Deal with pharmaceutical company challenges new office

by Kelly Wittman

A $1 million contract with a major pharmaceutical company catalyzed the development of a new office within the Academic Health Center, a boost that could open the door to much more corporate-sponsored research for the center.
The University struck a deal with pharmaceutical developers G.D. Searle and Co. March 17 to conduct clinical trials of drugs in development by the corporation. The deal is the first of its kind for the fledgling Research Support Services Office, which is being established to facilitate research agreements between the University and corporations for conducting medical research.
The idea for the research office was formed late last year to begin looking into the possible benefits of contract research, but the timely agreement with Searle has spurred AHC Provost Frank Cerra to add the Clinical Trials Center to the office. The center will administrate the Searle contract and eventually market the University to other corporations.
The contract marks the AHC’s entrance into the lucrative world of private contract research. Dr. Henry Frazer, president of Drug Research and Analysis Corporation in Montgomery, Ala., estimates that private contracting reaps profits that run into the billions of dollars each year.
Until now, all research was conducted after individual researchers contracted with companies for specific studies.
Beside the possibility that the contract with Searle will bring other research agreements with corporations, it could mean a new, stable revenue source for an AHC that has struggled with soft money problems, a highly competitive research community and reorganization.
“It’s a new source of funding to bolster the foundation in a time of changing resources,” said Dr. Leo Furcht, vice provost for research programs and services and a leader in the establishment of the research office.
The AHC has been the focus of a reorganization effort because the center fell into financial difficulty last year when “soft money” sources that were being used to pay tenured professors began to dry up.
Dr. Jim Cloyd, interim director for the Clinical Trials Center, said there is already a fair amount of industry-sponsored research at the University, but what makes this contract unique is that it is a master agreement — a declaration of a commitment by Searle and the University to place clinical studies at the AHC.
When University researchers individually conduct studies, the sponsor has no obligation to the University to bring in further research once they are completed, Cloyd said. The master agreement with Searle commits the company to placing a set amount of research here, he said.
The contract with Searle is a case of the proverbial cart going before the horse, Furcht said, because The Research Support Services Office is still a work in progress.
Furcht was chairman of group that was charged with dissecting the processes that go into corporate-sponsored research and developing a plan to streamline the University’s processes to make the school more attractive to potential partners, he said. The group just generated a series of proposals to be delivered into the hands of the AHC Consultative Committee for consideration when the Searle deal came through.
“The good news is we have a $1 million contract with Searle; the bad news is there is a bunch of work that needs to be done to perfect processes,” Furcht said.
Debra Dykhuis, a coordinator in Pharmacy Practice, has been working to get the Searle clinical trials off the ground. “We are some distance from enrolling patients yet. It’s a long, arduous process, and we haven’t made the progress with streamlining yet,” she said.
Dykhuis said that the University has found researchers to look into a drug for hypertension that Searle wants studied, as well as a researcher to conduct trials with an anti-inflammatory drug that Searle believes may have benefits for patients with Alzheimer’s, osteo and rhumetoid arthritis and migraine headaches. Dykhuis said she is still looking for an investigator for clinical trials on a new drug to treat cancer.
Cloyd said that if the words “interim,” “new” and “temporary” seem to be used a lot in reference to the clinical trials office, it’s because the Searle opportunity presented itself before the AHC had time to fully establish the Clinical Trials Center.
“The opportunity presented itself and rather than say ‘no, you’ll have to wait,’ the provost went ahead and took the opportunity,” Cloyd said. Permanent program administrators will be hired as the program develops, he said.
The program is important, Cloyd said, because there is some evidence that universities may lose the opportunity to do clinical research for corporations to more efficient contract research organizations. Administrators wondered if the University could not only remain competitive in the contract research industry, but also attract more corporate research dollars, he said. Evidence from other universities, such as Duke, and Washington University in St. Louis, indicates that the AHC could attract more contract research, Cloyd said.
One advantage the University has is that companies find that even though universities are less cost-efficient, they provide the proper inquisitive academic environment that is conducive to clinical trial research, he said.
But, Frazer said, “In the pharmaceutical industry, time is money.”
A swift investigation process is important because, during the clinical investigation of drugs, the patent “clock” is running. When the drug is registered at the patent office, other companies are prohibited from developing the same drug, but if the initial company’s application for approval is held up by a lengthy clinical trial or the Food and Drug Administration, the patent clock on the drug could run out. If the FDA holds a drug up in a long review process, it can grant a patent extension, but “that doesn’t happen too often,” Frazer said.
Other considerations may color a company’s choice of contract research organizations. Searle chose the University because the company is headquartered in Chicago and wanted to contract with a leading research center in the Midwest, said Dr. John Alexander, Searle’s executive vice president for medical research.
This contract involves clinical research of drugs in the early development stage, Alexander said, but Searle hopes to develop other agreements for more basic research at the University, including possible product research for Searle’s parent company Monsanto. “We have plans to look at other collaborative efforts,” Alexander said.