Strategy for Health and Research Innovation: A springboard for sustainability

Aware of the need for research and development in the health sector, the Malta Council for Science and Technology (MCST) launched a draft national strategy after 14 health and biotechnology related projects were initiated last year.

The National Strategy for Health and Research Innovation is open for a month of consultation following a drafting process involving a number of experts and stakeholders. The final document should be published by the end of January and implementation is planned to take place within five years.

Last year, the MCST commissioned the development of a dedicated strategy for health research and innovation in line with its mandate to identify areas of national priority and design and implement strategic approaches to enhance economic competitiveness and the quality of life.

The Health Research and Innovation Strategy for Malta, aims to develop an enabling health research and innovation ecosystem as a springboard for securing sustainable healthcare through the identification of areas and opportunities for undertaking health research in processes, diagnosis, treatments and service delivery.

The objectives are to improve the effectiveness and efficiency in these areas, attract investment and achieve long-term sustainability.

In an introductory address on Wednesday, MCST chairman Jeffrey Pullicino Orlando said the aim of the strategy is to create an ecosystem in health research and innovation as a basis that assures the sustainability of healthcare by identifying sectors and opportunities for research in processes, diagnosis, care and service provision.

The document also considers the economic, social and technological contexts and is in line with further government incentives in the field.

Dr Alec Lapira, who chaired the committee responsible for drafting the strategy, explained that it has four main aims: Reaching a vibrant and sustainable health research and innovation ecosystem; building the necessary capacity and competence for high quality research to improve well-being; supporting evidence-based policy making in human health: Outreach and take-up; and Leveraging internationalisation opportunities for economic growth and innovation in the health sector.

While expenditure in R&D exists and has increased in recent years, there is definitely more space for growth.

During the consultation process and in questionnaires filled in by some 83 healthcare professionals, it was highlighted that the lack of a legal and medical structure to help plan and carry out research is hindering progress.

Since resources and funding are lacking, the strategy includes assistance for professionals to apply for EU funding.

He pointed out that while existing expertise is high, this can be put to better use. In addition, there needs to be a portal that stores all research data for it to be available to researchers in the future.

Although collaboration between hospitals is possible, not all professionals are aware of it. The same applies for the industry.

The final aim will also involve investing in our island’s competitiveness and job creation.

Malta can become a hub of R&D in certain fields, while increasing our presence on international health organisations and research fora will help create niche tourism.

The strategy has not been drafted in a vacuum but the EU had concluded last May, that since there is no council for health research and innovation in Malta, one should be set up.

The main Research and Innovation Strategy is being finalised and two thematic strategies – one about manufacturing and the other about health, are underway.

These are to help in utilising EU funds in preparation for the 2014-2020 funding period.

The document is available in digital format on the MCST’s website and will be disseminated to professionals, doctors, researchers and University students for public consultation.

Copy of the draft strategy can be downloaded from http://mcst.gov.mt/about-us/news/healthresearch-and-innovation-strategy-malta.

Among the projects in health and biotechnology underway last year were five with a direct impact on the local population and some are being carried out in collaboration with the manufacturing industry:

Modular Intravenous Sets (MIVS)

Coordinated by Joseph Grima for Baxter (Malta) Ltd, the main objective of this project was to reduce the amount of raw materials required to manufacture Intravenous (IV) Sets and the packaging materials necessary to supply the product in a sterile state.

This was to be achieved by developing a number of components that allow the end user to ‘assemble’ the IV set s/he needs (in different configurations), with the possibility to re-use some of the components that do not come into contact with the patient or the fluid being administered.

Although this will reduce the amount of packaging, as part of the product will be re-used, the packaging used at the manufacturing stage had to be revised. To further define the scope of this development, market research was conducted with major Baxter customers across Europe by means of surveys and visits.

Baxter’s Regulatory Affairs function was also involved in defining the legislative constraints within which this development should operate.

A device that will be used on IV sets to control the flow of solution was designed.

At this stage, Baxter is evaluating whether to proceed with this project based on the investment required to commercialise the product and the current portfolio of projects being managed at a global level.

The grant value €113,513.

for

this project was of

Inflammation, Atherosclerosis, and Myocardial Infarction in the Maltese Population (IAAMI)

A project with a direct focus on the Maltese population with a grant value of €159,090 carried out between the Health Department and the University of Malta (Institute of Health Care) has two graduates furthering their studies in relation to it and a number of part-timers employed.

