SOP Part of $35 Million FDA Grant to Improve Drug Development Process

Research will contribute to project to make drug manufacturing safer.

By Steve Berberich
October 11, 2011

The University of Maryland School of Pharmacy and 10 other universities will conduct research over the next five years to improve drug manufacturing standards through a $35 million grant from the U.S. Food and Drug Administration (FDA) to the National Institute for Pharmaceutical Technology and Education (NIPTE).

According to a statement from NIPTE, the FDA grant is “a move that seeks to cut health care costs, create jobs, and improve drug safety.”

The grant comes 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 from abroad.

The FDA investment in research of drug development and manufacturing will not only improve America’s manufacturing competitiveness and create high-paying jobs at home, but will help to promote job retention in the U.S. by reversing the current outsourcing trends in the pharmaceutical industry in the long term by decreasing the cost of manufacture and by improving quality and safety of our drugs, according to the NIPTE.

“Outsourcing of drug manufacturing and drug intermediates are increasing at an alarming rate, potentially threatening overall quality of our drugs accompanied by huge job losses in this country,” said NIPTE Executive Director Prabir Basu. “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.”

“As a founding member of NIPTE, the University of Maryland School of Pharmacy has a strong history in industrial pharmacy, drug manufacturing, and research that supports critical FDA guidances for drug development,” said Natalie D. Eddington, PhD, FAAPS, professor and dean of the School of Pharmacy. “This initiative is a very unique opportunity to harness the research expertise in academia that is focused on pharmaceutical technology.”

Helen N. Winkle, Director, FDA Office of Pharmaceutical Sciences, said, “Progress in this area will mean safer, more efficient, and less costly drug production here in the US, and we are looking forward to NIPTE’s findings.”

NIPTE, Inc. is an academic, not-for-profit organization dedicated to fundamental research and education in pharmaceutical product development and manufacturing. NIPTE’s goal is to increase science and engineering-based understanding of this area so that novel state-of- the-art technologies can be developed and science-based regulations can be implemented. The technologies will also enable new drug discoveries to be brought to market faster with less variability, higher predictability of performance and at a significantly lower cost.

The FDA grant will support programs to rectify these drug development and manufacturing problems, by creating ways to reduce time to market, enabling new performance attributes, improving small-batch production, promote continuous manufacturing, saving money or energy, or reducing environmental impact from the manufacturing of products.

“We are thrilled to see the FDA’s commitment to invest in the science of pharmaceutical manufacturing,” said Basu. “I sincerely hope that other federal funding agencies will take the lead from the FDA and will take similar steps to fund this critical area of translational and manufacturing research to improve health care in the US.”

Stephen Hoag, PhD, an industrial pharmaceutics professor at the School of Pharmacy, will head the University of Maryland’s contribution to the NIPTE project. “Our school brings strong programs in drug manufacturing research and knowledge of the workings of the non-drug ingredients, or excipients. We have also developed a unique database of material properties of drugs that will be very useful.” Hoag is the director of the School of Pharmacy’s Good Manufacturing Practices (GMP) Core Facility, overseeing quality assurance and production. The GMP facility has nearly 20 years of experience in pharmaceutical formulation and the production of tablets and capsules.

Hoag said the NIPTE project will help boost the field of pharmaceutical technology in universities. T the number of professors studying pharmaceutical technology has declined in recent years.

NIPTE partners with 10 U.S. universities, which are leaders in pharmaceutical science and engineering. The participating universities include Duquesne University, Illinois Institute of Technology, Purdue University, Rutgers University, University of Puerto Rico, University of Connecticut, University of Iowa, University of Kentucky, University of Maryland, and the University of Minnesota.