The critical path

Editor’s Note:  This story, first published in 2005, has been updated.

Bill Snyder
Published: July, 2005

Raymond L. Woosley, M.D., Ph.D.
Photo by Casey McKee
During the past 20 years, Raymond L. Woosley, M.D., Ph.D., has contributed to current understanding of anti-arrhythmic drugs, helped discover the antihistamine Allegra and promoted post-marketing drug surveillance.

In 2005 the former Vanderbilt and Georgetown researcher took on a new challenge—directing a non-profit institute in Tucson called C-Path—Critical Path to Accelerate Therapies.

A joint effort of the University of Arizona, the U.S. Food and Drug Administration and SRI International, the institute aims to help develop a new “toolkit” that can safely speed up drug development.

“Science has generated a lot of new information… but the process of drug development hasn’t advanced,” explains Woosley, who formerly was vice president of the University of Arizona Health Sciences Center. “Companies have tried to take the path that’s been trod before and they’re afraid to innovate because they’re afraid the FDA might not accept the change.”

Yet in a 2004 report entitled “Critical Path,” the FDA called for exactly that: “powerful new scientific and technical methods such as animal- or computer-based predictive models, biomarkers for safety and effectiveness, and new clinical evaluation techniques… to improve predictability and efficiency along the path from laboratory concept to commercial product.”

The types of adverse reactions that force drugs off the market occur in fewer than one in 10,000 patients, Woosley wrote in the Winter 2005 issue of Issues in Science and Technology. To have any hope of detecting these relatively rare events before marketing, phase 3 trials would have to be increased by more than 10 fold, to include more than 30,000 patients. That would “only further delay development and increase the price of drugs,” he wrote.

Instead, Woosley recommends a “staged” approval process, which would allow rapid approval for a carefully defined patient population, then gradual expansion to other patient groups as long-term safety and efficacy is established. “This approach is similar to the way in which several AIDS drugs, such as the protease inhibitors, were developed and translated into clinical practice in two to four years,” he wrote.

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