Posted on December 23rd, 2011 by Francis S. Collins, MD, PhD
President Obama signed a spending bill that includes $30.7 billion for NIH and establishes the National Center for Advancing Translational Sciences (NCATS). Given the very challenging fiscal situation our country faces right now, we should all breathe a sigh of relief and express thanks to the Administration, the Congress, and the American people for providing a small increase for NIH for fiscal year 2012.
It’s been just over a year since we began planning for NCATS. Three months ago the President shared his excitement about NCATS, acknowledging the need to speed up the process of drug development. And he’s right, NCATS is coming at just the right time – we have an abundance of scientific advances and new technologies, but we are using old tools for many steps in therapeutic development. The goal of NCATS will be to develop new ways of doing translational research that the public and private research and development communities can adopt. Innovations that come out of NCATS are intended to cut down the time or expense needed to develop a new drug, or allow us to predict which compounds will work best and be safe earlier in development.
As we work to stand NCATS up, our search for the most talented candidate for a Director continues. In the meantime, I’m putting this brand new center in very capable hands. I’ve asked Dr. Tom Insel, Director of the National Institute of Mental Health, to be the Acting Director of NCATS and Dr. Kathy Hudson, my Deputy for Science, Outreach, and Policy, to be the Acting Deputy Director. I know they will oversee a smooth transition and will energize the talented NCATS staff.
NCATS is already poised to take on some exciting new initiatives, including a partnership with DARPA to develop a chip that can mimic human tissues for more predictive drug screening, as well as early efforts to streamline rescuing and repurposing of drugs and validation of promising drug targets. I look forward to watching this new center grow and become a force in the translational science arena.
Let me take this moment to wish all of you who follow this blog a happy and healthy Holiday season.
In June, the Department of Health and Human Services sent detailed budget information for the proposed NCATS to appropriators in the House and Senate; this document is now posted on the NIH website. In early September, Nature reporter, Meredith Wadman, obtained a copy of the budget document by requesting it from DHHS, a right afforded by the Freedom of Information Act.
Last April, NIH Director Francis Collins asked a group of NIH leaders to opine on the Clinical and Translational Science Awards (CTSA) program and its movement into the proposed new NIH center, the National Center for Advancing Translational Sciences (NCATS). Most members of the group have been deeply involved in advising NCRR on the CTSA program since its establishment five years ago. Dr. Collins asked the group to help determine how the strengths of the CTSAs could enhance the mission of NCATS and how to make the transition as smooth as possible.
This group, chaired by Dr. Stephen Katz, Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, presented final recommendations to Dr. Collins in late September. In a keynote address today, Dr. Collins shared these recommendations with the CTSA Principal Investigators at their Consortium Steering Committee Meeting in Rockville, MD.
Posted on September 23rd, 2011 by Dr. Kathy Hudson
Last Friday at a high school in Virginia, the President signed into law much-needed patent reform through the America Invents Act. The student who introduced the President wowed the crowd when she disclosed that she is a patent holder! The President spoke about innovation and invention and used the opportunity to share his enthusiasm for NIH’s proposal to create NCATS, a Center that he said, “will help companies reduce the time and cost of developing lifesaving drugs.”
Then, on Wednesday, an external NCATS working group to the advisory committee to the NIH Director, the ACD-NCATS Working Group, presented their findings to the ACD on a public teleconference. Their report describes the best ways that NCATS can speed the entire effort of getting effective medicines to patients. And these are the folks who know this world well; they come from pharma, biotech, universities, non-profits, and the venture capital world. Their Chair, Maria Freire, also an ACD member, did an outstanding job of leading this group and eloquently described the report and how the group came to each conclusion. She acknowledged that there had not been complete buy-in at the beginning, seven months ago when the group formed, and I think that was generous! This group, over a period of months, carefully considered the role and mission of NCATS and emerged with a report that is strongly supportive. The ACD accepted their findings by a unanimous vote.
Also on Wednesday the Senate Appropriations Committee reported out their bill for NIH for FY2012, which begins on October 1. We fared much better than expected in this terrible economic environment with a cut of only $190 million below the FY2011 levels, for a total NIH budget of $30.498 billion. But even in these tight times, NCATS is a priority and we are delighted that the Senate included the creation of NCATS in their bill.
