MORGANTOWN, W.Va. – Generic drugs save consumers and insurers billions of dollars a year. But before they make it to market, their manufacturers must prove to the Food and Drug Administration that their products are equally safe and effective as the branded medicines they will replace. Part of that process requires independent testing on healthy human volunteers.
“A lot of the public does not have a good understanding of clinical trials, but this is noble work,” Allie Karshenas, Ph.D., clinical director of the West Virginia University Clinical and Pharmacologic Research Center (CPRC) and associate professor in the WVU School of Pharmacy Department of Pharmaceutical Systems and Policy, said. “We’re engaged with one of the largest generic manufacturers in the world, and what WVU is doing will help millions of people get access to less expensive medicine and improve their healthcare.”
At WVU, Dr. Karshenas leads a drug testing center with 102 beds. Often, much of the space is in use with WVU students and other volunteers from West Virginia and neighboring states willing to spend a weekend or longer inside the research center under tight medical watch. The paid volunteers include retirees, people who are between jobs, and others who are attracted by the possibility of earning $1,000 or more across a couple of weekend stays.
A recent CPRC participant shared this note with staff: “Thanks for taking the extra time during screening and treating us like people, not just a number.”
The CPRC also provides a unique opportunity for students at the WVU School of Pharmacy. Starting late this fall, third- and fourth-year pharmacy students have the opportunity to participate in five-week rotations at the CPRC, which will give them hands-on experience in the development and testing of new generic drugs.
“From the industry perspective, WVU has a lot of credibility and recognition in this work. We have a very strong and dedicated partner here, Mylan Pharmaceuticals, and we’ve done a number of studies for them already. This creates unique opportunities for faculty and students to engage with the industry from a much, much closer distance,” Karshenas said.
Students start with a week-long rotation at Mylan’s manufacturing plant in Morgantown, followed by four weeks in CPRC’s testing facility.
“They’ll see the whole process, from manufacturing and testing in the plant, development of the study design, approval by the Institutional Review Board, recruitment of test subjects, dosing and data collection. There’s nowhere else in the world where a student can have that entire experience in one program,” Karshenas said.
Karshenas has also aligned the CPRC with the West Virginia Clinical and Translational Science Institute, a statewide effort to create science-based change in the health of people and communities. He sees a role for the CPRC as providing controlled laboratory tests for drugs for comparison with the results found in research that takes place in West Virginia community clinics and physician offices.
The CPRC has made quick progress since it was founded in 2012 and is planning for growth, such as expanding into working with biomarkers and diagnostics.
“We created 100 new jobs in Morgantown in just a year, and we’re bursting at the seams. This is going to grow with the intent to build a strong portal to the industry while paving the roads for the next generation of clinicians and healthcare professionals to gain direct knowledge of clinical trials,” Karshenas said.
For more information on the WVU Clinical and Pharmacologic Research Center, visit www.wvucprc.com.
