Transcript Introduction to FP7

National Strategy for Health
Research and Innovation
MCST 2012
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.
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
Relevant EU Health-Related Research Infrastructures and Initiatives
•
ELIXIR: Europe’s emerging infrastructure for biological information aims to construct 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.
•
Infrafrontier is 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
•
Euro‐BioImaging research 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.
•
SHARE is the ‘Survey of Health, Ageing and Retirement in Europe’, a
multidisciplinary and cross-national panel database of micro data on health, socioeconomic 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.
Malta R&D expenditure on health and medical
science by sector of performance
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
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, pharma production, 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.
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%
Malta’s Competitive Advantages
[survey responses]
Easy to get population data as Malta is a
small island
Highly prevalent diseases in Maltese
Need to plan health care services to meet
country's requirements
Existing expertise
Centralised health services
Geographical detachment
Patent Law
EU member state
0%
5%
10%
15%
20%
Percentage of Survey Respondents
25%
Priorities to be addressed [survey
responses]
0.8%
0.8%
0.8%
Safety at the place of work
0.8%
More data - made more accessible (on line)
3.9%
5.5%
Legislation to reduce conditions such as
asthma
7.9%
37.0%
National screening programme
Human Resources
8.7%
International (especially EU) networking
Updating course curricula
Create incentives to spend more time doing
research
33.9%
Structure for research, legal and institutional
More funding and less bureaucracy to apply
for funding
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 publicsector funding, public-private partnerships and/or seed funding
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.
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.
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 peerreviewedand 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
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.
Strategic Goals, Societal Challenges, Thematic Areas and Niche Areas
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
public health service
public health service
Improvement in the quality of life
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
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.
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 promote an ‘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.
Malta Health Research System [HRS]
Function
Financing
Operational Component
Define and articulate vision for a national health research
system (HRS)
Identify approproate health research priorities and
coordinate adherence to them
Set and monitor ethical standards for health research and
research partnerships
Monitor and evaluate the HRS
Secure research funds and allocate the accountably
Crearing and sustaining
resources
Build, strengthen, and sutain the human and physical
capacity to conduct, absorb, and utilise health research
Stewardship
Producing and using
research
Produce scientifically valid research outputs
Translate and communicate research to inform health
policy, strategies, practices, and public opinion
Promote the use of research to develop new tools
including drugs, vaccines, devices and other applications,
to improve health
Thanks for
your
attention!
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