MORRISVILLE, N.C. – Gentris Corporation, which makes and sells pharmacogenomic tests and biorepository services, brought in a new leadership team over the past year in an effort to grow the firm and take it to a new level.

So far, it’s working.

So says CEO Ameila Warner, who took the helm at Gentris last July and brought back Gentris founder and former CEO Michael Murphy as a member of the company’s board in November. Heath Knight also rejoined the company in February as vice president for corporate development, and Joseph Kessler was named chief operating officer.

People respond differently to drugs and drug doses. Just as one alcoholic drink barely affects some people and makes others tipsy, a drug dose safe for some people can cause adverse reactions in others. The U.S. Food and Drug Administration (FDA) recently issued industry guidance saying it expects pharmaceutical companies to collect a genetic sample from every patient in a clinical trial.

Optimizing Clinical Trials

Gentris helps pharmaceutical companies and clinical research organizations integrate pharmacogenomics into their drug development programs to deliver safer, more effective drugs to market more quickly.

“The more it becomes part of routine medical care, the better,” said Warner. “That way you don’t have to put a patient on a six-week trial to see if they respond to a drug.”

Incorporating genomic biomarkers into the drug development and clinical trial process allows biopharma companies to select the optimal group of patients to be enrolled into trials and reduce the number of adverse events. This has led to more successful clinical trials and decreased the time to market for compounds.

High-Value Growth

An industry expert, Warner is also the CEO and founder of Global Specimen Solutions Inc. and a past chair of the Industry Pharmacogenomics Working Group. She said the extensive industry connections and expertise of the new leadership team have helped Gentris sign eight new clients so far this year.

“Our sales have been growing tremendously the past few months,” she said, noting that the company had a profitable first quarter of the year and installed a new, state-of-the-art IT system in its lab. Warner expects to announce several new strategic partnerships and the company’s entry into new verticals in coming months.

The company’s new facility in Shanghai, China just passed its initial inspection by Chinese officials with no major findings – which Warner said “doesn’t happen very often.”

While confidentiality agreements prevent Warner from naming customers, she said Gentris currently works with 80 percent of the top 50 pharmaceutical companies and currently works with 60 clients.

Team Effort

Gentris was founded in 2001. They have overhauled its leadership over the past eight months, bringing in a new CEO, a new COO, and adding former CEO and founder Michael Murphy to its board.

Warner said Murphy, who was a mentor to her bringing domain expertise and a unique knowledge of the company, is helping to bring new connections and opportunities to Gentris. Kessler, the new COO, heads operations at its two labs – one in the Research Triangle Park facility and the other in Shanghai, China.

Kessler, a recognized expert in clinical specimen management, previously worked with Merck Research Laboratories, PPD, and DaVita Labs.

“He brought a lean Six Sigma approach to our lab operations and helped us optimize our procedures so we could take on new work and maintain quality,” Warner said.

With better characterization of patient populations, according the company, pharmacogenomics can help reduce drug failure rates by enabling drug companies to modify patients’ exposure to drugs based on their genomic drug-response profile. This ensures that the right drugs reach the right patients at the right doses.