Biotechnology Focus July/August 2011

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

Genomics COMMERCIALIZATION OPPORTUNITIES INSIDE:

CONVERTING RAW BIOMASS THROUGH PYROLYSIS INTO VALUABLE BIO-OIL PRODUCTS

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JULY/AUGUST 2011 VOLUME 14, NUMBER 7

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contents JULY/AUGUST 2011 – VOLUME 14 – NUMBER 7

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16

Making green crude from pyrolysis

FEATURES

12 Cancer Therapeutics and

Ontario Genomics Institute shifts its project focus towards commercialization opportunities

High Potency API Development

Opinion

The development of new oncology therapeutics, a key area of focus for pharmaceutical and biotechnology companies worldwide (By Matthew Frizzle)

14 Spotlight: Canada at BIO

A wrap-up of what Canada did at the Bio International Convention in Washington DC (Compiled by Biotechnology Focus and BIOTECanada)

18 Genomics Commercialization Opportunities A new mandate and change in philosophy has the Ontario Genomics Institute focused on job and wealth creation in the genomics sector (By Shawn Lawrence)

DEPARTMENTS 6

IN EVERY ISSUE

16 Spinning straw into gold

Research news

London Ontario based Agri-therm Inc. is making green crude from pyrolysis (By Mary Ann Colihan)

10 Business corner 26 New Products

22 ACROSS CANADA

29 Calendar of events 30 The Last Word

9 RESEARCH NEWS

BIOTECanada honours its Gold Leaf Award Winners, Allon Therapeutics wins early stage company of the year. www.bioscienceworld.ca

Borden Ladner Gervais’ Jeffrey Graham discusses Canada’s place in the global bio-economy (By Jeffrey Graham)

30 THE LAST WORD (By Bonnie Keuhl and Frédéric Sweeney)

JULY/AUGUST 2011 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S NOTE

BioFinance 2011: A more intimate affair Held May 31 to June 1st at the St. Andrew’s Club and Conference Centre in downtown Toronto, this year’s edition of Biofinance, Canada’s biggest investor conference for the life science industry, didn’t have the quantity of companies of past conferences, nor did it have the same number of attendees, but what it was lacking in size, it more than made up for in substance.

The consensus was that of the 46 or so companies giving presentations at the conference, the majority are doing better today than they were 12 months ago. The developments of the last three to four years have left behind a leaner yet stronger industry with companies whose quality platforms and exciting technologies are geared towards market niches. The conclusion: the quality of Canadian life sciences companies is higher than ever.

Overall, there was a real sense at this year’s event that Canadian Biotech as a whole was beginning to rebound from the economic uncertainty that has plagued it since the economic downturn of 2008. Moreover, companies are finding economic conditions in the industry more favourable to deal making. Specifically, companies are now raising funds again, and there actually is money out there for those who want it, even from Canadian Venture Capitalists.

“There were many successes in the Canadian biotech industry worth celebrating in 2011,” said Mr. Michael Stinson, Executive Director of BioFinance Canada in the lead up to the event. “On the product side, for example, Theratechnologies Inc. completed the lengthy and demanding process for the approval of their novel drug. This was complemented by other companies obtaining approval of specialty pharmaceutical products, medical devices and diagnostic products.”

“Also encouraging is that funding of public development stage healthcare companies has shown recent momentum,” continued Mr. Stinson. “Equity and convertible debt funding amounted to $259 million in Q4 2010, and seven companies have completed financings of over $10 million so far in 2011.”

In addition to the corporate presentations, BioFinance also featured a series of 14 panels, discussing everything from the investment landscape, financing, and management issues relevant to the industry.

Moreover, it was the belief of many of the panelists that Big Pharma is coming to the table looking for deals for early stage technologies, and Canadian biotech is in a prime position to capitalize.

Perhaps the biggest surprise of the two day event came from the luncheon panel session on the second day titled the view from Wall Street, where David Schechner of Canaccord Genuity speculated that we might be on the “verge of another biotech bubble.” During that same session, an interesting question was raised regarding Canadian relations with U.S. investors and what needs to be done to facilitate more interest from south of the border. One of the panelists commented that we’re too nice and polite in our business dealings, and for these reasons we’re just not trustworthy. This revelation left many in the room scratching their heads wondering what to do with this information.

As for the event as whole, Stinson said he was pleased with both the turn out and the feedback about the venue, and plans are already in place to have the event back at the St. Andrews Club and Conference Centre for 2012.

PUBLISHER/ EDITOR-IN-CHIEF STAFF WRITERS

CONTRIBUTING WRITERS

Terri Pavelic Shawn Lawrence Christopher Rogers Bonnie Keuhl

Frédéric Sweeney

Jeffrey Graham

Mary Ann Colihan

National Account Manager GRAPHIC DESIGNER CONTROLLER

Matthew Frizzle Patricia Bush Elena Pankova John R. Jones

MARKETING MANAGER

Mary Malofy

CIRCULATION DIRECTOR

James Zammit

circulation@promotive.net

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; Bonnie Kuehl, Scientific Insights Consulting Group Inc. 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 ABC Membership Applied For.

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R & D NEWS MaRS Innovation and GlaxoSmithKline partner to accelerate translational research

MaRS Innovation (MI) and GlaxoSmithKline Inc. (GSK) announce a new development fund (the GSK-MaRS Innovation Fund), that will support and fast-track the commercialization of some of the country’s most promising translational research coming from 16 leading academic health sciences centres, hospitals and universities derived from the MI membership.

“From the discovery of insulin in 1922 to the discovery of stem cells, Ontario has a rich, proud history of world-class medical and scientific breakthroughs.

Our partnership with GSK Canada furthers Ontario’s position as a major international research hub by providing much needed capital to fund exciting drug discovery and development technologies and bridging the gap to successful com-

mercialization,” said Rafi Hofstein, president and CEO for MaRS Innovation.

“The launch of this development fund is also part of a global trend where government, researchers and industry are partnering at the early stages of translational research with an eye to achieving global impact and improving patient care,” Hofstein added.

“GSK is proud to be working in collaboration with a leading partner in innovation research and development,” said Paul Lucas, president and CEO, GlaxoSmithKline Inc. “Collaborations such as these, where we share knowledge, expertise and resources, provide a highly effective way of progressing and commercializing cutting edge research. We hope that this collaboration will help to close the innovation gap in Canada.”

The GSK-MaRS Innovation Fund will support translational development projects with strong potential for commercialization in the following areas: drug development, diagnostics and healthcare delivery technologies. The strategic partnership will also provide access to capital and opportunities for early engagement with experts in drug development to guide and position technologies for successful commercialization through licensing transactions and/or start-up company creation.

Representatives from MI and GSK will select projects for further development under this three-year partnership.

Sanofi Pasteur opens $100M R&D Centre in Canada Sanofi Pasteur Limited has opened a new $101 million dollar vaccine research and development facility at Sanofi Pasteur’s Connaught Campus in north Toronto.

Mark Lievonen, president of Sanofi Pasteur commented at the opening held in June, “this new facility establishes the Connaught Campus as the North American Centre of Excellence in analytical and bioprocessing R&D for Sanofi Pasteur globally.”

He added that it solidifies the Toronto site as a national strategic asset for the research, development and manufacturing of vaccines that protect public health – in Canada and around the world.

6 BIOTECHNOLOGY FOCUS JULY/AUGUST 2011

The province of Ontario contributed $13.9 million to the project through the Biopharmaceutical Investment Program, part of the Next Generation of Jobs Fund. This investment helped retain a large vaccine R&D footprint in Ontario and will help secure future manufacturing jobs, since it is easier to reach commercial manufacturing scale for new products when R&D facilities are in close proximity to the actual manufacturing site.

“Sanofi Pasteur is a valued partner in our commitment to health care in Ontario,” said Premier Dalton McGuinty at the opening. “This impressive new building houses some of the most Continued on page 9

Clinical Trials & Patents Resverlogix Corp. (Calgary, AB) has completed its chronic repeated-dose toxicology studies on its lead compound, RVX-208, indicated for the reduction and prevention of atherosclerosis. These chronic toxicology studies support the initiation of its longer duration, Phase 2b, clinical trial ASSURE. As a first-in-class compound, RVX-208 underwent six and twelve month testing in rodents and non-rodents, respectively, and the analysis, results and reporting of these studies to the appropriate regulatory authorities, have been completed. With the safety studies complete, RVX-208 can now advance into trials of more than three months duration. The Phase 2b ASSURE trial, in which Intra Vascular Ultra Sound (IVUS) technology will be used to determine coronary arterial plaque regression, will have a treatment duration of six months. The IVUS measurement will be used as the trial’s primary endpoint.

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n Medicago Inc. (Québec, QC) reports positive results from a U.S. Phase 1 human clinical trial with its seasonal influenza vaccine candidate. All vaccine doses were found to be safe, well tolerated and also induced a solid immune response.

A total of 100 healthy volunteers between the ages 18 to 49 received one of the following; a single non-adjuvanted dose of Medicago’s H1N1 vaccine at varying doses (5ug, 13ug, 28ug), an injection of the placebo or an H1N1 vaccine from a licensed trivalent vaccine. No serious adverse events were reported during the trial and the vaccine was found to be well tolerated at all three dosage levels. Based on these results and subject to regulatory approval, Medicago intends to proceed with a U.S. Phase 2a trial for its seasonal trivalent vaccine with the recommended H1N1, H3N2 and B influenza strains.

DiagnoCure, Inc. (Québec, QC) reports the issuance of a new U.S. patent, and addition to DiagnoCure’s PCA3 prostate cancer biomarker portfolio. In addition to providing greater patent protection, this new patent bears an extended expiration date that lengthens by 20 months the term of the license that DiagnoCure granted to its commercial partner, GenProbe. This new U.S. patent, 7,960,109 “mRNA Ratios in Urinary Sediments and/or Urine as a Prognostic and/or Theranostic Marker for Prostate Cancer”, covers the particularities of the quantitative urinary test developed by GenProbe. This test allows the determination of a PCA3 score in urine following a digital rectal examination and indicates the probability of finding cancer in a prostate biopsy by associating a higher score with a greater probability of a positive biopsy, with a much greater precision than the traditional PSA test. The term of the license agreement with Gen-Probe is tied to the last-to-expire licensed patents. As a result, since this is now the patent with the latest expiration date, the duration of the Gen-Probe license will be extended to August 2027.

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R & D NEWS Rising stars in global health

Left to Right: Dr. Tore Godal, Gary Darmstadt, Tamar Manuelyan Atinc, Dr. John P. Holdren, Ms. Melinda Gates, Secretary Clinton, Dr. Peter A. Singer, Administrator Shah Grand Challenges Canada has announced 19 grants to Canadian innovators in the first phase of its Canadian Rising Stars in Global Health initiative. Grand Challenges Canada is a new global health organization funded

by Canada’s foreign aid budget. Its purpose is to fund research to address some of the most difficult global health issues through Integrated Innovation and save lives. Canada is the first country in the world to adopt a grand challenges approach to foreign aid.

