The National Center for Advancing Translational Science (NCATS) begins life with funding of $576,456,000 for fiscal 2012, 20% less than the $721,601,000 that National Institutes of Health Director Francis Collins had requested.

A major chunk of the decrease is the result of appropriators’ decision to slash funds for the first year of the Cures Acceleration Network (CAN) from the requested $100 million to $10 million. When Congress created the program as part of the Affordable Care Act, legislators pegged its initial funding level at $500 million.

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The small amount of money for CAN may not be such a bad thing, NIH Deputy Director for Science, Outreach and Policy Kathy Hudson said in a Dec. 21 interview. It gives NCATS time to develop the policies and infrastructure to implement matching grant and flexible funding options associated with the program before large amounts of money must be disbursed.

The NCATS funding is part of $30.7 billion provided for NIH in the comprehensive appropriations package signed into law by President Obama Dec. 23. That figure represents an increase of $299 million compared to the NIH budget in fiscal 2011.

NCATS was created by shifting translational science programs from other parts of NIH into the new entity, and adding CAN. Since NCATS’ existence would be effective with the president’s signature on the bill, NIH took a lot of steps in anticipation of the transition so “work can continue without disruption,” Hudson noted in the interview Also see "NIH Repurposing Of Failed Compounds Could Begin Soon; NCATS Plans Pilots" - Pink Sheet, 2 January, 2012..

The major component of NCATS is the Clinical and Translational Sciences Awards (CTSA) program, which came from the National Center for Research Resources, which was disbanded in the reorganization and whose grants programs are assigned to several NIH components.

CTSA is to receive at least $487,767,000 in fiscal 2012, a bump up of about $30 million from FY ’11. Other than the $10 million for CAN, the law does not specify how funding is to be distributed for the center’s other programs. However, a report from conferees who ironed out differences in the House and Senate appropriations bills says funding for the Therapeutics for Rare and Neglected Disease program should continue at $24 million.

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Market Models To Take Precedence

Although NIH had prepared for NCATS, the status of the new center remained in doubt until House and Senate conferees unveiled the final appropriations package of the year on Dec. 15, providing money for the bulk of government operations, including $69.7 billion for the Department of Health and Human Services. The original House spending bill for HHS did not include money for NCATS; the Senate version did.

Conferees created the new center because of “the need to develop models to assist research universities and institutes on the best ways to leverage and commercialize federally supported basic and applied biomedical research discoveries,” the conference report states. “This is the key reason why the conferees have agreed to create NCATS.”

But the conference report notes that public/private efforts in this area are beginning to show results and urges NIH to study and foster these models, which use pre-defined technology licensing terms to rapidly license new products and build a core of options for commercialization partnerships with pharmaceutical and biotechnology companies.

House and Senate conferees also warn that NIH-supported partnerships should “not inhibit creative market models.” Top priorities should be to develop tools to advance drug development “to the point at which it can reasonably be expected to be picked up by the private sector.”

Towards that end, they suggest that one criterion in selecting NCATS projects should be future market acceptance.

Conferees also urge NCATS to undertake the following activities:

A workshop with key research organizations, venture capitalists, pharmaceutical companies, the Patent and Trademark Office and FDA to consider how existing NIH and government mechanisms can be incorporated into market-based approaches for speeding commercialization of therapies;
Support for a study by the Institute of Medicine to evaluate the CTSA program and determine whether changes in the current mission are needed;
Request another IOM study on ways to accelerate development of cures in high-need areas, including an inventory of current activities in this area and a look at “patent authority, marketability, use of high-throughput analysis, regulatory timelines and cost structure issues related to the purpose of CAN;” and
An annual report on the Therapeutics for Rare and Neglected Diseases program on the number of projects started each year and each project’s cost and outcome; TRND was created at NIH in 2009 to ready compounds for licensing to biotech or pharmaceutical companies Also see "NIH Rare Diseases Project Could Have Broad Effect On Personalized Medicine" - Pink Sheet, 21 June, 2010..

Clinical Activities Limited

The appropriations bill includes not only funding for NCATS, but also the legislative language to create the center, whose purpose is to coordinate and develop resources that leverage basic research in support of translational science.

The laws’ authors again are careful to warn against infringement on market activity. They give NCATS a directive of “developing partnerships and working cooperatively to foster synergy in ways that do not create duplication, redundancy and competition with industry activities.”

While NCATS may develop infrastructure for clinical trials, the law limits NCATS support for trials through the end of Phase IIa. An exception is made for therapies for a rare disease or condition. In those cases, support can be provided through the end of Phase IIb, as long as the center provides 120 days advance public notice of its intent, receives no credible written notification that another public or private organization has timely plans for trials of a similar nature beyond phase IIa, and ensures there will be no increased federal government liability beyond the award value of the support.

NCATS is to publish an annual report containing a complete list of molecules studied; clinical trial activities being conducted; methods and tools in development; ongoing partnerships, with information such as the activities transferred to industry as a result of the partnership; and known research that will expand on the research activity of the center.

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