Biotechnology Focus February 2011

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

FEBRUARY 2011 VOLUME 14, NUMBER 2

VIDO’S NEW INTERVAC FACILITY Ready to join the fight against Infectious Disease

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contents february 2011 – VOLUME 14 – NUMBER 2

Sustainable Chemistry Alliance, forging a new legacy for Sarnia-Lambton

FEATURES

10

Pushing Canadian Infectious Disease Research to New Heights

Opinion

InterVac, Saskatoon’s new $150 million dollar level-3 bio-containment laboratory nears completion.

(By Shawn Lawrence)

16 Sustainable Chemistry

Traditionally a Canadian hub for petrochemicals, the Sarnia-Lambton area has expanded its breadth of research and innovation in the chemical sector into the realm of bio-product development.

(By Shawn Lawrence)

21 Finding an Innovative Way Forward

10

Canada’s new international vaccine centre (InterVac) prepares to opens its doors

DEPARTMENTS

IN EVERY ISSUE

6

Research news

8

Business corner

18 Innovator

BC based Verisante develops non-invasive

tool that allows for the detection of skin

cancer in mere seconds

(By Christopher Rogers)

25 New Products 28 Calendar of events

22 Across Borders

30 The Last Word

6 RESEARCH NEWS

Donnelly Centre researchers hit home run with “Green Monster” technology developed by Dr. Frederick (Fritz) Roth (pictured right) www.bioscienceworld.ca

Life Sciences British Columbia president Don Enns discusses Canada’s economic action plan

and what it means to the industry

(By Don Enns)

Ron Najafi discusses five important steps

for extending the life of the world’s

aresenal of antiobiotics

(By Ron Najafi)

30 THE LAST WORD

(By Carol Reynolds)

FEBRUARY 2011 BIOTECHNOLOGY FOCUS 3

BioTal

PUBLISHER’S NOTE

Funding still a critical issue

in biotech says national survey A new survey by PricewaterhouseCoopers and BIOTECanada shows that life science and biotech companies in Canada are relying on government support more than ever.

But that support, at least in terms of funding, it is increasingly hard to find. This shouldn’t come as a surprise. The industry has been lobbying for better incentives and increased access to funding for years. What has changed are the market conditions which have put many innovative companies at risk of leaving Canada or closing shop all together.

Although the Biotechnology industry in Canada has been telling government exactly what they need to create a thriving industry, specifically incentives and funding; it seems these two conditions are not being met.

The survey shows that the top success factors for the Canadian life sciences industry are: access to capital (from any source); increased Canadian venture capital; and more success stories from existing businesses.

In all, 78 per cent of respondents said that government can help our ailing biotech’s by creating incentives for risk capital, and another 63 per cent of respondents said government can help by implementing more favourable tax incentives. The problem with these results is that they imply that companies that can’t get funding or incentives here will look elsewhere, moving jobs, innovative products and people with them.

Similarly, 38 per cent of respondents said they would consider relocating for better incentives from foreign governments. A staggering figure in itself but when taken in conjunction with the 2009 finding of only two per cent, it is a huge jump.

Though the most effective means of creating change is still up for debate, more than half of respondents said that they still feel that effective lobbying of government is the most important action that the industry can undertake. Likewise, “focusing on success of current business” (48 per cent), and “recruiting experienced senior management” (42 per cent) were also cited as means for creating change.

As far as what the best case scenario would be in the case of a successful life science business in Canada, an overwhelming 90 per cent of respondents believed that being acquired would be in their best interests, with licensing or selling IP and co-development/ partnerships the next best alternatives at 71 per cent and 70 per cent respectively.

What does it all mean? Ostensibly, Canada must find a way to reduce risk for potential investors, either through incentive or funding, or risk losing the jobs and innovations that come along with a thriving life sciences industry. Recent initiatives such as the Action on Innovation on a national level, and OBEST in Ontario, both featured in last month’s Biotechnology Focus, are good examples of industry working together to create a working solution to present to government. We hope to further build on this momentum of exploring the Hot Button issues facing the industry, by asking for your input and taking part in a brief survey. The March issue is dedicated to “Hot Button” issues that you, our readers want to raise awareness and get in front of key levels of government. You can take our survey by visiting www.bioscienceworld.ca/survey2.

PUBLISHER/ EDITOR-IN-CHIEF

STAFF WRITERS

Terri Pavelic Shawn Lawrence

Christopher Rogers

CONTRIBUTING WRITERS

Carol Reynolds

Don Enns

Ron Najafi

Patricia Bush

National Account Manager

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CONTROLLER

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MARKETING MANAGER

Mary Malofy

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EDITORIAL ADVISORY BOARD Najla Guthrie, KGK Synergize; Pierre Bourassa, IRAP, Montréal; Brad Guthrie, Alberta Advanced Education and Technology; Carol Reynolds, Genome Prairie; Ulli Krull, UTM; John Kelly, Erie Innovation and Commercialization; Peter Pekos, Dalton Pharma Services; Brad Thompson, Oncolytics; Darrell Ethell, CanReg; John Hylton, John H. Hylton & Associates; Robert Foldes, Mentis Partners; Colette Rivet, BioTalent; Grant Tipler, RBC; Randal R.Goodfellow, P.Ag., Senior Vice President, Corporate Relations, Ensyn; Bob H. Sotiriadis, LLB,a partner with Leger Robic Richard; Dale Patterson, Genome Canada; Darcy Pawlik, Syngenta Seeds Canada Inc; Gail Garland, OBIO; Barry Gee, LifeSciences British Columbia Biotechnology Focus is published 10 times per year by Promotive Communications Inc. 24-4 Vata Court, Aurora, Ontario L4G 4B6 Phone 905-727-3875 Fax 905-727-4428 www.bioscienceworld.ca E-mail: biotechnology_focus@promotive.net Subscription rate in Canada $35/year; USA $60/year; other countries $100/year. All rights reserved. No part of this publication may be reproduced without written consent. Publications Mail Registration Number: 40052410 Return undeliverable Canadian addresses to: circulation dept – 24-4 Vata Court, Aurora, Ontario L4G 4B6 National Library of Canada ISSN 1486-3138 \ All opinions expressed herein are those of the contributors and do not necessarily reflect the views of the publisher or any person or organization associated with the magazine.

If you would like to order hard copy or electronic reprints of articles, contact Sandra Service 905-727-3875 x221 reprints@promotive.net

4 BIOTECHNOLOGY FOCUS FEBRUARY 2011

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R & D NEWS

Dr. Frederick (Fritz) Roth

Donnelly Centre researchers hit home run with “Green Monster” technology

The Green Monster is the nickname of the thirty-seven foot, three-inch (11.3 m) high left field wall at Fenway Park, home to the Boston Red Sox baseball team. The “Green Monster” is also the name for the leading edge technology developed by Dr. Frederick (Fritz) Roth to precisely delete multiple genes.

Dr. Roth, from Harvard, was jointly recruited to the Donnelly Centre for Cellular and Biomolecular Research (Donnelly Centre) at the University of Toronto and The Samuel Lunenfeld Research Institute (SLRI) this January 2011. Dr. Roth has both experimental and computational interests framed around large scale experiments to understand biological pathways structure and its relationship to phenotype and disease.

How does genotype give rise to phenotype? In other words, how do combinations of genes work together in an organism to give rise to its characteristics?

This is a question that Dr. Roth wants to address in Toronto. With the knowledge that phenotypes that might otherwise reveal a gene’s function can be obscured by genes with overlapping function, Dr. Roth developed the “Green Monster” technology that enables the precise de-

6 BIOTECHNOLOGY FOCUS

FEBRUARY 2011

letion of genes in a cyclical manner. In this method, a population of strains, each carrying a single deletion marked by an inducible green fluorescent protein (GFP) reporter gene is enticed into repeated rounds of mating.

Dr. Corey Nislow, a principal investigator at the Donnelly Centre, describes Dr. Roth as a “pre-eminent collaborator.” Indeed, the work described above was not carried out alone, but was collaboration involving Drs. Corey Nislow and Guri Giaever. The paper describing this collaboration, entitled “Knocking out multi-gene redundancies via cycles of sexual assortment and fluorescence selection”, came out for Advanced Online Publication on the 9th of January, 2011 on the Nature Methods website.

Dr. Roth has also worked with Donnelly researchers Drs. Brenda Andrews and Charles Boone as they systematically study double and triple mutants and with Drs. Corey Nislow and Guri Giaever on identifying drug targets via gene deletion. Dr. Roth decided to look for a method to easily make multi mutants or higher order combinations of mutants to speed up predicting and testing. In a field where some technologies are adopted and some are not, it is apparent that our researchers will be able to hit a few home runs with the “Green Monster” technology in Toronto.

“My team has had wonderful long distance collaborations with at least six research groups at the Donnelly Centre over the past seven years. At some point, it just felt like we should close the distance,” explains Dr. Roth.

Dr. Roth will set up research laboratories in both the Donnelly Centre for Cellular and Biomolecular Research and the SLRI. Dr. Roth is the Canada Excellence Research Chair in Integrative Biology. Roth, along with Drs. Andrews, Boone, Nislow and Giaever, is based at U of T’s Donnelly Centre for Cellular and Bimolecular Research, a unique centre in which 35 investigators from the Faculties of Medicine, Applied Science & Engineering, Pharmacy, and Arts & Science are brought together in an open, think-tank environment.