The next FOA for the Clinical and Translational Science Awards was set to be released in October. Yesterday, NCRR published a notice in the NIH Guide to let the community know that the CTSA FOA would be delayed until June, 2012. This will give the future NCATS leadership, in partnership with CTSA program staff, time to provide input into how CTSAs will be integrated into NCATS under one common mission, to advance the discipline of translational science. In addition, the CTSA program is five years old and, as with all programs, now is a good opportunity to take some time to take stock of lessons learned.
We are aware that the CTSAs that were awarded in 2008 are anticipating a new FOA this fall. These awards are set to expire in April, 2013. NIH will provide a cost extension for any lag between their current award and the start of the next award for successful applicants. The new FOA will be for renewals and new applications.
Today Science Translational Medicine published a commentary by Francis Collins, “Reengineering Translational Science: The Time is Right” in which he describes his motivation and vision for the proposed new National Center for Advancing Translational Sciences (NCATS). The paper lays out the plan and provides concrete examples of where NCATS may be able to make the largest contributions to the entire effort of translational research.
The mission of NCATS will be to catalyze the generation of innovative methods and technologies to enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. This mission and the vision for NCATS have been informed by NIH’s extensive and ongoing consultation with key stakeholders including patient and advocacy organizations, the biotechnology and pharmaceutical industry, and academic institutions. Please take a look at the paper and share your thoughts with us.
Posted on March 10th, 2011 by Francis S. Collins, MD, PhD
Next week I will speak to the community about my vision for NCATS on a webinar hosted by the nonprofit organization FasterCures. I will be joining Margaret Anderson, the Executive Director of FasterCures, who will moderate a question and answer period following my talk. Please join me and have your questions ready.
The SMRB held a public teleconference last Wednesday to hear about NIH activities related to the creation of NCATS. The Board heard from members of the public and from the chairs of the NIH working groups that have been charged with providing guidance on the proposed reorganization.
Dr. Larry Tabak presented the NCRR task force’s recommendations and Dr. Tom Insel summarized the recommendations of the Institute and Center Directors’ (ICD) NCATS working group. The ICD NCATS working group were asked to assist the NIH Director with creating NCATS. They concluded that the mission should be to advance the discipline of translational science and catalyze the development of novel diagnostics and therapeutics across a wide range of human diseases and conditions.
Dr. Stuart Zola of the National Primate Research Centers (NPRC), an NCRR program set to be placed within the Office of the Director (OD), expressed support for that decision. On a similar note, Dr. R. Balfour Sartor, the Director of the National Gnotobiotic Rodent Resource Center, applauded the recommendation to keep the comparative medicine division intact, which includes the NPRCs. Dr. Bobbie Ann Austin of the Association for Research in Vision and Ophthalmology recommended that the IDeA program not be placed in an Institute with a defined constituency (the task force has recommended placement into NIGMS). Contrary to this, Dr. Judith Van Houten, the President of the IDeA Principal Investigator Association, was pleased with the placement of IDeA into NIGMS but urged NIH to support the synergies between the RCMI and IDeA programs.
The Board heard strong support for the creation of NCATS. Dr. Richard Bucciarelli, a pediatrician, called on behalf of a handful of pediatric organizations to share their support and to urge that child health be a priority for NCATS. Dr. Adam Clark of FasterCures noted the importance of NCATS having no specific disease priority, but working to accelearate translational research regardless of disease type. James O’Leary of the Genetic Alliance stated strong support for the mission of NCATS to catalyze current NIH translational research. He encouraged NCATS to engage the public as part of that work. Amy Comstock Rick of the Parkinson’s Action Network (PAN) shared PAN’s strong support for the creation of NCATS. She also expressed concern with some of the reactions that this decision has been receiving, “The requests to slow down, to continue to analyze, and just wait are being made with all sincerity but they do not represent the views of all the stakeholders.” She went on to say that the proposed creation of NCATS “is designed to address some very real problems in this country and it’s time to hurry up and do so.”
The NCRR Task Force, co-chaired by Dr. Alan Guttmacher and me, has prepared recommendations for the NIH Director on the placement of NCRR programs within the NIH. These recommendations were developed through discussions with NCRR subject matter experts and through extensive consultation with multiple stakeholders, including grantees, professional organizations, and the public at large. In particular, the comments we received to the NCRR straw model post were extremely helpful; your engagement greatly influenced our final recommendations.
