Biotechnology Focus June 2013

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

BIOFUELS: FUELING GROWTH AND INNOVATION IN CANADA INSIDE:

ARE YOUR GENES PATENTABLE?

Publication Mail Registration Number: 40052410

JUNE 2013 VOLUME 16, NUMBER 5

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contents JUNE 2013 – VOLUME 16 – NUMBER 5

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12 Canada’s awash in biofuels

18 Opinion

18

Agri-Food Discovery Place

FEATURES BOUNTIFUL BIOFUELS Fueling growth and innovation in Canada (By Scott Thurlow)

AGRI-FOOD DISCOVERY PLACE Going beyond the bench to scale-up great ideas (By Shawn Lawrence)

16

DEPARTMENTS 6

RESEARCH NEWS

9

BUSINESS CORNER

IN EVERY ISSUE

16

25 NEW PRODUCTS

22

28 CALENDAR OF EVENTS

9 BUSINESS CORNER

Sanofi Canada opens new corporate head office in Laval

www.biotechnologyfocus.ca

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INNOVATOR How a Canadian entrepreneur found success south of the border (By Daniela Fisher)

ACROSS CANADA Are human genes patentable?

(By Carmela DeLuca, Micheline Gravelle and Amardeep Rana)

THE LAST WORD The bioeconomy: Ontario’s quiet powerhouse (By John Kelly)

June 2013 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S NOTE

PUBLISHER/ EDITOR-IN-CHIEF STAFF WRITERS

Editorial Interns

Bloom Burton & Co. event brings investors and biotech companies together On May 21 to 22, Canadian biotech companies and a multitude of investors from across North America convened in Toronto for the 2nd annual Bloom Burton & Co. Healthcare Investor Conference. Held at the Toronto Board of Trade at First Canadian Place, the conference was an opportunity for many of Canada’s bigger and more mature biotech companies to strut their stuff in front of an investor audience.

The conference itself was broken into three main parts. The first was the company presentations themselves where 33 presenting biotech firms (26 publicly traded and seven private) were each given 30 minutes to showcase themselves and their pipelines to an audience that included institutional investors. Then there was the one-on-one meeting system, where the event facilitated 150 one-on-one meetings between investors and company management. The third and final piece was the great lineup of speakers which included a morning keynote speech and a lunchtime panel discussion.

John Johnston, EVP and chief strategist at Davis Rea, kicked the morning off discussing the general economic and investment outlook in Canada and the U.S. He examined some broader economic issues, including interest rates, the stock exchange and the scarcity of capital.

The lunchtime panel provided a great way for attendees to get information on how their contemporaries view the investment field. The panel was made up of David Sable, portfolio manager, Special Situations Fund; Spencer Smith of Aisling Capital; Rachel Davies, associate portfolio manager at AGF; and Adam Bristol, portfolio manager at Aquilo Capital. Collectively, the panelists discussed how they felt about Canada and Canadian healthcare investment, and touched on topics such as liquidity, dilution and issues around raising capital.

Event organizer, Brian Bloom was pleased with attendance, which included approximately 150 to 170 investors among the 360 registrants, improving upon last year’s numbers. Feedback in terms of the event and the quality of presenting companies was also very good said Bloom adding that momentum from this year’s event means that perhaps, one day the event will blossom into something much bigger.

“What we wanted to do differently from other industry events was to really focus on the investor. Specifically from an event like this investors want to see high quality companies, they want access to management to discuss deals, and they want to hear thought provoking panels and speeches. I think we provided all of that and more.”

Similarly, the inaugural Bloom Burton & Co. Technology Transfer Conference which took place on May 21, also targeted the investor community. It featured presentations from 18 Ontario start-up companies, each seeking their first institutional or venture capital investment.

To conclude the festivities, Bloom Burton & Co. opened the Toronto Stock Exchange & TSX Venture Exchange on the morning of May 23.

Plans for a 2014 conference are already in the works, with an announcement coming sometime later this summer.

Terri Pavelic Shawn Lawrence Daniela Fisher Kayla Sippel Anan Rahman

CONTRIBUTING WRITERS

Amardeep Rana

Carmela DeLuca

John Kelly

Micheline Gravelle

National Account Manager GRAPHIC DESIGNER CONTROLLER MARKETING MANAGER

Scott Thurlow Marcello Sukhdeo Elena Pankova John R. Jones Mary Malofy

CIRCULATION DIRECTOR James Watson circulation@promotive.net Tel: 705-812-0611

EDITORIAL ADVISORY BOARD Celine Bak, Analytica Advisors; Rob Henderson, BioTalent Canada; Najla Guthrie, KGK Synergize; Pierre Bourassa, IRAP, Montréal; Murray McLaughlin, Sustainable Chemistry Alliance; Carol Reynolds, Wordmark Consulting Group Inc.; 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, Cognovie Inc.; Randal R.Goodfellow, P.Ag., Senior Vice President, Corporate Relations, Ensyn; Bob H. Sotiriadis, Robic LLP; Dale Patterson, Genome Canada; Darcy Pawlik, Syngenta Seeds Canada Inc; Gail Garland, OBIO; Barry Gee, CDRD; Bonnie Kuehl, Scientific Insights Consulting Group Inc.; Raphael Hofstein, MaRS Innovation 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.biotechnologyfocus.ca E-mail: biotechnology_focus@promotive.net Subscription rate in Canada $35/year; USA $60/year; other countries $100/year. All rights reserved. No part of this publication may be reproduced without written consent. Publications Mail Registration Number: 40052410 Return undeliverable Canadian addresses to: circulation dept – 24-4 Vata Court, Aurora, Ontario L4G 4B6 National Library of Canada ISSN 1486-3138 \ All opinions expressed herein are those of the contributors and do not necessarily reflect the views of the publisher or any person or organization associated with the magazine.

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

4 BIOTECHNOLOGY FOCUS June 2013

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R & D NEWS Outsmarting cancer and autoimmune disease

Science graduate student Amgad Albohy and post-doctoral fellow Yi Zhang are part of Chris Cairo’s team who have discovered new inhibitors to be used in cancer research, University of Alberta.

It turns out that some of the biological tricks used by the flu virus are important for understanding a range of serious health problems we are trying to solve.

A new discovery by University of Alberta (U of A) Faculty of Science researchers may help to learn more about these mechanisms—helping to generate new therapeutics for cancer and inflammatory disease.

The U of A team, led by Dr. Chris Cairo, PhD, a scientist in the Alberta Glycomics Centre and an associate professor of Chemistry at the U of A, has made a breakthrough in understanding some of the communication processes that occur between cells and viruses and between cells themselves.

“The drugs we use to combat the flu target a particular enzyme in the virus called neuraminidase (NEU). These drugs inhibit

the enzyme the virus uses to grab hold of cells, and particularly, the handle on the cell surface that it uses—known as sialic acid. We’re looking at how this process is involved in other diseases, by looking at how our own cells use sialic acid in biological processes, like when cells stick together or come apart,” explains Cairo. “The flu and human cells have this process in common—and it looks like these enzymes may play an important part in our understanding of cancer and inflammation.”

These cellular mechanisms are highly complex. Cairo and his team have been working on finding new compounds that will target the human enzyme family, of which there are several members. Finding compounds that are effective and selective all at once is a real challenge.

“It’s hard enough to make the right new compound, but to find one that is active and that discriminates between four different enzymes that are extremely similar can be an even bigger challenge,” Cairo emphasizes.

In their most recent paper, the group has found compounds that are highly effective for a single member of the enzyme family, and that are also active enough at low enough concentrations to be tested in animals. The U of A team is collaborating with a group at the University of Montréal to look at the activity of their new compounds in mice. The two groups have published their most recent results on neuraminidase inhibitors in ACS Medicinal Chemistry Letters and the Journal of Medicinal Chemistry.

To see this story online visit www.biotechnologyfocus.ca/outsmartingcancer-and-autoimmune-disease/

Alberta and Pfizer build on collaborative research program The Alberta-Pfizer Translational Research Collaboration is receiving new support from Pfizer and the Alberta government to advance healthcare research towards real-world application.

With additional investments from Pfizer of $500,000 and from the Alberta government of $250,000, the Alberta-Pfizer Translational Research Collaboration fund now totals $3.25 million.

The two sides announced the additional investments at the BIO International Convention held in Chicago, building on the original agreement signed in November of 2011 by the Alberta government, Alberta 6 BIOTECHNOLOGY FOCUS June 2013

Innovates – Health Solutions (AIHS) and Pfizer. The Alberta-Pfizer collaboration is administered by Alberta Innovates – Health Solutions, which oversees the independent, peer-review project selection process.

The collaboration supports health research in a wide variety of disciplines including one promising project that aims to identify which cancer patients will develop a resistance to certain chemotherapy drugs.

To see this story online visit www.biotechnologyfocus.ca/alberta-andpfizer-build-on-collaborative-researchprogram/

Clinical Trials & Patents OncoGenex Pharmaceuticals, Inc. (Vancouver, BC & Bothwell, WA) has initiated its Rainier™ trial, an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating OGX-427 in combination with ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) and gemcitabine in patients with previously untreated metastatic pancreatic cancer. Rainier will randomize approximately 130 patients to receive either OGX-427 or a placebo in combination with ABRAXANE and gemcitabine therapy. The primary endpoint of the trial will be overall survival, with additional analyses to evaluate progression-free survival (PFS), tumor response rates, safety, tolerability, and the effect of therapy on heat shock protein (Hsp27) levels. The trial is being sponsored by the Sarah Cannon Research Institute (SCRI) and will be conducted at approximately 12 sites in the U.S. Dr. Andrew H. Ko from the University of California, San Francisco and Dr. Johanna Bendell , director, GI Cancer Research Program at SCRI, will serve as the primary investigators on the trial.

n

n Stem Cell Therapeutics Corp. and its subsidiary Trillium Therapeutics (Toronto, ON) has completed dosing in its Phase 1 study of TTI-1612 in patients with interstitial cystitis/bladder pain syndrome (IC/BPS).

The study was designed to assess the safety and tolerability of single ascending doses of TTI-1612 in IC/BPS patients. Pharmacokinetics and changes in disease symptoms were also evaluated. A total of 28 patients were enrolled at four urology clinics in Southern Ontario. Preliminary data indicate that the drug is well tolerated and exhibits a favourable pharmacokinetic profile. Full results are expected to be published at a later date.

