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April 3, 2010

A Test to Catch Pro Athletes Cheating in Their Tracks

Thomas Dunlap ’94 leads company that’s quickly developed process for detecting human growth hormone

By Kevin Gray

Thomas Dunlap ’94 considered the options, about a dozen in all, for his new company’s first project. The decision was critical because Ceres Nanosciences needed to raise capital to ensure a viable launch. Two words leaped from the list: Cure cancer.

The initial thought, of course, was “That’s it!”

Slowly, the reality of making a sound business decision began to clear away the mist of grandeur. Dunlap would have to content himself with making a cure for cancer the long-term goal of the company. He could be encouraged by the fact that the principal scientists were already seeking to commercialize a cancer biomarker detection product.

Headquartered in Manassas, Va., Ceres holds an exclusive license from George Mason University (GMU) to develop commercial applications for the Nanotrap technology, in which particles are engineered to selectively collect and concentrate a diverse range of compounds from complex solutions, such as serum and urine. The technology was jointly developed by scientists at GMU and Italy’s Istituto Superiore di Sanit�.

Lance Liotta, a former deputy director of the National Institutes of Health and chief of pathology at the National Cancer Institute, and Emanuel “Chip” Petricoin, the senior cell tissue researcher for the Food & Drug Administration (FDA), are researchers at GMU and members of Ceres’ scientific advisory board. In the biotech field, Liotta and Petricoin represent a veritable dream team of research scientists.

For Dunlap, the opportunity to co-found Ceres Nanosciences with Liotta and Petrecoin was simply too good to pass up. The capability to make amazing discoveries was in place; now it was Dunlap’s job to help raise capital and create the demand and product recognition to allow these applications to reach the market.

Adding to his schedule wasn’t anything new for Dunlap. Already, he was a managing partner of law firm Dunlap, Grubb & Weaver, where his focus is commercial and intellectual property litigation, and a captain (armor) in the Virginia Army National Guard. (A graduate of Army officer candidate school, Dunlap holds U.S. Army Humvee and M1 Tank driver’s licenses.)

As Dunlap considered the first projects, he knew Ceres needed to take on one that could be completed and delivered quickly. And he had to garner attention.

“The potential projects included systems and devices that other scientists had already created, ones the Ceres scientists proposed making improvements to,” Dunlap explains. “But we were looking for something that hadn’t been done.”

The list had a single match for Ceres’ criteria. Despite its high profile, no one had ever been able to develop a means to detect human growth hormone (HGH) in urine. HGH, which is produced naturally by the pituitary gland, helps stimulate growth in the body. Synthetic HGH is used to, among other things, build muscle mass and speed the healing process. Illicit use of synthetic HGH by athletes seeking an edge remains a highly publicized issue in professional and international sports, as a reliable system of detection has proven to be elusive.

Another factor in the decision to develop a HGH-detection process was the lack of requirements for approval.

“Anything in the biotechnical or biomedical world that I have ever dealt with required approval from the FDA, which could cost the company hundreds of thousands of dollars in clinical trials,” Dunlap says. “In addition, the timeline for delivery of any product—even a diagnostic device—is at least five years.”

Before investing a lot of time and money for the HGH-detection device, Ceres hired an FDA expert.

“She spoke directly with the FDA and found that the administration would not regulate this product if we’re using it solely for anti-doping testing and not for medical purposes,” says Dunlap, an English graduate working toward an M.S. in biotechnology at the University of Maryland. “All I could think about was the exclusive market we would have without regulation. It was an easy sell to investors.”

Not only did Ceres Nanosciences set out to create an HGH-detection process, it also kicked up a whirlwind. Fueled by the positive prospects for the product, Ceres raised more than $1 million from investors in one month last summer. Then, once the decision was made to take on this project and the funding was secured, the scientists needed just another month to develop a promising process, during which nanoparticles attach to HGH in urine, allowing it to be detected without degradation of the sample.

A wave of media attention followed and Ceres recently entered into an agreement with the U.S. Anti-Doping Agency, which will fund a six-month study of the reliability of its HGH detection process.

“It’s amazing to think that we are a biotech company with a potential product release within two years of starting up,” Dunlap says. “The whole thing seems ridiculous. But at the same time, when you talk about world-class scientists, our scientists are the best among them.”

With top scientists in place, all Ceres Nanosciences needed for a successful launch was someone dedicated to making sound business decisions.

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