Parkinson Pipeline Project-treatment development database, research, FDA drug approval, PD clinical trials and sponsors, patient involvement

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Formulaic decision-making -- decision-making by the books -- drove out curiosity and judgment and investigational spirit in both of these failures.

Going on to the last item, we are not terribly better dealing with success, probably because we don't have that much experience.

[Laughter]

Let me guide you through a thought experiment. We are about to experience an explosion of Alzheimer's disease cases. Population statistics, incident rates and demographic changes indicate that the incidence of AD is doubling every five years. North America alone is going to have multiple millions of cases in a few more years, and when you look at the economic aspect of this, by 2030, the spending on Alzheimer’s disease will be as much as the total Medicare spending on everything in this country today.

This is not a stochastic process. This is not a maybe. This is going to happen plus or minus a little bit. This situation is best compared to astronomers following a meteor hurdling towards San Diego, aimed to hit a very precisely calculated place and time. What would we do if we had such a situation? I think we would take it a little more seriously than we take the economic meteor that's coming just as predictably our way.

Now what could we do? Let me postulate a sort of science fiction thought experiment. The science fiction goes like this -- what if we had a drug that eliminated amyloids? What if we knew, which parenthetically I don't think we do, but what if we knew that eliminating amyloids would have a beneficial effect on halting Alzheimer's disease? And what if we could controllably open the blood-brain barrier at a location of our choice sufficiently to allow large molecules to go through? The first two you can argue about. The third we can actually do. It turns out when we apply focused ultrasound we can open the tight junctions in the blood-brain barrier reversibly and predictably. We can take tracers and inject them intravenously and see the tracers travel through the openings and form a plume, similar to what we saw in the agar.

The plume is more or less spherical and happens at the desired place.

What if we could develop an instrument, an image-guided scanner of focused ultrasound hitting the right places, where amyloids concentrate and wipe them clean or halt their growth.

As I'm dreaming this up for this talk, I encounter a company that is dreaming about the same things. The company is in business to do focused ultrasound. They are actually working on this.

But this is not a cheap deal. Judging from what this company has spent on much simpler instruments, I think it's fair to say that the development cost would be somewhere in the neighborhood of $1 billion dollars.

How would we find a billion dollars to avoid the meteor?

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