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Texas Institute of Pre-Clinical Studies Leads Way in BioTechnology
By JENNIFER MADDOX





What would you say if you heard a rumor that Bryan/College Station could be the next leading force in biotechnology innovation? Todd McDaniel, President/CEO of The Research Valley Partnership, believes that statement could become a reality with the development of the Texas Institute for Preclinical Studies (TIPS).

TIPS was established by the Texas A&M Board of Regents at its May 25th meeting last year. The facility will be an organizational unit of the university, reporting to the vice president for research. It is considered to be the big sister to the Texas Institute for Genomic Medicine (TIGM), which is an independent, non-profit research center utilizing advanced technologies to discover breakthroughs in science and medicine and accelerate the pace of medical discoveries.

Through the combined efforts of projects like TIPS and TIGM, the Texas A&M System can potentially reach new heights in the field of biotechnology research and development.

“We’re one of only four or five communities in the entire country that has both a college of vet medicine and a college of medicine in our backyard,” said McDaniel.

TIPS will be a state-of-the-art facility that will provide core services in developing and conducting research activities, pre-clinical large animal studies using Good Laboratory Practices (GLP) and biomedical imaging to support pharmaceutical and medical equipment development. The facility will be under the direction of TIPS Director Theresa W. Fossum, D.V.M., an internationally-recognized veterinary surgeon and prominent leader in the field of heart research. Fossum is also director for cardiothoracic surgery and biomedical devices in the Michael E. DeBakey Institute at Texas A&M.

GLP research refers to FDA-mandated research that is required in order to get a drug or medical device approved and ready for the marketplace. The RVP points out that although there are 500 medical device, biotechnology, and drug discovery companies in Texas, there are few options for pre-clinical GLP testing, especially in large animals.

“In doing the initial market research when we worked on this project, if you’re an early-stage medical device company in Texas, the likelihood that you’re going to be able to do your GLP work here is almost zero,” said McDaniel. As a result, Texas companies are forced to take their research and development dollars elsewhere. Since most of the major GLP facilities are positioned on the east and west coasts, TIPS could attract regional companies.

Typically, it takes around 12 years and $1 billion to bring a new drug to the marketplace with only 1 in 8 drugs actually making it to the shelves. Therefore, another advantage that could draw companies to TIPS is the hope that the distinct features TIPS offers will be able to speed along the process.

TIPS will house 12,000 square feet of business incubator space designed for early-stage life science technology companies. McDaniel explained that because these start-ups will be adjacent to where their clinical GLP research is being done, the facility will have a “unique competitive position”. Also, the Research Valley will have emerging technology companies located right in its own backyard.

Since the facility will feature acute animal housing for 240 large animals, TIPS will have the opportunity to research animals that have naturally occurring, or spontaneous, disease. This is beneficial as animals with spontaneous disease tend to be better models than animals that have been given the disease specifically for research purposes. Animal and human diseases are often similar in cause and progression, and domestic animals and their owners typically react in the same way to environmental factors.

“So developing these spontaneous, naturally occurring models will hopefully reduce the cost and make it more efficient and easier to get drugs and devices to the marketplace,” explained Fossum.

As an added bonus, Fossum said that the animals benefit from the research as well. Therefore, both the animals and the people win.

In addition to providing GLP services, TIPS will also serve as a training facility that will prepare veterinarians, physicians, scientists, technicians and engineers to meet the needs of Texas’ biomedical industry. It will also serve as a key resource for training undergraduate and graduate students, and academic and industry personnel in regulatory issues.

According to the RVP, there are currently only 17 universities in the country that offer programs for certificates or degrees in regulatory affairs and none of those schools are in Texas. They are located in the northeast, the west coast, and in Georgia. GLP training and study director training is only offered through in-house customized programs, contract training or continuing education at trade conferences.

Besides benefiting research, TIPS could have a stunning impact on the local economy. The Perryman Group of Waco was hired to conduct an economic impact analysis on this project and the findings were startling. According to the report, “If Texas achieves a concentration of this activity equal to that of the US and becomes a ‘typical’ state with regard to these industries, gains of more than 12,900 jobs in the College Station-Bryan area and 131,700 in Texas could be expected as of the tenth year.”

The report also stated that “If Texas achieves a concentration of this activity equal to that of Minnesota, a state with preclinical capabilities which achieves a much greater concentration of the related manufacturing enterprises, the incremental jobs that could be expected are approximately 16,500 in the College Station-Bryan area and almost 163,700 in Texas.”

The report concluded that the TIPS project would be an “important addition to the biotechnology complex in Texas” and that it “can lead to sizable economic gains…The initiative’s potential to serve as a catalyst for development in key growth sectors is even greater.”

Because this project could be such an advantage for Texas, and so many research and development dollars are currently leaving the state, the office of the governor was compelled to take notice as well. “Very early on in the process, I met with a team from the university and from the system with the office of the governor,” said McDaniel. “And they were very clear that, if they were to participate, they fully expected the community to be a financial partner in this project as well. “

The community has indeed stepped up to meet their financial expectations. They will invest a cash grant of $500,000 per year for the first five years to defray initial start-up costs. Of that $500,000, the City of College Station will fund $250,000 per year, Brazos County will fund $166,000 per year, and the City of Bryan will fund $84,000 per year.

In addition, the community will invest at least $26 million in real and personal property. They have also committed to construct and maintain the 12,000 square feet business accelerator space, and TIPS has committed to work with the RVP on behalf of the community to secure emerging technology company tenants within the space. Plus, there will be RVP representation on the TIPS Board of Directors.

In all, TIPS has five funding sources totaling $62 million. Texas A&M University will contribute $47.8 million, Texas Emerging Technology Fund will give $6.0 million, Texas Economic Development bank will provide $4.2 million, The Research Valley Partnership will contribute $2.5 million, and the Texas Department of Transportation will donate $1.5 million.

The TIPS facility will include three buildings that will total approximately 112,000 square feet. The buildings will be located in the Texas A&M University Research Park at the northeast corner of Discovery Drive and Raymond Stotzer Parkway, and it will be situated next door to the TIGM facility. McDaniel points out that if plans are carried out to extend Discovery Drive to F&B Road which could then be extended to the Texas A&M Health Science Center, our community could have the makings of a research corridor.
Governor Rick Perry will attend the ground breaking ceremony, which is scheduled for the 28th of March. The facility is expected to open its doors in May of next year.