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Universities unite to research drug-development

By By Travis Robinett (Contact)

Thursday, November 10, 2005

The University of Kansas has joined 11 other universities to research the drug-development process in hopes of lowering the price tag and the time involved in manufacturing drugs.

The new National Institute for Pharmaceutical Technology and Education, which formed on Nov. 3, is led by Charles Rutledge, vice president for research at Purdue University, KU alumnus and a former KU professor.

The need for cheaper and faster drug development is clear. Getting a drug to the market can take 10 to 15 years and cost as much as $2 billion, said Vadim Gurvich, assistant director of the KU Center for Drug Discovery and associate director of the Institute.

Karen Mahoney, spokesperson for the FDA, said that any changes pharmaceutical companies made to FDA-approved drugs had to be reviewed. To make a change, a company has to turn in an application explaining the changes so the FDA can see that the drug still serves its intended purpose. That process takes time.

Gurvich said the companies were afraid to make changes because the FDA process took so long. He said the only way to improve the process was for companies to work together with the FDA. He said the institute would help by making new technologies, which could translate into lower costs, available to every company.

Mahoney said the FDA intended to do away with the applications for change with the help of the institute’s research. She said she hoped the research would cut down on time.

Getting a drug to the market takes so long because pharmaceutical companies use a trial-and-error approach, Gurvich said. He said the chemical reactions used to make drugs rely on specific conditions, such as the temperature at which the drug works best.

He said the companies test a wide range of variables and needed to narrow that range to produce drugs faster.

Gurvich said the Institute hopes to change the old-fashioned approach for testing drug quality, which was to make the drug and then analyze it when it’s finished. The institute wants to find ways to analyze the drug throughout the process so the manufacturer can make changes during development.

The institute has plans to develop drug-modeling tools like those the aerospace industry uses, Gurvich said. He said aerospace scientists design planes on computers because they have tools to predict how all the parts will behave.

“Ideally, we want to learn so much about processes during manufacturing that we can model them on computers. It’s a long shot but not impossible.”

Gurvich said that would require a combination of different scientific expertise.

“Twelve universities can do this,” he said.

Rutledge said the universities would collaborate through a board of directors. Most of the funding for the institute was from Purdue, but each University involved would contribute $7,500, he said. The institute will seek federal funding it hopes will be authorized by the end of this year.

— Edited by Becca Evanhoe

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