May 2, 2005
I want a new drug | A new Bangor firm tries to break into the growing clinical research market
By Taylor Smith
In January, Gail Baillargeon set up her new company, Acadia Clinical Research, which facilitates clinical research trials for pharmaceutical companies such as Novartis and GlaxoSmithKline, for a relatively paltry $15,000. She spent money on an electrocardiogram machine, an exam table and a centrifuge to test patients' blood samples, and rented an office suite in Bangor.
During her first year in business, Baillargeon hopes to break even through her work on a handful of clinical trials. Unlike most new entrepreneurs, Gail Baillargeon says she isn't in it for the money. Instead, she says it's the science that's the real hook.
While that might sound funny in the high-stakes pharmaceutical world, where companies earmark hundreds of millions of dollars to guide their drugs through the Food and Drug Administration's sometimes decade-long (or longer) approval process, Baillargeon's financial
expectations aren't out of line. Because of the FDA's tight regulations on clinical trials, which can involve testing the efficacy of a new drug or piece of medical hardware, any whiff of impropriety ˆ such as outsized compensation for the firm conducting a trial ˆ could spell trouble for the drug's future. "There aren't huge budgets because the FDA is watching," says Baillargeon. "If you pay someone big bucks, are they really in it for the science?"
The market for firms like Acadia Clinical Research, known as clinical research organizations or CROs, is growing. An August 2004 article in Applied Clinical Trials, an Iselin, N.J.-based trade magazine, pegged the CRO market at roughly $10 billion nationwide, and noted that it is growing at an average rate of more than 12% annually. Thomson CenterWatch, a Stamford, Conn.-based industry watcher, estimates that government, university and pharmaceutical groups will spend as much as $21 billion funding clinical trials in 2005.
Meanwhile, the growth in the market has meant more competition among CROs like Acadia Clinical Research. "There are lot of these freestanding places that do this," says Dr. Mark Henderson, an endocrinologist in Bangor who is working with Acadia Clinical Research on a diabetes trial. "If there's an entrepreneur who can put the team together, and if they do a good job, the drug companies will keep contacting them for trials."
Dr. Kenneth Ault, director of Maine Medical Center Research Institute in Scarborough, says the clinical research industry in recent years has shifted away from single-location trials at big university medical centers. Instead, drug companies increasingly are outsourcing research to hospitals like Maine Medical Center in Portland and smaller firms like Acadia Clinical Research. "Everybody knows the pharmaceutical industry is growing rapidly," he says. "And more and more, drug companies are turning towards small organizations to do their clinical trials."
Ault says the shift has been precipitated by the FDA's increasing oversight on clinical testing, which has led drug companies to expand the scope of their testing. Drug companies now, says Ault, often organize multi-center trials, where MMC might recruit 10 patients, while medical facilities across the country might monitor hundreds more.
As part of that growing trend, MMC in April announced a large-scale expansion of the Maine Medical Center Research Institute that will double its research capacity over the next five years. Ault says that MMC and MMCRI currently are conducting more than 290 clinical trials ˆ with at least 3,000 patients ˆ that cover new drugs, medical devices and new treatment protocols for established drugs. Ault expects to double the number of patients involved in these clinical trials under MMCRI's new strategic plan, which includes an increase in the number of researchers and medical investigators overseeing these trials.
On the cutting edge
Even though Baillargeon of Acadia Clinical Research has spent the last 17 years working on research trials at Eastern Maine Medical Center and through private physicians' offices like Northeast Cardiology Associates in Bangor, she isn't a doctor. Instead, her role is as a facilitator, matching drug companies' products with health care providers who can administer the tests, from drawing a patients' blood to evaluating their reaction to a particular drug.
Much of Baillargeon's research at EMMC was focused on oncology, the study of cancer, and her work at Northeast Cardiology Associates revolved around clinical trials for heart treatments. With Acadia Clinical Research, Baillargeon says she's able to expand the range of research, conducting trials for drugs that treat diseases such as diabetes. And through her long association with EMMC and other clinical research organizations in Maine, Baillargeon says she has fostered good relationships with some of the world's largest pharmaceutical companies, including New York-based Bristol-Myers Squibb and Swiss firm Novartis. "If a pharmaceutical company knows that we're good quality and that we follow guidelines," she says, "they know they'll get quality results."
Baillargeon says the pharmaceutical companies tend to come to her with a firm budget already drawn up, which outlines how much the company will pay for each patient and each step in the testing process. For example, Baillargeon will be allocated a certain amount ˆ which varies from company to company ˆ for drawing blood or administering an EKG. Some trials, she says, are straightforward, but others are labor intensive. "You might see a patient every other week, and have tons of labs drawn," says Baillargeon. "They might need an EKG, or maybe they need to be monitored in the office for an hour after taking a drug."
While Acadia Clinical Research and MMC aren't being handsomely compensated by drug companies, there's an upside to running the trials. The drugs or medical devices being tested typically are the newest of the new, which Baillargeon says is a way to get cutting-edge treatments to patients.
Ault agrees. He says research at MMC helped bring specialized coated stents to cardiac patients in Maine years before they were approved by the FDA in 2003. "Based on my experience [clinical research] is not that profitable," says Ault. "Most [doctors and researchers] get involved because they want the best drugs and products for their patients."
For her part, Baillargeon expects to keep growing her business as she continues taking on new trials from pharmaceutical companies. She expects to hire more staff in the next year or so, including a dietician and a nurse practitioner or physicians' assistant, and figures she'll need to expand her suite to include a conference room to host sponsors from pharmaceutical companies. Meanwhile, she admits that even though she's interested in becoming a better businesswoman, she's just as interested in watching the research her firm will help conduct."The research answers very important questions," she says. "Either something works or it doesn't work, and it's a little bit like being a detective. The good thing is that you're always learning; whenever you think that things are going to get boring, a new drug comes out."
