Specter Proposes Innovative Agency to Accelerate Cures for Diseases
Cures Acceleration Network aims to bridge "Valley of Death"
Tuesday, April 28, 2009 -
U.S. Senator Arlen Specter today introduced legislation that seeks to bridge the chasm between a basic scientific discovery and a new health treatment. The Cures Acceleration Network (CAN) Act would create an independent agency dedicated to advancing science from the laboratory into practice.
"The Cures Acceleration Network will turn discoveries in biomedical research into better health for the American people," Specter said. "We must do this on the scale and with the focus of the way we sent astronauts to the moon. And we need to start now. Americans battling cancer, autism, Alzheimer's, Parkinson's, diabetes and so many other dreaded diseases have not a minute to waste."
Many biomedical discoveries with the potential for development never advance beyond publication in a scientific journal due to a lack of resources or insurmountable red tape. The issue is so prevalent that researches have coined the term "the valley of death" to describe why promising discoveries, such as genes linked to cancer and Parkinson's disease, languish in the laboratory. The CAN Act seeks to release this untapped scientific knowledge with great potential for health and economic benefits.
The CAN Act would address the barriers in translational research by accomplishing two things: 1) establishing an independent agency known as the Cures Acceleration Network (CAN) to fund promising discoveries, and 2) reauthorizing the National Institute of Health (NIH) at a funding level of $40 billion in fiscal year 2010.
The CAN Act would fund two types of grant awards, each with an authorization of $1 billion in the first year and additional funds in succeeding fiscal years.
1) The Cures Acceleration Grant Awards will provide grants of up to $15 million per year per project with out-year funding available. These awards would be available to applicants who do not have access to private matching funds.
2) The Cures Acceleration Partnership Awards also would provide grants for up to $15 million per year per project with additional funds available in the out-years. However, grant awards would require a match of three Federal dollars to one grantee dollar, as a way to partially offset development costs.
For both grant types, the CAN Board may waive the award limitation as well as modify the matching requirement. Eligible grantees would include biotech companies, universities, patient advocacy organizations, pharmaceutical companies and research institutions.
To provide for expedited FDA approval, the grantees must establish protocols that comply with FDA standards to meet regulatory requirements at all stages of medical product development, review and approval. The provisions of the Bayh-Dole Act would apply.
The CAN grant proposals would be evaluated by a 24-member board comprised of experienced individuals of distinguished achievement and representative of a broad range of disciplinary interests including: venture capitalists and business executives with experience in managing scientific enterprises; scientists with expertise in the fields of basic research, biopharmaceuticals, drug discovery, drug delivery of medical products, bioinformatics, gene therapy or medical instrumentation, regulatory review and approval of medical products; and representatives of patient advocacy organizations.
A listing of groups that support the CAN Act, the Senator's floor remarks and the legislation are attached.