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THE BIOTECH CITY 10th Anniversary International Scientific and Business Symposium

Publication Mail Registration Number: 40052410

Biotech Focus_Layout 1 12-01-10 5:57 AM Page 1

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contents APRIL 2012 – VOLUME 15 – NUMBER 4

11 Facing Today’s Healthcare Challenges


11 The Biotech City 10th

23 TheOpinion debate over the most appropriate way to conduct comparative effectiveness research (CER)

International Scientific & Business Symposium

Facing today’s health care challenges (By Samir Mounir)


Best Practices for Intellectual Property

Management and University Agreements (By Nika V. Ketis)

21 First in Class Human Clinical Trials


Research news


Business corner


20 Innovator/Spotlight

28 Calendar of events

8 R&D News

EMD Millipore and the Centre for Commercialization of Regenerative Medicine announce collaboration

Are there regulatory differences between conducting a first in class human clinical trial in Canada vs. the U.S.? (By Anna Metcalfe and Joanne Wan)

Spartan Bioscience Inc. is achieving what no other company has been able to, commercializing the world’s first point-of-care DNA test (By Janet Damianopoulos)

23 Across Canada

The Evolution of the Drug Development Paradigm with CER (By Diane Gajewczyk)




Global Biopharma industry converges in British Columbia


Terri Pavelic Shawn Lawrence

Christopher Rogers

Janet Damianopoulos

Editorial Intern


Diane Gajewczyk

Joanne Wan

Nika V. Ketis

Samir Mounir

Anna Metcalfe

National Account Manager

Marcello Sukhdeo

Elena Pankova



On February 26 to 28,Vancouver, BC played host to BioPartnering North Amercia (BPN), one of the largest biopharma conferences in North America. Event organizers TVG, Life Sciences British Columbia, and hosts BIOTECanada and BioAlberta said they were happy with the broad turnout as well the high volume of activity at the event. This year marked the 10th anniversary of the conference which is a part of the TVG Conference Network and includes leading industry events in the U.S., Canada, Europe, China, Latin America, Australia and India. In all, 680 registered delegates from 422 companies and 28 countries attended to learn about the latest advances in biotech, from new discoveries and developments, to promising early stage technologies. Companies were definitely there to take advantage of the opportunity to network and sow the seeds of strategic partnerships: there were 1,875 meetings scheduled through the shows website, A big draw at the event was Deloitte’s 2011 Life Sciences Deal Analysis Year-inReview presentation. Deloitte’s analysis showed positive trends in financings, partnerships, and mergers and acquisitions. However, presenter Eric Walczykowski, general manager at ‘Deloitte Recap’ made note that while deals were up, venture capitalists were still sitting idle on the sidelines, although corporations, foundations and government grants were picking up the slack. Even still, roughly $115 billion changed hands in 2011, which far exceeded the average $49 billion per year in transactions over the past decade. Beyond attendance, multinational pharmaceutical companies were well represented at BPN with companies like AstraZeneca, GlaxoSmithKline Inc., Pfizer and Merck & Co. providing keynote addresses and presentations. Big pharma’s key message was that they were open to partnering, whether through collaboration or in-licensing. Piggy-backing on the event, Gowlings hosted a dinner which provided local businesses and international delegates a chance to network and mingle. Likewise, international delegations had the opportunity to visit local research centres and meet with biotech companies to learn more about the industry in BC. On this latter point, organizers placed heavy emphasis throughout the agenda on the importance of doing business with the Pacific Rim. This was reflected in the leadership sessions where there was plenty of dialogue on how and why it was best to build close ties with industry leaders and companies from Asia. In previous years BPN has welcomed delegations from Japan, Korea, China and India, and organizers said the intention going forward is to expand this aspect of BPN.


Mary Malofy

CIRCULATION DIRECTOR James Watson Tel: 705-812-0611

EDITORIAL ADVISORY BOARD Celine Bak, Analytica Advisors; Rob Henderson, BioTalent Canada; Najla Guthrie, KGK Synergize; Pierre Bourassa, IRAP, Montréal; Brad Guthrie, Alberta Advanced Education and Technology; Carol Reynolds, Genome Prairie; Ulli Krull, UTM; John Kelly, Erie Innovation and Commercialization; Peter Pekos, Dalton Pharma Services; Brad Thompson, Oncolytics; Darrell Ethell, CanReg; John Hylton, John H. Hylton & Associates; Robert Foldes, Cognovie Inc.; Grant Tipler, RBC; Randal R.Goodfellow, P.Ag., Senior Vice President, Corporate Relations, Ensyn; Bob H. Sotiriadis, LLB, a partner with Leger Robic Richard; Dale Patterson, Genome Canada; Darcy Pawlik, Syngenta Seeds Canada Inc; Gail Garland, OBIO; Barry Gee, LifeSciences British Columbia; Bonnie Kuehl, Scientific Insights Consulting Group Inc. Biotechnology Focus is published 10 times per year by Promotive Communications Inc. 24-4 Vata Court, Aurora, Ontario L4G 4B6 Phone 905-727-3875 Fax 905-727-4428 E-mail: 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 ABC Membership Applied For.



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Lorne Babiuk

Canada Gairdner Awards for 2012 announced

A University of Alberta researcher has won one of the world’s most prestigious international awards for research in medical science. Lorne Babiuk, a Canadian specialist in immunology, virology and vaccinology and vice-president of research at the University of Alberta, is the recipient of the Canada Gairdner Wightman Award, given annually to a Canadian who has shown outstanding leadership in medicine and medical science. Babiuk won the award for his work both on the national and international stages in vaccine development. The first vaccine that he was involved in was against rotavirus. The virus used to kill about 500,000 children every year and is now almost eliminated in North America. Since then,

Babiuk has been involved in developing six other vaccines, five of those being world firsts. In addition to the Wightman award, the Gairdner Foundation named seven international award winners and one global health award. The winners of the International Gairdner awards were Drs. Jeffrey C. Hall, Michael Rosbash, Michael W. Young, Thomas M. Jessell, Jeffrey V. Ravetch and Theresa and Eugene Lang. The Canada Gairdner Global Health Award, recognizing someone who is responsible for a scientific advancement that has made, or has the potential to make, a significant impact on health in the developing world, went to Brian M. Greenwood. “Our 2012 Canada Gairdner Awardees are a group of modern-day explorers who have dedicated their lives to using basic science to discover answers to puzzling medical challenges,” said Dr. John Dirks, president and scientific director of Gairdner. “Because of their tenacity and their dedication, we have a whole new realm of potential medical solutions open to us. It is our hope the Awards continue to inspire researchers to conquer unchartered medical territory.” The awards will be presented at a dinner in Toronto on October 25th as part of the Gairdner National Program, a month-long lecture series given by Canada Gairdner Award winners at 21 universities from St John’s to Vancouver. The National Program reaches students across the country, making the superstars of science accessible and inspiring the next generation of researchers. Since the Gairdner awards were created in 1959, 78 recipients have gone on to win a Nobel Prize.

LifeSciences British Columbia announces award winners Winners of the 2012 LifeSciences BC awards were announced in early March. Four individuals and one company were honoured. The Genome Award for Scientific Excellence went to Dr. Neil Cashman, professor and Canada Research Chair at the Brain Research Centre, University of British Columbia and Vancouver Coastal Health. Dr. Tim Durance, founder, chairman and co-CEO of EnWave Corporation picked up


APRIL 2012

the Innovation and Achievement Award. The Leadership Award went to Dr. Bruce M. McManus, director, NCE CECR Centre of Excellence for Prevention of Organ Failure at the University of British Columbia, while Neovasc Inc. was awarded the distinction of Medical Device Company of the Year. The Dr. Don Rix Award for Lifetime Achievement went to Dr. Ian de la Roche, adjunct professor, Forest Resource Management at the University of British Columbia.

Clinical Trials & Patents n Isotechnika Pharma Inc. (Edmonton, AB)

announces it has reached an agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment for its planned Phase 3 clinical trial of voclosporin, a drug to prevent kidney transplant rejection. Isotechnika received positive scientific advice from the European Medicines Agency on a planned Phase 3 trial in October 2011. The regulatory pathway forward for voclosporin is clear now in both the U.S. and EU so the company can finalize plans to initiate Phase 3 testing. The Phase 3 is expected to consist of two clinical trials, each of which is expected to enroll approximately 600 newly transplanted kidney patients. One trial will be conducted primarily in the U.S. and Canada while the second trial will be conducted primarily in Europe. n Stellar

Pharmaceuticals Inc. (London, ON) announces its subsidiary, Tribute Pharmaceuticals, was granted an approval by Health Canada for CAMBIA® (diclofenac potassium for oral solution) for the acute treatment of migraine attacks with or without aura in adults. CAMBIA is expected to be launched in Canada in the second half of 2012. CAMBIA is a water-soluble, buffered diclofenac potassium powder engineered using Dynamic Buffering Technology™, a patented absorption-enhancing technology developed by a Swiss company APR Applied Pharma Research S.A. It was specifically developed to address a widespread unmet need among patients by offering fast and effective relief of migraine pain. In randomized clinical trials, CAMBIA was shown to be effective in treating migraine pain, photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea, symptoms commonly associated with migraine attacks. CAMBIA was also shown to provide statistically significant onset of relief of migraine pain within 30 minutes. In clinical studies, CAMBIA reached statistical significance in patients treated with moderate -to-severe migraine pain.

n Oncolytics

Biotech Inc. (Calgary, AB) has entered into an agreement whereby the NCIC Clinical Trials Group (CTG) at Queen’s University in Kingston, ON, will sponsor and conduct a randomized Phase 2 study of REOLYSIN®, its proprietary formulation of the human reovirus (respiratory enteric orphan virus) in patients with recurrent or metastatic castration resistant prostate cancer. The study will be an open-label, randomized, non-blinded, Phase 2 clinical study of REOLYSIN given in combination with docetaxel versus docetaxel alone. Approximately 40 response evaluable patients will be enrolled in each arm.

