMD Solutions 4.26 million
11 The SC1 Work Programme in brief Promoting healthy ageing and personalised healthcare Call 'Personalised Medicine' 21 topics (34 in ): 10 in 2016, 10 in 2017, 1 open in 2016 & 2017 including 'coordination activities' 15 topics (17 in ): 12 in 2016, 3 in 2017 SME Instrument : 2 Topics Other Actions: 12 items (incl. InnovFin ID & "Birth Day Prize") Focus Area Digital Security: 1 Topic Focus Area Internet of Things: 1 Topic
12 Health Work Programme 2016/ Understanding health, well-being and disease SC-PM Multi omics for personalised therapies addressing diseases of the immune system M, (budget 30M), Closing date: 13 April 2016, Single-stage SC- PM New concepts in patient stratification 4-6 M (budget 40 M), closing dates: 4 Oct 2016, 11 Apr 2017, Two-stage SC-PM Diagnostic characterisation of rare diseases 15 M (budget 15 M), closing date: 11 Apr 2017, Single-stage SC-PM Networking and optimising the use of population and patient cohorts at EU level 8-10 M (budget 30 M), closing date: 13 Apr 2016, Single-stage
13 Health Work Programme 2016/ Preventing Disease SC-PM The European Biomonitoring Initiative 70% eligible costs up to 50 M 5 years, Closing date: 13 April 2016, Single-stage SC- PM Vaccine development for malaria and/or neglected infectious diseases 3-5 M Small specific, M larger platform (budget 40 M), closing date: 13 Apr 2016, Single-stage SC-PM Promoting mental health and well-being in the young 2-4 M (budget 20 M), closing dates: 4 Oct 2016, 11 Apr 2017, Two-stage
14 Health Work Programme 2016/ Treating and managing diseases SC-PM New therapies for rare diseases M, (budget 30M), Closing date: 13 April 2016, Single-stage SC- PM New therapies for chronic diseases 4-6 M (budget 60M), closing date: 13 Apr 2017, Single-stage SC-PM Comparing the effectiveness of existing healthcare interventions in the adult population 4-6 M (budget 40 M), closing dates: 4 Oct 2016, 11 Apr 2017, Two-stage SC-PM Clinical research on regenerative medicine 4-6 M (budget 30 M), closing date: 13 Apr 2016,??? 2017, Single-stage
15 Health Work Programme 2016/ Active ageing and self-management of health (CNECT DG calls) SC-PM PCP ehealth innovation in empowering the patient 4 M (90% eligible costs), (budget 18 M), Closing date: 16 Feb 2016, Single-stage SC- PM PPI Co-Fund PPI for deployment and scaling up of ICT solutions for active and healthy ageing 2-5 M (35% eligible costs) (budget 10.5 M), closing date: 16 Feb 2016, Single-stage SC-PM EU-Japan cooperation on novel ICT Robotics based solutions for active & healthy ageing at home or in care facilities 1-2 M (budget 5M), closing date: 12 Apr 2016, Single-stage SC-PM Personalised coaching for well-being of people as they age 3-4 M (budget 25 M), closing date: 31 Jan 2017, Single-stage
16 Health Work Programme 2016/ Methods and Data (CNECT DG calls) SC-PM In-silico trials for developing and assessing biomedical products 4-6 M, (budget 19M), Closing date: 14 Mar 2017, Single-stage SC- PM Personalised computer models and in-silico systems for wellbeing 4-6 M (budget 19 M), closing date: 14 Mar 2017, Single-stage SC-PM Big Data supporting Public Health policies 3-5 M (budget 10M), closing date: 16 Feb 2016, Single-stage SC-PM PPI for uptake of standards for the exchange of digitalised healthcare records 3-4 M (35% eligible costs)(budget 8.26 M), closing date: 14 Mar 2017, Single-stage SC-PM Development of new methods and measures for improved economic evaluation and efficiency measures in the health sector (budget 9M), closing date: 11 Apr 2017, Single-stage
17 Health Work Programme 2016/ Health care provision and integrated care SC-PM Implementation research for scaling up evidence based innovations and good practices in Europe and in low and middle-income countries 4-6 M, (budget 40M), Closing date: 13 Apr 2016, Single-stage
