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Medical Biotechnology Trends and Achievements in Iran

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Medical Biotechnology Trends and Achievements in Iran Brief Report Medical Biotechnology Trends and Achievements in Iran Fereidoun Mahboudi 1*, Haleh Hamedifar 2, and Hamideh Aghajani 3 1. Biotechnology Research Center, Pasteur Institute of Iran, Tehran Iran 2. CinnaGen Co, Tehran, Iran 3. Aryogen Co, Karaj, Iran Abstract A healthcare system has been the most important priority for all governments worldwide. Biotechnology products have affected the promotion of health care over the last thirty years. During the last several decades, Iran has achieved significant success in extending healthcare to the rural areas and in reducing the rates of infant mortality and increasing population growth. Bio- medical technology as a converging technology is considered a helpful tool to fulfill the Iranian healthcare missions. The number of biotechnology products has reached 148 in 2012. The total sales have increased to 98 billion USD with- out considering vaccines and plasma derived proteins in 2012. Iran is one of * Corresponding author: the leading countries in the Middle East and North Africa in the area of Medi- Fereidoun Mahboudi, Ph.D., Biotechnology Research Cen- cal biotechnology. The number of biotechnology medicines launched in Iran is Downloaded from http://www.ajmb.org ter, Pasteur Institute of Iran, 13 products until 2012. More than 15 products are in pipelines now. Manufac- Tehran, Iran turers are expecting to receive the market release for more than 8 products Tel: +98 21 66953311 by the end of 2012. Considering this information, Iran will lead the biotechnol- Fax: +98 21 66465132 ogy products especially in area of biosimilars in Asia after India in next three E-mail: [email protected] years. The present review will discuss leading policy, decision makers’ role, Received: 5 Aug 2012 human resource developing system and industry development in medical bio- Accepted: 30 Aug 2012 technology. Avicenna J Med Biotech 2012; 4(4): 200-205 Keywords: Biopharmaceutics, Human resources, Iran, Medical biotechnology Introduction "Biotechnology" was defined in 1919 by Karl ing organisms to the diagnosis or treatment of Ereky, a Hungarian engineer, to describe a disease. methods and techniques which produce sub- Modern Biotechnology or Molecular bio- stances from row materials with the aid of technology was shaped in the early 1970 by living organisms (1). A standard definition of the means of heterologous cloning in E.coli (3). biotechnology was achieved in the Conven- The first biopharmaceutical products, recom- tion on Biological Diversity (1992) – "any binant insulin and recombinant human growth technological application that uses biological hormone, were launched to the world market systems, living organisms or derivatives there in 1980’s (4). In this decade, more than 10 bio- of, to make or modify products and processes pharmaceutical products were approved by for specific use" (2). This definition was agreed the regulatory offices in the United States and by 168 member nations, and also accepted by European countries (4). From then, new and the Food and Agriculture Organization of the more affective vaccines, drugs and diagnostic United Nations (FAO) and the World Health tools have been developed by medical bio- Organization (WHO) (2). According to this def- technology for cancer, autoimmune disease, inition, medical biotechnology is applied liv and infectious diseases such as tuberculosis, 20020 Copyright © 2012, Avicenna Journal of Medical Biotechnology. All rights reserved. Vol. 4, No. 4, October-December 2012 20 Mahboudi F, et al malaria and HIV/AIDS. Figure 1 shows the Regenerative Medicine. In recent years, Iran new biopharmaceutical drugs approved by has registered achievements in this field for FDA since 1982 (5). Biopharmaceutical ap- more than 12 products (7). In this review, the provals are expected to further increase in the leading policy for developing biotechnology, coming years, with many applications pend- educational system and industries frontiers in ing or expected, including new classes of Iran will be explored. products, e.g., gene therapies, stem and other (5) Policy cellular therapies, and cancer vaccines . Due The advancement of biotechnology as a to its promising products, medical biotech- successful industry, confronts many challeng- nology is described as “technology of hope”. es related to research and development, crea- Therapeutic biotechnological products and tion of investment capital, technology transfer vaccines that are currently being marketed and technology absorption, patentability and have an annual market value of 98 billion intellectual property, affordability in pricing, USD, and benefiting over a hundred million (6) regulatory issues and public