Biotechnology Focus February 2012 by Promotive Communications

FEBRUARY 2012

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

VOLUME 15, NUMBER 2

inside:

INTERVAC New Opportunities in Infectious Disease Research

Transforming

DISCOVERYinto OPPORTUNITY

LEADING THE WAY IN TRANSLATING CANADIAN ACADEMIC HEALTH RESEARCH INTO A STRONG LIFE SCIENCES SECTOR

Publication Mail Registration Number: 40052410

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

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contents FEBRUARY 2012 – VOLUME 15 – NUMBER 2

23 New opportunities in Infectious disease research

FEATURES

11 Transforming discovery into opportunity How CDRD is leading the way in translating academic health research into a strong life science sector (By Natalie Dakers, Barry Gee and Michel Roberge)

11 CDRD president and CEO Natalie Dakers discusses how her organization facilitates the commercialization of new technologies

Opinion

Bench to bedside research support British Columbia Cancer Agency is committed to linking researchers with clinicians for better drug development (By Kevin Noel and Theresa Kennedy)

21 Tapping into the BC Innovation Engine Merck sees plenty of partnership and collaboration opportunities in British Columbia (By Shawn Lawrence)

DEPARTMENTS 6

Research news

Business corner

IN EVERY ISSUE

18 Innovator/Spotlight

EnWave Corporation develops a better way to preserve foods and other biomaterials (By Shawn Lawrence)

28 Calendar of events

23 Across Canada

7 R&D News

Bell Canada donates $2 million www.bioscienceworld.ca

InterVac: opening the door to new opportunities in infectious disease research (By Paul D. Hodgson)

FEBRUARY 2012 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S NOTE

PUBLISHER/ EDITOR-IN-CHIEF STAFF WRITERS

Budget 2012: What’s in store for biotech?

e’re on the eve of ‘Budget 2012’ folks. With high-risk loans and venture capital for start-ups and entrepreneurs severely lacking in Canadian biotech, the industry’s wish-list for the upcoming budget announcement is long and there are many companies clamouring to know what’s coming down the pipe. There are those hoping for the best, and equal in number, there are those bracing for the worst. If Stephen Harper’s recent Davos speech on innovation in Canada is any indication, innovation has rocketed to the top of the government’s agenda. Unhappy with the return the country is getting on the roughly $7 billion-a-year poured into research and development and bowing to public pressure, the government says it is focusing its efforts to improve our country’s innovation performance. A new national poll reinforces the public sentiment to do just that. The Angus Reid poll called: “Canada Speaks! 2012” shows that Canadians see health and medical research as an engine for economic growth. An overwhelming majority of Canadians (74 per cent) reject the idea of federal cuts to health research in the upcoming 2012 Federal Budget. Moreover most Canadians think that the federal government should maintain or increas funding for health and medical research (45 per cent and 30 per cent respectively). The fact that Canadians want government to support the industry should be seen as good news, so what’s the bad? One area of concern is the future of Canada’s Scientific Research and Experimental Development (SR&ED) program within the budget. It’s a program that is of immense importance to the biotech industry and others, handing out $3.5 billion in tax credits each year to some 25,000 companies. Released in October, 2011 by a group chaired by Open Text Corp chairman Tom Jenkins, the Jenkins report suggests revamping the SR&ED program and making it simpler. This is one idea that many in the industry I’ve talked to fully support. However, these same individuals are troubled by the report’s contention that the SR&ED tax credit is too generous and should be scaled back. Moreover, the idea of limiting the credit to just labour costs that was pitched in the report is equally worrisome. Regardless of what happens in the coming weeks, the industry will be impacted by this upcoming budget announcement. Perhaps Robert Foldes explained it best in his last word column in last month’s issue of Biotechnology Focus: “Efforts to improve access to and predictability of the SR&ED program are to be applauded, but efforts to dismantle or reduce its impact could quite easily deliver a death blow to an already fragile sector.”

Terri Pavelic Shawn Lawrence Christopher Rogers

CONTRIBUTING WRITERS

Barry Gee

Kevin Noel

Michel Roberge

Natalie Dakers

Paul Hodgson

Theresa Kennedy

National Account Manager

Marcello Sukhdeo

GRAPHIC DESIGNER CONTROLLER MARKETING MANAGER

Elena Pankova John R. Jones Mary Malofy

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

EDITORIAL ADVISORY BOARD Celine Bak, Analytica Advisors; Rob Henderson, BioTalent Canada; Najla Guthrie, KGK Synergize; Pierre Bourassa, IRAP, Montréal; 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 www.bioscienceworld.ca E-mail: biotechnology_focus@promotive.net Subscription rate in Canada $35/year; USA $60/year; other countries $100/year. All rights reserved. No part of this publication may be reproduced without written consent. Publications Mail Registration Number: 40052410 Return undeliverable Canadian addresses to: circulation dept – 24-4 Vata Court, Aurora, Ontario L4G 4B6 National Library of Canada ISSN 1486-3138 \ All opinions expressed herein are those of the contributors and do not necessarily reflect the views of the publisher or any person or organization associated with the magazine.

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R & D NEWS Xagenic Inc. Closes $10 Million Series A Financing

Dr. Shana Kelley Momentum continues behind MaRS Innovation (MI) spinoff, Xagenic Inc. and its breakthrough screening technology as the company reached a significant milestone with the completion of series A financing totaling $10 million. The financing comes from sources in the private and public sector including CTI Life Sciences Fund L.P., Qiagen N.V., and the Ontario Capital Growth Corporation through its Emerging Technologies Fund. “MI is proud that our first portfolio investment and first spin-off has reached such an important milestone in its evolution,” said Rafi Hofstein, CEO of MI. “With more than $12.2 million in funding secured to date and in such a short period of time, it’s clear that there’s tremendous excitement behind Xagenic’s breakthrough diagnostic technology and its potential benefits to patient care.” Diagnostic tests that are currently on

the market are considered complex, time consuming and require skilled laboratory technicians. Xagenic employs its patented nanostructured microelectrodes to achieve highly sensitive nucleic acid sensors that detect DNA and RNA at recordbreaking speed. The technology enables a faster detection of pathogens (in less than 30 minutes) and at the point-of-care (in either a physician’s office or at a patient’s bedside). For patients, a quicker diagnosis of conditions (ranging from infectious disease to cancer) can mean less anxiety and faster treatment decisions. “In today’s highly competitive economy, the success in attracting significant investment to Xagenic is a clear signal that Toronto is an outstanding place to incubate ideas, find discoveries and commercialize our successes,” said Dr. Shana Kelley, chief technical officer and founder of Xagenic Inc. “This investment in Xagenic will mean that we can advance our plans to commercialize our technology, create dynamic jobs and fuel the research economy.” Since its establishment in 2010, Torontobased Xagenic has secured funding from several Canadian-based organizations including: MaRS Innovation; the MaRS Investment Accelerator Fund; HTX, The Health Technology Exchange; the Ontario Institute for Cancer Research; and the Ontario Centre of Excellence (Centre for Commercialization of Research).

Feds invest $67.5 million into ‘personalized medicine’ The federal government will devote $67.5 million to research into tailoring medical treatments to fit individual patients by studying genetic markers and other disease indicators. The money will be funnelled through Genome Canada, the Canadian Institutes of Health Research and the Cancer Stem Cell Consortium. Researchers can get grants for programs lasting up to four years, but will have to line up matching funds from other sources before they are eligible to tap the government money. The program will look at a range of diseases and conditions, including cancer, mental health problems, skin diseases and rare diseases. The idea according to Genome Canada is to develop a set of tools to allow treatments to be custom6 BIOTECHNOLOGY FOCUS

FEBRUARY 2012

ized to the patient’s genetic markers. For example, a treatment might be of no help to people with certain genetic characteristics and knowing that in advance could save time and resources. It’s a move from the one-size-fits-all model that characterizes many of today’s treatments, Health Canada said in a news release. Health Minister Leona Aglukkaq said the research could pay big dividends by changing the way care is delivered. “The potential to understand a person’s genetic makeup and the specific character of their illness in order to best determine their treatment will significantly improve the quality of life for patients and their families and may show us the way to an improved health-care system,” she said in a statement.