Grand Challenges Canada participates in a consortium with Canada’s International Development Research Centre (IDRC) and the Canadian Institutes of Health Research (CIHR). Mr. David Malone, president of IDRC, joined Dr. Alain Beaudet, president of CIHR in congratulating the new grantees. “The grant recipients have all displayed enormous creativity and commitment to solving global health challenges,” said Dr. Beaudet. “It is exciting and very rewarding to have the opportunity to encourage them in their work.” David Malone adds, “we’re very pleased to see Grand Challenges Canada, Canada’s International Development Research Centre and the Canadian Institutes of Health Research take a ‘whole of Canada’ approach to creating the Canadian Rising Stars in Global Health initiative and supporting Canadians’ contribution to global health.”

In a first for a Canadian grant application process, the innovators each produced a short video to explain their ideas to Canadians. Through a rigorous peer review process, 19 innovators’ proposals were selected from across Canada each receiving a grant of $100,000. There will be three rounds of Canadian Rising Stars for a total of $20 million. Of this amount, approximately $14 million will be available for scale-up grants.

From a tattoo that delivers drugs to combat a debilitating and disfiguring disease; to solar powered tablets to train women in Haiti on HIV prevention; to a rugged, reliable fetal heart monitor that doesn’t require electricity in order to save babies’ lives in

Africa, Canadian innovators demonstrate creativity, bold ideas and big hearts in the quest to make a difference in the developing world and save lives.

Should their ideas be found robust, effective, and proven, the innovators will be eligible for an additional scale–up grant of up to $1 million for each proposal.

“When I ran the in the Olympic Torch Relay with my wife Sandra, we felt a sense of pride

in Canada as we had never felt before,” says Joseph L. Rotman, Chair of Grand Challenges Canada. “I feel the same sense of pride about these outstanding Canadian Rising Stars in Global Health who demonstrate the leadership Canadians can and do contribute to the international community.”

Says Dr. Peter A. Singer, chief executive officer of Grand Challenges Canada: “These innovators are dedicated to bringing change to the world’s poorest countries. They believe Canada has a leadership role in improving health conditions in the developing world. Collectively they are a source of pride for our country.”

Grand Challenges Canada is now sending a request for proposals for round two of Canadian Rising Stars in Global Health. In this round, proposal submissions will require developing world innovators to collaborate with Canadians on their bold ideas.

For more information please visit www. grandchallenges.ca

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JULY/AUGUST 2011 BIOTECHNOLOGY FOCUS 7

R & D NEWS AlgaeBio to enter nutraceuticals market with ultra-pure omega-3 fatty acid oils It’s pure and simple. Canada’s new player in the algae industry is gearing up for its debut in the nutraceutical and food additive markets.

Algae Biosciences Corporation, a Canadian public biotechnology company, began trading on the TSX Venture Exchange in early May. AlgaeBio’s production facilities near Holbrook, Ariz., are being expanded to reach large-scale commercial production levels before year’s end and the first order of business for the company will be ramping up the manufacture of ultra-pure omega-3 fatty acid oils.

Already, AlgaeBio is receiving extremely positive interest in its omega-3 product line, and is currently exploring international distribution channels.

According to scientific studies, omega-3 fatty acids improve heart joint, and brain

health, may be linked to lower diabetes risk, and are beneficial to cognitive functioning and development, especially for infants and children. Preliminary studies also suggest that the essential unsaturated fatty acids may be beneficial in treating depression while reducing the risk of breast cancer, colon cancer, prostate cancer and strokes.

Omega-3 is currently used in such food staples as bread, milk, yogurt, juice, breakfast cereal, spreadable oils, and infant formula. Currently, market demand for omega-3 fatty acid oils overwhelmingly exceeds industry production capacity, and premium prices are paid for the purest algae-based ingredients in food and nutritional products.

AlgaeBio has the potential to produce algae in an ultra-pure form, on a large scale and at a low cost.

AlgaeBio produces omega-3 products

Agricultural research celebrating Its roots What do Marquis wheat, blueberry juice and a reusable shipping container have in common? They were all developed at Agriculture and Agri-Food Canada (AAFC) research stations. AAFC celebrated an exciting milestone in Canadian agriculture history, as the month of June marked the 125th anniversary of the creation of the first agriculture research farms in Canada.

In June 1886, Parliament passed the Experimental Farm Station Act and created five research farms charged with conducting agriculture research to benefit Canadian farmers: Agassiz, British Columbia; Indian Head, Saskatchewan; Brandon, Manitoba; Ottawa, Ontario; and Nappan, Nova Scotia.

AAFC research began by developing new crop varieties suitable for Canadian climates to allow early settlers to cultivate their new land. Over the years, research produced significant new developments including canola, wheat varieties that resist rust, hardy soybeans, technology to process fruit and DNA analysis for early disease detection in plants.

Today, AAFC has a network of re-

8 BIOTECHNOLOGY FOCUS JULY/AUGUST 2011

search centres and stations across the country with 2,100 employees, including 500 researchers who work closely with farmers and the agriculture sector. AAFC scientists continue to find innovative ways to grow healthy, profitable foods with less impact on our environment. Scientific achievements have helped boost the farm gate for Canadian farmers. Canadian agriculture products are exported worldwide, and the agri-food sector is now the leading manufacturing employer in the country.

For more information on events taking place across the country to celebrate 125 years of agricultural research, please visit www.agr.gc.ca/scienceandinnovation.

that contain both EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) — essential fatty acids that cannot be produced by the human body — while the vast majority of competing products contain only DHA. And because AlgaeBio’s omega-3 products are plant-based, there’s none of the concern about potential environmental pollutants and contaminants that surrounds marine sources of omega-3, such as fish oil.

Saskatchewan and Manitoba to Partner on Bi-Provincial Innovation and Research Opportunities The Provinces of Saskatchewan and Manitoba signed a Letter of Intent (LOI) to cooperate on research and innovation initiatives at the BIO International Convention in Washington, DC. The LOI recognizes the two provinces’ history of cooperation in areas such as electricity, transportation and emergency response, and focuses on key priority areas of mutual interest in the research and innovation areas: • Crop agriculture • Bioenergy, bioproducts and environment • Human and animal health.

The Life Science Association of Manitoba (LSAM) and Ag-West Bio Inc., the biotechnology sector membership organizations in both provinces, applaud the nature of the LOI. “We work very closely with organizations in the sector in Manitoba and have a reciprocal agreement with Ag-West Bio in Saskatchewan.

Having the Provinces officially state their commitment to working together in the biotech sector is a very positive step forward,” said Tracey Maconachie, president of LSAM. A Bi-Provincial Genomics Innovation Summit was organized by Genome Prairie and held in Winnipeg in October of 2010. The event was well attended and supported by the Governments of Saskatchewan and Manitoba, industry and academic representatives. The discussions focused on key bi-provincial priority areas, all of which appeared in the LOI.

R & D NEWS Allon Therapeutics wins early stage company of the year BIOTECanada announces that Allon Therapeutics Inc. is this year’s Gold Leaf Award Early Stage Company of the Year winner.

BIOTECanada said Allon was chosen as the top pre-commercialization company in the Canadian biotechnology healthcare sector “by distinguishing themselves from their peers with demonstrated technology innovation and achieved milestones.”

Gordon McCauley, Allon’s president and CEO, said the prestigious Gold Leaf Award recognizes the company’s clinical trial successes and progress toward commercializing products in devastating degenerative brain diseases, such as Alzheimer’s, Parkinson’s and several types of frontotemporal dementia.

“Being chosen as Canada’s leading precommercial healthcare biotech company is a great honour and an enormous compliment to the dedication, innovation, and excellence demonstrated by our team every day,” said McCauley. “It is also important recognition of the investigators, patients, and caregivers we partner with to find solutions to these awful diseases.”

Gordon McCauley receives the award for Best Early-Stage Biotechnology Company - Health, presented

by Patricia Massetti, Executive director of Merck Canada. Photo: Allon Therapeutics Allon announced last month it had successfully enrolled 50 per cent of its 300-patient objective in a pivotal clinical trial evaluating lead drug candidate davunetide as a treatment for progressive supranuclear palsy (PSP), a rapidly progressing and fatal degenerative brain disease. The company is on track to complete enrolment by the end of 2011 and to report data approximately one year later.

The pivotal trial is being conducted under a Special Protocol Assessment granted by the United States Food and Drug Administration (FDA), which means that the agreed clinical trial design meets the FDA’s expectations for a pivotal study. Designation of davunetide for PSP as an orphan drug in the U.S. and the European Union brings significant commercial incentives for the company.

Continued from page 6 exciting talent anywhere, doing some of the most vital research in the world. We congratulate Sanofi Pasteur and look forward to new breakthroughs and new jobs.”

A national strategic asset The new R&D facility, known internally as “Building 95”, will help the company retain over 300 highly-skilled vaccine research positions and bring many of the company’s accomplished scientists and state-of-the-art technologies under one roof. In fact, the North American Centre of Excellence designation means the critical mass of scientific expertise at Connaught Campus is playing a lead role in advancing Sanofi Pasteur’s global vaccine pipeline.

The Toronto site manufactures many vaccines vital to public health with 94 per cent of its vaccine production being delivered to over 90 countries around the world. In fact, over 20 per cent of global sales at Sanofi Pasteur, the world’s largest vaccine company, are generated by vaccines manufactured at the Connaught Campus. Its strategic positions include: • The only manufacturer of 5-component acellular pertussis combination vaccines globally • The only manufacturer of polio (IPV) vaccine in the Americas • The only Canadian manufacturer of diphtheria and tetanus vaccines • The capacity to stockpile paediatric vaccines domestically to ensure security of supply for Canadian immunization programs In all, the company employs over 1,100 people at the Connaught Campus, including 300 in R&D and over 700 in highly-technical vaccine manufacturing jobs.

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BUSINESS CORNER Rx&D member companies invested $1.1 billion in research and development (R&D) in Canada last year despite an economic recession, a global industry restructuring and patient access gaps for new medicines and vaccines according to a PMPRB report.

“The commitment of our member companies to do research and development for the benefit of Canadians remains strong,” said Russell Williams, president of Canada’s Research-Based Pharmaceutical Companies (Rx&D). “Since 1993, Rx&D member companies’ total investment in R&D in Canada has averaged over 10 per cent of sales. The commitment made in 1987 was based on a favourable environment of access and reimbursement. That environment has significantly deteriorated and the commitment may no longer be sustainable unless Canada becomes more internationally competitive.”

Mr. Williams noted that Canada is losing its competitive edge in attracting clinical trials as indicated in the Sciences and Technology Innovation Council Report on clinical research commissioned by the federal government. In fact, due to deficiencies in the research infrastructure, it is estimated that almost 20 per cent of the committed investments from industry are not used and thus not reported by PMPRB. “Governments, research institutions and industry need to work cooperatively to reduce duplication and coordinate efforts to make our country a global destination for

clinical trials research. Clinical trials account for more than 75 per cent of applied research investments in Canada,” added Mr. Williams.

