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Imaging Technologies Top Agenda for Critical Path Effort at FDA

SAN FRANCISCO, April 21 (GenomeWeb News) - The US Food and Drug Administration believes certain imaging technologies can help drug makers track the behavior of fluorescent probes and monitor drug response rates in clinical trials, according to a senior FDA official.


The FDA's interest in this area could speed the pace at which computed tomography, magnetic resonance imaging, and other technologies are applied to drug development, and will likely buoy research underway at companies such as GE Healthcare and Siemens.


Janet Woodcock, acting deputy commissioner for operations at the FDA, said the agency believes these technologies could eventually help physicians determine whether patients are responding to certain therapies. Woodcock spoke at the Molecular Medicine Tri-Conference, held here yesterday.


"We lack a mechanism for rapidly - or even slowly - tracing the response of cancer patients [to potential therapies] in clinical trials," Woodcock said. "We want to see imaging technologies put to use here" to gauge such endpoints as tumor size reduction.


As part of FDA's Critical Path Initiative, an effort to apply new strategies and technologies to streamline the drug-approval process, "imaging technologies are at the forefront of our efforts," Woodcock told an early-morning audience at the 12th annual conference for pharma and biotech researchers.


It has been clear that FDA wants to expand the arsenal of tools that drug developers and FDA reviewers have at their disposal, but Woodcock's statements mark a rare instance in which the agency has singled out imaging technologies for special mention.


As examples of how imaging could be applied to drug discovery and development, Woodcock mentioned the need to facilitate the use of molecular probes in early-stage clinical trials, especially those involving cancer. Creating a "master file" listing all the known probes for fluorescent or other imaging experiments could be one of the first steps toward making imaging more useful to drug developers and FDA reviewers, she said.


The range of imaging technologies applicable to clinical trials should also include molecular-level imaging techniques, Woodcock said. Conventional imaging tools that capture images at the cellular, tumor, or organ level are the most ripe for use in drug-development studies, she said, but more advanced technologies should follow closely behind.


In her talk Woodcock said that the FDA plans to take concrete steps in the near future to encourage partnerships that would move these hopes forward. The agency's goal, she said, is "to move quickly so that people are encouraged" and see that the FDA is more than just paying lip service to applying imaging technologies to drug development.


To that end, the agency is helping organize a joint workshop with the Drug Information Association for May 5-6 to "explore the potential role of imaging in the transition from preclinical to clinical drug development, including the comparative strengths and limitations of specific imaging modalities in various study stages," among other topics.

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