Introduction
The research and development (R&D) process that ultimately leads to effective drugs is exceedingly difficult, and often the public does not understand the drug discovery pipeline. In a typical model, drug companies will research tens of thousands to millions of compounds and spend in excess of a billion dollars over a 10- to 20-year period just to have one drug reach the market.
The National Institutes of Health has aptly called the process of translating basic research into a viable product the “Valley of Death.” All too many promising drug candidates fall into this valley as the necessary testing for the Food and Drug Administration (FDA) and the complexity of human biology culminate in one failure after another. In 1996, the FDA approved more than 50 drugs; in 2009, that number plummeted to 26.
The reality today is that big pharmaceutical companies continue to rely on older breakthrough drugs for profits, and they are all too often failing in the development of effective new drugs. Moreover, drug companies are cutting back on long-term R&D in an attempt to improve immediate profits and returns for investors.
