Drug Development

Pharmacy Times, Volume 0, 0

The National Institute for PharmaceuticalTechnology and Education is acollaborative effort between 11 universitiesand the FDA. The partnership willconcentrate on learning more about theexact science involved in making pharmaceuticalsand looking for avenues tolower costs.

In March 2004, the FDA reportedthat it can cost as much as $1.7 billionto bring a new drug to market—a 50%jump over a 5-year period. A core partof the problem is a lack of fundamentalscientific knowledge, which has placedboth industry and regulators in a dangeroussituation. A regulatory requirementthat prevents companies fromenhancing a manufacturing processafter FDA approval is a key factor in therising drug-development costs.

"That $1.7-billion figure includes allof the money a company spends on thevarious steps of drug discovery and development,which is a considerable expensebecause only about 1 in 10 attemptsto develop new drugs succeeds,"said Ali Cinar, PhD, dean of the GraduateCollege at Illinois Institute of Technology."The development cost is sohigh that pharmaceutical companiescan only afford to market blockbusters."

Therefore, the need for new technologiesis warranted because it couldallow pharmaceutical companies to betterforecast the performance of a newdrug prior to development. This processwould allow companies to focus on candidatesthat are most likely to proceed.