Pharmacy School’s Relationship With FDA Yields Extraordinary Opportunity

The strong relationship between the U.S. Food and Drug Administration (FDA) and the pharmacy school has resulted in a group of graduate students visiting the agency’s site and interacting with FDA professionals.

Dr. James K. Drennen III, associate dean of the Mylan School of Pharmacy, and Dr. Ira Buckner, advisor to the American Association of Pharmaceutical Scientists (AAPS) student chapter, led 16 students and a visiting scholar on the June 19 visit to the Silver Spring, Md., site.

“The AAPS student chapter at Duquesne expressed interest in a visit to the FDA,” Drennen said. “The trip was organized through our contacts in the agency that have developed from our long-term relationship based on our work with the scientists and policymakers at the FDA.”

The faculty and students of the University’s Center for Pharmaceutical Technology have provided a variety of training programs for the FDA and the industry, including programs on quality risk management, process analytical technology and quality by design. In addition, Duquesne and consortium partners from other universities have been engaged in an FDA contract worth up to $35 million to enhance the drug manufacturing and drug development process.

“It was an excellent visit, offering our delegation interaction with several departments within the Center for Drug Evaluation and Research,” Drennen said.

Students heard four presentations related to the FDA operations and visited the agency’s product quality research labs.

“Because of our close interactions with the FDA’s Office of Pharmaceutical Science, we were able to offer an experience that enhanced students’ understanding of the agency, its structure and its challenges,” Buckner said. “We’re pleased to be able to offer this type of unique experience to our graduate students in pharmaceutical sciences.”