Updated 10/09/2012 10:57 AM
New drug development lab opens at UT
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The hard part of creating new medicine is getting the government to let you try them on people.
Drug Dynamics Institute Executive Director Janet Walkow says the Food and Drug Administration requires a set of safety studies for review before a drug can go to clinical trials.
It's called Good Laboratory Practices, and it’s a process that can take years and cost millions — until now.
The University of Texas has built just such a lab called UT Advance at the Drug Dynamics Institute.
"We provide that gap that researchers can't do, whether it's because of expertise, whether it's because of funds. Some companies are virtual, they don't have any lab space at all," Lab Manager Greg Lyness said. "We perform studies to ensure the potency and the strength. That there's no degradation products within a drug formulation like a tablet or a capsule."
Drug Dynamics Institute Assistant Director Dr. Alan Watts says the lab performs studies using standards already put in place by the FDA. For researchers and small biotech firms, it gives them access to knowledge and resources previously out of reach.
Stringent procedures and standards are key to the Good Laboratory Practices designation.
"We need to ensure that it's pure and that every chemical in there is exactly what we think it is," Watts said. "People don't always understand the amount of scrutiny, the testing, that goes into drug products, but in the end, it's all about human safety."
One of the first new drugs to use the UT access lab is a treatment for people with lung transplants.
The UT facility is one of only about a half dozen labs in the country to test inhaled drugs for human trials.