People fear change, and scientists are no exception. So, it was predictable that when the National Institutes of Health (NIH) decided to close the National Center for Research Resources (NCRR) and replace it with the new National Center for Advancing Translational Sciences (NCATS), not everyone would be happy. Some worried that NIH would be getting too involved in drug development, which, they argued, is better left to the private sector. Others worried that programs that should be kept together would be split up and transferred to different institutes. Many more worried about what would happen to their grants, which previously were funded by NCRR.
NIH officials say that translational researchers, including those supported by Clinical and Translational Science Awards (CTSA), have little to worry about. "The most striking thing is how little is going to change," National Institute of Mental Health (NIMH) Director and Acting NCATS Director Thomas Insel told Science Careers. "It's essentially a reorganization." However, over the next several years, some change seems inevitable.
The CTSA program accounted for the biggest chunk of the former NCRR budget, funding 60 translational science centers across the country. Between 2006 and 2011, NCRR selected between five and 12 centers per year to receive at least $20 million over 5 years to build partnerships between basic research scientists and clinical scientists and promote the translation of research findings into clinical applications. The program migrated wholesale to NCATS and will account for about $487 million of the new center's $575 million annual budget.
So far, NIH institute directors, including Insel, have said that they plan to continue the CTSA program. But it remains unclear how the program will change under NCATS. Insel told reporter Jocelyn Kaiser of ScienceInsider that "there's actually close to $500 million here [for the existing CTSA program], so there's actually quite a bit of funding to do some exciting science," which seems to suggest at least the possibility of changes in how those funds will be used in the future. When asked about this by Science Careers, Insel maintained that it was too early to speculate on renewal decisions for the existing CTSAs.
In the program's last year under NCRR, 10 of the original 12 CTSA centers were renewed. Insel declined to say whether NCATS expects to renew the remaining programs at comparable rates at the end of their first 5-year terms. He noted, however, that with the inception of the new center, "there's an opportunity to develop some more flexibility in the program, to give CTSAs a little more liberty to pursue the things they're best at."
William Crowley, a professor of medicine and director of clinical research at Massachusetts General Hospital in Boston and a national leader in clinical research, hopes NCATS will take advantage of that liberty to shake up its existing CTSA programs by rewarding the larger and, in his view, more productive programs. Currently, he says, the CTSA program isn't well designed to handle funding for large, multipart research consortiums such as those at Harvard University, Duke University, the University of Pennsylvania, and the University of California, San Francisco. But those centers contribute the most to translational research, he says. "When you try to put too many things into [a single CTSA], it's like putting a size-15 foot into a size-5 ballet slipper," he says.
Crowley suspects that NCATS may direct more of its funding toward these larger programs and either reduce funding for or deny renewals to current CTSAs that are less productive. "Not all of them are created equal," he says. "This is not an egalitarian society. This is a meritocracy."
CTSA institutional administrators don't seem to be worried about that possibility. Joan Lakoski, a professor of pharmacology and the associate vice chancellor for science education outreach, health sciences, at the University of Pittsburgh in Pennsylvania, says, "The directors of the CTSA programs that I've talked to are feeling pretty comfortable." Everyone is worried how the economic environment could affect funding decisions, she says, but beyond these broad economic concerns, most people involved with CTSAs have "a very positive vibe about NCATS." Insel and NIH Director Francis Collins "probably have some specific goals in mind, but in reality, we'll sort it out as we go along," Lakoski says. "It's a work in progress."
Even in the short term, some changes are likely. For example, NCATS is taking a more centralized approach to translational endeavors than NCRR. The new NCATS is likely to play a more central role in filling gaps left by industry. Insel says that NIH directors also hope NCATS might be used to drive the agenda on research and development for rare diseases and other overlooked maladies. To that end, NCATS is the new home for the Office of Rare Diseases Research, formerly housed under the Office of the Director of NIH, and the Therapeutics for Rare and Neglected Diseases program, formerly a part of the NIH Center for Translational Therapeutics.
Also, "There are now some gaps that have been created by changes in industry," Insel says. For example, his institute, NIMH, is "acutely aware of changes in CNS [central nervous system] drug development and R&D" that have made developing such drugs a low priority for the pharmaceutical industry, he says. "NCATS is going to be looking at those areas -- likely it's going to be disease-specific, maybe for certain rare diseases -- but [NCATS] will be looking at, 'Are there ways to reengineer the process or add new tools?' " The goal, he says, will be to help the other institutes accomplish their translational objectives.
In addition, Insel says he hopes that NCATS will take a leading role in promoting the search for alternative uses for existing FDA-approved medicines.
How does NCATS intend to carry out these plans? That's still being discussed, but Insel says the new center will almost certainly make more use of targeted funding solicitations. NCATS will also house infrastructure, such as components of the Molecular Libraries Program and the newly created Cures Acceleration Network, to help industry and academia collaborate "precompetitively" on tools and technology that benefit all researchers, such as faster DNA sequencing, therapeutic target validation, and novel biomarker discovery.
"The hope is that by putting [clinical and basic sciences] side by side and developing a bridge between them, we will see some exciting new opportunities for both of them," Insel says. "The preclinical [research] will now have a bridge to actually see translation for the things they're working on as well as a clinical innovation program that … will provide an on-ramp for some of the discoveries that have been coming out of the preclinical side that have to be tested."
One of the keys to making that happen may be training scientists in the necessary clinical and translational skills. In the 5 years it has existed, the CTSA program has become an important trainer of such scientists. In 2010, the CTSA program supported 445 graduate students and postdocs on graduate and postdoctoral fellowships, and 485 CTSA-related training grants to more senior scientists. Lakoski says that for young scientists with an interest in doing translational work, the creation of NCATS signals an increase in career opportunities in the near future.
"I think that the demand for individuals that understand the goals of clinical and translational research is going to be unquestionably growing," Lakoski says. "For the postdocs who have a basic science background who are finding difficulty getting that next position, this is the time for them to add to their skill sets so they can go into leadership positions or be parts of clinical-translational teams."
Gene Morse, who directs several HIV/AIDS clinical pharmacology research programs at the University of Buffalo, notes that combined with another recent change at NIH -- the move to multiple PIs for research grants -- NCATS should improve the research and career progression of scientists with clinical training. "In the past, if you went in as a clinical scientist to be a PI [principal investigator] but hadn't done a lot of the actual [basic] research, it was viewed as almost as if you couldn't be the PI," Morse says. "But now that NIH has also changed policy so you can go in with multiple PIs, the combination of that change, along with NCATS's new translational emphasis, allows for people to put together research teams that in the past were less common."