Life After FDA - Pharmaceutical Executive

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Life After FDA
From his new post, former FDA commissioner Mark McClellan talks about the current safety equation


Pharmaceutical Executive


Part of that gets to the heart of an initiative you started at FDA—Critical Path. Where do Critical Path and the issue of safety intersect?

When we started the Critical Path Initiative, it was about trying to bring some of the new sciences, like genomics, information technology, and imaging technology, to the forefront to find better ways to predict which drugs are going to work in which patients. And the new legislation includes strong bipartisan support and some funding and new opportunities for public and private collaboration to develop this science.

There are some Critical Path Projects that are now up and running. There's a biomarker initiative that's operating through the support of the Foundation for the National Institutes of Health. It's leading to some good new opportunities for improving the development process for cancer drugs. It's been an initiative that Ray Woosley's group at the Critical Path Institute in Arizona has supported for doing a better job of predicting which patients are going to have sensitive responses to what.

There's also a project looking at warfarin and how to optimally dose patients, which uses genomic information on liver-enzyme activity. It potentially has implications for predicting adverse events for other drugs that involve liver metabolism.

Those are just a couple of the examples that are in place now. With the new law, there's an opportunity for funding, for public/private collaboration, for major new initiatives to bring better science to many other areas of product development and use. There's certainly been a lot for industry to do, as well as new steps at FDA that will be needed to take advantage of that.

Despite these successes, it seems like the Critical Path has a large potential to stall out. What do you think?

Well, I'm an optimist at heart. And I think there's too much at stake for it not to work. It's certainly easy to think about barriers to more effective innovation and the needed regulatory enhancements. But what's really at stake is nothing short of major improvements of the health of the population. And there are so many opportunities in biotechnology today for developing better cures and more personalized treatments, for preventing the complications and the chronic diseases, that I don't think we can miss out on those opportunities for too long.

It is going to be some real work to take advantage of these opportunities. But, you know, the fact there is such strong bipartisan support for the legislation at a time when there are lots of disagreements on healthcare generally and lots of rancor in Washington shows that there's some real potential for doing things differently.


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