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CELERION, 8.19

Mamta Mandal reviews a procedure at Celerion. The company, which started out as Harris Labs, did its first clinical drug trial 50 years ago.

It was so long ago, nobody can find records on what drug was tested or what company manufactured it.

In 1969, the scientific company in Lincoln that was then called Harris Labs did its first clinical drug trial.

At the time, it was a unique concept. Pharmaceutical companies usually did their own drug safety studies, and independent clinical research testing wasn't really a thing yet.

CELERION, 8.19

Shaina Ives looks at the information on a tube before inputting data at Celerion.

Harris Labs had expanded into research, development and testing services for the pharmaceutical and other industries in 1957, but things really took off for the company once it did that first clinical test.

In the intervening years, the company founded by Lew Harris expanded several times, including setting up a 172-bed testing center in Lincoln and opening clinical research centers in other cities.

Michelle Combs, vice president of data management and biometrics for the company that's now called Celerion, said it took incredible foresight by Harris to believe that his company could take on those clinical research tasks and be a credible, independent third party on which drug companies could rely.

CELERION, 8.19

Brian Lee (left) demonstrates how to use a flow cytometer at Celerion. This year marks the 50th anniversary of the first clinical drug test in Lincoln.

"He really kind of created a whole industry, and it started right here in Lincoln, Nebraska," Combs said.

In the 50 years since, the company has done more than 6,000 clinical drug studies globally.

What Celerion does in Lincoln and at its other sites is called Phase 1 research, which Combs said is what is referred to as "first time in human studies."

It's basically the first stage after animal testing, where companies are trying to make sure the drug is safe to put in the human body before testing whether it does what it is supposed to do medically.

CELERION, 8.19

David Fox works with plasma at Celerion.

Combs said the Lincoln site, which also is Celerion's world headquarters, probably does more of those kinds of studies than any other site in the world, averaging 100 a year. About 1,500 people annually participate in those studies.

She said most companies doing clinical research testing focus on a niche, and Celerion's niche is what's called clinical pharmacology, which is essentially the science of how drugs work in humans.

That leads to studies that can range from seeing how a drug might interact with other drugs and food to measuring the body's absorption of a drug to watching for potential adverse effects on specific organs, such as the heart.

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CELERION, 8.19

Zuki Mohamed runs a machine as part of a demonstration at Celerion. The machine can do 96 sample readings at a time.

In the 50 years that Celerion has been doing those studies, the premise has remained the same, Combs said, but the technology involved has changed greatly.

Whereas early studies might only have involved blood tests and heart rate monitoring, studies done today might incorporate MRIs and other imaging tests.

"The complexity of these studies has just really exponentially increased," she said.

CELERION, 8.19

A machine that can take 96 sample readings at a time runs as part of a demonstration at Celerion.

Another change, Combs said, is the test subjects.

For years, volunteers were often college students and other young adults who might have counted on the studies as their primary source of income.

Now, Combs said, the vast majority of test subjects are older and have full-time jobs.

What hasn't changed, though, is the reliability of the test subjects.

Many of Celerion's clinical studies require multiple visits to its lab at 621 Rose St. and failure by subjects to follow through can compromise the results.

Those hired for studies in Lincoln "always come back," Combs said.

"They can be depended on to do what is necessary for the study," she said.

It doesn't hurt that the studies pay well, with Combs estimating Celerion paid out about $10 million to research participants last year in Lincoln alone.

The availability of reliable test participants is one of the reasons the company likes Lincoln, but another is the quality of its workforce.

Celerion has about 1,000 employees total, 400 of which are based in Lincoln doing not only clinical testing but also data management and bioanalytics.

Combs said the company's Lincoln site has many long-term employees who are highly educated, dedicated and loyal.

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Reach the writer at 402-473-2647 or molberding@journalstar.com.

On Twitter @LincolnBizBuzz.

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Business editor/reporter

Matt Olberding is a Lincoln native and University of Nebraska-Lincoln graduate who has been covering business for the Journal Star since 2005.

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