A team of scientists and researchers are also working on this project.

Atherosclerosis results in Myocardial Infarction (MI) or stroke, which are major causes of death in developed countries. Whilst lifestyle factors influencing risk for this disease are known, the genetic component, although shown to be present, has not been determined.

A collection of data and samples from Maltese patients with a history of MI and controls will be set up, together with relatives of cases.

This study will help us determine the cause of stroke in the Maltese population and the collection will be available for further studies to find new treatments and preventive strategies. Once finalised, the collection will also attract further research funds from the EU and other sources.

The collection is ongoing and samples are being banked. Standard operating procedures have been set up, including procedures for recruitment, consent, blood sampling, sample processing and storage, physical measurements and DNA and RNA isolation. A number of doctors and researchers have been trained in various aspects of the project.

Investigation of chaperone modulators as regulators of diabetes, cancer and stem cell expansion (HOTSPOTS)

A collaboration project involving the research expertise of the University of Malta’s Anatomy Department in Stem cells and cancer and the product development skills of the local biotech company ICP, has the potential to result in breakthrough results.

A particular ICP product known to enhance the cell’s ability of rapidly unregulated Heat Shock Proteins will be used in three fields. The first, to attempt to protect healthy cells over cancer cells with respect to damage from chemotherapy. The second field will be to see if such heat shock stimulation will help expand stem cell populations in blood. Finally, it will check whether this extract can enhance diabetic white cell function. Starting with the latter, very interestingly, in people with poorly controlled diabetes, it has been shown that a particular aspect of leukocyte function – the oxidative burst function that attacks bacteria – is enhanced by using this ICP product. This means that Tex-OE, the relevant product, may reduce infections in diabetic people.

The other results relate to chemotherapy. TexOE is normally effective in enhancing heat shock protein production and allowing cells to better survive stress. This has been shown by ICP on normal cells.

Interestingly, in tumour cell lines, the product does not seem to have such protective effects, especially with some drugs such as cisplatin and methotrexate. Thus by administering Tex-OE together with chemotherapy, one may protect healthy cells from chemotherapy, whilst allowing the chemotherapy to continue killing cancer cells.

The grant value €100,000.

for

this project was of

Identification of Genetic Factors Contributing to Coeliac Disease in the Maltese Population (COELIGENE)

Coordinated by Prof. Christian Scerri on behalf of the University of Malta (Faculty of Medicine & Surgery), this study has already attracted attention from foreign-based biotech companies interested in supporting further research.

Coeliac Disease is an inflammatory disease of the upper small intestine, caused by gluten ingestion in genetically susceptible individuals. This disease was, in the past, considered as an uncommon disorder with prevalence rates of 1 in 1,700 however, recent studies have shown that it may be more common and may affect as many as 1 in 133 individuals. Gluten is found in a number of cereals, including wheat, barley and rye, meaning that those suffering from this condition are affected by a broad range of foodstuffs.

The pathophysiology of coeliac disease is multifactoral and includes both genetic, as well as environmental factors. The full spectrum of genetic factors in coeliac disease is largely unknown. One way of identifying the predisposing gene is through the linkage analysis of genetic patterns amongst family members, where at least one (preferably more) of the members has the condition.

Further studies are being conducted and these can result in the identification of possible pathways to produce novel ways of treating coeliac disease.

Further research is possible on coeliac disease as well as other related disorders such as diabetes, rheumatoid, arthritis and other inflammatory bowel disorders.

The grant value for €50,082.

this project was of

Increasing the yield in the production of slow-release pellets in the manufacture of tablets and capsules (IYPOS)

This project is being coordinated by Lilian M. Azzopardi for the University of Malta (Department of Pharmacy) and is being carried out with the consortium Starpharma.

A total of €80,000 has been granted for this project. In the local Pharmaceutical Industry scenario, Research and Development (R&D) is based on the development of generic formulations. The number of pharmaceutical companies that manufacture slow-release, solid, oraldosage forms is limited due to the specialised knowledge required to carry out research to develop such formulation.

This project will help the pharmaceutical industry to improve upon the process that is currently being used, leading to a decrease in costs and manufacturing time, making the process more economically viable.

Improvements have already been made with regards to the coating-pan and method used in the production of slow-release, oral dosage forms and these have led to a decrease in the number of slow-release coatings required to achieve the stipulated dissolution rate. This method is currently being validated.

A post-graduate student reading for a Masters degree is working on this subject as her dissertation.