Biotechnology Focus October 2011

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Biotechnology Without Borders

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contents

OCTOBER 2011 – VOLUME 14 – NUMBER 9

Québec edition

11 FEATURES

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Biotechnology Without Borders

Building the Life Science Corridor in Québec and Ontario

BY SHAWN LAWRENCE

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BY SHAWN LAWRENCE By: Shawn Lawrence

Life Science Corridor

Biopolis Québec

By Shawn Lawrence

BIOTECHNOLOGY WITHOUT BORDERS BIOPOLIS QUÉBEC:

The Québec/Ontario Life Science Corridor Agreement

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Selling Québec’s biotechnology industry to the world

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On June 27th, Ontario and Quebec made it official, establishing the QuebecOntario Life Sciences Corridor by way of a memorandum of understanding reached between BiopolisQuébec, the alliance of leading life sciences regions in the province of Québec (Greater Montréal, Québec and Sherbrooke) and Life Sciences Ontario, the organization representing and promoting the life sciences in Ontario.

The first steps were taken in September 2009 when Ontario Premier Dalton McGuinty and Quebec Premier Jean Charest signed the Ontario-Québec Agreement on Trade and Co-operation.

History was again made in late February 2011, with the first-ever Ontario-Québec Economic Forum. The agreement was signed in the hopes of lowering barriers between the two provinces, and to encourage economic activity and collabo-

ration between the two sides. The development of three Innovation corridors around Information and Technology, Photonics and Life Sciences were considered priorities within the agreement.

Of the three, the Life Sciences Corridor was the first to come to fruition.

The announcement of the Life Science Corridor was made at the industry’s largest event: the BIO International Convention in Washington DC. With the eyes of the world upon them, Québec and Ontario served notice of their intention to be major players on the world stage.

“We are happy that one of the QuébecOntario corridor’s first achievements is in the life sciences, by drawing closer to our colleagues in Ontario, we will be able to position Eastern Canada as one of North America’s key growth areas in the life sciences,” said together Michelle Savoie, Montréal InVivo’s general manager, Carl Viel, president and CEO of Québec International, and Pierre Bélanger, director general of Sherbrooke Innopole when the agreement was signed.

On the Ontario side, Jason Locklin, president and chair of Life Sciences Ontario believes both sides will work well together in building a super cluster in central Canada.

“Working closely with BiopolisQuébec on programs and policy issues will benefit the sector in both provinces, and will help the Ontario and Quebec governments achieve their goal of greater

economic cooperacoopera tion,” said Locklin.

The Life Sciences CorCor ridor seeks to give a brand name to what is now one of the world’s largest biotech clusters. It will lead to more close associations between the two governments, as well as Biopolis Québec and Life Science Ontario. What’s more, the deal gives Ontario and Quebec the scale of size it needs to get the attention of global decision makers to generate better visibility for the two jurisdictions on the world stage, specifically in the eyes of potential investors.

“Our objective via this agreement is really to share best practices, but also to develop an action plan and identify common projects that can help stimulate the development of the life science sector in both of our provinces,” said Michelle Savoie. “Our jurisdictions share a skilled workforce, a solid research base and a proven record or reputation for life science innovation and excellence. The Corridor establishes a common business space that will reduce barriers to trade and encourage collaboration between the two sides.

It is a major step in creating a biotech powerhouse in Canada.”

Geographically, the Corridor is defined as the area from Windsor, ON in the west, to Rimouski, QC in the east.

Virtually all of the Québec and Ontario life science companies (approximately 1,109 companies) are concentrated in this area. In terms of the number of life sciences companies, the Corridor

Biotechnology Focus / October 2011

CQDM

The province of Québec has a lot of things going for it when it comes to life sciences and biotechnology.

In Québec, life sciences and health technologies provide employment to nearly 43 000 people in 620 organizations, including 150 research centers and 80 subsidiaries of foreign companies. Investments in Life Sciences R&D by Québec company’s represent about 30 per cent of all Canadian R&D expenditures in the sector.

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QUÉBEC

QUÉBEC

Ambitious, well timed and unprecedented; these are just some of the statements being bandied about as various stakeholders in Ontario and Quebec have come together to build a life science super cluster in central Canada.

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By Shawn Lawrence

Québec is also one of the few regions of the world where a company can undertake all development stages of a life science product, from basic research to the final product, including preclinical, clinical, manufacturing and marketing stages.

Even with all of this going for it, there were those that felt that Québec needed to do a better job of promoting itself abroad. Enter Biopolis Québec, a collaborative organization made up of the three prominent associations in the province, Québec International for Quebec City, Sherbrooke Innopole for Sherbrooke and Montréal In Vivo in Montreal.

Biopolis Québec was founded in 2010 with the main purpose to promote the

overall expertise and resources that exists in the province of Québec in Life Sciences and health technology sectors and leverage it under one umbrella to penetrate more competitive markets.

We first profiled the organization in our 2010 Biotechnology Focus October issue. In that article Michelle Savoie, general manager, Montreal In Vivo; Pierre Belanger, director general of Sherbrooke Innopole and Carl Viel, president and CEO of Quebec International discussed their intentions to give the whole province better visibility at the international level. One year later Biopolis Quebec has made its presence known on the international front branding the cluster as one, signing deals all over the globe.

“So far, we’ve been quite successful in giving a brand name to the industry here, drawing international attention to the province. As one organization, we’re stronger and we’re able to penetrate international markets far easier. And we’re already seeing deals at both an international level and a national level that wouldn’t have been possible without Biopolis Québec,” states Michelle Savoie.

One priority the group has come to consensus on is finding new ways to promote itself and the province internationally.

“From a regional perspective, we came up with several action items including getting a website (http:// www.quebeclifesciences.com/biopolisQuebec/index.asp) up and running,” said Carl Viel. The website includes an about Biopolis Quebec section, lists the founding organizations and partners, and presents the organizations current international activities. The site also provides an in depth asset map of the sector, highlighting Quebec’s strengths

and capabilities. “It’s a useful tool for our international counterparts seeking to learn more about us,” he added.

While promotion is the web sites main purpose, Biopolis Québec intends to use it as a platform for other purposes including as an educational tool for its members.

Promoting the local industry is only part of the job for Biopolis Québec. The organization is also tasked with the duty of identifying potential areas and partners for collaboration for the three regions. The recently announced collaboration with Life Sciences Ontario to build a broader inter-provincial life science corridor is an example of how Biopolis Quebec is fulfilling this mandate.

In addition to this, the group has been busy reaching out to other clusters, continuing to work with international partners at events, and collaboratively in international business partnerships.

The organization has also had a role to play in sealing agreements with broad European consortia on the Québec life science industries behalf.

This has included missions to France, Germany and Spain in search of deals that mirror the agreements Biopolis Québec signed with Biocat and the Catalan Biosciences Association in 2010. The organization has also gotten into the business of organizing its own events. For starters, BiopolisQuébec was a leading partner for the QuébecFrance Symposium – Biotechnologies.