R & D NEwS SFU scientists discover possible HIV vaccine tool Simon Fraser University (BC) Faculty of Health Sciences assistant professor Ralph Pantophlet and senior research assistant and lab manager Kate Auyeung along with colleagues in Italy have discovered a resemblance between the sugar molecules on the surface of the bacterium Rhizobium radiobacter and sugar molecules on the surface of the HIV virus. Their discovery, profiled in the Chemistry & Biology journal, could potentially lead to the first vaccine for the virus. The researchers believe the Rhizobium radiobacter sugar molecules could be used to trigger an immune response to HIV, which is normally delayed by the cloaking action of its sugar molecules thus allowing the virus to spread faster than we can fend it off. To trigger an immune response to the sugar molecules of Rhizobium radiobacter, the researchers have to find a protein to which they can attach the sugar molecules. Such a protein is necessary to trigger production

Federal Government supports Alberta’s Ag-bio industry

Ralph Pantophlet. SFU health scientist Ralph Pantophlet takes a close up look at a bacterium that he and his colleagues have discovered could help our immune system eliminate HIV. of antibodies and such antibodies could then target the sugar molecules of HIV. The researchers are applying to the Canadian Institutes for Health Research for funding in the hope of creating vaccine candidates ready for clinical trial within the next two years.

The Government of Canada will invest over $4.4 million through the Western Economic Diversification Canada in Alberta’s agricultural sector to test and commercialize new crop and grain products in order to create commercial opportunities and attract investment and industry partnerships. The Alberta Crop Industry Development Fund will create a manufacturing facility to produce crop-based protein and cellulose derivatives to be used in commercial products. Alberta Barley Commission and Alberta Innovates Bio Solutions are also lending support in the fund. The University of Alberta’s Cereal Protein and Cellulose Program laid groundwork for the initiative, having developed industrial products out of agricultural sources.

May 29 and 30, 2012 F U N D I N G I N N O V A T I V E C O M PA N I E S

St. Andrew’s Club & Conference Centre, 150 King Street West, Toronto

BioFinance 2012

is the leading investor conference in Canada for the life sciences industry. This event brings together key industry players interested in investment opportunities and issues affecting companies in the life sciences sector. Presenting companies span a range of industries including: biologics, medical devices, drug delivery, vaccines, diagnostics, bio-energy, green technologies, bio materials, industrial biotech, and research services. BioFinance 2012 will also feature 14 investor panels that address specific financing and management issues relevant to this industry.

• Contact • Tel 1-866-342-4933 APRIL 2012 BIOTECHNOLOGY FOCUS 7


The Canadian Institutes of Health Research (CIHR) and Canada’s Research-Based Pharmaceutical Companies (Rx&D) have renewed their research partnership in the hope of strengthening Canada’s position as a preferred location to conduct clinical research. Through the partnership, CIHR and Rx&D member companies will fund clinical research across Canada through a competitive, peer-reviewed process to improve the coordination of research activities. Rx&D member companies have set an objective to match CIHR clinical research commitments dollar-for-dollar. Specifically, it will play a key role in the implementation of the Strategy for Patient-Oriented Research, a national initiative that was announced last August with the goal of improving translation of research findings into clinical practice. “This partnership will better integrate health research and health care. By bring-

ing together researchers and industry, this partnership will accelerate the development of new clinical practices and health products which will have a direct impact on treatment and services provided to patients,” says Dr Alain Beaudet, CIHR’s president. Over the past ten years, CIHR and Rx&D have partnered on a collaborative research funding program. The program has supported a wide range of health research projects at universities and hospitals across Canada. “The innovative pharmaceutical industry plays a critical role in the discovery and development of medicines and vaccines that improve and save lives,” said Russell Williams, president of Rx&D. “It is our goal, through this partnership, to outpace global competition and to build Canada’s position as a leader in clinical research, to create jobs and increase R&D investments in Canada for the benefit of all Canadians.”

Feds invest in Biochar Technology Lakeland College receives $900,000 in federal funding to acquire two mobile pyrolysis units to produce, test, evaluate and demonstrate biochar products for agriculture and environmental marketplace. Alberta Innovates Technology Futures also supported the initiative, contributing $450,000. Biochar is a carbon-rich residue produced by pryolysis (burning organic

matter such as agricultural and forest waste in a low oxygen environment). Biochar has a number of beneficial agricultural uses that include improving soil texture and crop productivity as well as hastening re-vegetation of land that has lost its fertility. Studies have also indicated great potential of biochar to clean up wastewater in the petroleum sector.

University of Toronto physicist wins Canada gold medal for science

W. Richard Peltier

Clinical research partnership is renewed

On February 27, the Natural Sciences and Engineering Research Council of Canada (NSERC) awards were held at a ceremony hosted by Governor General of Canada David Johnston. Seven prizes were awarded to 19 individuals and teams of researchers. The most prestigious prize, the 2011 Gerhard Herzberg Canada Gold Medal for Science and Engineering was awarded to University of Toronto physicist, W. Richard Peltier, for his work in Earth system science. Peltier has developed models depicting the evolution of climate change over the past 750 million years and projecting it into the future. Winners of the prize receive up to $1 million to fund their research over the next five years. Other awards honoured graduate students, academic-industry partnerships, discoveries, and multidisciplinary research.

EMD Millipore and Centre for Commercialization of Regenerative Medicine announce collaboration

L-R Robert Shaw, EMD Millipore and Michael May, Centre for Commercialization of Regenerative Medicine launch first industry project. Photo: 8 BIOTECHNOLOGY FOCUS APRIL 2012

EMD Millipore, the Life Science division of Merck KGaA, and the Centre for Commercialization of Regenerative Medicine (CCRM) have announced a collaboration to develop optimized conditions for large-scale industrial stem cell cultivation. The goal, say both parties, is to meet growing demands for stem cell use in drug discovery and clinical applications. Specifically, the project aims to reduce the expenses and labor involved in production using 2D tissue culture vessels, instead enabling large-scale, cost efficient bioreactor production methodologies that can speed the process of commercializing stem cell-based therapies. “As the demand for stem cells used in drug discovery and clinical applications grows, effectively translating the promise of stem cells into therapeutic reality will

require large-scale, industrialized production under tightly controlled conditions,” said Robert Shaw, Commercial director of EMD Millipore’s Stem Cell Initiative. “At this time, production is typically achieved using stacks of 2D tissue culture vessels, which is an expensive and labour intensive process. This joint project will address those challenges and facilitate optimized, large-scale cultivation of stem cells which can accelerate the progress of therapies into the clinic.” Using EMD Millipore’s Mobius® CellReady stirred tank bioreactor in CCRM’s University of Toronto Banting Institute research facility, the partners will develop monitoring and control algorithms that will optimize methodology for the cultivation of adherent human pluripotent stem cells.

BUSINESS CORNER Investing in Alberta Biomass Alberta Innovates Bio Solutions, a provincial government agency that supports science and innovation to grow prosperity in Alberta’s agriculture, food and forestry sectors grants a total of $4 million to Edmonton based companies Ceapro Inc., Radient Technologies Inc. and TerraVerdae BioWorks Inc. The three companies are using Alberta biomass from agriculture, forestry and municipal waste to develop industrial products and were accepted to Alberta Innovates Bio Solutions’ Advanced Materials and Chemicals Program. Over the next three years the companies will receive financial support to aid commercialization of their products.

Microbix aiming to increase revenue

Microbix Biosystems is financing and licensing its three pipeline businesses, intent on making them financially secure and making cash flow positive by the end of the 2012 fiscal year.

May 29, 19, 2012 2011 Montréal, Canada

The pipeline businesses include LumiSort® livestock semen sexing technology, VIRUSMAX influenza vaccine and Kinlytic-urokinase thrombolytic agent. The company’s virology business that develops, manufactures and distributes infectious disease antigens for the medical diagnostic and vaccine research industries provides financial back up for the pipeline. Microbix’s plans include raising $14 million for a wholly-owned private company in order to complete development of the LumiSort technology; relocating a flu vaccine manufacturing plant after an accord in China was terminated and concluding a partnership agreement with India’s Xydus Cadily to maket Kinlytic. LumiSort is planned to launch

in 18 to 24 months, after raising the $14 million this year. A leading insemination company has purchased a stake in the technology. Microbix’s operating vehicle in China Crucible International Biotechnologies has completed engineering of a proposed manufacturing facility that it can relocate to another country and is in discussions now with potential country partners. In January, Microbix signed a letter of intent with India’s Zydus Cadila to market its urokinase drug, Kinlytic for the treatment of pulmonary embolism and catheter clearance. Microbix has retained rights to nonthrombolytic indications including oncology and ophthalmology.