18 Coordinating Actions SC1-HCO : Valorisation of FP7 Health & H2020 SC1 research results SC1-HCO : Standardisation of pre-analytical and analytical procedures for in vitro diagnostics in personalised medicine SC1-HCO : Implementing the Strategic Research Agenda on Personalised Medicine SC1-HCO : Towards globalisation of the Joint Programming Initiative on Antimicrobial resistance SC1-HCO : Coordinating personalised medicine research SC1-HCO : Towards an ERA-NET for building sustainable and resilient health system models SC1-HCO : Global Alliance for Chronic Diseases (GACD) SC1-HCO : Actions to bridge the divide in European health research & innovation SC1-HCO : Support for Europe s leading Health ICT SMEs* SC1-HCO : Coordinated action to support the recognition of Silver Economy opportunities arising from demographic change* SC1-HCO : Digital Health Literacy* SC1-HCO : Healthcare Workforce IT skills* SC1-HCO : EU-US interoperability roadmap* SC1-HCO : EU ehealth Interoperability conformity assessment* SC1-HCO : Standardisation needs in the field of ICT for Active & Healthy ageing* * 16 Feb 2016 closing, rest 13 April 2016 SC1-HCO April 2017
19
20 SME Instrument SMEInst Supporting innovative SMEs in the healthcare biotechnology sector a) Cell technologies in medical applications (all phase 1 & phase 2 deadlines 2016 & 2017) OR b) Clinical research for the validation of biomarkers and/or diagnostic medical devices (only at the first cut-off date in 2017 and for phase 2 applications phasing out of the topic PHC /2015) Phase 1 50K (6 months) Phase 2 1-5m (1-2 yrs) (Budget 35M 2016, 45m 2017)(100% eligible costs) Cut off dates 2016: Cut off dates 2017: Phase 1 Phase 2 24 Feb Feb May Apr Sep June Nov Oct 2016 Phase 1 Phase 2 15 Feb Jan May Apr Sep June Nov Oct 2017
21 SME Instrument SMEInst Accelerating market introduction of ICT solutions for Health Well-Being and Ageing Well Phase 1 50K lump sum (6 months) Phase m (1-2 yrs) (Budget 18M 2016, 12.5M 2017) (70% eligible costs) Cut off dates 2016: Cut off dates 2017: Phase 1 Phase 2 24 Feb Feb May Apr Sep June Nov Oct 2016 Phase 1 Phase 2 15 Feb Jan May Apr Sep June Nov Oct 2017
22 Competition is tough: only the best projects get funded
23 Where to Start Start preparing early as soon as draft Work Programme is available NCP Colleagues in university/ previously funded researchers Read Work Programme Participant portal download criteria for call Register as soon as call is open Check deadlines
24 Initial proposal ideas When formulating the idea, answer the following questions in the first few paragraphs: What problem are you trying to solve? Topic in call = problem defined by the EU, your proposal is the solution Is it a European problem? Scale, citizens affected, need for cooperation Is there a solution already available? Why doesn t the current solution work? What is the urgency of this work, why now and what will be the outcome if the research isn t undertaken? Why this consortium? Are you the best people to do this work?
25 What is important when setting up a consortium Balanced consortium with complementary skills Appropriate size for the project Credible management structures Multidisciplinary (depending on topic) Balanced with regard to countries and gender Happy to work with people for a number of years Up to the job, relevant, recent publications/expertise Industry partners/patient organisations etc. Don t carry extra partners Management must be smooth
26 What makes a strong proposal Get the evaluators attention in a ½ page! Ensure your proposed work meets the topic addressed in the call Follow exactly the structure given in the Guide for applicants Be as concise and precise as possible Give clear aims and objectives Methodology must be clear - must be clear what is proposed to be done! Outline methods and for clinical trials, recruitment numbers, inclusion/exclusion criteria etc. The consortium of partners must be excellent and appropriate for the tasks At stage 1, proposal idea should be well formed (a mini full proposal)
27 Write for the Evaluators Avoid jargon it can irritate evaluators! Respect the page limits and the order of the various sections (check Guide for Applicants and templates provided) Check spelling and grammar Have the evaluators in mind Make it easy to find information (refer to specific Work Packages, milestones etc.) Get a colleague to read full proposal if they cannot understand the objectives, neither will the evaluators Read the proposal and see how it flows avoid unnecessary repetition and contradictory statements NB: Sell your proposal!
