March 1, 2004
From the lab to the boardroom | A Scarborough company tries to capitalize on lessons learned in biomedical research
By Jess Kilby
Necessity is the mother of invention. This old saw holds especially true in the field of medical research, where new discoveries often raise more questions than they answer. Take, for example, the rapidly growing field of molecular genetic testing, a technology that's being used to detect everything from cancer and cystic fibrosis to HIV and, most recently, SARS.
The problem with molecular diagnostics? Laboraories are finding it hard to get their hands on adequate supplies of control samples (i.e., positive results) to test against, because the diseases in question are often rare. When a positive sample does become available, the edicts of patient confidentiality often make it complicated to share.
But a newly formed local company, Maine Molecular Quality Controls Inc., thinks it has a solution to this problem: synthetic control samples. The company will fabricate "diseased" batches of DNA and sell them to labs across the country, to be used as quality control markers in nucleic acid testing.
Based on preliminary market research, MMQCI co-founders Clark Rundell and Joan Gordon are pretty sure they've hit on a winning idea. They've already made successful test batches of the product, targeting cystic fibrosis, leukemia, tuberculosis and a host of other diseases. They've determined that, for the time being, their would-be competitors aren't interested in competing. They've signed a lease on a new, 6,200-square-foot facility in Scarborough and are set to move in on April 1. All that remains is the arduous task of securing FDA approval, and, perhaps even more daunting for a pair of dyed-in-the-wool scientists, learning how to run a successful startup business.
"I never thought I'd be doing this," says Gordon, who has taken on most of the business responsibilities for the company. "We're scientists, not business people. Decision-making is very difficult when you don't have the experience. It's very difficult to know when to hire a new person, when to market, how to set peoples' expectations properly. It's big things, and it's small things, like, how do you figure out how to put labels on little plastic bottles? Science is much easier than business, I think. It's not always reliable, but then neither is business."
Too fussy for the big guys
The field of molecular genetic testing was born in the late 1990s, and has experienced rapid growth in the past year. Catherine Long, a specialist in the nucleic acid testing market for Boston Biomedical Consultants, estimates the worldwide NAT market for 2003 at $1.5 billion. The U.S. market "just hit the billion-dollar mark" in 2002, she says, and is still growing significantly. She pegs it at a higher rate than the 18% worldwide growth that she estimates for 2002-2003, though she declines to give specific figures. (Long notes that all her numbers are preliminary estimates.)
NAT technology was still in its infancy, however, when Rundell and Gordon began the work that has become the cornerstone of their new company. Both scientists at the time were researchers at Maine Medical Center ˆ Rundell as the director of both chemistry and molecular pathology at MMC, and Gordon as a research associate in molecular controls at the Maine Medical Center Research Institute. Rundell was working on a nucleic acid test for HIV sequencing when it became apparent that something was lacking in the process.
"We were at the research institute when we set up the testing," Rundell says. "We realized we didn't have quality control, nor did anybody else in the nation. They have lot of genetic engineering capabilities [at MMCRI], and we came up with some ideas that we could make synthetic genetic material that had the sequence that you're testing for."
The science behind this concept, though cutting-edge, is not unique; Rundell notes that lab workers make synthetic genetic material "all the time, using common technologies." But when Rundell and Gordon approached the major diagnostic companies like Abbott Laboratories and Roche to see if they had any intention of making synthetic NAT quality controls, they said the work was "too fussy" for them, Rundell recalls.
"They said no, the market is too smallˆ and they couldn't afford the investment they would have to put into it," he says. "They said they're not going to make it; however, [they said] if you make it we'll be very interested."
MMCRI was also interested (see "Spinning off," p. 31). Based on this project and previous quality-control work that Rundell had done on site, the institute supported his application for two $100,000 Small Business Innovation grants, along with an $80,000 Maine Technology Institute grant. With that money, Rundell and Gordon formed MMQCI in 2000. Rundell, a self-professed "lab rat," is the company's technical director; Gordon is president.
Turning to busines
When MMQCI moves into its new facility in April, it will mean more than just better communication and more efficient resource management for the five-person staff. The move also signals a turning point for the company ˆ a transition from the intensive, mostly grant-funded scientific work to a more business-oriented phase. While grants from MTI and the National Institutes of Health will continue to fund MMQCI's ongoing research work, the company has so far invested at least $500,000 in loans and personal money toward finishing and equipping its new lab space.
