Personalized medicine comes into its own

Last November I hosted a webinar on the personalized medicine trend. It drove home one more time how an explosion of new genetics research is highlighting the mechanisms that dictate an individual's response to a therapy.

New FDA recommendations suggesting testing to guide physicians on the use of warfarin have helped highlight what will be a growing issue for developers of every size. As our understanding of genetics grows, we will increasingly be able to pinpoint subpopulations that will either be more likely to benefit more from a therapy or suffer severe side effects. This knowledge will make it possible to mount smaller trials able to produce better data on biotech drugs. And it will make it far easier to persuade payers of their potential value.

This years we'll see new technology make it much less expensive to do genomic sequencing, opening up a whole new playbook on development. As I've already noted, the FDA has made it clear that they want this data gathered during clinical trials. And new studies will have to take that into account long before recruitment begins.

Physicians have always used a hit or miss approach to medicine. And that will not end. But increasingly doctors will be able to play much better odds when they address a problem. We won't see the completion of this revolution in 2009--far from it--but we are likely to take several long strides in the right direction. And everyone in the industry needs to understand the consequences.

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