New UT drug testing lab to simplify FDA approval process

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Alan Watts, assistant director of the Drug Dynamics Institute, gives a tour of the lab at the UT Advance open house Monday morning. University researchers will be able to use these facilities to develop inhaled drug products and get them closer to FDA approval.

Photo Credit: Chelsea Purgahn | Daily Texan Staff

University researchers and entrepreneurs will now be able to work on crucial drug research more efficiently with the opening of the UT Advance lab on Monday. 

The new lab will test the effectiveness and safety of unapproved drugs under rigorous conditions. The tests at the new lab will fulfill a required step in the Federal Drug Administration approval process at a lower cost. Before the lab, UT researchers depended on outside facilities to conduct research for FDA approval.

UT Advance is the third component of the Drug Dynamics Institute, a research center in the College of Pharmacy. The institute also operates TherapeUTex and UTech Dorm Room, labs that work with drugs still in development stages.

Janet Walkow, Drug Dynamics Institute’s executive director and chief technology officer, said UT Advance will save drug researchers a substantial amount on time and money in their research efforts.

Walkow said this will allow a lot more proposed drugs worked on by UT researchers to make it through the first stages of the FDA approval process. 

“You have these great people doing research and in development activities, which is great, but unless you can meet FDA guidelines for establishing that something is safe enough to go into humans, it’s not going to go anywhere,” Walkow said. “I don’t want to leave intellectual property and research innovations on the lab bench.”

Walkow said the lab will also provide learning opportunities for students, as they will now be able to observe more ongoing research. Because the lab is federally regulated, students will not be able to actually work on the research or testing.

Alan Watts, assistant director of the Drug Dynamics Institute and UT Advance lab researcher, said the regulations and documents needed for any FDA approvals require the researchers to work methodically to record all the necessary data.

Watts said the lab will test the potency of a drug and check for degradation in tablets, capsules and aerosols. Watts said there will be an emphasis on aerosols, which can be more difficult to test.

“We would take a small sample and see if the active ingredient is still present at the same levels that it was initially,” Watts said. “What can occur sometimes is that there are instabilities and that drug will degrade and the patient doesn’t get the proper dose.”

At the lab’s opening ceremony, Sen. Kirk Watson said enhancing research is one of several components necessary for the University to become acknowledged in the medical community.

“I believe that Austin, Texas, can become a center for health care excellence, but in order to do that we need to achieve some goals,” Watson said. “Among those goals was a medical school. Another goal was that we have a 21st-century teaching hospital, but also among those goals was to enhance research like what we’re doing here.”

Printed on Tuesday, October 9, 2012 as: New UT lab seeks to simplify drug testing