Thursday, April 30, 2009

Let me get personal

Yesterday afternoon I attended another great Xconomy Forum on the future of biotech. (These guys do a great job, both in the newsletters, which I recommend highly, and in the forums they put on. They have unparalleled access to key thought leaders and industry executives, and their editorial commentary is always insightful and spot-on.) In the fireside discussion with Wally Gilbert and George Church, which was moderated by Jim Collins, the discussion migrated quickly to a focus on personalized medicine – a buzzword that, like pharmacogenomics, has been around for a while, stimulates much discussion, but has yet to be proven out as a commercial success. The notion that we can analyze a cheek swab and determine which therapeutic and at which dose is the appropriate one for your condition has an alluring appeal, but in my mind, it remains to be seen how to commercialize the concept.

Wally pointed out one of the problems with the concept that has been circling for some time – the presumed lack of interest of big pharma. The notion here is that a system to identify which patients will respond best to a particular drug would be anathema to an organization seeking to promote its product to the widest population possible.

When I was doing business development at Athena Diagnostics, we thought, back in the 90s before this dialogue had become as common as it now is, that we were very clever in thinking that big pharma might help us further monetize our enormous patent estate by recognizing the value we had in exclusive rights to disease markers. I am fond of saying that we were kicked out of every decent drug company in America. The problem is that when you go in to explain that you have rights to patents that can identify patients with disease, the clever drug company product managers lean over the table and say: “Let me get this straight. You have a way for me to reduce my market share?” We were quickly shown the door.

For some time, I’ve been saying that this creates an opportunity for enterprising biotech entrepreneurs. Let’s consider diseases with a clear hereditary component, but complex (non-Mendelian) inheritance, like diabetes or MS. I predict that we will find sub-populations, based on haplotypes or other genetic markers that are stratified into responder/non-responder and dosage classes. I further predict that each individual class will not be of interest to big pharma as a therapeutic development program since they need comparatively enormous revenue estimates to even get their attention. However, a $100M drug is a perfectly respectable target for a small biotech startup. Fast forward, and now there are ten small biotechs, each with a $100M product for a small subset of an enormous patient population, and together they cover 75% of the pie. Now you have the attention of big pharma. A single company that could acquire all of those technologies would own the market, and would be able to detail all ten products to their call points with a single sales force.

Personalization is one of those things like pornography. The Supreme Court effectively ruled that they couldn’t define what pornography was, but they knew it when they saw it. Similarly, everyone likes the idea that we will go to the doctor and he/she will (painlessly) analyze some aspect of our biology and prescribe a “cure” with no side effects. I like the idea too, but it’s going to be a while before ten startups figure out how to stratify the diabetes market and capitalize on their effort.

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