28 Work Programme Impact The expected impacts listed in the work programme under the relevant topic Enhancing innovation capacity and integration of new knowledge Strengthening the competitiveness and growth of companies by developing innovations meeting the needs of European and global markets; and, where relevant, by delivering such innovations to the markets Any other environmental, climate change and socially important impacts (not already covered above) Effectiveness of the proposed measures to exploit and disseminate the project results (including management of IPR), to communicate the project, and to manage research data where relevant
29 Impact Impact has become one of the key evaluation criteria in European research proposals. Researchers have difficulty in understanding the concept of 'Impact' and in explaining the potential impact of their proposals. EC wants to see results of your project proposals - the impact of your project on EU policies Publications in peer-reviewed high impact journals Patent applications Number of Union pieces of legislation referring to activities supported in the area of the different Societal Challenges
30 Impact Assessment Report (Horizon 2020) The overall results from the analysis of 726 projects (FP5) under Evimp-2, representing 992 million of EU-funding, reveal the following: The projects have generated or are expected to generate the following results in the short term: results in the short term: prototypes/demonstrators/pilots, 747 new software tools, publications, doctorates, 310 inputs into technical standards, 423 inputs into EU legislation texts, patent applications, 204 registered designs and other forms (IPR) the creation of 248 spin-off companies.
31 Impact Begin with potential impact design project around that Where does the project fit into the bigger picture Why does your idea matter How long does impact last for a number of years longer than project duration it is much broader than dissemination activities such as conference attendance and the publication of high quality academic papers
32 Impact What will come out of your project? 2) Who wants these results? 3) Why do they want these results? 4) How do you plan to inform them about the results? 5) What further steps will be needed? the potential impacts of the project should be clearly detailed and highlight the improvement for European competitiveness. Make reference to what is outlined in the work programme as expected impacts. For example, in the context of improvements to the quality of life, active ageing, and improvements in the efficiency of health and care systems you can refer to potential savings for healthcare systems by reduces hospitalisation costs. You can and should highlight the benefits of your method or offering by referring to cost-effectiveness, health economics and marketing strategies.
33 Impact tated%20template%20h2020_innovation.pdf Improved therapy/diagnosis/care or selfmanagement and patient sense of security Patient empowerment or improved family quality of life Assistance to the weaker classes of the population Reduction in care management costs Improved patient-health professional interaction System replication
34 Impact Discuss your impact on the related stakeholders. For example, why are they involved? How they will benefit from your innovation? And how they can support you? E.g., if local authorities are interested in assisting ageing people communities, consequently, your innovation might be of interest for these authorities and they might be keen on supporting you. Other good source on Impact:
35 Strategic Health Initiatives The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-saharan Africa, with a focus on phase II and III clinical trials. Global Research Collaboration for Infectious Disease Preparedness GloPID-R the only network of its kind to bring together research funding organizations on a global scale to facilitate an effective research response within 48 hours of a significant outbreak of a new or re-emerging infectious disease with pandemic potential The Innovative Medicines Initiative (IMI) is Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe. IMI is a joint undertaking between the European Union and the pharmaceutical industry association EFPIA. Global Alliance for Chronic Disease (GADC) fund, develop and facilitate innovative research collaborations between low- and middle-income and high-income countries in the fight against chronic diseases International Rare Disease Research Consortium IRDiRC is a consortium of research funding agencies and interested parties acting to accelerate research through collaborations investing in rare diseases research in order to achieve two main objectives by the year 2020, namely to deliver 200 new therapies for rare diseases and means to diagnose most rare diseases
36 Strategic Health Initiatives Joint Programming Initiatives Neurodegenerative Disease Research, JPND is the largest global research initiative aimed at tackling the challenge of neurodegenerative diseases (Ireland is a member) Joint Programming Initiative on Antimicrobial Resistance JPIAMR coordinates national funding and supports collaborative action to fill knowledge gaps in this field (Ireland is not a member) A healthy diet for a healthy life HDHL joint programming of research in the field of nutrition, food and health will provide for coordination of research on the impact of diet and lifestyles on health European Innovative Partnerships European Innovation Partnership on Active and Healthy Ageing aims to enhance European competitiveness and tackle the ageing challenge through research and innovation (Ireland is involved) Collage 3 star Reference Site
