Government Perspective on the Life Sciences

Transcription

1 Government Perspective on the Life Sciences Dr Chong-Chou Lee, Ph.D. Director, Science & Technology Advisory Group, Executive Yuan, Taipei, Taiwan Introduction Enormous advances and product innovations have been seen in the information and communications technology (ICT) and semiconductor sectors over the past two decades in Taiwan. This progress has helped to raise the quality and convenience of life and diminish geographic boundaries, making globalization a critical factor in gaining a competitive edge. Biotechnology and medical technology have helped to broaden the diversity of new medicines, extending the lifespan of humans. Automated machinery has also replaced traditional labor, paving the way for huge increases in productivity. However, over this period, the proportion of people with chronic illnesses has risen; this is especially the case for industrialized nations, which are saddled with low birth rates, aging populations, insufficient manpower, and concerns about medical care. Data compiled by the Ministry of the Interior indicate that population trends in Taiwan are similar to global trends. From 1991 to 2005, the birth rate continued to decline, pushing Taiwan increasingly towards becoming an aging society. In 2006, 10% of Taiwan s population was 65 years old or above; by 2014, this percentage will rise to 13%, after which the pace of aging will increase. In 2051, 37% of Taiwan s people are expected to be at least 65 years old, further highlighting concerns of an aging society. To accommodate and meet the society s future needs, it is important to employ modern technologies and tools to improve the efficacy of translational research and hasten the commercialization of innovative medicines in other words, to help in establishing a comprehensive well-being from a medical perspective. Thus, how the government allocates resources and promotes technology-related policies in consideration of all aspects including boosting national economic development and industrial competitiveness, fiscal burden, and social welfare is a critical issue and challenge. 790 APBN Vol. 11 No

2 The foundation for ICT and biotechnology was laid in the 20th century, enabling the 21st century to be the age where focus is on the integration of information, personalized medicine, and health care. Combining medical care, biotechnology, and information technology to provide comprehensive, round-the-clock, convenient services, as well as improving the quality of life in old age, is without a doubt an important trend. Biotechnology, electronics, and ICT will together drive economic growth this century. The biotechnology industry is already having a wide-ranging impact on national and corporate competitiveness. As a result, the government has singled out biotechnology as an important industry for development and is taking steps to help this industry set new milestones. Goals and Prospects for Development of Taiwan s Biotechnology Industry The development of the biotech industry will be closely correlated to the level of national competitiveness as well as the health and well being of residents. The government has included the biotech industry as an important emerging industry in both its Challenge 2008 National Development Plan and Two-Trillion, Two-Star industrial development projects. The government has introduced a range of incentives to promote investment in the biotech sector, with the aim of establishing a comprehensive biotech hardware and software peripherals chain that will hasten sectorwide development. The BioTaiwan Committee has, after lengthy meetings and coordination efforts, set forth three target areas for development, namely pharmaceutical manufacturing, medical devices, and agricultural biotechnology. A supra incubation center is being laid out to help nurture these industries. (1) Pharmaceuticals: having Taiwan become the Asian hub for biomedicine R&D and the manufacture of pharmaceuticals, an R&D center for drugs and treatment of designated important diseases, and a pharmacogenomics R&D center. (2) Medical devices: in the near term, to establish Taiwan as a high-end medical device OEM/ODM center and one of the world s top 10 hubs for medical devices. Over the medium and long term, to nurture at least three successful flagship top-end medical device companies in Taiwan. (3) Agricultural biotechnology: to establish Taiwan as an Asia Pacific healthy aquaculture breeding center, to develop a stable plant seed and seedling supply system, to create a specialized livestock breeder production system, and to introduce safe agricultural operational models. It is hoped that, with the promotional efforts initiated by the government, the biotech sector will post an average annual revenue growth of 25% in each of the coming five years and will attract an investment of about US$5 billion. It is expected that over 500 biotech companies will be created in Taiwan and that 18 success stories will be seen by Taiwan has set its sights on becoming an important link in the international biotech R&D and commercialization circle, as well as an Asia-Pacific biotech R&D, manufacturing, and operations center. Taiwan s Strategies in Promoting the Development of Biotech A high bar is set for those interested in entering the biotech sector. Enormous amounts of capital are required in the development of new drugs. In addition, the government must create an environment that respects intellectual property and must also set standards for medical care products. Governments in Asian countries such as Taiwan, Singapore, APBN Vol. 11 No

