Clinical development projects in the biotechnology industry
by John M. Guley
International Journal of Healthcare Technology and Management (IJHTM), Vol. 2, No. 5/6, 2000

Abstract: A major portion of both the time and cost of new drug and biological product development is the series of human clinical studies required to determine the safety and effectiveness of the drug before it can be marketed. This paper analyses data from 68 new drug and biological product development projects sponsored by US-based biotechnology companies over a period of 19 years, from 1979 to 1998. The type of collaboration in place for each project and the size of the sponsoring company were assessed for potential effects on the projects' clinical development times. While there was no statistical difference among the type of collaboration, the data shows evidence of a trend toward shorter clinical development times for drug development projects without a collaborative partner. Findings also indicated a significantly shorter clinical development time for projects sponsored by medium size versus small or large biotechnology companies. The results offer insight into the process of new drug development, along with pertinent information regarding resources that may help lead to success in the effort to reduce time involved in human clinical studies.

Online publication date: Mon, 30-Jun-2003

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