They also hosted their own event called International Interconnexions at the BIO International Convention in Washington, DC. “That event was held in partnership with Barcelona, Sweden and a couple of other regions and it was an opportunity to present the strengths of each of our

By Gail Garland, President & CEO OBIO

The brand names behind Québec’s bio-clusters COMPILED BY SHAWN LAWRENCE

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BIOSCIENCE INDUSTRY LEADERS DISCUSS ISSUES THAT MATTER

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First profiled in our October 2009 Biotechnology Focus issue, the Quebec Consortium for Drug Discovery (CQDM), was built as a first of its kind public-private partnership between universities, hospital, biotech companies and most impressive of all, a list of major players in the pharmaceutical industry that includes AstraZeneca, Merck, and Pfizer Canada. It’s a unique partnership where all the players work together in pursuit of common goals of investing more into R&D and developing together enabling tools that accelerate the drug discovery process.

“With pharma companies specifically facing pressure to put news drugs in clinic, they realized that they should work together in order to have the resources to develop tools that would eventually help in decreasing the time and the cost that the industry as a whole is facing for the discovery of new drugs. This system, which we call ‘open Biotechnology Focus / October 2011

On May 31, 2011 OBIO together with event sponsors, Sanofi, Torys, BDC and PWC hosted the Second Annual Quebec/Ontario Bioscience CEO dinner.

QUÉBEC

QUÉBEC

More and more, the industry is facing a lack of productivity and finding it hard to get new drugs to the market. With the industry being challenged to collectively think “outside the box” and to better understand the needs of funding innovation, the idea of ‘open innovation’ is gaining momentum.

step launching a new initiative aimed at building unconventional and highly innovative research projects geared towards impacting the drug discovery process. This new program is called Explore.

CQDM vice president, Research and Business Development Diane Gosselin explains there are many difference between the two programs.

“Explore covers projects that aren’t possible in the Focus Program model.

With Explore, we’re trying to fund something that is not possible to fund right now in Canada. Whereas the Focus program focuses on large-scale, multi-disciplinary, multi-institutional public-private partnerships types of projects, Explore is more small-scale.

It can be just one lab and the projects themselves are more out of the box thinking,” she said.

While different in nature, the goals of the two remain the same she adds.

“Both programs are geared towards funding tools that can help increase the productivity in general or facilitate the discovery of new drugs but with Explore it’s on a smaller scale yet with more risk and higher rewards. Explore is also geared toward talented researchers who wouldn’t otherwise have access to support from industry both in terms of funding and in an advisory role,” she said.

The Explore program is not only intended for research fields directly related to drug development, but also for all sectors that can provide solutions to the challenges faced in biopharmaceutical research (for example, engineering, nanotechnology, medical instrumentation, diagnostic products, translational medicine, imaging tools, etc.). The three new pharma companies joined CQDM for this one program specifically, but the

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The tradition started in 2010, to provide bioscience industry leadership with a unique opportunity to connect and discuss industry issues in a relaxed interactive setting while enjoying a fine meal and refreshments. Building on last year’s positive word of mouth, the 2011 event was over-subscribed. This year, over 50 guests from across Canada came together at, ‘The Rosewater Supper Club’ in downtown Toronto for a cocktail reception before joining tablemates and embarking on the evening’s agenda.

The conversation was enriched by the perspectives of guests from British Columbia and Manitoba in addition to Quebec and host province, Ontario.

Attendees included industry leadership from therapeutic, device, diagnostic and healthcare IT companies, lawyers with sector and IP expertise; accountants with industry experience in programs such as SR&ED (Scientific Research and Experimental Development Tax Incentive Program) and financial and capital market executives.

This year’s gathering was designed to build on conversations that started

at the 2010 Quebec/Ontario Bioscience CEO Dinner. Each table of guests was asked to choose three questions from a list of seven prepared by Helen Findlay, OBIO Director. Questions were designed to provoke discussion on a range of industry-relevant topics including: branding; industry sustainability and growth; government policy and opportunities for collaboration across country-wide networks.

The first topic of discussion at most tables was branding – the ongoing effort to create a clear understanding of human health bioscience and its potential to deliver innovative health care solutions and therapies from Canada. Branding was seen as an important objective, both locally and nationally, to ensure a common understanding throughout the ecosystem that supports and benefits from the indigenous health science biotechnology industry. Beyond branding, guests described the need to articulate industry’s ability to generate value while reducing system healthcare costs and creating both direct and ancillary jobs.

Next, discussion turned to industry advancements over the last year. Several companies were able to discuss financings that had closed in recent months enabling development pipelines to continue to move forward. Many of the evening’s guests had participated in OBEST™ (Ontario Bioscience Economic Strategy Team) over the last several months and expressed the view that OBEST represents a much needed framework to develop and implement a strategy for a commercially viable human health bioscience industry. Daniel Billen, PhD., Chair of the OBEST Advisory Board was present and recognized

for his leadership and for encouraging industry to develop goals and strategies that industry will implement while partnering with government to develop supportive policies.

Participants then spoke to the need for effective deployment of existing government programs and put forward ideas for future policy. Participants referenced examples of effective and highly competitive programs in other global jurisdictions where governments support health science biotechnology by creating an environment with favourable conditions for growth and sustainability. Programs that provide non-dilutive options for early stage companies were presented as being particularly attractive.

Programs that provide funding while de-risking technologies were recognized as particularly important by increasing follow-on investment opportunities.

One such program was the Small Business Innovation Research Program (SBIR) funded by US federal agencies.

The SBIR provides small businesses with feasibility and pre-commercial research funding for ideas that meet high priority research and development needs detailed by the US government and which have potential for commercialization. The SBIR program is highly competitive and focuses on performance and go/no-go decision points which results in the early termination of non-viable projects. Depending on the type of program, companies in the SBIR program are eligible for either grants (supply side) or procurement contracts (demand side). It has been shown that companies which successfully pass through the SBIR program

www.bioscienceworld.ca

OBIO’s 2nd Annual Québec and Ontario Bioscience CEO Dinner

Bioscience industry leaders discuss issues that matter

BY GAIL GARLAND

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The 3rd Annual Canadian Science Policy

Why it’s a must attend forum for the pharma and biotech sectors

BY MEHRDAD HARIRI

Biotechnology Focus / October 2011

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A model for smart innovation

The Quebec Consortium for Drug Discovery extends its reach

BY SHAWN LAWRENCE

At OBIO’s 2nd Annual Quebec and Ontario Bioscience CEO Dinner Event innovation,’ is a reasonable model,” says president and CEO of the CQDM, Dr. Max Fehlmann.

The idea he explains is having all the partners put their money in the same basket to fund risky projects and then share the profits.

“That’s a way to dilute the risks, and more projects can be funded with this model. As a result, there are more chances of having a project that gets off the ground, for the same investment,” he said.

The results from the CQDM’s first program, Focus, have been both positive and encouraging. Through this program, CQDM provides grants for up to $2 million, for a maximum period of three years. The Focus program is designed for academic research institutions as well as for private companies. Multidisciplinary collaborations between public and private sectors are also strongly encouraged in this program. Thus far, CQDM has financed 11 research projects for a total of $19.2 million disbursed amongst 17 research entities (nine academic research centers and eight private companies). Even though the first projects financed with this program will end in August 2012, several deliverables with high impact have already been generated.

