Purdue part of institute awarded up to $35 million by FDA

October 4, 2011

WEST LAFAYETTE, Ind. — Purdue University is part of a national institute that received a grant of up to $35 million over the next five years from the U.S. Food and Drug Administration.

The FDA awarded the grant to the National Institute for Pharmaceutical Technology and Education, or NIPTE, to improve manufacturing standards and ultimately cut health-care costs, create jobs and improve drug safety. 

Purdue was instrumental in the formation of NIPTE six years ago, and the university's combined strength in pharmacy and engineering bring important expertise to the problems faced in the production of today's medicines, said Craig Svensson, dean of Purdue's College of Pharmacy and member of NIPTE's board of directors.

Ten universities now comprise NIPTE, which focuses on collaborative research in pharmaceutical product development and manufacturing and is the only partnership of its kind.

Prabir Basu, executive director of NIPTE, said the grant comes at a time when the current cost of bringing a drug to market in the United States exceeds $1 billion and an increasing number of drugs and drug ingredients are being imported from abroad.

“Outsourcing of drugs and drug intermediates are increasing at an alarming rate, potentially threatening the overall quality of our drugs and leading to huge job losses in this country,” he said. “Development and manufacturing costs can be reduced, 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 address these drug development and manufacturing problems by creating ways to reduce time to market, enabling new performance attributes, improving small-batch production, promoting continuous manufacturing, saving money or energy, and reducing environmental impact from the manufacturing of products, he said. 

Svensson said this work could also alleviate medication shortages.

"At present we face serious shortages of critical medicines used in the treatment of a variety of diseases - especially cancer," he said. "Most of these shortages are the result of quality problems in the production of medicines. Current manufacturing processes are often inefficient, resulting in increased costs and delays in getting medicines to the market. It all comes down to providing patients with the best care and treatments possible."

Helen N. Winkle, director of the FDA office of pharmaceutical sciences, said she is looking forward to NIPTE's findings.

“Over the last several years, NIPTE has contributed a great deal of research toward our understanding of quality pharmaceutical manufacturing,” she said. “Progress in this area will mean safer, more efficient and less costly drug production here in the U.S.”

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. These technologies will also enable new drug discoveries to be brought to market faster with less variability, higher predictability of performance and significantly lower cost.

Stephen Byrn, Purdue's Charles B. Jordan Professor of Medicinal Chemistry, is chair of the faculty committee for NIPTE, and Gintaras Reklaitis, the Burton and Kathryn Gedge Distinguished Professor of Chemical Engineering, serves on the committee.

In addition to Purdue, NIPTE member universities include Duquesne University, Illinois Institute of Technology, Rutgers University, University of Puerto Rico, University of Connecticut, University of Iowa, University of Kentucky, University of Maryland - Baltimore, and the University of Minnesota.

Writer: Elizabeth K. Gardner, 765-494-2081, ekgardner@purdue.edu

Sources: Craig Svensson, 765-494-1368, Svensson@purdu.edu

                  Prabir Basu, pbasu@nipte.org

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