Thursday, April 12, 2012

NIH to repurpose failed leads?

(Let's call them "shelved" leads instead of the pejorative "failed." Some of the leads just lacked the organization will, expertise, or budget necessary to justify the risk of further investment.)

I find Collins' idea VERY interesting for a few reasons:

- this seems like a good role for government DD investment - the NIH can provide some very worthwhile assets & expertise, especially as leads may be repurposed from one disease class to another. (say, cancer to allergy application.) No pharma company has the breadth of expertise that the NIH does across their Institutes.

- this looks like a high leverage role for the NIH - theoretically, a small incremental investment in a shelved lead that is already proven safe in humans could have a HUGE return. However, the nature of the quest says that there will be ALOT of failure along the way, so much failure that pursuit of this mission by the private sector isn't economical.

-Politics: Any clinical success can make the NIH's mission more tangible to those who fund the NIH. The NIH does some great research, but since it is heavily biased towards early, basic research, not a lot of it can be used as a 'trophy' to gain more funding. Also, from the NIH perspective, a "win" from repurposing can come a lot sooner than a "win" from de novo drug discovery by NCATS, and by the nature of the repurposing work, the NIH can't step on any toes. If a pharma has shelved a program, how can they object to the NIH building off their earlier work? (I think we all know how pharma execs run from failed programs like cockroaches when the lights are turned on.)

-Also, while I'm not in love with the idea of the NIH taking a formal role in translational research, this seems like a smart way to dip a toe into drug discovery. Perhaps the NIH's DD experience to come from repurposing will help improve the DD regulatory process.

The devil is in the details, and in this case, it's the IP. What happens if a chemical patented by Company A for Disease X is found to be effective in Disease Y? Who owns the resulting IPR? There's no shortage of failed/shelved leads for the NIH to consider, so might they only pursue leads off patent or nearly off-patent?

The only question that I'd ask the NIH is "why does the NIH believe they have a higher probability of success with the "shelved" leads than the originating pharma team?" I can think of a few reasons, but I'd like to hear their rationale from them.

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