Needless to say, three years later the CQDM has performed beyond expectations. And not surprisingly, it continues to grow.

For starters, the number of pharma partners that have signed on with the CQDM has increased to six with the additions of Boehringer Ingelheim, Glaxo Smith Kline Inc. in February and the addition of Eli Lilly Canada in June.

With the arrival of the new partners, the CQDM also took another forward

Regional Spotlight Québec’s Bio-Clusters

Biotechnology Focus / October 2011

OBIO

CQDM: A MODEL FOR SMART INNOVATION

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Biopolis Québec

Selling Québec’s biotechnology industry to the world

DEPARTMENTS

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Research News

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Business Corner

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Across Canada

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Calendar of Events

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The Last Word

October 2011 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S NOTE PUBLISHER/ EDITOR-IN-CHIEF STAFF WRITERS

Terri Pavelic Shawn Lawrence Christopher Rogers

Innovation

CONTRIBUTING WRITERS

John Lawson Mehrdad Hariri

cannot happen in isolation

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lthough this issue of Biotechnology Focus is our third Québec themed issue, there is another strong theme that runs throughout almost all the content: the importance of collaboration.

Biotechnology is a difficult and competitive industry, but one that understands innovation cannot happen in isolation, especially in a country like ours. We cannot sell ourselves to the world competing against each other, and this is a reality that is not lost by our industry leaders. We need to work together in order to compete.

Turning to “The Last Word” first, Dr. John Lawson explains collaboration can mean as little as a discussion and as much as working together to achieve shared goals. There is an element of trust involved in the latter that is critical to the success of any partnership.

Moreover, collaboration requires careful planning.

The importance of collaboration is highlighted again in the case of the Québec/Ontario Life Science Corridor partnership. The groundwork for this cluster was fostered through the combined efforts of Québec Premier Jean Charest and Ontario Premier Dalton McGuinty in 2009 with the signing of a Quebec-Ontario agreement on trade and co-operation. The model will be one that allows the two sides to have equal voice, with great emphasis on industry participation, as well as industry and public sector collaboration. How this corridor initiative will shape up to change how research, innovation and life sciences business works in Ontario and Québec remains to be seen.

But by banding together, various stakeholders in Québec and Ontario should be applauded in their efforts to build a life science super-cluster in central Canada that will be able to compete with the largest bio-clusters around the world.

Likewise, CEO’s from both provinces got the chance to meet and mingle at the 2011 OBIO Quebec/Ontario Bioscience CEO dinner in May. The event was an opportunity for industry leaders to tackle the issues holding the industry back. In her article, OBIO president and CEO Gail Garland discusses the dinner and how it provided executives with the chance to meet face to face to tackle issues ranging from branding and industry advancements, to effective deployment of existing government programs.

Lastly, Shawn Lawrence looks closer at collaboration in the province of Québec by spotlighting the Québec Consortium for Drug Discovery (CQDM). The CQDM was first profiled by Biotechnology Focus in 2009 and its impressive list of partners has only grown since. The CQDM focuses on public-private partnerships usually involving universities, hospitals and biotech companies. The CQDM is even collaborating overseas.

A new initiative between CQDM and France-based Alsace BioValley aims to strengthen biomedical research in Québec and Alsace by aligning international resources.

All together, these initiatives and programs demonstrate that partnering for innovation is essential to a healthy bioscience industry in Canada. By working together, we enhance our ability to compete on the world stage.

Gail Garland

Michael Fenwick Patricia Folkins NATIONAL ACCOUNT MANAGER GRAPHIC DESIGNER CONTROLLER

Patricia Bush Elena Pankova John R. Jones

MARKETING MANAGER

Mary Malofy

CIRCULATION DIRECTOR

James Watson circulation@promotive.net

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

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

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Joining Forces to be Stronger in a Global Market!

The Life Sciences Ontario and BiopolisQuébec partnership agreement signed last June at BIO Washington creates new opportunities for investments in life sciences supported by the lowest business environment costs among the G7 countries. In addition, Québec-Ontario represents one of the most favourable tax environments in the world for innovation partnerships and a leading jurisdiction for life sciences patents.

Together, Québec and Ontario combined efforts makes the life sciences corridor the second largest in North America in terms of number of life sciences companies and brings a critical mass of:

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More than 1,100 companies 66 000 qualified people 490 undergraduate and graduate programs in biological and biomedicine sciences The majority of Canadian sales and export in life sciences Access to the majority of Canadian venture capital

www.biopolisquebec.com

www.lifesciencesontario.ca

Source: Combining Strengths, Maximizing Impact, The Québec-Ontario Life Sciences Corridor, 2011, PricewaterhouseCoopers LLP. BiopolisQuébec is the alliance of Québec International, Sherbrooke Innopole and Montréal InVivo.

Reply Card #4952

R & D NEWS State-of-the-art vaccine centre officially opens

Taken at the University of Saskatchewan VIDO-InterVac grand opening on September 16, 2011.

Photo by David Stobbe The $140-million International Vaccine Centre (InterVac) at the University of Saskatchewen held its official grand opening on September 16 to kick off National Biotech Week.

Prime Minister Stephen Harper was joined

by Saskatchewan Premier Brad Wall and other dignitaries in opening the door to a new era of vaccine research in Canada.

Operating as part of the U of S’s Vac-

cine and Infectious Disease Organization (VIDO), the new containment level 3 InterVac facility covers an area larger than two Canadian football fields. It provides specially designed facilities for scientists to safely conduct research into diseases such as tuberculosis, hepatitis C, HIV/AIDS, SARS, influenza, and prion diseases such as chronic wasting

disease and mad cow disease.

“InterVac ushers in a new era of vaccine research in Western Canada,” said Andrew Potter, VIDO-InterVac director and CEO. “This facility greatly enhances our capacity to develop vaccines and new methods of delivering them to animals and humans, and our ability to address questions of food and water safety for all Canadians.

What this centre’s going to do is develop strategies and technologies to protect Canadians against infectious diseases like SARS, pandemic influenza, West Nile virus and cattle producers, swine producers, etcetera as well against diseases of animals,” said Potter.

He added that InterVac will enable largerscale vaccine research and development than is currently possible in Canada and will help alleviate a worldwide shortage of specialized containment facility space for addressing many re-emerging and emerging diseases, the majority of which originate in animals.

“Scientists from across Canada and around the world will be able to use the facility,” he said but added the work could reach beyond Canada’s borders.

The dual-wing InterVac building includes containment laboratories for research and training of graduate students, as well as an animal wing with multi-species accommodation.

Gowlings recognizes winners of its annual biotech essay contest Gowlings, a national law firm, has named Susie Youn of Edmonton, Amanda Doggett of Winnipeg and Emma Maione of Winnipeg as the winners of its eighth annual Biotech Essay Contest.

