(Panoramic View Reports)
Panoramic View of the Life Science and Clinical Research Field (2013)/CRDS-FY2012-FR-04
Executive Summary

Life science is a field of research and development that can benefit the estab-lishment of a wide range of social foundations, including medicine, environment, and energy. Strategic promotion of this field has influences over national health policies and strategies such as energy strategies. Thus, identifying the overall pic-ture of life science, including trends of policies in other countries, is an important step for establishing research and development strategies in this field. This Execu-tive Summary describes the outcomes 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 disciplines.
JST-CRDS defines “life science” as “science and technology that can benefit for the understanding of life phenomena of living organisms (including humans) and healthy sustenance of humans and the earth (the environment).” JST-CRDS also categorized life science into two fields: <Life Science and Technology Field> and <Green Technology Field>. <Life Science and Technology Field> is a field necessary for benefiting society through medicine and further divided into 25 disciplines: basic research (7 disciplines in Biology segment for understanding humans), applied research (6 disciplines in Disease segment and 5 disciplines in Medical and Welfare segment), and research concerning ethics (7 disciplines in Social Aspect and Ethics segment). <Green Technology Field> is defined as a field concerning productive efficiency of bioproducts (food, biomass, biomaterial and energy) and environmental conservation and further divided into 11 disciplines: 3 disciplines in Food & Biomass segment, 4 disciplines in Material & Energy segment, and 4 disciplines in Environmental Conservation segment. The diagram below shows the overview of these wide-perspective view of the disciplines.

Life science has been quickly advancing with the rapid improvement of molecular biology and making progress with the advancement of measurement and analytical technologies. Large amounts of data have been produced in recent years thanks to the widespread use of next-generation sequencers, improved performance of mass spectrometers, and advancement of imaging technologies. Such improvements have resulted in the shift from the conventional hypothesis based experimental approach to the data-driven approach in which rules and patterns are found from a large amount of data, which led to the establishment of the current trend. The scale of data-driven approach is usually too large for a single laboratory to handle, and this approach requires the involvement of many people and groups with varieties of specialties. Therefore, this approach is also called “big science.” On the other hand, research that is small enough to be completed in one laboratory is called “small science.” While the current trend is shifting toward big science, important findings are still often produced in the settings of small science; therefore, it is important to promote both types of science in good balance. Other trend is the shift from research focused on individual elements, such as genes and proteins, to research to understand advanced life phenomena, such as tissues, individuals, and behavior, by systematically understanding the basic elements.
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 described below.

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 embryological 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 research and development is still weak, which is also the case in the embryological and regenerative research fields. This tendency becomes more prominent as research outcomes come closer to actual applications in society. This issue has been criticized for a while but still remains without improvement.

<The United States>
The United States stands at the top of the world in both basic research and ap-plied research in almost all research and development fields. Cutting-edge research is conducted with overwhelming financial power and many talented researchers. Specifically, 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. Only companies in the United States have manufactured next-generation sequencers to be sold in the market, 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.
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 ge-nome projects. Epidemiology is advanced in Europe, with especially highly devel-oped 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 de-velopment is better than Japan, of course, and the United States.

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 published research studies is greater than Japan in some of the research and development fields. The number of next-generation sequencers in use is increasing, and BGI has the largest number of next-generation sequencers in the world. While the level of the current genome science is still low, the people who gained experi-ence 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 and the United States back to China, which has been resulting in quali-tative 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 Europe, the United States, and Japan. The main focus of new pharmaceutical de-velopments is “me-too drugs” and biosimilars, while unique and new pharma-ceutical development is rarely conducted. Nonetheless, equipment for conducting clinical tests is abundant, and clinical studies are actively conducted by interna-tional pharmaceutical companies. The large number of approved regenerative medical products is also one of the characteristics in Korea.

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. Espe-cially, it is important to revise laws and regulations to encourage commercialization in many technological development fields like the revisions of the Pharmaceutical Affairs Law for the field of regenerative medicine ahead of other fields. 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 promoting venture com-panies to use research outcomes is also an urgent task.