NIH Names Dr. Christopher Austin as NCATS Director at the Joint Initial Meeting of the NCATS Advisory Council and CAN Review Board

Legislative Update
September 14, 2012

New NCATS Director Christopher Austin, M.D.

Today, National Institutes of Health (NIH) Director Francis Collins, M.D., Ph.D. announced Christopher Austin, M.D. as the Director of the National Center for Advancing Translational Sciences (NCATS). Dr. Austin, who previously served as Director of the NCATS Division of Pre-Clinical Innovation, received his medical degree from Harvard Medical School, where he performed a fellowship in developmental genetics of the retina. His first NIH grant was a Clinician-Scientist Award from the National Eye Institute (NEI). He succeeds NCATS Acting Director Thomas Insel, M.D., who continues to serve as the Director of the National Institute of Mental Health (NIMH).

The announcement was made at the first meeting of the NCATS Advisory Council, which was held jointly with the Cures Acceleration Network (CAN) Review Board-both entities were legislatively mandated. CAN, which was authorized by the Patient Protection and Affordable Care Act of 2010 [P.L. 111-148] as an NIH program to move research quickly from “bench to bedside,” was put into NCATS when the latter was established as NIH’s centralized translational research authority in the Fiscal Year (FY) Appropriations Conference Agreement [P.L. 112-74]. FY2012 CAN funding is $10 million, while overall NCATS funding is $575 million, driven primarily by the Clinical and Translational Science Awards (CTSA) program.

In his opening comments, Dr. Insel noted that NCATS’s mission is to find a “different way of doing business’ as it relates to the translation of basic research into diagnostics and therapeutics, which includes drugs, devices, and biologics. Although NCATS will serve as a catalyst for collaborations and can develop the infrastructure and support for clinical trials, it may not conduct these past Phase IIA. Specific goals include addressing the bottlenecks in translation, developing collaborations within and outside of the NIH, and engaging the advocacy community, especially as it relates to the NCATS portfolio.

Dr. Collins welcomed the attendees, noting their participation in this process of “disruptive innovation.” Rather than provide prepared remarks, he addressed questions about NCATS and CAN implementation. Highlights included:

• NIH Budget and Sequestration: Although noting that the President’s FY2013 budget request increases NCATS funding to $639 million, primarily due to a $40 million CAN increase, he was uncertain of the outcome of the appropriations process since Congress was preparing to vote on a six-month Continuing Resolution (CR) to fund the government in FY2013 at the FY2012 level. Regarding sequestration-the mandatory budget cuts to defense and non-defense discretionary funding scheduled to take effect on January 2, 2013-he reiterated his comments that it would have a “devastating” impact on NIH, cutting its budget by $2.4 billion and primarily affecting new and competing grants.
  


• Collaboration with Other DHHS Agencies: Dr. Collins noted that Department of Health and Human Services (DHHS) “sister” agency, the Food and Drug Administration (FDA), was represented at the meeting by Commissioner Margaret Hamburg, M.D., who serves as an Ex-Officio member. Both Dr. Hamburg and Dr. Collins spoke about FDA’s pivotal role in providing insights into the regulatory approval process, especially since NCATS’s purpose is to fast-track developments of therapeutics. Dr. Collins noted the establishment in 2010 of a joint NIH/FDA Leadership Council which has already resulted in numerous collaborations. He also announced that he recently met at length with Centers for Medicare and Medicaid Services (CMS) Acting Administrator Marilyn Tavenner to engage the agency in identifying the data it needs to make coverage decisions for new therapies and to discuss cost-effectiveness and patient-centered outcomes research issues.

The remainder of the day’s meeting was spent discussing the CTSA and Pre-Clinical Innovation programs at NIH, seeking attendee comments about barriers in translational research.

NIH Director Dr. Collins responds to participant questions as former NCATS Acting Director Thomas Insel, M.D. looks on

FDA Commissioner Margaret Hamburg, M.D., shown here at the February 24, 2010, release events for the new joint NIH/FDA leadership Council, attended the initial NCATS Advisory Council/CAN Review Board meeting as an Ex Officio member