MEDICAL BIOTECHNOLOGY COOPERATIVE CENTRE Overview Mission Statement Priority Areas Research Projects Who's Who Links Priority Setting Introduction Malaysia has a population of slightly less than 20 million, with about 60% aged between 15-64 years and economically active and approximately 51% living in urban areas. While demographic changes and rapid industrial and socioeconomic development are likely to shift disease patterns towards an increasing importance of the non-communicable disorders, it is nevertheless still true that communicable diseases are of tremendous importance and that a renewed effort must be made to invest in research which emphasises the control and prevention of such diseases. The technologies available today make it possible to raise the level of understanding of pathogenesis and the disease process for more effective diagnosis and vaccine design strategies. At the same time, there exist technologies, which enable us to bring sophisticated diagnostic technologies out of the research laboratories to the bedside or to the field where effective control requires rapid results and early feedback. It is thus considered important that the tools of biotechnology be brought to bear on the problem of improving diagnosis and disease prevention. Industry Analysis Diagnosis The Asia-Pacific 350-400 billion ringgit health care sector, expected to grow over 70% in the next five years includes not only devices and therapeutics but also diagnostics. The world market for diagnostics is about 30 billion ringgit, with at least 50% of this being based on biotechnology. The growth rate is at least 10% per annum, with the highest growth rates in biotechnology related areas. Within the diagnostic sector, immunodiagnostics and DNA based diagnostics are growing rapidly and are valued at RM10-12 billion globally while detection of infectious diseases being about RM8 billion. The market size of the pharmaceutical industry in Malaysia is currently valued at RM 500 – 600 million and growing. Since the diagnostic market is normally expected to be 10% of the total pharmaceutical market worldwide, it can be estimated that the diagnostic market in Malaysia alone is about RM50 to 60 million annually. The fastest rate of growth in the diagnostics market is immunodiagnostics and DNA based technology globally, and this coupled with the fact that for diagnostic products, entry cost are low with minimal regulatory barriers, it seems sensible to adopt the strategy of building a medical biotechnology industry on the firm foundation of diagnostics in the first instance. Clinical trials Present day drug development costs are extremely high and are currently estimated at $300 million per approved drug. Much of this skyrocketing rise is due to extremely high cost of clinical trials. In fact, this is one reason why we are beginning to see a shift in drug development activity offshore. In a 1995 study sponsored by the Health Industry Manufacturer’s Association (HIMA), in Washington, DC, 38% of the 526 respondents indicated an intent to move their clinical trials to Asia due to lower development costs.
On 30th May to 1st June 1994, the Ministry of Health organised the National Conference on the Setting of Medical Research Priorities for Medical Sector for the 7th Malaysia Plan, at Genting Highlands. The input to this conference were in line with the concept of Essential National Health Research (ENHR) which emphasises that the basis of decision making should be through the close collaboration of health researchers and managers, the community and the industrial sector. As such inputs were sought from the Ministry of Health, Malaysia, the medical faculties of Universiti Kebangsaan Malaysia, Universiti Sains Malaysia and Universiti Malaya, other institutes and organisations with interests in health research and non-governmental organisations with the interests in the health of the community. A total of 7 target areas were identified and details on priority programmes, themes and scope, were determined. Since the national research priorities for medical research has been determined by a broad forum sanctioned by the Ministry of Health, it remains necessary only to highlight areas of priority which requires particular attention from the National Biotechnology Directorate. At this time, a similar exercise of priority setting is being conducted by the Ministry of Health for the 8th Malaysian Plan.
Priority Area 1: Molecular Markers for Diagnosis and Disease Susceptibility. Conventional serological and histopathological techniques for diagnosis of infectious diseases and cancers will fast be outmoded by molecular methods, both based on recombinant products as well as on oligonucleotide sequences. Malaysia will be able to compete in the international arena in specific areas of modern diagnostics if we apply biotechnological methods to niche areas such as tropical infectious diseases and to specific neoplasms, which are common in or unique to Malaysia or the region. Other than determining molecular markers for diagnosis of acute disease, it is also important that we study genetic markers of disease susceptibility in order to better understand the epidemiology and distribution of diseases such as cancer. This kind of information gained will be useful in the prediction of risk factors and can generate useful data for health policy planning. Priority Area 2: DNA Vaccines and Vaccine delivery Systems. The next generation of vaccines, which will be important in medicine, will be DNA based vaccine and it is considered important that Malaysia acquire the capability to design and utilise such vaccines. Furthermore, the vehicles by which these vaccines will be administered will be far from conventional, and in this regard as well, Malaysia should be able to position ourselves favourably in the international arena. Priority Area 3: Neglected Diseases It has been noted that diseases such as fungal and leptospira infections have not received much attention from researchers nationally. While such infections may become more important in the future, particularly with the advent of AIDS in the region, it is considered necessary to encourage the submission of research proposals on a molecular approach to the study of the following diseases:
Conclusion It should be noted that the acquisition of state of the art technologies and the mastering of these are particularly important if Malaysia is to advance in the field of medical biotechnology. The approach the MDBCC will take is to use selected model systems to acquire and master these technologies and in doing so, to make the enabling technologies available to all researchers in the country through a series of training workshops and collaborations. |