Clinical Trials & Patents n Lorus Therapeutics Inc. (Toronto, ON) announces the enrollment of the first cancer patient in a Phase 1 clinical study evaluating its small molecule anticancer drug candidate LOR-253. The study plans to enroll approximately 22-37 patients during the dose escalation stage. In addition, up to ten patients will be added at the recommended Phase 2 dose level for assessment of tumour biomarkers related to the anticancer mechanism of LOR-253. Preference will be given to enrolment of patients with colorectal cancer and non-small cell lung cancer in this expanded treatment group, based on the strong anticancer efficacy of LOR-253 against these cancer types in preclinical studies. The open-label, dose escalation study will enroll patients with advanced or metastatic solid tumours for which no effective therapy is currently available, or whose cancer has not responded to conventional or standard therapies. The primary objectives of the study are to determine the maximum tolerated dose and recommended Phase 2 dose of LOR-253. Additional study objectives include the safety profile, anti-tumour activity, and pharmacokinetics of LOR-253. n Allon Therapeutics Inc. (Vancouver, BC) has initiated a Phase 2/3 clinical trial to evaluate the company’s lead neuroprotective drug candidate davunetide as a potential treatment for progressive supranuclear palsy (PSP), a rapidly-progressing and fatal degenerative brain disease. On January 4, 2011, the company announced that the study will be conducted under a Special Protocol Assessment (SPA), granted by the United States Food and Drug Administration (FDA).

Enrollment in the study began in the fourth quarter of 2010. Bruce Morimoto, Allon’s vice president of Drug Development, said this trial is a critical step forward in executing the company’s approval strategy for davunetide.

The Phase 2/3 double-blinded, placebo controlled trial in PSP will enroll approximately 300 patients randomized 1:1 to receive either placebo or 30 mg of davunetide twice a day for 12 months. The primary outcome measures will be the Progressive Supranuclear Palsy Rating Scale (PSPRS) and the Schwab and England Activities of Daily Living (SEADL) scale. Secondary measures will include Clinical Global Impression (CGI) and brain imaging by magnetic resonance tomography (MRI).

Additional exploratory endpoints include cognitive and executive function as well as cerebrospinal fluid (CSF) biomarkers.

R & D NEWS Breakthrough treatment for blocked arteries Patients who have run out of treatment options for a common heart condition have found new reason for hope in the world’s first trial of a plaque-softening enzyme.

Dr. Bradley Strauss, chief of Sunnybrook’s Schulich Heart Centre and Reichmann chair of Cardiovascular Sciences is conducting the world’s first clinical trial of a groundbreaking treatment for patients with coronary arteries that are completely blocked by plaque.

The promising new therapy is the first biological solution ever developed to treat chronic total occlusions (CTOs). It involves injecting the enzyme collagenase into a blocked artery to soften the plaque so a cardiologist can perform traditional angioplasty by sliding a small guide-wire through the otherwise impenetrable blockage and inserting a stent to re-open the artery and restore blood flow.

About 25 to 30 per cent of people tested with an angiogram at the Schulich Heart Centre are found to have at least one total blockage. Although not all patients with CTOs need to have angioplasty to open up the blocked artery, those who experience common symptoms like chest pain and difficulty breathing can benefit greatly from it.

In fact, successful angioplasty can relieve their symptoms and significantly improve

their quality of life almost immediately.

“Although many patients with this condition experience painful symptoms that would be relieved with angioplasty, the blockages are like cement and it is often impossible to get a guide-wire through them,” says Dr. Strauss, who is also a professor at the University of Toronto.

Until now, efforts to treat patients with CTOs have been focused on designing stronger, more deliberate guide-wires to forge through the blockage. The success rate of this method is currently around 50 per cent, compared to 95 per cent for arteries that are only partially blocked.

“Unfortunately, the low success rate of traditional angioplasty in patients with CTOs has meant that many are not candidates for the procedure and either have to be treated with medication alone, undergo bypass surgery or live with the pain,” says Strauss.

But this new approach to treatment could change that. Together with his team of clinician-scientists at Sunnybrook’s Schulich Heart Centre, Dr. Strauss is conducting a phase one, first-in-human clinical trial to test the safety and effectiveness of this new treatment. With a careful eye on adverse effects, the procedure has been preformed on four groups of patients - using increasing amounts of collagenase in each group. At each dose, results have been reviewed by an independent data safety monitoring board.

Participants were selected from a group of Sunnybrook patients who have undergone at least one failed angioplasty attempt. Results of the trial will be used to determine the best dose for a large-scale clinical trial.

The clinical trial is funded by the Canadian Institutes of Health Research (CIHR).

New centres of excellence share $61M in funding Five new Centres of Excellence for Commercialization and Research (CECR) have been established and are sharing a total of $61.1 million in funding from the federal government over the next five years.

The new centres are the MiQro Innovation Collaborative Centre (Bromont, Quebec), the Centre for Commercializa-

tion of Regenerative Medicine (Toronto, Ontario), the Centre for Imaging Technology Commercialization and Research (London, Ontario), Leading Operational Observations and Knowledge for the North (St. John’s, Newfoundland and Labrador) and the Wavefront Wireless Commercialization Centre (Vancouver, British Columbia).

Amorfix Alzheimer’s test detects aggregated beta amyloid in spinal fluid Amorfix Life Sciences, a product development company focused on diagnostics and therapeutics for misfolded protein diseases, announces preliminary results indicating that their human Alzheimer’s disease (AD) diagnostic assay can detect a signal from aggregated beta amyloid in the spinal fluid (CSF) from AD patients.

“These results represent a significant first step towards our goal of developing and commercializing an assay that will accurately identify patients with AD, a disease that currently affects more than five million people in North America, a number that is expected to grow dramatically as the population ages,” said Dr. Robert Gundel, Amorfix president and chief executive officer. “While there is still work to do, this represents an important milestone towards the development of a valuable asset for our company. A new diagnostic tool could enable the early detection and subsequent treatment of AD, while being a major adjunct to clinical research in the field.”

Alzheimer’s disease is a chronic neurodegenerative illness characterized in part by memory loss, confusion, disorientation, and mood changes. Currently, the only definitive diagnostic for AD is post-mortem examination of brain tissue to detect neurofibrillary tangles and deposits of aggregated misfolded beta amyloid in plaques in and around neural tissue. “The benefit of the Amorfix assay is the ability to detect a signal in CSF, which reflects the presence of aggregated beta amyloid in the brain,” said Dr. Louise Scrocchi, Associate director of Research and Development. This is an important first step in the development of a test to screen and monitor patients undergoing experimental therapies to reduce amyloid load.”

FEBRUARY 2011 BIOTECHNOLOGY FOCUS 7

BUSINESS CORNER New vice president of Corporate and Business Development for Ag-West Bio sector will be an asset to Ag-West. The networks he has already established in this province will serve him well in his new position.”

Cey has an extensive background in agriculture and the ag-biotech sector. While earning a B.Sc in Agriculture at the University of Saskatchewan, he worked for Dow, Agriculture Canada and Monsanto in various research capacities. Upon graduation he began his career with Cowan Fuel and Fertilizers out of Regina as a retail agronomist, and then with the Saskatchewan Wheat Pool as a senior commodity merchandiser, sourcing and trading special crops and helping design and implement a new grain handling system. He helped AgPro Grain establish their business in Alberta, and also worked with the Canadian Wheat Board as a Farm Business Representative. Most recently, Cey served as the director of Marketing in the Crop Supplies Department at Federated Co-operatives Ltd. in Saskatoon.

Mike Cey

Ag-West Bio announces that Mike Cey has been appointed VP of Corporate and Business Development. Cey assumed his responsibilities on January 17, 2011.

Wilf Keller, president and CEO of Ag-West Bio, says it is important for Ag-West to re-establish the position of Vice President. “The VP of Ag-West has a key role in keeping the industry moving ahead. The VP serves as government liaison, keeping provincial and federal governments up-to-date on regulatory and trade issues; he works with industry, research institutions, associations, and government agencies to identify and lead key strategic initiatives and execute collaborative projects to strengthen Saskatchewan’s ag-bioeconomy, and he provides strategic guidance in Ag-West Bio’s commercialization activities.”

Keller says the organization is confident in its selection of Cey for the VP position.

“Mike’s business skills combined with his understanding of the province’s ag-biotech

Dealmakers n Miraculins Inc. (Winnipeg, MB) preeclampsia program is being advanced in partnership with Alere, Inc., (Waltham, MA) one of the world’s largest diagnostic companies, with the goal of commercializing Miraculins’ preeclampsia biomarkers for worldwide distribution. Under the collaborative research and option agreement between the parties, Alere is responsible for developing immunoassays for Miraculins’ protein biomarkers and evaluating their performance in Alere’s global cohort of maternal patient blood samples. Importantly, Alere has now successfully completed the cloning and expression stage of development for a number of markers under the agreement, and in so doing has met and exceeded critical milestones under the development plan. n Healthscreen Solutions Inc. (Duluth, GA) announces its first pharmaceutical partnership with Sanofi-aventis Canada Inc. (Laval, QC), a pharmaceutical/biotech company focusing on research and development as well as cardiology, thrombosis, oncology, metabolic disorders, central nervous system, internal medicine and vaccines. The partnership will assist Healthscreen in expanding its Chronic Condition Management offering while providing sanofi-

8 BIOTECHNOLOGY FOCUS FEBRUARY 2011

aventis with a range of important clinical measurements to assist in research activities. n Theratechnologies

(Montréal, QC) announces that a distribution and licensing agreement was signed with Sanofi-aventis (Laval, QC) for the commercialization rights to EGRIFTATM (tesamorelin for injection) in Latin America, Africa and the Middle East for the treatment of excess abdominal fat in HIVinfected patients with lipodystrophy. Under the terms of the Agreement, Theratechnologies will be responsible to supply EGRIFTATM to Sanofi. Sanofi will buy EGRIFTATM from Theratechnologies at an undisclosed selling price.