In addition, Rx&D calls for improvements to intellectual property protection.

“We need a comprehensive approach where innovators can rely on an improved and more stable data protection regime. Our IP protections should be consistent with or better than those of our major trading partners. For example, Canada does not have an effective right of appeal for innovators in patent invalidity proceedings, but does offer an appeal for generics in the same proceedings, creating a one-sided and inequitable system,” indicated Mr. Williams.

Reducing the access gap to provide Canadians in all provinces more timely access to new treatments should also be a priority to all governments. A recent Rx&D international study found that Canada ranked 20th out of 25 countries in providing access to new medicines under public drug plans.

“We have the talented people to make Canada a research and innovation powerhouse,” Mr. Williams added. “We need a strategy to compete globally competition and capture a greater share of investment.

The time to do it is now.”

The PMPRB Report also shows Canadian patients also receive excellent value for their brand name prescription medicine.

Price increases were within the rate of inflation which was 0.3 per cent in 2009. Over

Russell Williams

New report confirms $1 billion plus invested in 2010 by Canada’s Pharmaceutical Sector

the past decade, prices for innovative medicines were below the international median.

In contrast, several studies have shown that Canadian generic drug prices are among the highest in the world. For example, the federal Competition Bureau found that Canadians and our health care system could save up to $800 million a year “if generic drugs were sold in a more competitive market.”

Concerned with high generic drug prices in Canada, the Health Council of Canada released last week a discussion paper to highlight “the complex reasons as to why generic drug prices are so high and the longstanding lack of transparency about how prices are set.”

“Working collaboratively, we can develop policies that will create more jobs and investment in the knowledge economy while giving patients choice and improved access to the new medicines and vaccines that improve and save lives,” concluded Mr. Williams.

Dealmakers n Canadian pharmaceutical services company Dalton Pharma Services (Toronto, ON) has entered into a manufacturing services agreement with Cambridge, MA specialty pharma company Zafgen Inc. Dalton Pharma Services will provide aseptic fill/finish services and analytical support under cGMP for Zafgen’s lead obesity treatment. “Dalton’s expert capabilities in the sterile manufacture of API’s and analysis combined with its strength in aseptic filling solidified the manufacturing agreement,” said James Vath, head of Drug Discovery and Development for Zafgen. “Adding Zafgen to our growing list of strategic relationships with innovative pharmaceutical clients is an important milestone for Dalton”, said Peter Pekos, president and CEO.

Medicure Inc. (Winnipeg, MN) announces its subsidiary, Medicure International, Inc. (Barbados) and Iroko Cardio, LLC (Philadelphia, PA) have entered into an agreement to advance

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AGGRASTAT® (tirofiban HCl) in each of their respective territories. Under the terms of the agreement, Medicure International will transfer to Iroko Cardio tirofiban drug substance and the rights to purchase additional quantities from a third party, and Iroko Cardio will make available to Medicure International certain analytical methods for testing tirofiban and, if requested

by Medicure International, certain data related to high dose bolus use of AGGRASTAT®. As consideration for the agreement, Iroko Cardio will make payment to Medicure International of US$1.91 million within six months from the date of the agreement. If Medicure International uses the Iroko Cardio data to obtain approval in the U.S. for high dose bolus use of AGGRASTAT®, Iroko Cardio may earn royalties of up to US$3.5 million on future U.S. sales of AGGRASTAT®.

Advitech Inc. (Quebec, QC) and Natunola Health Biosciences Inc. (Winchester, ON) have entered into a merger agreement to com-

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bine the business of both companies with the intent of creating a leading company in personal care and health food ingredients. Pursuant to the merger, Advitech will acquire all of the issued and outstanding shares of Natunola by way of an amalgamation between Natunola and 7894716 Canada Inc., a wholly-owned subsidiary of Advitech. The Natunola shareholders will receive common shares of Advitech based on a ratio of 4.75 common shares of Advitech (or 1.1875 common shares following a proposed 4 to 1 consolidation of Advitech shares for each common share of Natunola. All outstanding options to acquire Natunola common shares which are not exercised prior to the closing of the transaction will, subject to TSX Venture Exchange policies, be exchanged for Advitech options on the same terms. Following the Amalgamation, the Natunola shares will be delisted from the TSX-V and Natunola will continue its activities as a wholly-owned subsidiary of Advitech.

BUSINESS CORNER

Russell Williams

Canadian biotech losing ground — and capital — fast: Ernst & Young report With Canadian biotech companies capturing just two percent of all global capital raised in 2010, it’s clear the industry is losing ground on the global stage, Ernst & Young says.

This finding marks a five per cent drop since 2006.

Beyond borders, Ernst & Young’s annual global biotech industry report, shows public financing is going to only a select few companies, and private financing in Canada is at its lowest in ten years. Research and development in the sector is still decreasing and the industry hasn’t seen an initial public offering here since 2007.

“Band-aid solutions are not going to push this industry forward,” explains Paul Karamanoukian, Ernst & Young’s Canadian life sciences industry leader. “The Canadian biotech industry must look inward, get their businesses into fighting form, and reinvent themselves to capitalize on the opportunities born of the changing healthcare ecosystem.”

Karamanoukian says that means stretching dollars further to become as efficient and effective as possible.

“Healthcare is evolving into an outcomes-driven system, and there is huge potential for Canadian biotech,” he notes. “If you’re going to fail in this new business environment, you’ve got to fail fast, cut your losses, move on and start again. That’s the only way to compete.”

In actual dollars, the report found Canadian biotech raised more than US$482 million in 2010, a decrease of US$251 million compared to 2009. After removing the financing of US$325 million from one company, the sector actually raised 18 per cent more in 2010. But this is still the second lowest level in a decade.

Karamanoukian worries about what that means to Canadian companies fighting for a piece of the global pie.

“We’re at our lowest point in 10 years. But by focusing on business fundamentals and emerging opportunities, that could change.”

The report identifies four complementary approaches for biotech companies to sustain innovation in this increasingly challenging environment: 1. Prove it or lose it. In an outcomes-driven ecosystem, companies are under more pressure to prove that their products are differentiated.

2. Do more with less. Companies will need to find new ways to conduct capital raising/deployment and R&D more efficiently. That means being creative in raising, optimizing, preserving and investing scarce capital. For research and development, this could mean targeting products to smaller populations to increase efficiency at all stages of the process.

3. Build new competencies. To support the first two imperatives, managers will need different competencies like awareness of changing market dynamics, management discipline, performance measurements, the ability to measure value, and more.

4. Collaborate for co-ordinated action. Sustaining innovation will also take changes that biotech companies cannot make alone, requiring co-ordinated action with other stakeholders.

Intellipharmaceutics Announces Settlement for Its Generic Version of Effexor XR® Intellipharmaceutics and Wyeth LLC, a wholly owned subsidiary of Pfizer Inc., have settled the patent infringement litigation in the United States District Court for the Southern District of New York, relating to Intellipharmaceutics’ generic version of Effexor XR® (venlafaxine hydrochloride extended release) capsules.

Under the terms and conditions of the settlement agreement, Intellipharmaceutics has been granted a non-exclusive license to the patents in suit that will permit Intellipharmaceutics to launch a generic of Effexor XR® in the U.S. following U.S. Food and Drug Administration approval of this product. There can be no assurance of such approval of any product of Intellipharmaceutics.

“We are very pleased with the settlement of the litigation relating to our generic version of Effexor XR®, as this removes a significant barrier to the commercial launch of our generic product upon FDA approval,” commented Dr. Isa Odidi, CEO of Intellipharmaceutics. “With five products awaiting FDA approval, we continue to work aggressively to both advance and expand the number of products in our portfolio.”

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By: Matthew Frizzle

Oncology

Cancer

Therapeutics

and High Potency API Development

E

ncouragingly, the rates of cancer deaths have been declining over the last two decades, despite its continued prevalence. From 1991 to 2006 cancer death rates declined by 21 per cent for men and 12 per cent for women, according to the American Cancer Society (ACS) annual report, “Cancer Statistics 2010.”

Specifically, lung, prostrate, breast and colorectal forms of cancer have accounted for the majority of the decrease, which is attributed to early detection, better treatments and improved lifestyles (decrease in smoking for example). This is a major improvement for a challenging disease that has affected most families in some manner. However, cancer is still responsible for approximately 25 per cent of all deaths in

12 BIOTECHNOLOGY FOCUS JULY/AUGUST 2011

North America and remains a major health problem.

Further improvements can be expected from applying existing cancer knowledge and from continued research in prevention, early detection and new treatments. This article will focus on the latter and specifically for the development of new oncology therapeutics, which is a key focus area for Pharmaceutical/Biotechnology companies and research institutions worldwide. Currently, oncology therapeutics total approximately $48 billion in global sales, which represents 5 per cent of the pharmaceutical market. This figure is estimated to grow at rates between 12 to 15 per cent per year and beyond $75 billion by 2012, according to IMS Health. A review of all drug discovery pipelines reveals that approximately 30

per cent of new drug development projects target cancer indications.

The first class of cancer therapies utilized cytotoxic compounds. A key drug in this category was Taxol (Paclitaxel), which went on to achieve sales of $1.6 billon.

This first class compounds are toxic to all cells within the body, but particularly to cancer cells. Thereby, at the expense of the patient’s general health, the cancer cells are reduced through sustained treatment. The next class of compounds focuses on cancer mechanisms; disrupting cell replication pathways and limiting the proliferation of cancer cells. These compounds are often considered to be “cytostatic”.

By the shear biological nature of chemotherapeutics and the resulting mechanism of action, whether cytostatic or cytotoxic, these compounds are typically considered to be highly potent and can carry serious health consequences to the personnel that research and handle these materials. A high potency active pharmaceutical ingredient (HPAPI) is a molecule with an occupational exposure limit (OEL) of 10 µg/m3 or lower, which requires greater control of handling to minimize exposure and ultimately protect the people who work directly with these compounds. This includes thorough Environmental Health and Safety (EH&S) procedures/training for personnel and complex equipment designed for a highlevel of containment. Personal protective equipment (PPE) is used as a secondary precaution for handling such materials and cannot be solely relied on as a first line of defense. Safety is paramount for any organization carrying out chemical R&D, but even more important for handling HPAPI’s.

Constructing and operating a facility to

Oncology

Computer graphic of a molecule of taxol handle chemotherapeutics and cytotoxic variations requires considerable capital. Facilities often include dedicated suites, which are separated by positive flow airlocks.

Isolation units are also used within these spaces to contain processing equipment and material transfers. The isolation units are equipped with specialized seals at all closures and have permanently attached gloves for manipulation of the equipment.

Continual air sampling and monitoring may also be performed to ensure the systems are working correctly over time. Personnel are routinely trained on EH&S procedures, which is beyond what is required for carrying out chemistry development and

analytical services to support CMC activities for pre-clinical studies through Phase 3. The company has grown considerably and is currently staffed by 95 highly trained personnel.

