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Inside Track: Numbers cruncher helps pill pushers get to market
Statisticians like John Quiring demonstrate the efficacy of new drugs and medical devices to the FDA.
QST Consultations, the company Quiring launched in Allendale in 1985, plays a key role in the most important phase of commercialization of a new drug or device: getting it approved by the FDA. QST is a clinical research company that specializes in designing clinical studies, managing the resulting data, doing the statistical analysis and providing the medical writing service to prepare it for submission to the FDA.
QST clients over the years have ranged from small start-up companies with a new idea to world-famous firms like Bayer AG of Germany, which is still a client.
A few months ago, at a point in life when most people have retired, Quiring passed the title and responsibility of CEO to one of his longtime employees, but he still works full time for QST, which has 28 employees, and flies around the country to meet with clients as the firm’s chief science officer.
Quiring was born in Chicago Heights, Ill., about 25 miles south of the Windy City.
After high school, he attended a junior college but soon transferred to Roosevelt University in downtown Chicago. It took six years to earn his B.S. degree in math because he was going to school part time while working in a lab.
“I thought I wanted to be a chemist,” he said, but he discovered he was more suited to math than chemistry. Then, in his last year at Roosevelt, Quiring took a statistics course, and the professor said that if a student did well, he would try to get that student a fellowship to pay for graduate school. In the spring, Quiring received offers of seven fellowships.
He enrolled in graduate school in statistics at the University of Minnesota in 1966, because the Ph.D. program would allow him to include “a year’s worth of hardcore computer science” as a research tool. At the time, computers were in their infancy.
“I got in on the ground floor, and I loved the combination of statistics and computing, and in my second year of graduate school, I was already consulting.”
That was at Supervalu, a Minnesota-based grocery chain.
“We did marketing research to try to figure out whether people chose stores by price, service or quality, and we would do consumer-based studies to try to figure out how that all worked itself out.”
The studies weren’t so much customer surveys as they were observing how shoppers reacted in the stores, he said. Supervalu had a lot of stores, so it could do experiments involving various stores at the same time to see what worked. The company got so good at its market research that it created a special section in the corporation to market its research capabilities to other companies, including General Mills.
Quiring worked as a consultant to Supervalu through his first three years of grad school. Then he landed a more interesting gig: another consulting job, but this time at the Bureau of Mines in Minneapolis — “the explosive fragmentation unit,” he added. Researching the use of explosives in mining “fit well with my chemistry background and with my statistics.”
After receiving his doctorate, he was hired by Miles Laboratories, which had a successful consumer product: Alka-Seltzer. However, it was under fire by the FDA and targeted by one of Ralph Nader’s consumer protection groups, according to FundingUniverse. Nader’s people claimed Alka-Seltzer was an “irrational” mixture of aspirin — a known stomach irritant — and anti-acids to settle an upset stomach. Critics claimed it might be dangerous for people at risk of stomach bleeding, but eventually, Miles won its case and the FDA allowed it to remain on the market.
“I was, almost immediately upon arrival, thrust into the Alka-Seltzer defense committee to keep Alka-Seltzer on the market,” said Quiring.
That experience brought Quiring into direct contact with the FDA, because he designed the Alka-Seltzer experiments and defended the resulting data before the FDA.
Quiring said a statistician who works well on a team and listens carefully to the experts in biology and chemistry is “on the way to designing a topnotch clinical trial, and we do that today. Forty years later, I’m still doing the same thing.”
After two years at Miles Laboratories, Quiring applied for and got a position teaching statistics at Grand Valley State University. He said he had always felt an urge to teach because the fellowship that allowed him to go to grad school was from the National Defense Education Act, a federal initiative to spur higher education in the U.S.
However, even while at GVSU he continued to work as a consultant to Miles Laboratories. All told, the Alka-Seltzer project lasted seven years.
Quiring apparently became well known for his work representing clients before the FDA, because when word got out that he was no longer employed at Miles, he began receiving requests to work on other projects.
“I was always good at talking with people, in terms of making the correct explanations because, by then, I had had many years of consulting.”
All through his 10 years at GVSU, he was working on the side as a consultant on clinical trials. Finally, around 1985, he left GVSU to formally launch QST Consultations Ltd. One of the firm’s longest projects, which took more than 10 years and just wrapped up in 2010, were clinical trials to get FDA approval on Asthmatx Inc.’s Alair Bronchial Thermoplasty System, a new device for treating asthma in three sessions.
Quiring said there is increasing emphasis on the safety of new drugs and medical devices, which adds to the amount of time and expense involved in a clinical trial. His firm, he said, is “looking at trials that range anywhere from $30 million to $150 million” in total cost.
One of the reasons clinical trials cost more and take longer than previously is because federal regulations are getting stricter in the approvals process.
“Our submissions (to the FDA) need to be extremely accurate in the thousands of technical details that are contained in a submission,” said Quiring.
The high-pressure business of dealing with the FDA isn’t the only thing Quiring does. There is a flip side to his life, called Camp Douglas Smith. It is a youth camp on the north shore of Hamlin Lake in Mason County, which he owns and operates as a charitable organization.
It was a defunct youth camp when Quiring bought it in 1997.
“We’ve been putting it back together as the years go on,” he said. For the first few summers, it was used by a Christian youth organization, but the recession ended that. Now it is used each summer by a variety of groups, ranging from the Boy Scouts to track teams from GVSU and several Michigan high schools.
It sounds like a nice place for a statistician to decompress.