FDA unveils project to advance medical product innovations

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Health and Human Services (HHS) Secretary Mike Leavitt and the FDA recently released a list of research projects developed to advance innovation in medical products. The project – called the Critical Path Opportunities List – part of the FDA's Critical Path Initiative, is targeted towards modernizing medical product development and to get these innovations to market more quickly, according to a release.

The Opportunities List of 76 projects is a starter list with the hope of getting rid of the gap between biomedical discoveries and actual therapies available to patients who are sick right now. It is hoped that the Critical Path Initiative will make big gains in modernizing the drug development process by 2010.

"This Opportunities List enhances the health and well-being of Americans by fostering strong, sustained scientific advances in medicine to better public health," said Leavitt said. "Medical product development relies on cutting-edge scientific tools to help identify promising medical discoveries and target testing for benefits and risks when they are used by patients." 

A 2004 Critical Path Report organized by the HHS predicted a slowdown in the development of innovative medical therapies, and proposed an FDA-sponsored long-term initiative to address the problem.

"Right now, researchers are trying to bring 21st century medical innovations to market using 20th century tools to evaluate them. Under the Critical Path Initiative, we anticipate being able to dramatically increase the success rate in moving products from the lab to the patient," said Andrew C. von Eschenbach, MD, acting FDA Commissioner who is awaiting confirmation. "The keys to a smarter more modern medical product development process are the standardization of new tools to test potential products along with the unprecedented integration of information within government, industry and academic partnerships."

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. FDA's said that it believes that the two most important areas for improving medical product development are biomarker development and streamlining clinical trials.

Biomarkers are measurable characteristics in animals or humans that can help predict the performance of a product during development, reducing uncertainties about safety or effectiveness.

"Most researchers agree that a new generation of predictive biomarkers would dramatically improve the efficiency of product development, help identify safety problems before a product is on the market [and even before it is tested in humans], and facilitate the development of new types of clinical trials that will produce better data faster," said Janet Woodcock, MD, deputy commissioner for operations, head of FDA's Critical Path Initiative. "Similarly, researchers stressed that reforming the clinical trial process -- both trial design and trial conduct -- would dramatically improve the efficiency of product development, which means getting products to patients faster at less cost," Woodcock said.

Accomplishment of the research priorities will require unprecedented collaboration among public and private sector partners. The FDA plans to bring together partnerships and consortia to accomplish a majority of the projects. Over the next few weeks, the FDA will identify several priority Critical Path research opportunities. Some of the projects in the list could be undertaken by one organization; some will require collaborations coordinated and supported by the FDA.

For more information visit: http://www.fda.gov/oc/initiatives/criticalpath/