confidence. Cen- people worldwide . There are hundreds tral to this are two key factors: affordability more of these products in clinical develop- and accessibility to the products of biotech- ment. Medical biotechnology can deliver the nology. Policies that foster a balance between next wave of technological change that can be sustaining innovation and facilitating technol- as radical or even more pervasive than what ogy diffusion need to be put in place. The brought about by other technology like In- Ministry of Science, Research and Technolo- Downloaded from http://www.ajmb.org formation Technology. Employment genera- gy (MRS), The Ministry of Health and Medi- tion, intellectual wealth creation, expanding cal Education, Deputy of Research and tech- entrepreneurial opportunities, augmenting in- nology of Presidency, and Center for Cooper- dustrial growth are a few of the compelling ation of science and innovation of Presidency factors that warrant a focused approach this serves as the coordinating body for science technology. Therefore, Biotechnology is a and technology policy making. powerful and enabling technology for a coun- The priorities of medical biotechnology in- try like Iran which can revolutionize health- volve molecular detection of infectious and care and pharmaceutical industry. genetic diseases, production of recombinant The Iranian biotechnology sector has, over medicines and vaccines, and bioinformatics the last two decades, taken shape through a are defined by National Medical Biotechnolo- number of scattered and sporadic academic gy Network and National Molecular Medicine and industrial initiatives. Trends of medical network. Based on these activities, different biotechnology in Iran are in the fields of bio- committees and working groups are assigned pharmaceutical, Diagnosis, Cell Therapy, and for these tasks. The most active task groups for policy making and priority setting are as follow: - Biotechnology Committee under the super- vision of Science and Technology Deputy of Presidency: The major tasks of this committee is setting policy and priority setting for re- search and development and grant the applied research and investment grant for biotechnol- ogy startup companies. - Biotechnology Board for Medical Biotech- nology at Ministry of Health and Medical Ed- ucation: The task of this Board is helping to Figure 1. FDA approved biopharmaceutics 1982-2010 (5) set up postgraduate studies and curriculum Avicenna Journal of Medical Biotechnology, Vol. 4, No. 4, October-December 2012 201 Medical Biotechnology Trends and Achievements in Iran development in Medical Universities and re- growth rates and research achievements in the search centers. world. Meanwhile, majority of the young stu- - Biotechnology Committee at Environmental dents voluntarily were fighting and they were Department. in front line of the battles. In addition to the - Center for Cooperation of science, Technol- war, a high number of senior scientists immi- ogy and Innovation of Presidential office: grated to the Western countries in this period. The task of this center is to help for financial By the end of the war, research institutes had support and facilitate the rules and regulations access to more scientific environments and that help start up companies to get into the money resources to develop new technologies market. like biotechnology. Nowadays, more than 15 - High Tech Department at Ministry of Indus- biotechnology research centers and depart- try: This is an organization for supporting the ments are operating in Medical Universities. financial status for production specially works The first Iranian National Center for Bio- such as Venture capitalist at the governmental technology and Genetic Engineering (NCB level, in addition, to subsidize some portion of GE) was established in 1989 under the super- the Banking loans. vision of the Ministry of Science, Research - National Medical Biotech Network: This and Technology (MRST). Plant, animal, med- network tries to bring the scientists together to ical and marine, industrial and environmental work for a specific project at national level in biotechnologies are in the scope of NCBGE. areas of biopharmacutics and mega projects Aims of this center are defined as research Downloaded from http://www.ajmb.org and also, to help increase national capacity activities in the field of advanced molecular building for centers and scientists. Priority biology and biotechnology, promoting applied setting and scientific advice are two major and basic research in science and technology. duties of this network. Pasteur Institute of Iran, as the second bio- - National Molecular Medicine Network: This technology research center, started to work in network tries to bring the scientists together to this area in 1992. The first biotech and mo- work for a specific
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