Putting Drug Safety on Trial

Lynn Van Dermark, CEO of MedTrials Inc., is precise, focused, and driven, and she has to be. Big money rides on the work done by her Dallas company, whose tests help decide which new drugs and technologies get a green light from the FDA.

image of lynn van dermark
MIND OVER MATTER: As CEO of MedTrials, Lynn Van Dermark doesn’t manufacture any goods–her expertise is her product.
photography by Matt Hawthorne

Lynn Van Dermark is a force in motion. During one recent week, the CEO of MedTrials Inc. wrapped up some drug-safety audits in Spain and Sweden and flew home carrying a thick binder of her findings. She filled in for a sick colleague by teaching a class at the University of North Texas Health Science Center in Fort Worth, where she is a faculty member, then hurried back to Dallas that same day for a late meeting. Before the week was out, she would be on another plane headed for East Coast clients, the company’s Pennsylvania office, and a college-alumni board meeting in Virginia.

Even at this hectic pace, Van Dermark’s schedule is more leisurely these days than when she and partner Robin Newman started the Dallas-based company in 1993. “I averaged eight flights a week,” Van Dermark says. “Both Robin and I took on all kinds of projects and did what it took to get the business up and running.”

This year, with the help of nearly 60 empl­oyees, MedTrials, a full-service clinical-research consulting firm, is on track for double-digit growth. While Van Dermark declines to disclose MedTrials’ annual revenue, the company is a small- to mid-sized player in an industry with hundreds of U.S. competitors.

Van Dermark’s focused, driven style has played a big role in the company’s success. Once, when her 80-year-old mother was preparing to see a new physician, Van Dermark filled out all the papers for her, including a complete medical history. Impressed, the doctor called it the most detailed and accurate history he’d seen in all his years of practice.

“Hey,” Van Dermark said with a shrug. “That’s what I do for a living!”

When a mutual colleague introduced them 17 years ago, Van Dermark and Newman were both working as clinical research nurses. At the time, the medical field was exploding with health care companies rushing to bring products to market.

But the race to commercialize a new drug or medical technology is not a sprint—it’s a marathon. It can easily take 12 years from the moment a scientist makes a laboratory discovery to the time the resulting drug is available on a commercial scale. Each step of that journey—from the way human safety is assured, clinical trials are designed, patients are recruited, tests are conducted, results are monitored, and data is analyzed—impacts how quickly a new product might get the green light from the U.S. Food and Drug Administration. And very few of them do. Experts say that, of every 5,000 to 10,000 new “compounds” that are evaluated for further consideration, only one might become an FDA-approved drug.

Van Dermark and Newman saw the need for health care experts who could facilitate that long and arduous journey. There was a business opportunity, they believed, in helping others navigate the FDA approval maze.

“I could see Robin was entrepreneurial,” Van Dermark says. “I had already been working as an independent consultant and asked her to work with me on contracts that had clinical site-monitoring assignments throughout the U.S. We planned to build business more locally but soon realized that the opportunity was truly throughout the U.S.” Being centrally located in Dallas, with easy access to Dallas-Ft. Worth International Airport, was a great advantage.

The pair launched the company in 1993, working out of Van Dermark’s home office and putting their business expenses on her Visa card. Within a year, they had met the projections in their business plan.

“We don’t manufacture products,” Van Dermark says. “It’s our knowledge we’re selling.” That knowledge was in demand from day one, delivered in the form of training, consulting, monitoring, auditing, data-management, and other clinical-research support services.

Newman, who is now the company’s chief scientific officer,  believes that nursing was great preparation for going into business. “Nurses are very good problem solvers, they are very resourceful, and they know how to get along with people,” she says. “They’re also used to working on interdisciplinary teams. They understand where my skills end and yours begin. If they don’t have the tools or skills needed, they’re really good at figuring out who does have them.”

Such flexibility is important, because no two clinical research assignments are identical. MedTrials might be brought in early, for a brainstorming session with a scientist excited about a new discovery; or near the end of the FDA approval process, to crunch research numbers or present findings to an expert panel. Or it might get involved at any point along the way, perhaps as consultants to an ethics board, designers of a so-called  study protocol, or auditors of an investigator’s clinical records.

MedTrials has helped companies study antibiotics, a broad range of medical devices including heart stents and lasers for eye surgery, and biotechnology like novel chemotherapy treatments and bioengineered skin grafts. And, as much as Van Dermark would like to brag about the company’s accomplishments, the CEO finds herself apologizing because she’s bound by confidentiality agreements. Sometimes, she can’t even mention the name of a medical center or study site where she has worked. “I’m so excited about the work that we do, but frustrated because we can’t talk [specifically] about it,” she says.

Word is out about one local project, however. When the University of Texas Southwestern Medical Center received a $34 million grant last year from the National Institutes of Health, MedTrials was the only “industry partner” named amid numerous universities and hospitals. The NIH grant supports an ambitious interdisciplinary clinical research partnership, officially called the North and Central Texas Clinical and Translational Science Initiative. As part of that effort, MedTrials has been training research nurses, study coordinators, and other individuals responsible for collecting  data from the region’s various participating institutions.

“MedTrials is really the perfect industry partner for an academic medical center,” says Dr. Milton Packer, professor and chair of the department of clinical sciences at UT Southwestern Medical Center and leader of the initiative. “They understand our mission, which is a little differently focused than a conventional corporation. We don’t have shareholders; we’re not generating a profit. Our goal is to advance research in a quality manner. Our product is knowledge.”

Grasping the big picture as well as the details of clinical trials sets MedTrials’ chief executive apart, Packer believes. “Lynn Van Dermark is totally in command of her field,” he says. “She has been terrific—a delight to work with. She has assembled a fantastic team of people, but she is also very personally involved.”