“We were not only impressed by our three winners, but also by the quality and variety of topics from the 25 entries. Congratulations must be given to all those who entered,” said Konrad Sechley, principal and patent agent in Gowlings’ Vancouver office and a contest judge.

Launched during National Biotechnology Week in 2004, the contest supports students entering a Canadian post-secondary institution in a life sciences-related field.

Additionally, the contest gives Gowlings an opportunity to promote law as a career choice for those interested in working in the life sciences sector. Of the 150 life sciences-focused professionals at Gowlings, over 40 have life sciences-related degrees.

The top prize of $5,000 was won by Susie Youn, a graduate of Old Scona Academic in Edmonton for her essay, Cellular Alchemy: 6 BIOTECHNOLOGY FOCUS October 2011

Breakthroughs in Canadian Stem Cell Research.

“We touched on stem cells during biology class this year and the topic really piqued my interest,” Youn said. ”Luckily for me, it turned out that Canadians have made great progress in the field of stem cell research and engineering. This fall I’ll be studying at the University of Alberta’s Faculty of Science, where I hope to one day major in biological sciences.”

Second prize of a laptop went to Doggett (Kelvin High School, Winnipeg) for Magic at McMaster: Dr. Bhatia’s Discovery in Turning Human Skin Cells to Blood Cells, and third prize of an iPod Touch* was awarded to Maione (River East Collegiate, Winnipeg) for Canadians Make a Global Advance Against the Scourge of Malaria.

Gowlings partnered with Bioscience Education Canada, BIOTECanada and regional partners across the country to promote the event.

The panel of judges included Konrad Sechley, Gowlings; Cate McCready, vice presi-

dent, external affairs, BIOTECanada; Tony Legault, director of programs, Bioscience Education Canada; and Alison Symington, vice president, outreach, Ontario Genomics Institute, who brought their legal, education and industry expertise to the table.

R & D NEWS CDRD commercial arm to collaborate with Roche ment will support a mutual goal of transforming cutting-edge academic health research discoveries into viable commercial opportunities.

Natalie Dakers,

will provide Roche with access to Canada’s leading health research discoveries, and further build the company’s product pipeline. According to both parties, this invest-

The Centre for Drug Research and Development’s (CDRD’s) commercial arm, CDRD Ventures Inc. (CVI) has entered into a strategic collaboration agreement with F. Hoffmann-La Roche Ltd. (Roche).

Under the agreement Roche has committed several million dollars to support and jointly develop innovative health research technologies under the management of CVI. CDRD Ventures will drive the development of projects jointly selected in cooperation with Roche. The parties will collectively determine the most appropriate development paths for the intellectual property associated with the projects, and assess opportunities for collaboration, funding, management, and commercialization of these technologies.

“CDRD and CDRD Ventures are extremely pleased to be partnering with Roche, one of the most cutting-edge research-based companies in the world,” commented Natalie Dakers, president and CEO of CDRD. “This is the first industry investment into CDRD’s commercial arm which will allow us to successfully address the commercialization gap between academia and the private sector, and in doing so, bring new therapeutics to the patients who need them,” she said.

Karimah Es Sabar, senior vice president, Business and Strategic Affairs for CDRD added, “This partnership is a truly integrated, collaborative and strategic approach to research, innovation and commercialization. It will allow each of us to leverage world-class research and drug development expertise while extending Canada’s research alliances around the globe.”

CVI also stated that the newly-formed partnership will provide CVI with capital and additional world-class external expertise to further support Canadian health researchers in the development of novel therapeutics for the treatment of diseases with high unmet medical need. At the same time, it

Reply Card #4953 October 2011 BIOTECHNOLOGY FOCUS 7

BUSINESS CORNER

Cyril Schiever

Merck Canada Inc. names new president and managing director

Merck Canada Inc. announces the appointment of Cyril Schiever to the position of president and managing director.

Since 2009, Mr. Schiever served as managing director at Merck Sharp & Dohme in Greece, Cyprus and Malta where he successfully led the merger of Schering Plough and Merck Sharp & Dohme. He was also an active member of the Board of directors of the Hellenic Pharmaceutical Association in Greece. Prior to this, Schiever consecutively managed Schering Plough operations as general manager in the Gulf and East Africa, the Czech & Slovak Republics and Greece.

Born in France, Schiever’s career in the pharmaceutical industry spans more than twenty years including ten years at Sanofi where he held senior positions in Finance in the U.K. and Morocco.

Based in Montréal, Québec, Merck employs more than 1,600 people across Canada.

COLDSORE-FX® launched in Canada Afexa Life Sciences Inc. has officially launched COLDSORE-FX®, a new, unique cold sore treatment to help the one in five Canadians who suffer from cold sores.

About a third of Canadians who get cold sores regularly buy over-the-counter remedies, spending nearly $20 million a year on the products, according to the Nielsen Group, and experience mixed results. According to a nationwide survey on the subject of cold sores conducted

by ICOM, a division of Epsilon Targeting, 65 per cent of Canadian cold sore sufferers who had recently used a remedy were not completely satisfied with the results.

The most common explanations for dissatisfaction with the products that were then available were that the products didn’t seem to reduce the healing time, or didn’t seem to work at all.

While more than 26 million Canadians carry the cold sore virus, most are unaware they do so because it lies dormant and they never experience an outbreak.

But for the seven million Canadians who experience recurrent outbreaks, cold sores are a dreaded medical condition.

Afexa says its new product, which has been licensed by Health Canada with a Natural Product Number, is backed by clinical trials showing it significantly reduces the healing time. Cold sores usually last 10 days, and the trials dem-

onstrated that COLDSORE-FX cuts the duration by an average of four days versus placebo.

Toronto dermatologist Dr. Sandy Skotnicki-Grant says “I’ve reviewed the clinical trials that have been conducted on this product and believe COLDSORE-FX offers great therapeutic benefit for people who suffer from cold sores because it works at every stage of the outbreak, not just at the first tingle, and it helps cold sores heal four days faster. The fact that it’s natural, unlike the other options available, is a real advantage for consumers as well.”

Afexa’s co-founder and chief scientific officer, Dr. Jacqueline Shan, says “The active agent in COLDSORE-FX, Propolis ACF+, is a unique and proprietary extract derived from a natural source, as is the case with COLD-FX®. This new addition to Afexa’s range of polymolecular botanical medicines provides strong therapeutic benefit to sufferers.”

Zymeworks Inc. to collaborate with Merck in development of Bi-specific antibody therapeutics Zymeworks Inc. has reached a research collaboration agreement with Merck around Zymeworks’ proprietary Azymetric™ platform for the development of novel bi-specific antibody therapeutic candidates.

Bi-specific antibodies are designed to bind to two different drug targets for broad use in clinical applications such as oncology or autoimmune disease. Under the terms of the agreement Zymeworks has granted Merck, through a subsidiary, a worldwide license to develop and commercialize bi-specific antibodies generated through use of the Azymetric™ platform toward certain exclusive therapeutic targets. Both companies will collaborate to advance the technology platform, with Merck working to progress the bi-specific therapeutic antibody candidates 8 BIOTECHNOLOGY FOCUS October 2011

through clinical development.

