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Fundamental Problems Lie Ahead in the Drug Discovery and Commercialization Process
  1. George J. Brewer
  1. From the Department of Human Genetics and Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI
  1. Address correspondence to: Dr. George J. Brewer, Department of Human Genetics, University of Michigan, 5024 Kresge Bldg II, Ann Arbor, MI 48109-0534; tel: 734-764-5499; fax: 734-615-2048; e-mail: brewergj{at}umich.edu

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The upcoming years should be a golden age for drug discovery because the Human Genome Project, with the complete sequencing of the human genome, should reveal literally thousands of potential new drug targets. This new information, together with the increased understanding of transcription control, signaling pathways, protein structure and function, computer modeling of molecular interactions, and rational drug design (virtual screening), should bode well for a large series of drug discoveries based on molecular information.

If the above scenario is potentially valid, it is in everyone's interest to facilitate the process to make it happen because nothing less than the improved health of tens of millions of people in the United States, and hundreds of millions of people worldwide is at stake. However, it is now becoming apparent that the pharmaceutical industry, as presently structured, will not be able to translate these new opportunities into an adequate number of marketed drugs to sustain much of the industry financially. In fact, the current downtrend will continue if the industry continues on its present course, and it will be in serious trouble within the next 5 years. If the golden age is to happen, first, the pharmaceutical industry has to be restructured to make profits from smaller patient population markets, and, second, a partnership needs to be developed between industry and academia for drug discovery to make the whole process much less expensive and faster. For its part, academia is currently ill-prepared to play a significantly more important role in drug discovery. Thus, by analogy, we are looking at a two-wheeled cart to carry the burden of drug discovery into the next few decades, with the tire on the drug industry wheel already leaking badly and the tire on the academia wheel almost flat.

In this article, I review the current approaches …

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