Theratechnologies has kept all future development rights to EGRIFTATM and will be responsible for conducting research and development for any additional programs. Sanofi will be responsible to conduct all regulatory activities in the aforementioned territories in connection with EGRIFTATM for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, including seeking the approval of EGRIFTATM in the different countries. Theratechnologies granted Sanofi an option to commercialize EGRIFTATM in the aforementioned countries for other uses.

n Agrium

Inc. (Calgary, AB) has successfully completed its acquisition of AWB Limited at a price of (AUS) $1.50 per share in cash (purchase price of (AUS) $1.236-billion) as agreed to in the scheme of arrangement, including the (AUS) $0.15 per share franked dividend paid on November 30, 2010. “We are excited about the opportunity to merge AWB’s strong market presence and extensive experience with Agrium’s international crop input sourcing capabilities, with a view to further enhancing product and service offerings to Australian and New Zealand customers,” said Mike Wilson, Agrium CEO and president.

n Paladin

Labs Inc. has closed its previously announced agreement with ProStrakan Group plc. whereby Paladin will be granted an exclusive license to ProStrakan’s products for certain emerging territories and will acquire, by way of assignment, ProStrakan’s existing secured debt facility of GBP 50 million (CDN $77.23 million) with the addition of certain conversion rights. Moreover, Jonathan Ross Goodman, president and CEO of Paladin, joins the board of directors of ProStrakan effective immediately.

BUSINESS CORNER Angiotech Pharmaceuticals delisted from NASDAQ Trading of shares of Angiotech Pharmaceuticals, Inc. common stock has been transferred from the Nasdaq Stock Market to the OTCQB™ Marketplace effective January 13, 2011.

As announced by the company on January 5, 2011, Angiotech received a notice from Nasdaq stating Angiotech has not regained compliance with Nasdaq’s Listing Rule 5450(a)(1) within the 180 calendar day grace period ending January 3, 2011.

Angiotech has been advised by Pink OTC Markets, Inc., which operates an electronic

quotation service for securities traded over-the-counter, that its securities are immediately eligible for quotation on the OTCQB. The OTCQB is a market tier for OTCtraded companies that are registered and reporting with the Securities and Exchange Commission. The company has also been advised that its shares will trade under the symbol ANPI. Investors will be able to view real-time stock quotes for ANPI at www.otcmarkets. com. Angiotech’s common shares will still be tradable on the Toronto Stock Exchange under the trading symbol “ANP”.

Mike Cey

Bioniche completes Australian offer, raising $12.5 Million Canadian biopharmaceutical company Bioniche Life Sciences Inc. has successfully completed its Australian Offer of 8.6 million CHESS Depositary Instruments (CDIs) at A$1.45 per CDI, raising gross proceeds of A$12.5 million.

This is in addition to the (Cdn) $16.7 million raised through a concurrent Canadian Offer of 11.5 million common shares at $1.45 per share that closed on December 16, 2010. Total proceeds from the two offers are approximately $29.4 million, based on a January 3, 2011 exchange rate of $1.021 per (AUS) $.

It is expected that the company, subject to the approval of the Australian Securities Exchange (ASX), will be admitted to the Of-

ficial List of the ASX, and that the CDIs that were the subject of the Australian offer will commence trading on the ASX. The company’s code on the ASX will be “BNC”.

Upon completion of the Australian Offer, Bioniche will have 100.3 million common shares issued and outstanding, of which 8.6 million will be represented by an equal number of CDIs to allow Australian shareholders to trade their shareholding through the Australian CHESS system.

“We are pleased with the outcome of these financings and we welcome the many new investors who have joined us in both jurisdictions,” said Graeme McRae, chairman, president and CEO of Bioniche Life Sciences Inc adding that the funds raised

in the offers will be used to: expand the company’s current manufacturing capacity for Urocidin™ to meet expected global demand; pursue new human oncology applications using the company’s MCC platform through Phase I clinical testing; undertake a U.S.-based field trial of Econiche™ in support of a full license application in the U.S., followed by license applications in Australia, Europe and Latin America; complete the development of a second food safety vaccine for Salmonella; complete the development and registration of internallygenerated product opportunities in animal health and acquire the rights to certain externally-developed products/technologies in animal health.

Great People.

Great Chemistry.

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FEBRUARY 2011 BIOTECHNOLOGY FOCUS 9

By: Shawn Lawrence

Infectious Disease

Pushing Canadian

Infectious disease

research to new heights

C

onstruction of the new International Vaccine Centre (InterVac), the newest facility of the Vaccine and Infectious Disease Organization, on the campus of the University of Saskatchewan is nearing completion. Scheduled to open later this month, the facility will be among the largest of its kind in the world, and by far the largest infrastructure investment in vaccines ever made by Canada. Since shovels first broke ground in November of 2007, building the facility has been a demanding task affected by rising regional construction costs and other challenges. The benefits that this $140 million dollar containment level 3 facility will bring to vaccine research in Canada, however, are immeasurable. For starters, it is expected to dramatically improve the ability of researchers to safely work with new or emerging diseases. That alone makes its existence worth its weight in gold says Dr. Andrew Potter, CEO and director of VIDO-InterVac. Construction of InterVac prompted a name change to VIDO-InterVac, reflecting the expansion of capabilities that includes containment level 3 research. Potter describes VIDO-InterVac as a triumph of partnerships for both the province of Saskatchewan and Canada, as they work together to strengthen science in the country.

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Infectious Disease “If you look at the vaccine field internationally, Canada actually has punched well above our weight in research and development.

What this facility is going to do is allow us to keep going and advance our international reputation in the vaccine field, hopefully advancing additional manufacturing capabilities in Canada as well.

InterVac is an important piece of a large and important puzzle.

– Dr. Andrew Potter

“The Government of Canada, Canada Foundation for Innovation, the Government of Saskatchewan, the City of Saskatoon and the University of Saskatchewan all played a role in making the idea behind this facility a reality and they recognize the importance of the science generated within a facility like InterVac. In my view, the investment support made by the province is unparalleled. Saskatchewan is a province of only a million plus people, yet the government here understand that InterVac is needed to protect livelihoods and human health.”

The benefit InterVac will bring to Canada and Canadians in general should not be overlooked, Potter adds.

“If you look at the vaccine field internationally, Canada actually has punched well above our weight in research and development. What this facility is going to do is allow us to keep going and advance our international reputation in the vaccine field, hopefully advancing additional manufacturing capabilities in Canada as well. InterVac is an important piece of a large and important puzzle. When you combine InterVac with everything else that is here, including the people and translational pathways in place, it’s going to be a valuable contributor on the global scale,” states Potter.

According to Dr. Potter, InterVac will attract scientists from around the world to work on a wide range of disease causing pathogens that are emerging and spreading swiftly as a result of climate change and globalization. InterVac is designed for these types of level 3 organisms; or organisms that can be transmitted through the air and can cause serious or life threatening diseases.

“Biohazards are categorized into four levels. So the facility itself must be able to contain those particular

12 BIOTECHNOLOGY FOCUS FEBRUARY 2011

agents without any danger of escape. I think you can picture or imagine how difficult it is to seal a traditional laboratory off from the outside world. It’s not impossible to do, but it’s very expensive to do, and that’s where InterVac fits in the scheme,” he explains.

While currently there are about 90 level 3 (CL3) facilities in Canada, the majority are small labs associated with universities, not capable of supporting experiments involving multiple pathogens and multiple investigators. Some examples of CL3 diseases that can be examined at InterVac are tuberculosis; swine and avian influenza; HIV/AIDS; BSE or mad cow disease; chronic wasting disease; SARS; hepatitis C; West Nile virus and rabies.

Another key function of InterVac is that it can serve as training facility, providing a stimulating learning environment for undergraduates, postgraduates of the University of Saskatchewan and other universities around the world. It is one of the few facilities of this kind in the country that actually has a training mandate.

“InterVac adds new capabilities to the Vaccine and Infectious Disease Organization, a research organization of the University of Saskatchewan , and has an educational mandate associated with it. Students and scientists from any province across Canada as well as other countries are more than welcome to come in here to learn about level 3 research,” he says.

The training environment will translate into more Canadians becoming qualified to work in containment level 3 environments anywhere in the world.

When taking all this into consideration, there is no denying InterVac is a tremendous addition to the flourishing research cluster of life sciences R&D already in place at the U of S. InterVac will be open to both public and private research partnerships because as the name implies, the facility will have an international mandate. VIDO (Vaccine and Infectious Disease Organization) already houses researchers from more than 20 countries, and InterVac will expand this further.

