Arizona Biosciences News

New grants cement C-Path's role in setting research, treatment standards

Compiled from media reports

Summary:

Tucson's Critical Path Institute (C-Path) has announced details of two new grants to fund collaborations that will buttress its leadership role in setting standards for pharmaceutical research and patient treatment regimens. Separately, Gov. Janet Napolitano cited that distinctive role as she presented C-Path with an Arizona Innovation Award.

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Less than a month after celebrating the passage and signing of the landmark Safe and Effective Drug Development Act, the Critical Path Institute (C-Path) has announced details of two grants that will further buttress its leadership role in setting standards for pharmaceutical research and patient treatment regimens.

Both grants reflect C-Path's mission, to help implement the Critical Path Initiative of the Food and Drug Administration (FDA) by developing faster, safer, and smarter pathways to new medical products. The grants involve new collaborations between the Tucson-based nonprofit and research partners in government, academia, and industry.

C-Path's two-year, $2.1 million grant from Science Foundation Arizona will fund a cooperative effort with Ventana Medical Systems Inc. of Tucson to develop a set of standards for the FDA to employ when it evaluates diagnostic tools used in conjunction with drug therapies. Currently, C-Path and Ventana officials said, the FDA has no defined procedure for how it assesses diagnostics; consequently, diagnostics receive approval far too slowly, and no structure exists for co-submitting drugs and their companion diagnostics for FDA approval.

Ventana, which began as a developer of instruments for automated tissue-sample preparation and slide-staining, has become a world leader in cancer diagnostics. Its tools enable researchers and pharmaceutical developers to evaluate drug-compound safety and identify which subsets of patients will respond best to particular drugs or compounds. Such precise tailoring of treatment, involving the identification of individuals' genetic characteristics, forms the core of the emerging field of personalized medicine.

Under the grant, C-Path's new U.S. Diagnostics Standards (USDS) program will work to establish standards for diagnostics, and a pilot effort will apply the standards being developed to one of Ventana's companion diagnostics for lung cancer. That focus has drawn the support of both the FDA and the National Cancer Institute (NCI).

Ultimately, C-Path expects that USDS will yield a national laboratory in Arizona to provide independent assessment of new diagnostic tests, giving the FDA confidence in the reliability of tests submitted for its approval.

"The award from Science Foundation Arizona will fund an important step toward making the next generation of important patient care solutions a reality," said Jeffrey Cossman, C-Path's Chief Scientific Officer and the project's principal investigator. "The ultimate goal of the project is to guide the choice of targeted therapy so that patients receive the most effective treatments."

C-Path's second new grant—totaling $4 million over four years—comes from the federal Agency for Healthcare Research and Quality (AHRQ). The grant provides an extension of support for the Arizona Center for Education and Research on Therapeutics (AzCERT), one of 14 centers nationwide that AHRQ supports.

AzCERT, operated jointly with the Center for Health Outcomes and PharmacoEconomic Research in the University of Arizona's College of Pharmacy, was established with an emphasis on detection and prevention of adverse drug reactions, supporting C-Path's broader mission. The new grant will expand existing education and research programs, which particularly concentrate on preventing adverse drug reactions in women.

Each of the 14 CERTs nationwide focuses on a particular realm of education and research under the umbrella of increasing awareness of the benefits and risks of new, existing, or combined uses of therapeutics. The centers are designed to encourage extensive collaboration with private and public partners, and to disseminate findings broadly—to the general public, to other teams of researchers, and to policymakers.

One of AzCERT's signal achievements to date has been a collaborative effort with the FDA's Center for Drug Evaluation and Research to compile and make available online an educational module on adverse drug reactions. Other projects include a medication "webliography," which provides consumers a list of recommended websites for accurate drug information, and several tools to assist healthcare professionals in safely prescribing and dispensing medications.

Recognizing such efforts to strengthen drug safety and streamline the process of bringing new therapies to patients, Gov. Janet Napolitano presented C-Path with an Arizona Innovation Award on Oct. 18 at a ceremony in Tucson.

"Having assets such as C-Path, whose purpose is bringing promising medications, therapies and devices to market, is vital not just to Arizona's economy, but to public health, as well," Napolitano said.

Napolitano established the Arizona Innovations Awards in March as an outgrowth of her role chairing the National Governor's Association, where she led an "Innovation America" initiative. Other award winners include UA biosystems engineering professor and entrepreneur Mark Riley, Phoenix-based Provista Life Sciences, Tempe-based Kinetic Muscles and Cranial Technologies, and Kingman Regional Medical Center.


For more information:

"C-Path, Ventana to work with FDA on cancer patient-therapy matches," The Arizona Daily Star, 10/11/2007

"Drug safety center wins $4 million grant," The Arizona Daily Star, 10/17/2007

C-Path news release

Office of the Governor news release