Life science and clinical medicine are fields of research and development that can benefit the establishment of a wide range of social foundations, including medicine, food, and environment. Strategic promotion of these fields has influences over na-tional health/medical policies and strategies such as in agriculture, forestry, and fisheries. Thus, identifying the overall picture of scientific as well as policy trends in life science and clinical medicine is an important step for establishing research and development strategies in this field. This Executive Summary describes the out-comes of the investigations conducted by the Japan Science and Technology Agency, Center for Research and Development Strategy (JST-CRDS), with wide perspectives on the overall picture of life science, including research trends of foreign countries with the support of leading researchers and intellectuals in the applicable disci-plines.
JST-CRDS defines “life science and clinical medicine” as “science and technology that can benefit for the understanding of life phenomena of living organisms (in-cluding humans) and healthy sustenance of humans and the earth (the environment).”and set out the main focus areas of research and development based on the definition. Recognizing that to conduct comprehensive and consistent panoramic study, covering basic research, applied research and their relationship with the society, is a valid approach with a view to identifying and developing national strategies for research and development, we set the following four core fields of research and development for this study:<Intellectual and Technology Bases>, <Health and Medicine>, <Food and Environment>, and <Social Aspects and Ethics>. More specifically, these core fields are further divided into 7 sub-segments, consisting of 77 specific disciplines (12 disciplines in Basic Life Science; 14 disciplines in Next Generation Enabling Technologies; 9 disciplines in Drugs; 5 disciplines in Medical and Welfare Device; 18 disciplines in Health and Medicine; 11 disciplines in Green Biotechnologies; and 8 disciplines in Social Aspects and Ethics).
Life science has evolved rapidly and made great achievements by the emergence of the molecular biology since the middle of the 20th century. The main methodology and paradigm in the past life science researches are elementalism and reductionism, focusing individual genes and molecules. With all this achievement, however, this field of study could not solve the complexity of the life, entirely or fully. Moreover, various social problems have been still unsolved and remained in spite of the pro-gress. Meanwhile, by the recent significant and enormous advances in the analyt-ical or measuring technology, including next-generation sequencer, huge amounts of data sets are brought continuously and increasingly. Additionally, various big data from real society are available now, for example, electronic medical chart from medical administration or big data from the production activity (agriculture, forestry, and fishery). The movement of the utilization of those big data has come.
Based on the above mentioned background, a desirable direction and strategies for the promotion of the life science and clinical medicine research fields in our country, are as follows.
Through the analysis of the big data obtained from real society (mass), the issues to work on (themes) should be extracted. Life science researches corresponding those issues should be encouraged, thus, structures and function of life itself (human, animal, plant, microorganism, etc.) or mechanism of human disease should be in-vestigated. Then, obtained seeds from those researches should be transformed into the practical technologies by the “translational researches”, with fully considered regulatory science. For example, technologies for the health and medical purpose, clinical tests/trial should be carried out, technologies for food- or green biotechnol-ogy- related matters, tests/evaluations in non-model organisms including farm products or biomass feedstocks, and farm trials should be propelled. Next, those technologies produced by the above mentioned scenario should be further evaluated in the small groups, such as advanced medical care or cultivation in the special wards. Based on those various data from many practices, related technologies and systems should be polished, and then provided into bigger society (mass). Then, wide variety of big data will be provided from those trials again. By the analysis of those big data from repeated evaluations and trials in real society (mass), next issues to work on (themes) should be extracted again. Moral and ethical aspects and consensus forming should be always considered. Circulating above mentioned se-rial cycles continuously, innovations in various fields, including health, medical, food, and environment etc., will be accelerated and optimized, then impacts toward the society will be maximized.
The main characteristics of research and development in Japan, the United States, Europe, China, and Korea found through wide-perspective observations of target fields are as follows (see Chapter 2, Section2.2(4) for details).
Basic research in Japan has strong international competitiveness and is listed as one of the three major forces in the world along with the United States and Europe. The research standard in developmental and regenerative research is especially high, and research in this field is well recognized on the international stage. For example, Dr. Shinya Yamanaka (Kyoto University) was awarded the Nobel Prize in Physiology or Medicine for his work in the production of iPS cells in 2012, and the production of germ cells from ES or iPS cells was selected as the “Breakthrough of the Year 2012 (ten most recognized achievements in a year)” in Science Magazine in the United States. Yet, Japan’s international competitiveness in the applications of many re-search and development is still weak, which is also the case in the developmental and regenerative research fields. This tendency becomes more prominent as re-search outcomes come closer to actual applications in society. This issue has been criticized for a while but still remains without improvement. Research and devel-opment in health and medicine have been traditionally promoted by respective ministries, but from now on Japan Agency for Medical Research and Development (AMED), which will be established in April 2015, will play a major role.
