What Is the Future of Drug Development in the U.S.?

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The problem with making therapeutics work is the pipeline is too long and the failure rate is too high. If you're an engineer looking at this problem, which is what we're trying to do right now at NIH you try to identify what are those obstacles and how could we get around them, not project by project but systematically, take for instance how we figure out whether a drug is safe before you give it to somebody in a phase 1 trial, we do that by animal testing, that's the same way we've been doing it for a very long time, we all know it doesn't work very well, we've this collaboration with NIH and defensive advance research project agency, DARPA, that's the group that brought us the internet and GPS and some other pretty high techniques the goal is to take the revolution in stem cells that're happening all around us where you can take a skin cell from you and me and differentiate that into a liver cell, or a muscle cell, or a kidney cell.

Load those onto a bio-chip, out fit them with readouts that'll tel you about genetic expression, metabolites, proteins, and use that as a detector of whether a drug is going to be toxic or not. Add the drug to the chip and ask the chip are you happy, and you can tune that system with drugs while you know the answer.

That would be revolutionary, it would allow us to test many more compounds and I think give us more careful answers before we go into a clinical trial. That's just one idea. That would never happen by a single company effort, but between NIH, and DOPA, and companies, and the FDA all working together, we think we could get that obstacle out of the way.