Research on pharmaceutical research and development in the bioinformatics era

本研究旨在探讨生物信息学对药物研发过程和管理的影响。研究方法包括文献调查和对在日本和国外工作的研究人员、管理人员和专家的半结构化访谈。本研究还包括对英国、法国、瑞典和日本生物信息学的历史和现状的调查，重点是它与制药研发的关系。此外，研究者还研究了日本制药公司研发流程、组织和战略的变化。本研究认为，生物信息学将药物研发过程转变为与分子生物学方法相结合的过程。这促进了医药研发的技术合理性，但并不一定促进了经济合理性。部分原因是生物信息学没有涵盖制药研发的整个过程，部分原因是……更多的人类创造力和组织能力是评估数据所必需的，部分原因是生物信息学使用的成本、市场特征和竞争情况。所有这些因素都缓和了生物信息学对药物研发的经济影响。然而，可以肯定的是，生物信息学通过增加分子生物学机制（包括机制的社会塑造）方面，并通过促进不同类型组织（如大学、制药公司、初创企业等）之间的分工，显著改变了药物的研发过程。本研究亦探讨了学术界与企业界之间的“桥梁问题”，这与制药研发领域的分工有关。本研究结果以两篇英文期刊论文、四篇日文期刊论文、一篇国际学术会议报告、一篇国家学术会议报告（将于2006年9月举行）和一篇书评的形式发表。少

This study aims to investigate the influence of bioinformatics on the process and management of pharmaceutical research and development. The methodologies are document investigation and semi-structured interviews with researchers, managers and specialists working abroad and in Japan. The study also includes investigation about the history and the current situation of bioinformatics in the UK, France, Sweden and Japan, focusing on its relationship to the pharmaceutical R&D. In addition, the investigator researches the change of R&D process, organization and strategy in Japanese pharmaceutical companies.This study concludes that bioinformatics has changed the process of pharmaceutical R&D into the one accompanied with the molecular biological approach. This promotes the technological rationality of pharmaceutical R&D, but it does not necessarily promote the economic rationality. This is partly because bioinformatics does not cover the entire process of pharmaceutical R&D, partly because … More human creativity and organizational capabilities are necessary to evaluate the data, and partly because of the cost of bioinformatics use, the characteristics of market, and the situation of competition. All of these factors moderate the economic impact of bioinformatics on the pharmaceutical R&D. However, it is certain that bioinformatics significantly changes the R&D process of pharmaceuticals by adding to the aspect of the molecular biological mechanism (including the social shaping of the mechanism), and by facilitating the division of labor among different types of organization, such as universities, pharmaceutical companies, start-ups, and so on. This study also examines the "bridging problem" between the academic world and the business world, related to the division of labor in the area of pharmaceutical R&D.The results of this study are published as two English journal papers, four Japanese journal papers, one presentation at an international academic conference, one presentation at a national academic conference (to be held in September 2006) and a book review. Less