No abstract

Most existing researches treated pharmaceutical product development process as a sort of "black box." This paper, however, will focus on the product development process to explore the organizational capabilities and effective development patterns. Interviews and statistical analyses with leading companies in Japanese pharmaceutical industry indicated that "go or no-go decision" is the significant organizational capability, in fact differing among companies, which effects performances in pharmaceutical product development process. This organizational capability is accumulated through experiences in pharmaceutical product development projects.

From the mid-1990s to the mid-2000s, major institutional reform was undertaken in Japan to promote university-industry collaboration. The term "university-industry collaboration" appeared frequently in the media and became a fad. However, this did not last long, and it peaked in 2003. University-industry collaboration entered the spotlight again after 2010, when "open innovation" (Chesbrough, 2003) became popular in Japan. At that time, a new type of university-industry collaboration emerged. University-industry collaboration in Japan has traditionally taken the form of "small-scale, short-term, individual" contracts. In contrast, this new type of collaboration features "large-scale, long-term, comprehensive" contracts.

Empirical researches of new product developments began in earnest in the 1960s with the "grand approach." These researches clarified general success factors through the comprehensive analysis of successful project profiles. In the 1970s, the "focus approach" came to fore where analysis focused on specific themes in product development. The latter half of the 1980s saw the focus shift to the "process approach" where the relationship between management of product development process and performance was analyzed in detail.These trends suggest that one characteristic of product development research is a mainstream shift toward the advent of new research approaches in approximate ten-year cycles.