Stepping out from behind the curtain

Drug Discovery News
(July 2010)

By David Hutton

A contract research organization (CRO) is generally defined as a service organization providing support to the pharmaceutical and biotechnology industries. That’s just scratching the surface of what CROs are and what they do for the companies they serve. Like an onion, if you peel back the layers of these companies, you find they offer myriad services to meet the needs of a customer base that has complex needs.

CROs first began to dot the biotech landscape in the late 1970s. They quickly took on a growing role in research and development, expanding from drug discovery and preclinical work to clinical trials, manufacturing and even marketing. Cost containment due to the economic downturn and regulatory pressures within the pharma industry are now driving R&D outsourcing across the globe. As a result, the scope of the CRO industry is expanding, and the global market is predicted to hit $35 billion by 2013, according to a report by Business Insights.

In this story, the third and final installment of our multi-part series, we take a look at five different companies. While they aren’t the five largest CROs, they offer a cross-section view of the CRO industry and examples of the diversity ongoing today among CROs, the services they offer and the companies that they serve.

Midwest BioResearch LLC

Midwest BioResearch is part of WIL Research Co., a privately held global CRO and provider of drug development and chemical and food safety services. According to Mike Schlosser, president and founder of the Skokie, Ill.-based CRO, the companies’ expertise includes non-clinical toxicology, pharmacology, metabolism and both clinical and non-clinical, small- and large-molecule bioanalytical services. Non-clinical services include nonhuman primates, inhalation, developmental and reproductive toxicology and safety pharmacology.

Schlosser notes there are myriad services that can be outsourced to a CRO.

“Within the pharmaceutical industry, there is clinical trial work and preclinical or non-clinical activities; the latter can refer to drug screening activities, regulatory-driven studies for investigational new drug applications and drug and formulation manufacturing,” he says. “In addition, many of the preclinical CROs with the right expertise and knowledge base also support the chemical and food industries.”

One of the company’s fastest growing areas is in the analysis of protein/enzyme therapeutic drugs quantified in biological matrices such as plasma, and in characterizing antibodies formed against these large molecules, Schlosser adds.

“It was an area we had decades of experience in working at Searle/Pharmacia, and when Pfizer bought Pharmacia and shut down the Chicago site in 2003, we started Midwest BioResearch, which was acquired by WIL Research last year,” he says.

Schlosser notes that the industry is tending to see more consolidation of activities, with larger CROs strategically adding technologies to round out their service offerings to clients.

“Other continuing trends include U.S. CROs seeking partnerships in emerging markets such as China and India,” he adds. “Certainly, pharmaceutical companies are becoming more sophisticated about establishing strategic partnerships with CROs as pharma companies continue to reduce the scope of their in-house activities.”

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