High-tech products as complexes of advanced technologies require design rules based on modular systems, interfacing and standardization to manage the complicated relationships between the elemental technologies involved. This gave rise to the flourishing "de facto standard strategy", which have had much influence on the public standardization policy, particularly in accelerating the standard making process and handling relationships of standards with intellectual property. Meanwhile, public standard bodies are addressing several new agendas: development of"soft" standards concerning environmental management, security management, corporate social responsibility and various services; promotion of voluntary standards and internationally harmonized conformity assessment procedures as surrogates or complements of mandatory regulations; and heightened interest in national standardization policies, in both advanced and developing countries, for enhancing competitiveness and public policies. ISO is engaged. in several activities for better understanding of standardization among relevant circles.

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Standardization activities are strategically important in telecommunications, information, electronics and electrics industries. In these industries, layered business structure or modularization is becoming more popular and the necessary to precisely standardize the module interface is increasing. It often happens that marketable products need patents that are owned by many different companies since a large number of companies in the industries perform R&D in similar areas. Standardization activities are a mechanism to share patents among these patent holders. In addition, the economy of scale is a general nature in the industries. Companies in the industries must perform standardization activities strategically. However, it is not enough to simply participate in such activities. Companies should move proactively to have their patented and non-patented technologies incorporated in standards. They must participate in activities aggressively by submitting technical proposals, inviting and chairing meetings, and so on.

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Japan's industrial standardization policy originates from the governmental procurement standards established in the late Meiji period (about 1910). Since then, the major purpose of the standardization policy has undergone many transitions from export inspection to military procurement to export quality improvement. The GATT Standard Code (1980) and WTO/TBT Agreement (1995) have shown importance of the international leadership in standardization; the most important goal of the current standardization policy is establishing international standards based on Japanese technology. Many problems remain to be solved, however, to achieve the goal, as shown by the "General Strategy for International Standardization" established by the Intellectual Property Strategy Headquarters on December 6, 2006, which proposes intensified activities of the industrial sector, development of human re-sources, closer cooperation with other countries particularly in Asia, and development of fair practice rules in the area of international standardization. Specific policies along these lines are now under development. This article gives a historical review of Japan's standardization policy as the background of the present status, and discusses the purpose, methodology and current situations of the new standards and conformity assessment policy.

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Human resource development for international standardization activities has become a hot topic partly because of globalization and partly because of enterprise restructuring. Kurokawa[2] had summarized the status of 2005, and this paper updates the status as of 2006. We summarize the international meeting on "The Future of Global Education in Standards" held at Tokyo in February, 2006, which gave birth to International Committee for education about standardization (ICES). ICES 2007 was held at Delft in Netherlands in February 2007. ICES 2008 will be held at NIST, USA. Korean activities led by Korean Standards Association (KSA) have inspired the world in this area, and Japan Standards Association (JSA) and Hitotsubashi University have spawned new projects. Some of the issues and stumbling blocks on this area in Japan are also discussed : visualization, synchronization with world-wide activities, overcome of barriers with bureaucracy and academy, and promotion of young people.

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If a licensor refuses licensing of an essential patent to a standard, no one can use the standard. This is a case of "tragedy of anti-commons". In order to enhance accessibility to a standard, collective licensing of essential patents to the standard in a reasonable and non-discriminatory condition, that is patent pool licensing, can be used. A typical example of patent pool licensing is that of MPEG-2 by MPEG-LA in which a package of the essential patents to MPEG-2 standard is licensed. The other example is 3G patent platform licensing in which concluding a cross-licensing agreement on a portion of the patent portfolio is allowed for licensees if necessary. There are two important issues on patent pools. The first one is how to discourage the holders of essential patents to be outsiders and the second one is how to prevent from going out of anti-trust regulation. As for anti-trust issues, Japan Fair Trade Commission announced an anti-trust guideline on standard-related patent pooling in 2005. A scheme to raise less conflict with anti-trust regulation is using patent clearinghouse or licensing database. It is hoped that enhancing accessibility to the essential patents to standards be attained by selecting and using proper schemes of collective patent management.

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One of the true unseen powers of standardization is that it supports and controls our lives while we are not aware. The standard decides how different components are related and thereby supports relevant system. The unstable condition continues until a decision is made, but once the standard is formulated and widely disseminated in the market, it has the function of providing "rationality" in interactions between technologies in the society of technologies like the law and norm in the human society. Especially, the technical standard, once it is formulated and disseminated, plays the role of fostering the stabilized perception of relevant technology. In some sense, it is the objectification of subjective elements-economic/political purposes-in a neutral technical form. In other words, standardization does not merely assist in solving technical or business problems but serves as a means of providing objectivity and legitimacy in the technical discourse.

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Based on our US-Japan comparative research on development of a blockbuster drug, namely, Statin, we investigate what kind of innovation system would facilitate the type of innovation shouldering high social risks. In this paper, we elucidate the hypothesis that commercialization of a newly developed dug can be explained by the pattern and function of researcher-networks among university, industry and public R&D institutes built in response to the emergence of new scientific discovery. Comparing the type of researcher-networks in US and Japan, the paper sheds light on roles of the networks for information sharing and consensus making, enabling us to conclude how the networks contribute to the success of high-risk innovations.

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Biotech companies play important roles for drug discovery in the US pharmaceutical industry. The purpose of this study is to investigate which strategies of growth are effective for biotech startups. Core technologies, products and pipelines of 72 biotechs in the US were examined and the source of great success for smart biotechs was clarified. The technologies and diseases of interest of biotechs were quite different from those of big pharmas : biotechs are focusing their efforts on cancer or rare diseases to provide orphan drugs or fast track products by novel technologies such as biopharmaceuticals. The strategy for smart biotechs is symbiotic innovation, which means achievement of innovation in drug discovery with the collaboration of big pharmas at the clinical development stage. Furthermore, the multiple correlation analysis indicates the outstanding capacity for research and development is an essential trigger for smart biotechs.

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This paper is an exploration of a new type of institutional research alliance between university and industry in Japan. Numbers of university industry alliances are on the rise and industry fund to university research is increasing. We can observe that the institutional alliances between university and industry are started. In the Institutional alliances, both university and company set up management system and conduct R&D, education, personnel exchange, and so on. This paper focuses on R&D in the institutional research alliances and studies the alliance in terms of the purpose and effect of the alliance, management system and process from selection of research theme to evaluation research results.

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