By Allan Maurer
RESEARCH TRIANGLE PARK, NC—Concerns about drug safety are a high priority at the U.S. Food and Drug Administration, which has tightened its new drug approval process in the aftermath of high profile incidents where already approved medications caused unexpected harm. RTP-based Drug Safety Alliance (DSA) specializes in “pharmacovigilance” to help companies mitigate their drug safety risks.

Founded in 2000, DSA employs about 70 people. Many case managers bring a decade of experience in the field to helping companies monitor adverse incidents involving their drugs not only during clinical testing, but even after the drugs hit the market.

Founder and CEO Catherine Stokes tells TechJournal South DSA is uniquely focused to provide high-quality pre- and post-market drug safety services including domestic and international regulatory compliance, safety database support and hosting options, risk management and adverse event case management.

Prior to founding DSA, Stokes worked at GlaxoWellcome as Section Head in Drug Safety and Surveillance for nine years and also held positions in Clinical Research and Medicinal Chemistry for four years. She has a Master of Science degree in Medicinal Chemistry from the University of North Carolina, Chapel Hill.

The company goes a ways toward eliminating the so-called glass ceiling for women executives all by itself. Seven of its top management positions are held by women with high level qualifications.

Stokes says the company, initially funded by friends and family, is not seeking investments at this time.

DSA works with companies of varying sizes, but most have drugs in later clinical trials and some are billion dollar firms with branded products on the market. It currently has about 40 clients, Stokes says.

For firms with experimental treatments still in clinical trials, Stokes points out, “The biggest factor in getting a drug approved is showing an appropriate benefit/risk ratio.”

Companies running clinical trials have to aggregate their safety reports periodically, issuing 7-day and 15-day and annual reports that will be analyzed and submitted to the FDA.
“The post trial piece is even more complicated,” Stokes says. “It’s important to look for trends and signals in the data in real-time. The whole point of pharmacovigilance is finding a needle in a haystack.”

While it’s easy to fault drug companies or the FDA process for approved drugs that later prove to have some nasty adverse effects for some users, Stokes says that the likelihood of catching something like a small reaction in clinical trials is rare. “It’s not until you put it in the general population and people start using it, sometimes for off-label purposes, that you find the true risks,” she says. “If something was missed in clinical trials, it’s most likely because the population in the trial was so small they couldn’t detect it.”

DSA scans several databases, including the FDA’s and Europe’s to dig out hard to find signals of possible adverse drug effects. “It’s difficult to find a perfect tool,” though, Stokes admits. “It does require collaboration with people who know how to look at the data in an appropriate manner.”

At DSA, she says, they use a tiered approach to looking for signals. “The first couple of tiers note if there are any trends in the data. Then you look at the frequency of those over time.”

DSA is one of the first companies using the Empirica Trace adverse event reporting software. DSA manages all aspects of adverse event reporting including data collection, triage, tracking, and reporting from start to finish for both clinical and post-marketing products.

Once a case manager for a DSA client spots something that might be an adverse event, further analysis is done. Then, if the data suggests adverse events are happening, DSA would alert its client. “That can result in many things,” says Stokes. “If it’s something pretty significant, a drug may be recalled, or the company may just have to update its labels noting the additional possible adverse effects.”

There are different thresholds that determine how a company must respond. For some treatments, Stokes says, “There are so many underlying conditions that complicate the medical picture, it’s difficult to determine, sometimes.”

On the Web: www.drugsafetyalliance.com

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