The United States Patent Office has granted U.S. Patent No. 8,435,568, relating to compositions and methods of using WF10 and new derivative formulations for the treatment of allergic asthma, allergic rhinitis and atopic dermatitis to Nuvo Research Inc. (Mississauga, ON). In early 2010, after receiving Germany’s BfArM authorization, the company initiated a Phase 2 clinical trial to evaluate WF10 as a treatment for moderate to severe allergic rhinitis. The trial was a 60-subject, randomized, double blind, placebo-controlled, single-centre trial to assess the efficacy and safety of a regimen of five WF10 infusions for the treatment of patients with moderate to severe persistent allergic rhinitis. The trial met both its primary and secondary endpoints and no drug-related adverse events were reported by trial participants.

n

For more R&D news visit http://biotechnologyfocus.ca/ category/bio-pharma/

R & D NEWS Prime Minister announces support for bio-based innovation in PEI • $11,339,152 for five projects in Nova Scotia • $9,360,279 for four projects in Newfoundland and Labrador

Prime Minister Stephen Harper shakes hands with employees from Vector Aerospace Engine Services – Atlantic prior to announcing support for projects in PEI that will help generate jobs and growth.

Prime Minister Stephen Harper was in Prince Scotia and Newfoundland and Labrador in Edward Island on May 14 to announce $7.7 the coming weeks.

Funding will be provided through the million for bio-based innovation in PEI. Under the Atlantic Innovation Fund (AIF), three Atlantic Canada Opportunities Agency’s companies – all part of the PEI Bioscience (ACOA) Competitive Round 2012 of the AtCluster – will receive funding for their inno- lantic Innovation Fund (AIF) and distributed as follows: vative projects.

This funding is part of a total $39.9 million • $7,738,000 for three projects in Prince Edward Island investment for 17 projects in Atlantic Canada. The remaining 14 projects will be an- • $11,461,072 for five projects in New OBIO Ad throughout (Final):Layout 1 12-05-14 5:13 PM Page 1 Brunswick nounced New Brunswick, Nova

The companies receiving support in Prince Edward Island are: BioVectra Inc.: $2,958,000 will help BioVectra develop two generic drugs using sustained-release delivery technology, with the long-term goal of gaining regulatory approval to market the products across North America.

Delivra Inc.: $2,860,000 will support Delivra Inc.’s research to develop three new natural topical creams for treatment of common inflammatory conditions, namely joint pain, circulation issues and muscle fatigue.

Island Abbey Foods Ltd.: $1,920,000 will support Island Abbey Foods Ltd. to optimize its manufacturing processes to expand its line of honey-based products. Using 100 per cent pure dried honey, the company will work to produce therapeutic and preventative health products that contain bioactive compounds, including upper respiratory products, supplements and vitamins.

To see this story online visit www.biotechnologyfocus.ca/primeminister-announces-support-for-

Ontario Bioscience Innovation Organization

OBIO™ members lead innovation in the life sciences. Every facet of health care with a stake in innovation is represented on OBIO Advisory Boards.

Together, we’re building a bioscience cluster that nurtures and promotes development of innovative products and services to meet the health needs of growing Canadian and global markets.

Ontario Bioscience Innovation Organization is a trade name of Ontario Bioscience Industry Organization.

June 2013 BIOTECHNOLOGY FOCUS 7

R & D NEWS Medicago successfully produces VLP vaccine candidate for H7N9 virus Biopharma company Medicago Inc. has successfully produced a new VLP (VirusLike Particles) vaccine candidate for the H7N9 virus responsible for the current influenza outbreak in China.

“To our knowledge, Medicago is the first to produce a VLP vaccine candidate against this potential pandemic strain demonstrating our ability to be a first responder in a pandemic scenario,” said Andy Sheldon, president and CEO of Medicago.

Current influenza egg-based vaccine manufacturers can take up to six months to produce a vaccine for any new strain, whereas according to Sheldon, Medicago has the capability of cutting down this development time drastically. He added that Medicago is strongly positioned as a key player in addressing a potential pandemic.

The hemagglutinin (HA) sequence used for the development of the H7 VLP vaccine was obtained from the GISAID EpiFlu™ Database. In a press release, Medicago credits Dr. Jun Li and the Hangzhou Center for Disease Control and Prevention (China), respectively the author and the originating and submitting laboratory, for the sequence of HA of the isolate A/Hangzhou/1/2013 (sequence ID EPI_ISL_138977).

The company’s H7 VLP is currently being purified in preparation for immunogenicity studies in animal models.

In order to produce an influenza vaccine, Medicago requires only the genetic sequence of the viral strain. This significantly limits the delays that occur using traditional manufacturing systems.

To see this story online visit www.biotechnologyfocus.ca/medicagosuccessfully-produces-vlp-vaccine-candidate-for-h7n9-virus/

New genetic clues to breast and ovarian cancer

A major international study involving a Simon Fraser University scientist has found that sequence differences in a gene crucial to the maintenance of our chromosomes’ integrity predispose us to certain cancers.

Angela Brooks-Wilson, an associate professor in SFU’s biomedical physiology and kinesiology department and a scientist at the BC Cancer Agency, is one of more than 600 scientists from around the world who contributed to this study.

Published in the March online issue of the science journal Nature Genetics, the study is called: “Multiple independent variants at the TERT locus are associated with telomere length and risks of breast and ovarian cancer.”

The study found that variations in the se8 BIOTECHNOLOGY FOCUS June 2013

This is the first study that connects that inheritance to predisposition to breast and ovarian cancer.

“This discovery helps us better understand the biology that underlies these cancers, as well as better predict who is likely to develop them,” says Brooks-Wilson.

The SFU researcher is one of four investigators in the Ovarian Cancer in Alberta and British Columbia study (OVAL-BC). The interprovincial ovarian cancer study contributed samples and data to this new international study.

“About 140 individual smaller studies like OVAL-BC contributed samples from more than 150,000 women, data and analysis to make this new study happen. It’s a remarkable example of international collaboration.

I would say this is big science at its collegial best.”

The OVAL-BC study, based at the BC Cancer Agency, is investigating ovarian cancer risk associated with environmental and genetic factors, and their interactions. Between 2002 and 2011, 4,000 women were recruited to participate in the populationbased, case-control study, co-led by Nhu Le, scientist, Cancer Control Research, BC Cancer Agency and Linda Cook, professor, Division of Epidemiology & Biostatistics, University of New Mexico.

quencing of the TERT gene, which encodes an enzyme crucial to telomere maintenance, influence telomere length and our risk of getting breast and ovarian cancers.

Telomeres are structures that encapsulate our chromosomes’ ends and are often compared to the plastic protectors on the ends of shoelaces. These protective structures shorten in length over our lifespan, and when they become too short chromosomal cells should stop dividing.

Scientists have known for a while that if chromosomal ends become exposed this can lead to genetic damage and cancer. To see this story online visit They’ve also estimated that up to 80 per www.biotechnologyfocus.ca/new-geneticcent of telomere-length variation is in- clues-to-breast-and-ovarian-cancer/ herited.

BUSINESS CORNER Sanofi Canada opens new corporate head office in Laval Global healthcare company Sanofi Canada has opened a new head office in Laval, Québec. The new offices, together with a new Canadian centre for distribution in Kirkland, represent a $12 million commitment by Sanofi in the province.

Other Sanofi companies in Canada include Sanofi Canada (pharmaceuticals), Sanofi Pasteur (vaccines), Sanofi Consumer Health (health and beauty), Genzyme (rare diseases) and Merial (animal health).

The new head office, which includes large open concept areas designed to encourage collaboration, innovation and cross-functional partnership between teams, will continue to house Sanofi’s Canadian Clinical Study Unit (CSU) currently overseeing close to 70 clinical trials across the country.

The Kirkland distribution centre brings Sanofi’s consumer health products and pharmaceuticals together under one roof.

It will also house a new cosmeceutical laboratory for the purposes of continuing innovation in Sanofi Consumer Health’s NeoStrata® brand and bringing new health and beauty products to market.

“As part of Laval’s Biotech City, we remain committed to bringing innovative new medicines to Québec and Canada, and hope to those living with diabetes, cancer and other diseases,” said Jon Fairest, president and CEO of Sanofi Canada.

Photo from inauguration of new Sanofi Canada corporate headquarters, from left to right, Nicolas Marceau, Québec Minister of Finance and the Economy, Jon Fairest, President and CEO, Sanofi Canada, His Excellency Philippe Zeller Ambassador of France to Canada, Franca Mancino, VicePresident, Medical and Regulatory Affairs, Sanofi Canada and Alexandre Duplessis, Mayor of Laval (CNW Group/SANOFI).

“Our new head office and distribution centre ensure that Sanofi continues to benefit from the expertise in the life sciences sector that Québec has to offer.”

“Sanofi has a 45-year history in Laval dating back to 1968 with the construction of the Octo Laboratories site, later

becoming Nordic, and eventually the company we are today,” he added.

To see this story online visit www.biotechnologyfocus.ca/sanoficanada-inaugurates-new-corporatehead-office-in-laval/

David A. Dodd

Aeterna Zentaris Inc. appoints new president and CEO

David A. Dodd has been appointed president and CEO of Aeterna Zentaris Inc., succeeding Dr. Juergen Engel. Dodd has also been appointed as a director on the company’s board.

“With the appointment of David, we are taking an important first step in transforming Aeterna Zentaris from a company focused on R&D to a company focused on commercializing the promising compounds in our pipeline,” said Juergen Ernst, chairman of the board of directors.

Dodd’s executive management experience in the pharmaceutical and biotechnology industries spans more than 35 years. From December 2007 to June 2009, Dodd was president, CEO and chairman of BioReliance Corporation. From October 2006 to April 2009, he served as non-executive chairman of Stem Cell Sciences Plc., for a six-year term was president, CEO and director of Serologicals Corporation, and for a five year term was president and CEO of Sol-

vay Pharmaceuticals, Inc. and chairman of its subsidiary Unimed Pharmaceuticals, Inc. Currently, he serves as chair, Board of Directors, of GeoVax, Inc.; as a director on the Board of Aruna Biomedical; and, as a director on the Board of PNP Therapeutics, a clinical stage company, developing a novel nucleoside-booster treatment for solid tumor mass cancers. He also serves as CEO of RiversEdge BioVentures LLC, which he founded in 2009.