Life Science Technologies Ready-to-Go!

The Crossroad for BioTransfer, 5th edition, a technology licensing event not to be missed! Canadian research centres and universities will present to the biotech and pharma industry their best licensing opportunities in human health. 

Explore the potential of hundreds of technologies through our successful one-on-one Partnering formula Have a glance at available technologies for licensing-in on our website

May 29th, 2012, mark the date on your agenda! The event will be held at:

National Research Council, 6100 Royalmount Avenue, Montréal, Qc APRIL 2012 BIOTECHNOLOGY FOCUS 9

BUSINESS CORNER Valeant Pharmaceuticals International Inc. acquisition activity continues Valeant Pharmaceuticals International Inc. remains active on the acquisition front, this time signing an agreement to acquire certain assets from Austrian branded generics pharmaceutical company, Gerot Lannach whose major product is acetylsalicylic acid. The majority of sales from the assets are in Russia and Central Asia. There will be a 10-year exclusive supply agreement between the two companies for the acquired products and the opportunity for Valeant to introduce additional Gerot Lannach products into Valeant territories such as the emerging markets in South East Asia and Latin America. The companies will also explore opportunities for Gerot Lannach to obtain rights to Valeant products that are not marketed in Gerot Lannach territories. J. Michael Pearson, chairman and CEO of Valeant expressed belief in the Russian market as a positive investment opportunity citing an approximate 15 per cent projected growth. Valeant also announces the acquisition of 19.9 per cent minority equity investment in Brazilian tissue regeneration research com-

pany, Pele Nova Biotecnologia S.A. and of Brazilian sports and nutrition supplement company Probiotica Laboratorios Ltda. Valeant paid under $10 million for ownership of Pele Nova and will have representation on the board of directors, reduced royalty rate for Regederm (the biologic wound healing product), rights to all future products in Brazil and first right of refusal for global product rights. Valeant will acquire Probiotica for R$150 million. Net revenue in 2011 was approximately R$80 million and

double digit growth is expected in 2012. Finally, Valeant has acquired Eyetech Inc., a privately-owned ophthalmic biotechnology company dealing with diseases of the retina. Eyetech currently markets Macugen® in the U.S., the first anti-VEGF inhibitor approved for the treatment of wet age-related macular degeneration (AMD). Valeant will acquire Eyetech Inc. for an upfront payment and potential future milestones that total significantly less than two times sales.

Dealmakers n Agrium

Inc. (Calgary AB), a retail supplier of agricultural products and services announces an agreement with Glencore International plc (Baar, Switzerland) to acquire the majority of Viterra’s Agri-products business upon completion of Glencore’s recently announced supported acquisition of Viterra. Terms of the agreement allow Agrium to acquire approximately 90 per cent of Viterra’s Canadian retail facilities, all of its Australian retail facilities, and their minority position in a nitrogen facility located in Medicine Hat, AB. The acquisition price from Glencore is approximately $1.15 billion plus working capital, which is estimated at an average of $500 million.

n Miraculins

Inc. (Winnipeg, MB), and Stevens Company Limited announce an agreement to facilitate distribution of the PreVu® Non-Invasive Skin Cholesterol Point of Care (POC) test to the Canadian medical market. The Stevens Company will distribute the PreVu POC Test to medical professionals in clinical settings across the country. The Stevens Company will also purchase a start-up inventory sufficient for national servicing, which will represent Miraculins’ first commercial sale of the PreVu technology. Both companies will jointly participate in


promotional initiatives directed towards the medical segment. n CardioComm

Solutions, Inc. (Toronto, ON) enters into a five-year renewable software license and services agreement with Royal Philips Electronics (Amsterdam, the Netherlands). Under the agreement, CardioComm Solutions will integrate their proprietary GEMS™ (Global ECG Management System) software into Philips’ ECG management services. The agreement also extends licensing for a remote cardiac monitoring CardioComm Solutions ECG SDK viewer license, under which CardioComm Solutions’ ECG SDK software is being utilized.

n ProMetic

Life Sciences Inc. (Laval, QC) announces completion of milestones regarding the agreement entered into in March 2011 with Celgene Corporation for the worldwide rights to a commercial application of ProMetic’s Protein Technologies within a field of use. As a result, a US$10 million long-term debt owed to Abraxis BioScience LLC, a wholly-owned subsidiary of Celgene, has been completely and irrevocably forgiven. US$4 million of revenue had been recognized by ProMetic in the first half of 2011 effectively reducing said debt by the same

amount and leaving US$6 million as deferred revenue on ProMetic’s balance sheet. The recognition of said remaining US$6 million of deferred revenues will effectively reduce ProMetic’s current liabilities by the same amount. n Medicago

Inc. (Quebec, QC) announces a strategic alliance with Mitsubishi Tanabe Pharma Corporation (MTPC) through the execution of a Master Research Collaboration Agreement. The objectives are to develop and commercialize at least three new vaccines with MTPC who will provide funding for all research and development costs. In exchange for granting licensing rights, Medicago will be entitled to receive upfront and milestone payments as well as royalties for each product to be developed under this master agreement. Under this first agreement to develop a Rotavirus Like Particle (RLP) vaccine target, MTPC will have the option to license the RLP vaccine target and assume global development, regulatory and commercialization responsibilities while Medicago will be eligible to receive up to a total of $33 million in upfront and milestone payments as well as royalties on future sales of the RLP product. Medicago will receive an upfront payment of $3 million to begin the initial research on rotavirus.

Dr. Samir Mounir, Ph.D., MBA



HEALTHCARE CHALLENGES The pace of innovation in the life science industry (both biotech and pharma) in Canada is anaemic.




cies, angel investors, and venture capitalists. s a result, the innovation pipeline has dried up to critical levels. While This refreshing mix will hear conferences, only a few new drugs receive approval each year, none bears the interact, and participate in panel debates sales potential of its predecessors, yet each comes with an increasingly on topics such as development, regulations, higher R&D tag with fierce competition from China and India. At the innovations, new technologies, business same time, patents on today’s most successful products are expiring at an alarmstrategies and financing models. Scientific ing rate ($90 billion USD over the 2010 to 2014 period alone). leaders will highlight their latest advances Without a doubt, the current innovation cycle has produced highly effective and the innovation paths opening up ahead treatment and prevention measures. Should we worry that we seem to have of them. Business experts will discuss curreached the end of the cycle or should we rejoice over finding ourselves on the rent issues, from management trends in cusp of another? The latter is more likely. After all, a great number of serious emerging life science companies to business diseases and conditions continue to defy conventional drugs and technology. strategies and financing of new endeavours. Coupling innovation with an entrepreneurship-driven economy seems to be In Europe, the U.S. and Canada, we have the key. In their struggle to carve themselves a meaningful place in a landscape recently observed the pharmaceutical and riddled with contract research organizations, some universities have started listenbiotechnology industry’s move away from ing more closely to the needs expressed by the industry. In the corporate arena, the primary-care, blockbuster driven sales inventiveness serves those who decided to be different, who discarded the usual model. The transition is not over yet towards approaches that only led to slight variations on a drug theme. The new directions specialist secondary care, highly profitthey found led them to highly lucrative, innovative therapies. able biologic therapies and The cluster configuration offered by the global perspective marketCity of Biotechnology and Human Health of THE BIOTECH CITY LIFE SCIENCE CLUSTER ing. Mergers and acquisiMetropolitan Montréal (also known as the tions have performed as Biotech City) fosters the growth of biotechexpected, but they have also nology and pharmaceutical companies and demonstrated that the intehas established the City of Laval as an ideal grated model no longer suits environment for the life science and health the situation. Pfizer and GSK technologies industry. even broke an old, sacred The Biotech City happens to mark its 10th rule recently, when they Anniversary, on May 2 to 3, 2012, with a decided to share intellectual two-day International Scientific and Busiproperty and know-how in ness Symposium focused on the latest inthe development of new novations, developments, and new business drugs. Biologics and vacmodels in life sciences. For the past 10 years, cines, as well as other promthe Biotech City has served Canada’s life sciising research trails bearing ence and health technology industry with an longer exclusivity, will be at increasingly evolved and structured environthe forefront of the program, ment that, today, has become a research along with business models, and knowledge hotbed. With its exceptional intellectual property issues, platform for collaboration between academia and a regulatory landscape and industry, the Biotech City has truly fosthat is also changing (shall tered innovation while supporting business we say even adapting?). growth and creation, as well as commercial Our challenges today are development. The Biotech City therefore felt many, and complicated. particularly well positioned to draw some of Foremost among them are the best innovators worldwide and to feature our economic struggles an uncommonly rich program, filled with and the related, pressing the latest breakthroughs on highly-awaited need of our governments developments. and society for medical Why this Symposium now? In Canada, the and healthcare business elderly population is already responsible for solutions. Science and technology are seenearly 44 per cent of total healthcare expenditures, and this number can be ing critically important breakthroughs but, expected to rise further in the upcoming years. But Canada is only one of the to bring them to fruition sustainably, it is countries grappling with the issues brought about by an aging population. Japan, clear that all partners in this venture must the U.S. and all of Western Europe also face the same dilemma. “Facing Today’s adapt now. Waiting is just not an option Healthcare Challenges” therefore seemed a natural focus for this Biotech City Inanymore because investors, service firms, ternational Symposium, which will bring together more than 400 delegates from and even governments already recognize academia, the pharmaceutical industry, business management, regulatory agen-