Alphora continues to expand with its clients and has recently announced a $4 million capital project, which included the addition of new facilities and isolation systems to handle cytotoxic compounds.

Already having systems and considerable experience handling high potency API’s, this expansion was a logical progression technically. As well it represents a strong business opportunity as pipelines are ever expanding in oncology. This expansion makes Alphora one of a few Canadian, and

Founded in 2003 by Dr. Jan Oudenes, Alphora Research is a Mississauga Ontario based CRO that provides active pharmaceutical ingredient (API) Technology Development and pilot scale cGMP synthesis of small molecules. manufacturing for traditional non-HPAPI programs.

Founded in 2003 by Dr. Jan Oudenes, Alphora Research is a Mississauga, ON based CRO that provides active pharmaceutical ingredient (API) Technology Development and pilot scale cGMP synthesis of small molecules. Alphora’s FDA inspected operations total 45,000 sq. ft. and include synthetic laboratories, analytical laboratories, cGMP stability studies, cGMP kilo laboratories and a cGMP Pilot Plant. Alphora provides all the necessary process chemistry and

among a select group of North American based CRO’s that can work with cytotoxic API’s.

Rigorous cleaning procedures for processing equipment is important for all therapeutics, but due to the typically low therapeutic dose and mechanism of action of HPAPI’s, it is more important.

Proper cleaning procedures with validated analytical methods ensure public safety from possible cross contamination. This is even more important for multiple product facilities such as CRO’s, which are used

more frequently by pharmaceutical and emerging biotechnology companies. Even if companies have chemistry and manufacturing capabilities in-house, they often choose to outsource HPAPI projects due to the specialized technology and regulatory requirements. Alphora has a separate QC/ QA department that tests and verifies the cleanliness of all product contact equipment before it can be used.

In summary, it is exciting to observe the strides being made against cancer over a relatively short interval. However, this devastating disease remains a major health issue and is driving a considerable amount of research across all healthcare disciplines and specifically for new therapeutics. Due to the inherent safety concerns of these HPAPI’s and cytotoxic nature of oncology compounds, they require specialized equipment, safety procedures for personnel and cleaning procedures for patient safety.

References: 1. CA Cancer J Clin 2010, A. Jemal et al., “Cancer Statistics, 2010“ 2. Cancer Society’s Steering Committee on Cancer Statistics. Canadian Cancer Statistics 2011. Toronto, ON: Canadian Cancer Society; 2011. May 2011 3. IMS Health Press Release May 15, 2008 (http://www.imshealth.com/portal/site/ imshealth/menuitem.0103f29c72c419cd8 8f611019418c22a/?vgnextoid=41a67900b 55a5110VgnVCM10000071812ca2RCRD) 4. Chemical & Engineering News, “Contained Chemistry” June 16, 2008, Vol 86, Number 24, pp. 17-27 Mr. Frizzle is an Account manager at Alphora Research Inc., in the Business Development group.

He obtained a MSc degree in organic chemistry from the University of Western Ontario and has drug development experience in process chemistry, project management and business operations. Prior to joining Alphora in 2007 he held positions with Patheon and Amgen.

For more Oncology information visit our Drug Discovery Web Portal at www.bioscienceworld.ca JULY/AUGUST 2011 BIOTECHNOLOGY FOCUS 13

Compiled by Biotechnology Focus and BIOTECanada

SPOTLIGHT

CANADA PUTS ITS BEST FOOT FORWARD at Biotechnology’s annual jamboree

T

he 2011 BIO International Convention, the world’s largest biotechnology conference and trade show, took place from June 27 to 30 in Washington DC. In all, BIO drew more than 15,000 industry leaders from 48 states and 65 countries. Organizers stated that these numbers reflected increased international attendance and participation at the event and that there were also a record number of partnering meetings (21,183 in total between 2,410 companies).

On the floor, the BIO Exhibition featured more than 1,800 exhibitors and covered 180,000 square feet with 61 state and international pavilions.

Taking centre stage was Canadian delegation of 800 strong, which was once again the largest international delegation at the event. The delegation included leaders from industry and academia and they were joined by two Premiers (Alberta’s Ed Stelmach and Nova Scotia’s Darrell Dexter), Ministers and even Mayors.

The Canadian Pavilion opened in true Canadian fashion with an official puck drop ceremony. Minister of State (Science and Technology) Gary Goodyear led the delegation of biotechnology and pharmaceutical executives and scientific leaders to promote Canadian biotechnology while the kick off itself offered the chance to shine the spotlight on the best and brightest, and to tell the world about what’s happening in our own backyard.

“Having representatives from all three levels of government including two Premiers and five Ministers highlights the importance of our industry to the Canadian economy,” commented BIOTECanada president and 14 BIOTECHNOLOGY FOCUS JULY/AUGUST 2011

CEO Peter Brenders. “With more than seven per cent of our national GDP being generated every year as a result of biotechnology development and use, all regions of Canada are realizing the benefits of this growth.”

In the spirit of working together to strengthen the industry across the country, BIOTECanada hosted a bio-economy roundtable meeting to discuss the next opportunities for success as Canada grows its bio-economy. The roundtable included an in-depth analysis of where Canada was punching above its weight, and where it was lagging behind the competition.

Moreover several deals were signed among the provincial organizations including an agreement between Saskatchewan and Manitoba, and another between Ontario and Quebec.

Internationally, BIOTECanada announced a new agreement (memorandum of understanding) with the BioIndustry Association (BIA-United Kingdom) to encourage and foster cross-Atlantic collaborations within the industry in both the UK and Canada.

BIO concluded with BIOTECanada handing out its Gold Leaf Awards. Taking top honours for company of the year was Cadiome Pharma Corp., while Allon Therapeutics was the winner for Early Stage Health Company of the year. Other winners included EnWave Corporation for Early Stage Industrial and Agriculture Company of the Year, Sanofi Pasteur Limited for Contribution to Canadian Communities, Yves Rosconi won an individual award for Industry Leadership and Gordon Jans of Price Waterhouse Coopers was honoured for his contribution to the association.

The 2012 BIO International Convention will take place June 18-21 at the Boston Convention and Exhibition Center in Boston, Mass. For more information, please visit http://convention.bio.org/2012.aspx.

For more INNOVATORS information visit our PROFILES Web Portal at www.bioscienceworld.ca

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Reply Card #4924

By: Mary Ann Colihan

INNOVATOR

Green Crude

FrOM pYrOLYsis C onverting raw biomass through pyrolysis into valuable bio-oil products is a modern way to spin straw into gold.

London, ON based Agri-therm Inc. is on track to harvest the yield from this green crude oil.

Agri-therm is set to launch a commercial-grade mobile pyrolysis unit. “We will start to manufacture the MPS200 unit by June 1 and build it out over eight weeks,” says Jennifer MacDonald, the chief operating officer of Agri-therm.

This patented, portable unit can be hauled from farm field to vineyard to lumber mill to process a wide range of biomass waste such as corn stover, grape peels and wood chips. “There are millions of tons of biomass worldwide and we only use non-food waste” says MacDonald. “Mobility is our market niche – biomass can be seasonal and expensive to remove.”

In pyrolysis, biomass is broken-down at high heat in the absence of oxygen. The resulting condensation becomes bio-oil and the biochar - a charcoal-like substance - is the solid residue. Bio-oil can then be upgraded into value-added fuels, pharmaceuticals and chemicals, including environmentally friendly insecticides and pesticides. Char becomes an ecologic additive to fertilizer.

What gives pyrolysis lustre is that it is a closed-loop system. Offgases such as hydrogen, carbon monoxide and carbon dioxide are captured to fuel the combustion process.

Paul Paolatto is CEO of Agri-therm and executive director of WORLDiscoveries, the Business Development Office for the University of Western Ontario. “What makes this solution so compelling is that it can finally deliver on the world’s increasing demand for fuel from renewable sources in a cost effective and environmentally efficient manner,” says Paolatto.

Agri-therm can tap into the expertise of a highly-skilled biofuels research and development team located at The University of Western Ontario’s Institute of Chemicals from Alternative Resources (ICFAR) led by engineering professors Franco Berruti and Cedric Briens – global experts in pyrolysis. “Our location at ICFAR gives Agri-therm a close link to a teaching university,” says MacDonald. “We are a small start-up with access to a huge research facility that pioneered this R&D.” MacDonald braved the dragon’s den on CBC to raise funds for Cenabal Gourmet Organics - her start-up company that made healthy salad dressings - and was awarded $200,000. The Dragons were tame compared to the jungle for private equity. Agri-therm’s ask is $2-3 million. “We may need to go outside of Canada for funding but that is not our goal,” she says.

16 BIOTECHNOLOGY FOCUS JULY/AUGUST 2011

The Agri-Therm team

“Canada can be a tough place to raise capital particularly for early stage technology,” says Paolatto. “However, I am hoping that Agri-Therm’s value proposition is so persuasive that we fund the resources to realize its promise and keep the resulting manufacturing jobs at home.”

Agri-therm’s advanced prototype mobile pyrolysis unit, built by Abuma Manufacturing of London, is hardened for a wide-range of field conditions. “We had lots of run time and all kind of experiments in the past year to build the second generation system,” says MacDonald. “And we did extensive testing on the feeder, condensation train and fluidized bed reactor.”

INNOVATOR “We had lots of run time and all kind of experiments in the past year to build the second generation system, and we did extensive testing on the feeder, condensation train and fluidized bed reactor.”

– Jennifer MacDonald

As a result Agri-therm expects the MPS200 series will be ready this summer and can process six tons of biomass per day. “The University of Veracruz in Mexico will get the first MPS200 because they need higher capacity,” says MacDonald. “After 12 months of run time in the field we’ll start the design-build for the third generation - the commercial model – with a ten ton per day capacity.”

The biomass market potential is huge. “There is 1.4 billion tons of forestry waste alone per year globally and forestry products have the best heating value,” says MacDonald. “We just need a small fraction of that – just 1 per cent of this forestry waste would keep 5,400 mobile pyrolysis units working full time.”

Another benefit is that all pyrolysis by-products have value. Agritherm has just hired a post-doctoral expert in bio-char to focus on this promising application. “Lesser quality bio-oils can also be tweaked to produce higher quality bio-char that can be sold as a fertilizer additive and for carbon capture,” says MacDonald. “There is much interest in char because carbon is no longer bio-available - it’s a carbon sink. And when it is applied to substandard crop land, char helps retain water and greatly improves yield.”

Other vast market segments are also a target. “Animal renderings are promising but still need research,” she says.

These are the challenges that inspire Federico Berruti, an Ivey graduate and PhD candidate in engineering. Berruti is also a vice president at Agri-therm - the bridge between the technical and business people. His PhD research is focused specifically on feeder and demisting technologies – two critical aspects to make the pyrolysis unit cost-effective and energy efficient. “I love small business. I have a vision of being an entrepreneur and an academic,” says Berruti who holds a Vanier scholarship – a prestigious award that pays $50,000 per year to Canada’s top doctoral candidates.

