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May 2002
Vol. 5, No. 5, pp 7.
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Blockbuster efficiency
As those acquainted with the business side of the drug development industry well know, several drugs that account for much of the revenue and profit of the pharmaceutical business will come off patent protection in the next few years. Many drugs, some familiar to us because of consumer advertising, some not, should soon be offered in generic forms. A University of Maryland study of patent expirations indicates that more than 250 drugs will become available for generic manufacture by 2004, including 13 cardiovascular drugs, 6 central nervous system treatments, and 5 cancer therapies. Well-known drugs such as Prilosec will be available either as a generic prescription or, in the case of Claritin and its antihistamine cohorts Zyrtec and Allegra, as over-the-counter drugs similar to Benadryl. Schering-Plough has requested that Claritin be sold without prescription as one means of extending its marketing exclusivity, since generic makers of such a drug would be loath to enter a market in which they could not count on doctors to prescribe the drug.

Consideration of simple supply and demand leads to the inevitable conclusion that the drug prices paid by patients and their health insurance providers will undoubtedly be less than now. That of course means less revenue for pharmaceutical companies. While we have to believe that generic competition and lower pharmaceutical prices are in general beneficial, there is a downside. Less money will be available from earnings for further drug development. Given that it takes $500 million or more to bring a drug to market, there is the possibility that less money will be manifested as fewer drugs—and this at a time when we are just beginning to reap the benefits of identifying a host of new drug targets based on genomics and proteomics. What is needed is the ability to identify and develop drugs more efficiently. That, in a nutshell, is the promise of high-throughput screening.

We have a long history in science of improving health with the assistance of technology. The human condition has improved to the point that life expectancy is approaching eight decades, due to technologies ranging from stethoscopes to heart stents. Drug discovery is no different. A recent Frost and Sullivan market report indicates that 1 million drug candidates were screened each week as leads in 2001, a number that the report predicts will increase to 7 million per week by 2004. There is only one way to perform that number of tests, namely by automation.

In this issue, we look at some of these newer drug discovery technologies. In his feature “The matching game”, Randall C. Willis discusses the applications of the protein array biochip, an up-and-coming tool of high-throughput screening. The next generation of chips offers a tremendous amount of promise to the endeavor of drug and target discovery, not to mention their potential utility for diagnosis and prognosis. In the related Tool Box article, “A binding proposition”, Willis offers a primer on a key obstacle to the explosion of protein arrays on the market, namely the challenge of effectively sticking the protein on the chip, and the major solutions being put forward to overcome it.

Technology isn’t the only means to an effective drug development program. Organization, opportunity, and even just plain luck have been shown to be contributors to the pharmaceutical enterprise. But it is clear that technology, especially high-throughput screening automation, will grow in importance.

—James Ryan

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