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

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We have an empirical comparison. One of the largest cooperative ventures or perhaps the largest cooperative venture in this field has been done by people who put together the Alzheimer's Disease Neuroimaging Initiative or ADNI. It's a five-year research project, following a large number of people in different stages of the disease. It's a $60 million project. It's a train just like the Net-PD. It took four years to put together, money from different sources, and it was an exceptional result to put it together. I think it gives you an indication that putting together a billion dollar effort, meteor or no meteor, would be nearly impossible.

I guess part of my fee requires that I give you some specific suggestions of what to do on the three things that you need to address -- speed, the failure issue and the success issue.

Attitudes are extremely important. The semiconductor industry says “what matters is time to money”. By money we mean customers paying for the product; whoever gets there first, gets it all. In the bio-enterprise, my impression is the corresponding statement is “good science takes time”. Is that true? Yes. Does it help? No.

[Laughter]

I think we're going to go precisely nowhere for the next number of years until and unless we make progression biomarkers that measure quantitatively, objectively, the progression of the disease under any given condition, job number one, the top-priority job throughout the NIH. It is a key assignment that should be given in a significant fashion to the National Institute of Bioengineering,. It was formed to do this kind of projects but let’s fund it like me mean it, not with 1 percent of the total NIH budget, as we do today. The one sentence that I want to leave you with, "No progression biomarkers, no progress".

Failure: the one-liner that I would like to leave you with is, learn if not to love them, mine them. This one is truly an issue of attitude. After decades worth of cultural socialization by a rewards system it is very difficult to change by order.

The way the system works today, in my eyes, the reviewers are told to choose the best science. Best is a very dangerous word. If you wanted to advertise a consumer product on television and claim it to be the best, the federal government would be nailing you to prove that you know what best means and you know that your product is the best. There is no government agency objectively taking the test on that instruction.

People who apply to the reviewers, who are looking for the best science, second-guess the reviewers and give them what they want because they want to eat. The people who consistently play that game will get promoted and they will be playing the same game from the other side of the table. And the cycle repeats, and it becomes second nature – a culture is created.

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