3 and South Korea have served as the locomotive in hastening the development of the biotech industry. Taiwan s government has introduced the Promotion Program for Biotechnology Industry, which serves as the strategic blueprint to foster development of the sector. Development strategies include the following: (1) Creating a comprehensive legal and regulatory environment, establishing a certification system, and promoting the implementation of good practice standards; (2) Appropriating budgets to strengthen assistance and rewards, to promote investment and introduce technology, and to develop markets; (3) Appropriating budgets to boost R&D and technology transfers, commercialization, and applications; (4) Expanding the training and recruitment of industry-specific manpower; (5) Creating a framework to protect intellectual property; and (6) Promoting international reciprocal certification and establishing biotech industry information. These strategies may be amended or new ones drafted and implemented based on changes in the social environment or on the needs of specific industries as they reach certain levels of development. The Ministry of Economic Affairs Since the announcement of the Promotion Program for Biotechnology Industry in 1995, the Ministry of Economic Affairs (MOEA) has helped foster R&D by assisting in the establishment of the Development Center for Biotechnology, the Medical and Pharmaceutical Industry Technology and Development Center, and the Industrial Technology Research Institute's (ITRI s) Biomedical Engineering Research Laboratories and Medical Electronics and Device Technology Center. These institutions promote market-driven upstream and midstream biotech R&D. In addition, the five year Industrial Technology Development Program for the Chinese herbal medicine industry was carried out starting in The MOEA has introduced several funding programs (e.g. SBIR, Industrial Technology Development Program, Innovative Service R&D Program, Program for Innovative Applications, Program of Assistance in the Development of Innovative Products), and has helped the industry to obtain the critical technology required in an effort to promote investment and R&D. In addition, to support the Bio-Tech Island Project in order to create a comprehensive clinical trial R&D environment and to share the capital burden and risk of companies that execute clinical trials of drug candidates and innovative devices, the MOEA has instituted the Fast Track Review of Clinical Trial Funding Program. This measure is also aimed at hastening the testing of drugs and devices developed in Taiwan and at promoting rapid commercialization. The Department of Health The Department of Health (DOH) has established the Center for Drug Evaluation to help local firms and research agencies engage in drug and medical device R&D. The center offers a direct window for companies applying to register pharmaceuticals. It has also helped the DOH create a rigorous but efficient system to review new drug applications in accordance with international norms. Meanwhile, the DOH has established a Critical Path Consultation Service to stimulate and facilitate the modernization of new drug and device product development through the proof of concept process. This service 792 APBN Vol. 11 No

4 helps promote R&D and raises competitiveness. Also, the establishment of the National Health Research Institutes is helping to strengthen the clinical medicine research system, with the aim to establish evidence-based medical research and to resolve all types of problems faced in medical care. National Science Council The National Science Council has also launched national research programs in biopharmaceuticals, agricultural biotechnology, and genomic medicine in an effort to pool resources and hasten R&D. These programs are uniting researchers and integrating resources from related and research institutions. Chinese herbal medicine, new drugs, and biopharmaceuticals are key topics in the first program; while the agricultural biotechnology program centers on R&D related to flowering and medicinal plants, Taiwanese free range chickens, outstanding pigs, breeding high-quality aquatic animals, and meanwhile creating an application technology platform for molecular biology. The genomic medicine program focuses on creating an infrastructure for genomic research, exploring for susceptible genes and disease mechanisms, and developing animal models for diseases and methods of disease prevention. These national research programs encourage cross-sector research and cooperation, and seek to achieve optimum results given limited resources. Much progress is being seen in the technology transfer and commercialization of research achievements. The passage of the Basic Law for Science and Technology Policy, which covers technology and intellectual property management related measures, encourages researchers to become involved in the industry and promotes the flexible use of university human resources. The government has also created a plan that focuses on training and recruiting personnel for the biotechnology industry. The government is also involved in promoting the establishment of biotech parks in order to rapidly create clusters of biotech firms. The National Development Fund is providing investment and financing to underpin private sector investment in the biotech industry, and to enable companies in the sector to have access to the R&D and operating capital they require. IT and Healthcare In the 21st century, the application of information technology in bioinformatics and gene research will have an enormous impact on the development of personalized medicine. Because electronic medical records (EMRs) will boost efficiency in terms of medical treatment and supply chain management as well as provide consumers (patients) with the option of distance home care, and because Taiwan has well established electronics and ICT industries, great advantages will be generated if the IT system is combined with biotechnology and healthcare to enhance translational research and clinical trials. Hence, the government has initiated the Bio-Tech Island Project. Clinical Research The government will take advantage of Taiwan s high standards in medical care and top quality clinical research in an effort to create a biomedical technology island. Taiwan s expertise in electronics and information will be used in conjunction with its representative gene pool of ethnic Chinese groups to establish the National Health Informatics Project, the Taiwan Biobank, and the Clinical Trial and Research System. APBN Vol. 11 No

