Providing Safe and Effective Pharmaceuticals: FDA Reviewers in Training at DU
Some of the professionals who evaluate the safety and efficacy of pharmaceutical products are at Duquesne University this week to update their knowledge regarding modern methods of pharmaceutical development and manufacturing.
Duquesne University’s Center for Pharmaceutical Technology (DCPT), an academic research center in the Mylan School of Pharmacy and Graduate School of Pharmaceutical Sciences, is hosting 27 reviewers from the U.S. Food and Drug Administration (FDA) through Friday, Sept. 23. Through classroom sessions and hands-on laboratory experiences, the FDA scientists will study current methods and novel technologies with the pharmaceutical experts of the DCPT.
Duquesne is the only university in Pennsylvania and one of a handful of institutions nationwide to provide this type of training to FDA scientists who review new drug applications from the pharmaceutical industry and the manufacturing facilities where such products are made.
“The FDA reviewers are learning about Quality-by-Design, Process Analytical Technology, and other modern concepts and methods that state-of-the-art manufacturers use to produce pharmaceuticals,” explained Dr. James K. Drennen III, associate dean of research and graduate programs in Duquesne’s Mylan School of Pharmacy and director of the DCPT. Quality-by-Design is a manufacturing philosophy that guides product development, providing a scientific risk-based approach to product and process development and the control systems needed to efficiently manufacture safe and effective pharmaceutical products.
“This program is one example of the FDA’s effort to provide its regulatory staff with knowledge of the most modern technologies and practices so that they can do their job of protecting the American consumer,” said Drennen, who organized the program with Dr. Carl Anderson, associate professor of pharmaceutical sciences. A variety of faculty, scientific staff and graduate students will deliver the training in cooperation with DCPT partners Emerson Process Management and CAMO Software Inc.
The DCPT’s work has attracted FDA collaboration and industrial contracts since its founding in 2004. Additionally, because of its expertise in this area, Duquesne is one of 10 leading universities comprising the National Institute for Pharmaceutical Technology and Education, a consortium that is developing technologies and educational programs on process design, scale-up and validation for drug manufacturers.