Clinical Trials & Patents Stellar Pharmaceuticals Inc. (London, ON) has received another patent from the U.S. Patent and Trademark Office (USPTO) for intellectual property central to one of the company’s lead products, Uracyst® for the treatment of interstitial cystitis/painful bladder syndrome. Stellar’s second patent issued as U.S. Patent No. 8,084,441, entitled “Cystitis Treatment with High Dose Chondroitin Sulfate,” relates to the treatment of IC/PBS by instillation of an optimized unit dose of chondroitin sulfate that is at least 350mgs or more. Once issued, the patent will expire in 2023.

n Cynapsus Therapeutics Inc. (Toronto, ON) announces positive headline data from its recently completed human volunteer pilot proof-of-concept trial for APL 130277, a sublingual thin film strip formulation of apomorphine. The study showed a pharmacokinetic profile that compared favorably to injected apomorphine with a mean T-max of 25 minutes and good tolerability, and therefore confirms that APL-130277 has the potential to treat motor fluctuations or “off episodes” in Parkinson’s disease. n OncoGenex Pharmaceuticals, Inc. (Vancouver, BC) announces preliminary results from an investigator-sponsored Phase 1 study of patients with superficial bladder cancer with its investigational compound OGX-427 designed to inhibit the production of Hsp27. Hsp27 is a cell-survival protein expressed in many types of cancers including prostate, bladder, breast and non-small cell lung cancer. Overexpression of Hsp27 is thought to be an important factor leading to the development of treatment resistance and is associated with negative clinical outcomes in patients with various tumor types. In patients with superficial bladder cancer, preliminary results of the Phase 1 study demonstrated a trend towards decreased levels of Hsp27 and increased tumour cell death rates after intravesical treatment with OGX427. Additionally, of the 15 patients treated with OGX-427, 33 per cent had complete responses with no pathologic evidence of disease observed in post-surgical tissue following four doses of OGX-427 administered intravesically over an eight day period. The absence of residual disease post OGX-427 intravesical treatment prevented evaluation of Hsp27 levels and tumour cell death rates within tumour cells in these patients. No significant drug-related adverse events were reported and no dose limiting toxicity has been observed. Authors concluded OGX-427 was well tolerated with minimal toxicity.

R & D NEwS Bell Canada donates $2 million to upgrade and expand Douglas Institute Brain Bank in Montréal Thanks to an unprecedented $2 million gift from Bell Canada, the Douglas Mental Health University Institute will be able to improve facilities and expand recruitment and research activities for its brain bank. Part of Bell’s “Let’s talk mental health” initiative, the gift represents one of the largest donations ever made in Québec to a universityaffiliated mental health institute. The only brain bank of its kind in Canada and one of a select few worldwide, the facility will be renamed the Douglas-Bell Canada Brain Bank. Established in 1980 and holding an archive of close to 3,000 brains, it is considered Canada’s oldest brain bank. It operates around-the-clock, every day of the year and it provides highquality brain tissue samples to scientists all across Canada and in countries such as Japan, France, and the U.S., thus enabling them to increase their understanding of mental and neurodegenerative illnesses

From left: Lynne McVey, Executive Director, Douglas Institute; George Cope, CEO Bell and BCE; Naguib Mechawar, Director of the Douglas-Bell Canada Brain Bank; Martine Turcotte, Exec. Vice Chair, Québec, Bell; Jane Lalonde, President, Douglas Foundation and develop better prevention, treatment and recovery strategies. By comparing healthy brain tissue samples with those of individuals who have had a mental illness is the best way to understand the causes of diseases such as schizophrenia, depression, and bipolar disorders. Jane Lalonde, president of the Douglas Foundation, thanked Bell for the generous donation and said it was good news for individuals living with mental illness. “The Douglas Institute plays a leading role in mental health research and treatment and we are proud to welcome the organization as our newest partner in the

Bell Let’s Talk mental health initiative,” said George Cope, president and CEO of Bell Canada and BCE. “Aligned directly with our initiative’s research pillar, the work that the Douglas is undertaking here in Montréal will grow our understanding of the causes and effects of mental illness.” Bell Canada’s donation will go towards attracting and retaining highly qualified individuals to coordinate the brain bank’s operations, creating a Bell senior research fellowship in mental health; upgrading existing technology and purchasing state-ofthe-art equipment and improving and expanding laboratories and storage facilities.

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.

www.biofinance.ca

• Contact mstinson@biofinance.ca • Tel 1-866-342-4933 FEBRUARY 2012 BIOTECHNOLOGY FOCUS 7

R & D NEWS Internationally-respected Canadian researcher and founding CIHR president to fill prestigious leadership post

Dr. Alan Bernstein The Canadian Institute for Advanced Research announces the appointment of Dr. Alan Bernstein as the Institute’s new president and CEO commencing May 1, 2012. Last year, CEO Chaviva Hošek informed

the Board that she would be retiring and a rigorous international search for her successor began. Most recently, Dr. Bernstein was executive director of the Global HIV Vaccine Enterprise in New York, an international alliance of researchers and funders charged with accelerating the search for an HIV vaccine. From 2000 to 2007, Dr. Bernstein served as the inaugural president of the Canadian Institutes of Health Research, Canada’s federal agency for the support of health research, where he led the transformation of health research in Canada. “I have long admired CIFAR’s focus on identifying and supporting research that drives change and has the potential to improve human health, the environment, societies, technology and our understanding of the universe,” said Bernstein. “For the past 30 years, CIFAR has been

Breakthrough Treatment Successful for Blocked Arteries The world’s first clinical trial of a new treatment for patients with blocked coronary arteries has shown the novel approach to be safe with promising success rates. The study involved 20 patients with a coronary artery completely blocked by plaque, a condition called chronic total occlusion (CTO). Each patient received an injection of an investigational drug called MZ-004, an enzyme that softens the plaque over a 24-hour period so that a traditional angioplasty may be performed by advancing a guidewire through the otherwise impenetrable blockage, then inserting a stent to re-open the artery and restoring blood flow. Fifteen subjects, or 75 per cent, were able to successfully undergo angioplasty despite previous failed attempts. Published in the journal Circulation and funded by the Canadian Institutes of Health Research, the findings are poised to change the way patients with blocked

8 BIOTECHNOLOGY FOCUS FEBRUARY 2012

arteries are treated throughout the world, with a large multi-site, international clinical trial to begin later this year. “Due to the traditionally low success rate of angioplasty in patients with completely blocked arteries, many patients turn to bypass surgery or treatment with medications alone,” said Dr. Bradley Strauss, principal investigator and chief of Schulich Heart Centre at Sunnybrook, who developed the novel formulation

one of Canada’s leading global research assets. I am honoured to be selected to succeed Chaviva Hošek as its next president and CEO.” “Alan is a visionary leader who has a wealth of experience guiding pioneering enterprises that conduct leading-edge research and promote interdisciplinary collaboration, just like CIFAR,” said chair David Dodge. “It’s great to have him back in Canada.” David Dodge also recognized the extraordinary tenure of Chaviva Hošek who continues as CEO until April 30, 2012. “Under Chaviva’s leadership over the last eleven years, the Institute has developed as Canada’s premier centre for advanced research, linking top Canadian researchers to each other and to the world’s best,” he said. The Institute will be celebrating Dr. Hošek’s leadership and CIFAR’s 30th anniversary at a special event on June 12, 2012.

and approach. “This treatment provides patients with the option of receiving angioplasty, rather than having more invasive treatment with bypass surgery or living with pain and discomfort.” Currently approximately 20 per cent of patients having an angiogram are diagnosed with chronic total occlusions. Of this number, less than 10 per cent have angioplasty, with approximately 25 per cent receiving bypass surgery and the remaining 65 per cent presumably on medication alone. “Although not all patients with chronic total occlusions need to have an angioplasty to open up the blockage, those who experience chest pain and have difficulty breathing may be able benefit greatly,” adds Dr. Strauss, also a professor of Medicine at the University of Toronto and the founder of Matrizyme Pharma Corporation, the company responsible for the development of the drug. “In fact, successful angioplasty can relieve the symptoms almost immediately and significantly improve quality of life.”

BUSINESS CORNER Cangene axes 120 jobs and announces management changes Canadian biotechnology company Cangene Corp. is cutting 120 jobs, reducing its workforce by 17 per cent. The company also announced several changes to its management. Cangene sells immune therapeutics such as vaccines around the world to customers that include the U.S. military. Headquartered in Winnipeg, MB, Cangene has manufacturing plants in that city and in Baltimore, MD. Chief financial officer Michael Graham said the cuts will be made in most types of functions, but mostly in Winnipeg, and af-

fected individuals will be notified over the next month. “Aligning our workforce with our strategic focus on commercial products is a top priority and is expected to help Cangene drive value for its stakeholders,” said John Sedor, president and CEO. “Unfortunately, these changes affect talented people who have made important contributions to our orga-

nization. It’s never easy to make this type of decision, but it was necessary to better position the company for continued success.” Among the departures will be a senior vice-president for operations and a vicepresident for research and development. The company estimates the cuts will result in reducing future spending by $6-million to $7-million on an annualized basis.

