The Critical Path Institute’s new presence in Washington, DC, may help fuel its pharmacogenomics research, particularly drug-diagnostic co-development partnerships.
Earlier this month, the Tucson, Ariz.-based non-profit opened an office in the nation’s capital, which placed it in the midst of Congress, regulatory agencies, research organizations, and biotechnology companies. The new digs will likely help raise the profile of C-Path initiatives, including the institute’s PGx efforts.
“One of the reasons we opened offices there is so much of our work is with the NIH and the FDA,” C-Path Chief Scientific Officer Jeff Cossman told Pharmacogenomics Reporter last week. “We interact with scientists and leaders there so regularly that we need to have face-to-face contact with them. We’ve been involved on [Capitol] Hill as well.”
Cossman highlighted several PGx-focused research projects to gauge the clinical utility and validity of genetic tests for lung cancer drugs and the anticoagulant warfarin.
Last June, C-Path, in partnership with the University of Utah, received a $2 million, three-year FDA grant to evaluate the clinical validity and utility of genetic tests used to predict safer doses of warfarin. The university performed the 200-patient clinical study and C-Path is currently evaluating the methods used in the study to assure the FDA that the study results can be used to write dosage guidelines for warfarin based on genetic testing.
The FDA grant will also be used to evaluate biomarkers that predict the safety of cardiovascular drugs.
“One of the factors that have limited development of biomarkers is the lack of a clear path to FDA approval for such assays,” C-Path says on its website. “The results of this C-Path project should identify such a path to approval and would aid pharmaceutical and diagnostic companies as they develop new drugs and diagnostics. The new process created by the FDA for this project could serve as a model pathway for other personalized medicines.”
The institute is engaged in another warfarin study with the National Heart, Lung, and Blood Institute, which will follow 2,000 patients across 17 research centers to evaluate 10 genetic tests used to determine warfarin dosing. The study, which will also determine how factors such as age, gender, and weight might impact patients’ warfarin response, could lead to new pharmacogenetic dosing algorithms to reduce adverse events.
The FDA is in the process of updating warfarin’s label with genetic testing information. “The results of this study may inform drug label recommendations,” FDA states on its website.
C-Path is also working on a prospectively designed lung cancer study with the NCI. The study, slated to launch at the end of the year, will evaluate tests that gauge whether patients will benefit from anti-EGFR therapies.
According to Cossman, these research efforts will serve as models for FDA to issue guidelines about PGx and Rx-Dx codevelopment.
Traditionally, “the diagnostic companies … have developed their products independently,” he said. “But there has been strong calls from the FDA to companion diagnostics with drugs so you can personalize treatment. FDA would like to see [diagnostics] products submitted in parallel to drugs. So we’re trying to help create models for them. That’s what the warfarin and lung cancer projects are about, they’re models” for drug-diagnostic codevelopment.
C-Path will submit the findings from these studies to the FDA. The agency will then use the data as the evidence base for issuing guidances. FDA is slated to release a guidance on drug-diagnostic codevelopment this year.
“FDA doesn’t get a lot of funds for Critical Path opportunities. This would be another way to do that sort of thing.” The Reagan-Udall Institute “would be a foundation for the FDA, similar to the NIH Foundation for the NIH. This would be a funding source for the Critical Path activities.”
Following the Money
The C-Path Institute’s presence near Capitol Hill will help in advocacy efforts to garner more funding for all its research activities, including those that are focused on personalized medicine and PGx.
One such bill, the “Safe and Effective Drug Development Act of 2007” (H.R. 2592), aims to encourage the formation of public-private partnerships to advance innovations in medical treatments.
The bill, introduced in the House on June 6 by Rep. Gabrielle Giffords, a Democrat from Arizona, would commit $5 million to fund public-private partnerships under the aegis of the Critical Path Initiative.
According to Cossman, the institute was instrumental in helping to craft the language for the bill, and its proximity to Congress will likely open more opportunities to ask for additional federal funding for Critical Path efforts.
The House bill is related to a Senate bill, “Enhancing Drug Safety and Innovation Act of 2007” (S.484), to create the Reagan-Udall Institute for Applied Biomedical Research, which would essentially be a funding organization for FDA’s C-Path efforts. “The purpose of the Institute is to advance the Critical Path Initiative of the Food and Drug Administration to modernize medical product development, accelerate innovation, and enhance product safety,” the text of the legislation states.
“FDA doesn’t get a lot of funds for Critical Path opportunities. This would be another way to do that sort of thing,” Cossman said. The Reagan-Udall Institute “would be a foundation for the FDA, similar to the NIH Foundation for the NIH. This would be a funding source for the critical path activities. The House bill is linked to this [bill] in that it authorizes the forming of these public-private partnerships.”
According to the bill, the Reagan-Udall Institute would be located within 20 miles of Washington, DC.