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KU News Release

November 3, 2005
Contact: Dan Lara, University Relations, (785) 864-8855.

KU joins major universities, FDA to create institute to aid drug development

LAWRENCE -- The University of Kansas has joined with 11 other universities and the Food and Drug Administration to form a research institute devoted to learning more about drug manufacturing and to reducing the skyrocketing costs of drug development.

The collaboration, called the National Institute for Pharmaceutical Technology and Education (NIPTE), was announced this morning at a policy briefing by institute members on Capitol Hill in Washington, D.C.

The institute signed a memorandum of agreement with the FDA establishing the collaboration with academia and industry "to further pharmaceutical development and manufacturing innovations." KU will serve as a lead university in the institute.

"This institute is another important step in helping to solve a growing crisis - the ever-increasing costs associated with drug development," said Jim Roberts, vice provost for research and president of the KU Center for Research. "KU will add the world-class expertise of its School of Pharmacy and Higuchi Biosciences Center, as well as the departments of Chemistry and Chemical and Petroleum Engineering, to this partnership with the goal of significantly advancing the science and efficiency of drug development."

The FDA reported in a March 2004 white paper that the cost of bringing a new drug to market rose by about 50 percent over a five-year period to as high as $1.7 billion.

The institute will focus on specific research areas such as pharmaceutical development and manufacturing, process analytical technologies, synthesis of drug substances, modeling and informatics, regulatory science, drug safety and education.

"Pharmaceutical development and manufacturing processes have become so complex that it is increasingly more difficult to provide safe and effective drugs at a significantly lower cost to patients," said Charles Rutledge, vice president for research at Purdue University, West Lafayette, Ind., and one of the institute's founders. "Fundamental research must be conducted to change how pharmaceutical products are developed and manufactured."

Though drug discovery engages the most sophisticated research tools and technologies, drug development and manufacturing do not, said Vadim Gurvich, assistant director of KU's Center for Drug Discovery at the Higuchi Biosciences Center. The industry uses a trial-and- error approach to drug development that is very inefficient.

In addition, the manufacturing process for drugs often remains unchanged because of the high cost of FDA re-approval and inadequate scientific knowledge. This has a direct impact on quality and price of pharmaceuticals.

"Unless the manufacturing technology improves, the FDA will not relax regulations, but unless the FDA relaxes regulations, there is no incentive for the industry to change," Roberts said. "Fixing this gridlock will require a considerable national effort. The new institute represents a neutral third party to help reduce costs by developing new technologies in cooperation with the FDA."

A critical factor driving up drug-development costs is a regulatory requirement that prohibits companies from improving a manufacturing process after the FDA approves it, said Eric Munson, professor of pharmaceutical chemistry.

" Unless this situation is changed, safety concerns will not allow FDA regulatory practices to change, and drug prices will continue to rise for years to come," Munson said.

Besides Roberts, Gurvich and Munson, KU researchers Gunda Georg, university distinguished professor of medicinal chemistry and director of the Center for Drug Discovery; Charles Decedue, executive director of the HBC; and George Wilson, associate vice provost for research, provided leadership in the creation of the institute.

The institute is initially being supported with seed funding from its members while the universities are seeking federal funding.

For more detailed background on the new institute, go to: www.news.ku.edu/2005/November/Nov3/NIPTE.pdf.

Member universities of NIPTE:

University of Kansas
Duquesne University (Pittsburgh, Pa.)
Illinois Institute of Technology
Purdue University (West Lafayette, Ind.)
University of Connecticut
University of Iowa
University of Kentucky
University of Maryland
University of Minnesota
Rutgers University (New Brunswick, N.J.)
Universidad de Puerto Rico de Mayaguez
Universidad de Puerto Rico of San Juan

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The University of Kansas is a major comprehensive research and teaching university. University Relations is the central public relations office for KU's Lawrence campus.

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