Duquesne University and nine other university partners in a nationwide consortium have received a grant worth up to $35 million over the next five years from the U.S. Food and Drug Administration.
At a time when the current cost of bringing a drug to market in the U.S. exceeds $1 billion and an increasing number of drugs and drug ingredients are being imported, this FDA award is coming to the National Institute for Pharmaceutical Technology and Education (NIPTE) to improve drug manufacturing standards.
The grant is intended not only to improve America’s manufacturing competitiveness and create high-paying jobs at home, but will help to reverse outsourcing trends in the pharmaceutical industry by decreasing the cost of manufacture and by improving the quality and safety of our drugs.
“Duquesne and other collaborators in NIPTE have been working with the FDA to enhance the drug development process and to provide direction for the industry in terms of implementing modern control systems in the manufacturing process,” said Dr. James Drennen III, associate dean of research and graduate programs in Duquesne’s Mylan School of Pharmacy and director of the Duquesne University Center for Pharmaceutical Technology , an academic research center in the Mylan School of Pharmacy and the Graduate School of Pharmaceutical Sciences. “For instance, through the use of rapid non-invasive spectroscopic techniques, our industry can quickly check critical quality attributes of pharmaceuticals, in real-time, providing improved quality while optimizing manufacturing efficiency.”
Duquesne has played a key role in previous NIPTE initiatives and anticipates being highly involved in this new effort.
“Over the last several years, NIPTE has contributed a great deal of research toward our understanding of quality pharmaceutical manufacturing,” said Helen N. Winkle, director, FDA Office of Pharmaceutical Sciences.
NIPTE’s executive director, Dr. Prabir Basu, believes improvements can continue to be made to the pharmaceutical manufacturing process.
“The outsourcing of drugs and drug intermediates are increasing at an alarming rate, potentially threatening overall quality of our drugs, accompanied by huge job losses in this country,” Basu said. “Development and manufacturing costs can be reduced, the quality of our drugs can be improved, and outsourcing trends can be reversed by developing science-based standards for drug development and manufacturing.”
The FDA grant will support programs to rectify these drug development and manufacturing issues by creating ways to reduce time to market, enabling new performance attributes, improving small-batch production, promoting continuous manufacturing, saving money and energy and reducing environmental impact from the manufacturing process.