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Rising Pharma Demand Prompts CRO Covance to Fortify its Protein Biomarker Business

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This story originally ran on Dec. 2.

By Tony Fong

Increasing demand for its protein biomarker services has prompted Covance to ramp up its biomarker operations.

Last month, the Princeton, NJ-based contract research organization announced it had made Rules Based Medicine its exclusive third-party provider of multiplexed protein biomarker testing services. In return, the Austin, Texas biomarker testing laboratory will use Covance as its exclusive referral source for laboratory-based tests.

"We're seeing a good increase in biomarker requests … and the complexity of the requests [require] multiple biomarkers in a given study," Tom Turi, vice president of Covance's Biomarker Center of Excellence, told ProteoMonitor recently.

For example, in oncology drugs, a typical oncology trial now asks for protein- and genomic-based biomarkers and frequently a cell or tissue-based biomarker, he said.

"And our aim is to help clients improve the speed and efficiency of their clinical trials, and toward that end … we saw an opportunity to partner with Rules Based Medicine, which is a leader in Luminex technology and multiplexed-based technology, and be able to increase not only our capabilities but the types of tests [and] the breadth of tests that we offer on this platform," Turi added.

While Covance also offers Luminex and multiplexed technology, Turi said, RBM has "a much broader set of assays currently available than Covance has on the Luminex platform, especially around highly complex, multiplex assays."

The three-year deal with RBM provides Covance with extended new capabilities and new functionalities, including RBM's Multi-Analyte Profile technology for measuring up to hundreds of proteins in a small sample.

Covance also will now have access to RBM's portfolio of multiplexed assays, which Turi called "quite impressive. It is greater than what we have so it really extends and complements Covance's capabilities."

Financial terms of the deal were not disclosed.

The deal is the most recent move by Covance in the past year as it steps up its protein biomarker business. Last December the CRO acquired a minority stake in Montreal biomarker firm Caprion Proteomics, and early this year established its BCOE.

It also comes at a time when drug makers have been increasingly outsourcing their proteomic biomarker-related R&D, especially work connected to biomarker discovery, verification, and validation, after years of fruitless in-house research. That decision has created a windfall of sorts for CROs such as Covance, Turi said.

No hard data exists on the outsourcing of protein biomarker research to CROs in general, but according to Turi, despite the impression that pharma has turned its back on the proteomics field, in reality the industry is looking for more cost-effective and flexible methods for finding protein biomarkers. That's where CROs come into the picture, and to that end, Covance has seen demand for both discovery as well as development work, Turi added.

Before joining BCOE, Turi was senior director of translational biomarkers and mechanistic biology at Pfizer.

Biomarkers, he said, have become an "integral component of drug discovery and development." In the clinical phase, Covance's clients need to know if they have an effective target, whether their compounds can hit that target, and whether the compound has any effect on the target. Just as importantly, its clients want to know whether there are any early indications of safety issues with their candidate therapies.

And biomarkers can provide drug firms with answers to those concerns before multiple millions of dollars have been spent developing a drug that may not pan out.

Virtually every trial and study coming into Covance now has some biomarker component, Turi said. It was to address this that Covance decided to forge its deal with Caprion last year.

In addition to holding a minority stake in Caprion, Covance became the exclusive CRO distributor of Caprion's biomarker services. In return, Caprion provides biomarker discovery services to Covance. The two also are collaborating on the development of mass spectrometry-based multiple-reaction monitoring assays.

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Intellectual and Physical Foundation

The creation of its BCOE, however, provided an intellectual as well as physical foundation for Covance's biomarker business. The center is located in Greenfield, Ind., and is part of 1 million square feet of laboratory and office space Covance purchased from Eli Lilly in August 2008.

As one of the world's largest CROs, Covance provides services all along the drug discovery and development pipeline. In 2008, it posted receipts of $1.7 billion. During its most recently completed quarter, ended Sept. 30, it recorded revenue of almost $494 million.

Turi did not know how much Covance's total business is biomarker-based because the company does not break that out. In a press release announcing plans for the BCOE, though, the company said that the creation of the center was to accelerate and support the growth of its biomarker business.

According to Turi, the purpose of the center is to develop novel assays. "We focus on developing and optimizing assays in a rapid fashion across a broad spectrum of technologies and support either preclinical or early clinical studies that do not require a CLIA-regulated environment," he said. If such a setting is necessary, the assays are transferred into one of Covance's central labs where its researchers can perform those studies in a CLIA-regulated environment.

"If you think of proteomics as biomarker discovery, we will then take those candidate biomarkers and develop assays against them," he added. "We will assist our clients in evaluating those biomarkers, to qualify them if you will, either in preclinical species or clinical samples, and then develop really rugged, robust assays that are suitable for the appropriate endpoint that our client is requesting."

Covance's biomarker assay portfolio currently comprises about 500 CLIA-validated assays, a number that according to Turi grows almost daily. "We can support clinical trials with those assays all the way from Phase 1 through late stage Phase 3, Phase 4 clinical trials," he said.

Another responsibility of the BCOE is to identify, evaluate, and implement new and innovative technologies in the biomarker space.

"Within the biomarker space, there are so many breaking technologies that are emerging — whether it be genetic or genomic-based approaches, protein-based approaches, miniaturization, less invasive types of technologies or approaches, cell-based flow cytometry — and so we need to have a dedicated group that's going to focus on evaluating these types of technologies as we partner across the organization to understand what needs we might have internally," Turi said.

Mass spec remains the core technology for protein biomarker work, but he added that there are "a number of very, very interesting technologies" that are emerging onto the market that Covance is evaluating. He declined to identify them.

As the disease areas of interest among its pharma clients continue to evolve and new targets are being explored, BCOE is developing disease area expertise that is "focused on certain strategic disease areas that we think align very nicely with our client base portfolios," Turi said. The company is in the midst of hiring scientists who have "deep" understanding of specific therapeutic areas "and their entire focus is on biomarkers associated with those disease areas," either in identifying such biomarkers or developing assays against them.

Among Covance's clients are 19 of the top 20 drug firms, Turi said. As that industry undergoes its own upheaval, Covance is seeing benefits to its biomarker business, he said.

The consolidation happening within pharma is all about discovering and developing new drugs more efficiently, and as a result, Covance is seeing an increase in its clients "for a whole host of activities," Turi said.

Covance's biomarker business "is very strong if not increasing [and] we are not seeing any slowdown in the number of requests," resulting from pharma mergers, he said.

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