His Agri-therm team is trying to develop a new industrial process.

“We are working to separate and capture the very fine particles of bio-oils – they are essentially like a mist or an aerosol and a special device is required,” he says. “With filters you can get a pressure and flow problem. With the demisting device we use centrifugal force and throw droplets against a surface and collect them once they coalesce. This way you never build up pressure and it’s self-cleaning.

We are trying to reach the 98 per cent efficiency in our second generation unit.”

Agri-therm’s feeder technology has been designed for sticky biomass or residues - in addition to conventional feedstocks. Sticky

biomass can plug the feeder and spike energy use. “We have designed an intermittent, high-velocity slug system that shoots biomass slugs into the reactor,” says Berruti. “This helps flow and there is no particle size issue. We can handle cohesive or sticky and temperature sensitive biomass like chicken litter, lignins and meat residues. You don’t want meat residues in the system long because it can melt, get sticky and plug the feeder.”

The ICFAR feeder technology is a core area of R&D for Berruti’s team with many potential applications. “We may commercialize the feeder technology alone, as well as adding it to our MPS200 units,” he says. “We are manufacturing and testing them both at the laboratory and commercial scale.”

Berruti is excited about their renewable energy portfolio and says the market opportunity is huge with room for many players. “We can see working in the future with conventional oil companies,” he says. “Our core competencies are with reactor design and R&D. We are not into refining, mass-manufacturing, or transmission - we want our pyrolysis units in the field.”

On the horizon there are North American companies building large fixed pyrolysis plants with a strategy to use the existing infrastructure of conventional oil refineries and pipelines to process, upgrade and transport bio-oil. “Bio-oil is acidic with a high water and oxygen content and needs to be upgraded,” MacDonald explains. “Upgrading is not part of our business plan. But this is where our clients can send their bio-oil. And we can act as broker.”

The challenge with a fixed plant is that beyond 100 kilometers transporting biomass to the plant become unprofitable. “Our product will condense the biomass down into a low-volume, high value product that can then be shipped to a centralized upgrading facility,” says MacDonald. “By the time we are finished with our generation three prototype in 18 months we are confident there will be a growing market for bio-oil. And yes, we can see bio-oil going into our vehicles.”

Cost-effective, renewable crude from biomass waste, refined for our gas tanks – now there is a pot of gold.

For more INNOVATORS information visit our PROFILE Web Portal at www.bioscienceworld.ca

JULY/AUGUST 2011 BIOTECHNOLOGY FOCUS 17

By: Shawn Lawrence

Genomics

The Building Blocks of a

Genomics Industry

E

leven years ago, policy makers in Ontario recognized the enormous impact genomics could have on biology, on medicine and on our understanding of life itself. As such, they recognized the need to develop a strategic and proactive approach to supporting genomics research in Ontario by creating an organization to oversee efforts in this emerging science field. The Ontario Genomics Institute (OGI) has since spent the better part of its ten plus years as an advocate for and supporter of research development in genomics. In our June 2011 issue of Biotechnology Focus, OGI president Dr. Mark Poznansky discussed some of the ways OGI was supporting research development and also explained how genomics is changing the world and why supporting research in this exciting field is so very necessary.

“Quite frankly, the genomics sector is driving the entire biotechnology industry and not only in health but also in food, agriculture and the environment.

Genomics to us is the major driver of the life science economy, which is much larger than health so the bottom line is we need to do everything we can to stimulate this sector,” he said.

But supporting research is only part of the equation he explains.

There is also a need he says to find new ways of translating the

18 BIOTECHNOLOGY FOCUS JULY/AUGUST 2011

fruits of this research into commercialized products. It’s a philosophy that is gaining momentum at OGI. “We always knew that the next logical step at OGI was finding innovative ways to spark business development in the sector, so we have to go back a couple of month’s to when OGI set about on its new mission or objective, and that is to be a catalyst or a driver for the life sciences industry in Ontario,” states Dr. Poznansky.

This, he says is quite an important diversion from when supporting genomics research was OGI’s prime objective.

“Right now, OGI relies on two primary programs to fulfill its new mandate. The first is its Pre-Commercialization Business Development Fund or PBDF program and the second, which was just initiated six weeks ago, is the SPARK technology development program.”

Poznansky explains that OGI’s PBDF program invests in genomics, proteomics, and other ‘omics’ technologies that are in the proof-of-principle phase of research.

“The PBDF funds business (early stage business albeit) and entrepreneur scientists within academia. Our conditions are very simple, we take a little equity but it’s not a big deal for us, our major thing is not to make money on these things, it’s to help drive these commercial ideas and companies.”

Additionally, chosen projects must have potential to reach the marketplace.

Likewise, the idea behind the latter program (SPARK) is to ‘spark’ technology development and business creation.

“Primarily it is an approach that gives researchers the ability to obtain research funding. But the end goal of these unique investment and funding strategies is to spark company creation. It’s early stage funding for technology development and also for fasttracking a product from either an academic or private lab,” he said.

“This is a new initiative for OGI, similar to the type of grants given out at the Broad Institute in Boston. It’s geared to an academic who has a real bright idea for a product and there are instances he or she needs maybe $50,000 to do a couple of experiments over the course of six months. There’s just no funding mechanism for that currently. So, we saw that niche and that is why we created this program.”

The SPARK program was officially announced April 15, 2011 and proposals were due on June 15, 2011. Dr. Poznansky expects that funds will flow by mid-October.

“If the winning proposals just result in a nice publication then we will be disappointed, but if they result in products and big applications for commercialization of something then we will have succeeded. It’s a model American companies like Apple and Microsoft have

Genomics used to let its really bright people stimulate, to think, to make things happen outside of the box. We want to see if we can capture that with the universities in Ontario limited to the genomics area. Like the PBDF, we want to see what the product is, and we want to see what it is within the year, so it’s very aggressive on the innovation side and the to market side.

Just as an example, we just declared six of the applications ineligible because while they were great science, we didn’t see a market for the product, they weren’t commercially interesting opportunities.”

Dr. Poznansky is adamant that this is more than just about funding research for the sake of funding research. The goal he says is to fund technology that has the potential to be commercialized.

ArcticDx and DVS Sciences; two examples of Canadian genomics success stories Molecular diagnostics company ArcticDx is one such company that has grown out of applied research funding doled out by Genome Canada through OGI. It is also an example of how OGI’s funds can lead to company creation. Dr. Tom Hudson, OICR’s president and Scientific director, and Dr. Brent Zanke, then vice-president OICR and director of the Ontario Tumour Bank, were co-leaders of the Assessment of Risk for Colorectal Tumours in Canada (ARCTIC) project that included a project team of co-investigators from the U.S., France, England and Scotland.

The project was focused on the discovery of a genetic marker set that could predict future colorectal cancer risk.

“The decision to create a company was pretty straight forward,” says Dr. Zanke, founder, chairman and chief medical officer of ArcticDX. “It was originally perceived to be an opportunity to do large-scale genomics projects, but it is integral to the Genome Canada application process that a detailed description of how the discoveries are going to be commercialized are included and so from the very first day we anticipated a spinout company that would benefit from any intellectual property that might be identified and so the company was formed.”

Consistent with the company’s goal to offer personalized medicine through genomics, ArcticDx developed a test to predict people’s genetic susceptibility to age-related macular degeneration along side its flag ship colon cancer susceptibility product.

“The genetics of AMD are well defined and the condition is a huge public health problem,” says Zanke, “We were able to secure a dominant intellectual property position through inlicensing early in the discovery process.”

Remarkably within five years the company has been successful in its attempt to develop a test for AMD, and that it is already receiving market uptake. The test, Macula Risk®, can determine one’s inherited risk for AMD. It is being used in thousands of medical offices and its market uptake appears to be doubling every three months. The test is intended for patients who are over 65 and have a diagnosis of early or intermediate AMD. “This is the most common cause of common blindness in the developed world, and the way the disease works is that in your senior years, people get hard deposits in the back of their eyes, and in about 30 per cent of cases these hard deposits induce bleeding and if they bleed you get scar formation and you can’t see,” says Dr. Zanke.

Using the complete combination of AMD genes and smoking history, the test which is a cheek swab identifies those most likely to progress to advanced AMD with vision loss by detecting variations in genetic markers known to predict the early asymptomatic AMD. “The markers we have are about 83 per cent accurate, meaning that if you had an individual who has these dry deposits, you can predict about at an 80 per cent accuracy, whether that person would develop blindness associated AMD or not. After the cheek swab sample is taken, they are processed by a lab located in Denver, Colorado. The reports are then returned back to the practitioner, who is then encouraged to manage patients on a protocol developed in collaboration with retinal specialists in Nashville, Tenn. which we call the Nashville Protocol.

It provides a very clear road-map for optometrists and physicians.”

“It’s something pretty remarkable, that over the last five years we’ve identified other opportunities in molecular diagnostics, but at the same time have taken one from the concept stage to commercial profitability,” he says.

In 2010, OGI provided a $100,000 PBDF investment to specifically help with the commercialization of this product.

“We’ve used the PBDF investment to partially support studies in support of a planned filing for Food and Drug Administration (FDA) approval for Macula Risk®. So now we have the FDA study in play and we expect to get that study complete by the end of the calendar year.”

And now with the AMD product in an advanced state of sales and marketing, Zanke believes that the revenue from that will further drive what’s in the company’s pipeline, including the colorectal test that initiated the ARCTIC project and a growing list of pharmacogenomic opportunities.

“Primarily it is an approach that gives researchers the ability to obtain research funding. But the end goal of these unique investment and funding strategies is to spark company creation.” ­— Dr. Mark Poznansky Another company that was formed as a result of a project that received financial backing from both Genome Canada and OGI is DVS Sciences Inc. DVS is a beyond-earlystage biotechnology company that develops, manufactures and markets analytical instruments and reagents for high throughput, massively multi-parameter single cell analysis. The company itself spun out after OGI started funding it early on in 2005, with funds going to then principal investigator John Dick to build a mass spectrometer-based flow cytometer. Further funds were given to DVS Sciences via Genome Canada’s Technology Development Competition in 2008.

The culmination of six years of technology development has led to the development of a first-in-class analytical instrument, the CyTOF™ Mass Cytometer. The technology has been called a ‘game changer’ within the industry.

“It’s a cross between a flow cytometer and an atomic mass spectrometer,” says company president and founder Dr. Scott Tanner. “The device can be used whenever investigators need to know more about single cells, either for understanding the biochemistry of genesis or for rare cell detection. Current users apply it for immuno sub-population of complex samples, such as bone marrow; looking for correlates of viral pathogenesis; for identifying rare disease cells such as cancer stem cells or circulating tumour cells.

