ABSTRACT
The pharmaceutical industry faces signi cant and perhaps unprecedented pressures. Many experts now question whether current business models will be sustainable [1-4]. Blockbuster drugs, de ned as drugs with over $1 billion in annual sales, have historically provided the bulk of earnings within the pharmaceutical industry. These earnings support the discovery and development of new therapies. The pending demise of the so-called blockbuster drug (Table 2.1) has resulted in dramatic changes in the industry. All facets of the drug development continuum that range from drug discovery to development to manufacturing to sales and marketing have been impacted. Additionally, acceptable risk/bene t ratios are approaching zero, and thus, the regulatory hurdles for new drugs have never been higher [2-5]. The end result has been a decrease in industry productivity while costs (i.e., R&D expenditures) increase (Figure 2.1). Furthermore, the R&D cost for a new drug now exceeds $1.3 billion in 2005 [6,7].
