UI Hospitals and Clinics

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UI part of consortium receiving up to $35 million from FDA

The University of Iowa is part of a national consortium that has been awarded a five-year grant worth up to $35 million by the U.S. Food and Drug Administration to improve drug manufacturing standards that could cut health care costs, create jobs, and improve drug safety.

The grant was awarded to the National Institute for Pharmaceutical Technology and Education (NIPTE), an academic, not-for-profit organization dedicated to fundamental research and education in pharmaceutical product development and manufacturing. In addition to the UI, member institutions are Duquesne University, Illinois Institute of Technology, Purdue University, Rutgers University, University of Puerto Rico, University of Connecticut, University of Kentucky, University of Maryland-Baltimore, and the University of Minnesota.

"The FDA grant creates a federal funding stream for science in drug manufacturing. This grant is a major accomplishment of a relatively small set of pharmaceutics-oriented pharmacy schools that have strong engineering programs, and it gives the University of Iowa a unique opportunity for faculty in this area to compete for substantive research funding," said Jordan Cohen, UI vice president for research and economic development and a member of the NIPTE board of directors.

University of Iowa Pharmaceuticals (UIP), a division of the UI College of Pharmacy, is the most experienced university-affiliated FDA-registered drug manufacturing facility in the United States. Through collaborations with NIPTE, UIP has provided expertise and facilities for clinical trials supported by the National Institutes of Health.

"The University of Iowa's historical strength in this area, particularly in its clinical drug manufacturing program, has contributed greatly to the success of NIPTE initiatives with the FDA," Cohen said.

The FDA 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 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, quality of our drugs can be improved, and outsourcing trends can be reversed by developing science-based standards for drug development and manufacturing."

NIPTE's goal is to increase science and engineering-based understanding of pharmaceutical product development and manufacturing, resulting in the development of novel state-of-the-art technologies and the implementation of science-based regulations. The FDA grant will support programs that help reduce time to market, enable new performance attributes, improve small-batch production, promote continuous manufacturing, save money or energy, or reduce environmental impact from the manufacturing of products.

As part of the NIPTE consortium, UI faculty have already been involved in FDA-funded studies aimed at improving pharmaceutical product manufacturing and are leading another project to develop educational training for FDA reviewers.

"Although the specific projects that will be part of this new multi-year agreement with the FDA have yet to be specified, we fully anticipate that Iowa faculty from various colleges including engineering and pharmacy will continue to play key leadership roles and contribute their unique knowledge and resources to the NIPTE consortium in support of the FDA's strategic plans," said Lee Kirsch, PhD, UI professor of pharmaceutics and a member of the NIPTE faculty committee.

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