The Next Billionaire:

A Statistician Who Changed Medicine

 

Over the next few days, Dennis Gillings, a statistician who helped create the multibillion-dollar industry of conducting research studies for drug giants, is likely to enter an exclusive club: those with net worths above $1 billion.

Quintiles , the largest clinical research organization and the company Gillings founded, will price an initial public offering on Thursday or Friday with an expected range between $36 and $40 per share. Gillings will own 25,062,181 shares, so his stake in Quintiles alone will be worth between $902 million and $1 billion. Ross Mulken, an analyst at International Strategy & Investing Group, an independent research firm, thinks shares could trade in the low 40s, which would put Gillings’ stake securely in billionaire territory.

Gillings, who generally shuns the spotlight, already has one of the most popular billionaire perks: the University of North Carolina School of Public Health is named after Gillings — he gave a $50 million donation. He also owns his own airplane, which Quintiles sometimes uses.

The Quintiles IPO is something of a personal triumph: Gillings is proving Wall Street wrong by selling it shares. He and a consortium of private equity investors took the company private in 2003 for $1.7 billion after Wall Street lost faith in his strategy to not only do research for drug companies but also field sales forces for them and consult on other parts of their business. Out of the glare of the public markets, Quintiles has flourished. Service revenues last year were $3.7 billion, up 20% from 2010, according to the firm’s S-1 filing with the Securities and Exchange Commission, and net income was up 11% to $178 million. International Strategy and Investing Group estimates that sales will hit $4.3 billion by 2013.

The Quintiles story traces to a 1975 phone call between Gillings, then a 30-year-old Briton working as a statistics professor at University of North Carolina, Chapel Hill, and executives at Hoechst, which was then the largest drug company in the world. The drug giant wanted to know why 56 West Germans had died while taking one of its diabetes pills. It’s fear was that the side effects would doom its plans to introduce the product in the U.S. Gillings figured out that patients with kidney problems were building up toxic doses of the drug. Using lower doses in those patients would fix the problem, and the drug made it to the U.S. market with alerts about lowering the doses.

Gillings, with longish hair and bushy sideburns, didn’t look like a businessman. But he realized, he told me in 2010, that there was an opportunity. “It became apparent that there was the possibility of making the pharmaceuticals sector more efficient,” he said.

He founded Quintiles in 1982 in a 1,000-square-foot house with only five employees. He began to think of drug testing as a process that could be broken down into standardized steps to make it faster. He created a network of doctors interested in enrolling patients in clinical trials. He sent out monitors to doctors conducting a trial to make sure they weren’t taking any shortcuts that could cause problems with regulators later on. He hired dedicated data entry people who made sure that every relevant piece of patient information was correctly filed.

In the 1980s, clinical trials were mostly either conducted by academics, sometimes without industry support, or by drug companies who kept in-house expertise on not only designing but running the studies that got their drugs approved. The creation of middlemen – not just Quintiles but also Covance and Paraxel – changed the way studies were done, allowing them to become far larger as the process was industrialized. These days, even academic centers use Quintiles for some tasks. Only a few, including the Cleveland Clinic, Harvard University, and Duke, are real challengers to Quintiles and its peers. Now it is common for studies to be conducted in many countries, often taking advantage of the cost savings available when doctors and patients live in emerging markets like India or parts of Russia.

“Academic medical centers are primarily focused on advances in medicine,” Gillings told me in 2010. “But the logistics of managing a 20,000-patient trial across 50 countries is not their expertise. This is a hugely complex business, which isn’t the same business as high-powered medicine.”

Some say the commercialization of clinical trials has come with a downside. It created a business around recruiting patients into studies, perhaps not always in their best interest. And where academics who are conducting studies act as an ethical and scientific counterbalance to industry’s interests, a private-sector company may be more willing to cut corners to make its client happy. Some academics, for instance, think that CROs like Quintiles should stay away from analyzing data. These issues will be even more of an issue for Quintiles as it becomes a public company again.

Quintiles has also expanded its business model to also include getting royalties on some drugs it helps develop and sell, including with Eli Lilly and Allergan. From 2004 through 2011, Quintiles says it helped develop or commercialize 85% of central nervous system drugs, 76% of oncology drugs and 72% of cardiovascular drugs. Gillings is no longer CEO, but serves as executive chairman.