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FDA Is Trailing Indicator

Feb 15, 2006

David:  Since the space where most of us are looking for impact is pretty close to the clinic, I think that a lot of this is actually going to be directed from a regulatory angle. We knew that omics had arrived in large pharma when the FDA started asking for the data.

Colin:  But David, the FDA didn’t start asking for genomics data until relatively recently, and it was five, six, seven years ago that genomics really took hold and was ubiquitous throughout the industry.

Stan:  I agree with Colin on that. What the FDA is now doing is asking for voluntary genomics data submission. And it’s probably a minimum of five years before they get beyond voluntary to mandate it in the areas that they’re already looking at. It’s only when we all see the value very clearly that they will then start asking for it. The value for us would come in the form of improved failure rates in Phase III clinical trials.

Alex:  What is interesting is the white paper that [the FDA] put out on Innovation or Stagnation -- The Critical Path Initiative. They talk about trying to generally and broadly use technology and [to] encourage use of technology and specifically. I think the fact they even stuck a flag in the ground is encouraging. The industry reaction has been, maybe we need to take a little closer look at this, which is exactly what the FDA wanted.

Keith:  If you look at when we can really see that modeling has had an impact will be when companies like Pfizer take models to the FDA to prove their points, not when the FDA asks for them.

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