In stepping down from the role, Dr. Engel said he will pursue his passion in research and development.

To see this story online visit www.biotechnologyfocus.ca/ aeterna-zentaris-inc-appoints-newpresident-and-CEO/

June 2013 BIOTECHNOLOGY FOCUS 9

BUSINESS CORNER New Atlantic Canada venture capital fund open for business “Emerging Atlantic Canadian companies have had limited access to venture capital in the past,” said Premier Dexter. “As our economy starts to turn the corner, I believe if we help those companies take advantage of the opportunities on the horizon, it will be for the benefit of all Nova Scotians, and Atlantic Canadians.”

Nova Scotia’s $15-million commitment to the fund has been leveraged to $48.5 million. The other investors include: • New Brunswick ($15 million), • Prince Edward Island ($2.5 million), • BDC Venture Capital ($10 million), • Technology Venture Corp. ($5 million), • And the fund managers ($1 million) High-potential companies in Atlantic Canada now have more access to the funds they need to grow and compete in the international marketplace.

Build Ventures, a privately-managed venture capital fund launched on May 14, is actively seeking investment opportunities throughout the Atlantic provinces. The idea for this regional VC fund was brought forward in 2010 by Nova Scotia Premier Darrell Dexter.

In the coming months, Build Ventures is looking to raise additional private sector investment.

Headquartered in Halifax, the new regional VC fund will concentrate on making Series A investments. These are investments made in companies that are early stage, yet have an established business model, a solid team, a large target market, some revenue generation and now need ramp-up capital.

The focus will be on companies in information technology, clean technology, life sciences and other high-growth sectors. Build Ventures’ investments will be between $1 million and $5 million for each venture.

Reaction to the fund from the entrepreneurial community has been extremely positive.

“I know firsthand the impact early investors and venture capital has on a young company,” said Dr. Daniel Boyd, president and chief science officer of ABK Biomedical. “A private sector fund that targets earlystage investments is a critical ingredient for what’s next for this region.”

The fund managers are Patrick Keefe and Rob Barbara. Keefe has over 15 years of investment and entrepreneurial experience, and has spent the last several years with Innovacorp, overseeing its early-stage venture capital activities.

Barbara, also a seasoned investment manager, most recently spent 11 years with Burgundy Asset Management, a Toronto-based global investment management firm.

To see this story online visit www.biotechnologyfocus.ca/newatlantic-canada-venture-capital-

Dealmakers n Bioniche Life Sciences Inc. (Belleville, ON) has engaged U.S.-based Evercore Partners (New York, NY) to assist in its divestment of its Animal Health business. Evercore is an independent advisory firm in the U.S. that specializes in merger and acquisition transactions, divestitures and restructurings. As Evercore leads its work on the Animal Health side of the business, Bioniche is actively engaged in discussions with potential partners for its Phase 3 bladder cancer product, Urocidin™. n Advanced Proteome Therapeutics Corporation (Vancouver, BC) has reached an agreement with the Stanford University School of Medicine, Department of Radiology, to test protein conjugates and multimers as part of APC’s Foundation Trinity™ technology involving targeted, combination, and homogeneous therapy in a single anti-cancer agent. Stanford will be testing APC’s protein modifications to determine its effects on tumors in a variety of cancer disease states. n Cardiome Pharma Corp. (Vancouver, BC) has taken on responsibility for worldwide sales, marketing, and promotion of BRINAVESS™ (vernakalant IV) pursuant to a transition agreement signed with Merck & Co., Inc., known as MSD

10 BIOTECHNOLOGY FOCUS June 2013

outside the U.S. and Canada. Under the agreement, worldwide sales and marketing rights will transfer to Cardiome immediately. Cardiome will continue to receive relevant royalties on worldwide sales. Cardiome will also receive an undisclosed promotional services fee. Regulatory product rights and product distribution responsibility are expected to transfer to Cardiome on or about July 15, 2013, following which Cardiome will recognize all BRINAVESS™ revenue and Merck will cease paying royalties or any promotional services fee. Merck will either terminate or transfer Sponsor responsibility for each relevant clinical study to Cardiome by September 15, 2013. In addition to the transfer of the U.S. regulatory filings, Merck Canada Inc., a subsidiary of Merck, transferred its sponsorship of all vernakalant Canadian clinical trial applications to Cardiome. n Actavis, Inc. (Parisppanny, NJ) has acquired worldwide rights to Valeant Pharmaceuticals International’s (Montreal, QC) Metronidazole 1.3 per cent Vaginal Gel antibiotic development product, a topical antibiotic for the treatment of bacterial vaginosis. Under the terms of the agreement, Actavis Specialty Brands is acquiring the product for approximately $55 million, which includes upfront and certain milestone

payments, and minimal royalties for the first three years of commercialization. n Cipher Pharmaceuticals Inc. (Mississauga, ON) has entered into a definitive distribution and supply agreement with Tecnofarma International Ltd. under which Cipher has granted Tecnofarma the exclusive right to market, sell and distribute CIP-TRAMADOL ER in Latin America. Tecnofarma, headquartered in Uruguay, operates in 18 Latin American countries and will launch the product in certain territories, including Brazil and Mexico. n MaRS Innovation (MI) (Toronto, ON) and Pfizer Inc. are partnering to advance earlystage technologies related to human health in therapeutics and diagnostics. Through this collaboration, MaRS Innovation and Pfizer will jointly identify investment opportunities emerging from well-validated scientific research discoveries within MaRS Innovation’s 16 member institutions, including the University of Toronto and its nine affiliated teaching hospitals.

For more Business Corner news visit http://biotechnologyfocus.ca/category/ industryintel/

BUSINESS CORNER MethylGene initiates plan to reincorporate in the U.S. as Mirati Therapeutics, Inc. MethylGene Inc. has unanimously approved a proposal to change its jurisdiction of incorporation from the federal jurisdiction of Canada to the State of Delaware in the United States by way of a courtapproved plan of arrangement. The move was unanimously approved by the company’s board of directors.

Under the arrangement, MethylGene will create a holding corporation, Mirati

Therapeutics, Inc. Mirati will become the ultimate parent corporation of MethylGene and its subsidiaries. Concurrently with the arrangement, Mirati is making an application to list its shares of common stock on the NASDAQ Capital Market The Arrangement is subject to the approval of the Ontario Superior Court of Justice. In addition to approval by the Court, a special resolution approving the arrange-

ment must be approved at a special meeting to be held on June 25, 2013, by twothirds of the votes cast by shareholders of MethylGene, present in person or represented by proxy.

Stem Cell Therapeutics to begin trading on the U.S. OTCQX Marketplace

OTCQX International under the symbol SCTPF. OTCQX is a U.S. Over-The-Counter marketplace that provides international companies increased access and exposure to the U.S. market.

Roth Capital Partners will be the market maker for Stem Cell Therapeutics’ stock and will also serve as the company’s principal American liaison (PAL) on OTCQX, responsible for providing guidance on OTCQX requirements and U.S. securities laws. Roth Capital Partners is an investment banking firm dedicated to the small-cap public market and has been an innovator in this market since its inception in 1984.

“The U.S. capital markets are critically im-

portant in assuring viability of life sciences companies internationally and we undertake this step as part of a deliberate and long-term strategy,” commented Stem Cell Therapeutics’ chairman David Allan. “The admission to the OTCQX is one of several undertakings that the company committed to complete this year. The acquisition of Trillium, the inlicensing of the tigecycline program and the recent completion of dosing in the interstitial cystitis trial are among the others.”

Stem Cell Therapeutics Corp. announces the company’s stock is now trading on

To see this story online visit www.biotechnologyfocus.ca/methy lgene-initiates-plan-to-reincorporate-inthe-u-s-as-mirati-therapeutics-inc/

To see this story online visit www.biotechnologyfocus.ca/stemcell-therapeutics-to-begin-trading-onthe-u-s-otcqx-marketplace/

June 2013 BIOTECHNOLOGY FOCUS 11

By: Scott Thurlow

GREEN TECHNOLOGIES

Biofuels: fueling growth and innovation in canada

I

n Canada, we are blessed with a rich bounty of natural resources. Most often, we associate this with the abundance of petroleum-based resources which make Canada a world leader in traditional energy and fuel supply. In addition to this however, Canada also has a wealth of biomass and cropland from which energy crops can sprout. And while our domestic biofuels industry has grown into a working success, the simple fact is that to meet our growing energy needs and stresses, we need to do more. As a country, simply recognizing our clean-energy potential is no longer sufficient. Today, in the face of ever-increasing energy demands and global climate challenges, the need for innovation has never been greater. This is true both in terms of how we make our fuels, as well as capitalizing on the potential of where these fuels can come from;

12 BIOTECHNOLOGY FOCUS June 2013

be it our farmer’s fields or even our landfills.

Domestic renewable fuel production strengthens our economy, protects the air we breathe, and plays a key role in securing and diversifying our energy future. It also speaks directly to the value of continued innovation in Canada, both on the science and technology frontier as well as in modernizing the market options for the products grown on Canadian farms.

Already, the Canadian biofuels industry is creating a suite of innovative fuels. This includes traditional corn-based ethanol, biodiesel from canola, spent cooking oils and rendered animal residues. There are also advanced biofuels, notably feedstock agnostic cellulosic ethanol, which can include wood waste, forest biomass and reclaimed municipal solid waste. Right now, in addition to producing traditional biofuels, the industry is also at work improving efficiencies in the production of first-generation ethanol and biodiesel. This includes developing new processes and value-added co-products to advance Canada’s place in the emerging bio-economy.

When looking at innovation in the energy sector, the renewable fuels sector truly is the place where some of the most exciting work in the world is currently being done. This innovation started with the first-generation technology for domestic production of ethanol and biodiesel. From there, the industry has evolved with the advent of new technologies that promise to extract even more energy potential with a broader range of crops, including the production of biopolymers, nutraceuticals and other advanced food-related sources, industrial plastics and advanced biofuels like cellulosic ethanol.

