FDA's Critical Path Opportunities List to prioritize, streamline medical product development

By Lisa Kerner

Erie, Pa., March 16 - Health and Human Services secretary Mike Leavitt announced a Critical Path Opportunities List, intended to bring new medical discoveries to patients faster and less expensively, according to a Food and Drug Administration news release.

The announcement is the next major step in the FDA's Critical Path Initiative and is intended to modernize medical product development by 2010.

"Right now, researchers are trying to bring 21st century medical innovations to market using 20th century tools to evaluate them," acting FDA commissioner Dr. Andrew C. von Eschenbach said in the release.

"Under the Critical Path Initiative, we anticipate being able to dramatically increase the success rate in moving products from the lab to the patient."

The Opportunities List outlines an initial 76 projects as a starting point in identifying priorities for accomplishment under the Critical Path Initiative. The list was developed using feedback from the agency's 2004 Critical Path Report.

The Critical Path Opportunities Report is organized into six broad topic areas: development of biomarkers, clinical trial designs, bioinformatics, manufacturing, public health needs and pediatrics. Biomarker development and streamlining clinical trials were the two most important areas uncovered by the FDA.

Over the next few weeks, the FDA said it will identify several priority Critical Path research opportunities that could be undertaken by one or more organizations.

One opportunity, just announced, seeks to develop guidance on the use of standard biomarkers to predict safety in drug development. This research will be coordinated by the Critical Path Institute and carried out by a newly formed Predictive Safety Testing Partnership including: Bristol-Myers Squibb Co., Johnson & Johnson, Merck & Co., Novartis and Pfizer. The FDA will assist it in an advisory capacity, according to the release.

"It is important to note that the list released today is meant to spur a continued dialog among industry, academia, patient and professional groups and government organizations about the research priorities that need to be accomplished in our effort to modernize the medical product development process," deputy commissioner for operations and head of FDA's Critical Path Initiative Dr. Janet Woodcock said in the release.

"We believe it is crucial to build a national infrastructure to support and continually improve the Critical Path Initiative. Therefore, we must reach beyond specific opportunities and build collaborations to work together to encourage continued development of the Critical Path sciences."

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