The proposed National Center for Advancing Translational Sciences is one step closer to becoming a reality. This fall, the U.S. Senate Appropriations Committee approved its fiscal 2012 spending bill for the departments of Labor, Health and Human Services, and Education, which authorized the creation of NCATS as part of a broader restructuring of the National Institutes of Health that includes the termination of the National Center for Research Resources.
The bill also appropriates $20 million to activate the Cures Acceleration Network, a new NIH program that would be housed in NCATS. CAN, which was authorized but not funded in the healthcare reform bill that was signed into law in March 2010, will make grants to biotech companies, universities and patient-advocacy groups to develop what the bill’s authors dubbed “high-need cures,” and it will help facilitate FDA review for these therapeutics.
Thus far, the draft House appropriations bill contains no provisions for NCATS, though it does provide funding for CAN and the NIH Clinical and Translational Science Award program, which would be moved from NCRR to the new center if it is established. Final congressional approval of NCATS could come later this year if lawmakers approve a fiscal 2012 bill providing funding for the NIH.
Despite the uncertain funding situation, the NIH has been pressing ahead with plans for the translational research center. The NIH’s advisory committee to the director’s NCATS working group released a report Sept. 21 that identified seven key areas “ideally suited for NCATS activities”:
- 1. supporting and enabling high‐risk, high-reward projects for transforming, improving and accelerating the process of discovery, development and post‐market research for diagnostics, therapeutics and devices;
2. galvanizing and supporting new partnerships among the regulatory, academic, public, private and nonprofit sectors to address challenges in translational sciences;
3. collaborating with the Food and Drug Administration to conduct studies aimed at informing and improving the regulatory approval process;
4. encouraging the collection and analysis of data about failed projects so as to facilitate the open exchange of information regarding the scope, methods, analysis, results and lessons learned from research in the precompetitive space;
- 5. harnessing the power of the CTSA program by affording individual CTSAs flexibility in cultivating strengths and encouraging the formation of a strong national CTSA consortium;
6. promoting training in translational science by catalyzing novel training mechanisms, providing incentives for physician-scientists to seek cross-training in human biology and drug discovery, and exploring cross‐training of physicians and scientists between industry, academia and government labs; and
7. reviewing administrative processes at the NIH and NCATS to identify and overcome roadblocks to rapid and effective funding, management and termination of projects.
The report also identified areas that are ripe for innovation and inclusion into the NCATS portfolio. They include
- • target validation for rare and common diseases;
- • understanding and modeling drug toxicity;
- • systems pharmacology and how pharmacological agents affect cellular networks and contribute to pathology;
- • biomarkers and disease phenotyping;
- • new uses for established compounds;
- • imaging technologies;
- • developing more effective ways to incorporate FDA‐approved medical products into patient care; and
- • opportunities to collaborate with entities experimenting with the chemical space, including clean/green chemistry, inorganic chemistry and combinatorial chemistry.
The report emphasized that NCATS should not duplicate the translational research efforts of the other NIH institutes and centers or industry and that projects should be supported only until they attract commercial investment.