Reflecting on the importance of these innovators, the Canadian Renewable Fuels Association (CRFA) created a new committee and classification of membership specifically for the next-generation of biofuel producers in Canada. The new committee and its members represent leaders in advanced

GREEN TECHNOLOGIES

Figure 1: On a life cycle basis, and depending on feedstock, biofuels can reduce emissions by as much as 99 per cent when compared to petroleum-based fuels.

Figure 2: Canadian GHG Emissions by Economic Sector

Source: Environment Canada Distribution of Greenhouse Gas Emissions

by Economic Sector, Canada, 2010

biofuels with their cutting edge technologies and first-of-a-kind projects.

The inaugural committee members include Enerkem, a Québec-based company developing municipal solid waste-to-biofuels projects in Edmonton, AB and another one in partnership with GreenField Ethanol in Varennes, QC. Also included is Mascoma, a US-based company developing a project in Drayton Valley, AB utilizing its low-cost proprietary Consolidated BioProcessing technology for the conversion of biomass into cellulosic ethanol, xylose, Isopropanol and green electricity.

Advanced biofuel plants, like these innovative pioneers, contribute almost $1.2 billion every year to the domestic economy, and generate almost $240 million a year in federal and provincial tax revenues.

Moreover, in addition to the economic advantages, clean burning biofuels are proven to significantly reduce harmful greenhouse gas (GHG) and other emissions.

Around the world, our fuels and climate are linked together in a way that, left unchanged, will carry high environmental costs that will be paid by generations to come. And while the climate challenges facing our country,

governments and consumers are essentially global; this is not to say that our solutions to these problems cannot be local, domestic and even home grown.

Depending on the fuel in question, cleanburning biofuels can reduce GHGs by up to 99 per cent in the process when compared to traditional fossil fuels. The government’s transportation sector strategy for GHG emission reductions, of which biofuels are an integral part, cut carbon emissions by 4.2 megatonnes. This is equal to removing one million cars from the roads. These benefits are even greater with next-generation cellulosic ethanol, which requires less energy to produce than traditional gasoline and can reduce GHGs by as much as 60 per cent.

Canada’s transportation sector accounts for about one quarter of overall GHG emissions.

For this very reason, deploying alternative fuel technologies to reduce emissions from our transportation fuel presents a practical and essential solution. In fact, advanced biofuels made from non-recyclable and noncompostable municipal solid waste go a step further and carry a dual benefit - reducing GHG emissions while at the same time diverting waste from landfills. Essentially, this solves two significant environmental issues simultaneously.

Recognizing the known environmental and economic benefits of domestic biofuel production, Canada introduced mandated requirements for renewable fuel inclusion in order to take advantage of our significant biomass availability. Mandated levels of renewable fuel content have succeeded in securing a market for a product which burns cleaner when compared to petroleum-based alternatives. In addition, the federal ecoENERGY for Biofuels program has been highly effective in building-out a domestic industry for ethanol, resulting in the construction of several new facilities, and depending on seasonality, achieved its objective of including five per cent renewable content in all gasoline through domestic production. The government also established a two per cent mandate for renewable content in diesel which continues to be filled with a growing percentage of domestic product.

As a direct result of these mandates, Canada’s renewable fuels industry is domestically producing almost 1.8 billion litres of ethanol and, by the end of 2013, is expected to produce over 400 million litres of biodiesel in Canada. These renewable fuels are already being easily incorporated into the current transportation fuel infrastructure. The net result is that consumers receive the benefits of June 2013 BIOTECHNOLOGY FOCUS 13

GREEN TECHNOLOGIES

cleaner fuels, and Canada reduces its emissions while at the same time stimulating economic growth that comes with domestic biofuel production.

It is important, however, that these mandates be grown out over time and are by no means reduced. The CRFA is very concerned with a move by the government of Canada to reduce the mandated level for renewable diesel by excluding heating oil from the content required by the renewable fuel regulations. The proposal, based on the erroneous assumption that renewable diesel will adversely affect the cost of heating oil in Eastern Canada, would reduce the required volume of renewable diesel in Canada by as much as 15 per cent. Removing this product from the mandate will see a proportional decrease in the environmental benefit, and the available market for Canada’s innovative renewable fuels producers to meet this demand. Changing the mandate for heating oil will also further slow development of renewable fuels production and innovation in Canada’s Maritime provinces.

In many ways, these biofuels policies have ensured that Canada has kept pace with alternative fuel initiatives around the world.

And while our domestic biofuels industry is a working success, the simple fact is that to meet our growing energy needs and stresses, much more needs to be done.

Maintaining policies that require renewable content in fuel is essential in order for Canada’s continued build-out of its established renewable fuels platform. And, at the same time, steps must be taken to support the successful integration and commer14 BIOTECHNOLOGY FOCUS June 2013

cialization of emerging advanced biofuels technologies. Sustainable Development Technology Canada’s Next Generation Biofuels Fund is another key policy component for Canada’s renewable fuels industry and attracts private investment needed in the first years of operation. The fund, created in 2007, will be deployed toward establishing facilities that will produce the next generation of renewable fuels at a commercial stage and serves as a beacon for companies that are transitioning from an advanced demonstration stage toward a pathway to commercialization. If Canadian biofuels are to reach full potential, this fund has to be given the opportunity to succeed – and as construction begins on these plants, the economic impact will be re-invested into Canadian communities.

As a direct result of the aforementioned government programs and policies, Canadian advanced biofuels producers are establishing commercial plants that can produce biofuels from an array of new sources. They are also developing cutting-edge technologies and first-of-a-kind projects that prove the future of fuel is, in many ways, already here.

The CRFA and members remain committed to a strong domestic biofuels industry in Canada. As an industry, we also see the need to preserve and grow government support and consumer awareness to capitalize on the economic and climate benefits of domestic renewable fuel production, both from our first generation and advanced technological platforms.

Together, producers, decision makers and consumers must work together to promote

and support initiatives that drive energy diversity and long-term prosperity in Canada.

The CRFA will be advancing this important dialogue at its 10th Anniversary Summit from December 2 to 4, 2013, in Montréal QC. The theme is “Fueling Growth and Innovation,” reflecting Canada’s tremendous opportunity as well as great responsibly in continuing to develop traditional and emerging biofuels in Canada. As the past decade has shown, a thriving and fully realized domestic renewable fuels industry is possible and working in Canada. And, as we strive to meet our energy and climate demands in the years ahead, the economic and environmental benefits of biofuels - for consumers, our country, and ultimately our planet - will become more important than ever.

Scott Thurlow is President of the Canadian Renewable Fuels Association.

Founded in 1984, the Canadian Renewable Fuels Association (CRFA) is a non-profit organization with a mission to promote the use of renewable fuels for transportation through consumer awareness and government liaison activities.

To see this story online visit www.biotechnologyfocus.ca/ biofuels-fueling-growth-andinnovation-in-canada/

Have your voices heard!

Biotechnology Focus, Canada’s leading authority on the Canadian life science industry, is doing its part to raise awareness in preparation for National Biotech Week happening September 20 - 27, 2013.

We’d like to ask you for your input in this special issue by taking part in a brief survey to share your views on the sector.

http://biotechnologyfocus.ca/?p=6694

By Daniela Fisher

INNOVATOR

West coast ties:

A

s someone who co-founded a biotech company at age 30, Punit Dhillon has achieved many successes in the biotech industry in a very short period of time. At 27, he became one of the youngest Canadians to be appointed vice president of a publicly traded biotech company. While at that company, he raised over $125 million through multiple financings and licensing deals, and was involved in several major global acquisitions and a merger.

Perhaps his biggest achievement was cofounding OncoSec Medical two years ago.

The San Diego-based company is pioneering a revolutionary new treatment that uses electricity to zap advanced-stage skin cancer.

As president and CEO of OncoSec, Dhillon is leading the company to new frontiers in cancer treatment. An experienced veteran in the start-up field, he is an entrepreneur in every sense of the word.

From 1998 to 2003, Dhillon worked at MDS Capital Corporation (now Lumira Capital Corp.) where he had the opportunity to act as a consultant for several early-stage health and life science companies.

In 2003, he joined Inovio Pharmaceuticals, first as a contracts manager and within five years worked his way up to vice president of Finance and Operations. As vice president of finance, Dhillon played a major role in the acquisition and consolidation of Inovio AS, a Norwegian DNA delivery company, and led 16 BIOTECHNOLOGY FOCUS June 2013

a key merger with VGX Pharmaceuticals that shaped Inovio into the vaccine-focused company it is today. He also raised over $125 million through multiple financings and several licensing deals.

With each role, Dhillon increased his knowledge of the Canadian and international biotech landscapes. Equipped with a strong skill set in the areas of investment and financing for start-ups, as well as private sector business, Dhillon was ready to pursue new opportunities.

In 2011, a pioneering new technology at Inovio caught his eye. A true entrepreneur and visionary, Dhillon believed he could spin out a company based on the technology, called ImmunoPulse, to target unmet needs in skin cancer treatment.

“We saw a tremendous opportunity in the advancement of skin cancer treatment, where there were very limited treatment options for patients dealing with deadly, metastatic disease,” explains Dhillon. “Most of the treatment options revolved around surgery, chemotherapy or radiation. They were just not the right approach to deal with metastatic disease. We saw an opportunity to advance electroporation [and immunotherapy] in a way that would address this advanced-stage skin cancer.”

ImmunoPulse is a technology that uses an electrical pulse to create temporary pores in cells (electroporation), through which

Canadian entrepreneur finds success south of the border extracellular genetic material can pass and be assimilated into the cell’s DNA. In cancer cells, chemotherapeutics or gene-based cytokines can be delivered through the temporary pores, allowing for more effective treatment at significantly lower doses.

With this process in mind, the start-up licensed Inovio’s non-DNA vaccine technology and the intellectual property behind electroporation and in March 2011, OncoSec Medical emerged.

Under Dhillon’s leadership, the company has gone from zero development in its pipeline to three Phase 2 studies, all within two years. Since March 2011, it has raised working capital to the tune of $19 million.

Currently, the company is working on its revolutionary OncoSec Medical System™ (OMS), a delivery system for treating solid tumours, as well as expanding its ImmunoPulse pipeline.

For Dhillon, developing a treatment for metastatic skin cancer – which previously had no or limited treatment options – is his inspiration and the drive behind OncoSec Medical.

