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| KU joins major universities, FDA in effort to improve quality and reduce costs of pharmaceuticals The collaboration, called the National Institute for
Pharmaceutical Technology and Education (NIPTE), was announced November
3rd at a policy briefing by institute members on Capitol Hill in Washington,
D.C. Participating with KU are Duquesne University, the Illinois Institute
of Technology, Purdue University, Rutgers University, and the universities
of Puerto Rico, Connecticut, Iowa, Kentucky, Maryland and Minnesota. The
institute signed a memorandum of agreement with the FDA in June, establishing
the collaboration with academia and industry “to further pharmaceutical
development and manufacturing innovations.” KU will serve as a lead
university in the institute. A March 2004 FDA study reported 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. “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.” NIPTE 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. The organization will be led by director Prabir Basu of Purdue University and associate director Vadim Gurvich of KU. “Though drug discovery engages the most sophisticated research tools and technologies, drug development and manufacturing do not,” said 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, have
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. Higuchi
Biosciences Center |
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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.