BIOPHARMA he focus of the Biotech City these past 10 years has been to attract the highly skilled workforce found in Laval where, after an era of strong investments, the life science industry is visibly restructuring.

this new trend. It is therefore imperative that we learn to serve this purpose so as to build on the extraordinary promise of great science. The Biotech City International Scientific & Business Symposium plans to explore this changing paradigm and lead to answers and innovative solution pathways. Bringing relief to human disease and the future of the pharmaceutical and biotechnology industry lay heavily in the hands of yet unknown, small biotechnology entrepreneurs with poor or nonexistent track records. The growth and success of start-ups and early stage companies therefore depend almost entirely on government, contracts, incentives, and grants. These are the basic elements that stabilize valuations and make start-ups appealing to private and other public sources of supplemental funding, but many other issues stand in the way of development and success, including getting the right financial resources, ROI expectations, and patent prosecution. The Biotech City International Scientific & Business Symposium will look into the future, without a crystal ball or a safety net, but with the vast experience and broad understanding of experts. The focus of the Biotech City these past 10 years has been to attract the highly skilled workforce found in Laval where, after an era of strong investments, the life science industry is visibly restructuring. Indeed, to a degree, many big pharmas have pulled away from discovery to the profit of a focus on development, commercialization and marketing. Their new model to remain competitive and innovative hinges on their ability to identify promising products, acquire

licences and companies whose products they can develop. This new reality is also part of the program of the Biotech City Symposium. Speakers and panellists invited by the Symposium Organizing Committee are renowned scientists and executives well known for their business acumen in Canada, Europe and the U.S. A gathering of the brightest minds to present the latest developments in basic, targeted and applied research, under the themes of infectious diseases, cancer, and autoimmune, neurological and cardiovascular chronic disorders is an occasion not to be missed.

For more BIOPHARMA information visit our DRUG DISCOVERY Web Portal at


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By Nika V Ketis




As a follow up to the report that was published in the December, 2011 issue of Biotechnology Focus dealing with ownership of Intellectual Property (IP) in Canadian universities, this article considers best practices for IP management and agreements between universities and third parties.1 The Canadian Intellectual Property Office (CIPO) ranks seventh in the world in the volume of patent applications; Canada is the eighth largest economy; Canada’s population is 35th in size; and Canada is seen as an attractive location to obtain patent rights.2 In addition, Canada ranks eighth in the world in total number of patents currently in force worldwide and ninth in terms of patent fil-

ings by nations outside Canada.3 Clearly, IP policies at universities, the mecca of ingenuity, are key to ensuring that patent rights are attainable and innovations are economically exploited to the benefits of communities. However, IP policies can be a barrier to academic and industry interaction. Institutions in Canada have different sets of rules governing the ownership of intellectual property as previously reported in the December issue of Biotechnology Focus.4 In Canada, much of the IP is owned by the universities where the IP is created by their staff. The remainder is owned by the individuals or, in some cases, it is owned jointly with the university.5 In addition, Canada

has one of the highest levels of spin-off companies worldwide.6 Therefore, having the tools for easier access and collaboration between the university sector and industry is desirable.

Express Licensing Universities are struggling to find ways to limit inefficiencies in their negotiating processes as shown by the variable university IP policies.7 The express deal license has been implemented in the U.S. at Binghamton University. The term “BEST” is the acronym derived from “Binghamton Express Square Terms.” The intent of the agreement is that the BEST are attached to the research agreement with the industry partner having the option to exercise them. BEST is a template that universities may use to expedite the licensing process. As a result of BEST, the university is looking to a very modest licensing fee and recovery of its patent fees. The BEST license applies only to those industry partners that sponsor the research or intend to bring the invention to market. If another company wants to participate in the commercialization of the invention, a non-exclusive license can be drafted at their greater cost. BEST is suitable where a non-exclusive license is appropriate such as with microelectronics. BEST will likely never be used in cases of pharmaceuticals and medical devices where an exclusive license is sought. Rather, BEST appears most appropriate where speediness and high volume are of greater importance to the university than high revenue from a potential license. In the U.S., there have been early and positive reviews to the BEST deal license as it expedites the process and provides for easier and greater opportunity for industry and university partnership.8 In Canada, such an express licensing model may enable universities, various institutions and industry to streamline the negotiation process, and at the same time enable the establishment of standards and predictability for industry partners. Express licenses may provide the best deal license where a non-exclusive, royalty-free license on patentable inventions is appropriate. More recently, in the U.S., Pennsylvania State University (Penn State) announced that it will no longer mandate ownership of IP associated with industry-funded research.9 The IP in sponsored research agreements will be given to the sponsor(s) and Penn State will give the sponsor(s) a fixed price option to acquire anything developed with federal monies. The news from Penn State is significant



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Intellectual Property In Canada, an IP framework such as express licensing certainly could be a valuable tool given that express licensing could enable easier access and collaboration between the university sector and industry and promote innovation.

There should be a clear demarcation of ownership of the IP, control of the innovation and how the revenue generated from the innovation is to be divided. Providing that the contractual relationship is clear, the parties will be clear as to ownership, revenue, responsibility and liability.11 Such agreements should provide for easier access and collaboration between the university sector and industry.


as it is going against many years of established protocol in the U.S., Penn State is favouring its academic mission over its commercial ones. Penn State is the first university to make such a change. However, the University of British Columbia (UBC) had adopted a similar model to that of the Penn State. UBC allows the inventor to assign all IP from a project to a research sponsor for no further consideration. As such, this recent change in policy by Penn State will likely influence Canadian universities to consider adopting a similar position.

come of IP ownership disputes. Perhaps the best practice guide for universities is to keep abreast of research developments at various departments at the university through required filing and review of reports and lab books by investigators to mitigate backdoor filing of applications by inventors in their own names. The latter can be a valuable practice at Canadian universities who wish to be vigilant in ensuring their patent rights are protected.

Patent assignments (Stanford v Roche and Canada)10

In Canada, an IP framework such as express licensing certainly could be a valuable tool given that express licensing could enable easier access and collaboration between the university sector and industry and promote innovation. What carries most weight may not be the actual ownership of the IP, but who has control over the use and further development of the invention. Parties are wise to address these issues at the onset so as not to hinder the development and the use of research results, particularly, in a collaborative setting. Research tools and platform technologies should be non-exclusively licensed. If an exclusive license is required, limits should be set on the exclusivity. Even an exclusive license should preserve the rights of all researchers involved in creating the innovation and, if possible, researchers everywhere to be able to use and build on the technology in a university or teaching environment. An exclusive license should not block future development or use of the innovation. Provisions, such as the ability to nullify the license, should be included in the exclusive license that set limits in the event the IP is not fully exploited, developed or sublicensed. The nullification clauses may include the loss of the license, conversion from an exclusive license to a non-exclusive license or reduction in the scope of the license.

Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc. 563 U.S., 131 S.Ct. 2188 has brought about a change on how patent assignments are handled in a university setting in the U.S. As a result of the Stanford decision, universities in the U.S. cannot obtain legal title to faculty inventions until the invention is made, a patent application is filed, and the faculty member who is the inventor executes a written assignment that references the patent application. The assignment cannot be recorded by the United States Patent and Trademark Office (USPTO) unless it contains a patent application number or issued patent number. If a faculty member chooses to file a patent application in their own name and subsequently assigns the patent application to a third party, the recourse for the university is limited. The university may argue breach of contract (if assignment is to be made in the hiring contact) but not transfer of legal title to the application. The university seeking specific performance would be mute if the inventor had already transferred title to a third party as the title to the invention would have passed. Although this case is not binding in Canada, it serves as a reminder that the wording in agreements can significantly affect the out16 BIOTECHNOLOGY FOCUS APRIL 2012


1. Nika V. Ketis, Up-date on Ownership of Intellectual Property in Canadian Universities, December, 2011 issue of Biotechnology Focus. 2. CIPO website re: Strategic Plan 2007-2012 9 (last modified: 2011-12-02) http:// 3. Ibid. 4. Supra, note (i). 5. Ibid. 6. Denys G.T. Cooper, University Spin Off Firms and High Growth Firms in Canada, APEC SME Innovation Breifing (2007) December 31, 2007. 7. Supra, note (i). 8. Technology Transfer Tactics December, 2011 p 177. 9. Joe Petrucci, “Penn State Can Transcend Scandal with Groundbreaking IP Policy Shift� 10. Ted Hagelin, The not-so-obvious and potentially hazardous consequences of Stanford v. Roche ruling, Technology Transfer December, 2011 p 179. 11. E. Richard Gold & Tania Bubela, Drafting Effective Collaboration Research Agreements and Related Contracts, in Handbook on Best Practices, Chapter 7.5. Nika Ketis is a member of the Biotechnology, Corporate Commercial, IP Litigation, and IP and Technology law groups at Bennett Jones LLP. Bennett Jones LLP is a full service law firm with lawyers that can provide expertise across industry sectors to address legal and strategic issues relating to Canada, the United States and abroad.

