What is “CAN” and Why Should You Care? 

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By Lyle Dennis, Cavarocchi - Ruscio - Dennis Associates, LLC, Consultants to AASLD

Among the many new programs contained in the recently-enacted health insurance reform bill signed by the President on March 24 is a provision establishing something called the “Cures Acceleration Network” (CAN) at the National Institutes of Health. 

While most of the bill was focused on insurance and clinician related reform issues, Section 10409 of the legislation created a new research program specifically designed to bridge a gap in the therapeutic development pipeline between basic and clinical research – the so called “valley of death.” Funding for the program was authorized in the law at $500 million in the first year and at “such sums as may be appropriated” for the four years thereafter. The actual amount available will be established by the Appropriations Committees in the Fiscal Year 2011 appropriations bill that funds NIH. The law stipulates that only funds specifically appropriated for the CAN program may be used to fund its grants. Money may not be shifted from the institutes and centers, nor can it be taken from the Common Fund, for this program.

The Network will be overseen by the NIH Director, in whose office it will reside and who may award three new types of grant mechanisms of up to $15 million per year per project to entities including universities, biotech companies, medical centers, disease advocacy organizations and patient advocacy groups. The grants are to be paid in “one payment” to the approved grantees.

Cures Acceleration Partnership Awards would be one new type of grant mechanism that would require the grantee organization to match the NIH award at $1 for every $3 awarded. The Cures Acceleration Grant Awards would not require a match. Cures Acceleration Flexible Research Awards would give the NIH Director flexibility to use up to 20 percent of CAN appropriations for transactions other than grants, contracts, or cooperative agreements.

The law calls on the NIH Director to establish a Cures Acceleration Network Review Board to be composed of 24 members from the fields of “basic research, medicine, biopharmaceuticals, discovery and delivery of medical products, bioinformatics and gene therapy, medical instrumentation, and regulatory review and approval of medical products. At least four must be from venture capital or private equity organizations and have experience in private equity investing. At least eight must represent disease advocacy organizations.”

The provision is based on legislation originally introduced by Senator Arlen Specter (D-PA). In its initial formulation, the program would have been authorized at a level of $1.0 billion and would have been created as a freestanding entity. The authorizing committee working on health care reform cut the size in half and moved it into NIH to ensure greater coordination with the rest of the biomedical research enterprise.

Researchers with an interest in this aspect of the field will want to watch grants.gov for announcements. Although money has not yet been appropriated for this program, it is certainly possible that NIH will move quickly to set up the mechanism for eligible groups to apply so that it will be ready to move quickly when funds become available.

This electronic newsletter is a bi-weekly publication of AASLD and replaces the former bi-monthly print newsletter and weekly e-news. Members are welcome to submit articles and may send suggestions to aharan@aasld.org.