“That’s what has really been the driving force behind pushing this technology forward,” says Dhillon. “We have a technology that is changing the paradigm of the way cancer is being treated.”

The OMS consists of a generator and

INNOVATOR hand-held applicator designed to deliver DNA-based cytokines and chemotherapeutic agents to target solid tumour cancers.

The company currently has two products in its pipeline: ImmunoPulse, which delivers DNA-based cytokines; and NeoPulse, which delivers a chemotherapeutic.

ImmunoPulse triggers the body’s immune system to identify and eliminate local and metastasized cancer cells. Through electroporation, DNA IL-12 (a plasmid DNA with instructions to produce a protein that can target and destroy cancerous cells) is inserted into the cell. Upon entering, DNA IL-12 triggers the cell to produce the IL-12 protein, which finds and eliminates the cancerous cells as part of a natural immune response.

Its other product, NeoPulse, uses an anticancer drug called bleomycin to kill cancer cells while leaving the healthy cells intact.

Traditionally, bleomycin is administered in high doses intravenously. By inserting the chemotherapeutic directly into the cell, NeoPulse uses a significantly smaller dose

terms of establishing your development pipeline, even inspiring you to expand your platform.

“Imagine what is possible in the research setting where you’re entering into sponsored research arrangements with some of the top labs that are on the cutting edge of science or a particular field, and you’re looking to establish a broader research pipeline. That’s what we’re doing now.”

Currently, OncoSec Medical is working with the University of Pennsylvania’s Department of Pathology to expand its immunotherapy pipeline, and is looking to take its collaborations and studies global.

A better opportunity to collaborate with academic institutions was one of the reasons that Dhillon launched his company in the U.S. Originally from Vancouver, Dhillon chose to start his company in San Diego to take advantage of California’s strong venture capital climate and the collaboration opportunities with universities.

“We just saw that with our particular

“We saw a tremendous opportunity in advancement of skin cancer treatment, where there were very limited treatment options for patients dealing with deadly, metastatic disease.” — Punit Dhillon of the drug which allows for more effective treatment reducing its harmful side effects.

With this novel product platform, OncoSec Medical is making waves in the medical community. In 2012, the company launched three Phase 2 clinical trials using ImmunoPulse in three of the most difficult to treat skin cancers: metastatic melanoma, Merkel cell carcinoma, and cutaneous T-cell lymphoma.

Through these trials, the company is validating that its product platform can effectively treat a wide range of skin cancers that previously had very limited treatment options.

One important part of OncoSec’s development is its research collaborations with universities. Through academic partnerships, the company has worked with some of the world’s leading experts on these neglected forms of skin cancer.

“Universities end up being such a major resource in any company’s innovation strategy,” says Dhillon. “I think the academic collaboration between academics and industries is very important because of that inherent scientific expertise that’s going to help develop better therapies, and make sure that people who are on the front lines treating the patients can have input in terms of the design and outcome of a product.”

For companies, he says, it also helps in

technology, we wanted to advance it at the fastest pace that we could,” says Dhillon.

“That was by affiliating with these academic institutions that were interested in working with us and the regulations and access to capital that we had in the U.S.” As a Canadian who built up his empire south of the border, Dhillon brings a unique perspective to how Canada can restructure – not rebuild – its innovation ecosystem.

“We need to be reinforcing a culture of innovation and growth. Canadians are at the cutting edge of research. We have a tremendous amount of talent and resources that we could continue to deploy,” says Dhillon.

“I think Canada just needs to build from its strengths: definitely more academic institutional involvement and creating an environment for academic translational research.”

A proud Vancouverite whose family lives in British Columbia, he has kept close ties to Canada while living in San Diego. An avid blogger, Dhillon is an advocate for crossborder collaboration, as well as helping to grow Canada’s biotech industry, including supporting young entrepreneurship initiatives with a new initiative he is working on with colleagues called the Young Entrepreneurship Leadership Launchpad (YELL).

Having started his career in Vancouver, he

makes sure he is well-informed of the local biotech scene.

“I think the local biotech industry has definitely struggled over the last decade because we’ve had a limited number of deals being done compared to the past. The biggest things that have pushed the industry in that direction is a lack of reinvestment into the industry and sector,” says Dhillon.

“Unfortunately, Canadian investors haven’t seen enough home runs to sustain that kind of face in the market. It’s very unfortunate because biotechnology can be a very lucrative and important industry to public health.

But investors need to see that success.

Companies usually have more good ideas than money, so it’s more about getting that attitude back where investors can see that opportunity.”

He points to the U.S., and how it is doing a good job of promoting opportunities to investors.

“Biotech thrives really well here [in the United States] because you have great academic institutions, great incubation of new start-up technologies, just great dialogue between industry and academics, and also a lot of investors,” says Dhillon. “We need to reinvigorate that spark back in Canada.”

In terms of becoming a greener pasture for start-ups, Dhillon sees government involvement as crucial.

“I think that there is definitely a role for the government to play in terms of bringing back a funding environment that is more favourable to some of these riskier sectors,” says Dhillon. “Those kinds of programs can be in the forms of grants and tax incentives that can help mitigate the risk and restore the investors’ faith.”

For Canada’s biotech sector to truly succeed, it’s time to move beyond the nationalistic lens, says Dhillon. As we are increasingly involved in a more global economy, he believes Canadian innovators need to look outside the country for financing and expertise.

“Canada is not lacking in any way, it’s just a matter of continuing to build on our strengths,” says Dhillon. “We’re not the size of the U.S., so we can’t compare ourselves to them. We just need to continue to drive the right attitude.

There are certain things, like government programs, that we can create to make for a more investor-friendly atmosphere. On a macroscale, Canada doesn’t have to do too much.

It’s doing all the right things.”

To see this story online visit www.biotechnologyfocus.ca/ west-coast-ties/ June 2013 BIOTECHNOLOGY FOCUS 17

By Shawn Lawrence

AGRi-FOOD

AGRI-FOOD DISCOVERY PLACE:

Going beyond the bench to scale-up great ideas

T

he University of Alberta (U of A) has some of the most progressive and innovative talent and laboratory facilities in Canada. On its south campus in Edmonton, AB, you’ll find a world-class technology transfer facility that provides a critical step in the commercialization process.

A 5,000 square-metre pilot plant, AgriFood Discovery Place (AFDP) offers the

18 BIOTECHNOLOGY FOCUS June 2013

opportunity to conduct direct bench scale process development focused on health, food, energy, and a host of bio-products including biofuels and biodiesel.

“We are predominantly an applied research pilot plant facility with scale-up equipment that can link industry with academic researchers. The strength of this University of Alberta team and the credibility of our academics can readily assist industry in

validating their bench scale opportunities, in particular, they can support industry in bioresource process development, meat safety and processing,” explains Bob Rimes, executive director of AFDP. According to Rimes, bench top process development is most often not transferable to large scale commercial plants. Essentially, the goal of AFDP is to provide an avenue for great ideas that have proof of concept established at the bench and provide the first scale up of the projects on a journey to new industry commercialization.

AGRi-FOOD

“My job is pretty much to manage the day-to-day operation of the facility, specifically facility management, operations, occupational health and safety, financial monitoring and managing core personnel.

But, I also do as much business development as I can.”

— Bob Rimes

Spurred out of interest on the part of both the university and local colleges, and backed by government and industry, the facility was built in 2004/2005 and opened June 1, 2006. Today, it is equipped with a nominal $20 million of small-scale processing and bio-containment equipment and crop utilization and enhanced material support equipment. Moreover, AFDP plays an important role in the bio economic development of new products that hold the potential for new businesses and the sustainability of current businesses in Alberta and across the country. This aspect is what makes the facility truly unique, says Rimes.

“The fact that it serves not just academic staff from the University of Alberta and Alberta Agriculture and Rural Development, but it also serves industry clients is its greatest value. It really is a critical link in Alberta’s innovation system.”

And the facility has the potential to do so much more he adds.

“There is an opportunity here for industry clients, but more so for industry partnerships such as with small or mid-sized companies and larger industry who can use top-of-the-line equipment such as the bioreactors, or lab space, and have the expertise of the university’s academics and

AFDP scientists.”

For this reason, Rimes, who was hired in mid-2009, has many duties as executive director of the facility.

“My job is pretty much to manage the day-to-day operation of the facility, specifically facility management, operations, occupational health and safety, financial monitoring and managing core personnel.

But, I also do as much business development as I can,” he says.

It is on the business side that Rimes says he’s been faced with some tough challenges as AFDP competes with other facilities that are subsidized.

June 2013 BIOTECHNOLOGY FOCUS 19

AGRi-FOOD

The MSPRU is a Level 2 Biocontainment meat processing facility allowing research on food borne pathogens such as E.coli and Listeria.

As such, the MSPRU is able to assist the meat and food processing industry to carry out hazard analysis and critical control points validation projects in a state-of-the-art facility that simulates an industrial setting.

“We are all vying for the same client dollars,” he says but counters that the university facility has many advantages for potential clients.

For starters, it offers a wide range of expertise from both within the U of A Food Science and Bio Resource Technology group, the U of A Department of Chemical & Materials Engineering, as well as experienced scientists and engineers from the Food and Bio Industrial division of Alberta Agriculture and Rural Development. Having the ability to leverage the expertise of world class researchers is a tremendous asset, he says.

“Our clients have access to the experts and the credibility of the University of Alberta, and they have expertise in the facility with people on the floor who truly understand not only the equipment and the location, but the projects coming in.”

He adds that academic support, together with core operation teams, will be a must going forward in order to bring the facility to full capacity.

In addition to the talent, what’s inside AFDP also sets it apart from its competition. For starters, the facility has multiple labs filled with top-of-the-line equipment.

More specifically, AFDP is comprised of three functional working areas: the Level 2 Meat Safety, Processing Research Unit (MSPRU) and Fermentation Laboratory, Crop Utilization & Enhanced Materials Research Unit (CUEMRU) and lastly an administrative support wing.

The MSPRU is a Level 2 Biocontainment meat processing facility allowing research on food borne pathogens such as E.coli 20 BIOTECHNOLOGY FOCUS June 2013

and Listeria. As such, the MSPRU is able to assist the meat and food processing industry to carry out hazard analysis and critical control points validation projects in a state-of-the-art facility that simulates an industrial setting.

