National Strategy for Health Research and Innovation MCST 2012

1. National Strategy for Health Research and Innovation MCST 2012

2. Background, mission, vision and general principles In 2011, the Malta Council for Science and Technology commissioned the development of a dedicated strategy for health research and innovation in line with its mandate from Government to identify areas of national priority and design and implement strategic approaches to enhance economic competitiveness and quality of life. Mission and Vision of the Strategy - to develop an enabling health research and innovation ecosystem as a springboard for securing sustainable health care through the identification of areas and opportunities for undertaking health research in processes, diagnosis, treatments and delivery of health care services with the objective of improving the effectiveness and efficiency in these areas, attracting investment and of achieving long-term sustainability. No health research and innovation can be undertaken unless all the stakeholders especially, medical consultants and physicians, are on board. Malta needs to identify its Unique Selling Propositions (USPs). Malta is ideal as a pilot centre for pilot projects in health care, such as bio-banking, testing new drugs, servicing clinical trials and health tourism. A set of indicators to measure progress is proposed: outcome of health research will result in a better quality service for the patients if policies that integrate health research and patient care are implemented and if there is an effective co-ordination system among all relevant stakeholders.

3. Drivers Health research and innovation generate a range of direct and indirect benefits leading to the enhancement of the efficiency and effectiveness of health care and the welfare systems in Malta. Health research promotes economic growth in the long term, particularly because it tackles demographic challenges while ensuring that the most effective policies are being implemented through evidence-based research. The Strategy promotes long-term sustainability and seeks to encourage the uptake of funding opportunities on the basis of four important goals which seek to ensure optimal implementation through good governance practices involving the establishment of ethical standards. These goals are: • Developing a vibrant and sustainable health research and innovation framework • Building the necessary capacity and competence for high quality research to improve well-being • Supporting evidence-based policy-making in human health and ensuring outreach and take-up • Internationalisation opportunities for economic growth and innovation in the health sector

4. Relevant EU Health-Related Research Infrastructures and Initiatives • ELIXIR: Europe’s emerging infrastructure for biological information aims toconstruct and operate a sustainable infrastructure for biological information in Europe to support life science research and its translation to medicine and the environment, the bio-industries and society. • BBMRI:Biobanking and Biomolecular Resources Research Infrastructure aims to construct a pan-European Biobanking and Biomolecular Resources Research Infrastructure for biomedical and biological research in Europe and worldwide, building on existing infrastructures, resources and technologies, specifically complemented with innovative components and properly embedded into European ethical, legal and societal frameworks. • EATRIS:European Advanced Translational Research InfraStructure in Medicine aims to provide infrastructure to allow a faster and more efficient transfer of research discoveries into new products to prevent, diagnose or treat diseases. • ECRIN: European Clinical Research Infrastructures Network provides information, consulting and services to investigators and sponsors in the preparation and in the conduct of multinational clinical studies, for any category of clinical research and in any disease area. • Infrafrontieris a research infrastructure that provides the biomedical research community with the tools needed to unravel the role of gene function in human disease. • Instruct is the research infrastructure dealing that deals with the study of structural biology i.e. combining integrated structural biology with cell biology

5. Euro‐BioImagingresearch infrastructure shall deploy a distributed biological and biomedical imaging infrastructure in Europe in a coordinated and harmonized manner • EU-Openscreen, the European Infrastructure of Open Screening Platforms for Chemical Biology, integrates high-throughput screening platforms, chemical libraries, chemical resources for hit discovery and optimisation, bio- and cheminformatics support, and a database containing screening results, assay protocols, and chemical information. • ERINHA, the adapted pan European BSL4 infrastructure, will face any pandemic outcome from emerging and re-emerging infectious diseases, which is a scientific challenge that implies coordinated survey and study of level 4 pathogens. • ISBE, the Information Systems Biology-Europe infrastructure, aims to support the convergence of life sciences with information technology and system science in order to allow researchers to address how the interaction of biological components leads to the functioning of living organisms and to create models representing these interactions. This will have applications in medicine, such as in the design of pharmaceuticals as well as on agriculture, and environment. • MIRRI, the EU Microbial Resource Research Infrastructure, will seek to improve access to the best microbial resources (i.e. strains of viruses, bacteria and fungi) which are the essential raw material for biotechnology. This will have a strong impact on research in the agricultural, food, healthcare and biotechnological sectors. Applications range from research on crop pathogens for sanitary and animal health reasons to research on human pathogens and bio security. MIRRI will build the European platform within the future Global Biological Resource Centre Network (GBRCN) for microorganisms.

6. SHARE is the ‘Survey of Health, Ageing and Retirement in Europe’, a multidisciplinary and cross-national panel database of micro data on health, socio-economic status and social and family networks of more than 55,000 individuals from 20 European countries aged 50 or over. In 2011, SHARE was the first infrastructure to be awarded ERIC status. • Innovative Medicines Initiative (IMI) is an EU supported public-private initiative aimed at speeding up the development of better and safer medicines for patients. It aims to foster collaboration between all relevant stakeholders including large and small biopharmaceutical and healthcare companies, regulators, academia and patients. IMI is an industry driven programme with research priorities identified on a yearly basis by a governing board consisting mainly by representatives of the EU pharmaceutical community. The overall research agenda of the IMI targets the following bottlenecks in the development of effective pharmaceutical agents, including Predictivity of Safety Evaluation, Predictivity of Efficacy Evaluation, Knowledge Management and Education and Training.

