Hamner, UNC-CH teaming to test medicines

The newest research center in the Triangle has a tall task: keeping bad medicines off drugstore shelves.

The University of North Carolina at Chapel Hill and the Hamner Institutes of Health Sciences will announce this morning that they are teaming to open a Center for Drug Safety Sciences on the Hamner campus in Research Triangle Park.

The partners will spend $10 million over the first three years on the center, which will work with drug companies and federal regulators to find cheaper and better ways to catch fatal flaws in medicines before they are approved.

The animal tests and drug development tools that have been used and refined over decades often fail to flush out faulty drugs, said Dr. Paul Watkins, a UNC-CH professor of medicine who will head the drug safety center.

"Many drugs never hurt a rat, a dog, a monkey," Watkins said. "Once it gets out in the real world, these things are found."

In the past 10 years, drugmakers have pulled about 20 medicines off pharmacy shelves because of serious, sometimes fatal, side effects, according to the Food and Drug Administration. All of the withdrawn drugs, including treatments for diabetes, pain and high cholesterol, were approved for sale after passing FDA safety reviews.

Regulators have clamped down, especially since Vioxx, a popular painkiller, was linked to an increased risk of heart attack. But the increased scrutiny has mainly resulted in more testing, higher drug development costs and delayed approvals of some drugs desperately needed by patients.

The number of new drugs that received FDA approval sank to a 24-year low last year. At the same time, getting drugs approved is taking longer and requiring more work. Little progress has been made to predict which drugs may cause rare but potentially fatal side effects.

The UNC-CH and Hamner drug safety center aims to change that.

By next summer, about 20 researchers are expected to be gathering data and running experiments. They will work on real-world projects funded by pharmaceutical companies. They also will begin to feed clues into a computer to find patterns that could let researchers make predictions for other drugs.

The partnership was lauded by the pharmaceutical industry, which will benefit from the research.

Rare side effects are often linked to certain genetic makeups in patients, said Alan Goldhammer, vice president of scientific and regulatory affairs at PhRMA, the pharmaceutical industry's trade group. "We want to give each patient the right medicine."

How center will work

The center's staff will include Watkins, who will retain his UNC-CH position, and four faculty members paid by the UNC-CH schools of pharmacy and medicine. Watkins, who has begun recruiting efforts, said each faculty member is likely to bring along postdoctoral fellows and federal grant money to do the work.

The Hamner Institutes will provide the space, a new, 14,000-square-foot research lab with room for as many as 80 people. The drug safety center's staff will work closely with Hamner researchers, who have more than 30 years of expertise in tracking the health effects of toxic chemicals.

Forging the partnership to establish the drug safety center is part of a vision that William Greenlee, the Hamner's chief executive, has pursued the past few years. Greenlee hopes to turn the Hamner, formerly a little-known affiliate of the U.S. chemical industry, into a series of health research centers sprawling across its 56-acre campus.

Creating key alliances

To realize his vision, Greenlee and Rick Williams, the Hamner's chief business officer, are trying to establish ties with most universities in the region, including Duke University in Durham, Wake Forest University in Winston-Salem and East Carolina University in Greenville.

"We knew we could not do it alone," Greenlee said.

UNC-CH was the first to agree.

The decision allowed the university to keep Watkins, a well-known expert in drug-induced liver injuries who has helped the school attract millions in federal research funds.

Most recently, Watkins helped the university land a $61 million grant from the National Institutes of Health.

Watkins was being courted by Vanderbilt University to establish a drug safety research center on its campus in Nashville. "People in the know realize that's the next big thing," Watkins said.

Establishing the center in the Triangle puts UNC-CH and Hamner at the forefront of medical research, said Charles Hamner, the former head of the N.C. Biotechnology Center and a driving force in turning the Triangle into a biotech hot spot.

"This will give North Carolina the capstone needed for intellectual development and training," Hamner said.