Making the MSPRU more unique is that it is Canada’s only pre-pilot plant with a Level 2 bio-containment and solvent extraction facility under the same roof, but totally separated by walls and independent ventilation systems.

Likewise, the CUEMRU is beneficial to pre-pilot scale processing of plant and animal bioresource process development. The primary areas of focus for the CUEMRU are meat science, functional ingredients, fermentation, grain science, animal nutrition, industry by-products and bio refining.

“The fermentation lab is home to a full fermentation line of upstream equipment from 5L bio-reactors to 140L, and also has 750L and 2,000L tanks,” he says.

Already there are some examples of entrepreneurs that have successfully moved onto the next phase in development through partnering with AFDP. It all adds up to a significant contribution and push for the bio-economy in Alberta.

To see this story online visit www.biotechnologyfocus.ca/ agri-food-discovery-place-goingbeyond-the-bench-to-scale-upgreat-ideas/

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ACROSS CANADA

PATENTING GENES IN CANADA By: Carmela DeLuca, Micheline Gravelle and Amardeep Rana

With our neighbours to the south once again battling in the highest court of their land over whether or not “genes” should be patentable, it is interesting to consider the patent situation in Canada and assess what implications the U.S. situation may hold for Canadian enterprises relying on gene patents.

A

s most in the diagnostics industry are aware, the U.S. Supreme court is presently hearing a challenge to “gene patents” related to breast cancer-related genes, BRCA1 and BRCA2, owned or licensed to diagnostic giant Myriad Genetics.

“Gene patents” can be described as generally falling into two categories: 1) patents that claim isolated nucleic acid molecules (e.g. “genes” which are specific nucleic acid sequences encoded in the form of DNA, RNA, or cDNA nucleic acid molecules); and 2) patents that claim methods using isolated nucleic acid molecules. The first category includes claims to “isolated DNA.” The second category encompasses methods for identifying a condition associated with a defective disease gene (i.e. diagnostic methods) and methods of identifying a therapeutic candidate substance to treat a disease related to a defective gene (i.e. screening methods). One or more of these types of patent claims can be found in a single patent.

Although both categories of gene patents were at issue in the Myriad Genetics dispute, the sole question presently before the Supreme Court is whether or not human genes are patentable.

The attack on the BRCA patents is being led by the American Civil Liberties Union (ACLU) and various other parties who argue that human genes cannot be patented because they are classic products of 22 BIOTECHNOLOGY FOCUS June 2013

nature, and that gene patents violate the First Amendment and stifle diagnostic testing and research. Little empirical evidence seems to support the stifling of diagnostic testing and research, but the argument has gained traction in the U.S. The initial suit was heard in the United States District Court for the Southern District of New York and a first decision, which found all of the contested claims invalid, was rendered on March 29, 2010.

Claims to “isolated DNA” containing sequences found in nature were determined to be unpatentable subject matter, and methods involving the comparison of DNA sequences were considered to be abstract mental processes and thus not patent eligible. A drug screening claim was also found unpatentable for covering a “basic scientific principle.” Myriad appealed the decision to the Federal Circuit and the appeal was allowed in part, denying claims that involved merely “comparing DNA sequences” as patent eligible, but finding that Myriad’s isolated DNA claims were different than the DNA found in nature and that the screening claim was patent eligible as well. A first petition to the Supreme Court followed, which vacated the Federal Circuit decision and required the Federal Circuit to rehear the case in light of the U.S. Supreme Court’s decision in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 566 U. S. ____, 132 S. Ct. 1289. Prometheus, as reported in the October issue of Biotechnology Focus, has made patenting diagnostic methods that rely on a novel correlation much more difficult in the U.S. The Federal Circuit nonetheless held its ground and in August 2012, issued an almost identical decision to its first decision. Tenaciously, the ACLU filed a second appeal which is now being heard by the Supreme Court. The Court’s decision is expected by the end of June

ACROSS CANADA Patentable subject matter must be something with physical existence, or something that manifests a discernible effect or change.

The fact that a claimed method has a practical application is not enough to meet the requirement of physical existence.

2013. Regardless of the direction of the ruling, it is sure to be a landmark in the practice of gene patenting and have heavy implications for diagnostic and personalized medicine patents as well.

Unlike the U.S., Canadian courts have not seen direct challenges regarding the patentability of genes.

The patentability of “genes” (including human genes) is nevertheless well established in Canadian law and has been explicitly affirmed by the Supreme Court of Canada in Monsanto Canada Inc v Schmeiser, 2004 SCC 34 at 22-24, and implicitly affirmed by the Supreme Court in Harvard College v. Canada (Commissioner of Patents), 2002 SCC 76.

For example, in Canada claims to “isolated” molecules such as “an isolated nucleic acid,” “an isolated DNA,” “an isolated cDNA” or “an isolated RNA” are patentable. While higher life forms, including plants, and non-isolated molecules which occur in nature are not patentable in themselves, in Monsanto, the Court held that a claim to a gene can be infringed through use without isolating the gene, even if the use occurs within a higher organism (at 77-78): “It is uncontested that Monsanto’s patented claim is only for the gene and cell that it developed. […] The more difficult question — and the nub of this case — is whether, by cultivating plants containing the cell and gene, the appellants used the patented components of those plants. The position taken by Arbour J. assumes that this inquiry is redundant and that the only way a patent may be infringed is to use the patented invention in isolation.

This position flies in the face of century-old patent law, which holds that where a defendant’s commercial or business activity involves a thing of which a patented part is a significant or important component, infringement is established. It is no defence to say that the thing actually used was not patented, but only one of its components.”

There are some peculiarities to Canadian patent law concerning gene patents. Functional sequences with greater than 80 per cent identity to an isolated nucleic acid can often be obtained, as can functional sequences that hybridize under stringent conditions. However, in Canada it is necessary to define the “stringent conditions” in the claims.

Diagnostic methods are generally patentable in Canada. However, there are two specific concerns that must be considered. First, to be patentable, a diagnostic method must not be a method of medical treatment. Typically, diagnostic methods will not be considered methods of medical treatment if they do not have a direct therapeutic effect. Exceptions to this rule include if the method involves surgery or excision of tissue/organs/tumour samples.

Second, the diagnostic method claims as drafted must constitute patentable subject matter under s.2 of the Patent Act. The recent Federal Court of Appeal case of Canada (Attorney General) v Amazon.com Inc, 2011 FCA 328 provides the most current statement of the law in this area. In Amazon.com, the Court endorsed a broad definition of “invention” under s.2 of the Patent Act as “the application of [a] new knowledge to effect a desired result which has an undisputed commercial value.” While Amazon.com did not establish a single definitive test for patentable subject matter, leaving individual cases to be determined on a case-by-case basis, the Court did provide some guidance. According to the Court, it is an error in law to parse a claim into novel and non-novel elements and then assess patentability solely on the basis of the novel elements. The proper analysis requires identifying if “the subject matter defined by the claim,” and not the contribution over the prior art, falls within the definition of “invention” in the Patent Act. Patentable subject matter must be something with physical existence, or something that manifests a discernible effect or change. The fact that a claimed method has a practical application is not enough to meet the requirement of physical existence. Ultimately what is required when assessing method claims is that the subject matter of a claim purposively constructed must be more than a “mere scientific principle or abstract theorem.”

Contrary to the U.S., a diagnostic method involving a new correlation should be patentable in Canada if it recites a physical step (for example a step of assaying the status of a biomarker in a subject), even if the steps are otherwise known and obvious.

Not surprisingly however, the U.S. situation, combined with some home grown case-law, has had some influence on how the Patent Office assesses what is considered patentable subject matter in the gene patent arena.

In response to the FCA’s decision in Amazon.com, the Canadian Intellectual Property Office (CIPO) issued three draft practice notices regarding “Diagnostic Methods and Medical Uses”1 (DMMU) “Inventive Concept,”2 as well as “Statutory Subject Matter under the Patent Act.”3 The draft notice pertaining to “Inventive Concept” has been revised and was implemented on March 8, 2013 as practice notice “Examination Practice Respecting Purposive Construction.”4 According to the practice notice, examination is to be based on purposive construction consistent with Amazon, and all reference to “inventive concept” has been removed.

The other two draft practice notices have not been implemented at this time.

The DMMU draft notice set a high bar for patentability of diagJune 2013 BIOTECHNOLOGY FOCUS 23

ACROSS CANADA

nostic methods, similar to that required in the US. According to the DMMU draft notice, a purposive construction is to be performed on the claim in order to determine the inventive concept. For a diagnostic claim to be considered statutory, the inventive concept “must provide a solution to a technical problem and either have physical existence or manifest a discernible effect or change.” This requirement raises some concerns in regards to diagnostic method claims, which often contain only data acquisition and analysis steps. However in light of U.S. jurisprudence, recent drafting practice generally includes one or more physical steps. The DMMU draft notice further indicates that the step of physically assessing an analyte (or biomarker) could be sufficient to render the claim statutory. However, statutory subject matter is not present merely because a physical step is identified in the claim. If a known analyte (e.g. gene variant) has been previously assessed using equivalent analytical techniques, the inventive concept of the claim may be limited to the “significance or interpretation of the acquired data, which is considered to be an abstract method, and therefore not statutory subject matter” (DMMU, at pg. 2). This position is a departure from previous Canadian practice and seems to be influenced by U.S. case-law.

The “Examination Practice Respecting Purposive Construction” appears to have now recognized that “inventive concept” is not to be used to determine patentable subject matter, as the use of an “inventive concept” for this purpose was expressly rejected by the FCA in Amazon.com (at 47). Assuming the draft notices are implemented, it is expected that the “Diagnostic Methods and Medical Uses” and the “Statutory Subject Matter under the Patent Act” practice notices will be updated to remove reliance on the “inventive concept” in accordance with the current examination practice notice requiring purposive construction.

In addition to meeting the threshold of whether a gene patent is patent eligible, obtaining protection for gene patents requires a demonstration of utility–that the isolated sequence has a useful function and that it does what is promised. The utility must be found in application. It can be demonstrated or based on sound prediction at the Canadian filing date. But you need to be careful with what you promise!

