President signs Rep. Giffords’ bill, opens doors for C-Path

October 4, 2007

By hammersmith

Nine months into her first term, U.S. Rep. Gabrielle Giffords of Tucson has had her first bill signed into law, a professional milestone that is also a boon to the Tucson-based Critical Path Institute (C-Path).

On Sept. 27, President Bush signed the Food and Drug Administration (FDA) Amendments Act of 2007, which codifies additional funding and greater authority for the FDA to address drug-safety concerns.

One portion of the act contains Giffords’ bill, the “Safe and Effective Drug Development Act,” which authorizes expanded collaborations between the FDA, universities, nonprofit research teams, and private industry to achieve quicker and safer development of new pharmaceuticals.

Giffords announced the bill’s signing on Sept. 28 at the Arizona Cancer Center in Tucson, where she was joined by Raymond Woosley, C-Path’s president and CEO, along with David Alberts, director of the Arizona Cancer Center, and Gregory Pivirotto, president and CEO of the University Medical Center.

“Patients will be the [bill’s] ultimate beneficiaries by having access to potentially life saving therapies faster, with greater assurance of their safety,” Giffords said.

The bill authorizes the FDA to create “critical path public private partnerships” between the FDA and universities or nonprofit entities, a model that Dr. Woosley says C-Path has demonstrated successfully since it was founded in 2005. He worked closely with Giffords’ staff as she wrote the original bill.

“The public private partnerships authorized in this bill make it possible for the FDA to collaborate with university scientists like those here in the Arizona Cancer Center and scientists working in industry who have ideas and tools to better test new drugs,” Dr. Woosley said in his remarks following Giffords’ announcement.

Raymond WoosleyC-Path is a publicly funded, nonprofit research and education institute to serve as a trusted third party for collaborations between scientists and others from government, industry, and academia. C-Path was founded jointly by the University of Arizona, the FDA, and SRI (formerly the Stanford Research Institute). Its mission is to help implement the FDA’s Critical Path Initiative by developing faster, safer, and smarter pathways to new medical products.

Dr. Woosley cited as an example of C-Path’s work the Predictive Safety Testing Consortium, which gathers scientists from the 16 largest pharmaceutical companies and scientists from the FDA and its European and Japanese counterparts to share laboratory best practices for testing drug safety.

“Early results have identified tests that should shave years off the process and actually increase our ability to detect potentially toxic drugs before they enter human testing,” Dr. Woosley said.

The signing of Giffords’ bill will make available as much as $5 million in new funding for C-Path to pursue, Dr. Woosley told the Business Journal of Phoenix.

“The southern Arizona community created C-Path and Congresswoman Giffords has now made the concept behind C-Path a part of our federal government,” Dr. Woosley said. “This legislation will save lives and increase our nation’s return on its investment in biomedical research.”

For more information:

Bush signs Giffords’ bill to speed safer drugs to market,” Tucson Citizen, 09/29/2007

New federal law paves way for CPath, others in drug development field,” Business Journal of Arizona, 09/28/2007

Critical Path Institute