“We are delighted to establish a strategic collaboration with the exceptional biologics team at Merck to advance our revolutionary bi-specific antibody platform,” Ali Tehrani, Ph.D., CEO of Zymeworks, said. “This is an important validation of our scientific

leadership in the field of structure-guided protein engineering and we look forward to working with Merck to realizing the full value of this novel platform technology across a range of therapeutic indications.”

“Zymeworks’ technology platform has the potential to provide a unique solution for engineering novel antibodies,” said Richard Murray, Ph.D., senior vice president, biologics research at Merck.

Additionally, Zymeworks will receive an upfront fee and is eligible to receive research, development and regulatory milestones with a potential value of up to US $187 million, as well as tiered royalty payments on sales of products. Merck will have exclusive worldwide commercialization rights to products derived from the collaboration.

The Québec-Ontario Life Science Corridor:

Showcasing Ontario and Québec as a world-class centre for life science reaserch

10 14 16 20 24

Biotechnology Without Borders Biopolis Québec: Selling Québec to the world Québec Regional Bio-cluster Spotlight CQDM: A Model For Smart Innovation OBIO’s 2nd Annual Québec and Ontario Bioscience CEO Dinner Event

Le Chateau Frontenac.

Photo credit: Jean-Francois Bergeron, Enviro Foto Downtown Sherbrooke.

Photo credit: Destination Sherbrooke

By: Shawn Lawrence

Life Science corridor

BioTechNoLoGY WiThouT BorderS The Québec/Ontario Life Science Corridor Agreement

quéBec

Ambitious, well timed and unprecedented; these are just some of the statements being bandied about as various stakeholders in Ontario and Québec have come together to build a life science super cluster in central Canada.

10

On June 27th, Ontario and Québec made it official, establishing a QuébecOntario Life Sciences Corridor by way of a memorandum of understanding reached between BiopolisQuébec, the alliance of leading life sciences regions in the province of Québec (Greater Montréal, Québec City and Sherbrooke) and Life Sciences Ontario, the organization representing and promoting life sciences in Ontario.

The first steps were taken in September 2009 when Ontario Premier Dalton McGuinty and Québec Premier Jean Charest signed the Ontario-Québec Agreement on Trade and Co-operation.

History was again made in late February 2011, with the first-ever Ontario-Québec Economic Forum. The agreement was signed in the hopes of lowering barriers between the two provinces, and

Biotechnology Focus / October 2011

to encourage economic activity and collaboration between the two sides. The development of three Innovation corridors around Information and Technology, Photonics and Life Sciences were considered priorities within the agreement. Of the three, the Life Sciences Corridor is the first to come to fruition.

The announcement of the Life Science Corridor was made at the industry’s largest event: the BIO International Convention in Washington DC. With the eyes of the world upon them, Québec and Ontario served notice of their intention to be major players on the world stage.

“We are happy that one of the QuébecOntario corridor’s first achievements is in the life sciences, by drawing closer to our colleagues in Ontario, we will be able to position Eastern Canada as one of North America’s key growth areas in the life sciences,” said together Michelle Savoie, Montréal InVivo’s general manager, Carl Viel, president and CEO of Québec International, and Pierre Bélanger, director general of Sherbrooke Innopole when the agreement was signed.

On the Ontario side, Jason Locklin, president and chair of Life Sciences Ontario believes both sides will work well together in building a super cluster in South East Canada.

“Working closely with BiopolisQuébec on programs and policy issues will

benefit the sector in both provinces, and will help the Ontario and Québec governments achieve their goal of greater economic cooperation,” said Locklin.

The Life Sciences Corridor seeks to give a brand name to what is now one of the world’s largest biotech clusters.

It will lead to more close associations between the two governments, as well as Biopolis Québec and Life Science Ontario. What’s more, the deal gives Ontario and Québec the scale of size it needs to get the attention of global decision makers to generate better visibility for the two jurisdictions on the world stage, specifically in the eyes of potential investors.

“Our objective via this agreement is really to share best practices, but also to develop an action plan and identify common projects that can help stimulate the development of the life science sector in both of our provinces,” said Michelle Savoie. “Our jurisdictions share a skilled workforce, a solid research base and a proven record or reputation for life science innovation and excellence. The Corridor establishes a common business space that will reduce barriers to trade and encourage collaboration between the two sides. It is a major step in creating a life sciences powerhouse in Canada.”

Geographically, the Corridor is defined as the area from Windsor, ON in the west, to Rimouski, QC in the east.

Members of BiopolisQuébec and Life Sciences Ontario sign the Life Science Corridor MOU in the presence of Québec, Ontario and Federal ministers at the BIO International Convention in Washington DC. Photo credit: Ontario Ministry of Research & Innovation

Virtually all of the Québec and Ontario life science companies (approximately 1,109 companies) are concentrated in this area. In terms of the number of life sciences companies, the Corridor exceeds other mega bio-clusters such as Massachusetts, BioValley and Medicon Valley.

Global industry leaders such as Pfizer, sanofi-aventis,Novartis, GlaxoSmithKline, Roche, Astra Zeneca, Merck, Johnson & Johnson, Eli Lilly, BristolMyers Squibb all have their Canadian headquarters in the corridor. The corridor is also the most densely populated and highly industrialized region in all of Canada.

While Ontario and Québec individually each have significant life science capabilities and assets, they have struggled to attract the attention of global decision makers and investors to their provinces.

By uniting as one, both BiopolisQuébec and Life Science Ontario hope that Investors are more likely to take a second look at the region. Essentially the alliance also gives the two provinces and the organizations better footing when it comes to competing against foreign jurisdictions, bioclusters and regions for investments “One only needs to take a look at what’s going on in other parts the world, whether in France, Sweden or the U.S., the big bio-cluster model is a trend that is being embraced all over. We felt if we

wanted to have a bigger punch when we go to events such as BIO (BIO International Convention), the best idea is to do so under one banner, the Québec/Ontario Life Sciences Corridor,” stated Viel.

Josée Blanchard, Sherbrooke Life Science director Business Development, also believes that pooling together the two provinces’ respective strengths will drive capital to the area thus spurring innovation and creating jobs.

“To work together gives us a bigger power play to stand out on the international scene. It will give us a competitive edge,” she said adding the true value of this as a marketing tool is to intensify the collaborations between the provinces.

Moreover, she explains that the Corridor is about telling a coherent story to the world and making it easier for someone to drop a million dollar investment into the region.

At the same time, she commented that each region has its own particularities and strengths to attract investment.

“For example, Sherbrooke has more than 600 scientists working in 12 institutional research centers in Life sciences and some exclusive equipment that cannot be found anywhere else in Canada such as two Gamma knives and two cyclotrons. Montréal and Québec have other exclusivities and strengths so say for instance a foreign company is considering relocating to the corridor,

they can find the global environment and facilities they need.”

Blanchard also believes that the partnership not only creates visibility for the major cities in the Corridor but also the smaller ones.

