On the surface, the James L. Winkle College of Pharmacy’s master’s of pharmaceutical sciences program in drug development is geared toward the non-traditional student—meaning students seeking a graduate degree while working full time. But the term “non-traditional” also applies to the kind of person this program is designed to attract.
“These students are a very diverse group of people coming together by design or accident. They are learning from each other as much as from the instructors, and we are learning from them too,” says Pankaj Desai, PhD, program director and professor of pharmacokinetics.
Desai spearheaded the development of this program and has served as the director since its launch in 2004.
There is a growing need at biopharmaceutical companies and clinical research organizations (CROs) for employees cross-trained in scientific and regulatory aspects of drug development, says Desai.
Two second-year students enrolled in the program—Brenna Carey, PhD, who works full time at Cincinnati Children’s Hospital Medical Center in the department of pulmonary biology and neonatology, and Lindsay Boeing, who holds a BA in biology and psychology and works full time as a clinical studies project manager for Kendle International Inc., a CRO—exemplify this sought after diversity of backgrounds.
“I see myself transitioning from a basic scientist to more of a translational scientist,” says Carey, adding that she now has a better understanding of the drug development process and the regulations that the government has set forth.
The coursework has been enlightening as well for Boeing: “I can see now how a clinical trial is designed—whether it is a Phase I study or a large Phase III trial—and how a detailed protocol comes to be, why it’s important and why it has to be done a certain way.”
While the program drives the students to achieve a better understanding of reasoning and protocols, it also facilitates career enhancement, says adjunct professor William Sietsema, PhD, vice president of regulatory affairs at Kendle.
“Graduates of this program move on to bigger and better things (with their current employer or with another employer),” Sietsema says.
And because the curriculum is a mix of different aspects of industry and government, it’s necessary that the student population be a mix of education and experiences, says adjunct professor Kevin Skare, PhD, who retired from Procter & Gamble as the senior director of global medical operations.
“Our students,” Skare says, “have such a diversity of backgrounds. We have those like Lindsay with their bachelor’s, but we have PhDs, MDs and PharmDs as well.”
Skare and Sietsema co-teach the Phase II and III clinical trials courses. Since its inception in 2004, the program has graduated 36 students. There are currently 20 students in the program.