5 This will provide a database to carry out vertical development of the medical and health industry, spark industrial upgrading, generate enormous business opportunities, and trigger the development of new drugs in Taiwan. It will also pave the way for the development of cell and gene therapies, the monitoring of drug side-effects, and disease screening and prevention. From a broader perspective, it is expected that these efforts will enable Taiwan to become an Asian hub for research in genomic medicine and a clinical research center. Present State of Taiwan s Biotech Industry Taiwan s biotechnology industry generated revenues of US$5.4 billion in 2006, with medical devices, drug manufacturing, and emerging biotech industries accounting for US$2.1 billion, US$1.98 billion, and US$1.3 billion, respectively. Industry revenues posted 13% annual growth in Taiwan is home to 1136 companies involved in medical device, pharmaceutical, and emerging biotech industries; and about people are employed at these firms. Over 7000 jobs have been created since Industry investment has increased considerably since the introduction of the Promotion Program for Biotechnology Industry. Private investment in the biotech sector rose from US$279 million in 1997 to US$640 million in 2006, with the largest proportion (US$288 million) invested in emerging biotech industries. As of 2006, 34 biotech companies were approved to be listed on the main stock exchange or over-thecounter market, while another 17 firms in the industry were listed on Taiwan s Emerging Stock Market. Patents Patents are the driver of a knowledge-based economy. Thanks to the government s policies supporting life science research, Taiwan successfully obtained a total of 729 biotechrelated patents from 2001 to In 2005 alone, Taiwan published research papers, with those in the field of clinical medicine comprising the largest amount at 20% of the total. A number of papers were also published in the fields of chemistry, biology, biochemistry, and pharmacology. Traditional Chinese Medicine The five-year Industrial Technology Development Program for the Chinese herbal medicine industry and other national-scale projects have pinpointed liver disease, asthma, antiaging, and immune regulation therapeutic drugs as the main focus of technology and product development. Since the introduction of these projects, a number of new drug candidates selected by the and research communities have obtained investigational new drug (IND) approval and some have even entered the clinical trial stage. These new drug candidates mostly address cancer, asthma, metabolic disorders, central nervous system diseases, and ulcers. All of these ailments are chronic and the potential markets for drugs are huge. A number of new drugs developed in Taiwan have entered stage II clinical trials, while one new Chinese herbal medicine and one botanical drug have received approval to go on the market. These results indicate that the government s aggressive efforts to create a top-notch R&D environment are paying off, as more and more new drugs and products are being developed and are entering the clinical trial stage. 794 APBN Vol. 11 No

