The Fiscal Year 2012 spending bill enabled the National Institutes of Health to establish the new National Center for Advancing Translational Sciences (NCATS). The Center is intended to develop innovative methods and technologies to reduce, remove, or bypass time-consuming bottlenecks that exist in the pipeline between a scientific discovery and development of new ways to improve human health. In January, the director of the National Institute of Mental Health, Thomas R. Insel, M.D., was formally designated acting director of the newly established NCATS. Ann Bonham, Ph.D., Chief Scientific Officer at the Association of American Medical Colleges, recently posed some questions to Dr. Insel concerning the start-up of NCATS.
Dr. Bonham: NCATS is envisioned as a hub for catalyzing innovations in translational science, working closely with partners in the regulatory, academic, nonprofit, and private sectors. How will NCATS engage these communities to identify and overcome hurdles that slow the development of effective treatments and cures?
Dr. Insel: All of these sectors — regulatory, academic, nonprofit, and private — have been involved in the creation and design of this new institute and in the search for a permanent NCATS director, and all ultimately will be represented on the advisory board or council to oversee NCATS activities. There is strong evidence of this engagement already in the initial NCATS projects. For example, the “tissue on a chip” project for predictive toxicology involves FDA and DARPA. Our efforts in rescue and repurposing involve FDA and the private sector. And, of course, the academic health centers that have received Clinical and Translational Science Awards (CTSA) have already demonstrated an unprecedented ability to engage nonprofit, private, and community partners.
Dr. Bonham: The NIH Clinical Center has been working to build bridges between NIH-intramural and NIH-extramurally funded investigators. Do you see a role for NCATS in providing a venue for building collaborations across those communities?
Dr. Insel: You might consider NCATS and its Cures Acceleration Network (CAN) as an opportunity to conduct experiments on how we can better support science at NIH. The intramural–extramural divide — and it has been a divide — no longer best serves the interests of either community. NCATS’ intramural component, the Division of Preclinical Innovation, does not look like any other NIH intramural program. What’s unique is that nearly all of the scientists were recruited from industry; most of the projects are with extramural partners; and the mission is to provide tools or products in addition to publishing papers.
The other major component of NCATS, the Division of Clinical Innovation, includes the CTSA program. At the first CTSA Consortium meeting in 2006, CTSA PIs voted to include the Clinical Center in their discussions, and many extramural CTSA investigators have collaborated with Clinical Center investigators through its Bench to Bedside awards. The great opportunity now is to extend this bridge of extramural and intramural investigators in translational sciences by sharing best practices, new tools, and clinical resources.
Dr. Bonham: Do you anticipate that NCATS will directly engage in new training models to help the research workforce advance innovations in translational science?
Dr. Insel: One of the great successes of the CTSA program has been its development of training programs for clinical researchers and allied professionals in the many aspects of translational science. Our most recent count identified 445 T trainees — as well as 485 K scholars — across the CTSA Consortium. As the CTSA program incorporates the mission of NCATS, I would expect this emphasis on training to be sustained and to be expanded in specific areas of need, from informatics to pharmacology.
Dr. Bonham: What role do you hope NCATS can play in shaping and addressing NIH’s health disparities research agenda?
Dr. Insel: Roughly 80 percent of the NCATS budget is the CTSA program, and the CTSAs have, from inception, conducted research aimed at reducing minority health disparities. In 2011, some 50 National Institute on Minority Health and Health Disparities (NIMHD) researchers received support through CTSAs, undoubtedly aided by consortium efforts and progress in community engagement. We especially are proud of the high proportion of research volunteers from minority communities who have partnered with CTSA researchers. To name a few: the CTSA’s Telehealth project has reached remote minority populations in Arkansas; the University of Washington Community Outreach programs have partnered with tribal organizations in the Northwest, including Alaska; and the CTSAs at Chicago, Pittsburgh, and Ohio State have developed key links to local minority communities.
Dr. Bonham: Given that NCATS has been successfully launched, what do you see as success for the Center?
Dr. Insel: As with any new venture, you need to look for short-term and long-term successes. In the short term of 2012, I want to see permanent leadership, a council, and a fully integrated program in place so that the Division of Preclinical Innovation (which consists primarily of former National Human Genome Research Institute programs) and the Division of Clinical Innovation (which consists primarily of the CTSA program) are truly a single effort guided by a shared mission. Over the next three to five years, success will be defined by how well NCATS delivers on its mission of advancing the discipline of translational science through tools and resources to accelerate the process. Success also can be measured by how the CTSAs are serving the missions of the other institutes at NIH, and through examples of where the NCATS innovation of translational science has had an impact on human health.
Dr. Bonham: How soon do you think the NCATS Council and the Cures Acceleration Network Board will be established? Are nominations for these important bodies currently being accepted?
Dr. Insel: We already have invited nominees for the NCATS Council and the Cures Acceleration Network Board. The appointment process takes several months. Fortunately, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Council has volunteered to serve NCATS in the interim. We have invited some of the former National Center for Research Resources Council members to join the next NIDDK Council meeting for the discussion of NCATS programs.