Impressive PRESENCE

NEUREKA IS EXPANDING HEALTH SCIENCES RESEARCH AND BIOTECH UP NORTH

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By Deborah Komlos

Apart from the scenic vista facing its Sudbury, Ont. headquarters, the Northern Centre for Biotechnology and Clinical Research (Neureka!) has a wealth of inspiration.

Neureka was founded eight years ago when a group of five stakeholders in the area acted on a vision to diversify the region’s economy, explains Magdy Basta, PhD, the centre’s president and CEO.

The strategy, he says, was to build an infrastructure to initially target medical research. In 1998, Basta and his secretary were the first two employees at the centre, in a facility that occupied less than 2,000 square feet. Today, the centre has 49 employees in about 15 times the facility space. Basta says the plan is to increase Neureka’s personnel count to around 75 employees over the next 18 months.

Though growth has been positive, starting up was difficult.

“There was no infrastructure for biotech in the north; in addition to that, no critical mass for biotech. On top of all that, there was no seed money,” Basta says, adding that the public had no understanding of what biotech means.

“So, we really designed the first business plan on a two-tier organization, and we meant to do that to really speed up the process of development,” he says.

Networking for Studies
The Clinical Research Division was established, Basta says, to build a very strong network of national and international research collaborations. Currently, the centre has research contracts with over 80 multinational pharmaceutical clients and research institutes worldwide, and will work with up to 100 clinical research physicians this year. Studies contracted include those dealing with diabetes, cardiovascular disorders and mental health, among others.

The centre also plans to have research links with the Northern Ontario Medical School (NOMS), which has two campuses: the Northwest Campus at Lakehead University (Thunder Bay, ON), and the Northeast Campus at Laurentian University (Sudbury, ON). Basta is a professor of microbiology at NOMS as well as an adjunct professor of biochemistry at Laurentian.

Basta attributes Neureka’s success in establishing its clinical research base to particular strategies taken by the organization. One decision was to give Neureka a not-for-profit status. This allowed it to focus on its long-term plan to build a very strong research network.

Another important decision was to handle all aspects of clinical research in-house, Basta says. Clinical research involves much more than just clinical work, he points out, such as regulatory work, ethical considerations and quality control. The centre has created a department to address each of these components.

Bench to Market
Neureka’s other organizational tier, the Biotechnology Division, has a very clear focus, Basta says: “from the bench to the market.”

The goal, he says, is to transfer intellectual property from research institutes or universities to new products or new services. Basta’s 15 years’ experience in the biotech industry has helped tremendously to “give a very practical vision to how you transfer the idea to product,” he says.

“Biomedical is the first priority. Second is bioenvironment, biomining, bioforestry,” Basta says. “For sure the biomining and bioforestry is coming from a realization of our environment, and it’s an industry that is established in northern Ontario.”

A result of having a commercialization focus, he says, is the opportunity to spin off technologies into new companies — something that Basta says is certainly possible for the centre’s lead product: a kit for the measurement of oxidized low-density lipoproteins (ox-LDL). It is known that patients with coronary artery disease have significantly elevated levels of ox-LDL in their plasma.

“This is a very exciting project because the market is desperately needed all over the world, and in addition to that, the size of the market is extremely high for the applications,” Basta says. The centre hopes to file for the kit’s 510(k) regulatory approval with the U.S. Food and Drug Administration by year’s end.

Project leader Robert Hamel, PhD, explains that the idea of measuring oxidation in lipids is not new. Rather, the novel aspect is the direct measurement of lipid oxidation.

“When you’re measuring oxidation in lipids in a classical way, typically you would do a lipid-extraction procedure and then you would measure the diene conjugation using a spectrophotometer,” Hamel says. “And with that, you are able to get a concentration . . . you’d get the amount of lipid oxidation. We’re using this diene conjugation to get a direct measurement of the level of oxidation in your lipids.”

