The University of Texas at Austin is opening a laboratory that fills a critical gap in the process of developing new drugs and biotechnology products.
Potential drugs will be tested for effectiveness and safety under rigorous conditions in the facility. Passing such a test is required before the U.S. Food and Drug Administration (FDA) allows a drug into human clinical trials. The tests could also aid in filing for patents and reaching commercialization agreements for pharmaceuticals and biomedical technology.
The laboratory, called UT Advance, is at the Dell Pediatric Research Institute near the Dell Children's Medical Center of Central Texas.
Researchers at The University of Texas at Austin are developing drugs to treat lung transplant recipients and people suffering from cancer, viruses such as influenza and other diseases. University researchers have developed about 60 drug and drug-delivery technologies that have been commercialized or are available for commercialization, according to the university's Office of Technology Commercialization.
"We have outstanding preclinical research programs in drug development and targeted drug delivery," said M. Lynn Crismon, dean of the College of Pharmacy. "This facility will help our researchers in these areas move more efficiently and effectively to get their discoveries into human trials."
The lab could also play a role in the Central Texas biomedical community. It will be open for use by biotech companies and other entities outside the university.
"The new laboratory space at the Dell Pediatric Research Institute is another example of the tremendous health, medicine and research assets that we have in Central Texas," said state Sen. Kirk Watson. "This is a critical resource not only for our university researchers, but also for the larger community that will benefit from its discoveries. And it demonstrates the potential of this region to grow our economy by investing in these kinds of resources."
The facility costs about $1 million to set up and is being funded by the university.
This type of facility is called a Good Laboratory Practices (GLP) laboratory. A GLP facility certifies that a potential drug is safe to use in clinical trials involving humans. It provides assurance that procedures and documentation meet FDA requirements.
"These are the final, pivotal studies that the FDA will review before they are allowed into human trials," said Janet Walkow, executive director and chief technology officer of the university's Drug Dynamics Institute, which oversees the GLP lab.
Having GLP capabilities at the university will reduce costs and time that researchers have spent on such tests in commercial facilities.
UT Advance will focus on inhaled drug products, which several university researchers are working on. There are few GLPs around the country that test inhaled drugs.
The first potential drug the university's GLP will test comes from a collaboration between William O. "Bill" Williams, a pharmacy professor at the university, and Dr. Jay I. Peters, a professor at the University of Texas Health Science Center in San Antonio. They are developing an inhaled immune suppressing drug capable of treating patients who have had a lung transplant.
The testing for the drug will begin later this year.
With the GLP facility, the Drug Dynamics Institute has three complementary facilities that help researchers through the drug development process.
At the TherapeUTex lab, researchers can test the proof of concept for potential drugs. The UTech Dorm Room provides the wet lab space, tools and other resources to fledgling biotech companies for further development. And GLP studies are the final testing stage before human trials.