<The United States>
The United States stands at the top of the world in both basic research and applied research in almost all research and development fields. Cutting-edge research is conducted with overwhelming financial power and many talented researchers. Spe-cifically, the strength of the United States is in data-driven approach, such as omics research, and many trends in today’s research in life science are produced in the United States. Financial and cultural foundations for nurturing venture companies have been established in the United States, and the capacity to commercialize the outcomes of basic research is high. Most of the next-generation sequencers to be sold in the market have been manufactured by companies in the United States, indicating the strength in basic technological development and international applications that support cutting-edge technologies. Such a trend has been continuing for a long time, and the United States is expected to continue being the leader in research activities. In recent years, there have been major organizational reforms to promote translational research at the National Institutes of Health (NIH). Moreover, the President launched Precision Medicine Initiative in the 2015 State of the Union Address to promote more precise medicine by taking into account “individual varia-bility in genes, environment, and lifestyle for each person” (http://www.nih.gov/precisionmedicine/)
In green biotechnology field, commercial-scale cellulosic ethanol biorefinery started the production in 2014, with the support from DOE. Approximately 210,000 tons of CO2 emissions will be avoided annually through the cellulosic ethanol pro-duction by this plant. 1000 Molecules program was also started by DAPRA to seek how to design or find the pathway to make basic 1000 kinds of molecules using bio-technology.
The United Kingdom, Germany, and France have long histories of conducting great basic research, and the research level is as high as the United States. The Trust Sanger Institute in the United Kingdom has purchased more than 50 next-generation sequencers, and they have been contributing to international genome projects. Epidemiology is advanced in Europe, with especially highly developed systems for researching epidemiology, including genomes in northern Europe. The international competitiveness in commercializing research outcomes is about the same as the United States, if not slightly lower. Many global pharmaceutical companies are located in Europe, and the environment for conducting clinical development is better than Japan, of course, and the United States.
In green biotechnology field, the success of the Food Valley in Netherland is no-table. The Food Vally is a world scale industry/academia/government cooperation through the coordination and promotion by Food Valley Foundation, boosting inno-vation performance in agricultural research and development. Many kinds of prod-ucts and services are created through the The Food Vally‘s research and develop-ment, which is designed along with the intention of customers. This system enables Neitherland to get an excess of exports over imports in the agricultural products by the successful processing trade, in spite of limited territory and not very productive soil in Netherland. Seven priorities in Horizon2020 were proposed, including “Food security, sustainable agriculture, marine and maritime research & bioeconomy”. In biorefinery, commercial-scale demo plants using inedible (including cellulosic) bio-mass are now under construction. Especially, an Italian company invented the industrial technologies about bio ethanol production from inedible biomass, and has already developed globally.
While competitiveness in basic research is lower than Europe, the United States, and Japan, the progress in recent years has been very fast, and the number of pub-lished research studies is greater than Japan in some of the research and develop-ment fields. The number of next-generation sequencers in use is increasing, and Beijing Genomics Institute(BGI) has the largest number of next-generation se-quencers in the world. While the level of the current genome science is still low, the people who gained experience in BGI are expected to raise the research standards in the future. Also, there is a government policy to invite Chinese researchers with recognized achievements in Europe or the United States back to China, which has been resulting in qualitative improvements in research. Asian headquarters of global pharmaceutical companies are beginning to gather in Shanghai, and the environment for conducting clinical research has been established.
Basic research and applied research of Korea are still immature compared to Eu-rope, the United States, and Japan. The main focus of new pharmaceutical devel-opments is “me-too drugs” and biosimilars, while unique and new pharmaceutical development is rarely conducted. Nonetheless, equipment for conducting clinical tests is abundant, and clinical studies are actively conducted by international pharmaceutical companies. The large number of approved regenerative medical products is also one of the characteristics in Korea.
In green biotechnology field, the Golden Seed Project, which is a strategic national research and development project for mainly seeds or other agricultural products, has started 2013, to develop seeds and increase export capacities through the leading role of private camanies.
Future Earth has started in 2013 as a big global platform for international scien-tific collaboration on global environmental change, bringing together in partnership with existing programmes sponsored by several organization, including Interna-tional Council for Science (ICSU), etc. This programme regards that most urgent task toward the global environmental change is to reduce the consumption of fossil fuel through the energy saving and/or renewable energy development. This pro-gramme emphasizes the collaboration across disciplinary in background, not only within academic disciplines (including natural scinces, social science, engineering science, and cultural science; “interdisciplinary”), but also beyond academic disci-pline (including many stakeholders, such as research community, business, science founders, policy community, and wider society; “transdisciplinary”). This interdisci-plinary initiative is jointly established and scientifically sponsored by an alliance that includes ICSU and the Belmont Forum, and so on.
As described so far, in the field of life science, the basic research in Japan has strong competitiveness, which tends to decrease as research outcomes get closer to commercialization. Thus, policies, including systems for strengthening the ability to apply outcomes of basic research to commercial uses must be established. Especially, it is important to revise laws and regulations to encourage commercialization in many technological development fields like the revisions of the Pharmaceutical Af-fairs Law. Also, there are delays in the integration and application of necessary medical data for conducting next-generation research and development. Therefore, the development of strategic and comprehensive research environment for promot-ing venture companies to use research outcomes is also an urgent task.
This report mainly illustrates an outlook of research and development in life sci-ence and clinical medicine (Chapter 2) and trends in specific research disciplines (Chapter 3). In parallel to this report, several workshops (attended by 133 experts in total) were organized to identify potential seeds for future strategies out of the re-port. The summary-report of the workshops will be available in the end of March 2015 throughthe JST-CRDS website (http://www.jst.go.jp/crds/report/index.html)