Covance Takes on Biomarkers

By Malorye A. Allison

Covance is one of the world’s largest contract research organizations, and so it’s new Biomarker Services initiative illustrates two big trends– the need for biomarkers and the push to outsource research and development. 

“There is a clear service gap in the industry related to biomarkers,” says Gordon Kapke, senior director, Biomarker Services at Covance. The most obvious change is that Covance will be able to incorporate biomarkers into a much wider range of studies, even when the number of samples is relatively small. To make that possible, the company has made some strategic changes, added some tools to its “belt,” and adjusted its philosophy.

The challenge was to fully understand the need and then create a strategy that worked across all divisions involved. 

As a first step, Covance’s marketing department pulled together a biomarker expert panel, comprising staff from a range of divisions. “You don’t have to sit in a lab to serve on the panel,” says Kapke. “We have people from early development, but also from Market Access and Periapproval [Phase IIIb and IV].” That panel meets on a monthly basis to review demand for biomarker services. It also makes recommendations for changes the company should make to meet those needs.

In addition, a biomarker advisory panel was formed that includes experts from industry. “The panel members represent a cross section of the marketplace,” says Kapke. “They can tell us what gaps they see in service delivery, and how that fits with our global capabilities.” 

The company already has substantial tools and expertise in place for a range of biomarker-related studies. “We have over 200 PhDs, MDs, or DVMs at our various facilities,” Kapke says. “So we have a lot of capability, the secret is to get the information from customers about what they need.”

Because the biomarkers in question are used for research and not patients care, Covance is also equipped to do most typical studies. Covance Research Products produces custom antibodies, and several of the company’s labs design immunoassays. According to Kapke, Covance Central Laboratory Services has more than 400 active assays on tap. 

The rub, he says, can come when customers want unusual assays. While the company will develop such tests, “Once you go outside commercially available products a lot of questions need to be answered,” he says. “People need to understand what is known and what is possible.”

Currently, the most common requests are for traditional assays. The demand for genomic assays has been slowly increasing, but it has yet to reach the proportions that were originally anticipated. “As the human genome was being sequenced, we thought the floodgates would burst open any day,” he says. “It just has not been that way.”

Covance uses partners for gene expression studies, but does some SNP analysis internally. The company has four continuously active Cytochrome P450 tests. A handful of other SNP tests are available upon request. 

“We see some activity around genomics,” Kapke says. But that activity is “very low indeed” compared to more traditional metabolite or protein immunoassays. Of these, cytokine molecules appear to be a growing area of interest, although a wider variety of assays are being requested. “We’re getting more unusual requests,” he says, “It’s to the point where I have to look up some of the molecules to see what they are.”

The major barrier keeping CROs from doing a lot of biomarker work is the volumes of samples involved. A proof of concept in Phase I or II may use just 100 samples, and typically it’s hard for CROs to justify such small sample runs, or to price them. 

Covance is shifting its strategy and now bidding more often on small volume biomarker work. “That doesn’t mean every request will end up with a home here,” Kapke says. 

Customers also need to do their homework and to plan carefully. “Pharma needs to carefully strategize,’ he says. That means planning to get the samples if you’ll need them and deciding just what the markers will be used for. 

The vast majority of the tests Covance is doing are proof of concept tests done in a small number of patients – from about 200 to 300 -- to guide larger scale Phase II or III trials. The key here, according to Kapke, is to “know the biology and exactly what you want to test.” 

And, if no commercial products exist for the test, it may take a year to build an assay from scratch. “You can’t expect to build an assay in time for your Phase II if the test is esoteric and you are launching the trial in 3 months,” he says.

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