Biostatistics: the hidden path to life science innovation

This exploratory paper investigates the infrastructure for life-science-based new product development. The practice of biostatistics has long been seen as a crucial element of the regulatory process for approving the release of new drugs and medical devices, but the authors hypothesize that it serves a larger role in the new product development process in pharmaceutical and biotechnology firms. To this end, they focus on the management of Biostatistics and related know how such as data mining in the discovery, testing, and commercialization of new products. Their results are drawn from a number of in-depth case studies of biostatistical practices in a variety of firms engaged in life-science product development. The findings point to the importance of biostatistics in providing both technical and strategic information. To the extent that Biostatistics is managed as a learning system, it is critical for building core capability and enabling resource configurations that create value