Redefining moment: contract-research organizations in North Carolina have expanded beyond traditional parameters to meet customers' needs and emerging trends.

• Position: BIOTECHNOLOGY ROUND TABLE - Interview

Contract-resedrch organizations now work more closely with the Federal Drug Administration and foreign companies, are more involved in the clinical realin and have taken on more risk as a result. But North Carolina's resourees, including its universities, pharmaceurical companies and established CROs, have helped it grow, A panel of insiders recently gathered at the North Carolina Biltechnogy Center in Research Triangle Park to discuss the industry and make predictions about its future, Participating were Christine Warrington, Raleigh-based executive director of Women in Bio; Paula Brown Stafford, president of the clinical division of Durbam-based Quintiles Transnational Corp.; John Stewart, partner at Charlotte-based Dixon Hughes Goodman LLP; Yves Ribeill, CEO of RTP-based Seynexis Ine,; Lisa Zimtenerman, vice president of clinical operations at Chapel Hill-based Pozen Inc,; Jackie Moore, clinical-trials manager at East Carolina University, Dr, Andrew Muir, associate professor and director of gastroenterology resaearch at Duke Clinical Research Inditute in Durnanr; and Marga Oortgiesen, vice predident of drug development and managing director of Durbam-based Cato Research Ltd. Sponesored by Duke Clinical Research Institute, Quintiles. Charlotte-based Dixon Hughes Goodman LLP, James G. Cammon Research Center in Charlotte and the Biotech Center, its president and CEO, Norris Tolson, moderated the discussion, Following is a transcript, edited for brevity and clarity.

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What is the role of a contract-research organization in the biopharmaceutical industry?

Stafford: To partner with the biopharmaceutical industry to provide services throughout a products life cycle.

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Muir: Duke has all the services of the traditional CRO plus faculty who can partner and work with sponsors to develop programs.

Zimmerman: At Pozcn, we have our own services in-house, but we have to enlist the help of the CROs in our universities and area. We look for faculty, statistical and clinical expertise.

Warrington: There are about 390 CROs in North America. North Carolina carries a quarter of available resources in this industry. We're critically important.

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Stewart: In addition to the actual number of organizations, two of the world s three largest are based here.

Oortgiesen: At Cato Research, we like to partner with biotech companies, which offer a lot of expertise. But there are certain areas where we can help. We offer traditional services, such as clinical management and monitoring, but we also do a lot of regulatory-affairs consulting, such as representing companies at the Federal Drug Administration. We also facilitate FDA meetings and assist with strategies for drug development, including in manufacturing and crafting a...