WVU Health Sciences announced March 7 the formation of the West Virginia University Clinical and Pharmacological Research Center to conduct clinical trials of medications being developed for use in the United States and elsewhere.
"All medications used in the U.S. must be rigorously tested to meet the standards set by the FDA (Food and Drug Administration) and other regulatory agencies," said Dorian Williams, a board-certified family physician, a certified physician investigator and long-time member of the WVU School of Medicine faculty who serves as medical director of CPRC and currently is the interim director of the organization.
"These tests include highly monitored and regulated trials with healthy human subjects," Williams said.
"By contracting with CPRC for these tests, manufacturers can be assured that their products will be tested under the high standards required by the FDA and that the tests will be conducted in a short time frame at a reasonable cost," he said. "This leads to more efficient delivery of drugs to the marketplace and lower overall healthcare costs."
The CPRC will recruit volunteers from the Morgantown area and beyond to participate in testing of pharmaceuticals.
"Our first priority is protecting the health and safety of research volunteers and making sure each volunteer is fully informed before participating," said Williams.
Having the center at WVU creates opportunities for partnerships with the pharmaceutical and biotechnology industries, according to WVU Chancellor for Health Sciences Christopher C. Colenda.
"This is an important investment for the economic future of our community," Colenda said.
Created by the WVU Research Corporation and the WVU Health Sciences Center, the contract research organization has created 21 full-time jobs at its testing center on Chestnut Ridge Road in Morgantown.
CPRC expects to employ up to 60 part-time staff, mostly health professionals, who will conduct and monitor testing.
Although CPRC is new, healthy-subject pharmaceutical research has been conducted in Morgantown for more than three decades.
WVU graduate and family physician Thomas Clark established a clinical and pharmacologic research unit in Morgantown in 1979 and conducted the first trials in 1982. This later became a part of Kendle International Inc., a publicly-traded contract research corporation.
Kendle was acquired by INC Research, LLC, in mid-2011. INC Research closed the Morgantown location in July 2012, leaving the community without this service for the first time since the 1980s. Williams was affiliated with Kendle and INC Research from 1982 to 2012 and served as medical director of the Morgantown facility for 12 years.
Mylan, one of the world's leading generics and specialty pharmaceutical companies, operates a manufacturing facility in Morgantown and has entered into an agreement with CPRC to receive services formerly provided by the earlier enterprises. CPRC will actively seek additional industry clients. The current projection is that CPRC will have an annual local economic impact of $7 million.
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