Optimizing Knowledge Creation at Bristol-Myers Squibb—a Case Study within Pharmaceutical Development

The drug development process is a long complex multidisciplinary endeavor. Much of the activity to support the registration and manufacture of a new medicine is developed in the area known as chemistry, manufacturing, and controls (CMC) in reference to the common designation in regulatory filings. The Bristol-Myers Squibb (BMS) Pharmaceutical Development (PD) division of Research and Development sought to bring transparency and efficiency to the process of CMC drug development by creating a “roadmap” to assist in communications and planning. The resulting knowledge roadmap was built from a distillation of the activities normally encountered in CMC drug development to show how knowledge is generated to support decisions and deliverables. The techniques of selecting and representing knowledge assets are discussed as well as the logistics and change management to deliver the tool to PD and enable its adoption by various stakeholders. This approach has resulted in a knowledge management strategy for PD.