Research Is Key for New Firm
Research Is Key for New Firm

Franklin Willis
Pharmaceutical research is a big business, and some of that is creeping into Little Rock. In February 2006, the Lynn Institute of the Ozarks opened in town as part of the larger Lynn Institute system.

How Lynn got into Little Rock, like most things, was a combination of timing and luck.

"I would say it was coincidence," said chief operating officer Franklin Willis. "We happened to hire Dr. (Paul) Wylie's nephew in Oklahoma City and it went from there."

As for Wylie, who serves as medical director in Little Rock he became interested in the work that Lynn was doing from his talks with his nephew and, "I saw a community need for a company that promotes and manages pharmaceutical research in Arkansas ... one that performed the research in a very ethical manner and was of good quality."

Lynn is part of the larger Elite Research Network, which "is an association of independent groups that stretches from Miami to Anaheim," Willis explained. "(They) have outstanding reputations as a group of associated sites that the pharmaceutical companies could count on."

And, due to the high cost of research, that is really the key, said Willis.

"It costs $15,000 for every investigative site," he said, and it isn't just one site.

"It all depends on the drug," said Harmony Kerr, who serves as director of clinical trials. "Some of the trials may have as many as 30 sites and all of them may not be in the United States. For the really big trials, you'll have sites around the world."

But every day the drug is in trials, it costs the pharmaceutical companies money — big money.

"It costs a million dollars a day on every day of the delay on the blockbuster drugs," Willis said. "The clock is ticking on the patent as they go through the process. If it takes 10 years to get through the trials, the company will have seven years left, if they get it done in three years, they have 14. The cost is from the loss time, time is really big money in this area."



The Process

Rounding up physicians and people willing to go through the clinical trial process isn't an easy one. "We've been very particular on whom we have chosen to participate," said Willis, who has five or six physicians doing research for Lynn. "We keep those numbers low on purpose. The whole key here is to do it exceptionally well, and establishing with the pharmaceutical companies that we do excellent work here in Little Rock. That it in itself will grow the business, and if you do a study well, then the pharmaceutical companies will come back to you."

But why Little Rock?

"We like the size," Willis said. "Our model hasn't been to go to the big cities, but go to the places between 200,000 and 1 million. That really fits the model of what we are trying to do."

The group has locations in Oklahoma City, and Norman, Okla., with two locations in Colorado — Pueblo and Colorado Springs.

"Goal number one is to be very successful here in Little Rock," Willis said. "Until we achieve that, we don't have any other goals." Wylie's first involvement with research wasn't pharmaceutical but related to medical devices, mostly for the treatment of sleep apnea. Finding patients hasn't been easy, according to Wylie.

"One of the things that surprises physicians and other people is how specific a patient type or disease type we're looking for," he said. "Out of 100, you might find eight or nine who could participate, and not all of those will want to do it. So you might actually find five who are willing to do the study.

"Finding people to do clinical studies ... is not always easy."



Putting It to Work

Dr. Judy McDonald, an obstetrician/gynecologist who splits her time between Little Rock and Hot Springs, is involved with research at Lynn.

She is working on a drug that will treat endometriosis.

"It's a drug delivered by vaginal ring," McDonald said, "which means a very small dose of medication is highly effective, hence, fewer side effects. That's one of the problems of treating endometriosis, the side effects profile is so great that a lot of women will drop out."

Every trial is different, from the number of people involved to the length of the research. And the costs can be astronomical.

"The average is $1 billion to get one drug on the market," Kerr said.

But Lynn's research, unlike the research done at a medical school, is considered phase III.

"That's the last one, before they go for approval," Kerr said. "Our bread and butter is phase III, that's our bulk."



ie.
November 2006
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