Thomas Insel
NIMH
This month the National Institutes of Health (NIH) began to implement the largest reorganization of the sprawling company $ 30.6 billion in a decade. He launched a new $ 575 million National Centre for Advancing Translational Sciences (NCATS) which aims to fight against bottlenecks in drug development and accelerate the translation of basic discoveries in treatment.
The NCATS plan has sparked much debate when it was proposed last year. Some industry scientists said they feared that the NIH was moving away from basic research in drug development. Many researchers were also concerned about the loss of programs within another NIH center that was to be dismantled, the National Center for Research Resources (NCRR). Ultimately, Congress has to change, but set certain conditions. For example, the draft law on costs last month that established NCATS request several reports and studies outside the center's activities and states that it can not support, clinical trials in expensive final stage of the kind usually made by the industry.
In an interview with Science Insider last week, the National Institute of Mental Health (NIMH) Director Thomas Insel, acting director of NCATS, rejected reports that industry is skeptical. Industry leaders said NIH they "love to get help" improve their R & D efforts, Insel said. NCATS continue initiatives launched last year to find new uses for old drugs, develop a chip of drug toxicity, and work with industry to validate "targets", the structure of the protein or the cell that drugs designed to modulate. NIH Director Francis Collins described other possible directions from the design of the virtual drug research on marketed drugs, in an article Science Translational medicine last summer.
As NCATS takes shape, perhaps the most uncertain about the future are directors of programs funded by the Price of clinical and translational sciences (CTSAs), part of NCRR. These grants support large translational research at 60 academic medical centers. The program of $ 487 million represents the bulk of the budget NCATS (the only new money is Congress approved $ 10 million for Cures Acceleration Network Centre). Some managers fear that CSEC components that do not relate to the development of therapeutic products, such as behavioral research and community engagement will be trimmed.
Insel said NIH wants to preserve the range of CSEC activities, but adds that the program should expect to "evolve".
According Insel, the CTSAs in the new center will be supervised by a clinical innovation division headed by Acting Director Josephine Briggs, who will also remain in his current position as director of the National Center for Complementary and alternative Medicine. A division of preclinical innovation will house a collection of programs mostly intramural, including small molecule screening and development of drugs for rare diseases to $ 44 million. So far, these programs have been managed by the National Human Genome Research Institute (NHGRI) led by Christopher Austin; it will serve as director of the Preclinical Division NCATS. (NCATS Some programs also have funding from the Common Fund for NIH, a pot of money in the office of the NIH.)
Insel edited remarks follow.
Q: Why NIH need NCATS when many NIH Institutes are already translational research
TI: I will answer this question with NIMH my hat because I'm a good amount of translational science in NIMH. But NCATS will do is not what we do at NIMH.
We need a place to really look at the whole translation process in a way that can consider how it might be restructured, consider how we can make a difference in partnership with both advocacy groups and industry. Consider where the opportunities are great for innovation that are not only related to schizophrenia or autism or bipolar disorder but who are really generic. They will in all of medicine.
And rather than do that 27 times, it might be good to have a place where we say, "We will solve this problem. Let us really look at this in a very careful way and actually do something we have never been as an institute that is doing experiments on the translation itself. "This is a really exciting time to start looking for it first time
. Q: Why do you think NCATS was so controversial last year when it was proposed
TI: I 'm not even going to Va there I was not part of this fight and I will not even begin to contemplate what the questions were
Q:... Some scientists of industry expressed skepticism about NCATS. They are worried that this will attract scientists away from basic research. They are also worried that the NIH will make drug development.
IT :. There was a lot of concern about it at some point in the past. We brought a lot of people from outside. We had this working group of the Advisory Committee of the NIH Director; Maria Freire [president of the Lasker Foundation] chaired it. I do not think these are the questions we heard most often. It was actually the opposite. What we heard was that nobody was particularly happy with the way that R & D is going on, whether in the public or private sector.
We never heard anyone come forward and say, "You know what, we understand how to do this, it works very well" Actually what we heard was, this works. not very well everywhere, we would like to help
. Q: the prices in translational academic medical centers make up the bulk of the budget of NCATS, but much of what they do seem to fit with the mission of NCATS Should they be ready to change
iT.? I think if there is a change, it will be able that will not move all CSEC will be exactly the same whether in community engagement, or is first in man trial. We will look at power, to the extent possible, they cultivate do best
. Q: How will you pay for something new
TI: well, it is actually near $ 500 million here [for the existing CTSA program], so there is indeed some funding for an exciting science. I do not think there is a question of not being able to do new things. But I think part of what we're going to have these centers is to help develop the flexibility they do not feel they have right now. I was there at the beginning of the roadmap [former NIH Director Elias Zerhouni's set of cross-NIH initiatives] when we establish this and we have always understood that the CTSAs was a fantastic opportunity to restructure clinical research in academic health centers and provide a new home for it .
But I do not think anyone believes it was a year 3 or 5 year project and it would be done and finished. It has always been considered as an evolving program.
Q: Do NCATS clinical trials of funds
T.I :. The CTSAs lacks the funds to carry out large-scale clinical trials. This is not to how they are supported. They are supporting infrastructure.
Q: But are not there components NCATS that can fund the testing
TI: This could happen, but that is on a very small scale. You're talking about relatively small amounts of dollars for both TRND [Therapeutics for Rare and Neglected Diseases] and now also for the CAN.
Q: Do NCATS have an intramural program
T.I :. There are two answers to this question. The first answer is yes. The division of preclinical innovation in large intramural portion. But having said that, one of the things I'm most excited to play this interim role is that it is a chance to try some experiments. One of the issues that we now struggling with is, "Can we get out of this rigid separation between intramural and extramural?"
It gets really interesting when you think of something like [the rare diseases program] is technically an intramural program, but 0% of what they do is done with extramural collaborations. they do not have a large intramural faculty which is on a busy track they do not have a large number of FTEs [staff positions]; it is a very different way to work for the NIH
so we try to NCATS as a place to raise questions about. relationship between intramural and extramural to how we can get them to cross talk and provide a much more dynamic kind of relationship that we have had until now
. Q: Is this search for a permanent director moving along
TI:. is. I co-chair this search with [NHGRI Director] Eric Green. Eric and I were assisted by a special search committee that includes both NIH and non-NIH. We had an excellent response to various advertisements and solicitations that we put there. We look forward to interviewing candidates in the near future.
Q :. On someone's blog had speculated that you might be a candidate
T.I :. I can answer very clearly. I have a job that keeps me busy NIMH and I am very attached to it and I am not a candidate for director of NCATS.
* January 11: An earlier version of this article stated that Christopher Austin will be the acting director of NCATS division of preclinical innovation; he will be the director.
0 Komentar