Scientific Rationale
Benefit to Public
| How will the proposed NCATS be evaluated in the short-term and the long-term? |
| What should the taxpayer expect to get out of this proposed Center? |
Proposed Organization
Logistics & Public Input
Impact on Research Portfolio
| Will any of NCRR’s current programs be eliminated? |
| How would all of these changes affect current research activities at NIH? |
| How will this process affect current grants and contracts? |
Impact on Employees
| Would any NIH employees lose their jobs in this reorganization? |
Scientific Rationale
Why is this proposed Center needed? Rapid progress in scientific research and the increased availability of innovative technologies have generated unprecedented potential for advancing the translation of basic discoveries into therapeutics. At the same time, the process of drug discovery remains a challenging and risk-laden endeavor. These opportunities and challenges have prompted the National Institutes of Health to propose formation of a new Center focused on accelerating the development and delivery of new, more effective therapeutics. This proposed Center is envisioned to be a tremendous resource for the entire translational science community. It would develop and offer innovative services and expertise in moving promising products through the development pipeline, as well as develop novel approaches to therapeutics development, stimulate new avenues for basic scientific discovery, and complement the strengths of existing NIH research activities.
Why is now the time to establish such a Center? We believe that now is the time to take bold action and transform our nation’s translational research enterprise. In recent years, NIH-supported researchers across the nation have made tremendous progress in identifying the molecular causes of both rare and common diseases—discoveries that have revealed hundreds of new therapeutic targets. Also, thanks in large part to NIH’s Molecular Libraries Program, Therapeutics for Rare and Neglected Diseases program, Rapid Access to Interventional Development program, and Clinical and Translational Science Awards, academic researchers have gained greater access to expertise and resources that enable them to play more active roles in therapeutic development. These developments have prompted new partnerships in which NIH-supported investigators work to “de-risk” drug and therapeutic development projects and render them more attractive for private sector investment—the crucial step in the process of moving discoveries from lab to clinic.
Why is it important to get this done for FY12? Every family that has ended up at the end of a medical odyssey only to learn that we do not yet have an effective treatment or cure knows why we are in a hurry. While we have learned an enormous amount about disease and health from our research investments, many diseases and conditions lack treatments. Dr. Collins, the NIH Director, asked a key advisory committee to look at how NIH could realign our resources to speed development of new interventions and they concluded that the scientific opportunities are here now. NIH feels compelled to move quickly to get this proposed new Center running so that it may accelerate the important translational work that is ongoing at NIH.
What exactly would this proposed Center do? The central role of the proposed Center would be to establish and provide focused, integrated, and systematic approaches for building new bridges that link basic discovery research with therapeutics development and clinical care. Translational sciences are increasingly becoming multi-sector endeavors involving industry, government, academia, and other sectors. Through the proposed Center, NIH would play a key role in convening these cross-sector collaborations to advance therapeutics development. The proposed Center also could house the recently authorized Cures Acceleration Network (CAN) and focus research efforts in high-need areas that attract little commercial interest, such as rare and neglected diseases, and drug rescue and repurposing research. The functions and activities of the proposed Center would include:
- providing a visible, central locus for access to resources, tools, and expertise related to translational medicine;
- streamlining and improving the process of therapeutics development;
- serving as a catalyst, resource, and convener for collaborative interactions by supporting novel and innovative partnerships between multiple key stakeholders, including academia, government, industry, venture capitalists, and non-profit organizations;
- expanding the pre-competitive space by, among other things, enabling and providing incentives for greater sharing of scientific information and publication of negative results;
- supporting and strengthening translational medicine and therapeutics research, including providing access to services and resources for high-throughput screening, assay development, medicinal chemistry, and preclinical modeling;
- training translational research investigators; and
- enhancing communication among all stakeholders.
What sorts of therapeutics would be the focus of the proposed Center? In addition to strengthening and streamlining the process of developing small-molecule compounds into drugs, the Center would support research aimed at accelerating the development of a full range of products and techniques for the diagnosis, treatment, and prevention of disease, including diagnostics, biologics, medical devices, and behavioral interventions.
How would the proposed Center affect other translational science efforts supported by NIH? Would it compete with the private sector? The proposed Center would enhance—not supplant—the many other cutting-edge translational research activities supported by NIH’s categorical Institutes and Centers and the NIH Clinical Center. Furthermore, this Center would not compete with therapeutic development in the private sector, and would focus research efforts in areas that attract little commercial interest.
Benefit to Public
How will the proposed NCATS be evaluated in the short-term and the long-term? Evaluation measures, especially for the short-term, for this new proposed Center will need to be developed and communicated in the coming months. A working group of the Advisory Committee to the NIH Director will be assembled and charged, among other things, with this task. The long-term success of the proposed NCATS will be measured by its impact on speeding interventions (particularly for rare and neglected diseases) through the drug discovery pipeline of the nation.
What should the taxpayer expect to get out of this proposed Center? The taxpayer should expect to see the NIH use the proposed new Center to advance translational science in new and innovative ways. Specifically, NCATS, if created, will use novel funding mechanisms to speed promising projects into the translational pipeline; reengineer aspects of the therapeutics development process; increase collaboration with FDA early in drug development; and enhance partnership between NIH, the private sector, and a broad range of stakeholders who are eager to see more therapeutics come to market.
Proposed Organization
What would the proposed Center be called? NIH has proposed that the new entity be named the National Center for Advancing Translational Sciences (NCATS).