During her first year in business, Baillargeon hopes to break even through her work on a handful of clinical trials. Unlike most new entrepreneurs, Gail Baillargeon says she isn't in it for the money. Instead, she says it's the science that's the real hook.
While that might sound funny in the high-stakes pharmaceutical world, where companies earmark hundreds of millions of dollars to guide their drugs through the Food and Drug Administration's sometimes decade-long (or longer) approval process, Baillargeon's financial
expectations aren't out of line. Because of the FDA's tight regulations on clinical trials, which can involve testing the efficacy of a new drug or piece of medical hardware, any whiff of impropriety ˆ such as outsized compensation for the firm conducting a trial ˆ could spell trouble for the drug's future. "There aren't huge budgets because the FDA is watching," says Baillargeon. "If you pay someone big bucks, are they really in it for the science?"
The market for firms like Acadia Clinical Research, known as clinical research organizations or CROs, is growing. An August 2004 article in Applied Clinical Trials, an Iselin, N.J.-based trade magazine, pegged the CRO market at roughly $10 billion nationwide, and noted that it is growing at an average rate of more than 12% annually. Thomson CenterWatch, a Stamford, Conn.-based industry watcher, estimates that government, university and pharmaceutical groups will spend as much as $21 billion funding clinical trials in 2005.
Meanwhile, the growth in the market has meant more competition among CROs like Acadia Clinical Research. "There are lot of these freestanding places that do this," says Dr. Mark Henderson, an endocrinologist in Bangor who is working with Acadia Clinical Research on a diabetes trial. "If there's an entrepreneur who can put the team together, and if they do a good job, the drug companies will keep contacting them for trials."
Dr. Kenneth Ault, director of Maine Medical Center Research Institute in Scarborough, says the clinical research industry in recent years has shifted away from single-location trials at big university medical centers. Instead, drug companies increasingly are outsourcing research to hospitals like Maine Medical Center in Portland and smaller firms like Acadia Clinical Research. "Everybody knows the pharmaceutical industry is growing rapidly," he says. "And more and more, drug companies are turning towards small organizations to do their clinical trials."
Ault says the shift has been precipitated by the FDA's increasing oversight on clinical testing, which has led drug companies to expand the scope of their testing. Drug companies now, says Ault, often organize multi-center trials, where MMC might recruit 10 patients, while medical facilities across the country might monitor hundreds more.
As part of that growing trend, MMC in April announced a large-scale expansion of the Maine Medical Center Research Institute that will double its research capacity over the next five years. Ault says that MMC and MMCRI currently are conducting more than 290 clinical trials ˆ with at least 3,000 patients ˆ that cover new drugs, medical devices and new treatment protocols for established drugs. Ault expects to double the number of patients involved in these clinical trials under MMCRI's new strategic plan, which includes an increase in the number of researchers and medical investigators overseeing these trials.
On the cutting edge
Even though Baillargeon of Acadia Clinical Research has spent the last 17 years working on research trials at Eastern Maine Medical Center and through private physicians' offices like Northeast Cardiology Associates in Bangor, she isn't a doctor. Instead, her role is as a facilitator, matching drug companies' products with health care providers who can administer the tests, from drawing a patients' blood to evaluating their reaction to a particular drug.
Much of Baillargeon's research at EMMC was focused on oncology, the study of cancer, and her work at Northeast Cardiology Associates revolved around clinical trials for heart treatments. With Acadia Clinical Research, Baillargeon says she's able to expand the range of research, conducting trials for drugs that treat diseases such as diabetes. And through her long association with EMMC and other clinical research organizations in Maine, Baillargeon says she has fostered good relationships with some of the world's largest pharmaceutical companies, including New York-based Bristol-Myers Squibb and Swiss firm Novartis. "If a pharmaceutical company knows that we're good quality and that we follow guidelines," she says, "they know they'll get quality results."
Baillargeon says the pharmaceutical companies tend to come to her with a firm budget already drawn up, which outlines how much the company will pay for each patient and each step in the testing process. For example, Baillargeon will be allocated a certain amount ˆ which varies from company to company ˆ for drawing blood or administering an EKG. Some trials, she says, are straightforward, but others are labor intensive. "You might see a patient every other week, and have tons of labs drawn," says Baillargeon. "They might need an EKG, or maybe they need to be monitored in the office for an hour after taking a drug."
While Acadia Clinical Research and MMC aren't being handsomely compensated by drug companies, there's an upside to running the trials. The drugs or medical devices being tested typically are the newest of the new, which Baillargeon says is a way to get cutting-edge treatments to patients.
Ault agrees. He says research at MMC helped bring specialized coated stents to cardiac patients in Maine years before they were approved by the FDA in 2003. "Based on my experience [clinical research] is not that profitable," says Ault. "Most [doctors and researchers] get involved because they want the best drugs and products for their patients."
For her part, Baillargeon expects to keep growing her business as she continues taking on new trials from pharmaceutical companies. She expects to hire more staff in the next year or so, including a dietician and a nurse practitioner or physicians' assistant, and figures she'll need to expand her suite to include a conference room to host sponsors from pharmaceutical companies. Meanwhile, she admits that even though she's interested in becoming a better businesswoman, she's just as interested in watching the research her firm will help conduct."The research answers very important questions," she says. "Either something works or it doesn't work, and it's a little bit like being a detective. The good thing is that you're always learning; whenever you think that things are going to get boring, a new drug comes out."
Most Recent
Most Recent
Comments