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May 1, 2009 (Vol. 29, No. 9)

Recent Decisions Curtail Personalized Medicine

Impact of Past and Future Decisions on Industry Development Could Be Onerous

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    Brenda Herschbach Jarrell, Ph.D., J.D.

    Personalized medicine is the latest buzzword promising to revolutionize the pharmaceutical industry. Old-fashioned drug development has been based on the law of averages—relying on large clinical trials to identify drugs that prove safe and effective in a majority of patients. Personalized medicine offers the promise of identifying specific individuals, based on their genetic information, who are likely to respond well (or poorly) to a particular therapy.

    The promise of personalized medicine is that it will facilitate development of more effective targeted therapies, will invite new (and smaller) players into the pharmaceutical arena, and will offer new commercial opportunities for established pharmaceutical players. For example, the expansion of personalized medicine has generated substantial commercial opportunities for diagnostics companies and for information management (e.g., bioinformatics) companies in the pharmaceutical arena.

    Moreover, personalized medicine raises the possibility of smaller, less expensive, and more predictable clinical trials. Simultaneous reductions in risk and expense allow more and smaller companies that otherwise do not have the resources to afford a traditional clinical trial into the pharmaceutical development industry. Additionally, efficacy rates in the targeted populations are likely to be materially higher than they would be in the general population, which will encourage doctors and patients alike to embrace therapies based on personalized medicine products. 

    Personalized medicine strategies also provide systems for companies with marketed therapeutics to improve efficacy and/or reduce side effects over time, based on, for example, pharmacogenomics studies on patients receiving therapy. Personalized medicine, therefore, simultaneously creates possibilities for improved therapies and new business opportunities.  Seems like a good idea, right?

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    Fangli Chen, Ph.D., J.D.

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