October 2003

Revitalizing Drug Discovery

Continued from page 1

By Stephen S. Hall

The stakes in this game are higher than ever. The pipelines of future products at many pharmaceutical companies emit no more than a trickle of largely prosaic, me-too drugs-copycat cholesterol reducers and mood elevators-just as the patents on pharmaceutical blockbusters such as Zocor and Paxil are about to expire. And despite the industry's steady increase in R&D expenditure, which now totals more than $25 billion annually in the United States alone, U.S. Food and Drug Administration statistics show a steady decline in the approval of "new molecular entities"-drugs whose active ingredients have never before been approved in the United States-since 1996 (see graph, above). In part, the decline indicates that much of the low-hanging fruit has been plucked; but it also points to the fact that it takes a number of years for new technologies to be incorporated into the drug discovery process.

To refill the pipeline, and to squeeze that one additional success out of every ten human trials, pharmaceutical companies have been doing all they can to reap the benefits of the latest advances in molecular biology, changing everything from corporate culture (right down to the hallways running between their labs) to the nature of their collaborations with university researchers. They are seeking to combine the basic fascination of academic biological research with the passion and entrepreneurial zest of biotechnology companies, all coupled to the economic brawn of major corporations. This transition has been under way at many pharmaceutical companies for several years, but firms are now moving rapidly to search out mergers, forge collaborations with academic groups, strike deals with biotechnology companies, and establish outposts near hotbeds of university research. In short, drug companies are positioning themselves-geographically, technologically, and even sociologically-to take full advantage of the gush of information that is revolutionizing biology and medicine.