The technology came out of my research group - it was initially conceived when we JULY/AUGUST 2011 BIOTECHNOLOGY FOCUS 19

Genomics

“The solution for that problem was to tag the affinity reagents, and principally those are antibodies with stable isotopes (atoms of elements), and measure those atoms with an atomic mass spectrometer.” ­— Dr. Scott Tanner

were working for the company MDS Sciex.

But in order to further develop it and bring it to market we had to make the decision to leave MDS Sciex and move to the University of Toronto.”

There, Tanner and his team benefited from support from Genome Canada through OGI and a variety of other public and private foundations, which in turn allowed them to establish DVS Sciences Inc. to develop the instrument and bring it to the market.

“In all it came out to $17 million, of which explicitly $6.5 million came from OGI, and the rest from co- funding, i.e. the ORF Global Leadership fund award we got last year and the Ontario Research Fund –Technology Development fund we had two years ago.

We’ve also had funding from Canadian funding agencies such as HTX, OCE, ORF, OICR.” The device uniquely combines the considerable analytical capabilities of atomic mass spectrometry with the power of flow cytometry for cellular analysis. The instrument extends the assay capability to simultaneous quantitative and independent determination of up to 100 biomarkers in individual cells.

According to Tanner, the device has many research applications.

“When one is interested in the heterogeneity of a sample, that is if you’re looking for a rare population of cells in a complex matrix of cells, the right technology for that is called flow cytometry. In flow cytometry, 20 BIOTECHNOLOGY FOCUS JULY/AUGUST 2011

you recognize proteins with antibodies or genes with oligonucleotides (affinity assays) and the affinity products are conjugated to fluorophores, and so in conventional flow cytometry you do fluorescent detection of the antigens at the single cell level. The challenge with flow cytometry is if you try to measure more than four things at the same time, then the fluorescent signals overlap and they require compensation between detection channels which is increasingly difficult with the more parameters you do.”

The solution for that problem says Tanner was to tag the affinity reagents with stable isotopes (atoms of elements), and measure those atoms with an atomic mass spectrometer.

“The advantage being that there are many stable isotopes of many elements that can be used as probes, and the mass spectrometer gives exquisite resolution between the channels so that no compensation is required.

We’re really fundamentally no longer limited in the number of things we can measure at a single time at the single cell level. Today we can do 35, and in a few months we’ll be looking at doing 60 at a time, and it’s conceivable to do a hundred parameters at the same time at the single cell level at a 1,000 cells per second. The basis of its transformative nature lies in the incredible amount of information that it makes available. Instead of trying to identify a cell with a fairly small feature fingerprint, we’re looking at the massive multiplex signature of cells, and that allows very good and confident recognition of a rare cell in a complex matrix, but also allows the interrogation of translational pathways that are the functional proteomics of the cell,” Tanner explains.

As such, the functional proteins that are translated from the genes and that are the machinery of the cell can be interrogated in many dimensions simultaneously because the device has independent probes for measuring those.

In addition to the CyTOF™ Mass Cytometer, DVS Sciences Inc. is also the manufacturer of (the metal-labeled) reagents that the instrument reads, which are called MAXPAR® (standing for maximum parameters), and the supporting technologies used for simplifying massively multi-parameter analysis of single cells. The MAXPAR reagents include a reagent set for appending stable isotope tags to affinity reagents, including a methacrylate polymer that has 30 repeat units that bind 30 atoms of stable isotope atoms.

Combined with the MAXPAR reagents, CyTOF™ is a tool that Dr. Tanner believes has the potential to set a new standard in

hospitals, clinics and research departments around the world.

“That’s our clientele really. Firstly researchers who are interested in the genesis of disease, those are going to be cancer researchers, viral pathogenesis researchers, people who are looking at what is happening at the single cell level that causes a disease to form and interrogating that at the protein level, not necessarily only at the gene level. And for Drug Discovery, we can interrogate many target pathways simultaneously to identify when a drug interacts with a particular translational pathway (which is what a drug does), and you can come up with all the parallel pathways that are either stimulated or suppressed at the same time, and it will give the drug discovery people far more information before they go to the clinic, enabling them to “fail early and fail often”, but take the right products into the clinical trial. And a third group is clinical researchers who are looking for diagnostic panels that will be used in the personalized health prognosis market or looking at signatures of disease so that they could be monitored through diagnosis, treatment, remission and, hopefully not, but relapse,” he said.

Overall, Tanner believes that the development of the technology wouldn’t have been possible without the assistance of OGI. “OGI has been a terrific opportunity for us: it was a mechanism that facilitated us to get going and I’m glad we did this in Canada.

We couldn’t have done this any other way.”

While OGI definitely had a role to play in both the ArcticDx and DVS Science Inc. stories, Dr. Poznansky believes that the true credit for the early successes of these companies should go with the scientists and researchers who had the vision to take these technologies, develop them and see them through to the market.

“I have a silly expression that I sometimes use, credit is infinitely divisible,” he commented. “Helping them overcome the challenges and the hurdles, and taking one of the original chances on them. Sure we’ve been very important to the process, but their science is the true success story. They both came forward with financially viable commercial ideas that were past the academic laboratory stage, and they had the drive to take them through to commercialization.”

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

We don’t go home happy until you do.

Maurice

Downtown Ottawa 377 O’Connor St. 800.465.7275 victoriapark.com

and the snow storm

Maurice, our Front Desk Agent, isn’t exactly a huge fan of the snow.

And driving in the stuff? He dislikes that even more. But one cold, grey December evening, our intrepid Maurice ventured out into one of the biggest storms of the season.

What could have driven him to drive into this tempest? His sense of duty.

You see, one of our guests had left an important item behind.

Knowing that a cab wouldn’t make it to the airport in time to reunite our guest with his property, Maurice took matters, as well as a frigid steering wheel, into his own hands. Arriving at the airport with mere minutes to spare, Maurice personally handed the item to our surprised, and extremely relieved, traveller. Proof once again that, even after you’ve left our hotel, you’re still a VIP.

Really,

ReallyBig Hotel Suites.

The moment.You know it.

It happens any time you stay at a new hotel, right after you swipe your room key. The moment before you open the door. Will the room be big, or small? Light, or dark?

Nice, or not?

and feature real bedrooms, real kitchens and real living rooms. And they don’t cost any more than those of our competitors. Really, why would you stay any place else?

Here’s what you’ll find the moment you open your door at Albert at Bay—space, and lots of it. Our suites are the biggest in Ottawa

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613.238.8858

RESERVATIONS 800.267.6644 ALBERTATBAY.COM

Reply Card #4924

by Jeffrey Graham

Across Canada

COMMERCIALIZATION OF BIOTECHNOLOGY

IN CANADA

There has never been a better time to commercialize biotechnology in Canada. After more than a quarter century of experience with its applications finding their way into the global economy, Canada is poised to make its greatest impact on the global bio-economy.

22 BIOTECHNOLOGY FOCUS JULY/AUGUST 2011

across canada The 2010 Global Biotechnology Survey prepared by Scientific America reinforces the promise of biotechnology commercialization in Canada. The survey found that Canada ranked behind only the United States and Singapore, in terms of the foundation for biotechnology based on IP production and activity, biotechnology innovation intensity (application), enterprise support, educational and workforce strength, and general foundations (R&D expenditures per GDP).

While medical biotechnology attracts the most public attention, the Canadian bioeconomy transcends the entire Canadian economy. As noted by BIOTECanada in its report on the Ontario bio-economy, car seat foam made from soybeans, new vaccines, bio-diesel and engine oils made from oil seed crops, biological therapies for Alzheimer’s and cancer, new plastic composites from agricultural sources, trans fat free cooking oil, renewable biomass energy sources, and biological based environmental control systems, are examples of the applications of biotechnology to many sectors of the economy.

In the recent Canadian federal election, the Conservative Party of Canada campaigned on a platform that included strong support for research and development. The new Government will be looking for advice from a panel of experts that is conducting a comprehensive review of all Canadian federal business research and development initiatives. The objective of the review, to be completed later this year, is to ensure the investments of our federal government deliver results. According to KPMG, Canada’s R&D environment ranks first in

terms of cost competitiveness for biomedical R&D amongst the G-7 nations. Canada has also established the fastest rate of growth in external patent applications and in industry investment in R&D among G-7 countries. Canada provides 20-year patent protection for pharmaceuticals, ensuring a favourable and stable investment climate for innovation. Recent amendments to data protection provisions in the Food and Drug Regulations, will benefit innovative drug companies by guaranteeing a minimum of eight years of market exclusivity for their products. A further six months of protection is available to drugs, which have been subject to paediatric studies.

Canada has many other strengths. Overall, as a location for manufacturing, Canada has the lowest costs to establish and operate a manufacturing facility when compared to all other G-7 countries. Federal taxation offers a 20 per cent non-refundable tax credit for public companies and a 35 per cent refundable tax credit for private companies on current R&D expenditures, including capital expenditures on R&D and machinery and equipment. The Scientific Research & Experimental Development (SR&ED) program provides tax incentives to eligible companies that develop new or improved technologically advanced products or processes in Canada. When these incentives are combined with similar tax credits from Canada’s provincial governments, the after tax cost of R&D expenditures can be reduced by as much as 60 per cent. These generous incentives mean Canada has the lowest effective tax rate amongst its major competitors.

The 2010 Global Biotechnology Survey prepared by Scientific America reinforces the promise of biotechnology commercialization in Canada.

Last year the Canadian federal government made changes to the Income Tax Act (Canada) that mean certain foreign investors such as U.S. venture capital funds are no longer required to file Canadian tax returns on top of their foreign tax returns, or fill out section 116 certificates upon exit.

It is believed that this change will open the doors for investment into Canadian biotechnology firms, and signals an “open for busi-

reply Card #4925 JULY/AUGUST 2011 BIOTECHNOLOGY FOCUS 23

Across Canada

The current provincial government of Ontario has demonstrated its commitment to fostering a bio-economy through a wide range of program initiatives, based primarily in the Ministries of Research and Innovation and the Agriculture, Food and Rural Affairs.

ness” attitude by the Canadian government.

Equally important to creating a favourable environment for the Canadian bioeconomy, is a strong overall economy.

Canada’s economic performance continues to lead all other members of the G-7 Group of industrialized nations. The Organization for Economic Co-operation and Development (OECD) reported that Canada’s economy grew by 6.2 per cent in the first three months of this year. The OECD expects Canada’s economy to grow 4.5 per cent through the second quarter - nearly twice the G-7 average.

While capital formation and availability continues to be over weighted in favour of Canada’s natural resource based sector, there are signs that capital availability for technology sectors that are biotechnologyrelated is strengthening. This is particularly true in the clean-tech sector where a number of new funding initiatives have been announced in recent months.

In addition to a strengthening economy, and a federal government committed to a stable tax environment, one can expect to see continuing support for the bio-economy from provincial governments in regions of the country where a significant cluster of biotechnology already exists.

The current provincial government of Ontario has demonstrated its commitment to fostering a bio-economy through a wide range of program initiatives, based primarily in the Ministries of Research and Innovation and the Agriculture, Food and Rural Affairs.