It is now standard practice, at least with respect to pharmaceutical patents, to attack patent as lacking utility on the basis that the claimed compound does not deliver the promise of the patent. The courts have found that “[i]f the inventors do state a specific promise in the patent, the court must evaluate utility against this promise.

Just a mere scintilla of utility is insufficient in the face of a specific promise that requires more” (Teva Canada Ltd v Novartis AG, 2013 FC 141 at 169).

As for all inventions, sufficient and enabling disclosure is also a necessary requirement for obtaining protection. For isolated nucleic acid molecules this typically involves disclosing the gene sequence and a description of the nucleic acid used.

24 BIOTECHNOLOGY FOCUS June 2013

Although Canadian protection for gene patents seems situated on sounder footing, Canadian biotechs rely on the U.S. market. An alternative to patenting is the use of trade secrets. Trade secrets have the benefit of never expiring although protection is lost if an invention is reverse engineered or otherwise revealed. Despite these risks, companies like Coca-Cola have demonstrated that trade secrets can be very valuable protection.

But what is to prevent innovators from utilizing trade secret protection for their diagnostic innovations? This may already be happening. Myriad, for example, has developed a proprietary database at their own cost cataloguing new mutations it has identified in patient samples. The database is not available to the public. Myriad has used this information to the benefit of its patients and reduced the frequency with which it reports a variant of unknown significance compared to European BRCA testing services.5 Such proprietary information could provide companies like Myriad with much greater protection for their investment.

Given the uncertainty and diminishing protection for diagnostic patents in light of Prometheus and other cases in the U.S., Canadian diagnostic companies who want to develop a U.S. presence may choose to forego patenting and keep gene variants that are diagnostic or associated with disease risk as trade secrets, possibly providing an in house service for assessing risk similar to Myriad. Of course, if another identifies the variant, exclusivity is lost but this may be a risk worth taking where patent protection is diminished. Alternatively, diminishing patent protection could cause decreased investment in diagnostics and personalized medicine, with enterprises avoiding investing in development of such tests due to possible lack of return.

Only time will tell.

References: 1. http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/ eng/wr03443.html 2. http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/ eng/wr03442.html 3. http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/ eng/wr03444.html 4. http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/ eng/wr03628.html 5. Cook-Deagan et al, The next controversy in genetic testing: clinical data as trade secrets? European Journal of Human Genetics doi: 10.1038/ejhg.2012.217 Carmela DeLuca is an associate and registered patent agent at Bereskin & Parr LLP. Carmela’s practice focuses on patent matters, including advising on the management of patent portfolios in Canada and abroad, the preparation and prosecution of patent applications in the life sciences and the analysis of patent issues such as validity, infringement and freedom to operate.

Micheline Gravelle is a partner, registered patent agent, and head of Biotechnology & Pharmaceutical practice group at Bereskin & Parr LLP. Micheline has work experience in the chemistry, microbiology, immunology and molecular biology fields and has worked in the industry for multinational companies, government agencies and in a hospital laboratory.

Amardeep Rana in an articling student with Bereskin & Parr LLP.

To see this story online visit www.biotechnologyfocus.ca/patenting-genes-in-canada/

NEW PRODUCTS Microspectrophotometer Elliot Scientific now offers the new 20/30 PV™ Series UV-Vis-NIR Microspectrophotometer from CRAIC Technologies. This latest product excels in rapid, non-destructive analysis of many types of sub-micron or larger samples from the deep ultraviolet to the near infrared. The Microspectrophotometer features touch-screen tools, calibrated variable apertures, a highresolution digital imaging system, and an

laser diode operates at a temperature range of up to 50oC at 100mW in the 637nm visible wavelength band in a TO industry standard 5.6mm package with N type pin configuration. Oclaro releases its second laser diode, the HL65051DG, operating at up to 60oC and delivers 120mW in the 660nm wavelength band in a 5.6mm diameter TO industry standard package.

Web: www.oclaro.com Sterisonic incubator Panasonic’s MCO-19AIC Sterisonic® UVH cell culture incubator sets a new standard for advanced sterilization and decontamination cycle time. It is designed for a wide array of applications in biomedical, pharmaceutical, medical research and clinical laboratory settings. The Sterisonic incubator has a documented two-hour in situ H2O2 sequence and features interior components with a CO2 sampling loop that are sterilized in situ with no additional need for removal or separate autoclaving.

Pipettes Mettler Toledo presents its next generation of Rainin multichannel pipettes. The manual Rainin Pipet-Lite XLS+ and electronic Rainin E4 XLS+ offer users durable, lightweight liquid ends and new mechanical designs that all but eliminate hand strain while ensuring the highest channel-to-channel consistency. To prevent cross-contamination, pipettes have reduced stiction (piston stickiness), which helps to eliminate splash-up.

Web: www.mt.com

Web: www.panasonic.com/biomedical

Shaking incubator Bibby Scientific introduces its new SI600C cooled shaking incubator, the latest addition to the Stuart range of benchtop science equipment. The SI600C is a combined shaker and incubator, with a separate recirculating chiller to extend the achievable temperature range.

With the inclusion of this chiller, the SI600C incubator can now run at 15˚C below the ambient temperature of the room, to a minimum internal temperature of 5˚C. The SI600C cooled shaking incubator can hold up to six 2L flasks of various types without requiring tulip clamps or tools. BioCote antimicrobial protection guards against contamination and reduces the risk of sample loss.

Extractor Supercritical Fluid Technologies introduces its new pilot scale supercritical extractor for the processing of natural products. The SFT-NPX-10 performs supercritical fluid extractions in single or dual 10L sample vessels with single or dual separators. The Coriolis mass flow meter and pneumatic CO2 pump with an integral pre-chiller guarantee precision and efficiency. A programmable controller upgrade is available. The use of supercritical CO2 provides high diffusivity and pressure tunable solvency power without annoying residual solvents.

Web: www.stuart-equipment.com

extended spectral range. Ideal for use in thin film metrology, surface Plasmon resonance, and protein crystal measurement to name just a few.

Web: www.elliotscientific.com/442-0/ CRAIC-Technologies/ Laser Diode Oclaro announces the first ever high-power red laser diode to offer an inbuilt monitor photodiode at a lasing wavelength of 637nm. System designers can control optical power output by monitoring the photodiode current and adjusting power variants and temperature. The

Web: www.supercriticalfluids.com

June 2013 BIOTECHNOLOGY FOCUS 25

NEW PRODUCTS Vented Enclosure Air Science introduces a new series of Vented Enclosures for the containment of airborne particulates during manipulation and transfer of potent compounds. The turbulent-free design ensures precise and safe use in every situation. Ventilated Enclosures come in custom sizes with ductless and carbon/HEPA-filter technology for added safety. They fea-

ture an easy-to-change filtration system and without ducts, the Enclosures can be installed almost anywhere.

Web: www.airscience.com Peristaltic Pump Aalborg releases its new TPV RP Adjustable RPM with Dispensing Peristaltic Pumps designed to pump liquids of low to high viscosity. The new models can start and stop dispensing liquids at up to seven time relay intervals.

Pumps can run from 0 to 300 RPM, with a flow range of 0-5000 mL/min with 0.5 in. of ID tubing. The TPV RP Models feature a compact and versatile design, a 24 VDC brushless motor, an adjustable tubing subassembly, and a programmable timer. The pumps are ideal for laboratory, processing, and OEM applications.

Web: www.Aalborg.com Syringe Pump CMA Microdialysis delivers its new CMA 4004 Syringe Pump designed for microdialysis applications in pre-clinical research. The Syringe Pump holds up to 4 syringes with flow rates from 0.54 pl/min to 11.70 ml/min. It includes a built-in syringe library containing the most commonly used microdialysis syringes.

26 BIOTECHNOLOGY FOCUS June 2013

is safe and reliable, with its open circuit detection, short circuit protection, and automatic recovery in the event of a power failure.

Web: www.harvardapparatus.com Chromatin Detection EMD Millipore introduces their Magna ChIP® HiSens chromatin immunoprecipitation kits that detect specific regions of chromatinassociated DNA. Two versions of the kit exist: The Magna ChIP® HiSens kit contains reagents, buffers, beads for ChIP, materials for chromatin preparation and isolation; The EZ-Magna ChIP® HiSens kit includes positive and negative control antibodies and a validated qPCR primer set in addition to the standard kit’s contents.

Researchers can also ChIP from 10,000 to 1,000,000 million cells or cell equivalents with the kit’s single buffer system, delivering low backgrounds and high signal-tonoise ratios for ultra-sensitive detection.

Web: www.

HoeferInc.com Warming Plate Scienceware® unveils its new CultureTemp™ 37oC Warming Plate, optimal for trypsinizing cells during cell passaging. It maintains a temperature of 37oC (±1oC), which reduces the risk of cell death and the need to enter CO2 incubators. The plate’s small size, merely 7 x 8”, allows it to be easily installed anywhere in the lab. The CultureTemp™ plate also features a 15-minute count down timer

Web: www.millipore.com/catalogue Metering Pump Fluid Metering, Inc. releases its STH and STQ Duplex metering pumps for the unidirectional flow of

and UV-resistant polypropylene housing that resists damage under germicidal UV lights. It is water resistant and safe for cleaning for Ethanol or IPA.

Web: www.belart.com

liquids in diagnostic and analytic instrumentation. The variety of adjustable pump heads can be combined to achieve a displacement ratio anywhere between 1:1 and 500:1. The single, solid ceramic piston in the pump’s fluid path acts as both a pump and a valve performing maintenance-free cycles at ±1 per cent precision without recalibration.

Web: www.fmipump.com Power Supply Hoefer, Inc. introduces their new 600 Volt Power Supply (PS600) designed for electrophoresis and blotting techniques. This new model has three different power levels including 600 V, 750 mA, and 150 W, and can operate continuously or as set on its 999 timer. The PS600

LED Light L.J. Star breaks ground with its LED Luminaire Series 55-EX now including six LED lights to produce up to 138 per cent more light output depending on the output angle. This light is ideal for illuminating the interior of process vessels, such as tanks, reactors, hoppers, and pipelines.

The Series 55-EX boasts about its 50,000 hours of maintenance-free light without heat. Its compact size and lack of delicate filaments make it shock and vibration resistant, which is ideal for harsh applications. Available in fall 2013.

