A new clinic that is on the cusp of conducting human trials in Indianapolis could distinguish itself as a key player in drug development, not only within the state, but nationally as well.
Centurion Clinical Research LLC serves pharmaceutical companies and medical-device makers that need to test their products before they can be approved for widespread use. That first phase, in which healthy people are paid to participate in the overnight studies, is critical in determining the safety and success of a treatment.
"Without people volunteering, there won't be cures for these diseases," Centurion CEO William McGinnis said.
McGinnis and company President Michael Smiricky, both former Eli Lilly and Co. executives, are part of a group of 10 investors who raised more than $2 million to launch Centurion. It is the only commercial clinic in the city and just the second in the state that hosts Phase I trials.
Lilly is considering closing its private research laboratories after announcing in August it would double the amount of research and development work it outsources to Covance Inc. The New Jerseybased company has an 800-bed clinic in Evansville.
Centurion's clinic, which opened in June in a building on Naab Road near St. Vincent Hospital, contains 46 dormitory beds and eight hospital beds to accommodate patients participating in overnight trials. It ultimately plans to have 80 dorm beds and 12 hospital beds.
The clinic will conduct its first trial by the end of the month and so far has contracts to do five more, which could help leaders achieve their goal of reaching at least $10 million in revenue next year. With more than 2,000 drugs awaiting Federal Drug Administration approval to proceed to clinical trials, the market could be lucrative.
Drug companies typically outsource the management of clinical trials to a contract research organization, or CRO, like Centurion.
Centurion is leasing 22,000 square feet of space and employs 18 full-time and 11 part-time workers. Dr. Karen Rodman is the full-time medical director.
McGinnis and Smiricky are banking on the contacts they built during their years at Lilly, the experience of their staff, and the high-tech features of the facility to compete with the more than 50 clinics within the United States-and countless more outside the country-that conduct human trials.
To land its first contract-with an international pharmaceutical firm-Centurion bid against not only many of those rivals but others in China, India and Europe as well.
Dr. Alfonso Alanis, CEO of contract researcher Anaclim LLC, welcomes Centurion's arrival. Anaclim recruits physicians and manages trials that progress beyond the first phase. Those phases last much longer and involve patients afflicted with the actual disease.
Alanis is a Lilly retiree as well and is referring clients in search of a Phase I clinic to Centurion.
"The company might be new," he said, "but these are people who have lots and lots of experience."
Safety, security critical
Indeed, McGinnis and Smiricky are a formidable duo who both ascended to leadership positions at Lilly.
McGinnis, 61, spent 27 years at the local drug manufacturer, serving as general manager of the medical devices and diagnostics division of Lilly Canada before it became Guidant Canada. He also served as general manager of the diabetes alliance between Lilly Canada and Boehringer Mannheim Canada.
After retiring from Lilly in April 2000, McGinnis returned north of the border to serve as CEO and vice chairman of two biotech companies. His travels later took him to Minnesota, where he led two startup firms.
Smiricky, 59, spent 15 years at Lilly before retiring in 2006 as regional research manager of its research laboratories. He also serves as a consultant to several biotech companies in the United States and Canada.
The two spared no expense in equipping Centurion's space with the latest technology and equipment. A testing system that records heart rhythms cost six figures. Certain drugs can affect the nervous system and cause changes in cardiac function.
A state-of-the-art sterile hood, manufactured by Containment Technologies Group in Greenwood is used in the mixing of drugs for pharmaceutical clients. The half life of some medicines, particularly cancer vaccines, is so short they must be made on site.
Security is a top concern as well, particularly when ensuring volunteers are drug-free. The toilet water in the rest rooms is dyed deep blue to discourage volunteers from diluting their urine samples during drug testing. Sinks outside the rest rooms in the screening areas further deter cheating.
Participants are issued scrubs and store their clothes in locked containers to prevent them from smuggling food and cigarettes into the clinic. Technicians also draw blood to screen for HIV and Hepatitis C and D.
The in-house pharmacy is triple-locked to prevent the theft of drugs, and alarms are tripped when doors open, for instance, if anyone attempts to leave the floor. Ceiling tiles in the dorms are bolted down to thwart efforts to climb into a room occupied by the opposite sex, or to stash food. Volunteers are monitored by staff during lunch to ensure dietary restrictions are enforced.
Because most cell phones contain cameras, they are prohibited on the premises. Pay phones are available, however. Access to the women's rest room is restricted via a key code. Security cameras provide additional monitoring.
A "quiet room" is available for reading and watching television, and a billiards table and video games provide volunteers a bit of leisure.
Centurion's medical director or a contracted physician is on site around the clock during trials.
Pay not only benefit
Clinical trials typically are conducted in four stages, with the first including a small group of 20 to 80 healthy volunteers monitored to assess the safety of a drug. These trials often are conducted in an inpatient clinic, like Centurion, where subjects are monitored by staff.
Centurion's first trial that will be conducted later this month requires a stay of about a week. Trials pay in the range of a few hundred dollars to several thousand, depending upon the length of stay and clinic. But money is not the only motivating factor, Centurion's McGinnis said.
"If you don't have health care, it's a good way to get a physical," he said. "But they do it for the altruism, too."
Paul Clough of Texas operates www.justanotherlabrat.com, a Web site devoted to clinical trials.
"I try to get people to see beyond the money and for them to understand what the clinical trials are really about," said Clough, who admitted he makes up to $25,000 annually volunteering in six to seven trials a year.
Participants must wait 30 days between trials to ensure the tested drug has exited the body.
Centurion has built a database of 1,000 prospects by recruiting at job fairs and advertising in the local weekly alternative newspaper Nuvo. The age range of volunteers normally is 18 to 55. The most common disqualifier is obesity, McGinnis said.
Centurion can host patients for all four trial phases, but those following the first stage only occasionally require an overnight stay.
Of the six trials Centurion so far has booked, four involve large, multinational pharmaceutical companies.
"We have some early validation," McGinnis said, "which makes us feel good."
On a larger scale, Centurion provides another link in the chain of drug development, which allows companies to develop a drug from start to finish in Indiana.
"That is something you could not do in this state," Alanis at Anaclim said, "unless your name was Lilly."