“As the smallest cluster in the corridor, Sherbrooke may have the most to gain from the opportunities generated by this partnership. Usually, when a company or investor from abroad looks at opportunities in Canada or Québec, their focus is on Toronto or Montréal.

Few know much about Sherbrooke or even Québec City or Ottawa. This agreement should shine a light on those lesser known regions. And if it means in the end that foreign investment finds its way to either Ontario or Québec instead of other clusters such as Boston or Silicon Valley, then it’s the best move possible.”

For Carl Viel, the partnership offers other potential incentives that go beyond attracting international interest from investors, specifically in regards to global competition for talent and trade.

“It strengthens the value proposition of doing business in the region. It provides more options, whether it’s finding a location that suits your business needs, recruiting talent from abroad or pairing up experts that fit your scientific needs, there are lots of possibilities for a company or individual looking to relocate to the Corridor. The corridor allows for free movement of people, businesses, goods and ideas,” he said.

Together stakeholders on both sides of the border are already discussing ways to best work together in promoting the alliance. This includes developing marketing tools to make their presence felt globally and the use of websites and asset maps to really spell out the capacity and strength of each province.

The Price Waterhouse Coppers (PWC) report written in conjunction with the Ministère du développment économique de l’innovation et de exportation, and the Ontario Ministry of Research and Innovation titled: Combining Strengths, Maximizing Impact, is the first in a series of publications geared towards promoting the two sides as one.

In this report, each province’s strengths are highlighted while potential collaborations are also discussed. According to the report, Ontario and Québec make up more than half of Canada’s population and generate 60 per cent of the

Biotechnology Focus / October 2011

québec

Life Science Corridor

11

québec

Life Science Corridor

12

country’s GDP. In 2009 alone, the total pharmaceutical exports from the two provinces constituted 93 per cent of the $7.7 billion in Canadian exports. The two jurisdictions are also the largest centers for venture capital in the country. In terms of talent and facilitating the next generation of life science entrepreneurs and researchers, the corridor is home to 21 leading universities and offer more than 490 undergraduate and graduate programs in biological and biomedical sciences. The area is home outstanding research and academic infrastructure.

Even prior to the partnership, Ontario and Québec were already each other’s biggest trading partners.

Additionally, the two provinces benefit from billions of dollars in federal and provincial funding programs. For starters, the Québec government plans to invest more than $120 million over the next three years into its internationallyrenowned biopharmaceutical industry and has implemented its new strategy for research and innovation, while Ontario is investing $161 million through its Life Sciences Commercialization Strategy, which will support biotech startups, facilitate clinical trials, and support research and development in healthcare technology. An alliance means that this pool of money increases in size and reach. While the success of the corridor will inevitably be judged on its ability to spur investment, domestically the corridor means the possibility of more collaborative projects from province to province.

For these reasons, industry operating in the corridor, ranging from big pharma to small biotech, is 100 per cent behind this initiative.

“There’s support from the Canadian based multinational pharma and biotechnology companies who are interested in making this work as they believe that if one can create an environment that encourages a strong and healthy start up industry, with collaboration within the sector on both sides of the border, the net result will lead to the development of more great science that will help make Canada a stronger and more viable life sciences community,” stated Lorne Meikle, CEO Management Dynamics Ltd. and director Life Sciences Ontario.

Both Biopolis Québec and Life Sciences Ontario subscribe to the theory that innovation cannot take place in isolation

and this is an agreement that ensures that lines of communication between the two provinces will remain open indefinitely. Moreover, the corridor partnership offers a chance to learn from one another.

“I think they (partners in Ontario) want to see and learn what we’re doing right from an R&D perspective, and from our point of view, Ontario has been doing extremely well on the oncology side where they have been able to bring together a few hospitals under patient agreements.

Ontario has been doing some interesting things from a clinical point of view as well, things we can definitely learn from,” said Viel.

The Ontario side is very interested in how Québec has managed to get greater assistance for its start-up companies compared to other jurisdictions in Canada through its innovative government policies. At the same time Ontario wants to work with Québec on how the two sides can jointly develop policies that will help early stage biotech companies move forward toward commercialization.

“We’re looking for changes in policies that will help investors invest and have some protection on their investments so they feel comfortable investing. This is something Québec is doing very well.

By working with Biopolis Québec, we believe we jointly can come up with new recommendations that if enacted will see tax policy changes that will enable investors to make investments in Life Sciences, here in Ontario,” states Meikle. He added that the Corridor will lead to joint efforts by the two provinces through their life sciences organizations to work more closely with the finance departments in both regions to leverage some change at the federal level.

“I think the goal is for both parties to build on each other’s strengths leveling the playing field because we feel that working in this way will lead toward the establishment of a stronger community that can focus on the future which is greater than trying to steal from each other. It’s a matter of taking some of their policies and some of ours and trying to get them to blend so that the playing field is quite level and that life science in these two regions will make Canadian life sciences stronger,” he said.

One area of focus that has already been established between members of Biopo-

lisQuébec and Life Sciences Ontario is the establishment of a cross-border mentorship program. LSO’s Mentorship program is designed for science and business professionals at any stage in their career and matches people based on interests of protégés and industry experience of mentors to facilitate a good fit between the mentoring partners. Members of BiopolisQuébec are just about to start their own mentorship program to mentor small companies, using senior executives from its established industry presence. There is the possibility of connecting the two mentorship programs expanding the number of mentors in both provinces.

“They hope to work closely with us to develop this program and use some of our mentors in their program and we would use some of their mentors on our end. I think a cross border mentorship program is an initiative that finds a natural home under the broader framework of the corridor,” Meikle said.

The Next Steps for the Corridor The two sides have held their first work meeting at BIO2011 in Washington, DC. but have been in a holding pattern until the Ontario Provincial election was completed. A working session is planned for November 3 in Montréal where Meikle and the new Executive Director for Life Science Ontario, Jason Field will lead the LSO part of the initiatives. The priority going forward is to create list of common goals and act upon them. The first step is establishing an effective governance structure for the corridor to work out exactly how the two sides will work together to market this corridor to the world, and if successful, how they will manage responses from potential investors.

The model will be one that allows the two sides to have equal voice, with great emphasis on industry participation, industry and public sector collaboration.

All of these things will be ingredients in the mix.

A private sector advisory committee of the larger economic partnership will be engaged on how the best way for the governance of the corridor to be managed.

The goal is to have the governance model established by BIO 2012.

Biotechnology Focus / October 2011

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Biopolis québec

By Shawn Lawrence

BiopoLiS quéBec: Selling québec’s biotechnology industry to the world

quéBec

The province of Québec has a lot of things going for it when it comes to life sciences and biotechnology. In Québec, life sciences and health technologies provide employment to nearly 28,600 people in 301 companies.

Investments in Life Sciences R&D by Québec company’s represent about 30 per cent of all Canadian R&D expenditures in the sector.

14

Québec is also one of the few regions in the world where a company can undertake all development stages of a life science product, from basic research to the final product, including preclinical, clinical, manufacturing and marketing stages.