Dr. Potter has worked at the VIDO for the past 25 years, initially as a research scientist, and then Associate Director Research. With his current role as director and CEO expanded to include the management of InterVac, Potter believes the decision to build the facility in Saskatoon and connect it with VIDO was both strategic and the right choice.

“I think it’s a logical location given the framework of the university and VIDO. We’ve got one of the few veterinary colleges across Canada; we’ve got the university faculties required for multidisciplinary research in the infectious disease field, and we’ve got VIDO’s track record of translational research and collaboration with public and private research organizations around the world.”

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The successful Italian testimonials participating at BioPartnering 2011 are: A. Menarini IFR www.menarini.it C. Musso: cmusso@menarini.it Areta International www.aretaint.com L. Cavenaghi: lcavenaghi@aretaint.com Assobiotec Industry Association: www.assobiotec.it L. Vingiani: assobiotec@federchimica.it Bracco Imagining spa www.braccoimaging.com D. Fujii: dennis.fujii@bru.bracco.com CROM Group www.cromgroup.com M. Mosconi: margherita.mosconi@cromgroup.com Menarini Biotech srl www.menarini-biotech.com C. Panzarella: cpanzarella@menarini-biotech.it Pharma & Biotech Advisors P. Barbanti: barbanti@pharmaebiotech.com Proge Farm srl www.progefarm.it E. Tosi: etosi@progefarm.it Proge Medica srl G. Dondi: progemedica@libero.it Recordati Industria Chimica e Farmaceutica spa www.recordati.it.

P. Ferlenga: ferlenga.p@recordati.it Italian Trade Commission Trade Promotion Section of the Consulate Generale of Italy 180, Dundas Street West Suite 2002, P.O. BOX N째2 M5G 1Z8 Toronto, Ontario, Canada toronto@ice.it Tel: +1 416 598 1566 Fax: +1 416 598 1610

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Infectious Disease

“It goes without saying that InterVac also strengthens the VIDO brand. InterVac offers a unique combination of capabilities that will propels VIDO to the foreground on the international infectious disease research scene.

Quick to give credit where it is due, Potter points to the man who came up with idea for InterVac and a proactive approach to managing infectious diseases.”

“It was Dr. Lorne Babiuk who ten years ago had the vision for a facility like InterVac, well before Canada encountered the SARS and the BSE crises, or even the H1N1 pandemic that hit the country last year. Those situations demonstrated that building a Level 3 biocontainment facility was necessary. SARS prompted an initiative called SARS accelerated vaccine initiative or SAV, formed nationwide to figure out new ways of developing vaccines quickly. When it came to actually testing the vaccines, they found there was a critical shortage of appropriate facilities across the country. It was almost as if Dr. Babiuk had a crystal ball and could see what the future was going to be and it is because of him the idea of InterVac came to fruition. When you look back at the more recent situation involving H1N1, you’ll note all levels of government were developing policy that was not necessarily based on evidence. InterVac will provide the infrastructure and capacity needed do the research studies that will guide policy and address future outbreaks in a very proactive fashion,” comments Dr. Potter.

Moreover infections transmitted from animals to humans account for a significant proportion of new and re-emerging diseases. These types of diseases can only be studied in a laboratory both big enough and able to contain the pathogens.

One such disease is chronic wasting disease (CWD), a progressive, fatal and incurable prion disease which has spread significantly within deer and elk populations in Canada and the United States.

Further transmission within captive and wild herds, and to other species such as moose and caribou, would have serious economic impacts on alternative livestock, game farm and hunting industries, and on the diets of many Canadians, particularly in Northern and aboriginal communities, emphasizing the potential social impact CWD may have.

“Right now CWD is not a huge issue, but the potential of it to become one is huge. No one has ever shown that it can cause disease in humans but again do we wait until we have a human case. InterVac’s containment level 3 facilities will enable further work on a vaccine against CWD and related diseases of humans and animals,” said Potter.

Constructing InterVac Associate Director, Operations and Maintenance for VIDO-InterVac Cam Ewart has “lived in and breathed” the building right from its initial planning stages right through to completion and like Dr. Potter, he sees the great potential of having InterVac associated with VIDO. “It goes without saying that InterVac also strengthens the VIDO brand. InterVac offers a unique combination of capabilities that will propels VIDO to the foreground on the international infectious disease research scene. It creates opportunity, it creates ca14 BIOTECHNOLOGY FOCUS FEBRUARY 2011

pacity for research and we’ve always said right from day one, one of our mantras is that science drives everything,” he said.

As one of the individuals who oversaw construction of the facility every step of the way, Ewart explains that it was important to incorporate flexibility and adaptability into the buildings design right from the get go.

“This particular brand of science, of virology and immunology is very fluid. It changes yearly if not monthly as new and emerging diseases come around.

There are different techniques, procedures and research activities that people want to do to make sure that they’re focusing on that particular disease and illness and it’s not something that is a definable activity or definable niche. As such this is a unique building, not just because of the nature of the building but also its flexibility and complexity,” said Ewart.

To build the building one of the very best high containment architects in the world was hired: Smith Carter.

“With offices in Atlanta, GA and Winnipeg, Smith Carter has developed a very strong reputation in constructing bio-containment facilities. They’re kind of the crème of the crème of the high-containment architects and their client list includes the highest profile institutions and organizations within the industry. They’ve worked for the Centre for Disease Control (CDC) and the National Institute for Health (NIH). Their involvement was paramount for our design activities and they took us back to square one, talking about the kinds of science we wanted to do in the building, the flexibilities we wanted to build into it and developed a strong plan for the facility,” he said.

Ewart explains that because bio-containment facilities are evolving, there’s always a need to work towards implementing newer technologies and newer features. So equipping InterVac with all the newest bells and whistles was a priority.

Infectious Disease “There are certain features at InterVac that are unlike any other facility. There are 18 isolation rooms for animal housing, and each room is capable of housing multiple species of animals like cattle, pigs, birds, mice and even horses. There are six additional level 3 labs at the facility. As with any bio-containment facility, safety and containment are paramount, especially regarding potential exposure to infectious agents. The important thing to remember is that a bio-containment facility’s primary function is in fact containment, under all conditions. As part of this, air pressure resistant doors are located at all key laboratory entrance points, all exhaust air must pass through two HEPA (high efficiency particulate air) filters and no air is re-circulated.”

According to Ewart, these filters remove a minimum of 99.97 per cent of airborne particles that are 0.3 micrometers in diameter.

“The building also has back-up systems for every critical building function and system, and all air handlers are built with extra capacity so if one of them fails, another one will kick in and pick-up the slack,” he said.

Ewart adds that these HEPA filters are not only unique in nature but also undergo rigorous checks or scans to ensure they are doing their job properly.

“Historically, monitoring these types of filters has been a manual task but like most of things found in this building, our HEPA filters are technologically advanced. They have a robotic feature that is both more accurate and allows users to benchmark filter performance from year to year.”

As Ewart explains, inclusion of this kind of technology is a statement of the advancing science of biocontainment design that InterVac is fortunate enough to have incorporated in its design. In terms of fail safes and backup systems, the building has three very large emergency generators that power everything in the building.

With all its bells and whistles, there is little risk of pathogens escaping the facility. In fact InterVac has been constructed to exceed current containment level 3 regulations.

The Next Steps What lies ahead for the facility says Ewart, is a pretty intensive commissioning phase that starts in March and will run for an estimated four months if all goes well. After commissioning is done, InterVac will be ready for the certification process when the federal regulatory bodies will do their inspections testing to make sure all the safety mechanisms are in place, and all the requirements are met. Essentially they will be challenging the building. When commissioning and certification are done, the building will be ready for the purpose it was built.

“We’re not out of the woods yet, but there’s definitely a light at the end of the tunnel now,” says Ewart.

“We’re all excited about this and looking forward to having the doors open, and really showing to the people who have backed this project that it was worth the investment,” adds Potter.

While there are concerns about the high cost of the facility and the delays that have gotten in its way, both Ewart and Potter believe that despite it all the facility will pay for itself.

“It’s not so much about recouping the money, but rather an investment into what it’s going to produce.

Obviously when you have high end scientific facilities of this type, there will be an economic spin-off in the types of jobs that will be created. You’ll also have agreements coming from the discoveries and royalties for the intellectual property that it creates. There are economic benefits to that but when you get a facility of this magnitude combined with facilities like our Canadian Light Source, another major science initiative on our campus, you intensify the collaboration and scientific research which is important for the university, the city, and the province. This amplifies our attractiveness to all potential international research partners,” says Ewart.

For Dr Potter, the cost to construct InterVac is minimal when compared to the effects of an infectious disease outbreak.

“The cost of SARS globally was $100 billion. The Walkerton outbreak cost was $150 million for the province of Ontario. Infectious diseases have a phenomenal cost, whether it’s a direct or indirect social cost. The smallpox vaccine paid for itself within the first year of immunizations being given and that’s a single vaccine. There is no question that this facility will pay for itself. The cost of this facility is substantial, but if you look at the impact of disease from a cost stand-point, it’s absolutely worth it,” says Potter.

