FDA to partner with industry, academia as it moves further down ‘Critical Path’

The FDA said yesterday it will partner with the pharmaceutical industry and academia to further its efforts in speeding up drug development times under the Critical Path Initiative. First, the agency issued a call to industry and the academic community to take on 76 specific projects designed to aid in bringing drugs to market more safely and efficiently. These research projects, if accomplished, will modernize the drug development process by 2010 and help get medicines to patients quicker and at a lower cost, the FDA said. The challenge was issued in the form of a list called the Critical Path Opportunities List—developed on the basis of feedback to the FDA’s 2004 Critical Path report, a diagnosis of the slowdown in the development of innovative therapies followed by a proposed long-term initiative to address the problem. The agency also announced yesterday the formation of a consortium between the Critical Path Institute—the independent, publicly funded, nonprofit organization dedicated to the Critical Path Initiative and co-founded by the FDA, the University of Arizona and SRI International—and some of the world’s largest pharmaceutical companies. Member companies include Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Pfizer, Roche and Schering-Plough. The goal of the consortium is to enable these companies to share knowledge and resources, the agency said in a statement. This will allow pharmaceutical companies to determine which of the lab tests they have developed individually should be recommended by the FDA to screen drugs and better understand the potential side effects before the drugs enter clinical testing in humans. “This is a very important opportunity for the FDA to transform the opportunities in being able to care for patients and for the public . . . a major step forward in the FDA’s Critical Path Initiative to personalize medicine,” said acting FDA commissioner Andrew von Eschenbach during a press conference held to announce the agency’s new initiatives. “This is the public and the private sector together joining in an effort to be able to modernize opportunities in product development. This is more than just the iteration of a list of initiatives. This really signals a major step forward in creating the FDA of the future. An FDA that will be science led and that will be facilitating the progress that we must make to best serve patients and the public.” Health and Human Services secretary Mike Leavitt said, “The power of public-private partnerships is vital to accomplish the tasks set forth in the Critical Path opportunities list. The predictive safety-testing consortium is a prime example of the collaborative culture that must exist to modernize the development process. The collective sharing of scientific information and research across the entire healthcare community is crucial to ignite the medical innovation required to keep pace with biomedical research.”