A new Indianapolis company plans to attack the chronic shortage of minority patients in drug trials armed only with 11 employees and the wisdom of a couple Eli Lilly and Co. executives.
However, the founders of Anaclim believe they'll find ample success by focusing exclusively on the growing push for diversity in the $10 billion contractresearch industry.
Anaclim, which occupies a mostly empty office at Intech Park, could double its staff quickly and start raking in eight-figure revenue within three years, according to two of its founders, Lilly veterans Dr. Alfonso Alanis and Rex Alexander.
Pharmaceutical companies have increased their reliance over the past decade on contract-research organizations, which recruit patients to participate in drug studies, according to Jeffrey Trewhitt, a spokesman for the Washington, D.C.-based Pharmaceutical Research and Manufacturers of America.
"At a time when clinical testing for a single drug requires an average of about 5,000 volunteer patients, it is important to have expert assistance," he said.
Anaclim will provide this assistance with a twist: It aims to become the only organization that focuses solely on recruiting minority patients.
"It's certainly an underserved segment of the industry," said Dan McDonald, vice president of Thomson CenterWatch, a Boston firm that monitors the clinical-trial business. "That is a pretty big issue that they're addressing."
Most contract-research organizations have boosted their minority recruitment, said Roni Thaler, president and CEO of The Center for Information and Study on Clinical Research Participation, another Bostonbased company.
But neither she nor McDonald knows of another company that shares Anaclim's sole focus on minorities.
Medical necessity drives the need for Anaclim, Alanis said.
He pointed to the development of tailored medicines like the drug BiDil, which was approved by the U.S. Food and Drug Administration earlier this year to treat heart failure in black patients.
Research has shown that ethnic or racial groups respond differently to some medical treatments and that some conditions affect certain populations more than others.
"Yet when new treatments are studied, it turns out most of the companies tend to provide data on white Americans," Alanis said.
For example, Hispanics make up 12 percent of the population of U.S. diabetes patients, according to FDA data. But they total only 3 percent of diabetes trial participants.
"That has been a chronic problem in the pharmaceutical industry," Alanis said.
The reasons are numerous. A lack of trust, particularly among blacks, hampers trial participation, according to Nancy Jewell, president and CEO of the Indiana Minority Health Coalition.
Language barriers present another obstacle, as does cultural misunderstanding. For instance, some cultures require a researcher to seek permission from men in a household before they enroll women in a study, said Jewell, whose coalition has started a program to boost clinical trial awareness and participation among minority patients and providers.
Awareness is another problem, said Cecilia Acosta, executive director of the Hispanic/Latino Minority Health Coalition of Greater Indianapolis. Members of the Hispanic community generally learn about studies only when their doctor tells them, she said.
Acosta thinks researchers could find more patients if, for instance, they passed out brochures through Wishard Health Services' Hispanic Health Project or through community churches.
"That's the best way to target our community, going to where they are," she said. "If you go there, they will trust you more."
Anaclim plans to build its business by using a network of more than 1,400 doctors to recruit minority patients. It announced last month that it signed an agreement with Cincinnati-based Therapeutics Research Assistance Consortium to boost its access to doctors and clinical investigators.
Doctors who treat minority patients understand cultural differences and can overcome language barriers, Alexander said.
Those doctors also bring with them a built-in sense of trust, Jewell noted.
"Patients become very comfortable with trusting their physician, especially if they've been going to them for a while," she said.
Anaclim also has plenty of experience to help its start. Alexander worked for nearly 34 years at Lilly, where he spent most of his time in clinical project management.
Alanis, Anaclim's majority owner and a native of Mexico City, is still employed by Lilly. He's on loan from the drugmaker, where he has spent 20 years working in clinical development.
"We know exactly what is expected of us," Alanis said.
Alexander agreed, "If you don't deliver a quality product at the worst on time, you may not be invited back to the party."
Aside from recruiting minority patients, Anaclim also will work on project monitoring and data management. That means it will help collect and then process data.
"We don't just identify minority patients, we conduct the clinical trial," Alexander said.
The company registered with the state to do business last March, but it spent several months polishing its research and recruiting, securing necessary certifications, building its network and hiring staff.
Anaclim expects to start its work early this year, and its first customer probably will be Lilly, Alanis said.
He quickly added that Anaclim is not another Lilly spin off. He also expects to work with several other drug companies, biotech firms and other contractresearch organizations.
Alanis expects Anaclim to handle between four and six clinical trials its first year, but its capacity will expand over time.
Anaclim occupies about 8,000 square feet in the Intech One building. Much of that space is filled with empty cubicles and computer desks. Alanis signed a five-year lease for the space. He wanted an office that provided room to grow.
"We aspire to stay here, to be another significant health care business," he said.