NIH is creating the National Center for Advancing Translational Sciences (NCATS) as a response to the growing body of basic research that is not being applied in the clinic. It will focus on the oft-neglected gray area between research and development—so-called translational medicine.
The center was created as a result of a review conducted by the NIH Scientific Management Review Board (SMRB) at the request of Francis Collins, Ph.D., NIH director, which he issued on May 19, 2010. The SMRB concluded that a successful translational medicine program could not be effected through incremental changes that augment and expand an existing body within the agency but instead would be achieved best through a bold, new, focused center systematically engineered to accelerate translation.
Dr. Collins expects to have the center up and running by October 1. The formation of NCATS largely dismantles the National Center for Research Resources (NCRR), which on January 16 reported that most of its programs would be spread across four NIH institutes. Documents released on NCRR’s website show that nine programs, including three of NCRR’s primate research centers, have not found a new NIH institute to call home permanently; while one is marked "not yet assigned," eight are under an Interim Infrastructure Unit.
"There are some programs within NCRR where the exact best answer for where they should be located is going to be difficult to arrive at in a short period of time," Dr. Collins explained in an interview with a ScienceInsider reporter. "And hence the idea of creating this interim unit for such programs to reside in until it becomes easier to determine what the right answer is."
NCATS will adopt NCRR’s Clinical and Translational Science Awards program as well as select projects from the National Human Genome Research Institute, the National Center for Research Resources, and the director’s common fund. For example, the new Cures Acceleration Network, which was authorized by the Affordable Care Act, would also be part of NCATS. These programs are together valued at over $700 million, according to The New York Times.
"The final budget for the proposed center is unknown at the present time," the NIH notes. "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."
The NCATS is expected to focus research efforts in areas that attract little commercial interest. In addition to strengthening and streamlining the process of developing small molecule compounds into drugs, the center says that it will 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.
As the NIH steps in to "de-risk drug development," the institute will have to rally support and up financing beyond the current $1 billion. Translational medicine is not just risky business, it is also expensive. While it is tough to quantify spending on only translation research, contract R&D was estimated to be a $42 billion in 2009, according to Kalorama Information.
Commenting on the establishment of NCATS, Bruce Carlson, publisher for Kalorama Information, comments, "It’s a positive development, especially for CRO firms, though the bulk of product development will still be handled by industry. New dollars entering into this market will provide some welcome opportunity for CROs, but it is small compared to what the industry will spend on R&D."
Considering that NIH’s investment is currently a small percentage of the industry’s, NCATS comes with its skeptics. Furthermore the GOP is threatening to cut funding for the NIH. That said there are many bases yet to be covered in biomedical research. "I am a little frustrated to see how many of the discoveries that do look as though they have therapeutic implications are waiting for the pharmaceutical industry to follow through with them," Dr. Collins told The New York Times. NCATS is still to be appointed a leader, and the months that ensue will bring into focus what projects it takes over from other NIH centers and where else it will spend its money.