“We’re all excited about this and looking forward to having the doors open, and really showing to the people who have backed this project that it was worth the investment.”

For more Infectious Disease information visit our Drug Discovery Web Portal at www.bioscienceworld.ca FEBRUARY 2011 BIOTECHNOLOGY FOCUS 15

By: Shawn Lawrence

Spotlight

Sustainable Chemistry Alliance,

forging a new legacy for Sarnia-Lambton In the heart of Canada’s chemical valley, there is an exciting movement afoot.

Traditionally a Canadian hub for petrochemicals and refined petroleum products, the Sarnia-Lambton area has expanded its breadth of research and innovation in the chemical sector into the realm of bio-product development. Much of this growth and movement towards bio-based products has been industry lead, but other parties including academia and government are also taking part in this new industry renaissance.

At the forefront of this emerging commitment to the bio-product sector is the Sustainable Chemistry Alliance (SCA), an organization supported through funding and headquartered at the new Bioindustrial Innovation Centre (BIC) at the Sarnia-Lambton Campus of the University of Western Ontario Research Park. The SCA evolved from the former Ontario Chemistry Value Chain Initiative, which had been implementing a strategy designed to bridge the gap between biochemistry and synthetic chemistry. The SCA focuses on the development of solutions to the impacts of climate change, peak oil, energy security, the need for safe water, and the use of scarce natural resources.

Founding president and CEO, Dr. Murray McLaughlin explains that the SCA focuses on commercialization aspects of green and sustainable technologies.

“We get involved in doing investments in start-up companies, helping to build cluster programs and whatever else to promote the sector.”

According to McLaughlin, the SCA has $5 million that it uses towards investing in companies focusing on bio-chemical production, the green and sustainable sector, as well the development of new ways to combine of petrochemicals and bio-chemicals that are moving through pilot and demonstration scale.

“These are companies that are going into a small facility or going beyond a lab bench, maybe from producing a few kilograms to a few hundred kilograms, and then transitioning into a more demonstrational scale,” he said.

Drawing on the area’s strength as the country’s largest cluster of chemical, plastics, allied manufacturing, petrochemical and research and development facilities, Sarnia-Lambton’s 16 BIOTECHNOLOGY FOCUS FEBRUARY 2011

pre-existing infrastructure has given it an edge in establishing itself as a centre for biotechnology research and a logical location for establishing the Bioindustrial Innovation Center and the Sustainable Chemistry Alliance.

“Sarnia is a community on the edge of change, in an industry sector that is just realizing change is around it. The petrochemical industry is shifting to a hybrid chemical industry. Hybrid chemicals are a combination of green chemistry (bio-based) and petrochemicals with the ability to provide consumers with a broad choice of cleaner products. The facilities to make this change happen are already present in Sarnia, but the benefit is that we’ve got a community in Sarnia between the county and the city itself, and the industry base (the petro-chemical industry), that are all highly supportive of this initiative and they see the benefits of having Sarnia build off these strengths and build the bio-based and hybrid chemical based industry to supplement that,” said McLaughlin.

In addition to his role with the SCA, Dr. McLaughlin also heads up Canada’s Bioindustrial Innovation Centre (BIC), which is as mentioned the Hub or home of the SCA. The campus facility has significant research and pilot capabilities for companies that are ready to move into pilot scale, and looking for space.

Funding for the BIC includes $15 million in funding from the federal Centres of Excellence for Commercialization and Research and $10 million in capital funding from the Ontario Ministry of Research & Innovation.

“The BIC is equipped with all the various things that companies need to ‘plug and play’ into whether its steam, heat, CO2 or whatever they need to give them the ability to do pilot scale production.”

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The Research Park, formerly Dow Chemical Canadian headquarters, includes four buildings with office space and call centres, and is managed by the University Western Ontario Research Parks. The BIC manages an incubator facility within the Sarnia-Lambton Park, that recently went through a massive renovation prior to its opening in October.

The centre is expected to attract start-up companies needing pilot facility space and bio-industrial plants needing land to SarniaLambton and create hundreds of jobs. At the same time, it will facilitate the commercialization of large-scale industrial biotechnology concepts to create a significant cluster around hybrid chemistry in Sarnia in partnership with the existing chemical industry.

“That’s what we’re hoping is that companies that come into the pilot space, will see Sarnia as a choice for their next expansion.

We really want to build a cluster around this whole bio-based area-chemicals, biofuels and bio-mass production,” he said while further elaborating on how it all ties together and the role of the Sustainable Chemistry Alliance (SCA) in conjunction with the BIC. “These two organizations have separate mandates, but are linked in their focus on green and sustainable innovations. It’s more that the BIC takes care of the incubator facility and filling it while the SCA takes care of the investments in start up companies.”

In terms of the latter, the types of companies SCA invests in are not just provincial but national in scope.

“The companies can be located anywhere in Canada, most are in Ontario, but we have some outside of the province as well.”

Thus far, the SCA has been very successful says McLaughlin.

“We’ve got seven investments completed and a total of nine projects already approved by the board. I think right now we’re really on track to start seeing some good things begin to happen, with the BIC facilities now fully renovated , we’re just starting to put together our promotional materials to market that program and start building occupancy.

The SCA is also getting close to full investment, and it’s only taken a little over a year to reach that point. A Canadian cluster is forming in Sarnia.”

FEBRUARY 2011 BIOTECHNOLOGY FOCUS 17

By: Christopher Rogers

INNOVATOR

Detecting innovation: Verisante and the path to its ingenious cancer diagnostic tool

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In case you haven’t heard, Verisante Technology, Inc., is a BC-based life science company that has entered into an exclusive licensing agreement with the BC Cancer Agency for rights to a non-invasive tool that allows for the detection of skin cancer in two seconds. It’s also easy enough for a physician’s assistant or a nurse to use to quickly and efficiently scan every mole on a patient’s body and then, have a doctor review the results to make better biopsy decisions.

18 BIOTECHNOLOGY FOCUS FEBRUARY 2011

Dr. Haishan Zeng

The tool, known as the Verisante Aura™ uses a multimodality imaging and spectroscopy system originally invented at the BC Cancer Agency.

Dr. Haishan Zeng, PhD, one of the coinventors, is a senior scientist at the BC Cancer Agency’s Research Centre and associate professor of dermatology and skin science at the University of British Columbia. He said that the device has been in development for approximately 10 years.

“We targeted a powerful analytical method called Raman spectroscopy,” he said. “Raman spectroscopy uses a laser to probe molecular vibrations and gives very specific, fingerprint-like spectral patterns for tissue biochemical composition identification.”

However, the technology was not ready to be leveraged on a commercially viable scale; it wasn’t practical for clinical applications. The team had to make a number of breakthroughs to make it practical, and they did. Zeng said they sped up the data acquisition time from minutes to seconds, developed a compact Raman probe for non-invasive measurement and created a real-time data processing algorithm.

The technology works by measuring biochemical changes in tissues and cells using inelastic light scattering.

“Near-infrared laser light is used to illuminate the skin. Proprietary optics and sensitive light detectors are employed to analyze the back-scattered light. The light scattering patterns are determined by the biochemical compositions,” Zeng said.

This allows for the measurements to be taken in a non-invasive way and the results are displayed on a monitor in real-time.

Zeng said that the technology uses an algorithm to analyze the acquired biochemical information instantaneously and indicate to the physician the probability that a lesion is likely to be cancer. “The probability number is based on the acquired biochemical information, which when combined with a physician’s clinical experiences, improves diagnosis.”

In 2006, Thomas Braun, founded Verisante Technology, Inc. (then T-Ray Science, Inc.) to collaborate with the University of Waterloo on a cancer imaging technology, similar to what the company eventually settled into with the BC Cancer Agency. When the company began, it was a collaboration between only three people: Braun, an accountant, and a medical device engineer. Braun, who was previously a business lawyer specialized in representing small high-tech companies, corporate finance transactions, mergers and acquisitions, and technology licensing agreements. He felt that starting his own medical device company was a natural evolution for his career.

Braun and his colleagues began by raising money from friends and family and then moved on to accredited investors and business associates.

“It’s not easy to start a company - it’s hard and there are plenty of challenges to overcome but we’ve been finding that when people find out about this technology they realize that it’s something they can relate to because of their personal experience; we’re very excited about it,” he said.

In late 2009 the company went public, and shortly after, in March 2010, began negotiating their current licensing agreement with the BC Cancer Agency.

Braun, CEO of Verisante Technology, Inc., felt that the imaging technology available to be licensed by the BC Cancer Agency, was more advanced than Verisante’s because it was backed by a six year clinical study of approximately 1,000 lesions conducted at the Skin Care Centre at the Vancouver General Hospital. The principal investigator of the study was Dr. Harvey Lui, head of the Department of Dermatology and Skin Science at the University of British Columbia and one of the leading skin cancer experts in the world. The

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INNOVATOR study’s published preliminary results have shown that out of the 274 skin lesions that were flagged for biopsy, the Verisante Aura identified all 34 cases of melanoma.

Through the licensing agreement, Verisante also gained access to the people who work in the laboratories of the BC Cancer Agency like Dr. Zeng. Braun noted that Zeng’s unique background in biophysics makes him invaluable because of his dual expertise in biology and physics.

