The enormity of success that is symbolized by the growth of Triangle-born Quintiles from a trailer to a global health care giant struck one of its longest serving employees when she walked into its spacious new headquarters.

One might call it a moving experience.

“It was a great source of pride when I first walked into Quintiles Plaza when it opened in 2009 to realize what I had helped build over the years,” said Paula Brown Stafford, Quintiles’ president of Clinical Development.

“It literally brought tears to my eyes.

“Helping give jobs to 25,000 people around the world gives you a great sense of pride to have helped created those livelihoods for people – and helping bring new products to market and to patients globally.”

Stafford is among the most amazed by the remarkable success story of a company whose origins date to the study of numbers and statistics – thus its name Quintiles.

She now oversees some 15,000 people as president of Clinical Development. But her own career advancement as Quintiles’ 23rd employee to one of its most senior in tenure and responsibility as impressive as that is doesn’t rank as large as what she has seen and participated in at the company founded in a trailer on the campus of UNC-Chapel Hill.

“Never,” Stafford said when asked if she had ever envisioned Quintiles become such a global company.

“I joined a statistical consulting company providing data management and statistical analysis. I didn’t know what a [contract research organization] was in 1985. Two years later, we BECAME a CRO when clinical services were added.

“Ten years after that, the company changed dramatically again becoming a biopharmaceutical services company with the addition of our commercialization business.”

Quintiles, the world’s largest life science services firm, began its 31st year as a company as February ended with 25,000 employees around the globe and continues to be in growth mode, making acquisitions while forming new partnerships from Russia to Singapore.

Since the company is privately held, it does not disclose financials, details about its growth come from other areas such as a growing global presence and other measures. For example: “If you take any prescription drug, chances are Quintiles helped develop or commercialize it in some fashion,” a company spokesperson says.

Dr. Dennis Gillings, who was a professor at UNC-Chapel Hill, and Dr. Gary Koch, also a UNC professor, launched Quintiles based on their work in statistics and the realization after some consulting work that a sideline could be turned into a business.

Dr. Gillings remains chairman and chief executive officer while Dr. Koch works with the company in a consulting role. Other than Dr. Gillings and Chief Operating Officer John Ratliff, few workers are more senior than Stafford, so WRAL Tech Wire asked to interview her to gain inside perspective about the “Q” story.

[QUINTILES ARCHIVE: Check out a decade of Quintiles stories as reported in WRAL Tech Wire by clicking here.]

Stafford joined Quintiles as a biostatistician and now is responsible for direction of Quintiles’ Phase I-IV clinical services in which the company works with drug companies to test possible new drugs. Over the years she rose through the ranks, working in project management, business development, scientific operations and general management.

A graduate of UNC where she earned a Bachelor of Science degree and a Masters in Public Health, Stafford is the chair-elect of the Clinical Data Interchange Standards Consortium and is a Foundation Board member at UNC’s School of Public Health. She is an advisory board member as well for the UNC School of Medicine. Business experience outside of Quintiles includes serving on the board of Bio-Imaging Technologies.

In a wide-ranging interview, Stafford talked at length about the company, its leader, its strategy, the increasing importance of data in the life science industry, the increasingly complexity of that data, and what’s in the future for Quintiles.

“The Vision of the Company”

In Stafford’s opinion, Dr. Gillings is a primary reason why Quintiles has enjoyed such success, launching as a small privately held venture to becoming a Wall Street player as a public company to reversion to a private firm when Gillings became disillusioned with the demands and short-term views imposed on public firms by investors.

“He’s been enormous because he has consistently been the vision of the company and stays extremely involved, traveling to visit employees, customers and shareholders,” Stafford said. “His commitment has been unwavering to what this organization delivers in terms of healthier humans worldwide.”

While Quintiles embraces a relatively new marketing slogan as “New Health,” Stafford likes a different term that she believes captures the Quintiles mantra.

“I still believe in the Quintiles values: Teamwork, Leadership, Customer Service, Integrity and Quality.

“TLC with a high IQ.”

The Q&A with Stafford

As president of Clinical Development, you hold what must be one of the most important jobs in the company. Tell us about the job, and the responsibility you feel for the company in that role.

As president of Clinical Development, I oversee 15,000 employees globally providing service for Phase I-IV clinical trials.

My responsibility is to our employees, customers, shareholders, and the patients we serve. I’m responsible for overall operational delivery across these services. I’m very focused on providing quality services and improving productivity.

Today it takes $.1.3 billion to bring a new drug to market. My desire is to decrease that cost-per-product and to enable more products to be brought to market for the same spend.

You started as a biostatistician – what led to your interest in that field. The understanding of data/numbers obviously has been crucial to Quintiles from the beginning given its name.

I was a biostatics assistant, part time, when I joined Quintiles, in the UNC School of Public Health (now the Gillings School of Public Health). I originally came to UNC to major in pharmacy.

I soon discovered that I hated chemistry, but loved “Statistics 23.” As a sophomore, I was trying to choose my major, wanting the math and science, but not the blood.

I was introduced to Dr. Craig Turnbull in the School of Public Health, in biostatistics. From my very first meeting with him, I knew that this was exactly what I was looking for. It combined everything I enjoyed.

Why in your view are those numbers so important, and has that importance grown over the years?

The statistics we present prove a hypothesis around the efficacy and safety of a new product. The statistics tell the story about a drug and FDA reviewers replicate them. We came into the industry with exploratory analysis looking beyond initial hypotheses to determine the value of a product.

Is compiling and making sense of data more difficult or easier now given the advances in science such as genome research?

It becomes more complex. Scientists love the complexity. In some sense, it’s what is costing the industry more money in the short term, but new statistical genomics data and adaptive trials allow you to adapt trials as you go along, ultimately decreasing the cost of clinical development.

How has Quintiles played a key role in that area? It must have, given the company’s growing business.

We have a statistical drug development group within Quintiles that is 100 percent dedicated to developing new trial designs and statistical methodology for the industry. We created this group two years ago to develop new methodologies for the industry.

The company has gone through ups and downs as all companies do – Quintiles went public, went private, etc. What were the most difficult moments? What have been the best?

The worst is when you don’t make your budget or have a dissatisfied customer. Or when a product you had high hopes for to help patients doesn’t get approved, when your team has worked so hard.

The best moments are when new products win approval. My number one best moment was the approval for Glucophage in the US for type-II diabetes. It’s a drug my grandmother has been on ever since the product was approved, and as a product manager, it was my first approved new product. I attended the FDA Advisory Committee meeting. It was career changing to attend the meeting with my customer.

Quintiles has made several acquisitions recently and continues to expand with new ventures and partnerships oversees. You’re already the world’s largest life sciences services firm – what’s next?

Where we’re going next is trying to fill out our capabilities to provide a knowledge-based offering; more of the expertise. Quintiles is using data-driven technologies to better inform designs and decisions and moving back full-circle into that consulting world, plus the resources.

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