The technology is based on patents held by a collaborator in Finland, Hamel says, and Neureka holds exclusive rights to the patents. Hamel changed the technology to develop what he says is “a more friendly kit” that’s easier to work with. “What we’ve done is we’ve changed the solvent so that one, it’s less dense than water, so the organic phase is much easier to collect,” he says.

Hamel says the procedure time has also been improved substantially: an assay that previously required a few hours’ work can now be completed in less than an hour.

The technology has already been tested in Finland on 500 samples taken from normal individuals whose diets, lifestyles and exercise regimes are being monitored, Hamel says.

Basta says Neureka is now collaborating on a second study with the New York University School of Medicine (New York, NY).

Improved Understanding
West Nile virus research is another key project at Neureka, Basta says. William Procunier, PhD is conducting an intense study on the vector transmission dynamics of the virus in northeastern Ontario.

“The epidemiology of the disease is apparently atypical, at least in terms of clinical incidence, in that nobody’s reported a case up here even though some people may have actually been bitten,” says Procunier, director of the Biotechnology Division. The virus has been found in both birds and mosquitoes, he adds, and there are potentially six vector mosquito species currently in northeastern Ontario.

Procunier says his group has done some preliminary work and is planning to use PCR technology being tested by his colleagues at Auburn University (Auburn, AL) and the University of Alabama at Birmingham (Birmingham, AL) to identify blood meals to help determine which host the mosquitoes are preferentially biting. This would allow researchers to follow a trail of the West Nile virus from mosquitoes identified as carriers, he explains.

Such work would contribute to improved understanding of disease epidemiology, Procunier says, and to the development of control strategies.

Procunier’s second project, in collaboration with the Auburn group, is looking at the antihemostatic factors produced from northern Ontario blackfly bites.

“It’s an interesting model because you’re essentially looking at, in one sense, a wound, and in another sense, a site for injection,” Procunier says. “When we give someone a needle, of course you’re going to be injecting things . . . And in terms of insects that bite, of course they’ve co-evolved in mammalian systems for millions of years and it’s probably a very good system in that way.”

The flies produce antihemostatic factors that are similar to human antihemostatic factors that regulate the process of hemostatis, Procunier says. For instance, anti-thrombins are useful for preventing blood clotting in diseases such as thrombocytopenia. Such factors, therefore, have promising pharmaceutical value.

Paradigm Shifts
While the ideas are there and exciting projects are underway, Neureka faces big challenges, Basta says.

“One of (the challenges) is really to keep educating the public, and as well the people in the political arena and the government and all that, about the benefit of having biotechnology as a new industry to add another dimension in the economic development of the north, in addition to the established industry like mining and forestry,” Basta says

An even stronger challenge, he says, is southern Ontario’s perception of the north as merely the traditional reservoir of resources.

Despite these obstacles, Basta has much enthusiasm. He believes the north is starting to realize that it has opportunities in biotechnology, and that Neureka has been very instrumental in showing that this industry can survive and grow in northern Ontario. He also hopes that the centre can be replicated in many cities around the north, which will increase the profile of biotech across the country. Already, the centre has four satellite branches in northern Ontario.

But Basta emphasizes that the north cannot be developed unless it has a very strong link to the south. Neureka’s satellite office in Oakville, Ont. is helping to maintain the organization’s connections to southern Ontario.

Also aiming to strengthen biotech presence in the north is the Ontario government’s Northern Ontario Biotechnology Initiative (NOBI), part of the Biotechnology Cluster Innovation Program, which will award up to $2.2 million for business plans dealing with biotech infrastructure across Ontario. Under NOBI, Neureka was chosen to lead five regional communities in northern Ontario to help biotechnology become part of the economic agenda in each of those areas.

“Ninety per cent of the geographical area is northern Ontario, and 10 per cent is southern Ontario,” Basta says. “So we have to look at . . . how we can enrich this very huge geographical area with different industries.

“When we established here in northern Ontario, we established on the objective of how we can build a new industry, and how we can really have this become an economic engine in the community,” Basta says.

He believes that biotech up north will build on the core that Neureka has created. “This is the nucleus.”