ABSTRACT
This chapter aims to development project managers with the history, concepts, use cases, and best practices of applying Agile to the drug development process so that we can leverage this methodology as one of the tools in our toolkit. While waterfall and Agile appear at opposite ends of the spectrum in terms of flexibility and adaptability, there may be a blend of these two approaches into a hybrid methodology that works well for drug development. Though many aspects of drug development are regulated and amenable to Agile practice, there are some areas where Agile can be applied effectively. However, the success of Agile in many industries has led many biopharma companies to evaluate the use of Agile in drug development. In an HBR article published in 2019, the authors describe their experience with implementing Agile practices in a variety of science-driven businesses, from drug development to chemical manufacturing.
