Newswise — Officials will meet today (Thursday, Nov. 3) in Washington, D.C., to announce an 11-university research partnership with the Food and Drug Administration aimed at reducing the skyrocketing cost of drug development and manufacturing.
The collaboration, called the National Institute for Pharmaceutical Technology and Education, or NIPTE, will focus on learning more about the precise science involved in making pharmaceuticals and exploring ways to reduce costs. The institute will be announced during an 8 a.m. (EST) breakfast briefing in Room B-354 of the Rayburn House Office Building on Capitol Hill. Talks will be presented by Charles Rutledge, vice president for research at Purdue University and one of the institute's founders; Marilyn Speedie, dean of the College of Pharmacy at the University of Minnesota; and Jordan Cohen, dean and professor in the College of Pharmacy at the University of Iowa.
A question-and-answer session will follow the presentations.
"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 Rutledge, a professor of pharmacology and former dean of pharmacy. "Fundamental research must be conducted to change how pharmaceutical products are developed and manufactured.
"This type of research is best conducted by scientists at our leading academic institutions who are making innovative advances in pharmaceutical manufacturing."
The institute is a research partnership between the universities and the FDA, which signed a memorandum of agreement establishing the collaboration with academia and industry "to further pharmaceutical development and manufacturing innovations."
Researchers in the collaboration will strive to improve the science of drug development.
"The idea is to better understand the basic physics and chemistry to design better drug-development processes, instrumentation to monitor the processes and create better quality control schemes - what we call having a science base for the manufacture of these products," said Stephen Byrn, head of Purdue's Department of Industrial Pharmacy. "For example, when you make a tablet, you mix granular materials and compress them all together. What's not well understood is the basic physics of how these various granular materials will stick together, how they dissolve and so on. As a result, the industry uses a trial-and-error approach to drug development."
This knowledge could lead to a more efficient science-based regulation of product manufacturing, which could lower production costs, he said
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 issues driving up drug development costs are complex and involve a delicate interplay of factors in regulation, the marketplace and science," said Michael J. Pikal, Pfizer Distinguished Endowed Chair in Pharmaceutical Technology at the University of Connecticut, a member of the institute. "The industry uses the most sophisticated research tools to discover new drugs, but the actual development and manufacturing of these pharmaceuticals is very inefficient."
Central to the problem is a lack of fundamental scientific knowledge, which has placed both industry and regulators in a precarious situation.
"It's sort of a Catch-22 because, 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," said James Roberts, vice provost for research at the University of Kansas. "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 it is approved by the FDA.
"Just think about any other consumer product," said John Parks, associate vice president for research at the University of Kentucky, another institute member. "In the case of average consumer products, when a company first puts it into the marketplace, it charges a price. During the life of the manufacturing process, each year the company keeps improving the manufacturing process by which the product is made, and the cost goes down. It's called a learning curve."
In the pharmaceutical industry, however, it is difficult to make changes to the drug manufacturing process even during clinical trials, he said.
"In fact, once the manufacturing process is registered with the FDA, changes can be made only after getting appropriate regulatory approvals," Parks said. "As a result, there is really no learning curve, and the production costs cannot be substantially reduced."
The "patent life" of a new drug is 20 years, meaning a company has that long to recoup its expenses before generics can be introduced. Once the patent is filed, however, it typically takes many years to finish developing the drug and get it on the market, leaving less time to recover costs.
Another issue is that the discovery process has become more complicated because "the low-hanging fruit is not there anymore," said Ali Cinar, dean of Graduate College at Illinois Institute of Technology.
"That $1.7 billion figure includes all of the money a company spends on the various steps of drug discovery and development, which is a considerable expense because only about one in 10 attempts to develop new drugs succeeds," he said. "The development cost is so high that pharmaceutical companies can only afford to market blockbusters.
"Consequently, if the drug doesn't hold promise to make a billion dollars a year, companies don't even develop it. That prevents many potentially good medicines from reaching consumers."
New technologies could enable pharmaceutical companies to better predict the performance of a new drug before it is developed, allowing companies to concentrate on candidates that are most likely to succeed.
"We recognize the problem is too extensive for one single institution to tackle, so we've brought together many institutions that have significant pharmacy and chemical engineering programs," Rutledge said.
The institute is initially being supported with seed funding from its members, and the universities are seeking federal funding.
The 11 universities, along with officials from each institution, are:
"¢ Duquesne University: Alan Seadler, Edward V. Fritsky Chair in Biotechnology Leadership; James Drennen, associate professor of pharmaceutics.
"¢ Illinois Institute of Technology: Ali Cinar, dean of graduate college; Dimitri Hatziavramidis, research professor of chemical engineering and director of the Particle Technology and Crystallization Center.
"¢ Purdue University: Prabir Basu, director of the institute; Stephen Byrn, head of Department of Industrial Pharmacy; Charles Rutledge, vice president for research; G.V. Reklaitis, the Edward W. Comings Professor of Chemical Engineering.
"¢ Rutgers University: Michael Klein, dean of the School of Engineering; Fernando Muzzio, professor of chemical engineering.
"¢ University of Puerto Rico: Lesbia Hernandez, dean (San Juan); Nelson Cardona, dean (Mayaguez); Evone Ghaly, associate director of the Center for Pharmaceutical Processing Research; Rodolfo Romanach, professor of chemistry; Carlos Velazquez, professor of chemical engineering.
"¢ University of Connecticut: Robert McCarthy, dean and professor of the School of Pharmacy; Michael Pikal, Pfizer Distinguished Endowed Chair in Pharmaceutical Technology; Robin Bogner, associate professor of pharmaceutics.
"¢ University of Iowa: Rolland Poust, professor of pharmaceutics; Lee Kirsch, associate professor of pharmaceutics.
"¢ University of Kansas: James Roberts, professor of electrical engineering and vice provost for research; Vadim Gurvich, assistant director of the Center for Drug Discovery; Eric Munson, professor of pharmaceutical chemistry.
"¢ University of Kentucky: John Parks, associate vice president for research; Michael Jay, professor of pharmaceutical sciences.
"¢ University of Maryland School of Pharmacy: James L. Hughes, vice president of research and development; Stephen Hoag, professor of pharmacy.
"¢ University of Minnesota: Marilyn Speedie, dean of the College of Pharmacy; Raj G. Suryanarayanan, professor of pharmaceutics; David Grant, professor of pharmaceutics.
Related Web site:
National Institute of Pharmaceutical Technology and Education: http://www.nipte.org
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