Zeng discussed the steps involved in developing the Verisante technology. First, the research in biomedical optics was needed, second, the clinical needs had to be understood, and finally, a solution (in the form of the Verisante Aura™) was formulated. Then, patent applications were filed, a prototype developed, clinical tests were conducted, and finally, results were published. Zeng said the inventor group was assisted in the entire licensing process by the BC Cancer Agency Technology Development Office in finding a commercial partner and entering a licensing agreement.

Verisante is currently listed on the TSX Venture Exchange and has a market cap of $10 million. However, as Braun said, the potential for the company, based on comparable companies in the market is much greater. Braun pointed to a number of other development-stage medical imaging companies that are now achieving market caps of up to $100 million.

“Essentially, once we get our approvals and we start selling, it’s possible that the market could give us a similar valuation,” Braun said. “But the financial market for medical device companies right now is tough, and the market wants to see companies hitting their milestones, getting approvals and start selling. That’s our business model and that’s our value proposition.”

One of the biggest concerns in the lifescience industry is that it’s very difficult for home-grown technologies to get their innovations implemented within Canada. Luckily, Braun doesn’t foresee this problem.

“I don’t, and I really think we need to judge each company and each product on its own merit,” he said. “…In our case, [the Verisante Aura™] is coming out of a government agency (the BC Cancer Agency)… they’ve decided they need this device in order to save lives, and save money.”

Early detection is always the best way to improve cancer survival rates, and the Aura™ would help to simplify the diagnostic process, improving the time it takes to get life-saving information. Also, the early detection will help save the Canadian health 20 BIOTECHNOLOGY FOCUS FEBRUARY 2011

“Every dermatologist I talk to thinks this is the holy grail of dermatology - every patient I talks to who has had any kind of a brush with cancer wants to get their whole body scanned.”

– Thomas Braun

care system countless dollars. Braun noted the cost difference between treating an early stage tumour and a late stage tumour jumps from a few thousand to over $100,000.

“From a health economic perspective…this is a very attractive proposition,” he said.

The process is very straightforward: 21 biomarkers are scanned in a half second, then if problem lesions are identified, follow-up with a specialist is required for a full biopsy and confirmation with a pathology report.

“With this device I don’t think we’re going to have any problems,” Braun said. “Every dermatologist I talk to thinks this is the holy grail of dermatology - every patient I talk to who has had any kind of a brush with cancer wants to get their whole body scanned.”

Perhaps the most innovative part of the Verisante business plan is that the device can be leveraged for multiple cancer diagnostic tools. A small business like Verisante normally can’t afford to develop multiple products because they just don’t have the resources. But as Braun noted, 95 per cent of the Verisante device is the same, there are simply different probe attachments and algorithms for different internal cancers.

In November, Verisante announced another licensing agreement with the BC Cancer Agency for the early detection of lung cancer. In addition, it now also holds the licenses for all gastrointestinal tract and cervical cancers.

“Essentially, we have a pipeline of technology because you have a device that can be used for all of these different cancers with just a different probe attached and different software,” Braun said.

All that stands in the way are clinical studies for each of the different cancers. The Verisante Core™ device for lung cancer detection currently has a study underway. Braun said the initial results are promising, with 50 patients already having been scanned. The lung cancer studies require fewer patients than the skin cancer trial because there are

fewer variations of lesions to distinguish between. Braun was hopeful the study would conclude within the next 12 to 18 months, but it depends on the flow of patients.

These devices are being developed with leading experts in their fields. The lung cancer study is being headed by Dr. Stephen Lam, MD, FRCPC, professor of medicine at the University of British Columbia, chair of the Lung Tumour Group and leader of the Lung Cancer Prevention Program at the BC Cancer Agency.

All the devices used to detect internal cancers versus external skin lesions use fibre optic light delivery/collection probes. Zeng said these are being developed to reach inside various internal organs such as the bronchial tree (lung cancer) and the gastrointestinal tract.

The importance of the non-invasive biopsy technology should not be understated.

“It is critically important to have an optical biopsy system such as the Verisante Core™ device to help make informed surgical decisions, because endoscopists and surgeons do not want to take unnecessary biopsies of lung tissue. For optimum patient health, benign lesions should be left alone,” said Lam. Work has also started on a study for colon cancer. “We’re quite enthusiastic about these other clinical studies that have already begun…We’re going to have a train of products as each clinical study is finished, hitting the market,” Braun said.

Braun is anticipating that the next studies will be straightforward. The plan, after the colon cancer study, is to follow with cervical cancer. The prioritization for the devices is based on the need. Lung cancer is the biggest killer, followed by colon and cervical.

For more Innovator information visit our Profiles Web Portal at www.bioscienceworld.ca

By Don Enns, President Life Sciences British Columbia

Commercialization

Finding an Innovative

Way Forward T

o say the last couple of years have been challenging is not only an understatement but is also inherently obvious. However, it is also my opinion that it is how we respond to these types of trials that best defines who we are as individuals, organizations, and indeed, even a nation. Although tremendously unsettling, the socio-economic conditions we now face are forcing us as to have a dialogue that we may not have otherwise had, and I hope will also force us to be more innovative than we may have otherwise been. The key issue, at least in my mind, will be how that conversation translates into definitive, concrete and innovative action that will move not only the life sciences industry forward, but strengthen Canada’s overall economic position.

1

The nature of the discussion occurring around the country cannot focus solely on the ‘knowledge’ based economy. The reality is that our resources are a fundamental driver of our economy and in strong demand for the foreseeable future.

In BC, resources account for about three quarters of the economy! The conversation should be about how we can develop new sectors while at the same time instilling knowledge and innovation into every aspect of the economy.

2

Innovation by its very nature enhances productivity which ultimately leads to a sustainable economy. Whether it is capital expenditure per capita, productivity improvements or business expenditures on R&D (BERD), Canada lags the rest of the world. The Federal R&D Review Panel is currently reviewing Canada’s competitiveness in this regard, and it is my hope that they will revise the existing SR&ED program; shift the ratio of indirect to direct support and at least comment on the need for an integrated and comprehensive innovation strategy that will address tax, immigration, trade, intellectual property, etc.

3

Albeit good policy, the Federal Government’s recent move to limit household debt (via mortgage restrictions) seems somewhat ironic given their own fiscal position!

In setting the stage, let us consider that Canada’s federal debt equates to about 80 per cent of GDP according to the IMF. China eclipsed Canada in 2010 and now accounts for a greater share of total US imports. In BC, health expenditures are equivalent to around 45 per cent of the provincial budget.

Without fundamental restructuring, our health system as we know it today is not sustainable in the long term. There is no question that reform of some nature is required, provided it does not involve moving towards the regime employed by our neighbours to the south. I’m of the opinion that although there is enormous innovation that occurs within the health system, we do not always seem to foster the adoption of new technologies or fully recognize their economic and health benefits. The genomics expertise resident within our country resulting from a concerted effort by the Federal Government a decade ago is but one example. Provided we can further embed this expertise within the health system, we have great health and economic benefits to gain. Post-marketing and surveillance of drugs are yet another example that could improve patient outcomes while also generating sources of revenues.

Over the next few months, Canada’s Economic Action Plan (aka: stimulus spending) as well as that of many other nations (including the US) will result in reduced expenditures. It is critically important that these reductions are implemented in a thoughtful and comprehensive manner. They cannot be predicated solely upon short-term cost savings but rather, the return they will provide in future years.

The challenges we have and will continue to face don’t discriminate between industry, non-profit and the public sector. In fact, I am sure there will be some rather interesting

partnerships that result from this discussion.

Therein lies the essence of this opinion piece, let’s ensure the dialogue we are having translates in to definitive and timely action by us all.

For more Best Practices information visit our COMMERCIALIZATION Web Portal at www.bioscienceworld.ca FEBRUARY 2011 BIOTECHNOLOGY FOCUS 21

by Ron Najafi, PhD

Across Borders

5 Important Steps for Extending the Life of the World’s Arsenal of

Antibiotics On November 5th, 2010, The New York Times ran an article

by Andrew Pollack titled “Antibiotics Research Subsidies Weighed by U.S.” It reported that government officials are considering offering financial incentives to the pharmaceutical industry to spur the development of vitally needed antibiotics.

Such proposals, Pollack writes, “have taken on more urgency as bacteria steadily become resistant to virtually all existing drugs at the same time that a considerable number of pharmaceutical giants have abandoned this field in search of more lucrative medicines.”

One of the most interesting opinions in the article came from Ramanan Laxminarayan, director of the Extending the Cure project on antibiotic resistance at the policy organization Resources for the Future. He notes that the government could focus on conserving the effectiveness of existing antibiotics by preventing their unnecessary use in people and farm animals and by requiring better infection control measures in hospitals.

As the head of a company focused on the development of compounds to treat and prevent a wide range of infections without causing bacterial resistance, this is an issue I find both fascinating and vitally important. Based on my experience in the field, five steps must be followed in order to extend the functional life of our antibiotic arsenal.

