Campbell produces clinical research materials

Buies Creek, N.C.- It has taken some time, but Campbell University’s Pharmaceutical Sciences Institute (CUPSI) housed in the School of Pharmacy Research Facility is now qualified to produce clinical trial materials for clinical investigations. Dr. William Stagner, director of CUPSI, announced recently that Duke University was the first client for CUPSI to manufacture material for use in human subjects.

“To be able to work with such a reputable and distinguished organization as Duke University Medical Center our first time out just reinforces Campbell’s credibility and place in the Pharmaceutical Sciences community,” Stagner said. “It is an outstanding recognition of our program and what we are trying to accomplish.”

The Pharmacy Research Facility was dedicated on Nov. 9, 2001. This facility was built to provide an interface between industry and academia for the enhancement of the School of Pharmacy’s unique educational programs, development of its faculty, and be a valuable resource for pharmaceutical development. Campbell began seeking FDA (U.S. Food and Drug Administration) approval to develop drug delivery systems and to manufacture supplies for human clinical studies soon after the construction of the state-of-the-art 7,000 square-foot facility. In 2005, Dr. Stagner and Dr. Mali Gupta, associate professor of Pharmaceutical Sciences, were hired to join the CUPSI Management Team and begin in earnest the FDA qualification process for CUSPI and the research facility.

“It’s been a very arduous process, but we have recently qualified the Institute for the Good Manufacturing Practice (GMP) requirements that are regulated through the FDA,” Stagner said. “Being GMP qualified allows us to make oral liquids, tablets, capsules, topical creams and ointments to be used in research studies.”

GMP qualification also opens up a whole new avenue of economic possibilities for Campbell. In addition to being an education resource for students, CUPSI will build a client base with revenue income to support education and research for the Pharmacy School and the greater university and potentially the community.

The School of Pharmacy Research Facility and CUPSI at Campbell were the vision of Dr. Emanuel Diliberto, professor and chairman of the Department of Pharmaceutical Sciences. “Dr. Diliberto was keenly aware of the shortage of personnel in the health care industry and pushed for the creation of Pharmaceutical Sciences and Clinical Research programs at Campbell,” Stagner said. “Thanks to his vision and the support of Dean Ronald Maddox, we now have two uniquely positioned academic programs and GMP capabilities that support the drug development process.

Photo Copy: From left, Drs. Mali Gupta and William Stagner work with students in the Good Manufacturing Practice area of Campbell University Pharmaceutical Science Institute. (Photo by Amber Nelson)