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New WVU center will do human trials for new drugs

Vicki Smith, Associated Press

MORGANTOWN, W.Va. (AP) -- West Virginia University has launched a research center to conduct human clinical trials on new drugs that are being developed, and its first partner is the generic drug maker Mylan Inc.

The Clinical and Pharmacological Research Center will recruit volunteers from Morgantown and beyond to participate in the trials, which could lead to partnerships with other companies in the pharmaceutical and biotechnology industries, said WVU Health Sciences Chancellor Christopher Colenda.

"This is an important investment for the economic future of our community," he said.

The venture was created by the WVU Research Corp. and the WVU Health Sciences Center. It already has a contract with Pennsylvania-based Mylan, which has a manufacturing facility in Morgantown.

Mylan officials didn't immediately comment Friday on what kind of drugs the center would test first or when those trials would begin.

Dr. Dorian Williams, the center's interim director, said the health and safety of volunteers is the top priority, and all will be fully informed of the risks they face. Participants are paid, but Williams said those payments are strictly regulated and related to the amount of time and blood draws required.

"Short, two-weekend studies would typically pay around $200-500," he said, "while longer studies that require a lot of returns to the center could pay more."

WVU students may participate, but trials are open to anyone who wants to get involved and who meets the eligibility criteria. While most subjects will come from the Morgantown area, some may travel from farther away. Williams said that would likely depend on the nature of the trial.

Every drug trial will have its own criteria for inclusion and exclusion. Some, for example, will allow subjects to take other medications, but most will not. Most also have weight restrictions and do not allow smokers.

WVU estimates the center could have a $7 million impact on the local economy. The center has already created 21 full-time jobs, it says, and expects to employ up to 60 part-time staff.

Fred King, vice president for research at WVU, calls the center "a critical part of the research ecosystem" that will help attract and retain pharmaceutical and biomedical companies in the region.

The center will give drug makers assurance that their products have been tested to rigorous Food and Drug Administration standards in a short time and at a reasonable cost, Williams said. All clinical trials are heavily regulated with specific protocols, and all must be approved by an external Institutional Review Board in WVU's Office of Research Integrity and Compliance.

Although the center is new, WVU says pharmaceutical research has been done in Morgantown for more than three decades.

Dr. Thomas Clark set up a research unit in 1979 and conducted the first trials in 1982. His facility became a part of Kendle International Inc., which was acquired last year by INC Research LLC.

INC Research closed the Morgantown location last summer, leaving the community without such a facility for the first time in three decades.

Williams was affiliated with Kendle and INC Research from 1982-2012 and served as medical director of the Morgantown facility for 12 years. The new center is in the former Kendle building.