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FDA, Beckman Coulter, Dharmacon, Cancer Research UK


Imaging Technologies Top Agenda for Critical Path Effort at FDA

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 fluorescence imaging, automated microscopy, computed tomography, and magnetic resonance imaging are applied to drug discovery and development.

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 Molecular Medicine Tri-Conference held in San Francisco last week, GenomeWeb News, a Cell-Based Assay News sister publication reported.

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 goals, 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.

Beckman Coulter Leases New Facility Near Los Angeles

Beckman Coulter is one of the new tenants in a newly constructed office park in southern California, according to local news reports last week.

The 138-acre Chino South Business Park, developed by Oltmans Construction Co. and Carson Co., comprises a 182,000-square-feet lease and a 137,000-square-foot lease.

The building that will house Beckman Coulter is located in Chino, west of Los Angeles, and is a "concrete tilt-up structure" designed by RGA Architects of Irvine, Calif., according to Beckman is headquartered in Fullerton, located southwest of Chino.

The website quoted Matt Vanderhorst, president of the Carson Cos., as saying that Beckman Coulter leased the new facility. The size or duration of Beckman's lease was not immediately known.

When completed, the Chino South Business Parkwill have 2.5 million square feet of real estate, and "is designed for major distribution operations as well as companies that require extensive and sophisticated tenant improvements," the website reported. It added that Fischer Scientific is currently an occupant with a 162,000 square-foot lease.

Dharmacon to Supply siRNA Libraries to Cancer Research UK

RNAi reagent provider Dharmacon said last week that it has signed a deal to provide its siRNA libraries to Cancer Research UK for use in drug discovery and development.

According to Dharmacon, the libraries will initially include protein kinase genes and associated pathways. They will be used by Cancer Research UK scientists studying signal transduction, protein phosphorylation, secretory pathways, and biochemical regulatory mechanisms.

If this research is successful, Cancer Research UK intends to use larger siRNA libraries, Julian Downward, principal scientist at the Signal Transduction Laboratory at the research institute, said in a statement.

Specific terms of the arrangement were not disclosed.


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