Even with all of this going for it, there were those that felt that Québec needed to do a better job of promoting itself abroad. Enter BiopolisQuébec, a collaborative organization made up of the three prominent associations in the province, Québec International for Québec City, Sherbrooke Innopole for Sherbrooke and Montréal InVivo for the Greater Montreal area.

BiopolisQuébec was founded in 2010 with the main purpose to promote the overall expertise and resources that exists in Québec’s Life Sciences and health technology sectors. We first profiled the

Biotechnology Focus / October 2011

organization in our 2010 Biotechnology Focus October issue. In that article Michelle Savoie, general manager, Montreal InVivo; Pierre Belanger, director general of Sherbrooke Innopole and Carl Viel, president and CEO of Quebec International discussed their intentions to make the province more visible at the international level. One year later BiopolisQuébec has made its presence known on the international front branding the cluster as one, signing deals all over the globe.

“So far, we’ve been quite successful in giving a brand name to the industry here, drawing international attention to the province. As one organization, we’re stronger and we’re able to penetrate international markets far easier.

And we’re already seeing deals at both an international level and a national level that wouldn’t have been possible without BiopolisQuébec,” states Savoie.

One priority the group has come to consensus on is finding new ways to promote itself and the province internationally.

“From a regional perspective, we came up with several action items including getting a website (http://www. quebeclifesciences.com/biopolisQuebec/ index.asp) up and running,” said Viel.

The website includes an about BiopolisQuébec section, lists the founding organizations and partners, and presents the organizations current international activities. The site also provides an in depth asset map of the sector, highlighting Québec’s strengths and capabilities.

“It’s a useful tool for our international counterparts seeking to learn more about us,” Viel added.

While promotion is the web sites main purpose, BiopolisQuébec intends to

use it as a platform for other purposes including as an educational tool for its members.

Promoting the local industry is only part of BiopolisQuébec’s role. The organization is also tasked with the duty of identifying potential areas and partners for collaboration for its members. The recently announced collaboration with Life Sciences Ontario to build a broader inter-provincial life science corridor is an example of how BiopolisQuébec is fulfilling this mandate.

In addition to this, the group has been busy reaching out to other clusters, continuing to work with international partners at events, and collaboratively in international business partnerships.

The organization has also had a role to play in sealing agreements with broad European consortia on the Québec life science industry’s behalf.

This has included missions to France, Germany and Spain in search of deals that mirror the agreements Biopolis Québec signed with Biocat and the Catalan Biosciences Association in 2010. The organization has also gotten into the business of organizing its own events. For starters, BiopolisQuébec was a leading partner for the QuébecFrance Symposium – Biotechnologies.

They also hosted their own event called International Interconnexions at the BIO International Convention in Washington, DC. “That event was held in partnership with Barcelona, Sweden and a couple of other regions and it was an opportunity to present the strengths of each of our regions, but we also discussed areas of common focus such as personalized medicine,” said Savoie.

International Interconnexions gave at-

Biopolis Québec

Another Biopolis Québec Led Initiative Biopolis Québec has taken a lead role spearheading the provinces personalized health care initiative.

“We have created a network for personalized health care in Québec which is now an official organization,” said Savoie adding a temporary board has been put in place to run the organization and that this network has identified four priority points for which it would like to see projects developed and implemented.

Those four priorities are: 1) The development and consolidation of an integrated platform for analytical and clinical validation of personal health care solutions. 2) The development and commercial demonstration of personal health care-specific biomarkers. 3) The

development and commercial demonstration of personal health care digital solutions and decision-making tools. 4) The development and consolidation of an integrated platform to demonstrate the impacts of the implementation of personal health care on the health care system.

The government of Québec has announced as part of its April, 2011 budget an investment of $20 million into this initiative to be invested over

the next four years. That figure will be matched by at least an equivalent amount from the private sector made up of companies across the various sectors of the industry.

“We are quite pleased with the results and the government committing to invest in the initiative. Our hope is that the first few projects that are going to be funded through that $40 million budget will be able to integrate all of those components,” Savoie said.

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québec

tendees the opportunity to network with other international companies, centers and institutional communities, as well as participate in a debate addressing the need for international growth. Attendees were also able to engage in one-on-one meetings with potential partners. In total more than 90 people attended the event.

Josée Blanchard from Sherbrooke Innopole said plans are underway to host the event again.

“I think based on its success, we are going to try to establish a tradition of Interconnexions events, host it in Québec possibly as a substitute or in partnership with BioContact Québec next fall. We want to attract visitors and potential partners to Québec to meet our companies. At the same time, the goal for this event will be to reach as wide an audience as we can including big pharma, the medical device sector, functional foods and other sectors of the life sciences,” stated Blanchard.

Related to the BIOCAT deal, one of the first concrete projects from this agreement was the establishment of a summer school for medication and drug development. The first summer school was held this past summer and took place in Barcelona, Spain. According to Savoie, it was positively received to the point that plans are underway to have another summer school, this time in Québec. Plans are also in the works for further collaborative efforts between Biopolis Québec and BIOCAT.

For a quick response please fax: 905-727-4428 or e-mail: circulation@promotive.net

Biotechnology Focus / October 2011

15

BioTale

québec regional Spotlight

Photo: Jean-Francois Bergeron, Enviro Foto

Photo: Destination Sherbrooke

quéBec ciTY:

quéBec

The greater Québec City region is the second-largest biopharmaceutical hub in the province and boasts a wealth of biopharmaceutical expertise. Moreover the city is home to the largest concentration of researchers per capita in Canada.

16

If there is one area of expertise that the city is most known for, it’s infectious disease research. Québec City has a large industry presence that includes three manufacturing facilities, two of which are for vaccines and one for diagnostic kits. Among them, GlaxoSmithKline is Canada’s leading flu vaccine manufacturer and its state-of-the-art vaccine manufacturing facility ensures Canada’s domestic self-sufficiency in the event of a pandemic. Medicago Inc. is a rising star in the industry and is a made in Québec success story. This year the company took home the Frost & Sullivan North American Enabling Technology Award in the vaccines market. BD Diagnostic Geneohm, a subsidiary of BD, is a major global player in the field of

Biotechnology Focus / October 2011

home to high-Tech industry

molecular diagnostics manufacturing in vitro PCR diagnostic kits which are used to detect and identify a variety of infectious agents and genetic variations.

Its proprietary plant-based Proficia™ vaccines development technology is an innovative alternative to traditional vaccine productions systems such as egg-based and cell-based vaccine production technologies.

In addition to its status as a hotbed of cutting-edge diagnostic and vaccine research, the city is also prominent in areas of natural health and wellness products. For example, a new partnership agreement was recently signed

by Québec City with Cosmetic Valley, a perfume and cosmetic industry cluster west of Paris, France.

While other regions life science communities are struggling with the current economic climate, Québec City is thriving.

“Over the last few years we’ve been very fortunate,” says Carl Viel, president and CEO of Québec International, the region’s economic development agency.