Québec has been very effective in developing and sustaining policy initiatives that have resulted in Québec attracting and retaining an enhanced level of bio-pharmaceutical research and development activities. Of all Canadian jurisdictions, Québec has long recognized the potential to attract biopharmaceutical research and development ac24 BIOTECHNOLOGY FOCUS JULY/AUGUST 2011

tivities by enhancing formulary access and protecting brand medicines from generic competition.

In Western Canada, the governments of Saskatchewan and British Columbia have also made a strong impact on the development of local bio-economies. For example, Saskatchewan is recognized as one of the world’s leading Ag-biotech research centres. British Columbia has been the home of some of Canada’s greatest commercial success in biotechnology, including QLT, ID Biomedical and Angiotech. Other parts of Canada have also worked hard to nurture biotechnology in their jurisdictions, including the Maritime provinces, Alberta and Manitoba.

Looking Ahead In the fall, there will be an election in the province of Ontario. It is reasonable to expect that both of the lead political parties Liberals and Conservatives, will continue to be committed to promoting research and innovation, including support for the bio-economy. In the next year or so, there will also be elections in Québec and British Columbia. These jurisdictions are likely to continue their support for their respective bio-economies.

These upcoming provincial elections present opportunities for industry groups to lobby for greater support. The two main national associations - BIOTECanada and Rx&D - have both presented important agendas for further reform. BIOTECanada has tended to lead advocacy efforts to enhance the SR&ED tax credit regime, seeking reforms to extend the refundable tax benefits to companies that are not Canadian controlled private corporations. In addition, BIOTECanada has developed and advanced a credible and well researched position to advocate for permission to

adopt share structures that allow investors in emerging companies to use losses incurred by such companies to off-set income, i.e., flow-through shares. Canada’s current flowthrough shares program was enacted by the Canadian federal government in 1954 as a means of encouraging private sector investment for natural resources exploration. Today, flow-through shares issued by oil, gas, mining and renewable energy companies have been instrumental in Canada’s success as a leading resource nation. The hope of many industry leaders is that the Canadian government will create similar incentives to ensure that Canada’s status as a leading biotechnology jurisdiction.

Rx&D has made a strong case that Canada’s intellectual property laws need to be enhanced to ensure that Canada has a system of protection that is an incentive for companies to establish in Canada. In addition, Rx&D members have also made an effective case for government procurement of pharmaceutical products that encourage local commercialization.

Over the next few years, as the bioeconomy continues to contribute to Canada’s prosperity, one can expect that the important ground work that has been laid to facilitate commercialization will begin to pay enhanced dividends.

Jeffrey Graham is a partner of Borden Ladner Gervais LLP and the head of the firm’s national life sciences practice.

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

NEW PRODUCTS Titrator JM Science’s AQUACOUNTER® Volumetric Karl Fischer Titrator (AQV-300) is reliable, easy-to-use and has state-ofthe-art performance features which allows measure of moisture content from low to high concentrations quickly and accurately.

The AQV-300 has six built-in calculation modes to accommodate solid, liquid and gas samples. It includes a statistics package with one-touch calculations. Four files with preset conditions can be stored in memory and allows instant recall of data for up to 20 samples. A built-in detector monitors titration status and a direct key access allows entry of titration parameters.

This compact unit comes with DVD training movie, plasticized Quick-Start guide for use in the lab, paper and pdf manual. Also included, complete accessories, download software for transferring results to a laptop or PC, RS-232 cable, and AQUACOUNTER® KF Reagent starter kit. Choice of thermal printer or impact printer is available.

Reply Card #4926 Pipette Biohit Inc. has introduced a new eLINE Pipette with a range from 0.1 µl to 5 µl and super pipetting feature. Extremely rapid piston movement allows complete emptying of the tip, making it possible to dispense the very small volumes from the air which is not possible with the regular pipettes. Pipetting small volumes against receiving vessel wall or under the liquid surface to get all liquid out of the tip causes contamination risk, decreased precision, and slow pipetting work. Usually contaminations can be avoided by changing the tip between dispensing, but with the eLINE 0.1 - 5 µl 26 BIOTECHNOLOGY FOCUS JULY/AUGUST 2011

dispensing from the air enables continuous work with the same tip as there’s no need to touch the vessel or liquid. The super pipetting feature makes it possible to get the dispensed volume inside e.g. the microplate well when the problem is the electricity of the microplate causing the drop stick to the surface of the well.

fragile protein samples. The instrument also features a temperature control capability, making it suitable for performing automated temperature studies.

Reply Card #4927 Workstation The Shimadzu Perfinity

Reply Card #4929

workstation automates protein sample preparation, allowing users to start with serum and have peptides ready for LC-MS analysis in as little as ten minutes. In addition to a dramatic reduction in sample prep time, the system generates CV values of less than ten per cent for the overall process of affinity selection, proteolysis, and peptide assay. This automated process removes much of the equipment and manual labor associated with more common sample preparation techniques of proteins for LCMS analysis, freeing the scientist up to dedicate more time to more intellectually challenging activities.

Reply Card #4928 Mobility Instrument Wyatt Technology Corporation Möbius™ electrophoretic mobility instrument can measure precise protein charges. With innovative optical design, Möbius boosts the sensitivity of mobility measurements, enabling protein net charge characterization at much lower concentrations than previously possible.

The key to the successful measurement of a proteins’ mobility lies in a much shortened measurement time and the availability of sufficient data to average away molecular diffusion. The Möbius achieves these goals through massive parallelism of its light scattering detection and extends the measurable molecular size range below two nm. A reduced measurement time of fewer than 60 seconds, in most cases, contributes to excellent preservation of precious and

EASY-nLC 1000 The Thermo Scientific EASY-nLC 1000 is the newest addition to the EASY-nLC family of nano-LC products.

The EASY-nLC 1000 is unique in its ability to facilitate dedicated separation of biomolecules, such as proteins and peptides, at ultra-high pressures. The instrument can seamlessly integrate with the complete range of Thermo Scientific mass spectrometry (MS) systems for instant, trouble-free operation and uses shorter gradients on 50 µm UHPLC columns with 1.9 µm beads.

The EASY-nLC 1000 facilitates peptide and protein identifications by providing higher pressure ratings, along with independent and simultaneous variations of bead size and column length. The device operates on the Thermo Scientific Xcalibur software platform, easily connecting and interfacing with the full suite of Thermo Scientific LC-MS systems. Additionally, the split-free, nano-flow capability of the new system provides excellent retention-time reproducibility (below 0.4 per cent RSD), even for very complex samples. The simple integrated configuration is both easy-to-use and robust.

Reply Card #4930

NEW PRODUCTS Log-EZ The log-EZ from TandD Corp. can be easily used to measure and record temperature and humidity in various places such as laboratories, production facilities, warehouses, office buildings, homes or any location where these parameters are important. The range of each log-EZ is up to 150 ft. and up to 16 loggers can be connected to a single system. By “daisychaining” the individual loggers, communication over a considerable distance can be achieved. Wireless communication makes data transmission easy and simple with no need for cables or gathering the log-EZ units to collect the data. The units have a temperature range of 0 to 50°C (±1°C) and a humidity range of 15 to 90% RH (±6%RH), which are can be viewed on a large and easy to read LCD display. The log-EZ records data and can store 1,440 readings. Current readings can be viewed in real-time on a PC, and recorded data can be automatically downloaded and archived for future reference. For ultrasimple setup, the kit includes the RTR-322 recorder, the RTR-320 USB transceiver, software and mounting bracket.

Reply Card #4931 JEM-2800 The JEM-2800 is JEOL’s latest addition to its lineup of 100-300kV TEMs and most recently the ARM200F atomic resolution TEM. The JEM-2800 speeds specimen observation through fully automatic functions including adjustment of focus, astigmatism, contrast, brightness, crystal zone axis alignment, and height. Switching between analysis modes is seamless, and quick data collection shortens turnaround time between samples. An operator navigation system and on-screen operating guide make the JEM-2800 a high throughput, user-friendly TEM for any skill level. Additional features and key specifications of the JEM-2800 include a Schottky field-emission electron gun, highly stable eucentric side-entry goniometer stage, a magnification range of 100X to 150,000,000X using STEM, 0.1nm TEM resolution and 0.20nm BF/DF STEM resolution.

Reply Card #4932 Pipette The new Thermo Scientific F1ClipTip pipette and tip system is the latest addition to a new generation of Thermo Fisher Scientific ergonomic products. The F1-ClipTip™ system provides extremely light-touch dispensing and tip ejection for superior ergonomic performance. The manual liquid handling system includes all of the proven features of the Thermo Scientific F1 pipettes, but adds an innovative tip interface that takes pipetting to new levels of liquid dispensing consistency. ClipTip pipette tips have a hydrophobic inner surface to prevent liquid retention, while optional filter tips use the aerosol resistant tip (ART) self-sealing barrier to reduce cross-contamination. With the new F1-ClipTip pipette and tip system, users can clip it and forget it. It’s that simple. As a complete system for secure pipetting, the pipettes and tips are available in a variety of formats or as a Good Laboratory Pipetting (GLP) Kit.

Reply Card #4933

Spectrometer The new EDX-LE from Shimadzu Scientific Instruments is an energy dispersive X-ray (EDX) fluorescence spectrometer designed specifically for screening elements regulated

by RoHS/ELV directives. Its automated analysis functions improve operability without sacrificing a high level of inspection reliability. The EDX-LE is equipped with a detector that does not require liquid nitrogen, thereby achieving lower operational costs and easier maintenance.

It has been optimized for the RoHS/ELV screening of materials, individual parts and other samples that are substantially homogenous. The spectrometer is suited to screening a limited range of samples for fixed control criteria. Additionally, the EDX-LE offers various features that promote simple screening. Users can customize the easy set-up functions according to the management method. Threshold values can be set for each material or element, and the screening judgment also can be changed according to the input method used for threshold values.

Reply Card #4934 Microcentrifuge Eppendorf’s refrigerated 24-place microcentrifuge comes equipped with many innovative and usable design features, and has won a red dot: product design 2011 award for design excellence in the life science and medicine category. With its very compact size, low access height and near-silent operation - even without the rotor lid the centrifuge fits easily into molecular and biological research laboratories. Four different rotors ensure versatility, while users can choose between rotary control knobs or a keypad. A quick pre-cooling function allows the centrifuge’s temperature to go from 21ºC to 4ºC in only 8 minutes. The centrifuge has been developed to meet latest emission and ecological requirements.

Reply Card #4935 JULY/AUGUST 2011 BIOTECHNOLOGY FOCUS 27

NEW PRODUCTS Mobile Bench Labconco’s multi-use mobile bench provides bench space and transports equipment from lab to lab. It is made of durable and chemical-resistant epoxy-coated 18-gauge welded steel frames of 5.1 cm square tubing and is painted with tough, corrosion-resistant, dry powder epoxy in glacier white. The bench also features 12.7 cm diameter, non-marking polyurethane casters that absorb vibration over rough, uneven floors for stability and quiet operation. The work

surface is fiber board with high pressure melamine laminate that is 2.8 cm thick.