37 Strategic Health Initiatives AAL Ambient Assisted Living Joint Programme - a funding activity with the aim of enhancing the quality of life of older people and strengthening the industrial base in Europe through the use of ICT (Ireland involved through Enterprise Ireland) EIT European Institute of Innovation & Technology aims to enhance Europe s ability to innovate, which translates into adapting quickly to the fast pace of development, being one step ahead in providing solutions to rapidly emerging societal problems and developing products that meet the demands and desires of consumers (TCD received award as part of colocation centre with UK)
38 Use supports available
39 Social Science and Humanities Under Horizon 2020, the social sciences and humanities (SSH) are given an enhanced role as a cross-cutting issue aimed at improving our assessment of and response to complex societal issues. Therefore, where relevant, the research and innovation chain should include contributions from SSH disciplines such as sociology, economics, psychology, political science, history and cultural sciences
40 2014 Work Programme 9 SSH-flagged topics flagged as relevant to integrate SSH elements PHC 1, PHC-5, PHC 6, PHC-17, PHC- 23, PHC -31, HCO-5, HCO-14 and HCO-15 What does SSH-flagged mean? Topics dedicated to SSH research Issues are framed mainly from SSH perspective Relevant project partners come from SSH discipline Topics with a significant SSH component SSH expertise is an integral, though not exclusive part of the research design of topics Solutions to the problem are to be generated by integrating knowledge stemming from both SSH disciplines and non-ssh
41 Examples of Projects Life course pathways underlying social differences in healthy ageing (LIFEPATH) WP: Life-course socioeconomic pathways towards healthy ageing and the role of modifiable risk factors LIFEPATH integrates biology, biostatistics, epidemiology and epigenomics approaches with social science approaches (sociology, economics & public health policies) Specific challenge (topic description PHC-01)..interaction between the genetic make-up of individual human beings and behavioural, environmental factors
42 How to include/assess SSH Some specific SSH areas that might be considered for health research are: ethics, vulnerability, inequality and legal matters SSH needs to be initiated upstream, and not simply considered as an add-on help achieving impact through SSH Important to check: a) the level of interaction between STEM and SSH; b) the level of rigour of application of SSH c) and, in the scope, the areas that go beyond health economics Importance to disseminate more information on good practices in embedding SSH
43 Flagged SSH topics Proposals under these topics are expected to take into account the social, economic, behavioural, institutional, historical and/or cultural dimensions, as appropriate, of a societal issue. Applicants should therefore ensure that: contributions from the SSH are integrated at various stages of their proposed project, and the actions required, participants and disciplines involved as well as the added value of SSH contributions are clearly stated in the proposal. Where relevant, applicants may also include contributions from the SSH in a project proposal under any H2020 research topic.
44 Examples in Health Research 1. The variability between patients in responses to same treatment is one of the most challenging health care problems: Need to unravel the mechanisms of how peoples expectations affect immune and endocrine responses and related health outcomes, through the use of multidisciplinary methods in experimental studies (Social science, biomedical and life sciences, neuroscience and humanities) 2. How healthy ageing individuals manage to stabilise their quality of life & health in real life: To examine the determinants of healthy instead of ill ageing and the factors stabilising instead of declining health, through evidence standard for real life instead of laboratory outcomes with results on the level of individuals instead of populations (gerontology, clinical and experimental psychology, ethnology, psychotherapy, robotics)
45 Flagged topics 2016 SC1-PM : Networking and optimising the use of population and patient cohorts at EU level Clinical, public health & socio-economic research, deployment of policy strategies, new types data geographical, genetic, ehealth records SC1-PM : The European Human Biomonitoring Initiative Public engagement, dissemination, communication, training, policy, lifestyle management, environmental, occupational, epidemiological surveys, capacity building, best practice SC1-PM : New therapies for chronic diseases Involve patients & take their views into account wherever relevant Non-pharmacological therapies
