The National Institute of Health (NIH) is opening a new institute to discover new drugs. It will be called the National Center for Advancing Translational Sciences (Center). The premise of the Center is to help the drug industry and society overcome 15 years of declining research productivity. Let me say right now, I don't get it. I don't mind NIH trying to find new drugs. It's apple pie and motherhood. Save for one small, minor point: For those past 15 years when Industry was struggling, universities and startup biotech ventures were dutifully using NIH funds to find new drugs. I am questioning the unique value proposition that the new Center is bringing to the table.
In a New York Times article, Dr. Francis Collins, the director of the Institute, and others talk about mental health and the lack of new drugs in this area. The mental health field poses tough obstacles. Human drug trial failure rates are over twice as high for mental illness than any other area. I am going to guess and say the new Center will not find new drugs. They may find new drug candidates (i.e., drugs before they are tested in man), but even this seems a bit unlikely.
As you can see, I am skeptical. That said, I think there is a place for the Center IF they start trying to look at why the entire Industry (including universities) has been relatively unsuccessful.
- Identify Best Practices - Aside from Stanford and MIT, there are few universities that have had much luck converting research into products in the marketplace. Anyone who has dealt with any early stage technology venture knows that university structures and associated technology transfer offices can be an impenetrable barrier to moving from research to commercialization. There are success stories. One in particular is the Weizmann Institute of Science in Israel. It is a pure research facility. No faculty member was ever given a position to commercialize anything. Yet, they have the highest conversion rate from patents to Industry of any entity in the world. Discovering why there are a handful of successes would be a very good goal for the Center. It would be even better to force these best practices associated with real success upon universities receiving federal dollars. We all know universities are not going to change their ways without external pressure.
- Look Where Economics Doesn't Work - Pharmaceutical companies try to make a profit (some might say too much profit, but until you walk in their shoes be careful). Part of making a profit is ensuring that a drug has patent and FDA protection. There are many failed drug trials that focused on molecules that are now near or at the end of their useful protected life. Yet, there are many researchers who think going back and looking at these failures may discover some gems. A drug that fails in a Phase III trial (i.e., last stage of human testing) may have failed for efficacy, NOT safety. Why did it fail? There may now be new diagnostic tests that were not available when the drug trial was carried out. Identifying patients at an earlier point of onset may help these failed drugs. We know that in animal trials, the drug is administered at an earlier point of onset of the disease. In any case, the Center should look first in the last place that Industry will look, where the economics offer the pharmaceutical companies the least incentive.
- Start With the Pharmaceutical Industry - The Pharmaceutical Industry is as concerned about the 15-year drought as the public. The Center should find ways to encourage cross-pollination of ideas where perhaps patent protection, anti-trust or some other business barrier can be overcome by the Center. Don't recreate the wheel. Understanding failure is as important as understanding success.