The bench is strong and supports loads up to 245 kg.

Reply Card #4936 Pumps Valco Instruments new generation of liquid handling pumps are designed for precision handling of liquids and/or gases, producing a bidirectional pulseless flow with a range of over six orders of magnitude (5 nL/min to 5 mL/min or

SRC101

Name:_________________________________Title: ____________________________________

1 µL/min to 25 mL/min, depending on model). Manufacturer says the pumps offer better performance than syringe pumps and eliminates the need for refill cycles and syringe changes. The positive displacement pumps are self-priming and tolerant of any gas which may find its way into the fluid lines. There is no separate fill cycle, and the capacity is unlimited.

Company: ______________________________Dept: ___________________________________

Reply Card #4937

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Business Address : _______________________________________________________________ City:_____________________________Prov: __________Postal Code: ____________________ Telephone: ___________________________Fax: ______________________________________ E-mail: ________________________________________________________________________ On occasion, BIOTECHNOLOGY FOCUS will send third-party information on products & services related to the lab and life science industries. These may be cancelled at any time. Please check here if you do NOT wish to receive these.

TITLE 50 51 52 53 54 55

Executive Mgmt.

Academic Research Quality Control/Assurance R&D Mgmt.

Lawyer Student

COMPANYs PRIMARY BUSINESS ACTIVITY 50 Private Industry 51 University/College 52 Hospital/Medical Centre 53 Research Institute/Foundation

56 Financial Management 57 Business/Corporate Development 58 Consultant 59 Lab Technician/Research Assistant 60 Sales/Marketing 61 Regulatory Affairs/Validation 99 Other (Specify): ______________________ 54 Pharmaceutical Co. 55 Government 56 Financial Services 99 Other (Specify): ______________________

B Recommend

A B C D E F G

Analysis Instruments Basic Lab Equipment Chemicals/Biochemicals Chromatography – Gas Chromatography – Liquid Filtration, Water Purification LIMS

H I J K L M Y

Liquid Handling & Sample Prep Microscopes, Optics, Cameras Safety & Hygiene Spectroscopy Testing Systems/Equipment Vacuum Equipment None of the Above

C88 Product Development Stage (check all that apply) A Research/Development B Pilot/Scaleup

C86 Buying Influence A Authorize

C87 Which products are used in your lab?

Counter Pen Control Company’s new Counter Pen is a combination marker and digital counter designed for the lab.

Each time a black mark is made with the felt-tipped pen, it automatically sounds a beep, and LCD displays the counts. Use it to count cell growth on petri dishes, inventory parts, and tally samples received.

Touch, sound, and count occur simultaneously. Impossible to make an error, even when interrupted—marks hold your place and counter holds your total.

Durable ABS plastic unit provides audio/ visual counts to 99999 with reset button, on/off switch, and pen cap.

C Production/Manufacturing D Tech Transfer E Not applicable

C Specify

PLEASE ENTER THE READER SERVICE CARD NUMBER TO RECEIVE INFORMATION

C89 Are you building a new lab?

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C90 We have the following enewsletters: Numbers for advertised products can be found on the ad and in the advertisers’ index

1 Biotechnology Focus Weekly 2 Laboratory focus Weekly 3 Drug Discovery

4 Commercialization 5 Bio-energy 6 Nutritional Products

For a quick response please fax: 905-727-4428 or e-mail: circulation@promotive.net 28 BIOTECHNOLOGY FOCUS JULY/AUGUST 2011

Reply Card #4938

CALENDAR JULY 2011 July 26-30 ASCLS Annual Meeting Venue: Atlanta, GA Tel: 301-657-2768 Fax: 301-657-2909 Email: ascls@ascls.org Web: www.ascls.org

International Conference on Nanotechnology Venue: Ottawa, ON Email: Info@International-ASET.com Web: http://icnfa2011. international-aset.com

August 7-11 Microscopy and Microanalysis 2011 Venue: Nashville, TN Tel: 703-234-4115 Fax: 703-435-4390 Email: AssociationManagement@ microscopy.org Web: www.microscopy.org

August 28-31 ICASS and CCACC 2011 Symposia Venue: Toronto, ON

National Biotech Week Web: www.imagenenation.ca

SEPTEMBER 2011

HSE Canada 2011 Venue: Toronto, ON Tel: 647-893-8984 Email: nate@hsecanada.ca Web: www.hsecanada.ca

September 3

July 27-29

AUGUST 2011

Fax: 905-589-0059 Email: janette@etpsymposium.com Website: www.csass.org

International Pain Summit Venue: Montreal, QC Tel: 206-283-0311 Fax: 206-283-9403 Email: iaspdesk@iasp-pain.org Web: www.iasp-pain.org

September 7-10 World Molecular Imaging Congress Venue: San Diego, CA Tel: 310-215-9730 Fax: 310-215-9731 Email: ami@ami-imaging.org Web: www.ami-imaging.org

September 13-15 Stem Cells USA & Regenerative Medicine Congress Venue: Boston, MA Tel: 212-379-6322 Fax: 212-379-6319 Email: enquiry.us@terrapinn.com Web: www.terrapinn.com

September 16-23

September 27-28

September 29-October 1 BCSLS Congress 2011 Venue: Castlegar, BC Tel: 604-714-1760 Fax: 604-738-4080 Email: bcsls@telus.net Web: www.bcsls.net

OCTOBER 2011 October 5-6 BioContact Quebec Venue: Québec, QC Web: www.biocontact.ca

October 11-15 International Congress of Human Genetics Venue: Montréal, QC Tel: 301-634-7300 Fax: 301-634-7079 Email: paulinem@ashg.org Web: www.ashg.org/

Company & Advertiser Index COMPANY

Page RC

COMPANY

Page RC

Advitech Inc...................................................10........................................

Intellipharmaceutics Inc................................11........................................

Albert at Bay........................................................ 21......................................4924

JM Science.....................................................26................................ 4926

Algae Biosciences Corporation.......................8.........................................

Labconco.......................................................28................................ 4936

Allon Therapeutics Inc....................................9.........................................

MaRS Innovation.............................................6.........................................

AX Source Consulting Inc................................... 7.......................................4921

Medicago Inc...................................................6.........................................

Biohit Inc........................................................26................................ 4927

Medicure Inc..................................................10........................................

BioTalent Canada................................................. 2....................................... 4919

POI Business Interiors........................................ 15......................................4924

BIOTECanada........................................................................................... 9

Resverlogix Corp.............................................6.........................................

Borden Ladner Gervais....................................... 9.......................................4922

Rx&D..............................................................10........................................

Children’s Miracle Network.............................. 23......................................4925

Sanofi Pasteur.................................................6.........................................

Dalton Pharma Services.................................10........................................

Shimadzu....................................................26, 27................... 4928, 4934

DiagnoCure Inc...............................................6.........................................

TandD Corporation........................................27................................ 4931

Eppendorf......................................................... 27, 32........................ 4935, 4940

Thermo Scientific........................................26, 27................... 4930, 4833

Ernst & Young................................................11........................................

Valco Instruments..........................................28................................ 4937

Fisher Scientific................................................... 11......................................4923

VWR ....................................................................... 5.......................................4920

GlaxoSmithKline.............................................6.........................................

Wyatt Technology Corporation......................26................................ 4929

JULY/AUGUST 2011 BIOTECHNOLOGY FOCUS 29

THE LAST WORD

By Dr. Bonnie Kuehl and Frédéric Sweeney

Don’t blame the player, blame the game

I

Dr. Bonnie Kuehl is CEO and founder of Scientific Insights® Consulting Group Inc.

Frédéric Sweeney is vice president of Business Development and Corporate Strategy for Tornado Medical Systems.

had lunch with a young scientist professional a few weeks ago. He is just starting his career and is excited about the possibilities of helping develop and launch new pharmaceutical products in Ontario. He has spent the past few months attending various conferences and seminars to learn about what opportunities are available and to discover where his talents may be best used.

During lunch he shared with me that despite having heard some presentations several times, at different venues, he remained unclear about the product and the needs of the company doing the presentation. In essence, despite telling their story the message being told remained unknown to at least one, and I am sure more, of the listeners.

I have always found that the opinions of young enthusiastic professionals in a given industry to be a fascinating exercise; akin to young children who ask unbiased, tough questions about life as they enter adulthood, young professionals have an inert ability to doubt, question and challenge the status quo, which, in the case of our beloved biotech industry, is nothing to write home about.

Don’t get me wrong: it is true, the value propositions are unclear, the messages are mixed and the presentations sometime border on schizophrenia.

Consider the following when making a presentation: Vision, Strategy, Passion Developing a good business plan or a story should involve three key elements: a vision of where it will end or a goal, a plan on how to get to the end, and finally passion or true desire to give it your all to achieve the goal.

Vision and passion without strategy will leave you circling or treading water while you continue to determine how to reach the goal. Vision and strategy without passion will get you to the goal, eventually, but with little pride in your accomplishment.

As emerging companies begin to develop their message and their story, it is important that they remember the three key elements of a good story and that consideration be given to who is delivering the message. Indeed, all companies should consider both the elements and the person delivering the message when developing their plan or story.

Delivering the Message Finding the right person is important when choosing who will tell the story and deliver your important 30 BIOTECHNOLOGY FOCUS JULY/AUGUST 2011

message. The person needs to be knowledgeable about the product, the end goal, and the strategy or path to achieve the goal. Reciting data and reams of information will neither excite nor educate your audience about your product. The presenter should be fully involved in developing the story and key messages in order to own the story, as well as being passionate and well-prepared in their delivery and ability to address questions.

Consider the following about the key people in a company. Scientists spend a great deal of their time defending their findings and conclusions. They have passion and a hypothesis (goal) but their strategy is driven by road blocks and caution lights, with many intersecting paths. The business person is trained to develop a strategy to achieve a goal. Their time is spent finding ways around road blocks and looking for the path with the greatest number of green lights or the greatest chance of successfully achieving the goal, however the business person is not usually an expert on the product and its capabilities. Together, the scientist and the business person can successfully move a product from the hypothesis phase to successful commercialization if they have the financing combined with some constructive feedback or guidance from financing and industry experts.

However, the financing environment is dry and populated by investors who if they happen to have some money left over may not be the best at giving feedback and guidance. Good feedback is hard to give and requires a significant amount of thought as well as some altruism. Unfortunately, only a handful of investors will take the time to provide companies with constructive feedback, especially on their vision and strategy.

Consider all of these challenges the next time you sit at a conference and wonder why the presentations are so unfocused with the value proposition lost in a sea of random cookie-cutter market segmentation slides copied from a 2007 market report. Try not to blame the presenter, who may be representing a company which has yet to clearly define the three key elements, or whose vision and strategy have been influenced by the dozen or so investors with whom they have met who made random comments on the vision and strategy but did not take the time to provide some intelligent, constructive feedback.

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