22 BIOTECHNOLOGY FOCUS FEBRUARY 2011

Across Borders

1 First, we must immediately stop and assess the use of antibiotics as additives to the feed of our farm animals, and specifically prevent the unnecessary use of antibiotics in animals that are not sick. This is an important part of making the public more aware of the excessive use of antibiotics and the associated potential health risks. In a CBS News report that aired on July 16, Katie Couric highlighted the overuse of antibiotics in farm animals. Congress has urged farmers to stop the overuse of antibiotics in animals because it is creating new, drugresistant strains of bacteria that can spread to humans. The CBS report spotlighted Dr. Stuart Levy, the individual who identified tetracycline resistance in chickens more than 30 years ago. In that case, nearly all of the E. coli in the intestinal tracts of the chickens became tetracycline-resistant after one week of treatment.

drug pressures. We need to monitor the fate of all the mega-quantities of polysporin, Neosporin and Bacitracin that are consumed off the store shelves: Do they end up in our wastewater systems and landfills and become a breeding ground for new superbugs?

What happens to the groundwater runoff from farms, sewage systems and landfills?

We need to understand the fate and ramifications of antibiotics in our wastewater and runoff systems.

2011 Award Recipients Please join us for an evening dedicated to the recognition of individuals who have contributed much to the success of the life science sector.

E. coli bacteria. Photo: Eric Erbe

LIFETIME ACHIEVEMENT AWARD

Next, we should immediately assess and monitor the impact of antibiotics entering our public and farm waste-management systems. Research must be undertaken now regarding the ultimate impact of antibiotics in the environment. Sub-lethal quantities of antibiotics are known to create an environment for the development of resistance and multi-drug resistance mechanisms. The fast replication cycles of bacteria coupled with the mistakes made during replication give these pathogens a Darwinian advantage in responding to and overcoming antibiotic

x

x

A highly respected leader who has inspired and led the community to imagine a bigger future in biotech

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An individual who is highly recognized as a significant contributor in more than one of the following domains: industry, government, academia and volunteerism

Cal Stiller

2

COMMUNITY SERVICE AWARD An individual who has helped build the biotech community and strengthen its global reputation, where he or she has gone above and beyond the call of duty.

Gord Surgeoner

VOLUNTEER OF THE YEAR

PUBLIC SERVICE AWARD

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x

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An interactive participant in the biotech community who volunteers for various committees and receives no remuneration An individual who finds a way to help and adds energy to biotech events.

Bonnie Kuehl

Len Crispino

An individual who has helped build the life science community in Ontario in various ways that could include: innovative policy, structural support, development of research, commercialization of intellectual property or developing public -private partnerships.

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Wednesday, February 23rd, 2011 Liberty Grand – Exhibition Place, 25 British Columbia Road Cocktails 5:30, Dinner 6:30 Dress: Business Attire Presenting Sponsor

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FEBRUARY 2011 BIOTECHNOLOGY FOCUS 23

Across Borders

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3

Fourth, when we attack bacteria with agents targeted against one particular cellular mechanism— for example, the way that the fluoroquinolones target DNA gyrase—the bugs simply mutate that mechanism to make it resistant, and then pass the mutation around until all bugs are resistant and the agent is useless. This will always be true of targeted agents, so we need more of these agents every few years, and limiting their use in agriculture (including aquaculture) is a great idea. We urgently need a parallel initiative in the development of multi-target agents that attack so many targets that the bugs cannot sidestep them. All bacteria are susceptible to phenol and chlorhexidine, even though these compounds have been used since Florence Nightingale.

The trick, with multi-target agents, is to make sure that the human host is not one of the targets. Consequently, we need subtle agents that attack multiple bacterial targets, while being non-damaging to human tissues. Subtle and selective multi-target agents are the key to solving this huge problem. Bacteria cannot develop mutational resistance to them, and we understand the biofilm problems that confer non-mutational resistance to them. As a result, they are pivotal for our survival and should have fasttrack treatment by all agencies.

Third, we must undertake more research to provide us with safe and effective antibiotics utilizing new mechanisms without the development of resistance. My company is developing a new class of agents with a novel mechanism of action that kills pathogens without showing resistance. Unfortunately, developing additional antibiotics in existing classes of compounds that are showing drug resistance may not help.

This is because bugs that have developed a resistance to a member of a specific class of drug—e.g. the fluoroquinolone class of antibiotics, like Cipro—can apply the same resistance mechanism to the rest of that class. Resistance mechanisms can also be transferred to other bacteria, making the resistance issue a larger problem. A recent example of the latter is the case of the New Delhi metallo-beta-lactamase (NDM-1) resistance.

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Finally, we should encourage and incentivize the pharmaceutical and biotech industry to develop safe and effective non-antibiotic anti-infectives that could replace all topical antibiotics for eyes, skin, ear, overthe-counter antibiotics, etc. Once a topical antibiotic develops resistance, that resistant gene will find its way into all sorts of pathogenic bacteria. Bacteria love to share survival mechanisms.

Overall, we need to understand the sources of antibiotic resistance—whether it originates in farms, sewers, landfills, or other locations—and find ways to save our precious few antibiotics for systemic blood-borne infections. We also must aim for appropriate use of antibiotics in humans and in our farm animals, have a better understanding and guidelines for infection control, and strongly encourage antibiotic stewardship. Otherwise, the overall result will be fewer effective drugs to treat bad bugs.

Ron Najafi, PhD is chairman and CEO of NovaBay Pharmaceuticals, Inc (NBY)., an Emeryville, CA-based biotechnology company developing anti-infective compounds for the treatment and prevention of antibioticresistant infections. He can be reached at rnajafi@novabaypharma.com.

24 BIOTECHNOLOGY FOCUS FEBRUARY 2011

For more Across Borders information visit our Best Practices Web Portal at www.bioscienceworld.ca

NEW PRODUCTS Nucleic acid purification kits Thermo Scientific KingFisher nucleic acid purification kits contain all relevant buffers and reagents and are designed and optimized for use with Thermo Scientific KingFisher magnetic particle processors.

When used in conjunction with Thermo Scientific KingFisher magnetic particle processors, the process is automated. The kits are available for a range of sample types from blood toplate materials.

Reply Card #4838 Bechtop Ovens Available in three different models, the new Thermo Scientific Heratherm ovens come in 60, 100 or 180 litre sizes with a choice of gravity or mechanical convection. The three models: General Protocol, Advanced Protocol, and Advanced Protocol Security, focus on energy efficiency, sample safety and ease-of-use. The ovens have insulation and heat-decoupled door to reduce energy consumption and minimize heat transfer to the environment. All three models meet all laboratory, clinical and industrial heating and drying needs. The General Protocol oven operates up to 250 0C, and incorporate a timer function. The Advanced Protocol ovens can reach temperatures of 330 0C and offer superior temperature uniformity to its sibling. The Advanced Protocol models also have extended timer function with the ability to choose weekly, real-time or hour-driven settings. It can also store up to 10 pre-defined cycles. The Advanced Protocol Security ovens include an additional under temperature alarm and a lockable door with an alarm.

field pusher and dual stage reflectron with an ion detection system in an optimized time-of-flight geometry. Together these features provide a new dimension of high resolution, exact mass and quantitative performance uniquely available at acquisition rates that are compatible with UPLC separations. Further bolstering the system’s performance capabilities is UPLC/MSE, a method of data acquisition that allows users to view high-quality, unambiguous exact mass precursor and fragment ion data from a single data set; in essence the ability to see all the data, all the time. Finally, the Xevo G2 Tof ensures scientists can future-proof this laboratory investment with an upgrade path to QTof functionality that enables exact mass MS/ MS capability using the same hardware.

mixers, agitators and reactors that meet ASME-BPE 2009 standards for cleanablility. The seals are suitable replacements for Flowserve® Type VRA, John Crane® Type 32, and others. They feature sloped internal surfaces to facilitate drainage and enhance cleanability, including the debris well flush ports.

Reply Card #4840 Titrator With six built-in calculation modes, JM Science’s AQUACOUNTER® Coulometric Karl Fischer Titrator (AQ-300), can accommodate solid, liquid and gas

Reply Card #4842

samples. Performance features include a fritless cell option and one-touch calculations. The titrator can instantly recall data of up to 20 samples with it’s memory and can also store up to four files with preset conditions. The unit also features a detector for monitoring titration status.

The titrator also has balance and computer interfaces for GLP and ISO documentation.

Training documentation is provided on DVD, and a quick start guide is available.

Reply Card #4839

Reply Card #4841

Mass spectrometer Waters Corporation introduces the Waters® Xevo® G2 Tof (time-of-flight) mass spectrometer (MS) with UPLC®/MSE and QuanTof™ technology. The Xevo G2 Tof brings research-grade SYNAPT® G2 technology in an accessible, bench-top system offering quantitative and qualitative performance.

The QuanTof technology combines a high

Dry-running mechanical seals Sharpe Mixers’ RD dry-running mechanical seals were developed for sanitary applications where product contamination from barrier fluids is unacceptable. The seals are capable of handling a 0.150” total run-out, these fully BPE compliant seals feature a proprietary carbon blend, and are sypplied with or without a debris well. Designed for

Starter Packs Kimble Chase, manufacturer of laboratory glassware products worldwide, offers Starter Packs to researchers so they can buy just what they need. Starter Packs are available for Erlenmeyer flasks, graduated cylinders and Griffin beakers, in just the right assortment of sizes. The packs are designed for labs that are just starting out, or for labs that stock items only according to their needs.

Kimble Chase Starter Packs contain one of each item in the most popular sizes; for instance, the Starter Pack for Erlenmeyer flasks includes a 50, 125, 250, 500 and 1000 mL sized flask.

