Drug Development

Published Online: Thursday, December 1, 2005

The National Institute for Pharmaceutical Technology and Education is a collaborative effort between 11 universities and the FDA. The partnership will concentrate on learning more about the exact science involved in making pharmaceuticals and looking for avenues to lower costs.

In March 2004, the FDA reported that it can cost as much as $1.7 billion to bring a new drug to market—a 50% jump over a 5-year period. A core part of the problem is a lack of fundamental scientific knowledge, which has placed both industry and regulators in a dangerous situation. A regulatory requirement that prevents companies from enhancing a manufacturing process after FDA approval is a key factor in the rising drug-development costs.

"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 1 in 10 attempts to develop new drugs succeeds," said Ali Cinar, PhD, dean of the Graduate College at Illinois Institute of Technology. "The development cost is so high that pharmaceutical companies can only afford to market blockbusters."

Therefore, the need for new technologies is warranted because it could allow pharmaceutical companies to better forecast the performance of a new drug prior to development. This process would allow companies to focus on candidates that are most likely to proceed.

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