For more Intellectual Property information visit our Best Practices Web Portal at

By: Anna Metcalfe and Joanne Wan

Clinical Trials FEATURE

Are there regulatory differences between conducting a First-in-Human trial in

Canada vs the United States? Many companies consider running their initial or First-in-Human (FIH) clinical studies in Canada and/or the United States (U.S.). Prior to this, a regulatory submission must be made to either Health Canada or the U.S. Food and Drug Administration (FDA), respectively.


hese agencies will review the submission and decide whether to approve and allow the clinical study to proceed or not. Thus, it is important to have an understanding of any differences in the information required to support a FIH clinical trial in each jurisdiction. A FIH trial is usually a Phase 1 study conducted in a healthy normal population of adults to test the safety of the drug and determine if there are any dose limiting toxicities. This article will highlight regulatory and submission-specific similarities and differences to be able to conduct a FIH trial in Canada and in the U.S. for a new chemical entity drug that is a small molecule. Though not intended for FIH oncology trials, some of the information described could be applicable to biologics and oncology products. In planning for the FIH study, the sponsor will establish the method for manufacturing the drug and perform non-clinical studies to determine the safe starting dose and doses of the drug to be tested. These data are compiled into the regulatory submission to each country’s respective regulatory agency: • In Canada, a sponsor must submit a Clinical Trial Application (CTA) to the Therapeutic Products Directorate1 (TPD) at Health Canada; and • In the U.S., a sponsor must submit an Investigational New Drug Application (IND) to the Center for Drug Evaluation and Research (CDER) at the FDA.2 Unfortunately, there are differences in the IND and CTA, the major ones are in the content of nonclinical data and manufacturing information required, as well as in the submission format. These are discussed in the following sections.

Non-clinical (or Pre-clinical) Testing Requirements: These studies refer to the in vitro and in vivo (animal) studies conducted to assess the performance of a drug and the potential toxic effects of a drug. The non-clinical studies required to support the FIH trial (and subsequent clinical trials) in Canada and the U.S. are similar for both countries and follow the guidelines published by the International Conference on Harmonisation of Technical Requirements

for Registration of Pharmaceuticals for Human Use (ICH). For a typical small-molecule, non-oncology product, this would include assessments of genotoxicity, pharmacokinetic and/or toxicokinetic evaluations, and safety pharmacology studies, as well as repeat-dose toxicity studies that are of a sufficient duration to support the proposed clinical trial design.3 It should be noted that most FIH trials are typically conducted in healthy males. If women are included, the clinical trial protocol would usually have specific criteria to exclude women of child bearing potential (WOCBP) or include pregnancy prevention measures. There are a few instances where women of reproductive potential will be included in the FIH trial, but this may have an impact on the nonclinical testing requirements, particularly in Canada. Health Canada released a Policy Issue statement indicating that they intend to amend policies to ensure that information on fetal toxicity and teratogenicity is provided to women of child bearing potential to assist them in making informed choices prior to participating in a trial.4 In the U.S., assessments of embryo-fetal toxicity may be deferred until before Phase 3 trials if appropriate pregnancy prevention precautions are incorporated into the clinical trial.3 The non-clinical program will establish the safe starting dose and support the doses to be tested in the FIH trial. Sponsors are encouraged to consult the appropriate regulatory agency and request a meeting that includes discussions on the nonclinical testing requirements for the FIH trial prior to filing the CTA or IND.

Manufacturing Requirements: Manufacturing refers to information regarding the composition, method of manufacture, packaging, and controls of the drug substance and drug product. In both Canada and the U.S., drug products to be tested in a Phase 1 clinical trial should be manufactured in acAPRIL 2012 BIOTECHNOLOGY FOCUS 17

Clinical Trials cordance with current Good ManufacturThe non-clinical program will establish ing Practices (cGMP). Health Canada has the safe starting dose and support the provided guidance on the manufacturing information requirements (referred to as doses to be tested in the FIH trial. Quality) in a document entitled “Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals”.5 The FDA has outlined what their expectations are for Module 1 allows for country specific information, such as the submission forms, module 2 contains summaries of manufacturing, nonmanufacturing requirements (referred to as Chemistry, Manufacturing, and Controls or CMC) to support a FIH (Phase 1) clinical trial clinical data (and if applicable any clinical data), whereas module 3 contains full manufacturing data, module 4 contain all non-clinical in a guidance document entitled “cGMP for Phase 1 Investigational Drugs”.6 reports (and publications), and module 5 contains clinical reports (and publications). Both Health Canada and FDA follow manufacturing guidelines The CTA for a small molecule contains only modules 1 and 2 whereas published by ICH. Thus the type and amount of manufacturing information to support a FIH clinical trial does not differ in content, the IND requires all modules 1 to 5 to be submitted. Module 1 will but only in how it is compiled, formatted, and submitted to each contain the Investigator’s Brochure which is a summary of all known information of the drug and required for any clinical trial per Good regulatory agency, but more on this below. Clinical Practice (GCP) ICH guidelines.9 Some of the specific differences in module 1 are the protocol synopsis for the CTA vs the general Content and Format of the IND and CTA: investigational plan for the IND and the placement of the clinical trial Regulatory submissions can often be very complex depending on protocol, which is module 1 for the CTA and module 5 for the IND. the type of drug under development, and the amount of data generA major difference exists in non-clinical information: in the U.S. nonated to support the first submission. In order to try and streamline clinical information is summarized in module 2 and study reports are the submission process, the content and format of regulatory submissions should comply with the general requirements of the Common submitted to the FDA in module 4. Health Canada does not require full non-clinical reports, hence non-clinical information is only summarized Technical Document (CTD) format as outlined by ICH. The CTD within the Investigator’s Brochure and must be kept current and upformat includes the provision of modules 1, 2, 3, 4 and 5, where dated when new data are available. There are also differences in how each module contains specific types of information (see Table 1). manufacturing information for a small molecule new chemical entity is This allows for similar information to be provided to each agency. presented: for the CTA, all manufacturing information is summarized in However, not every jurisdiction will accept exactly the same information, so there are specific differences with respect to place- the Quality Overall Summary (QOS) in module 2, whereas for the IND, the same information would be provided in module 3. ment and content of information in a CTA and IND. In Canada, the requirements for a CTA are outlined in the Guidance for Clinical Trial Sponsors7, while in the U.S., INDs will need to contain the informaConcluding Thoughts: tion outlined in the Federal Code of Regulations part 21 section This article has provided a snapshot overview of the differences 312 (21 CFR 312)8, and the many specific FDA CTD guidances. The between CTA and IND regulatory submissions but has not gone into details of the requirements for manufacturing, the non-clinical differences between a CTA and IND are briefly outlined in Table 1. Table 1. Outline of Regulatory Submission Differences in CTA and IND for a FIH Trial


Canadian CTA


1-Adminsitrative Information

Health Canada Forms Investigator’s Brochure Protocol Synopsis (PSEAT-CTA) Protocol and Informed Consent Form

FDA Forms Investigator’s Brochure General Investigational Plan

2-CTD Summaries

Quality Overall Summary (QOS)

Some Sponsors will include a QOS, though Module 3 is preferred. Nonclinical summary

3- Quality

Not required


4- Nonclinical Reports

Not required


5-Clinical Reports

Not required

Required (If any) Protocol and Informed Consent submitted in Module 5


Clinical Trials program, or preparing the regulatory submission for the FIH trial. Though it could appear that the IND submission (modules 1 to 5) may take longer to prepare than the CTA (modules 1 to 2), this may in fact not be the case. Proper planning will ensure that study reports required for any regulatory submission do not become the rate limiting step. Full study data are required to complete the Investigator’s Brochure, so preparation goes hand-in-hand. Finally, it is important to submit a complete submission with full data disclosure so that it is not either withdrawn by Health Canada or put on clinical hold by the FDA due to manufacturing, safety concerns, or inadequate clinical trial design. Regardless of the jurisdiction, sponsors should ensure that they have the appropriate regulatory, clinical, non-clinical, and manufacturing expertise for the proper planning and execution of a CTA or IND-enabling program.

