Evaluation of research and development activites in universities, national laboratories and other governmental organizations has been implemented since the "General Guidelines for Evaluation of National Research and Development Activities"was established in August 1997. The current evaluation criteria include the number of published papers, frequency of citations and number of patents granted, which are not adequate for subject areas where the number of papers does not count, and therefore do not allow comparison between different subject areas. Another problem is that, whereas evaluation of a program before starting the research is a clear-cutone with a go/no-go result, the result of interim evaluation or evaluation of final results is not clearly reflected in the policy. In other words, the current evaluation system dose not provide a feedback mechanism to achieve more effective and efficient distribution for research resources. A system in which evaluation results are reflected in research planning, with a flexibility allowing for reevaluation, is urgently required.

抄録全体を表示

Introduction of the practice based on the International Conference on Harmonization-Good Clinical Practice(ICH-GCP)has provided an international satandard for drug development, and enabled applications for approval of new drugs to the Japanese Government on the basis of clinical trial results obtained in other countries. Actually, however, clinical trials based on ICH-GCP are almost infeasible in Japan, since the ICH guidelines, particularly the GCP, are rooted in Western healthcare systems and customs. Their incongruity with the Japanese practices has already produced confusion. The present paper discusses the problems for each of the four participants in clinical trials : administration, pharmaceutical industry, doctors and medical institutions, and patients. The author elucidates the origins of the problems and proposes possible steps to solve them. These problems belong to obstacles for Japan's "internationalization"along with many others in finance, administration, research and education.

抄録全体を表示

Life sciences including drug development will certainly be the leading industry in the 21st century, following information technology. A peculiarity of this area is requirements of ethical nature as exemplified by the problems of genetic engineering. Japan has not been successful in developing science and technology policy in the field of health care. Health care should be incorporated in a system of science and technology policy, covering all aspects in basic and clinical research along with popularization, as well as those in promotion, evaluation and regulation. This paper reviews American and European policies on life science research and health care as a first step to identify the goal and problems of the Japanese policy to be established in future.

抄録全体を表示

Development of truly epoch-making new drugs is always related to innovative discoveries or theories of highest level. Fruit of development efforts by corporate scientists, such drugs are rooted in academic research in national laboratories or universities. In resent years, however, success in basic research often leads to establishment of a small venture enterprise, which acquire a wide range of patents for its potential products. This trend, particularly prominent in the U.S., makes a published paper rather a belated starting point of a drug development program. The lead-time until commercialization of a drug, estimated to be about 13 years, is correspondingly being shortened to about five years in near future. These circumstances urge pharmaceutical companies to perform some basic research by themselves. Takeda is trying to base its target of drug development efforts on studies of orphan receptors and their ligands. Innovative pharmaceuticals should result from discovery of new orphan receptors/ligands and enzymes in genomic study. This approach will necessitate further advances in technology as well as reflections on the methodology.

抄録全体を表示

General aspects of drug development are reviewed and problems in modern drug development management are discussed in relation to global networking. Recent changes experienced in drug development have two major factors : innovative technologies derived from basic research, such as genomics, and expansion of global networking in development including clinical trials. The latter is motivated by the need to handle a large amount of data obtained in the process of development utilizing informatics. Another important aspect of modern drug development is strategy that allows timely decision making. Increased investment on drug discovery and globalized clinical studies has resulted in higher risk. The author reviews present circumstances of management in the pharmaceutical companies which have global development systems.

抄録全体を表示

Creative research and development and the resulting original business ares are necessitated in today's Japan, as never before, for economic growth, employment creation and contribution to the rest of the world. The government has recognized"risk"for the first time as a leading concept in official publications : Chapter 3 of the newest edition of the White Paper on Economy is entitled"For Creation of Ordered Risk". Innovation is the driving force of economic growth but never free from risk. Although legislative measures for promotion of venture capitals have been taken and the budget for science and technology have been increased, Japan suffers from shortage of persons with talent to lead the risky innovative developments, while the traditional education has produced a huge population for administration and control : there is a gap between supply and demand of talented people. The present work contains a survey of data and opinion related to this problem. The gap is reflected in technological trade balance(particularly the low level of patent applications to other countries), industry's view on capabilities of new employees and the present status of graduate students. The problem seems to lie in poor understanding of the competitive situation for the industry by the educational circle, as well as in the time lag between industrial innovation and academic reform. Mutual understanding of the industry and academia in a common platform is needed to fill the gap. The author states that creative people is the most important asset for Japan to obtain a status of an advanced country.

抄録全体を表示

本論文は, 日本の電気機器と医薬品産業における14の大企業について, 研究開発(R&D)のグローバル化を, 計量書誌学的手法とアンケート調査の両側面から分析したものである。その結果, 両産業ともに1990年代に入り, R&Dのグローバル化が増加傾向にあること, R&Dのグローバル化が自社の海外子会社のみでの活動と海外の大学や公的研究機関との共同研究によって, 行われていることが分かった。産業別においては, 電気機器産業の方が医薬品産業よりも早くグローバル化をしていることも判明した。次に, 統計的手法を用いた結果, 同産業の企業間でもグローバル化の程度やパターンに相違が存在していることが分かった。R&Dのグローバル化の動機としては, 両産業ともに技術的要因を重要としているが, 産業別では, 電気機器産業は技術的要因をより重要とし, 医薬品産業は技術的・需要的両要因を重要としていることが分かった。

抄録全体を表示

TVゲームは90年代における日本の代表的イノベーションであり, ハードウェアに加えソフトを大量に輸出するなど, コンテンツ開発においても国際的に健闘している。なぜ, 日本のゲームソフト企業が競争力を持つことになったのであろうか。本研究は予備的な聞き取り調査をもとに, 300社にのぼる企業を対象にデータベースを作成し, 同産業の競争力分析を行なった。そこで浮かび上がったのはゲームソフト開発を促進する既存企業の多角化とベンチャー企業の参入による「東京ゲームソフトクラスター」の存在である。まず, ゲームソフト企業を生み出す既存産業の立地に依存してクラスターの形成は始まり, ビジネスソフト開発からの参入, また, 各種コンテンツビジネスからの参入によって異なった空間的クラスターが形成されている。一方, 開発者が起業しゲームソフト市場に参入しようとする場合, ベンチャー企業はその発展段階にあわせて適当なクラスターを選択している。デジタルコンテンツ産業におけるクラスターの誕生はソフト化/知識化を目指す日本の産業社会に対して多くの含意を与えることになる。

抄録全体を表示