Novadaq names MAQUET Cardiovascular exclusive U.S. distributor of CO2 heart laser products

Novadaq Technologies Inc., a developer of real-time imaging systems for use in the operating room, and MAQUET Cardiovascular, a provider of innovative products for cardiac surgery, vascular intervention and cardiac support, announce that the companies have signed an agreement naming MAQUET Cardiovascular as the exclusive distributor of Novadaq’s CO2 Heart Laser™ Systems and procedure kits in the U.S. The CO2 Heart Laser System for Transmyocardial Revascularization (TMR) is indicated for use in patients suffering from severe angina that is not amenable to traditional medical or coronary revascularization therapies. During the TMR procedure, the CO2 Heart Laser creates small channels in the heart tissue which stimulate improvements in blood flow to regions of the heart. “The alliance with MAQUET represents Novadaq’s fourth commercial agreement with a market leader,” said Dr. Arun Menawat, president and CEO, Novadaq. “We are excited that the CO2 Heart Laser will now be sold in the U.S.” BER BioFocus_Mar2011_OUT.indd 1

2/9/11 10:00:13 AM FEBRUARY 2012 BIOTECHNOLOGY FOCUS 9

BUSINESS CORNER Xenon to Collaborate with Genentech Xenon announces a strategic alliance with Genentech, a member of the Roche Group to discover and develop compounds and companion diagnostics for the potential treatment of pain. “We are delighted to be collaborating with Genentech,” said Simon Pimstone, president and CEO of Xenon. “Genentech is among the world’s leading biotech companies and an ideal strategic partner for Xenon as we share a common emphasis on using

human genetics for drug development. Further, this collaboration allows Xenon to both deepen and broaden our pipeline of novel medicines in development.” Under the terms of the agreement, Genentech has an exclusive license to compounds and a non-exclusive license to diagnostics from Xenon for development and commercialization of products. Xenon will receive an undisclosed up-front payment, research funding and is eligible to receive research, development and commercialization milestone payments, totaling up to $646 million for multiple products and indications. In addition, Xenon will receive royalties on sales of products resulting from the collaboration. Michael Hayden, CSO of Xenon added: “This new alliance, which represents our sixth partnership with a major pharmaceutical company to date, once again highlights the keen interest in Xenon’s unique genetics approach and in our translational R&D capabilities.”

KGK Syngergize Inc. announces lawsuit settlement with Sourceone Global Partners Inc. KGK Synergize Inc. (KGK) announces it has reached a settlement in a lawsuit against SourceOne Global Partners, Inc., initiated by SourceOne on December 29, 2008, in U.S. District Court for the Northern District of Illinois. Details of the settlement are confidential and will remain undisclosed. “KGK is pleased to have resolved this matter on business terms in lieu of further protracted litigation,” said Najla Guthrie, CEO of KGK adding that KGK’s patents remain valid and enforceable.

Isotechnika terminates existing agreement with ILJIN Consistent with prior communications from Isotechnika, the company is pursuing discussions with ILJIN Life Science Co., Ltd. to potentially change the current relationship with ILJIN in order to better advance

the voclosporin program. The company has therefore chosen to exercise its right to terminate the existing development, distribution and license agreement with ILJIN. In doing so, Isotechnika secures full rights

to voclosporin for transplant and autoimmune indications in the U.S. and other regions outside of Canada, Israel, South Africa, China, Taiwan and Hong Kong. The company already owns full rights in Europe.

Dealmakers Amorfix Life Sciences (Mississauga, ON) has signed a letter of intent with JSW-Lifesciences GmbH, an Austrian contract research organization specializing in Alzheimer’s and other CNS diseases, to license its pre-clinical Alzheimer’s disease diagnostic test, the Amorfix Aggregated Abeta Assay (the A4). The LOI sets out the business and financial terms which the parties have agreed will be part of any formal agreements, including exclusivity of the license to perform the A4 as a service in the area of pre-clinical Alzheimer’s disease studies, transfer of know-how and technology, and supply of key proprietary materials from Amorfix. In return, JSW will commit to minimum annual sales, a royalty on net sales, and defined marketing activities. Terms of the LOI will only become binding once they are incorporated into a formal agreement.

Apricus Biosciences, Inc. (San Diego, CA)

10 BIOTECHNOLOGY FOCUS FEBRUARY 2012

and Stellar Pharmaceuticals Inc. (Milton, ON) have signed an exclusive license agreement where Stellar Pharma has the exclusive right to sell Apricus Bio’s MycoVa™ product for the treatment of onychomycosis (nail fungus) in Canada, following receipt of Canadian regulatory approval for such product. The exclusive license agreement provides for an up-front payment, regulatory approval milestone, sales achievement milestones and royalty payments during the term of the agreement. Aeterna Zentaris Inc. (Québec, QC) has entered into a collaboration agreement with Ventana Medical Systems, Inc. (Tuscon, AZ), a member of the Roche Group, to develop a companion diagnostic for the immunohistochemical determination of luteinizing hormone-releasing hormone (LHRH) receptor expression, for the company’s doxorubicin LHRH targeted conjugate compound, AEZS-108. In humans, n

LHRH receptors are expressed in a significant proportion of endometrial, ovarian, breast, bladder, prostate and pancreatic tumors. AEZS108 specifically targets LHRH receptors and therefore, could prove to be more efficient in treating patients with these types of LHRHreceptor positive cancers. Phase 2 trials with AEZS-108 for LHRH-receptor positive advanced endometrial and ovarian cancer have recently been successfully completed. n Mandel Scientific, (Guelph, ON) a Canadian distributor of scientific instrumentation and supplies for the analytical and life sciences marketplace, said it has acquired InterSciences, a Markham-based distributor of analytical and life science products. The acquisition took effect on February 1, and for the first three months, InterSciences will continue to operate as a separate subsidiary, after which its operations will be merged with those of Mandel.

By Natalie Dakers, Barry Gee, and Dr. Michel Roberge Centre for Drug Research and Development (CDRD) President & CEO, Natalie Dakers Photo by: Todd Duncan of Todd Duncan Photography

COMMERCIALIzATION

overnments around the world have made huge investments in academic health research, investments that play a critical role in building strong scientific cultures and knowledge economies, and that have immense potential to be the genesis of new therapies for patients. Much, if not most of this health research investment has been made into academia, but there exists a significant gap however in translating the resulting discoveries into commercially viable investment opportunities for the private sector. Canada is no exception to this, with its long history of innovation dating back to Banting and Best and the discovery of insulin in 1922. Since then, Canada has continued to be a global innovation leader, and has invested heavily in the development of our life sciences industry. As a result, the industry has grown dramatically over the last two decades, and our bio-based economy is now estimated to be valued at more than $78 billion (or about 6.5 per cent of our national GDP), second only to the U.S. Despite this success however, we (along with countries around the world) continue to struggle with how to successfully translate academic health research discoveries into actual new medicines. The Canadian Federal Government has increased research funding threefold over the last 20 years (Canada’s three major research granting bodies’ investments are now approaching $3 billion/year) with approximately half of this investment going into health sciences. Canadian university R&D has been so strongly supported in fact, that it now ranks second among the OECD as % of GDP. At the same time, direct and indirect Federal Government support of business R&D ranks second in the world. These billions of dollars invested in Canada (and worldwide) however have resulted in unfortunately relatively few new medicines and therapies brought to market.

TRANSFORMING DISCOVERY INTO OPPORTUNITY

Leading the way in translating Canadian academic health research into a strong life sciences sector FEBRUARY 2012 BIOTECHNOLOGY FOCUS 11

Commercialization

A significant factor influencing this struggle, exacerbated by the current difficult economic environment, is that venture capital firms have become more risk averse and less willing to invest in early technology opportunities arising straight from academia. Global pharmaceutical companies are also facing challenges, including impending patent expirations on blockbuster drugs, the increasing cost of bringing new drugs to market, and today’s regulatory hurdles – all leading to the reorganization and redirecting of their research and development strategies. To rebuild its pipeline of drug candidates, pharma is increasingly interested in accessing innovative academic discoveries. Global pharma in fact now represents the largest single source of private sector health R&D in Canada, and we see companies such as Pfizer establishing new translational research centres and initiatives such as their new Centers for Therapeutic Innovation entrepreneurial research unit, a network of partnerships that aims to speed translation of biomedical research into life-saving medicines. However, academic research laboratories can rarely advance their discoveries to the proof-of-concept stage that marks the transition between an interesting discovery and a commercially viable investment opportunity for the private sector. As a consequence, we have seen a number of translational centers 12 BIOTECHNOLOGY FOCUS FEBRUARY 2012

and initiatives launched to try to fill this commercialization gap. When we bring all of these factors and players into consideration, it becomes abundantly clear that additional focus and resources must be directed toward the transfer of academic research to the private sector such that it can be successfully commercialized and brought to patients. New translational research organizations are therefore rising up around the globe, and a wide variety of models and structures are being explored, ranging from virtual centers that outsource all research and development activities to those that are fully-equipped and staffed to support such activities, and from centers led by academic institutions or government agencies to those driven exclusively by the private sector, while numerous combinations thereof are also emerging in the form of hybrid organizations. Irrespective of the model being pursued, these centers face multiple common challenges, including how to bridge the significant differences in scientific culture and values that exist between academia and industry; how to identify therapeutically and commercially promising projects from highly innovative and extremely early discoveries; and how to fund drug discovery activities that align neither with the traditional mandate of public granting agencies nor with current funding strategies of the private sector.