Reply Card #4843 FEBRUARY 2011 BIOTECHNOLOGY FOCUS 25

NeW PROdUCTs Peristaltic pump The 400/RX1 peristaltic pump is ideal for catheter washing and cooling applications requiring pressures to 100 psi or flow rates up to 80 ml/ min, featuring ergonomic and error-free tube loading and unloading, a clear guard for full view of pump operation and guardopen safety switch. The pump is available to medical device OEms as a complete plugand-play cased pump or as a panel mount unit. With no seals or valves, Watson-marlow peristaltic pumps offer contamination-

free pumping and are easy to use and are available with custom configurations for fast delivery and lean manufacturing in applications including irrigation, washing and cooling, vacuum and aspiration and reagent dilution and sampling. All fluid being pumped is completely contained within the tubing, so cleaning the pump is as simple as replacing a disposable tube-set.

The pump has a unique cover/ loading lever that lifts the track when opened to facilitate loading of the disposable tubing. The cover

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comes with an integrated switch that can be wired to turn the pump off when the cover is opened. When closed, the clear cover gives a full view of the pump operation, and verification that the tube is loaded correctly. The pump accepts tube sizes from 1/6” to 3/16” ID, and has 4 stainless steel rollers for low pulsation of the flow stream. The rollers use lowfriction ball bearings for optimum tube life at high pressures.

Reply Card #4844 spectrophotometer The new Thermo Scientific multiskan GO UV-Vis spectrophotometer offers free wavelength selection for both 96- and 384-well plates and various types of cuvettes making it an ideal tool for virtually any photometric research application, including DnA, RnA and protein analysis. The multiskan GO spectrophotometer can support endpoint, kinetic and spectral scanning assays at very fast speeds. Any measurement wavelength between 200 and 1000 nm can be selected at any time with the advanced monochromator-based optical system, which also allows the complete spectrum of a sample to be scanned in less than 10 seconds. Temperaturecritical assays benefit from the precise temperature control feature. Extensive automatic self diagnostics at instrument start-up verifies all major instrument functionalities and continuous runtime control of optical and mechanical functions, ensuring stable day-to-day and year-on-year performance and reliability.

Energy use by the unit is minimized by an automatic power save function, reducing energy consumption by up to 70 per cent. The instrument can be controlled as a standalone unit with dedicated software for quick and simple cuvette and plate measurements.

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THE DELIVERY EXPERTS

CALENDAR FEBRUARY 2011

Fax: (412) 825-3224 Email: info@pittcon.org Web: www.pittcon.org

Feb 14-16 Cold Chain Management & Temperature Control Summit Venue: Toronto, ON Tel: 1-800-882-8684 Email info@iqpc.com Web: www.coldchainpharm.com

Feb. 27 – March 1 9th Annual BioPartnering North America™ Venue: Vancouver Convention Centre, Vancouver, BC Tel: (831) 464-4230 Web: http://www.techvision.com/bpn/

APRIL 2011

Venue: Montreal, QC Tel: (780) 492-0950 Fax: (780) 492-0951 Email: bberekoff@cspscanada.org Web: www.cspscanada.org

April 6-8

May 31-June 1

ACETECH Symposium Venue: Whistler, BC Tel: (604) 683-5852 Fax: (604) 683-3879 Web: www.acetech.org

BioFinance Venue: Toronto, ON Tel. 1-866-342-4933 Fax: 1-866-342-4934 Email: mstinson@biofinance.ca Web: www.biofinance.ca

April 30-May 3 ACRP 2011 Conference & Expo Venue: Seattle, WA Web: www.acrp2011.com

Feb 28-March 1

May 8-11 World Congress on Industrial Biotechnology and Bioprocessing Venue: Toronto, ON Tel: (202) 962-6630 Email: worldcongress@bio.org Web: www.bio.org/worldcongress

MARCH 2011 March 13-18

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PITTCON Conference & Expo Venue: Atlanta, GA Tel: 1-800-825-3221

June 19-23 Drug Information Association 47th Annual Meeting Venue: Chicago, IL Web: www.diahome.org

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June 27-30 BIO International Convention Venue: Washington, DC Tel: (202) 962-9200 Fax: (202) 488-6301 Email: info@bio.org Web: www.convention.bio.org

Canadian Society for Pharmaceutical Sciences Symposium

Company & Advertiser Index COMPANY

Page

RC

COMPANY

Page

RC

Agrium Inc......................................................8.........................................

JM Science.....................................................25................................ 4841

Ag-West Bio.....................................................8.........................................

Kimble Chase.................................................25................................ 4843

Allon Therapeutics Inc....................................6.........................................

Life Sciences Ontario......................................... 23......................................4837

Amorfix Life Sciences......................................7.........................................

Lorus Therapeutics Inc....................................6.........................................

Angiotech Pharmaceuticals............................9.........................................

Miraculins Inc..................................................8.........................................

Bioniche Life Sciences Inc...............................9.........................................

Paladin Labs Inc..............................................8.........................................

BioTalent Canada................................................. 5.......................................4832

POI......................................................................... 31......................................4847

Caledon Laboratory Chemicals........................ 9.......................................4833

Sanofi-aventis Canada....................................8.........................................

Canadian Institutes of Health Research..........7.........................................

Sanyo.............................................................11................................ 4833

Donnelly Centre for Cellular and...............................................................

Sharpe Mixers................................................25................................ 4842

Biomolecular Research...................................6.........................................

Theratechnologies..........................................8.........................................

Eppendorf............................................................ 32......................................4848

Thermo Fisher Scientific.............................25, 26......... 4838, 4839, 4845

Fisher Scientific.................................................... 2.......................................4831

VIDO...................................................................... 19......................................4836

GEA Westfalia Separator Canada Inc.............. 17......................................4835

VWR....................................................................... 27......................................4846

Italian Trade Commission................................. 13......................................4834

Waters Corporation........................................25................................ 4840

28 BIOTECHNOLOGY FOCUS FEBRUARY 2011

F e a

WE’VE GONE GREEN! Get all the latest news and information about the Canadian bioscience industry from our digital edition of Biotechnology Focus!

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THE LAST WORD

By Carol Reynolds

Communicating to Stakeholders: You have to tell it to sell it

R

Carol Reynolds

i

o v t n a n

esearchers uncover innovative of potential harm to export markets discoveries in their labs, but be conducted before the sale of “Innovation unless they communicate any new genetically engineered their findings effectively, seed is permitted.” Essentially, is not about managing no one knows about them, nor the intent of this Bill is very change; it’s about creating noble; however the emotional can investors be inspired to continue to fund their research. execution could clearly leave the appropriate space Enter communications. Drivthe door open for misinterprefor change.” ing the articulation vehicle for tation. Increased regulations, Dr. Peter Philips, these scientists helps them to for example, may prevent Professor, Johnson Shoyama convey the importance of their the sale of new high yielding Graduate School of Public Policy, research projects to government, varieties to farmers. The direct University of Saskatchewan industry and fellow academics. In impact is reduced competitiveaddition, relaying the importance of ness, lower profit margins at the such discoveries to the general public has farm gate and increased reliance on the potential to stimulate stakeholder support, farm safety nets. or, at the very least, inspire them to ask hard quesBy providing objective observations, researchers tions like “Why do we need to know that?” and “Is such as Dr. Peter Phillips relayed important informathat ethical?” tion about the impact the passing of this Bill could While some may perceive these questions as open- have on farmers and on the research community. ing cans of worms, prying the lid open for such The AGRI committee should be commended for debate is necessary to gain public acceptance while agreeing to hear testimonies from industry, academonstrating objectivity and transparency. Govern- demia and research organizations about the potential ments must ask the difficult questions; opposition par- impact the passing of this Bill could have on their ties exist to ensure this. However, when multi-party representative sectors. Furthermore, it is promising committees come to a consensus, it demonstrates that the committee has agreed to pursue further study open-mindedness and cooperation to achieve a com- in the biotechnology cluster pockets across Canada. mon goal.

Clearly, this committee realizes the value of biotechSometimes new technologies are met with regula- nology and the impact it is having in Canada. tory roadblocks, resulting from misinformation and Effective messaging needs to be a priority for biofear. We owe it to the public and governing officials technology research organizations. We can do great to provide the most recent research and advanced research in our labs, but if no one tells the world information so wise, safe decisions can be made. By about it, no one reaps the benefits. Get heard. Tell providing this information as objective third parties, the world about your research. Communicate how research and biotechnology organizations are viewed it’s going to impact an average Canadian. Explain as experts in their fields; as go-to sources for reliable, how your research can benefit the economy. And timely information upon which regulatory decisions one last thing – please practise explaining it in lay can be made. terms – remember, not everyone you talk to will Realizing the important role biotechnology plays in have a PhD. the Canadian agriculture sector is a prime example.

The federal standing committee on Agriculture and Got something to say?

Agri-Food (AGRI) recently heard from witnesses on @ Please send your comments/letters to the impact Bill C-474 would have on the research and biotechnology_focus@promotive.net agriculture sectors. The Bill’s intent was to “amend the Seed Regulations Act to require that an analysis

30 BIOTECHNOLOGY FOCUS FEBRUARY 2011

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