References: 1. 2. 3. ICH 2009 Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2). Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/ M3_R2/Step4/M3_R2__Guideline.pdf 4. Policy issue from the Drugs Directorate inclusion of women in clinical trials during drug development dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/women_ femmes_pol-eng.pdf 5. Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals 6. cGMP for Phase I Investigational Drugs downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070273.pdf. 7. Guidance for Clinical Trial Sponsors. dhp-mps/prodpharma/applic-demande/guide-ld/clini/ctdcta_ctddec-eng.php. 8. Code of Federal Regulations. Part 312. Investigational New Drug Application. cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312 9. Good Clinical Practice: Consolidated Guideline. ICH E6(R1). May 1996. Anna Metcalfe, RAC. is the Vice President of Regulatory Affairs within the Pharmaceutical & Healthcare Group at Intertek Cantox. Ms. Metcalfe has successfully acted as Project Leader for the development of a number of drug candidates from the nonclinical stage to marketing authorizations in the US, Canada, and EU. She can be reached in Mississauga at 905-542-2900 or Joanne Wan, Ph.D. (Pharmacology and Toxicology), DABT. is a Senior Program Manager of Toxicology at Intertek Cantox. She can be reached in Mississauga at 905-542-2900 or

For more Clinical Trials information visit our Drug Discovery Web Portal at APRIL 2012 BIOTECHNOLOGY FOCUS 19 BioLynx Biotechnology Focus Ad Mar 2012.indd 1

12-03-28 3:17 PM

By: Janet Damianopoulos



Naming a company after the Spartan warriors of Ancient Greece takes ambition and implies some pretty high expectations to live up to. Ottawa, Ont. based Spartan Bioscience Inc. is proving to be worthy of its namesake, stunning the biotechnology industry by achieving what no other company has been able to – commercializing the world’s first point-of-care DNA test. This milestone proved the company could achieve victory in the face of impossible odds - a recurrent feat for which company founder Paul lem (M.D.) greatly admires the Spartans of old. Lem is no stranger to the Spartan work ethic, having been trained in clinical medicine and spending several years reviewing evidencebased research on well-being (he authored a book in 2008 entitled Master Life Faster) in addition to his occupation as an entrepreneur. His interest in research and innovation is long-standing. “Ever since I was a kid I always wanted to be an inventor,” he said when asked how the seeds of Spartan Bioscience took root. On the advice that it would be easier to obtain research grants with a medical degree, Lem entered medical school at the University of Ottawa, planning to become a clinician scientist after graduation. But the inventor in him would not be overshadowed, as he worked on several projects in his free time. Eventually, with the help of the University of Ottawa’s Technology Transfer offi ce, he 20 BIOTECHNOLOGY FOCUS APRIL 2012

filed a provisional patent for a universal multiplex PCR buffer. This device became the basis for Plexagen Diagnostics, the first independent venture Lem pursued. During his first year of medical residency in Toronto, he entered the BioNorth Business Competition in Ottawa and took fi rst place, which led to significant financial backing to commercialize the technology. Lem and his business partner were just 26 at the time. Lem was given the opportunity to take a leave from residency to start up Plexagen with $1.2 million initial funding. After two years of learning the ropes, the company wound down. Before returning to residency, Lem took up a post with DNA collection products manufacturer DNA Genotek, leading the commercialization team for Oragene™ a DNA collection device from saliva. After two years in this position he decided it

was time to strike out on his own again and with the resurrection of some technology from the Plexagen days, Spartan Bioscience was born. Six years later, the company has earned itself an impressive track record and is stirring up some very exciting developments in biotechnology. Spartan’s initial vision was to take DNA testing all the way down from central lab analyzers to bedside tests. The original product of Spartan Bioscience was the Spartan DX, a four-well endpoint PCR instrument. This evolved into the DX-12 (with 12 wells rather than four), which had more throughput capacity for labs. Not wanting to simply target labs but rather to focus on point-of-care, the Spartan RX platform was created by adding front-end DNA collection plus DNA extraction, and then integrating everything into one box enabling sample to result within an hour. After winning the 2010 Premier’s Catalyst Award for Best Young Innovator, Lem was able to fund a research collaboration with the University of Ottawa Heart Institute to run the fi rst ever clinical trial of a DNA bedside test, using the new Spartan RX platform. The Spartan system can be used to identify patients who carry a mutation of the CYP2C19 gene known as the CYP2C19*2 allele, which interferes with metabolism of a leading drug for cardiac stent patients, Plavix® (or clopidogrel). Patients typically take the drug for one year after their stent, and this interference reduces efficacy of



After winning the 2010 Premier’s Catalyst Award for Best Young Innovator, Lem was able to fund a research collaboration with the University of Ottawa Heart Institute to run the first ever clinical trial of a DNA bedside test, using the new Spartan RX platform.

the drug and potentially leads to serious complications such as another heart attack, stroke, or even death. By identifying the 30 per cent of the population that carries the CYP2C19*2 allele, cardiologists can prescribe newer anti-platelet drugs, which are unaffected by the mutation, rather than Plavix. Over the course of the study, nurses ran the Spartan system at point-of-care to identify cardiac stent patients who carried the allele. Carriers went on a newer anti-platelet drug while non-carriers went on standard Plavix therapy. Investigators found that the personalized medicine approach was able to completely eliminate non-response to Plavix. The study’s results have garnered worldwide media attention for Spartan Bioscience. Spartan has a number of additional projects going on around the world at the moment, one of which is a two-year 4,000 patient, 400-site study in Italy called the GENE-MATRIX. Cardiac stent patients will be tracked after having been tested by the Spartan system at point-of-care. The study will provide information on how many patients do better or are saved by rapid genotyping and personalized anti-platelet therapy. Another high-profile project is a follow-up study at the University of Ottawa Heart Institute called RAPID STEMI. This study is using the Spartan RX system to test patients with serious heart attacks known as STEMIs (ST Elevated Myocardial Infarctions). The study will investigate the effects of a personalized medicine approach in this population. Of course, with so much activity comes great challenges, of which Lem says the most pressing is raising capital for the com22 BIOTECHNOLOGY FOCUS APRIL 2012

pany. The hardware requires infrastructure complete with engineers, regulatory and quality personnel, and microbiologists to name a few, and it also requires substantial capital. When Spartan Bioscience began, angel investors lived up to their names and poured millions of dollars into the fledgling company. Since then, Lem has become an expert at investment pitches, having done hundreds in search of potential investors. Effective as its products have been so far, Spartan Bioscience as a small Canadian company must spread the word that they have done the seemingly impossible where multiple companies have failed and billions have been spent. Now, the company must make a name for itself. To this end, Lem has also spent a good portion of the past year flying around the globe paying visits to cardiologists and giving live demonstrations of the company’s system. After the live demonstration, he leaves the system behind for potential clients to try themselves and verify that it works. So far, the company’s efforts have been paying off. Lem cites strong mentorship and a long track record of experiential learning as the key elements in the company’s success and in reaching its goals for the future. “It’s so much better if you can find a mentor who has the experience so that you don’t have to learn by trial and error. The difficulty is how do you convince a mentor who is very successful and usually already independently wealthy to spend time mentoring you?” Spartan Bioscience hired Larry D’Andrea as chief executive officer two years ago and he has fulfilled that function, helping Spartan get to the next level, coaching and mentoring, formulating strategy and implementing processes necessary to generate success.

Toward that end of increasing mentorship and sharing of experiential learning, Lem started up the organization Fresh Founders ( in Ottawa around the same time that Spartan Bioscience was founded. This organization is intended exclusively for young entrepreneurs running their own companies and provides a forum for them to share information, support each other and gain greater understanding of the entrepreneurial world. Lem says it is the most useful organization that he’s ever been part of and adds such initiatives are important to keep Canadian talent in Canada to help build industry here. What does the future hold for Spartan Bioscience? Lem would like to reach the point where a whole new market for point-of-care DNA testing opens up. In much the same way that personal computers exploded into all sorts of applications that comprised an entirely new industry, he would like to see point-ofcare DNA testing take off and cover as great a span. And he is confident that it can happen. “I’ve been in biotech for almost 10 years now and I think I’m getting to the point now where I have the skills and experience and connections to do big things in biotech. It’s taken me 10 years of practice every single day.” Paul Lem and the team at Spartan Bioscience have certainly put in the dedication and practice necessary to achieve the skill set they now possess and to put Spartan Bioscience on the biotechnology map. We’ll see if these Spartans go down in biotech history.

For more Innovator information visit our Profiles Web Portal at

By:Diane Gajewczyk PhD, MBA


The Evolution of the Drug Development Paradigm with CER

Regulatory Approval

is Not Enough!

The heavy lifting of biopharmaceutical drug development is legendary. Accounts of numerous expensive and failed drug trials, high compound attrition rates, unforeseen safety issues and difficulties in drug scale-up abound. It is no wonder then, that new pharmaceutical compounds to treat existing and new disease targets command a significant price.


hese compounds are not commodity items-they are high value, important tools in the evolving standard of care. Yet, it is interesting to note that as these advanced treatments successfully pass the gauntlets of development milestones and are ultimately approved by regulatory authorities, they are not necessarily made available to the patients that need them most. Not in Canada you say, with our policy of universal healthcare for all! Unfortunately so, and here’s why. Following the receipt of approval from Health Canada by issuance of an NOC (notice of compliance), and after PMPRB (Patented Medicines Pricing Review Board) review of manufacturers’ pricing for the drug product, the product must then be considered for formulary listing. This is a critical step as these recommendations determine many patients’ access to drugs, including critical, life saving therapies. It is the Common Drug Review (CDR) committee, formed in 2003, that is tasked with making the for-

mulary listing recommendation through an assessment of clinical effectiveness and cost effectiveness. The CDR is a national committee, with the intent of streamlining and standardizing the reviews across the country (except for Québec). However, the recommendations of the CDR are non-binding and many provinces conduct their own reviews and make their own formulary determinations. While this province-specific customization can be seen as a way to best address the health needs of the local population, it is at this juncture that Canada’s universal healthcare policy begins to fragment, as we see that there is no true universal access to important medicines across the country due to patchwork formularies. A recent paper on the performance of the CDR process illustrates that there are further issues. A review of drugs listed in the five year period before the CDR and the five year period after the CDR review indicated that there was a decline in the proportion of drugs listed after the CDR was instituted. Furthermore, the general prevailing sentiment among industry and patient advocacy groups is that the CDR focuses more on cost containment than on objective analyses of clinical and cost effectiveness of the treatments under review. So what can be done to improve the CDR listing recommendations process and ensure that Canadians get access to the most current drug treatments available? Industry struggles with finding the best solution, likely to the same extent that the CDR expert committees do. This may be surprising to an external observer, given the resources put into the CDR process, but if you delve into the basis of decision making, the issues and complexity involved become apparent. The evaluation of clinical and economic effectiveness of drugs should be performed on the basis of the drug’s comparative effectiveness to other treatments, drug related or not, in the standard of care for a particular condition. Furthermore, the clinician/patient/payer needs APRIL 2012 BIOTECHNOLOGY FOCUS 23