In Canada, our Federal and Provincial Governments also understand this paradigm, and are working together alongside industry and post-secondary institutions to take decisive action to ensure we also maximize innovation through the successful translation of research, and take our rightful place in the global innovation stage. To this end, the Federal Government has created the Centres of Excellence for Commercialization and Research Program with an investment of $285 million over five years (2007-2012) to support centers that advance research and facilitate the commercialization of technologies. To date, 17 centers have been established including The Centre for Drug Research and Development (CDRD), a national centre headquartered in Vancouver. CDRD is a “bricks and mortar” organization with 85 employees and trainees with scientific, business, and project management expertise. It is equipped for drug screening, therapeutic antibody generation, drug target evaluation, medicinal chemistry, drug delivery, as well as in vitro and in vivo pharmacology, toxicology, and ADME studies. CDRD is a not-for-profit organization that operates fully independently of any academic institution or private sector company. Instead, it has affiliations with major universities and health sciences research centers across Canada as well as select international centers, which enable researchers at all of

Photos: Todd Duncan of Todd Duncan Photography

Commercialization

these institutions to access its capabilities and resources. CDRD aims to bring together, in as many ways as possible, the best drug development practices of both academia and industry. It was founded by academic researchers and business leaders with established track records in commercializing discoveries from university laboratories, and in founding successful biotech companies, thereby possessing first-hand knowledge of the challenges of early-stage drug discovery and development. This type of direct industry experience was a key criterion in building CDRD’s senior management and entire team. CDRD’s team collaborates with principal investigators to undertake projects with the highest level of commercial potential, screened against rigorous scientific and business criteria to optimally design them for commercial success. Milestone-driven, outcomes-focused drug development under professional project management is then undertaken, as the projects are carried out according to industry practices with more strictly defined experiments, budgets, timelines, and reporting than is commonly employed in academia. The objective of the research plan is to develop early drug candidates to the proof-ofprinciple stage with demonstration of efficacy in animal models of human disease. And with most projects being very early stage in

nature, they often require several iterations before the true commercial potential can be fully evaluated. The projects with the more promising data are continued at CDRD, and those that require further research can be then returned to the investigator’s laboratory for further exploration, should they choose. To support the projects, CDRD facilitates the leveraging of external funding via granting agencies such as the Canadian Institutes for Health Research Proof-of-Principle program, and through funds raised via CDRD’s established partnership with international industry. This structure enables CDRD to carry out key experiments on a number of projects per year, enhancing their data packages to identify those showing therapeutic and commercialization potential, and making them increasingly attractive to potential commercialization partners. Commercialization is enabled through licensing by the academic researcher’s institution technology transfer office. In addition, CDRD has established a commercial arm, CDRD Ventures Inc. (CVI), to act as an interface between CDRD and industry, in-license selected intellectual property generated from CDRD projects directly from the affiliated institution or inventor, and form strategic partnerships with pharmaceutical and biotech companies to further develop and commercialize the technologies. Profits from CVI will flow back to the not-for-profit CDRD to support

ongoing drug development projects. The global life sciences industry has the potential to bring an unlimited number of benefits to literally billions of people around the world. But those benefits are far from guaranteed. The life sciences industry is still relatively young and continues to mature, and so too must the strategies employed to translate research discoveries, and realize their associated benefits. The work of innovative translational centers such as CDRD will significantly increase the prospects of health research discoveries being further developed by commercialization partners, therein fueling the global life sciences industry with a robust pipeline of more fully-validated and de-risked technologies. This is why CDRD’s vision is to change the culture of scientific innovation and commercialization impacting human health, and why we must all collectively work together on a global scale to share our respective knowledge on successful (and unsuccessful) ways to bridge the gaps in the commercialization process, and to ultimately benefit patients around the world.

For more Commercialization information visit our Drug Discovery Web Portal at www.bioscienceworld.ca FEBRUARY 2012 BIOTECHNOLOGY FOCUS 13

By: Kevin Noel and Theresa Kennedy

CANCER

Bench to Bedside

RESEARCH SUPPORT

Dr. Sam Abraham is on a mission. Driven by a mandate to ‘make a difference in the clinic,’ British Columbia Cancer Agency’s vice president of research is intent on building research partnerships with private sector companies engaged in cancer research.

“We’ve got enormous research capabilities and expertise to offer biotech and big pharma in their efforts to develop new cancer therapeutics,” says Abraham, explaining, “we’re absolutely focused on improving outcomes for our patients.” It’s not as though his agency is new to the partnership game. Since 2002 the value of partnership contracts at BC Cancer Agency has grown by 300 per cent. The BC Cancer Agency’s clinical trials unit (CTU) has been a strong contributor to that growth. The CTU initiates about 50 cancer-related clinical trials every year, half of which are conducted for external clients. Although most of that work is for the pharmaceutical sector, CTU director Dr. Kim Chi says his unit has much 14 BIOTECHNOLOGY FOCUS FEBRUARY 2012

to offer small biotechnology firms needing research support. “We provide access to internationally renowned clinical investigators and help facilitate the progress of a client’s research program through the necessary protocols. We can bring in the resources needed for qualitative studies and if a company wants us to lead their study and develop their product, we can even do that,” says Chi. One biotech company that has taken full advantage of CTU’s specialized expertise is Vancouverbased Oncogenex. In 2005 CTU conducted the Phase 1 clinical trial of Oncogenex’s OGX-011 drug candidate for the treatment of prostate cancer. Following those initial studies to establish the safety of the new compound, Chi led the Phase 2 clinical trials, and is currently the Canadian principal investigator for a multinational Phase 3 trial of the drug. “We’ve had a rich and deep relationship with CTU,” says Oncogenex CEO, Scott Cormack. “They’ve been very good in helping us to advance our programs.” Cormack has also found compelling reasons for continuing to conduct clinical trials of his company’s cancer drugs in Vancouver.

Photo: BC Cancer Agency vice-president of research Dr. Sam Abraham

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Cancer

As all cancer patients in British Columbia are treated through one organization – BC Cancer Agency – the catchment area for clinical trials conducted by the Vancouver-based CTU is the entire province, with its population of 4.5 million. An added advantage is that every BC patient enrolled in a clinical trial comes with a comprehensive history of any previous treatments they’ve received. “Typically, for a clinical trial you’re looking for patients with identified treatment histories,” says Cormack. “Depending on the trial phase, you might want them to be ‘chemo naïve,’ that is, patients who have not previously had chemotherapy.” A key advantage of Vancouver as a location for clinical trials over major centres in the US is the relatively large population of minimally pre-treated cancer patients it offers. By comparison, cancer patients recruited for clinical trials in US centres are more likely to have had an extensive history of previous treatment.

Photos provided by Cameron Heryet Photography by Video Production Multi-Media Services, BC Cancer Agency 16 BIOTECHNOLOGY FOCUS FEBRUARY 2012

“Overall, the CTU has served Oncogenex exceedingly well in their ability to deliver quality data, the integrity of that data, and the speed with which they can bring patients in and advance our programs,” says Cormack. “We’ve had such a spectacular collaborative relationship, we have no reason to do anything differently.” The Centre for Translational and Applied Genomics (CTAG) is another core BC Cancer Agency research unit providing support to external clients. In April 2011, CTAG became the first research facility in Western Canada to obtain full accreditation from the College of American Pathologists. Gaining CAP accreditation cuts a significant distinction between CTAG and other contract research facilities, according to its medical director, Dr. David Huntsman. “We bring a higher level of academic and research credibility than other contract research labs,” says Huntsman. “We offer the rigour of a clinical laboratory applied to research problems, using the latest available pathology tools.” And without core funding for the clinical lab Huntsman says CTAG has developed a very business-minded approach to the market for research lab services and the needs of industry partners. “We’ve gone quite far from the way clinical pathology is usually practiced,” says Huntsman. “In fact, we don’t know of any other clinical pathology labs who are also involved in major research collaborations and doing clinical work for clinical trials.” The prototype for BC Cancer Agency research support units engaging with private sector research partners was established in 1997 with the Investigational Drug Progam (IDP), which offers a range of pre-clinical services and manufactures parenteral (injectible) drugs for biotech and other clients engaged in clinical trials research. Over the past 15 years, the IDP has produced 120 batches of ex-

