KU joins effort to reduce drug costs
University takes lead role in research institute
Vadim Gurvich, assistant director of KU's Center for Drug Discovery at the Higuchi Biosciences Center, plans to use his area of expertise as the university takes a leading role in helping to reduce the costs of developing drugs.
A synthetic chemistry specialist, Gurvich said a focus of his work will be synthesizing molecules, a major step in developing new drugs. He will have a lot of help.
KU 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 recently at a policy briefing by institute members 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.
Gurvich was elected an associate director of the institute and said KU has already worked hard, taking the lead in shaping the direction of NIPTE.
"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, president of the KU Center for Research and a member of NIPTE's Board of Directors. "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.
Gurvich said various "centers of excellence" will be developed at NIPTE member institutions.
"Here at KU we're planning to work on the development of active pharmaceutical ingredients, vaccine development and pharmaceutics," Gurvich said of the university's planned center of excellence.
The center of excellence will seek solutions to one of the main problems that led to the formation of NIPTE.
"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., one of the institute's founders and a former KU dean. "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, Gurvich said. The industry uses a trial-and-error approach to drug development that is inefficient.
The ultimate goal is to drastically improve development efficiency, using the model of an industry known for being on the cutting edge.
"The main idea is to try to mimic the aerospace industry, so you can design the entire drug manufacturing process on the computer," Gurvich said. "It is a very ambitious goal, but we feel that this is something we can do eventually."
In addition, the manufacturing processes for drugs often remain unchanged for decades because of the high cost of FDA re-approval and inadequate scientific knowledge.
"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.
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 Mayagüez
- Universidad de Puerto Rico of San Juan
Gurvich said he thinks it has the potential to make an impact on reducing drug development costs, which in turn could reduce the price of drugs for consumers.