7. Malta R&D expenditure on health and medical science by sector of performance

8. National R&I Programme [2004-2011] has funded 12 projects (27% of funded projects] in health and biotechnology fields: • COELIGENE - Identification of Genetic Factors Contributing to Coeliac Disease in the Maltese Population • Transcriptional Regulation and Promoter Genetic Variation of the Chemokine Receptor 4 (CCR4) Gene with Special Pharmacogenetic Relevance to Novel Therapeutic Targets in Asthma. • The Design of a Series of Non-Steroidal Oestrogen and Androgen Receptor Antagonists • Screening of Maltese Medicinal and Aromatic Plants for Pharmacological Activity • Development of a modular intravenous set • Intelligent Design and Manufacture of Micro-Parts for Biomedical Applications - Case Study - The Development of a Laparoscopic Surgery Tool • Bio-Structor - A Portable Software Tool for Biological Visualization • Inflammation Atherosclerosis and Myocardial Infarction in the Maltese Population • Pervasive Nursing And docToral Assistant (PINATA) • Identification of Neuroprotectants from Terrestrial and Marine Plant Extracts in Neurodegenerative Disorders of the Amyloid Type • Investigation of Chaperone Modulators as Regulators of Diabetes, Cancer and Stem cell Expansion • Stent – Manufacture, Architecture, Research, Treatment

9. Methodology A) Oct – Dec 2010: Setting up of steering group . Throughout the whole process, the steering group met regularly, approximately every six weeks. B) Jan – April 2011: Questionnaire [Prof Christian Scerri & Dr Gordon Cordina] to all health professionals to help identify Malta’s comparative advantages in different health niches; identify potential benefits to exploiting these advantages and difficulties which are limiting Malta from attaining its potential in such niches; and give an indication of possible policies and the likely resource costs which could help address these obstacles. (launched Feb 2011). A total of 83 professionals in health science and related professions give their input to this exercise. C) Apr-Aug 2011: On the basis of the feedback received, six focus groups were identified and meetings (between one and two meetings for each group) were held: • Airway diseases and environment • Social, health behaviour and psychology • Genetics, pharmacogenetics, family related, pharmaproduction, cancer and dental • Cardiac/coronary, diabetes and obesity • Design of devices/equipment, ICT applications • Neuro, muscoskeletal/ locomotor and mental D) Oct’11- Feb ‘12: SWOT analysis held through one-to-one interviews [Dr Janet Mifsud] with 49 health professionals. E) A desk review [Prof Christian Scerri] of the papers published with Malta as the affiliation country for at least one author and identified through Pubmed was undertaken. F) Draft Strategy was presented to the Board of Directors of the Malta Council for Science and Technology in April 2012.

10. Malta’s Constraints [Survey Responses] Lack of funding including expertise to apply for EU funding Lack of incentives & structure for research & needs assessment Lack of human resources Lack of awareness of local health problems University & Medical School ties not well established Lack of time Lack of data Geographical & environmental restrictions Lack of infrastructural services Lack of awareness of Malta's niche potential among researchers 0% 5% 10% 15% 20% 25% 30% 35%

11. Malta’s Competitive Advantages [survey responses]

12. Priorities to be addressed [survey responses]

13. Goal 1 - Towards a vibrant and sustainable Health R&I Framework – key recommendations Recommendation 1 : Set up a National Governance Framework for Health R&I Set up a National governance framework for Health Research and Innovation to oversee the development of an enabling ecosystem for health research and innovation.; establish regulatory governance that facilitates, validates, and valorises Health R&I. Apart from its advisory capacity, the centre will have the remit to drive and support investments in appropriate capacity-building measures including internationalization efforts, to develop a high profile for the sector in Malta and abroad. Recommendation 2: Increase Funding for Health R&I Increase funding for health R&I to drive capacity-building of the sector which supports an appropriate balance of specialization and inter-disciplinarity and coves translational research in a variety of disciplines in meeting the societal challenges. The aim is to stimulate different sources of funding including public-sector funding, public-private partnerships and/or seed funding

14. Goal 1: Health R&I framework Recommendation 3: Ensure enhanced access to health research facilities Ensure enhanced access to quality health research infrastructures and enable researchers to network between each other as well as to join international research networks. development of clusters and research networks involving academic and other research professionals in the public and private sector allows for better time management and secures the allocation of due time for conducting high-quality research. Recommendation 4: Enhance Use of Public Procurement to stimulate R&I a. Encourage proactive use of EU public procurement directives as a means for stimulating public and private sector investments in health research and innovation. b. Enhance the role of the Public Service (both as purchaser and regulator) as early user of health innovative products by developing capacities for implementing public procurement for research and innovation c. Support the Public Service to act as a catalyst in private procurement, through the establishment of credit guarantees for innovative health services, training in innovative procurement techniques and intellectual property protection, and the purchase for private use of innovative services and products.