What existing NIH programs will become a part of the proposed Center? The proposed Center would be formed initially by integrating selected translational research programs now located within the National Human Genome Research Institute (NHGRI), the National Center for Research Resources (NCRR), and the NIH Director’s Common Fund. For example, the Clinical and Translational Science Awards (CTSA) program in NCRR would be included. Another component could be the new Cures Acceleration Network (CAN), which was authorized by the Affordable Care Act.
Has the leadership of the proposed new Center been chosen? No. NIH will conduct a thorough National search to find the Director for the proposed new Center.
Logistics & Public Input
What is the timeline for creating this Center? Given the importance of this effort and the tremendous opportunities to advance the pace of delivering cures to patients, the agency is proceeding rapidly to establish this new Center. The process of establishing a new Center must be done with considerable care, and careful deliberations by the SMRB and others have guided NIH’s decision-making to date. The agency will continue to pursue a careful process and aim to ensure that any path forward improves and advances translational science at the NIH.
Why didn’t the SMRB consider a model where other translational medicine programs would be placed within the existing NCRR organization? The SMRB concluded that these functions could not be achieved effectively by incremental changes that augment and expand an existing body within the agency, but instead, could be achieved best through a bold, new, focused center systematically engineered to accelerate translation. The NIH Director agrees that gradual organizational evolution is not adequate to meet today’s challenges and opportunities.
Is it really feasible to create this proposed Center on this condensed timeline? Yes. It is expected that the programmatic decisions will be completed by early Spring which leaves several months to work through the administrative implementation steps in time for the start of the new fiscal year. The NIH Director intends to present a detailed plan for the proposed Center to Health and Human Services Secretary Kathleen Sebelius in mid 2011. If all goes as planned, NIH hopes to have the reorganization take effect on October 1, 2011.
What process will NIH use to develop the detailed plan it intends to present to the HHS Secretary? To guide this major realignment of resources within NIH, the NIH Director has asked NIH Principal Deputy Director Lawrence A. Tabak, D.D.S., Ph.D., and National Institute of Child Health and Human Development Director Alan E. Guttmacher, M.D., to head a task force of NIH scientific experts. The task force will review existing programs recommended for inclusion in the new Center, assess the impact of the new Center on other relevant NIH programs (including those currently within the National Center for Research Resources (NCRR)), and develop an implementation plan for establishing the new Center. More details about the task force’s activities and timeline will be provided as they become available.
Why aren’t there any members of NCRR on the task force?
The task force is composed of individuals who do not have a programmatic stake in the NCRR programs that may get moved into other Institutes and Centers. Although there is no one from NCRR on the task force, the task force is relying heavily on content experts from NCRR to provide detailed information, insights, and recommendations about the programs that they manage.
Will there be any opportunities for public input in this process? Our goal is to be as open and transparent as possible throughout this process. On May 19, 2010, at a public session of the NIH Scientific Management Review Board (SMRB), the NIH Director issued a charge to the Board to identify the attributes, activities, and functional capabilities of an effective translational medicine program at NIH and recommend the optimal organization of existing NIH programs, networks, and centers for inclusion in this new effort. Various components of the vision were discussed at five SMRB meetings, which were open to the public and afforded the opportunity for public comment. Extensive public comment was provided, particularly at the December 7, 2010, SMRB meeting. The SMRB also held a two-day stakeholder consultation on the topic, convening experts from across industry, academia, the non-profit sector, venture capital, and patient advocacy. On Dec. 8, 2010, NIH Director Francis Collins held three teleconferences with stakeholders, including NCRR employees, CTSA principal investigators, and NCRR-supported extramural scientists. On Dec. 9, 2010, the Advisory Committee to the Director (ACD) met. This meeting occurs bi-annually and is open to the public. The ACD was briefed on the SMRB’s recommendations that NIH realign its resources to establish a new Center devoted to advancing translational sciences. Moving forward, there will be many additional opportunities for public input, including opportunities to submit comments online, face-to-face meetings, and teleconferences hosted by NIH leadership.
What is the role of the HHS Secretary and Congress in this? Under the Public Health Service Act, the Secretary has the authority to establish, abolish, or reorganize the functions of NIH institutes and centers. If the Secretary makes a determination that such a change is needed, she would give notice to the appropriate Congressional committees, which are the House Energy and Commerce and Senate HELP committees. Reorganization cannot take effect until 180 days after that notice. In addition, the appropriations committees would need to be notified and provided with the budget details for the new center and the transferred programs so the redistribution of funding needed to implement the reorganization can be reviewed and included in the FY 2012 appropriations act.
Impact on Research Portfolio
Will any of NCRR’s current programs be eliminated? There are no plans to eliminate any programs at NCRR through this analysis or proposed reorganization. The NCRR Task Force will look at every NCRR program and suggest the programs that make the most scientific sense to go to the proposed NCATS and those that make the most scientific sense to go to other NIH Institutes or Centers.
How would all of these changes affect current research activities at NIH? All translational science programs at NIH will continue at full strength throughout this time of realignment and change. We must not flag in our efforts to help all those who are desperately awaiting new ways to detect, treat, and prevent disease.
How will this process affect current grants and contracts? At this point, there will be no impact on current grants and contracts.
Impact on Employees
Would any NIH employees lose their jobs in this reorganization? All changes will be done in a way to protect and respect the people and the science in all affected ICs. As with any reorganization, people, understandably, are concerned about their jobs. Our goal is to ensure continued employment at NIH for all affected persons. Not everyone will retain their current positions however; we will work to find a comparable position for them either within the new Center or within another part of the NIH.