Clinical trial business in growth phase

Brigitte M. Klaib, owner of MCB Clinical Research and her daughter Kristin Scalva, president of MCB, organize files and other supplies in the future patient lounge in their new facility on S. Parkside Drive. The new facility will be able offer clients more services.

Brigitte Klaib knew Colorado Springs was prime territory for a clinical drug trial facility because her job as a pharmaceutical consultant never required that she travel here.

“I probably flew 300,000 miles a year all over the country and not once in 15 years did they ever send me to Colorado Springs,” Klaib said.

Her grandparents lived in Colorado Springs and she hoped for an excuse to see them.

Klaib researched the Springs market and found that there was indeed an opportunity for a clinical drug trial business.

But location isn’t the only reason she decided to create a clinical drug trial business. The real reason was more personal — her mother.

MCB is named for Klaib’s late mother, Marie Claire Bossaert.

Klaib was getting her master’s degree in forensics chemistry and physics when her mother was diagnosed with colon cancer, and told she had a few months to live. Klaib had access to trade journals and was able to recommend cutting-edge clinical trial programs that gave her mother access to life-saving drugs that wouldn’t be on the market for another two to I0 years.

Bossaert lived six years and was able to meet grandchildren, learn to ski and travel around the world because of those drugs, Klaib said.

And that started Klaib’s interest. She began working with a drug trial program at Stanford University and then traveled all over the country to work with trial facilities as a consultant.

When she first opened MCB, business was slow and Klaib had to keep her consulting job. As she flew around the country, her daughter Kristin Slcava ran the research facility here.

“We’ve definitely come a long way,” Scalva said. “When I started speaking with physicians, a lot of them were very hesitant just because there hadn’t been a lot of research going on here.”

Today, MCB has relationships with 33 different doctors who conduct drug, treatment and testing research. The business is now expanding to include phase I drug trials. Klaib said MCB will be the only phase I testing site in the city. That’s the first level of drug testing, one that few drugs make it past.

Another prominent clinical trial facility, the Lynn Health Sciences Institute, advertises that it specializes in phase-II and phase-III testing.

Steady growth during the past five years means more doctors getting involved in research. MCB has also developed relationships with the drug companies creating the medicine.

It also means that the company outgrew its location and had to move to bigger quarters to house phase 1 patients.

“We’ve just so outgrown our facility,” Scalva said.

The companies, which include big names like Abbot, DB Diagnostics, Eli Lilly and Pfizer along with numerous lesser-known manufacturers, have been sending more and more business to the little company, Klaib said.

MCB had a facility near Austin Bluffs Parkway and Academy Boulevard with three exam rooms.

The new location at 110 South Parkside Drive off of Printer’s Parkway, boasts 20 patient rooms and plenty of office space. The move will allow MCB to keep a large volume of volunteers overnight for observation, which is a requirement for many Phase I tests, Klaib said.

Phase I drugs have typically never had any human contact at all in the past, Klaib said. Many times, the tests rely on healthy volunteers who do not suffer from the maladies the drugs are designed to treat. The trials are simply meant to test how effectively the drugs get into the system.

Only one in every 3,000 phase I drugs progress beyond that stage, Klaib said.

Phase I tests require more monitoring, more staff and more space. That’s one of the primary reasons Klaib wanted to move into the larger facility. She said she also expects to at least double her staff from seven to I4 within the next few months.

Phase I tests also pay more than phases II through IV.

“Phase I trials are more of a money maker, I guess you could say,” Scalva said.

Volunteers are required to stay overnight multiple days for monitoring and doctors have to devote more time to monitoring patients, taking samples and recording test results.

As a result, the drug companies pay more.

The business is different from doctors’ offices or hospitals, because the money comes from pharmaceutical companies — not from patients.

In fact, the patients get paid. MCB pays the doctors who do the clinical research. and the patients who volunteer for the programs.

Being able to get in on the ground floor of testing, and reap the financial benefits will also benefit patients, she said.

“We plan on investing a lot in the comfort of our (volunteers),” Scalva said.

Since people have to stay overnight several days in a row, the mother and daughter are turning the largest room in the new building, which used to be a vocational training facility, into a recreation room that will have a big screen TV, comfy couches and board games.

Every volunteer will have his or her own private room. Scalva and Klaib hope to have a limo service pick up and drop off volunteers and will have meals catered by quality local restaurants.

MCB does all phases of testing, but the added space will make it a premier phase-I facility, Klaib said. She started getting calls from drug companies months ago asking how soon she could have her facility online.

MCB focuses on clinical research in gynecology and psychology because its most active doctors work in those fields, Klaib said. Physicians also test other drugs, but typically not cancer drugs.

It’s long been a disappointment to her, because cancer research is her passion. She said that the doctors who do research with her are independent physicians who do not work for institutions. But oncologists almost always work for hospitals and they are more limited in what types of research they can do outside their institutions.

But because Klaib is so passionate about cancer and cancer research, her new facility will have a cancer resource center where Klaib can direct cancer suffers to clinical trials and hospitals around the country on the cutting edge of cancer research. She can also help families find grants and foundations that will support them financially.