46 Flagged topics 2016 SC1-PM :PCP- ehealth innovation in empowering the patient User acceptance of ICT based technologies, training of professionals, domestic rehabilitation (physical & cognitive), communication, patient consent SC1-PM :EU-Japan cooperation on Novel ICT Robotics based solutions for active and healthy ageing at home or in care facilities Multidisciplinary research including behavioural, sociological, health Solutions should be: cost-effective, acceptable to end-users, applicable to realistic settings, driven by needs, interests & lifestyles of older people, reduction of isolation & loneliness, adaptation towards different histories & cultures across the EU Legal, ethical & social issues to be considered
47 Flagged topic 2016 SC1-PM : Implementation research for scaling-up of evidence based innovations and good practice in Europe and low-and middle-income countries Economic, social benefits, reducing inequalities, relevant stakeholder and end users identified & involved throughout project, input from patients, organisational & resource requirements (data, personnel & financial). Appropriate contextual, financial and political-economy analysis
48 Flagged Coordinating & Support Actions 2016 SC1-HCO : Coordinating personalised medicine research Interdisciplinary approach, develop policies, guidelines addressing policy-related, economic and socio-cultural factors, awareness raising among general public SC1-HCO : Towards an ERA-NET for building sustainable 7 resilient health care models Scientific-technological, socio-economic objectives SC1-HCO : Coordinating action to support the recognition of Silver Economy opportunities arising from demographic change Improving quality of life, integrated communication & innovation concept, addressing key stakeholders and sectors of the Silver Economy, such as advertising, innovative consumer products and services, age-friendly workplaces, age friendly living environments SC1-HCO : Coordinating personalised medicine research Interdisciplinary approach, develop policies, guidelines addressing policy-related, economic and socio-cultural factors, awareness raising among general public SC1-HCO : Towards an ERA-NET for building sustainable 7 resilient health care models Scientific-technological, socio-economic objectives SC1-HCO : Coordinating action to support the recognition of Silver Economy opportunities arising from demographic change Improving quality of life, integrated communication & innovation concept, addressing key stakeholders and sectors of the Silver Economy, such as advertising, innovative consumer products and services, age-friendly workplaces, age friendly living environments
49 Flagged Coordinating & Support Actions 2016 SC1-HCO : Digital health literacy Open access online courses, interactive learning environment, tailored to users needs, take into account and quantify, demographic, social, cultural and gender differences, better understanding for citizens of online information SC1-HCO : Healthcare Workforce IT skills Shortage of ehealth workers across clinical, social care informatics and administration, dearth structured education & training
50 Flagged topics in 2017 SC1-PM : promoting mental health and well-being in the young Interventions should build on but may go beyond biological, psychological and social determinants such as societal, cultural, work life, lifestyle, epidemiological, economic, & environmental, multidisciplinary approach, involving young, pay particular attention to ethical issues, reducing inequalities SC1-PM : New therapies for rare diseases Potential economic & public health aspects of new therapies, engage with patient organisations
51 Flagged topics in 2017 SC1-PM : Comparing the effectiveness of existing healthcare interventions in the adult population Socio-economic impact, health & socio-economic outcomes (quality of life, patient mortality, morbidity costs & performance of health systems), gender and factors affecting health equity SC1-PM : Personalised coaching for well-being and care of people as they age Physiological & behavioural data, age related issues in daily life, diet, physical activity, risk avoidance, leisure, social participation, multidisciplinary research
52 Flagged topics in 2017 SC1-PM : Personalised computer models and in-silico systems for well-being Computer modelling to aggregate various information sets e.g. molecular, biochemical, medical imaging, social, lifestyle economic, occupational, environment, psychological, gender. Proposals will focus on multidisciplinary research in medicine, SSH and ICT SC1-PM : Development of new methods and measures for improved economic evaluation and efficacy measures in the health sector topic to be developed during 2016
53 Flagged Coordinator & Support Actions 2017 SC1-HCO : Actions to bridge the divide in European Health research & innovation Concrete measures for tackling structural barriers to health research and innovation including those related to capacity, skills, policy, regulatory, environment and economic & socio-cultural factors including equality issues and gender dimension
54 Health NCPs & ND for Ireland Kay Duggan-Walls Health Research Board Ciaran Duffy Enterprise Ireland Patricia Clarke (National Delegate) Health Research Board
55 For further information contact Kay Duggan-Walls tel (01)
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