NIH's New Translational Chief on How to Solve Pharma's Woes

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NIH's New Translational Chief on How to Solve Pharma's Woes -

head of the translation. Christopher Austin was the first director of NCATS.

Maggie Bartlett, NHGRI

In September, Christopher Austin entered what some might consider a hot seat: the leadership of the National Health Institutes of the new __gVirt_NP_NN_NNPS

Austin, 52, is a development Neurogeneticist who spent 7 years at Merck before joining NIH to oversee the translation of programs of NIH genome institute. In an interview last week with Science Insider, it seemed undaunted by public criticism of NCATS. Austin's remarks were edited for clarity.

Q: Could you describe the mission of NCAT in your own words

CA: It boils down to science by which fundamental discoveries are transformed into tangible improvements in the prevention and treatment and disease. It is a process that has never been subjected to the scientific method. This applies to the different stages of the translation process, which are remarkably empirical even today. You speak of optimization of medicinal chemistry and toxicity assessment or how to enroll patients in clinical trials, they are remarkably process of trial and error. And therefore, they are very inefficient and they fail most often. And which is the subject of the study of NCAT.

Operationally, there are three Ds: NCATS must develop, demonstrate, and disseminate improvements in the process. These improvements could be technical, scientific, or they could be the paradigmatic, those of collaboration, intellectual property issues, regulation: they are all strictly scientific.

Q: The former CEO of Merck Roy Vagelos has said that if someone thinks NCATS can achieve something that industry does not already, "you believe in fairies."

C.A. what Roy has to Merck in the 80 and 0 really is legendary. It is very well respected by everyone in the field.

At the same time, it is clear to me and to many people in the pharmaceutical industry there are many things that the pharmaceutical or biotech industry would like to do but can not do either because the return on investment is not big enough; there is a short-term business imperative, which makes studying difficult or impossible general principles; or it does not correspond to the strategic goals of the company.

I do not think that's a question that companies have not thought about these things. It's just that these are things that do not generate short-term revenue.

Q: What are the first things on your plate

CA: The most CSEC is great [Clinical and Translational Science Awards] program. It is about 80%, 85% of the budget of NCATS. I spend an enormous amount of time learning the program. And I really was very, very impressed with the quality of the people and work and initiative of the people in the institutions [with CTSAs].

Q :. The CTSAs are worried about what will happen to them

CA: I think that to some extent these misperceptions about what NCATS would do come back maybe a year and a half now that the famous article in the [ New York ] Times [suggesting that NCATS would develop drugs]. We still live that down. It was just not an accurate representation of what NCATS would never do. It led to a concern by CSEC IPs [principal investigators] they would all be converted to drug developers or something.

It is true that they are in a different institution from the one they were before. [That institute's] mission was different from the mission of NCATS. So [the CTSAs] evolve over time. But it's a good thing; which is a good thing.

Q :? How are you doing new things with a flat budget

CA: There are obviously new things we want to do that we will not be able to do it without [new] funds. It is particularly difficult for a new center that has a very ambitious mission with a lot of people counting on us. But half a billion dollars is still a lot of money and I think there is much we can do with it.

Q: How will you measure the success of NCATS?

C.A. If you look at the mission of NCATS, he talks about process improvement and efficiency improvement . The problem is that it is a very soft zone and there are many things that you could potentially measure. If you look at what happened in the pharmaceutical industry, and my former company was like that, there were really well-meaning efforts to establish measures that would make sense, and people gathered measurements and comprehensive programs failed for various reasons.

So there will not be a measure, there will be some measures of portfolio in the long term, some short term, some intermediate results, some high risk, some low risk. And in the end we will have a composite score that will hopefully be reasonably positive.

We also want to have measures to failure as long as you fail for the reason you publish and why. We will not have many publications as a significant extent. Of course, we will have papers, but it is not the mission of NCATS.

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