Abstract

Anne Jeanne Barzyk and François-Xavier Lacasse*

ABSTRACT

Successful drug development requires an integrated approach. Over the past few decades, there have been considerable changes to the ways drug development has been conducted. To increase efficiency and to comply with the requirements of regulatory agencies,[1] many companies have chosen to apply the Six Sigma method,[2] implement new project management strategies,[3] to avoid pitfalls and be more efficient, and follow the Quality by Design approach.[4] However, the reality shows that it has been mainly large companies that have applied these improvement methods, which are costly in terms of both expenses and human resources and which pose enormous challenges for biotechnology and start-up firms. It should also be kept in mind that the Six Sigma and project management areas of expertise were not originally intended for drug development. Finally, many achievements have highlighted the scientific skills of those involved in drug development and project management. However, few articles or testimonials have mentioned (1) the challenge of implementing project and operational management in drug development; (2) the dependence of scientific and pharmaceutical discoveries on regulatory requirements, which have changed and become more stringent over time; or in particular, (3) the importance of the human element — of bridging gaps between people from very different fields (such as science, management, and government) in order to streamline the path to an effective drug launch as much as possible.