ABSTRACT

In the past several decades, it has been recognized that increasing spending of biomedical research does not re¨ect an increase in the success rate of pharmaceutical/clinical research and development. Woodcock (2005) indicated that the low success rate of pharmaceutical/clinical development could be because (1) there is a diminished margin for improvement that escalates the level of difŒculty in proving drug beneŒts, (2) genomics and other new sciences have not yet reached their full potential, (3) mergers and other business arrangements have decreased candidates, (4) easy targets are the focus as chronic diseases are harder to study, (5) failure rates have not improved, and (6) rapidly escalating costs and complexity decreases willingness/ability to bring many candidates forward into the clinic.