6 Table 1. Clinical Trials and Trials Carried Out by Research Centers National Taiwan University Hospital National Cheng Kung University Hospital Tri-Service General Hospital Taipei Municipal Wan-Fang Hospital Total Phase I Phase II Phase III Phase IV Other Total Source: Department of Health, Science and Technology Unit. Clinical Trials Up to 700 clinical trials of new drugs were carried out from 2001 to 2005; of these, multinational clinical trials accounted for 400. In 2005, clinical trials were being held at home and overseas on 29 new drugs developed in Taiwan. At present, a total of 205 clinical trials are being carried out, including those executed by the sector or funded by manufacturers. This large number indicates that the international community acknowledges the quality of clinical trials carried out in Taiwan. Particularly worthy of attention are stage I and stage II clinical trials of new drugs, which are both highly complex and critical to the future of the drug in question. These trials lead to a go/no-go decision, and have a close bearing on reducing the attrition rate of candidate drugs. Translational research, top-notch clinical trials, and research center projects have enabled Taiwan to move gradually from focusing on the stage III phase of clinical trials to the critical stage I phase, while at the same time establishing more and more expertise in the field. This will be of great assistance to the development of new drugs in Taiwan in the future. GMP The DOH has introduced Good Manufacturing Practice (GMP) for Western medicine as well as a current GMP (cgmp) system in an effort to ensure that the quality of drugs reaches international standards. In addition, as botanical drugs are increasingly used to create new drugs, the DOH, starting in 2005, began implementing GMP for Chinese medicine manufacturers. As of the end of 2005, 161 local manufacturers of Western medicine had passed the cgmp validation and complied with regulatory requirement, while the number of GMP Chinese medicine factories stood at 103. This shows that the manufacturing quality of drug products in Taiwan has reached international standards, which is helping to boost local production and bolster export competitiveness. An increasing number of success stories regarding licensing/cooperation with multinational drug manufacturers has been seen in recent years. For example, AbGenomics has developed therapeutic monoclonal antibodies and has exclusively licensed Boehringer Ingelheim, the world s 15th largest drug manufacturer, to carry out follow-up development. Panion & BF Biotech has licensed its new kidney drug APBN Vol. 11 No

7 to Keryx Biopharmaceuticals. PhytoHealth and Biokey Inc have engaged in strategic cooperation in the joint development of a new drug to treat osteoporosis in the American market. Meanwhile, ScinoPharm Taiwan and Abbott have codeveloped a drug-eluting coronary stent that has been approved for sale in Europe. All of these successful stories show that Taiwan is increasingly playing a valuable role as part of the global network in developing new drugs. Prospects The biotechnology industry is becoming an important motor driving economic growth in the 21st century, and is a key indicator of international competitiveness. For these reasons, it is not surprising that many countries are emphasizing the development of this sector. The Taiwan government has spared no effort in establishing an outstanding environment to foster technological innovation, clinical research, and high-quality practices in drug manufacturing. Taiwan is gaining an increasing number of international patents in the biotechnology field and is home to a rising number of new drug candidates. Multinational clinical trials and international licensing/cooperation projects are also on the rise. The large talent pool in the biotech field along with the efforts of the government and biotech companies have jointly helped to create these accomplishments. Over the past decade, the number of new drugs reaching the market has not met expectations. Meanwhile, the cost of developing new drugs continues to skyrocket. The enormous capital needs associated with developing new drugs is indeed a barrier to the commercialization of successful research among biotech start-ups. Taiwan s venture capital industry has long been more conservative in its investment in biotech compared with the amount of funds it invests in the electronics, semiconductor, and ICT sectors. This is partially due to the lack of valuation mechanisms for biotech firms. In addition, Taiwan has yet to produce a major success story in the biotech sector; as a result, biotech firms are able to raise only a limited amount of funds via the avenues available to them. In light of this, the government in the future will need to create the means for biotech firms to obtain the capital they need. In addition, brand new incubation models will focus on integrating the limited resources available and specializing in the diagnosis and treatment of designated important diseases. This will enable research carried out in Taiwan to reach global standards in these target areas, and will hasten the creation of success stories. Once this is achieved, Taiwan will be on its way to becoming a biomedical technology island and will play an important role in the international biotechnology industry. Contact details: Professor Chong-Chou Lee, Ph.D. Director, Biotech Office, Science & Technology Advisory Group The Executive Yuan Taiwan cclee@stag.gov.tw 796 APBN Vol. 11 No