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MDS Pharma opens large Phase I unit

By Kirsty Barnes, 28-Jan-2008

Related topics: Clinical Development, Phase I-II

MDS Pharma Services has opened its new Phase I clinic in Arizona - the largest of its kind on the US west coast.

Built to the tune of $25m, the new 300-bed facility more than triples the capacity of the firm's Phase I presence in Phoenix, which combined with a nearby existing unit, totals 420 beds.

One of the therapeutic focus areas at the new clinic is ophthalmology, and there is an on-site centre dedicated to this specialty area, which "saves time on studies requiring examinations by optometrists and ophthalmologists," a company spokesperson told Outsourcing-Pharma.com.

The facility also has a cardiac safety testing centre with 65 beds. The spokesperson said: "It uses a leansigma-optimised process that allows QTc studies to be run in large groups, expediting these important studies."

"Twice as many participants can now be enrolled on study at one time without a significant change in staffing requirements. This has reduced overall study timelines for clients while maintaining economic feasibility of conducting QT trials."

There is a trend towards conducting QTc studies in Phase I because they need to be done as a precautionary measure on all drugs that may have the ability to affect the heart.

This was mandated by the US Food and Drug Administration (FDA) two years ago following a number of concerns over drugs that were found to induce rhythmic disturbances.

Meanwhile, the area of Phase I research itself is also a growing business area in the contract research space, with many industry players making plans to grow their Phase I businesses globally.

The market is expected to experience growth between 13.4 and 16.0 per cent annually through 2010.

MDS Pharma is continuing its efforts to move on from financial difficulties caused in its Pharma Services segment by an FDA review of its Montreal-area bioanalytical facilities, that is largely now resolved.

The firm has recently consolidated its central laboratory operations in Europe, finalising the closure of UK facility in Sittingbourne; while in North America, its Montreal team transferred DMPK operations to Bothell, Washington and LC-MS operations to Lincoln, Nebraska; and also completed most of the staff reductions at its St. Laurent facility.

In addition to building the new Phase I unit in Arizona, MDS also recently expanded its central lab operations in Beijing, China "to meet the growing demands" from biopharma companies now operating in the country.