ABSTRACT
Investment in pharmaceutical research and development has more than
doubled in the past decade; however, the increase in spending for biomed-
ical research does not reflect an increased success rate of pharmaceutical
development. (Figure 1.1). Reasons for this include the following: (1) a di-
minished margin for improvement escalates the level of difficulty in proving
drug benefits; (2) genomics and other new sciences have not yet reached
their full potential; (3) mergers and other business arrangements have de-
creased candidates; (4) easy targets are the focus as chronic diseases are
more difficult to study; (5) failure rates have not improved; and (6) rapidly
escalating costs and complexity decrease willingness/ability to bring many
candidates forward into the clinic (Woodcock, 2004).