Cancer

“They’re fantastic,” says StemCell’s director of contract assay services, Dr. “We do everything needed for getting Jackie Damen. “Consistency in animal a new drug candidate approved for studies data is tough to achieve, but the data we get from IDP is always wildly clinical trials,” says Waterhouse, “from consistent.” animal studies to manufacturing and In the past, Damen says inconsistency in animal study results was largely due the analytical work required to ensure to a lack of standards and good laborathe drug is pure and stable.“ tory practices (GLP) certification, but IDP has always been “ahead of the curve in — Dr. Dawn Waterhouse making sure their standards are up to the latest guidelines.” Damen, who manages contract reperimental compounds for industry and academic researchers, al- search services on behalf of StemCell for large pharmaceutical comthough most academics can’t afford the service. As IDP production panies, also appreciates the quick response and turnaround times manager Dr. Dawn Waterhouse explains, “It’s very expensive to she gets from IDP. “I always tell my pharma clients that once they run a clean room and to maintain good manufacturing practices.” get me their compound, I can have (animal studies) set up within IDP’s mandate is to develop promising anti-cancer compounds 2-3 weeks, which is almost unheard of,” says Damen. Through its close connection to BC Cancer Agency clinicians and to the point where they can be tested in early-phase clinical trials. The unit is equipped to conduct all tests required to ensure a patients, IDP also offers support for early-phase clinical trials, with new compound is safe for use with human patients, and is able to runners available 24/7 to collect pharmacokinetic samples (blood manufacture compounds to the quantity required for small-phase and urine samples) from patients – a level of support Waterhouse says is unmatched in Canada. clinical trials – up to 10 litres at a time. But perhaps the most compelling advantage IDP offers biotech “We do everything needed for getting a new drug candidate approved for clinical trials,” says Waterhouse, “from animal studies firms working on new cancer therapies is access to top clinical to manufacturing and the analytical work required to ensure the researchers for invaluable guidance about their candidate products. “Most small biotechs don’t have the money to hire a medical drug is pure and stable.“ Vancouver-based biotech company StemCell Technologies has advisor, but if they work with us we can provide oncologists specialized in their particular area to help guide their product used IDP’s services for its animal studies since 2003. development,” says Waterhouse. Clinicians can offer practical suggestions about formulation, dosing and whether to focus on toxicity or efficacy. “Health Canada doesn’t care about efficacy, but clinicians do, so you have to consider both when developing a new drug,” says Waterhouse. “Working with clinicians on drug development like this helps increase the chances of getting your clinical trial approved and funded.” Forging closer linkages between drug researchers and clinicians is a key element of Dr. Sam Abraham’s mission at BC Cancer Agency. According to Abraham, the future of drug development lies not in simply producing ever more medications, but in knowing which patients respond best to which therapies. “It’s a question of affordability,” says Abraham. “With the rising costs of health care and the expense and extent of the medications we use, we can’t afford to continue doing things that aren’t effective. The onus is now on us to know which drugs work best for which patients. ”

For more Cancer information visit our Drug Discovery Web Portal at www.bioscienceworld.ca FEBRUARY 2012 BIOTECHNOLOGY FOCUS 17

By Shawn Lawrence

Innovator

Microwave Magic: Vancouver’s EnWave is riding a wave of results

Consider it a new spin on an old idea. Dr. Tim Durance isn’t the first scientist to come up with the concept of applying microwave energy in a vacuum to biological materials, but he’s probably been the most successful at it. Durance is co-CEO and founder of EnWave Corp., a Vancouver-based industrial technology company that is developing technologies for the dehydration of food, live or active bulk liquids, and sensitive pharmaceuticals. The company’s current technology dates back to 1996 when Durance first developed the prototype of the Radiant Energy Vacuum (“REV”) machine. Since then, the company has gone on to produce and sell commercial-scale machines for food dehydration as well as develop a number of prototypes for drying bulk liquids and pharmaceuticals in vials.

he drying of biological materials is a big market and one that EnWave, with Durance’s revolutionary technology is hoping to capitalize on. So far, the results have been stellar. The first of the commercial platforms developed by the company was nutraREV™. Uses for the platform include dehydrating fruits, vegetables, low-fat snacks, meats and seafood at, or below room temperatures. For decades, people have been using freeze dryers for dehydrating many food products. While freeze drying is an excellent process

18 BIOTECHNOLOGY FOCUS FEBRUARY 2012

and will produce an excellent product, it tends to take days to dry things this way, anywhere from 24 to 72 hours. Durance explains these bottlenecks are non-existent with nutraREV™. “Because nutraREV™ is continuous rather than done in huge batches like in freeze drying, one nutraREV™ machine is capable of producing up to 300 kg per hour of dried product, which is the same output as seven large freeze dryers,” he says. Moreover nutraREV™ also produces a higher quality end product because it can

dry quickly without high temperatures, and without the destructive effects of heat or the high oxidation levels that can lead to spoilage. While the nutraREV™ has the potential to be the envy of the food drying industry, EnWave also has four other microwave drying platforms including powderREV™, which can be used to dehydrate bulk food cultures, probiotics and fine chemicals such as enzymes; the bioREV™ and freezeREV™ platforms which can be used for live or active pharmaceutical dehydration and high-speed dehydration of live or active pharmaceuticals in sterile vials; and the quantaREV™ which is the newest of the REV platforms and can be used by food and chemical production companies that require high-volume, lowtemperature dehydration of solids, liquids, granular or encapsulated products. EnWave also owns the U.S. patents and know-how for a sixth platform known as MIVAP™. A tray-based vacuum-microwave technology, MIVAP™ was developed by German company Hans Binder Maschinenbau GmbH, and is very much similar to the REV platforms. “Basically all of our REV technologies operate with the same principle, the differences between the technologies lies in the scale of the equipment and the specific handling characteristics of the products that they deal with. They also look very different in terms of size and scale,” says Durance. How the technology works sounds simple enough: you combine microwave energy with vacuum pressure to control the temper-

Innovator ature at which liquids boil and subsequently evaporate. According to Durance, what the vacuum does is it allows the user to adjust the atmospheric temperature ranging from freeze drying temperatures up to the boiling point of atmospheric pressure. “You can choose the temperature of drying and dry very quickly. The idea is that if you lower pressure, you lower the boiling point of solids, including water. For example, if you start to go up a mountain the boiling point of water goes down as the pressure gets lower. If you lower the boiling point you can dry things quickly without them getting hot because it doesn’t matter how fast you add the energy, as long as there’s water there, the energy you add to the system at low pressure will cause water to boil and evaporate. The problem with drying under a vacuum has been (to this point) that it’s difficult to transfer energy because the vacuum acts as an insulator. However, microwaves are unique because they can pass through the vacuum with no problems, and they are able to penetrate the material and heat the water in the organism. This combination allows you to dry things very fast, theoretically as fast as you want,” he explains. So why is it now possible to use microwaves to dehydrate foods and other biomaterials, or more specifically why wasn’t the technology developed before? “When I originally had the idea, as often happens you check the literature and sure enough the idea has been explored. Back in the 1950’s there was work being done with microwaves to dry antibiotics and other bioorganisms. McDonnell Douglas even built a fairly large unit in the 1980’s based on a microwave vacuum. But Microwave equipment wasn’t fully developed at that point, it wasn’t reliable and was rather expensive so the whole concept kind of got shelved.” With advancements in microwave technology, Durance saw renewed potential in the idea and new avenues to make it happen. His experiments began with home microwave units, beginning at Durance’s lab at the University of British Columbia where he had been a professor in the Department of Food, Nutrition and Health program since 1987. His experiments started with potato chips and moving into other food products, Durance tested his theories out and found them to be successful. With a string of successful experiments, Durance made the tough decision to crossover from academia into the private sector. The decision wasn’t so much a choice but a necessity.

“Money or lack thereof was a motivating factor in leaving the academic world and starting the company, but not in the traditional sense. Originally, I was interested in founding the company because building the platform required more funding than was possible through normal academic funding channels. I knew we had to build the equipment and this required engineering work that was going to cost millions of dollars.” While establishing EnWave as a business did open doors to new financial possibilities, it also forced Durance to face some harsh realities. “Initially when EnWave was established, I was mostly involved just on the science side. We hired professional managers to handle the business side of things. Unfortunately

that didn’t go so well, as we ran short on money and by 2001, everyone involved to that point pretty much left the company.” Like many scientists before him who believed in the validity of their inventions, Durance persevered, assuming the role of CEO. “It was a tough decision, but I just believed it would work and wasn’t willing to let it go. We were doing lab scale tests of one or ten kilos an hour, but it wasn’t compelling or viable. We needed to at least have a device capable of hundreds of kilos of products an hour because large companies weren’t interested in just a concept, no matter how logical it might sound. They needed to see commercial equipment or at least see it on the horizon before backing it.” For Durance, there were more struggles

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FEBRUARY 2012 BIOTECHNOLOGY FOCUS 19

Innovator “When I first originally had the idea, as often happens you check the literature and sure enough the idea has been explored. Back in the 1950’s there was work being done with microwaves to dry antibiotics and other bio-organisms.”