ACROSS CANADA to understand how the drug performs in the real world. Typically, the randomized controlled trials (RCT’s) performed during the drug development process and reviewed by regulatory authorities, are conducted in very specific patient populations, controlled for comorbidities, so as not to obscure the effect of the drug. However, the broader population of patients may not fit the specific criteria of these trials, and once the drug is approved and used more widely, there are often additional observations made, both on a safety and efficacy level that inform the opinion of the “effectiveness” of the drug. In addition, the performance of the drug relative to other available drugs in the same or different classes is also of interest in assessing “effectiveness”. This is the “real world” data that most payers want to see Maurice, our Front Desk Agent, and has isn’t opened upaan additional exactly huge fan of the area snow.of study known as comparative And driving in the stuff?effectiveness He dislikes even more. But one cold,submisgrey research, that or CER. However, CDR December evening, our intrepid sions areMaurice usually ventured made just after approval, out into one of and before is storms extensive market adopthethere biggest of the season. What could have driven drive tion of the approved drug, so ithim is to unlikely into sponsors this tempest? His have sense this of duty. that industry would type You see, one of our guests had left of data available. Given that CER is a trend an important item behind. that is here to stay as governments struggle

Maurice and the snow storm

to sustainably fund the healthcare system, there is an emerging pressure on industry to generate some of this type of data during the drug development cycle. This modification of the current drug development paradigm is not trivial, as it involves an incremental data burden, with a very fundamental shift in design of trials. In most cases, this data will incur an additional expense in time and resources, which will push up the costs associated with drug development. There are different types of studies that may be used in CER, which include randomized controlled trials with a comparator treatment arm, meta-analyses to synthesize data across published studies, and observational studies, which observe patients over a period of time to look at the link between exposure to a treatment and the health outcome of the Knowing that a cab wouldn’t make it Observational studies topatient. the airport in time to reunite ourmay also be conducted a prospective guest with hisin property, Mauricemanner took (observmatters, as wellinasreal a frigid ing patients time)steering or they may be retwheel, into his own hands. Arriving on analyses atrospective, the airport based with mere minutes of to databases of patient records. Choosing the best spare, Maurice personally handed the study type, item our surprised, and extremely andtothen the best study design (appropriate relieved, traveller. Proof onceetc) again endpoints, comparators for a specific that, even after you’ve left our hotel, drug is a subject of intense debate among you’re still a VIP. industry medical professionals, government

We don’t go home happy until you do.

agencies and payers. As an industry medical professional supporting CDR and formulary submissions, you struggle to find the best Downtown Ottawa way forward in a murky and 377 O’Connor St. ill-defined path to generate800.465.7275 the requisite “real world data” and provide a reasonable comparative fectiveness data package to show that your drug, in this patient, at this time, is the most cost effective treatment alternative. The debate over the most appropriate way to conduct CER is complex, and ultimately, the approach to each drug must be considered on a case by case basis. To understand why this can be such a daunting task, consider some of the issues that must be addressed in the study design. First of all, there is the choice of appropriate compara-


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ACRoss CAnADA The endpoints in a CER trial should provide comparative drug data, and inform not only performance in clinical endpoints, but also patient outcomes, including quality of life measurements, which can then be factored into economic effectiveness of a drug. tor. If this data is to be generated during the drug development process, then the most appropriate comparator would be the treatment of choice at the time of launch of your drug. However, the competitive landscape of treatment alternatives rapidly changes with either attrition of drugs or surprising positive results which may eclipse your comparator, and the choice you make at Phase 2/3 (where you would have to begin to generate the CER data to support formulary submissions), may not be relevant by the time your drug undergoes formulary review. Next, assuming that you have made a suitable comparator therapy choice, you must decide on the patient population to be studied. Most drug developers understand the heterogeneity in patient response to a specific drug, and in truth, this is one of the driving forces for real world data. However, in creating the study design, do you focus on a heterogeneous population so that the payer can assess the generalizability of your drug to the general

patient population, or do you design studies in specific patient subpopulations to demonstrate to the payer the optimal patient population in which your drug should be used? Both approaches bear risk. As drug treatments become increasingly sophisticated at targeting specific molecular mechanisms, it may not be appropriate to assess a drug for general population use. However, if patient sub-populations are used in CER studies, then the question of the validity of the biomarkers used to identify these patients must be considered, as well as the costs involved in developing the biomarker, and the potential for reimbursement for biomarker testing. Furthermore, the more specific the population tested, the greater the risk of restrictions on the drug label and therefore limited potential clinical uptake. Finally, which study design to use must be considered. On fi rst blush, observational studies appear to be well suited to provide health outcome data. However, the gold standard

of evidence based medicine is the RCT, and many clinicians are suspect of basing their clinical decisions on observational studies alone. Furthermore, in order to generate robust data, prospective observational studies require very large patient cohorts, and the length of the trials can be very long. It is unlikely that this type of study would be economically feasible to begin until after drug approval, and long after the formulary decision is made. Retrospective studies may be more cost effective, but again, only become feasible after your drug has been used widespread in a clinical setting. A possible compromise to generate some relevant outcome data prior to formulary review may be the use of a RCT incorporating a specific comparator arm. However, the methodology and endpoint of this type of RCT is very different than the RCT design used in drug registration trials. The endpoints in a CER trial should provide comparative drug data, and inform not only performance in clinical endpoints, but also patient outcomes, including quality of life measurements, which can then be factored into economic effectiveness of a drug. At the end of the day, in this struggle between health, economic needs of payer

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Across Canada studies. Payers also need to come to the realization that the perfect data set on which to make a formulary decision may not be possible. A compromise interim solution that some drug companies have reached involves risk sharing or performance agreements where the drug company may reimburse the payer if their drug’s performance in a population is not achieved. However, this is a band-aid solution, and does not address the fundamental issues of data generation. Another shortfall in the Canadian system is the limited input

decision makers, clinicians’ decisions about medical treatment alternatives, and ultimately, Canadian patients’ access to the most current medicines, it may not be possible to satisfy all parties given the current regulatory and healthcare system infrastructure and processes.

Where do we go from here? Drug companies and payers need to engage in more productive discussions on the issues surrounding trial designs with an appreciation on both sides as to the limits and issues involved in conducting CER and outcomes


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of the patient population in formulary decisions. This is in direct contrast to the evolving system in the U.S. in which patient centred outcomes and patient input is paramount. The recent establishment of PCORI (patient centred outcomes research institute) with $1 billion in government funding, will help to drive this type of input and create some consensus on methodology for assessment of patient outcomes. Canadian stakeholders may benefit from this data in the coming years. The introduction of electronic health records may also facilitate retrospective outcome studies and make them more robust, comprehensive and cost effective. There is also probably some opportunity for streamlining the post-approval period of PMPRB, CDR and provincial formulary review, and perhaps a government review of the right balance to ensure Canadians’ access to medicine, within the context of value-based pricing should be considered. As governments struggle to find ways to sustainably fund future healthcare needs for their citizens, it is fiscally responsible to examine clinical and economic effectiveness of new drugs entering the market. However, caution must be paid in making reasonable data requests for formulary decision assessment. If the data burden becomes so onerous as to become economically unfeasible for drugmakers to undertake, then Canada may have to be prepared to be treated as a tertiary launch country, so that the requisite real world data may be compiled from” first launch” countries. Canadians would then need to travel to other countries, perhaps even emerging nations, to access the most current treatments. The pharmaceutical and biotech industries also need to bring CER considerations into the drug development paradigm earlier, so that reimbursement decisions can be facilitated. In the end, we all need to work together to ensure that Canadian patients are given the opportunity to access the right drug, at the right time for their specific conditions.