Web: www.ljstar.com

NEW PRODUCTS Small Centrifuge Thermo Fischer offers lightning/surge protection for Scientific, Inc. launches its new Thermo amplified models, fused polyurethane Scientific small cables, premium temperature perforbenchtop mance, compensated temperature range, centrifuge with protective nose cones and customizable new card:Layout 1 1/31/2013 9:09 AM Page 1 the flexibility cable lengths. The pressure transducers to adapt to the make mV/V, 0 to 5Vdc, 0 to 10Vdc, and 4 needs of clinical to 20 mA outputs available and include and research a 5-point NIST Traceable Calibration. The applications.

PX709GW transducers come in 0.20 per This centrifuge cent standard accuracy or 0.08 per cent offers an easyhigh accuracy models for precise depth to-use auto-lock or level measurements in water-related rotor exchange, applications.

Thermo Scientific Web: www.omega.ca ClickSeal biocontainment lids for one-handed sample SRC101 protection, and a glove- and detergentfriendly interface featuring one-touch operation and optional password protection. The Thermo Scientific small benchtop centrifuge is built for safety, versatility and I wish to receive/continue to receive a complimentary subscription to reliability.

Yes No BIOTECHNOLOGY FOCUS Web: www.thermoscientific.com/ smallbenchcentrifuge Sanitary Mixer Sharpe Mixers announces their new line of USDA-approved sanitary mixers custom-built to suit the customer’s needs. The Sharpe Portable Sanitary Mixers feature the M5 Quick-Lock mounting system and a hex base that can hold open-ended wrenches. All models are built with an off-the-shelf motor, shaft, and impeller options. The Portable Sanitary Mixers blend liquids from 50 to 50,000 gallons at viscosities from 1.0 to 50,000 cps.

Shafts for the mixers are available 0.75”,

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Web: www.sharpemixers.com Pressure Transducer Omega introduces its new series of pressure transducers with precision micromachined silicon sensors. The PX709GW

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CALENDAR AUGUST 2013

Venue: Indianapolis, IN Tel: 202-872-6061 Email: nationalmeetings@acs.org Web: http://portal.acs.org/portal/acs/ corg/content?_nfpb=true&_pageLabel=PP_ SUPERARTICLE&node_id=1051&use_ sec=false&sec_url_var=region1&__ uuid=d87ec41d-c0d7-4095-86592307a79d2d40

August 5-8 AAPM Annual Meeting Venue: Indianapolis, IN Tel: 301-209-3350 Fax: 301-209-0862 Email: 2013.aapm@aapm.org Web: http://www.aapm.org/ meetings/2013AM/

September 9-12

August 5-7 Fourth International Conference on Nanotechnology: Fundamentals and Applications Venue: Toronto, ON Tel: 613-695-3040 Email: icnfa2013@International-ASET.com Web: http://icnfa2013.international-aset.com/

August 10-14 2013 APS-MSA Joint Meeting Venue: Austin, TX Tel: 651-454-7250 Fax: 651-454-0766 Email: aps@scisoc.org Web: http://www.apsnet.org/meetings/ annual/Pages/default.aspx

SEPTEMBER 2013 September 8-12 246th ACS National Meeting & Exposition

Fourth BioMarine International Business Convention Venue: Halifax, NS Email: contact@biomarine.org Web: http://www.biomarine.org/

September 15-18 EnviroAnalysis 2013 Conference Venue: Toronto, ON Tel: 613-232-6252 Fax: 613-232-5862 Email: enviroanalysis@cheminst.ca Web: http://www.enviroanalysis2013.ca/

September 16-18 ASM Heat Treating Society 27th Conference and Exposition Venue: Indianapolis, IN Tel: 440-338-5151 Fax: 440-338-4634 Email: memberservicecenter@ asminternational.org

Web: http://www.asminternational.org/ content/Events/heattreat/

September 23-25 Pharmaceutical Strategic Alliances Conference Venue: New York, NY Tel: 908-547-2037 Email: d.struble@elsevier.com Web: http://www.elsevierbi.com/mkt/Conf/ PSA/2012

September 26-27 Sherbrooke International Life Sciences Summit Venue: Sherbrooke, QC Tel: 819-821-5577 Email: meduchaine@sherbrooke-innopole. com Web: http://sils-sherbrooke.com/

OCTOBER 2013 October 5-9 Fourth ASM Conference on Salmonella: The Bacterium, the Host and the Environment Venue: Boston, MA Tel: 202-737-3600 Email: meetingsinfo@asmusa.org Web: http://conferences.asm.org/index.php/ upcoming-conferences/4th-asm-conferenceon-salmonella-the-bacterium-the-host-andthe-environment

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Company & Advertiser Index COMPANY

Page Website

Advanced Proteome Therapeutics Corporation.......................................... 10 .................................................................. www.advancedproteome.com Albert at Bay.......................................................................................................31..................................................................................... www.albertatbay.com Aurora Biomed....................................................................................................2 ................................................................................www.aurorabiomed.com Bioniche Life Sciences Inc............................................................................ 10 .....................................................................................www.bioniche.com Best Western Victoria Park Suites...................................................................31....................................................................................www.victoriapark.com Cardiome Pharma Corp............................................................................... 10.....................................................................................www.cardiome.com Children’s Miracle Network .............................................................................11................................................................www.childrensmiraclenetwork.ca Cipher Pharmaceuticals Inc......................................................................... 10............................................................................. www.cipherpharma.com Eppendorf...........................................................................................................32.......................................................................................www.eppendorf.com MaRS Innovation.......................................................................................... 10.......................................................................... www.marsinnovation.com Merck & Co. Inc............................................................................................ 10..........................................................................................www.merck.com Nuvo Research Inc........................................................................................ 6...............................................................................www.nuvoresearch.com Oncogenex Pharmaceuticals Inc................................................................... 6...................................................................................www.oncogenex.com Ontario Bioscience Innovation Organization................................................7.......................................................................................................www.obio.ca Panasonic.............................................................................................................5.................................................................. www.panasonic.com/biomedical Pfizer Inc...................................................................................................... 10.............................................................................................. www.pfizer.ca POI Business Interiors.......................................................................................21........................................................................................................ www.poi.ca Stemcell Therapeutics Corp.......................................................................... 6...............................................................................www.stemcellthera.com Trillium Therapeutics.................................................................................... 6..................................................................... www.trilliumtherapeutics.com Valeant Pharmaceuticals International Inc................................................... 10........................................................................................ www.valeant.com VWR.......................................................................................................................2.................................................................................................... www.vwr.com 28 BIOTECHNOLOGY FOCUS June 2013

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THE LAST WORD

By John Kelly

Ontario’s Quiet Powerhouse –

THE BIOECONOMY

John Kelly, Vice President, Erie Innovation and Commercialization

Ontario has traditionally seen its economic base primarily supported through the manufacturing sector, and although there has been a recent decline in this sector, it still managed to ship over $258 billion in 2011. Another economic driver for the province is the agriculture and food sector, contributing $66 billion in 2011. Building synergies between these areas is one of the goals for the emerging bioeconomy, and Ontario is emerging as one of the global players in this market.

The bioeconomy was really kick-started by the emergence of biofuel production, with ethanol from corn being a mainstay across North America. In Ontario, Greenfield Ethanol in Chatham, Tiverton and Johnstown, Integrated Grain Processors Co-operative in Aylmer, and Suncor in Sarnia produce the majority of fuel ethanol. The biofuel sector is also supported by the production of bio-diesel and methane from agricultural sources.

These developments form only one part of the equation for the bioeconomy. The development of petroleum replacement carbon chain-based chemicals presents an immense opportunity. The synthesis of chemical intermediates and end use products from bio-based starting points is gaining momentum.

Whether it is through the creation of bio-polymers from plant, animal or algal oils, the creation of starch based chemicals, or the use of plant-based fibres as a structural component, the sourcing of agricultural inputs into the manufacturing sector represents a terrific market for primary producers.

Major companies have been creating chemical intermediates from bio-based sources for use in the primary manufacturing sector. This list of companies includes the likes of Lanxess, Bioamber, Ingredion, Jungbunzlauer and more, all of whom have manufacturing plants based in Ontario. This province has global leaders in bioeconomy-based innovation. For example, The Woodbridge Group from Mississauga has produced a soybean, bio-based polyurethane foam which has been incorporated into the Ford Escape.

Magna now has bio-based car components as well.

Jungbunzlauer, a Swiss company with operations in Port Colborne, Ontario, is a global producer of fermented bioproducts including citric acid, gluconates, special salts and other products. These products have roles to play as intermediates in the food, beverage, pharmaceutical, personal care, cleaners and detergents and other industrial applications such as textiles, plastics and fine films.

Life Science Ontario’s 2013 Emerging Life Sciences Company of the Year EcoSynthetix Inc. is producing proprietary eco-based bio-latex binders derived from

30 BIOTECHNOLOGY FOCUS June 2013

renewable crop resources like corn and potatoes, as a complete replacement for petroleum-based emulsion polymers.Their EcoSphere technology is manufactured into a powdered form using their patented process while still retaining the high performance characteristics of its petroleum-based counterpart.

This gives it a significant advantage in that the dry product can be shipped at a much lower cost than the competition. Paints, coating, paper and paperboard, adhesives, carpet and other textiles are but a few of the applications of this bio-based product. And the carbon footprint is two-thirds lower than the conventional product, making it more eco-friendly.

The development of the bio-based sector is not without its challenges. The business for these companies is very competitive. Even though they may be able to manufacture these products with perhaps a lower environmental footprint, they must be cost competitive. It takes a long time and a large amount of capital to build infrastructure for a chemical plant, and it must be scalable. It also takes a large investment in research and development to get to the end point desired by the company. Add to this market uncertainty compared to petroleum-based chemicals, government policies that are often time-limited, and investors who want very fast returns.

The connection of the chemistry sector to the agricultural sector has benefits well beyond the supply chain model. The impact on rural economies with the development of sustainable markets and diverse inputs offers real possibilities for the creation of new industries, new jobs, and a revitalization of the rural sector. This is very attractive for government policy supporting the bioeconomy.

This bio-based manufacturing economy has the opportunity to have the same impact as previous waves of economic development, including manufacturing in the mid 20th century and the information technology boom of the late 90s through the early 2000s. The 21st century will be the bio-based economic century.

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