ahead as he tried to get enough money to develop the technology to a point where large companies would take an interest. It took some time, but in 2008 things started to fall in place for Durance and his company. For starters, Durance was finally able to build the first continuous nutraREV™ machine capable of commercial production levels of dried berries. “That was the true turning point for the company, and it wasn’t long after that we partnered with CAL-SAN Enterprises Ltd, a major blueberry producer in Richmond, BC. That partnership was significant because it validated the technology and put us on the map.” Other food producers took notice, and before long EnWave was being sought out for its nutraREV™ technology by other prospective partners, including food industry giants like Nestlé, Kelloggs, Grupo Bimbo, Grimmway Farms, Bonduelle Canada and Ocean Spray Cranberrries (all present day partners of EnWave). Along the way, Durance aspired to find ways for the REV technology to fit into other areas. Specifically, he believed that the REV platform could impact the biopharmaceutical market in the same way it had the food industry. “Before we built our first nutraREV™ machine, we actually toyed with the idea of making pharmaceuticals our lead interest or our first business development priority. The drying of enzymes for example, drying of bacteria cultures, other things you wouldn’t associate with the drying of foods. We wanted to address the same issues, to build a platform capable of addressing the pharma industry’s need to dry under lower temperature, without the destruction of the bioactive components.” According to Durance, the idea was that once commercial success was realized on the food side, EnWave would move into the pharmaceutical market more aggressively, and expand on its platform selection. This approach led to the development of the 20 BIOTECHNOLOGY FOCUS FEBRUARY 2012

five new platforms, as well as research and development deals to assess the viability of the REV technology in the pharmaceutical space. One such R&D agreement was signed with Merck in December 2011. Additionally, EnWave also began working with different groups at UBC and with the Saskatchewan Research Council to test one of the company’s pharmaceutical dehydrators. Needless to say it’s been a very active last four years for EnWave Corp. At the same time, the accolades for EnWave continue to pile up alongside the growing list of partners in both the Food and Pharma Industries. The company has won four innovation awards from worldwide food science organizations and was recognized with a BIOTECanada Gold Leaf Award at last year’s World Biotechnology Conference in Washington, DC. “We’re getting exposure and it’s both gratifying and useful for credibility within the industry and with other scientists. It’s remarkable, we don’t do a lot of self-promotion but a lot of people are coming to us asking us what we’re about. These awards are useful in that way,” he said. All the while, the company continues to grow. In the past five years alone, it has grown from having just one employee to over 25 at three separate facilities including a biotechnology lab, a pilot plant and an engineering facility. The key component to this growth is EnWave’s business strategy and how it earns its revenue. It clients for the machines, but also earns a small royalty on the sale of products the machines make. “I think a big reason large companies are interested is because our business model encourages exclusivity and that’s made possible because we have a strong patent position with our technology. So in return for a royalty on production, we guarantee our partners that we won’t sell to their competitors essentially. It might be in a territory, or it might be worldwide depending on the com-

pany. And that’s one of their big concerns, keeping their market share or taking market share from their competitors, so being able to take a beneficial technology exclusively is of value to them.” Overall, adapting to the role of CEO has been a bit of a learning curve for Durance, but one that he has embraced. “I’ve found that I’ve really enjoyed it. It’s exciting to see the technology platform really going through to the commercial stage. It’s a different set of skills than being a scientist, being able to tell what could realistically be and not be accomplished in the business world, but it’s been exciting to learn and I’ve certainly needed some help along the way.” He’s had no regrets in taking on the role or taking the idea forward other than possibly wishing he would’ve done it sooner. “I think that’s the one thing I’d would’ve done differently is articulate the bigger dream much earlier. In the beginning we had some indications that this could maybe be very large but we were reluctant to say so publicly because we didn’t know how big the hurdles were going to be. I think it’s important to articulate the big dream from the beginning, and that I think would’ve sped up the process quite a bit. It would’ve opened more doors sooner and accelerated the development hugely. From a scientific point of view you want to tend to prove it before you tell anyone about it. From a business point of view I think you need to take a different approach, you have to take more risks and say this is where we’re going, and if it works this is how big it can be. You have to sell people on the dream in order to get the investment you need.”

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

By: Shawn Lawrence

Collaboration

Collaboration key to Merck’s B.C. Strategy I

t’s commonly known that as pharma companies face declining productivity from inhouse R&D operations, many have become more reliant on external alliances to produce the medicines and vaccines of tomorrow. Notwithstanding all the original research that is conducted at Merck labs globally, Merck also realizes that the next great discovery in medicine may come from outside of Merck’s laboratories. This is why partnering has become an essential component in the company’s strategy. Already one of the top R&D investors in Canada, the company has established its presence in the province of British Columbia and is interested in local, regional and global opportunities both in the private and public sectors to partner. “We’ve had ongoing partnerships and research collaborations with different investigators at Simon Fraser University (SFU) and UBC for instance, as well as many companies in the province,” says Jennifer Chan, Merck’s Vice President, Policy and Communications, in Canada. Among the more notable of these collaborations was a $1.4 million donation from Merck Canada to Simon Fraser University. The donation included an equipment donation and will support research and teaching in a number of areas that affect human health, including virology, immunology, toxicology, biochemistry and pathology. “This donation was really to enable research, to make a difference for the students and

Merck: Licensing and Our Top Line

professors at SFU, and encourage the advancement of knowledge on chronic and infectious diseases through Canadian-based research. By providing this equipment, we are thus contributing to the future of the B.C. biopharmaceutical industry,” says Chan. Another way that Merck is active in the province is in the clinical space. “Certainly when looking at B.C., if you look at our clinical research activity, the province is a key contributor in terms of the patients that are recruited in our clinical trials conducted globally in a number of therapeutic areas, such as infectious diseases, cardiovascular, diabetes, oncology, respiratory and vaccines,” she said. Even more impressive is Merck’s partnering efforts in the province’s private sector. Reflecting B.C.’s vibrant life sciences sector, Merck has partnered with innovative companies in the province that are developing new therapies, including: Cardiome for the development of a drug treatment for atrial fibrillation; Alectos in the therapeutic area of Alzheimer’s disease; Xenon for cardiovascular disease; EnWave to determine the feasibility of the Radiant Energy Vacuum (REV) technology for the rapid, controlled dehydration FEBRUARY 2012 BIOTECHNOLOGY FOCUS 21

Collaboration

of biological materials; and Zymeworks for the development of bi-specific antibodies that can bind to two different drug targets. To facilitate these partnerships and to find the best science, innovation and technology out there, Merck has scientific scouts, all of them senior scientists stationed around the globe. As the scientific representative for licensing and external research in Canada and Director, World Wide Licensing and External Research, Dr. Steven Xanthoudakis is the primary point of contact for the Canadian community. While he is based in Montréal, he has a pulse of what’s going on in the province and he has much to say on what drives Merck’s keen interest in these types of companies. “When you look at Merck’s activity in terms of partnering record, I think we’ve been extremely active in Vancouver relative to other regions in the past 6 years. It wasn’t by design, but what’s happened here in B.C. is the technologies that are being developed amongst the various companies that we’ve partnered with are all strategically very good fits with our existing R&D interests. These companies have been able to define what the unmet medical need is that Merck is trying to address,” he explains. As a scout, the most important part of Xanthoudakis’ role is building relationships. Moreover, what he looks for in prospective partners and opportunities is first and foremost a strategic fit. “Obviously we want to expand our pipeline or to address a potential gap in the pipeline and we’re in need of a product or

Track Record… Success in Building Partnerships

“We’ve had ongoing partnerships and research collaborations with different investigators at Simon Fraser University (SFU) and UBC for instance, as well as many companies in the province.” — Jennifer Chan a technology at a particular stage of development, so the key driver is our pipeline. But beyond that a lot has to do with the company itself, the management, how viable we feel the company is, and whether or not we feel the company can actually deliver on the research collaboration if in fact we are going to collaborate with them on the research as opposed to doing all the R&D ourselves,” he says. “Whenever possible we strive to leverage the expertise and experience of our partners.” Among the more notable of these research collaborations is the $800 million deal signed with Cardiome Pharma Corp. and its heart drug vernakalant in March 2009. “In the case of Cardiome, we knew what the company was working on since 2006, but the technology wasn’t sufficiently developed for uptake and it didn’t align itself with our strategic interests in the cardiovascular space when they first approached us. Yet as they advanced their program along, our own focus changed and we made the deci-

sion that atrial fibrillation was an area we wanted to get into. So, our cardiovascular franchise went looking for an opportunity and Cardiome became the right fit as a partner,” he said. While Cardiome is an example of a partnership that was facilitated because the company was further along in its development, Xanthoudakis says that Merck is not discriminatory to early stage companies. “Most of these deals are very early stage deals with the exception of Cardiome, which is now a marketed product in the EU and some other regions. Everything is in the discovery to pre- IND (Investigational New Drug) stage, or it’s an enabling technology. We seek partners at all stages of research and development, and platform technologies as well. For example, SFU spin-out Alectos Therapeutic was a very young company when we partnered with them. They were working on a novel target that was of interest to Merck and they had started a program to develop compounds that modulate O-linked N-acetylglucosaminidase (O-GlcNAcase), an enzyme that is believed to be involved in the development of Alzheimer’s disease and potentially other disorders. They had a program that was at an early stage but one that was exciting to us. EnWave was a very recent deal. They have a microwave drying technology that our vaccine group sees potential value in for the development of vaccines. It is a truly enabling technology if it works for vaccines. In the case of Xenon, we’ve had multiple discussions with this company. The latest deal that we did with them around new cardiovascular targets and research was a logical follow-up to the numerous previous interactions that we had with the company. We both value the synergy that has been created as a result of the partnership.” Sometimes changes at the global organicontinued on page 28

22 BIOTECHNOLOGY FOCUS FEBRUARY 2012

By: Paul D. Hodgson

InterVac D

uring the past decade the world has been challenged by a number of emerging and reemerging infectious diseases affecting both humans and animals. Examples include SARS, tuberculosis, avian and swine influenza, West Nile virus, and neurodegenerative prion diseases including bovine spongiform encephalopathy (i.e., mad cow disease) and chronic wasting disease. In addition, an estimated 180 million people worldwide are infected with the hepatitis C virus and 34 million with HIV, the causative agent of AIDS. Canada, in particular Ontario, Saskatchewan, Alberta and British Columbia, is all too familiar with the socio-economic impact of these diseases. SARS cost Canada (primarily Toronto and Vancouver) $1.5 billion; BSE cost the Canadian cattle industry (primarily Alberta and Saskatchewan) over $6.5 billion; hepatitis C, costs the Canadian

Canada’s new $140 million International Vaccine Centre (InterVac) at the University of Saskatchewan’s Vaccine and Infectious Disease Organization provides CL3 capacity to work with all types of diseases with the aim to improve the health of animals and humans.

