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.

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.