Paula Brown Stafford - Women in Biotech 2012

Paula Brown Stafford
Company: Quintiles
Title: President of clinical development
Industry experience: 27 years
Focus: Operational excellence in clinical trials, growing business

Paula Brown Stafford has not only helped to make Quintiles one of the top CROs in the biopharma industry, but she also has "wanted to make sure there was a culture at Quintiles so every woman who joined knew there was nothing there in their way." Today, 65% of Quintiles' employees are women and half of the company's executives are female.

When she's not nurturing future leaders, she's working hard for Quintiles' clients. As head of the clinical division, Stafford sees her role as "truly trying to help transform drug development in our industry." We are in the age of "the new health"; a huge part of this transformation is making clinical trials as efficient as possible. In an ideal world, trials would only enroll patients suited to the compound being tested. As Stafford notes, "with personalized medicine, we're trying to get to the point where we expose less and less patients to a drug without a specific genetic makeup."

Stafford focuses on three major areas at Quintiles: One is risk-based trial management, and another is the planning and design of product portfolios for customers, including individual study protocols (ISPs). This involves using the massive amounts of data Quintiles has collected throughout its rich history along with data from outside sources to utilize a data-driven planning and design process. Thirdly--and perhaps most dear to Stafford's heart--she has recently capitalized on a 12-year-old vision to be able to deliver real-time trial data monitoring to clients.

In June 2011, Quintiles launched a tool it developed called Infosario, which can integrate data from different sources during the trial process. Version 2 of this tool has just been unveiled and includes new capabilities such as the addition of study indicators. Stafford sees this product as a true representation of the people, knowledge and technologies Quintiles has to offer, and it is, in her words, her "pride and joy."

The role of a CRO today is, according to Stafford, to help clients make better decisions and therefore be more successful. "We know how to help our customers manage risk because we understand how to take risk out of the development process." As Stafford points out, the company has worked across many therapeutic areas. Some companies need help understanding product portfolios, and, more importantly, some companies need help knowing when to cut ties with a failed program. Stafford sees helping customers make these tough, often risk analysis-based decisions as crucial to successful CRO-biopharma partnerships. "We know how to help our customers manage risk, because we know how to take risk out of the development process."

Listening to Stafford explain the ambition and potential of her company and others like it made it easy to understand how she has come so far. She understands and anticipates the needs of customers, and keeps the ultimate goals at the forefront of her efforts. The business looked a bit different 30 years ago, Stafford told FierceBiotech. From the time the last patient came out of a trial to seeing results took 6 months. Then customers started demanding that time be cut to 6 weeks. Now, to be the best, results should be deliverable within 6 days. And the only way to do that, Stafford asserted, is to monitor a trial on an ongoing basis, make good decisions and procure the people and technology to understand the data so that when the trial is over, it's just a "push of the button" to see results.

Stafford's plans for further growth and operational excellence at Quintiles and in the industry as a whole include, on a personal level, developing future leaders in the industry. "I'm helping to lead a changing landscape," Stafford says. "I feel like it's my job to create the future leaders."

Stafford also serves on an external advisory board--as the only representative of a private company--to a group of researchers at the University of North Carolina at Chapel Hill who have received a CTSA (Clinical Translational Sciences Award) NIH grant. The goal of these grants is to move compounds from the "chemistry bench to the bedside." Part of the industry's investment in these projects is to study the efficacy of academic institutions in advancing drugs. Partnerships between academia and Big Pharma companies are becoming more and more common, and Stafford's ground-floor insight is invaluable.

"A lot of what I do," she says, "is helping to connect dots across different consortiums across the industry and what we do here at Quintiles."

-- Jennifer Levin (email | Twitter)

Paula Brown Stafford - Women in Biotech 2012
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