ACROSS CANADA

New Opportunities in Infectious Disease Research

healthcare system about $1 billion annually. A beef cow from BC recently tested positive for bovine TB - a reportable disease by CFIA – in a US packing plant. This could have shut the Canada US border, but fortunately it was viewed as an isolated incident. The herd was destroyed. Microbes are the ultimate opportunists, striking stealthily and spreading quickly making the worldwide

impact of these diseases astronomical. Research to address the underlying mechanisms that pathogens use to cause disease has been hampered by the critical shortage of appropriate facilities in Canada and around the world. Because of their capacity to produce serious disease and the fact the majority of these diseases are all transmissible between species (zoonotic) they need

LtoR Dr. Andrew Potter, Director, Saskatoon Mayor Don Atchinson, UofS President Peter McKinnon, Prime Minister Stephen Harper, Saskatchewan Premier Brad Wall and UofS VP Research Dr. Karen Chad at InterVac’s grand opening celebration in September FEBRUARY 2012 BIOTECHNOLOGY FOCUS 23

ACROSS CANADA

Dr. Sylvia van den Hurk, PhD. student Sunita Awate, and Dr. Volker Gerdts tour Prime Minister Stephen Harper through the InterVac facilities

to be studied in a higher level of containment than is commonly used for other infectious diseases. This is termed Level 3 (CL3) or Biosafety Level 3 (BSL3). This containment includes special engineering design features to ensure the safety of the personnel and the general public while advancing research and development. Aside from the excellent federal facilities located in Winnipeg and Alberta, capacity in Canada to study CL3 diseases in large animals is relatively limited. This has impeded our ability to develop much needed vaccines and to generate data needed to guide public policy. Canada’s new $140 million International Vaccine Centre (InterVac) at the University of Saskatchewan’s Vaccine and Infectious Disease Organization provides CL3 capacity to work with all types of diseases in an aim to improve the health of animals and humans. Housing 18 CL3 isolation suites, six CL3 laboratories, a select agent lab (for agents that have potential use in biological terrorism) and a dedicated CL3 aerobiology lab, InterVac is one of only three vaccine research facilities in Canada that can house large animals and is one of only a few in the world with the capacity to generate statistically sound data suitable for the regulatory approval of vaccines and other anti-infective compounds. InterVac helps offset the international shortage of CL3 laboratories and keeps Canada on the 24 BIOTECHNOLOGY FOCUS FEBRUARY 2012

forefront of infectious disease research and vaccine development. This creates huge beneficial opportunities for both human and animal health. Vaccination is widely accepted to be the most cost-effective way to control infectious diseases with an estimated benefit:cost ratio of $5:1 in direct health care costs and $17:1 if societal costs are included. Vaccination is routinely stated to have done more to reduce human mortality than any other healthcare intervention. This importance of InterVac to Canada’s strategic advantage was recently highlighted by the attendance of Prime Minister Stephen Harper; Saskatchewan Premier Brad Wall; and Saskatoon Mayor Don Atchison during InterVac’s grand opening celebration and the commencement of Canada’s National Biotech week in Saskatoon on September 16, 2011. All three governments have invested substantially in the capital costs of the facility. Once the facility is certified and reaches full operational capacity, scientists from Canada and around the world will be able to utilize InterVac to research new infectious disease threats and develop strategies to mitigate the risk to humans and animals through novel anti-infective therapies and vaccines and by providing additional information for those with an interest in helping define government policies. Canada has been very successful in both the development of new vaccines and

This importance of InterVac to Canada’s strategic advantage was recently highlighted by the attendance of Prime Minister Stephen Harper; Saskatchewan Premier Brad Wall; and Saskatoon Mayor Don Atchison during InterVac’s grand opening celebration and the commencement of Canada’s National Biotech week in Saskatoon on September 16, 2011. creation of immunization strategies internationally. These successes include the work of Connaught Laboratories on polio immunization, the National Research Council of Canada’s novel vaccine technology for meningococcal disease, and the Vaccine and Infectious Disease Organization’s six world firsts in the animal vaccine sector. InterVac’s contribution to the health of Canadians and to the economic competitiveness of Canada’s vaccine sector will be significant. The work that will be carried out at InterVac will build on a rich history of Canadian successes in the vaccine field and will help ensure that we retain our competitive advantage.

The next challenge Nobody can predict what the next infectious threat is going to be or when it will occur, but it is generally recognized there will be one and the odds are it will be a level 3 zoonotic agent. InterVac is a principal asset in Canada’s infrastructure to help ensure we are prepared as a nation.

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

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NEW PRODUCTS Spectrometer The new Eppendorf BioSpectrometer ® combines accuracy and sensitivity with outstanding flexibility in a small robust instrument. The BioSpectrometer extends Eppendorf’s current detection product line by offering scanning capabilities allowing routine and complex methods such as measuring cytotoxicity, proteins, fluorescent dyes and more! The BioSpectrometer kinetic model features a temperature-controlled cuvette shaft that requires no additional accessories in order to study enzyme or substrate kinetics. Scanning spectrum as well as individual wavelength measurements can be monitored in the spectral range of 200 nm to 830 nm. Pre-programmed methods facilitate quick start applications and prevent errors, while a USB port is provided for simple data transfer. No PC is necessary to operate the system and integrated data processing options enable basic data processing directly on the device. Apart from standard cuvettes such as the Eppendorf UVette, the BioSpectrometer can also accommodate microlitrr volumes.

www.eppendorf.com PCR Instruments The Eppendorf Mastercycler nexus family of PCR instruments offers excellent reproducibility, low noise emission and the versatility to use all types of consumables. Up to three units may be combined for higher throughput, while software capability enables users to access a booking schedule for the instrument and receive email notification when the PCR cycle is finished. Low energy consumption and a small footprint add to the advantages of the Mastercycler nexus for both academic and industrial research laboratories. Designed to be affordable, flexible and reliable, the Mastercycler nexus incorporates Eppendorf’s flexlid™ concept with automatic height adjustment of the lid. In combination with the universal block this allows use of the widest variety of PCR consumables, from large 0.5 mL tubes down to low profile plates and strips, and therefore a correspondingly 26 BIOTECHNOLOGY FOCUS FEBRUARY 2012

wide range of reaction volumes. Excellent block homogeneity and temperature accuracy deliver highly reproducible results. The Mastercycler nexus gradient model provides a true gradient with 12 different temperatures and features SteadySlope® technology to ensure that the heating and cooling ramp rates are identical in both optimization and routine experiments. The Mastercycler nexus is ideal for all PCR applications due to its flexible sample volume capabilities and can accommodate emulsion PCR, in situ PCR, and low to high throughput.

Pipettes The Hamilton MICROLAB 600 is a highly precise syringe pump with a graphical user interface designed to quickly and easily dilute and dispense volumes from 10µL to 50mL. This positive displacement system provides better than 99 per cent accuracy, independent of a liquid’s viscosity, vapor pressure, and temperature. The inert fluid path minimizes sample carry over and is compatible with harsh chemicals. The Microlab® 600 diluter and dispenser can now be used in CFR 21 Part 11 and FDA GMP/GLP-compliant laboratories thanks to a new package that now comes standard on all advanced Microlab 600 devices. You can customize the security of your instrument, adhere to regulatory requirements and manage files easier than ever before.

www.eppendorf.com Flow Tester The Uson Optima vT Leak and Flow Tester includes one or two test channels with four sensors each, totally customizable pneumatics, multiple built-in automated calculators, myriad data handling and storage options and other features that combine to make the Optima best-match test technology for the greatest number of leak and flow test applications. The Optima has capabilities for vacuum decay tests, pressure decay leak testing, differential pressure decay leak tests, mass flow leak detection (including back pressure and differential), upstream and downstream cracking pressure, pressure rise tests, burst tests, laminar flow tests, force decay testing, and occlusion testing. Other features include state-ofthe-art microcontrollers comparable to those used in the most sophisticated and demanding consumer electronics applications, built-in automated calculators to speed testing and data handling, fully customizable pneumatic controls and large easy-to-read full color touch screen display with intuitive user interface.

