Grant helps UI lead the way from lab to clinic

On Sept. 18, The University of Iowa became one of only 24 research institutions in the nation to be awarded a Clinical and Translational Science Award (CTSA) from the National Institutes of Health (NIH). The five-year, $33.8 million award is the second-largest research award in UI history.

This was good news for investigators like Janet Fairley, MD, professor and head of the UI Department of Dermatology, who has an active basic and clinical science research program.

“All of us were really pleased to hear the CTSA had h1 been funded. To be awarded the grant early on gives us the ability to move forward and become a real leader in translational science.” — Janet Fairley, MD

"All of us were really pleased to hear the CTSA had been funded," Fairley said. "To be awarded the grant early on gives us the ability to move forward and become a real leader in translational science."

Fairley’s research is a perfect example of the kinds of projects that the CTSA will support. Her team is investigating a skin disorder called bullous pemphigoid, an autoimmune skin disease in which a person’s immune system produces autoantibodies that attack the skin, causing painful blisters. Current treatment involves suppressing the patient’s immune system with steroids, but that carries many associated risks such as unrelated infections as well as undesirable side effects. Since bullous pemphigoid most often develops in the elderly who are more likely to have other health issues, the treatment can be especially risky.

"It was discovered, probably 40 years ago, that patients with bullous pemphigoid had elevated total IgE levels, but most people thought it was a side effect of the disease. We characterized the IgE antibodies and found they were pathogenic," Fairley said.

Fairley wants to find out if treating patients with a monoclonal anti-IgE antibody will help or even stop the disease. "We are currently in the process of bringing this out of the lab and translating it to the clinic," Fairley said. "We’re enrolling subjects right now in a trial that will test the safety and efficacy of Xolair, an anti-IgE drug that’s already approved for asthma, to see if it will also treat bullous pemphigoid."

UI leaders hope that the CTSA will help these kinds of projects to expand and proliferate here. The CTSA is designed to advance the discipline of clinical and translational science and make it easier for researchers to work together, both within institutions and through a consortium of all CTSA awardees. The NIH, as part of its "Roadmap for Medical Research," established the consortium of research centers to lead the way in translating scientific advances into new treatments for patients. Twelve institutions first received CTSAs in October 2006. When fully implemented by 2012, the initiative will support 60 academic medical centers that are part of the consortium.

Gary Hunninghake, MD, the Sterba Professor of Internal Medicine and the College’s senior associate dean for clinical and translational sciences, worked for more than two years on the UI’s application for the grant. Hunninghake said the CTSA is "life and death for a research institution."

"No research institution will continue in any real way without this grant," Hunninghake said. "It’s that important. It’s absolutely essential to do biomedical research of any kind."

The CTSA will fund the UI’s Institute for Clinical and Translational Science, an overarching structure for all clinical and translational research at the UI. Approved by the Board of Regents, State of Iowa, in December 2006, the Institute is already up and running and includes researchers from several different colleges, including dentistry, nursing, pharmacy, public health, engineering, liberal arts and sciences as well as the CCOM.

"Any project that potentially involves research with patients, human subjects, or even public policy and outcomes can relate to this Institute," Hunninghake said. "The vision is that anybody who does research, even basic research, that has applications to people can be part of this Institute."

As part of its mission, the UI Institute for Clinical and Translational Science will:

Engage the state of Iowa as a partner in clinical and translational research. Reaching beyond the UI campus to conduct clinical trials and bring cutting-edge treatments to patients is an integral component of the Institute, which has already established partnerships with Iowa Health Systems, Mercy Health Network, the Iowa Hospital Association, Wellmark Blue Cross/Blue Shield, Iowa Medical Society, Unity Health System and Genesis Health System. The Institute will expand already existing outreach programs in four Iowa communities—Des Moines, Davenport, Waterloo and Sioux City/Sioux Falls. After initiating Institute activities in these communities, the goal is to extend this network throughout Iowa and South Dakota.
Expand and pursue multidisciplinary research opportunities involving the CCOM and collaborators in the colleges of Dentistry, Education, Engineering, Law, Liberal Arts and Sciences, Nursing, Pharmacy, Public Health and the UI Graduate College.
Create an infrastructure for training programs designed to prepare more students and junior faculty for careers in clinical and translational science. A number of already successful UI training programs will come together to result in new master’s and PhD degrees in "clinical and translational science." The home for this new program will be within the Institute. Six areas—epidemiology, biostatistics, clinical epidemiology, bioinformatics, research ethics and research survival skills—will make up the core curriculum for the new Clinical and Translational Science degree programs. The centerpiece of the training program will be a mentored research practicum directed by one of 30 senior scientists with national reputations. Mentors will be core or affiliated Institute faculty with strong track records in publication, funding, cross-disciplinary research and nurturing young scientists.
Partner with Iowa State University and the University of Arizona to foster new research collaborations and maintain a diverse pool of study participants for clinical trials.
Forge new and strengthen existing partnerships with industry sponsors involved in clinical and translational science. Fairley is excited about the prospect of what might be possible with the expanded support provided by the CTSA grant. "It will really enhance the infrastructure that is needed to do this type of research," she said. "Resources like the General Clinical Research Center, which the CTSA will replace and expand, are instrumental in helping us deliver what’s in the lab to the patient, and improving patient care and expanding knowledge really is the bottom line."