References 1. Gamble J-M, Weir D.L., Johnson J.A., Eurich D.T. (2011) Analysis of Drug Coverage before and after the implementation of Canada’s Common Drug Review. CMAJ

For more Across Canada information visit our Drug Discovery Web Portal at

NEW PRODUCTS Latch Rack Thermo Fisher Scientific Inc. announces its new Thermo Scientific Universal Latch Rack for use with 2 mL and 5 mL Nunc cryobank tubes as well as cryogenic tubes. The rack incorporates a highly flexible lid, which can pivot or be lifted off, making it suitable for handheld pipetting as well as automated dispensing via robotic picking and placing. As a result, users have the ability to switch between manual and automated formats while protecting samples from the surrounding environment, while the non-locking design is automation friendly. Furthermore, a latch locks the lid in place, providing safe, stackable and secure storage to maximize freezer space with 48 tubes per rack for internally threaded caps or 24 tubes per rack for externally threaded caps. The format is also compatible with the complete portfolio of Thermo Scientific sample-tracking and storage equipment, including handheld and automated decappers as well as 2D barcode readers, allowing customers to create a fully integrated and traceable cold storage workflow.

certificate and is tested to industrial CE standards. A user selectable analog output of either 0 to 5 Vdc, 0 to 10 Vdc, or 4 to 20 mA is standard on all models and a built-in wireless transmitter option is also available.

to be important predictors of disease progression and patient prognosis in haematological cancers, while providing good backbone coverage. These features facilitate the identification of key genomic aberrations, while the complimentary, CytoSure Interpret Software allows singleclick data analysis. The new CytoSure™ Haematological Cancer +SNP array offers aCGH and LOH detection on a single array by utilising a unique SNP probe design. Analysis is carried out using an intensitybased comparison between the two SNP alleles, meaning that no changes to the standard aCGH protocol are required and any reference sample can be used. This allows the two tests to operate effectively on the same array.

Flow Calorimeter Enhance enzyme discovery and optimisation with the new chipCAL, an innovative low volume flow calorimeter from TTP Labtech. chipCAL’s fast throughput enables characterisation of enzyme activity to be achieved within two to 10 minutes per sample, thus opening the door to high-throughput enzyme screening. In addition, chipCAL is suitable for monitoring a range of processes in the biopharma, food and fermentation industries. Microarrays Oxford Gene Technology has released the first in a number of new microarrays for use in cancer research. The new CytoSure™ Haematological Cancer +SNP array is optimized for the study of the haematological malignancies Chronic Lymphocytic Leukaemia (CLL) and Multiple Myeloma (MM), as well as Myeloproliferative Neoplasms (MPN) and Myelodysplastic Syndromes (MDS). The array offers detection of both copy number variation (CNV) and loss of heterozygosity (LOH) on a single chip for these diseases. This is achieved by utilising OGT’s array design, which combines long oligo array comparative genomic hybridisation (aCGH) probes for CNV detection with fully validated single nucleotide polymorphism (SNP) content for identifying LOH. The probes on the new array target regions known

Pressure Gauge Omega introduces its DPGM409 pressure gauge with metric fittings and ranges. The DPGM409 covers the full spectrum in pressure measurement with gage, sealed gage, absolute, compound gage, vacuum, and barometric pressure ranges. Its core is a highly stable micromachined silicon sensor with 0.08 per cent accuracy. Each unit is supplied with a five-point NIST traceable calibration Direct Detect™ EMD Millipore launches the Direct Detect™ system for rapid, simplified protein quantitation. The Direct Detect™ system exploits EMD Millipore’s membrane expertise to enable infrared-based measurement of amide bonds in protein chains, an intrinsic component of every protein, without relying on amino acid composition, dye-binding properties, or redox potential. The system employs a hydrophilic polytetrafluoroethylene (PTFE) membrane designed to be transparent in most of the infrared spectral region and enables application of biomolecule solutions directly onto the membrane. Additionally the Direct Detect™ system can measure protein concentrations from 0.2 mg/mL to 5 mg/ mL within seconds, without any bio- or immunochemical staining, directly from samples, including buffered solutions. It can also be used to provide information on non-protein sample components, such as lipids and nucleic acids. APRIL 2012 BIOTECHNOLOGY FOCUS 27

CALENDAR MAY 2012 May 2-6 ARVO 2012 Venue: Ft Lauderdale, FL Tel: (240) 221-2900 Fax: (240) 221-0370 Email: Web:

May 6-10 4th ASM Conference on Prokaryotic Cell Biology and Development Venue: Montreal, QC Tel: (202) 942-9248 Email: Web:

May 9-11 Biotech 2012 Venue: Shenzhen, China Email: Web:

May 15-18 Interdependence 2012 Conference and Exposition Venue: Vancouver, BC Tel: (604) 681-2153 Fax: (604) 681-1049 Email: Web: What-We-Do/Interdependence-2012/ Conference/conferenceprogram.aspx

May 22-24

June 2-4

C21 BioVentures (C21) Venue: Napa, CA Tel: + 1 (831) 464.4230 Fax: + 1 (831) 515-5070 Web:

AAMI 2012 Conference & Expo Venue: Charlotte, NC Tel: (703) 525-4890 Ext. 1210 Fax: (703) 525-1067 Email: Web:

May 23-24 China BIO Partnering Forum Venue: Suzhou, China Email: / Web:

May 25-27 How to Talk about Science Venue: Victoria, BC Email: Web:

May 27-30 CMA4CH Mediterraneum Meeting 2012 Venue: Rome, Italy Email: Web: index2.html

JUNE 2012 June 1-6 CYTO 2012 Venue: Leipzig, Germany Email: / Web:

June 4-6 APIC Annual Conference Venue: San Antonio, TX Tel: (202) 789-1890 / (800) 650-4570 Fax: (202) 789-1899 Email: Web:

June 11-12 Life Science Innovation Northwest 2012 Venue: Seattle, WA Tel: (206) 456-9567 Fax: (206) 456-9561 Email: Web: displaycommon. cfm?an=1&subarticlenbr=145







June 13-16 15th International Congress on Infectious Diseases (ICID) Venue; Bangkok, Thailand Tel: (617) 277-0551 Fax: (617) 278-9113 Email: Web:

Company & Advertiser Index COMPANY Page Website AlbertatBay.........................................................................................................24..................................................................................... Agrium Inc................................................................................................... 10........................................................................................ Biofinance............................................................................................................7........................................................................................... Biotalent Canada.................................................................................................2.............................................................................................. Biotech City Symposium..................................................................................25.................................................................................... Biotransfer...........................................................................................................9.......................................................................................... Caledon Labs......................................................................................................13.................................................................................... EMD Millipore................................................................................................ 8............................................................................... Gairdner Foundation..................................................................................... Ion Isotechnika Pharma Inc................................................................................. 6.................................................................................. Life Sciences British Columbia...................................................................... Medicago Inc................................................................................................ Microbix Biosystems..................................................................................... Miraculins Inc............................................................................................... 10................................................................................... MJS Biolynx Inc...................................................................................................19................................................................................................ Omega......................................................................................................... Oncolytics Biotech Inc.................................................................................. 6........................................................................ POI........................................................................................................................31........................................................................................................ ProMetic Life Sciences................................................................................. 10..................................................................................... Stellar Pharmaceuticals Inc........................................................................... Thermo Fisher Scientific.............................................................................. TVG.......................................................................................................................15............................................................................... VWR.......................................................................................................................5.................................................................................................... 28 BIOTECHNOLOGY FOCUS APRIL 2012


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By Carol Reynolds

Efficiency Scouting

Carol Reynolds, President, Wordmark Consulting Group Inc.

We count on our governments’ responsiveness to changing economic climates, enabling our economy to weather storms and sustain consistent growth. In times of uncertainty, it is a natural response to draw in and protect what we have and to guard against competition. However, with today’s more globalized society, aligning with allies and focusing on common priorities keeps organizations ahead of the game. We know “efficiencyscouting” is inevitable by our funders, partners and stakeholders so it makes sense to start collaborating on our own instead of waiting until funding cuts force us to diversify or look elsewhere for support.

Investing in innovation is driving Saskatchewan’s economy forward Provincial governments need to be proactive and seek out interprovincial and international collaborative activities. Saskatchewan is a leader in actively pursuing opportunities across borders. In response to current and future worker shortages, the province has engaged in various trade missions including a recent one to Ireland to seek skilled workers for construction and mining. Provincial MOUs for research and development activities are also being signed with India, China and abroad. The Saskatchewan government, for example is taking the biotechnology and innovation files to a new level of leadership. With $99 million announced in last month’s provincial budget for research and development, Saskatchewan is leading the way in this area, especially in the agricultural biotechnology, nuclear and energy sectors. The province is home to national centers of specialized excellence like the Canadian Light Source 30 BIOTECHNOLOGY FOCUS APRIL 2012

Synchrotron, Vaccine and Infectious Disease Organization, National Research Council- Plant Biotechnology Institute, Canadian Centre for Nuclear Innovation and the Petroleum Technology Research Centre.

Open for business 9 - 5 While reaching out and graying borders can be beneficial to all involved, protecting our country’s own interests and being wary about “giving away the farm” is also something we need to keep in mind. Intellectual property needs to be protected while being promoted, research needs to be funded while being responsive to industry requirements. With powerhouse countries like India and China feeling economic impacts, Canada and Saskatchewan need to maintain their integrity and independence, while preserving their reputations of having borders open for collaboration – a delicate balancing act. In all of this, let’s remember it is our governments’ roles to stimulate the economy, sustain growth and provide a ‘hand up’ to our researchers and the business communities through tax credits and incentives. Co-funding is not a dirty word. We are past the days and ways of thinking about research funding with a sense of entitlement. Let’s think outside the CBC TV with rabbit ears and look toward the big screen plasma connected to global satellites.


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Biotechnology Focus April 2012  

Biotechnology Focus April 2012 The evolution of the drug development paradigm The Biotech City Innovator Spotlight: Spartan Bioscience Inc.

Biotechnology Focus April 2012  

Biotechnology Focus April 2012 The evolution of the drug development paradigm The Biotech City Innovator Spotlight: Spartan Bioscience Inc.