MMQCI's income will be limited while it seeks FDA approval; since its various controls are still pending approval, they can only be sold to labs in small quantities as test materials. Gordon says she'll be happy if the company makes $100,000 in 2004. For 2005, she says "we could do $1 million."
Both Rundell and Gordon admit that the business side of things has not come easily to them. "We'll definitely be hiring marketing and sales people," Rundell says. "We fully know that this not something that we know how to do."
After attending a series of MTI workshops on technology commercialization in 2002, Gordon sought out Meriby Sweet, one of the workshop presenters, as a mentor. Sweet, a technology business counselor with the Maine Small Business Development Centers, helped MMQCI draw up a business plan that was ready for commercialization and capital investment. "They had received government grants, MTI awards, filed a couple of patents, done all the right business things to protect the technology," Sweet says. "The next step was to get the funding to have their own facility."
Since Rundell and Gordon had both spent many years working in the biomedical industry, Sweet says they had a pretty good sense of their market. (In fact, Rundell notes that "since there's only a fairly small number of labs [doing NAT], it turns outˆ that we actually personally known almost everybody involved.")
Sweet's job, then, was to distill MMQCI's highly technical work into a sales pitch that potential lenders could easily understand. In talking with Mainebiz, Sweet emphasizes the uniquely humanitarian nature of MMQCI's technology. "What they have focused on are diseases that are asymptomatic until they are in later stages," she says. "So things that are invisible, for which there are no tests.
"Cystic fibrosis is one of those diseases whose impact can be mitigated by early treatment," she adds. "It's not like a cold, where you say 'I think I'm coming down with a scratchy throat.' Suddenly it's wham, full-fledged, and there's no way to treat it. So this is huge, wonderful ˆ this is for invisible diseases."
Looking forward, Gordon says she'd like to ship the first quality control tests by this fall."We need enough product in our refrigerators to be able to meet the demand," she says.
And while the focus for the time being is on winning FDA approval for MMQCI's current tests, Rundell anticipates that the company will some day offer "a family of 100 or more products that will address several major nucleic acid tests."
"This, to us, is extremely exciting," he says, "because what we're doing here is trying to fill a real need ˆ and we're able to it with this real cutting-edge technology."
The problem with molecular diagnostics? Laboraories are finding it hard to get their hands on adequate supplies of control samples (i.e., positive results) to test against, because the diseases in question are often rare. When a positive sample does become available, the edicts of patient confidentiality often make it complicated to share.
But a newly formed local company, Maine Molecular Quality Controls Inc., thinks it has a solution to this problem: synthetic control samples. The company will fabricate "diseased" batches of DNA and sell them to labs across the country, to be used as quality control markers in nucleic acid testing.
Based on preliminary market research, MMQCI co-founders Clark Rundell and Joan Gordon are pretty sure they've hit on a winning idea. They've already made successful test batches of the product, targeting cystic fibrosis, leukemia, tuberculosis and a host of other diseases. They've determined that, for the time being, their would-be competitors aren't interested in competing. They've signed a lease on a new, 6,200-square-foot facility in Scarborough and are set to move in on April 1. All that remains is the arduous task of securing FDA approval, and, perhaps even more daunting for a pair of dyed-in-the-wool scientists, learning how to run a successful startup business.
"I never thought I'd be doing this," says Gordon, who has taken on most of the business responsibilities for the company. "We're scientists, not business people. Decision-making is very difficult when you don't have the experience. It's very difficult to know when to hire a new person, when to market, how to set peoples' expectations properly. It's big things, and it's small things, like, how do you figure out how to put labels on little plastic bottles? Science is much easier than business, I think. It's not always reliable, but then neither is business."
Too fussy for the big guys
The field of molecular genetic testing was born in the late 1990s, and has experienced rapid growth in the past year. Catherine Long, a specialist in the nucleic acid testing market for Boston Biomedical Consultants, estimates the worldwide NAT market for 2003 at $1.5 billion. The U.S. market "just hit the billion-dollar mark" in 2002, she says, and is still growing significantly. She pegs it at a higher rate than the 18% worldwide growth that she estimates for 2002-2003, though she declines to give specific figures. (Long notes that all her numbers are preliminary estimates.)