www.uson.com

www.hamiltonrobotics.com Spectrometer:The Maya2000 Pro-VISNIR from Ocean Optics is a back-thinned 2D FFT-CCD spectrometer with high sensitivity, 80 per cent peak quantum efficiency and excellent VIS-NIR response. The spectrometer is ideal for low light-level applications such as Raman, as well as for analysis of gases used in semiconductor processing and measurement of biological samples in the life sciences. It has a low-etalon, scientific-grade detector that provides high quantum efficiency from 400 to 1100 nm. Other features include triggering functions for providing accurate timing and synchronization between the spectrometer and other devices. Three low-jitter trigger modes and normal (free-running spectral acquisition) operating modes are possible. Applications include pulsing a light source when acquiring a spectra and synchronizing spectral acquisition to coordinate with samples moving through a process stream or sensors reaching a certain temperature level. In addition, Maya2000 Pro-VIS-NIR supports RS-232 communications and has a 30-pin connector and 10 user-programmable digital I/Os. Its enhanced onboard programmable high-speed FPGA controller enables triggering and provides other performance advantages. www.oceanoptics.com

NEW PRODUCTS Water Purification System EMD Millipore announces the availability of its new range of Direct-Q® water purification systems. First launched in 2005, the systems have acquired a dedicated user base of scientists who rely on the all-in-one systems to produce high quality pure and ultrapure water—directly from tap water—for a wide variety of applications. Using the feedback of Direct-Q® users, EMD Millipore has now increased the capabilities of these water purification systems and made them even easier to use. The new, expanded and updated range now includes models capable of supplying 50, 100 or 150 litres of pure water per day, and up to 30 litres per hour of ultrapure water. The high-quality ultrapure water produced by the systems is suitable for critical applications – such as chromatography work; the preparation of blanks and standard solutions in spectrophotometry, spectroscopy and other analytical techniques; and the preparation of buffers for biochemical experiments. Pure water from the system can be used for general glassware washing. In addition, water quality can be “fine-tuned” to meet specific requirements. Direct-Q® systems are available with a built-in 185/254 nm UV lamp, which serves to reduce the level of organics for critical applications such as HPLC work, as well as destroy bacteria.

www.emdmillipore.com Sensors and Reagents Axela Inc. announces the commercial launch of its dotLab® mX System along with its new panelPlusTM Sensors and Reagents. The new dotLab® mX System, which uses diffractive optics technology for the real time monitoring of protein interactions,

features an intuitive user interface to streamline method development and data management. The new software version includes a fully integrated set of data analysis tools that automate the analysis and reporting of multiplex assays, along with bar code tracking of sensor and sample information for greater assay reproducibility and quality control. The System also incorporates 21 CFR Part 11 support for users who are operating in a regulated environment. Axela’s panelPlusTM Sensors provides researchers with highly flexible, user defined multiplex panels for real time immunoassays on the dotLab® mX System. Researchers can easily address the proteins of their choice for automated creation of customized multiplex panels. Generic antibody capture reagents are also available pre-conjugated to facilitate the rapid development of personalized immunoassays. In addition, the panelPlusTM Sensors employ universal regeneration conditions that permit the use of fresh capture reagent for each assay, improving performance while reducing the total cost per assay. Overall, the combination of the dotLab® mX System with panelPlusTM reagents provides full automation and significantly improves assay robustness.

Shakers are easy to program and include a function that restricts unauthorized or inadvertent changes to key functions. The incubated bench-top model includes class-leading, +/-0.3 ºC temperature uniformity for optimum growth, and the spacious chamber holds six two-litre flasks. Both the MaxQ HP incubated and refrigerated floor models feature a HEPA filter for maximum protection from contamination, a directed airflow system for optimum temperature uniformity of +/0.2 ºC and ideal growth conditions, and an ergonomic design for easy access. A wide temperature range, from 5 ºC above ambient to 80 ºC in the incubated shakers and four to 60 ºC in the refrigerated shakers, supports almost any requirement.

www.thermofisher.com Solutions Beckman Coulter Life Sciences launches the SPRIworks HT*, a highthroughput solution for fragment library preparation on Illumina next generation

www.axelabiosensors.com Benchtop shaker Thermo Fisher Scientific Inc. introduces the Thermo Scientific MaxQ High Performance (HP) Orbital Digital Shakers. Consisting of open air and incubated bench-top models and incubated or refrigerated floor models, the MaxQ® HP Shaker range is ideal for sensitive cultures. The sturdy units will provide a “hard shake” for bacteria with a speed range from 25 to 525 rpm, while the brushless DC motors allow maintenance-free, 24/7 operation. The MaxQ HP

sequencers. The system, allows researchers to process libraries with greater speed and sample reproducibility. SPRIworks HT utilizes built-in SPRI (Solid Phase Reversible Immobilization)-based per-well size selection. User interaction is seamless and requires as little as 15 minutes of hands-on time. Up to 96 samples can be prepared in as little as three hours without size selection, or six hours with size selection. SPRIworks HT offers a reagent kit for library preparation that includes sizing solution and PCR reagents. Protocols are automated via a suite of methods built on the Beckman Coulter Biomek FXP Liquid Handling Workstation. Per-well size selection provides users with the flexibility to process samples for multiple applications in a single run.

www.beckmancoulter.com

FEBRUARY 2012 BIOTECHNOLOGY FOCUS 27

Collaboration continued from page 22

“When you look at Merck’s activity in terms of partnering record, I think we’ve been extremely active in Vancouver relative to other regions in the past 6 years. “ — Dr. Steven Xanthoudakis

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zational level can lead to new priorities for partnering. “That was certainly the case with Zymeworks. I’ve watched that company grow from just a couple of people to in excess of 30 people now but when they started off, they were really focused on enzyme engineering. It wasn’t until their antibody platform really started to take shape about a year and a half ago, that we saw the potential to partner. What ultimately drove the deal with Zymeworks was our own merger with Schering-Plough. It was pretty serendipitous timing because after that merger, Merck gained significant biologics capability and we realized that the technology they were developing around antibody engineering was something that could further enable our new in-house antibody efforts. So, between them shifting their focus and our need being basically created because of the merger, it all came together.” On how the relationships are struck, Xanthoudakis says there are often wide combinations of factors at work. “It’s really a combination of things that bring these opportunities to us, and allow us to engage in partnering discussions and sign deals. Sometimes it’s just word of mouth between people at the company who have either previously had an affiliation with Merck or know somebody at Merck. Sometimes it’s just through pure scouting, as was the case for the EnWave and Alectos deals. Sometimes it’s a case of we’ve already established a relationship with the company and want to pursue a collaboration with them, like with Cardiome, Xenon and Zymeworks.” He adds that Merck certainly has every intention of expanding its footprint in B.C. through more partnerships if the fit makes strategic sense. “What I say about B.C. I think applies to the rest of the country quite frankly. Certainly we’re committed to increasing our partnering efforts and that commitment comes from the most senior levels of our organization, starting with our CEO Ken Frazier right on down the chain. Our doors are open.”

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February 27-March 1

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COMPANY & ADVERTISER INDEX CoMPanY

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Axela Inc. ..................................................................................................................27 ................................................................................. www.axelabiosensors.com Beckman Coulter Life Sciences ............................................................................27 ................................................................................. www.beckmancoulter.com Bereskin& Parr ..........................................................................................................9 .........................................................................................www.bereskinparr.com BioFinance ................................................................................................................7 ................................................................................................ www.biofinance.ca BioPartnering North America...............................................................................31 ...................................................................................www.techvision.com/bpn BioTalent Canada.....................................................................................................2 ................................................................................................... www.biotalent.ca Cangene ....................................................................................................................9 ................................................................................................................................... EMD Millipore ..........................................................................................................27 ...................................................................................... www.emdmillipore.com Eppendorf ............................................................................................................ 26, 32 ........................................................................................ www.eppendorf.com Genome Canada ......................................................................................................6 ................................................................................................................................... Hamilton robotics .................................................................................................26 ............................................................................... www.hamiltonrobotics.com Isotechnika ..............................................................................................................10 .................................................................................................................................. KGK Synergize Inc...................................................................................................10 .................................................................................................................................. Life Sciences Ontario .............................................................................................19 ................................................................................ www.lifesciencesontario.ca Novadaq Technologies Inc. ...................................................................................9 ................................................................................................................................... Ocean Optics ...........................................................................................................26 .........................................................................................www.oceanoptics.com OncoGenex Pharmaceuticals Inc. ........................................................................6 ................................................................................................................................... POI Business Interiors ............................................................................................15 ............................................................................................................. www.poi.ca Stellar Pharmacueticals Inc. ...............................................................................6, 10 ................................................................................................................................ Thermo Fisher Scientific .......................................................................................27 .......................................................................................www.thermofisher.com Uson ..........................................................................................................................26 ......................................................................................................www.uson.com VWr ............................................................................................................................5 ......................................................................................................... www.vwr.com Xenon Pharmaceuticals Inc. .................................................................................10 .................................................................................................................................. 30 BIOTECHNOLOGY FOCUS FEBRUARY 2012

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