Abstract

The ever increasing cost of discovery and development of new pharmaceutical agents mandates that risk be managed more aggressively. Decisions that are based on data, well-understood experience, and the value of the project itself must be made sooner in the overall process. Uncontrolled risk must be addressed and managed. The reward system within pharma must treat negative decisions as productive and important. Clearly, risk must be addressed concertedly at the technical, strategic, and organizational levels. This is not an option. When we do our job well in discovery and early development, a compounds chances in the clinic, the regulatory area, and the market will all be better.

Keywords: pharmacokinetic, biomarkers, target candidate profile (tcp), non-competitive technologies, biological targets