NAT technology was still in its infancy, however, when Rundell and Gordon began the work that has become the cornerstone of their new company. Both scientists at the time were researchers at Maine Medical Center ˆ Rundell as the director of both chemistry and molecular pathology at MMC, and Gordon as a research associate in molecular controls at the Maine Medical Center Research Institute. Rundell was working on a nucleic acid test for HIV sequencing when it became apparent that something was lacking in the process.
"We were at the research institute when we set up the testing," Rundell says. "We realized we didn't have quality control, nor did anybody else in the nation. They have lot of genetic engineering capabilities [at MMCRI], and we came up with some ideas that we could make synthetic genetic material that had the sequence that you're testing for."
The science behind this concept, though cutting-edge, is not unique; Rundell notes that lab workers make synthetic genetic material "all the time, using common technologies." But when Rundell and Gordon approached the major diagnostic companies like Abbott Laboratories and Roche to see if they had any intention of making synthetic NAT quality controls, they said the work was "too fussy" for them, Rundell recalls.
"They said no, the market is too smallˆ and they couldn't afford the investment they would have to put into it," he says. "They said they're not going to make it; however, [they said] if you make it we'll be very interested."
MMCRI was also interested (see "Spinning off," p. 31). Based on this project and previous quality-control work that Rundell had done on site, the institute supported his application for two $100,000 Small Business Innovation grants, along with an $80,000 Maine Technology Institute grant. With that money, Rundell and Gordon formed MMQCI in 2000. Rundell, a self-professed "lab rat," is the company's technical director; Gordon is president.
Turning to busines
When MMQCI moves into its new facility in April, it will mean more than just better communication and more efficient resource management for the five-person staff. The move also signals a turning point for the company ˆ a transition from the intensive, mostly grant-funded scientific work to a more business-oriented phase. While grants from MTI and the National Institutes of Health will continue to fund MMQCI's ongoing research work, the company has so far invested at least $500,000 in loans and personal money toward finishing and equipping its new lab space.
MMQCI's income will be limited while it seeks FDA approval; since its various controls are still pending approval, they can only be sold to labs in small quantities as test materials. Gordon says she'll be happy if the company makes $100,000 in 2004. For 2005, she says "we could do $1 million."
Both Rundell and Gordon admit that the business side of things has not come easily to them. "We'll definitely be hiring marketing and sales people," Rundell says. "We fully know that this not something that we know how to do."
After attending a series of MTI workshops on technology commercialization in 2002, Gordon sought out Meriby Sweet, one of the workshop presenters, as a mentor. Sweet, a technology business counselor with the Maine Small Business Development Centers, helped MMQCI draw up a business plan that was ready for commercialization and capital investment. "They had received government grants, MTI awards, filed a couple of patents, done all the right business things to protect the technology," Sweet says. "The next step was to get the funding to have their own facility."
Since Rundell and Gordon had both spent many years working in the biomedical industry, Sweet says they had a pretty good sense of their market. (In fact, Rundell notes that "since there's only a fairly small number of labs [doing NAT], it turns outˆ that we actually personally known almost everybody involved.")
Sweet's job, then, was to distill MMQCI's highly technical work into a sales pitch that potential lenders could easily understand. In talking with Mainebiz, Sweet emphasizes the uniquely humanitarian nature of MMQCI's technology. "What they have focused on are diseases that are asymptomatic until they are in later stages," she says. "So things that are invisible, for which there are no tests.
"Cystic fibrosis is one of those diseases whose impact can be mitigated by early treatment," she adds. "It's not like a cold, where you say 'I think I'm coming down with a scratchy throat.' Suddenly it's wham, full-fledged, and there's no way to treat it. So this is huge, wonderful ˆ this is for invisible diseases."
Looking forward, Gordon says she'd like to ship the first quality control tests by this fall."We need enough product in our refrigerators to be able to meet the demand," she says.
And while the focus for the time being is on winning FDA approval for MMQCI's current tests, Rundell anticipates that the company will some day offer "a family of 100 or more products that will address several major nucleic acid tests."
"This, to us, is extremely exciting," he says, "because what we're doing here is trying to fill a real need ˆ and we're able to it with this real cutting-edge technology."
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