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Banking on biomarkers
PRINCETON, N.J.—For at least two years, drug development services company Covance Inc. has been on the road to developing a strong biomarker strategy, particularly since announcing the formation of its Biomarker Expert Team in March 2007, which was dedicated to development, validation and testing of biomarkers. With a trio of actions in December 2008—taking a minority stake investment in a proteomics firm, creating a new vice president position and beginning plans for a center of excellence—Covance's strategy is "really coming together," says Laurene Isip, head of corporate communications for Covance.
From Covance's perspective, the lead news is that the company in mid-December purchased a minority equity stake in Caprion Proteomics, a provider of proteomics-based services to the pharmaceutical industry, to further enhance its biomarker service offerings to clients.
Under the terms of the investment agreement, Covance will serve as the exclusive contract research organization distributor of Caprion's proteomic biomarker services and Caprion will in turn serve as Covance's exclusive proteomic discovery provider.
"We are very pleased to be adding Caprion's solid scientific capabilities and leading biomarker technology platform to Covance's lineup," says Deborah Tanner, corporate senior vice president and president of Covance Central Laboratory Services. "We expect that our clients will have a keen interest in this additional capability, given Caprion's impressive track record of accelerating biomarker validation for early drug safety and efficacy assessment."
Expanding Covance's abilities in the biomarker arena is important, Tanner believes, because the company has long seen that a significant need exists among pharmaceutical, biotechnology and drug development customers for high-throughput biomarker development services. Furthering such capabilities, she notes, "will significantly increase the effectiveness and efficiency of our clients' drug development programs in terms of speed, cost, and quality."
Essentially, by combining the scientific and operations experience of both companies, Covance can now offer customers "distinct and uniquely integrated biomarker solutions from discovery through validation and into clinical deployments," Isip says, adding: "Caprion's platform links protein to biology seamlessly and they have a strong pharmaceutical and biotech customer base. They are a strong biomarker player and they have unique data capture and data processing technology to go along with our own expertise in this area."
Covance also announced in December that it had created the new position of vice president of biomarkers, a role that will be held by Dr. Thomas Turi, who joins Covance with more than 14 years of experience leading drug discovery projects that ranged from exploratory through early development programs. At Covance, Turi will be responsible for leading Covance's Biomarker Expert Team, the panel of scientists representing Covance's biomarker capabilities, and will lead the creation the company's Center of Excellence for Biomarkers in Greenfield, Ind.—a facility made possible by Eli Lilly and Co.'s sale of its Greenfield Laboratories to Covance in August, along with a $1.6 billion, 10-year deal between Lilly Covance for toxicology and clinical development work. Most recently, Turi served as the senior director of translational biomarkers and mechanistic biology at Pfizer's laboratories in Groton, Conn.
Looking to cover the dual need for discovery and development of biomarker capabilities, the Biomarker Center of Excellence will focus specifically on biomarker testing and validation. It will leverage the discovery support services of Caprion and of the services that already reside at Greenfield, including in vivo preclinical safety and efficacy assessment, and a variety of preclinical imaging modalities.
Together, these three strategic moves will help Covance further capitalize on the emerging service market in biomarker discovery, verification, validation, and deployment across the drug development continuum—from early proof of concept through late-stage clinical trials and post-marketing surveillance.
Currently, pharmaceutical companies are adopting biomarker strategies for the vast majority of new drug candidates, Covance reports, and the company's leaders are confident in the predictions of industry watchers that biomarkers will be a standard aspect of drug development for any novel compound within the next 10 years.
In fact, the U.S. FDA's 2006 Critical Path Initiative listed biomarkers as one of the two areas with the greatest impact on modernizing drug development and approval, Isip points out. DDN