The Task Force used the following considerations and guiding principles in developing these recommendations:
The scientific synergies that could be achieved by placing the NCRR program in adjacency to existing (or in the case of NCATS, proposed) portfolio/mission of the recipient IC versus the existing synergies among the NCRR programs.
The “goodness of fit” for the NCRR program within the recipient IC versus the negative effects of adding a program that is disproportionately large and/or not well aligned to the recipient IC’s current (or in the case of NCATS, proposed) mission.
The level of disruption to long-standing NCRR programs led by dedicated NCRR staff versus the disruptive innovation from reassigning NCRR staff to enable interactions with new colleagues and/or new programs.
Posted on January 24th, 2011 by Francis S. Collins, MD, PhD; Josephine Briggs, MD; Anthony Fauci, MD; Eric Green, MD, PhD; Alan Guttmacher, MD; Thomas Insel, MD; Story Landis, PhD; Griffin Rodgers, MD, MACP; Harold Varmus, MD; Kathy Hudson, PhD; and Lawrence A. Tabak, DDS, PhD
By now, many of you have read the recent New York Times article or related news coverage, about NIH’s plan to establish the National Center for Advancing Translational Sciences (NCATS).
While we are pleased that the newsmediahave recognized NIH’s efforts as a significant development for translational research, the Times article contains some misleading statements that we would like to clarify. Those statements suggest that a much larger shakeup of NIH is underway than is actually contemplated.
So, to set the record straight, we want to share with you what we know at this point in time:
The proposal for NCATS is that it will be assembled primarily from existing programs within the National Center for Research Resources (NCRR), the NIH Common Fund, and the National Human Genome Research Institute (NHGRI).
NCATS is not intended to be a drug company. It is a facilitator of translational research across the NIH and complementary to translational research already being conducted and supported on a large scale in the individual NIH Institutes and Centers. NCATS will seek ways to leverage science to bring new ideas and materials to the attention of industry by demonstrating their value.
The final budget for the proposed center is unknown at the present time. For the most part, the budget and staff for each relocated program will remain with that program. Thus, the overall budget for NCATS will be the sum of the imported programs—an amount much smaller than the several billion dollars currently being spent on translational research by existing Institutes and Centers.
There are no plans to “cannibalize” the budgets or programs of other NIH Institutes and Centers to form NCATS.
NIH remains committed to continued support for basic, translational, and clinical research. The new Center will bring several existing efforts together in new ways to enhance the ability of all NIH Institutes and Centers to perform research that leads to the development of drugs, diagnostics, devices, vaccines, and strategies for prevention.
We are working together to develop important details of these plans and are gathering information from a wide range of internal and external stakeholders. This information will be used to shape NIH’s final vision for NCATS. Until that information is systematically and objectively evaluated, the plan for NCATS remains a work in progress.
However, one thing is certain: NIH will continue to seek out new ways to advance our common cause—improving human health through science—even in difficult budgetary times. Every NIH Institute and Center is pursuing novel, imaginative plans of its own, and the creation of NCATS is just one of many exciting initiatives that we, working collectively, hope to achieve this year.
Francis S. Collins, M.D., Ph.D., Director, National Institutes of Health
MEMBERS OF THE INSTITUTE AND CENTER DIRECTORS NCATS WORKING GROUP:
Eric Green, M.D., Ph.D., Director, National Human Genome Research Institute (co-chair)
Thomas Insel, M.D., Director, National Institute of Mental Health (co-chair)
Josephine Briggs, M.D., Director, National Center for Complementary and Alternative Medicine
Anthony Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases
Alan Guttmacher, M.D., Director, National Institute of Child Health and Human Development
Story Landis, Ph.D., Director, National Institute of Neurological Diseases and Stroke
Griffin Rodgers, M.D., MACP, Director, National Institute of Diabetes and Digestive and Kidney Diseases
Harold Varmus, M.D., Director, National Cancer Institute
Kathy Hudson, Ph.D., Deputy Director for Science, Outreach, and Policy, NIH
Lawrence A. Tabak, D.D.S., Ph.D., Deputy Director, NIH