By the time MedTrials hit the three-year mark in 1996, it had 20 employees and was ready to move to the next level. Then, “our business model changed in the mid-’90s,” Van Dermark remembers. “We realized that the best fit and greatest opportunity were in supporting trial sponsors, rather than contracting directly to the clinical trial sites.”

The company’s original name, Clinical Research Consultants of Dallas Inc., didn’t fit, and was changed to MedTrials Inc., to more accurately reflect its mission. Brian Morgan was brought in as CFO, and later transitioned to COO and became a minority shareholder in the business.

Today, 80 percent of MedTrials’ income derives from long-term clinical research projects and multi-party global projects. The balance is from training and other services. “Although it’s not the majority of our revenue, training is our face to [the] industry,” Van Dermark says. “That’s become a wonderful way for potential clients to notice us.”

When she teaches how-to sessions at industry conferences, Van Dermark will usually be approached afterward with questions. For example, an attendee might describe difficulty recruiting and enrolling patients who are willing to undergo experimental treatments; as a result, research studies aren’t completed on time. The attendee will ask Van Dermark, “Can your company help me?”

The answer, of course, is typically yes. This conversation—a request for help which leads to a potential new working relationship—plays itself out in various forms at the numerous conferences MedTrials attends each year. “It’s just wonderful,” Van Dermark says, “because we’ve established our credibility.”

For a client struggling to recruit patients into a study, Van Dermark might help brainstorm about strategic advertising and how to reach the target demographic, or she may suggest mentoring for the support staff who enroll patients into the study.

There have been times when Van Dermark and her team even trained employees of competing clinical research organizations. “It’s a high-turnover industry,” Van Dermark says, explaining why she would assist MedTrials’ competitors. “These individuals might come to work for us, or they may become future clients. There is so much business in this growing industry, it’s not that much of a threat.”

In 2001, the company began to adjust its structure again. Project managers were freed up from supervisory duties so they could focus exclusively on project activities. Three years later, MedTrials acquired the capabilities of a Pennsylvania firm specializing in biostatistics data management. Those resources were moved into larger quarters and expanded, enabling MedTrials to handle electronic data capture, data management, and biostatistics in-house.

Poised for growth, MedTrials sought and received certification as a women-owned business. Van Dermark is happy to show the fat application binder, neatly documented with copies of tax returns, leases, and personnel rosters, which the company submitted for the approval process. This certification offers MedTrials significant new opportunities by increasing the company’s appeal and visibility to large corporations with diversity initiatives.

MedTrials’ Dallas headquarters occupies 13,000 square feet of office space near UT Southwestern Medical Center; the company maintains an additional 9,000 square feet in Pennsylvania for its informatics division. To position MedTrials for even bigger contracts, Van Dermark reorganized the company further last year, widening the tier of upper management and creating more distinct departments.

A few years back, just to be sure she was making smart business decisions, Van Dermark earned an M.B.A. from Baylor University. “I want to do what’s best for this company,” she says. “Some people just want to hold on and control, regardless of whether they have the skill set to fill the functions of that role.” Business school boosted her confidence that she was indeed where she belonged. It also reinforced her belief in the importance of fitting the right people to the right positions. Now, she says, she’s got a great leadership team in place.

Chief Scientific Officer Newman, for example, covers for Van Dermark as needed, and keeps her eye on opportunities and issues surrounding new research. Newman also has a prominent role in the clinical-research services industry, serving as past chairman of the board of trustees for the Association of Clinical Research Professionals, which has more than 20,000 members worldwide.

Clinical research is a $10 billion market enjoying double-digit growth. With so many opportunities available, staff turnover is high, so Van Dermark is constantly on the lookout for good talent. Recent graduates are rarely ready, however, because clinical research demands a specific skill set, medical knowledge, and very detail-oriented work habits. “Compulsiveness is an advantage in this business, really required almost,” she says. “We need to make sure things are done right.”

One way Van Dermark motivates her work force is by offering career-advancement and job-skills training. The Dallas headquarters caters in lunch each Friday, so staff can attend internal training sessions on various topics. An outside expert might explain a new technology, for example, or an internal expert might share how-to tips.

Van Dermark says she and her staff sometimes talk about how to handle delicate business conversations. “The client is always right, except when they tell us to do something that isn’t in the best interest of a project, or is illegal,” she says. “This is a highly regulated business and you can’t skip certain steps. Those are really tough negotiations with the client.”

It’s never easy to give a customer disappointing news. But in this field, circumstances may warrant it. For example, monitoring may reveal that cancer patients are not responding as hoped to an innovative new product, so the study has to be scrapped. Not only is that bad news for the sponsoring organization, it can be hard on MedTrials employee morale.

“It’s devastating to our staff to work on a product for three years, helping to do the research, being excited about the study, and waiting for the results—and then to find out you won’t get to market,” Van Dermark says. As a result, she goes out of her way to encourage her people to feel good about their efforts. “Good research doesn’t always mean that you come up with the answers you want, but you come up with the right answers and reliable information,” she says. “Everything we do is going to impact health care decisions down the line.”

CEO Snapshot
Lynn Dixon Van Dermark
CEO, MedTrials Inc.

Personal History: Born in New Jersey in 1965. Married with five children.
Education: B.S. in nursing, University of Virginia, 1987. M.B.A. from Baylor University, 2004.
Work History: Before founding MedTrials in 1993, worked as a senior research and charge nurse and as a clinic manager for various healthcare facilities in Dallas; Centreville, Va.; and Vienna, Va.
Hobbies: “I love to travel, but mainly I enjoy spending time with my family.”


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