ABSTRACT

The second step of the GRIDALL process is to identify and manage risks to project goals. Drug development is inherently risky business, and some risks are manageable, whereas others are not. For manageable risks, project managers should use a consistent and methodical process to identify assess, respond to, and monitor risks. This chapter describes some of the typical risks of developing drugs, including unmanageable risks that are used to adjust program valuations. It then walks through a four-step risk management process. Finally, it describes some best practices for keeping the risk management process finely tuned and useful.