Clinical and Pharmacologic Research Center is crucial resource for WVU

Testing center for generic drugs aids students and consumers

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,” said Allie Karshenas, PhD, clinical director of WVU’s Clinical and Pharmacologic Research Center (CPRC). “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. 

“Until you test a medicinal formulation in people – and a lot of people – you cannot predict the outcomes of that drug in patients,” Karshenas said. “Currently, there’s no computer or simulation model that can replicate the complexity and the variations among humans. Some drugs work differently in men and women and in people of different ethnicities and races. You have to test, and you have to make sure physicians understand how the medicines work for different people.”

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.”

For CPRC’s staff of 100, safety is their top concern. “With the regulatory oversight that we have, and the safety checks in place, I would recommend this to my own family. We have medical staff on site 24 hours a day. The study designs are all based on safety, and we disclose all the risks on the front end to the study volunteers. Any participant can withdraw his or her consent at any point if they are uncomfortable or worried.”

Free-standing testing centers have a long history in the pharmaceutical industry, including in Morgantown. But the global company that last operated a center in West Virginia closed that location several years ago. Karshenas, who worked there, left the state for other opportunities in the industry.  

But the new start-up lured him back. “What attracted me to Morgantown is the opportunity to do something completely new and different,” he said. “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.”

Third- and fourth-year pharmacy students at WVU can participate in five-week rotations at the CPRC, which will give them hands-on experience in the development and testing of new generic drugs. “They start with a week of rotation at Mylan’s manufacturing plant in Morgantown – then four weeks in CPRC’s testing facility that’s next door,” Karshenas said. “They 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.”

“The CPRC fits precisely with the priorities we’ve established at WVU – conducting research that can improve the health of West Virginians and training researchers with clinical and translational skills,” said Glenn Dillon, PhD, WVU’s vice president for health sciencesresearch and graduate education. “We’re fortunate to have an excellent relationship with our partner Mylan – a partnership that provides educational opportunities for our students, residents, and fellows across the Health Sciences Center.”

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.

He’s also planning for growth based on the quick progress the CPRC has made since it was founded in 2012. “We’ve been very successful in testing pharmaceuticals and are looking toward expanding into working with biomarkers and diagnostics,” he said. “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.”