15. Goal 2 - Building the necessary capacity and competence for high quality research to improve well-being – Recommendation 5: Attract high quality researchers a. Provide a set of attractive conditions to increase the number and profile of local researchers engaged in medical and health research and to attract high quality researchers from overseas, particularly, in areas of national priority. b. Develop an enabling environment conducive to research, through the establishment of an excellent health research management system. Recommendation 6: Support Capacity-building and forward planning a. Map current research capacity and competence by area in order to project current research strengths, locally and abroad, and as a means to define better future needs for capacity-building. b. Facilitate forward planning by tertiary institutions at post-graduate, doctoral and post-doctoral level to build critical mass and develop defined and structured research units. c. Encourage postgraduate and doctoral level studies and research in health through well-designed programmes and incentives. Recommendation 7: Build critical mass and enhancing the potential of researchers a. Set up incentives to encourage clustering of researchers from the various fields including medical, engineering and ICT. b. Encourage the setup of Knowledge Transfer Partnerships (KTP) between academic institutions and industrial partners (both local and foreign) to encourage rewarding collaborations with innovative businesses as well as to gain ideas for further research and development projects.

16. Goal 3 - Supporting evidence-based policy making in human health: outreach and take-up – key recommendations Recommendation 8: Ensure Dissemination and Take-up of results a.Increase the publication and dissemination of research findings in peer- reviewedand on peer-reviewed journals b. Build the competence for communication and exploitation of research results to develop new tools and research applications to improve the health of the population. c. Utilise results as an educational tool to change the habits, behaviour and opinion of the general public on health issues. Recommendation 9: Enable Access to research results and new knowledge a. Enable access to research results and the transfer of knowledge needs to be improved to ensure that research evidence is transferred into practice. b. Integrate and validate data obtained from routine clinical examinations and investigations. c. Set up an online portal to disseminate information and research evidence. d. Introduce compulsory training in entrepreneurship

17. Goal 4 -Leveraging internationalisation opportunities for economic growth and innovation in the health sector – key recommendation Recommendation 10: Invest in competitiveness and job creation a. Study and design a competitive package of policy measures and incentives to target local and foreign investment in particular niche areas. b. Review the full range of internationalization opportunities instrumental in addressing the Strategy’s objectives. c. Ensure a strong national drive to coordinate health, biotech and life science initiatives which exploit Malta’s competitive advantage. d. increase private sector awareness of the value-added gained from investments in research and innovation to enhance competitiveness. e. Introduce compulsory training in entrepreneurship and related hands-on experience.

18. Strategic Goals, Societal Challenges, Thematic Areas and Niche Areas

19. Potential Roadmap from the HRS. Potential Outcomes Next 5 years Next 20 years Next 10 years Improved ICT infrastructure within the health sector A thriving research culture within the Research-led and evidence-based Improvement in the quality of life public health service public health service Increased and stabilised industry Changing mentality of research Financial Savings brought about investment in clinincal research in funders, particulary government through research results the health service sector More patients and health professionals participating in health Longitudinal studies research with high qiality protocols and early access to new intervention and prevention strategies Collection of samples for genetic Health and healthcare improved by studies research evidence New therapies (eg. From endemic Infrastructure for research groups sources) and techniques Promotions by all the relevant stakeholders including public sector, Follow-up studies professionals and policy makers Steady relationship between local Better awareness and international organisations Formal collaboration between Mater Extensive research sector Dei and UoM

20. Indicators to measure progress: • Indicators relate to stewardship, the level of financing of health research in Malta, the value added of health research towards the Maltese economy and the number of health related articles and national patents published. • Medium term targets relate to increased knowledge, better utilization of knowledge and an improved health care industry. • Intermediate to long term benefits accruing throughout the whole process, include social and economic benefits, political and administrative benefits and benefits to future researchers.

21. EuCHR [European Council for Health Research] , Brussels May 2012 • Promoting strategic planning and synergy with other European programmes at national, regional, and EU level, including the ECRIN, ELIXIR, the Innovative Medicines Initiative (IMI), the Marie Curie actions, relevant infrastructural initiatives as well as the other five societal challenges outlined in Horizon 2020; • Providing incentives to encourage the contribution from other science and technology (S&T) fields (such as nanotechnology, engineering, information and communications technology (ICT), environmental research, nuclear physics or space research), as well as the economic and social science fields; • Providing authoritative advice on the steering of EU-funded research; • Providing scientific advice for new regulatory measures needed to ensure progress of health research in Europe. • The EuCHR will promotean ‘innovation-friendly’ environment, and encourage the containment of healthcare costs, promote health and research competitiveness and aim to reduce inequalities. To do this, a new dynamic for networking between academia, clinical practitioners, industry and the regulatory agencies will be promoted, in an effort to encourage public-private partnerships. • The significant regulatory pressures placed on the biomedical community11 are slowing down innovation. The EuCHR can create strategies to support biomedical researchers streamline the increasing red tape.

22. Malta Health Research System [HRS]

23. Thanks for your attention!