In describing the current industry landscape in the city, Viel speaks glowingly.

“We’ve had our share of success stories like Medicago We’ve also seen a lot of money pumped into the region by way of deals such as the $300 million deal between Bayer Pharmaceuticals and local biotech company Endoceutics for the development of a female Viagra.

Another recent highlight was B&D opening a R&D facility and manufacturing site in Québec City,” he said.

Viel credits the existing infrastructure that is present and how it supports entrepreneurs and encourages company creation. At the same time, Québec International fosters growth and development, supports key business sectors and attracts talent and investment to the region. The goal Viel said is to bring companies, research centers and educational institutions together to the table to undertake co-operative efforts.

“One thing that makes Québec City stand-out is the capability of local researchers to transform their discoveries and translate them into company creation. This was the case with Anapharm. The company was a spinout from Laval University, and has grown to become one of the largest CRO’s in the country,” said Viel.

The story of Anapharm isn’t an isolated occurrence either. In fact many biopharmaceutical companies in the metropolitan region of Québec City are derived from research conducted at Laval University.

“This reflects the quality of research being done at the university and the power of technology platforms they develop,” he said.

A second aspect Viel lists is the region’s high concentration of talent in specialized fields.

Continued on page 18

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Québec Regional Spotlight Continued from page 16 “If you look in infectious disease, the research capabilities that we have there are very strong, backed with very capable people. Another area of strength is genomics, and a lot of people don’t know that one of the lead genomics researchers in the country is based out of Québec City. There are a lot of areas where in terms of research capacity we’re punching above our weight.”

The city also benefits from a strong

pharma presence that includes companies such as AstraZeneca, GlaxoSmithKline, Merck Frosst, Pfizer and Sanofi-aventis. There are also more than 6,000 researchers, 400 laboratories, groups, consortiums institutes and R&D centers in the greater Québec City Metropolitan area. He adds that there are also elements in Québec City that encourage new open innovation practices designed to facilitate exchanges between innovation stakeholders (e.g.

private companies, research centers, universities and other partners) and to bring them to a level of collaboration previously unattainable using traditional mechanisms and alliances.

These practices also enable companies to tap into the strengths of the external community and to generate potential solutions to specific problems.

“We have a culture here of working together and that is the secret to our success,” he said.

Montréal: A thriving life sciences community

québec

The Montréal life science and health technology cluster is a thriving community front and center on the world stage. The cluster is comprised of more than 620 organizations, including 150 research organizations and 80 subsidiaries of foreign companies.

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With its large number of pharmaceutical organizations, biotechnology companies and university research institutions, it is one of the few places in the world where one can conduct every phase of creation of a new drug, from basic research through to commercialization. In all, the city is home to 70 per cent of the provinces life science companies and organizations.

The brand name for the life sciences and health technologies cluster of the greater Montreal region is Montréal InVivo. Montréal InVivo operates not just as a catalyst in the development of the cluster, but also as an organization that brings companies, research centers and educational institutions together to the table to undertake co-operative efforts.

According to Michelle Savoie, it’s Montréal InVivo’s goal to ensure the cluster works together to further the overall chain of research and innovation right through to commercialization.

“Montréal InVivo places emphasis on Biotechnology Focus / October 2011

partnerships and finding new ways to create linkages and encouraging collaboration. This includes getting groups that wouldn’t normally associate with one another to work together for the betterment of the cluster,” she said.

“One of the best examples is our initiative in personalized healthcare that emerged from broad consultations of over 150 people in the Province.”

She explains that the places where life sciences are performing the best— i.e. California, Massachusetts and North Carolina—are the same places where the linkages among large pharmaceutical and biotech companies, as well as research organizations are the strongest. As such, Montréal InVivo places heavy emphasis on building linkages in the industry.

Moreover, the organization also functions as a business development arm for the city by its collaboration with organizations such as Montréal International and Investment Québec to recruit and attract business to the Greater Montréal area. To meet this goal, Montréal InVivo has aggressively sought to develop and create partnerships domestically (including establishing Biopolis Québec with its partners in Sherbrooke and Québec City), as well as at the international level.

In line with its mandate, Montréal InVivo is developing a new website called Montreal R&D Connect. The goal of the website is to encourage collaborative projects between big pharma firms and local researchers and biotech companies by providing a listing of local technologies and platforms in the R&D stage to make it easier for pharma companies to sort through and choose potential partnering opportunities.

“The mandate of the website is to list R&D investment or partnership opportunities in the greater Montreal area,” states Savoie. “It’s about capitalizing on the new model of drug development where pharma companies are outsourcing their R&D activities.”

To build the website Montréal InVivo has conducted surveys with different research centers to compile its list of local platforms and technologies. Montréal InVivo has also turned to local pharma for advice on how to best build the website.

“We’ve consulted pharma companies located in the Montréal area to make sure that we have a good understanding of the type of information they need from potential partners on this website.

We’ve also developed a template to present information on the site to make sure that it’s consistent,” she said.

According to Savoie, the website will be launched at the end of the year.

In terms of local success stories, Theratechnologies Inc. tops the list.

The company recently succeeded in having its lead molecule Egrifta™ approved by the U.S. Food and Drug Administration (FDA). The molecule, works by reducing excess abdominal fat in HIV-infected patients with lipodystrophy. What makes Egrifta’s story all the more interesting is that it was developed from start to finish in the Montréal area.

Other companies in Montréal, such as Caprion, Angiochem, Altethia, Milestone Pharma, Vertex Canada, Acasti Pharma and Mimetogen are also positioned for success.

Continued on page 29

Reply Card #4956

cqdM

By Shawn Lawrence

cqdM: A ModeL For SMArT iNNovATioN

quéBec

More and more, the industry is facing a lack of productivity and finding it hard to get new drugs to the market. With the industry being challenged to collectively think “outside the box” and to better understand the needs of funding innovation, the idea of ‘open innovation’ is gaining momentum.

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First profiled in the October 2009 issue of Biotechnology Focus, the Québec Consortium for Drug Discovery (CQDM), was built as a first of its kind publicprivate partnership between universities, hospital, biotech companies and most impressive of all, a list of major players in the pharmaceutical industry that includes AstraZeneca, Merck, and Pfizer Canada. It’s a unique partnership where all the players work together in pursuit of common goals of investing more into R&D and developing together enabling tools that accelerate the drug discovery process.

“With pharma companies specifically facing pressure to put news drugs in clinic, they realized that they should work together in order to have the resources to develop tools that would eventually help in decreasing the time

Biotechnology Focus / October 2011

and the cost that the industry as a whole is facing for the discovery of new drugs.

This system, which we call ‘open innovation,’ is a reasonable model,” said president and CEO of the CQDM, Dr. Max Fehlmann.

The idea, he explained is having all the partners put their money in the same basket to fund risky projects and then share the profits.

“That’s a way to dilute the risks, and more projects can be funded with this model. As a result, there are more chances of having a project that gets off the ground, for the same investment,” he said.

The results from the CQDM’s first program, Focus, have been both positive and encouraging. Through this program, CQDM provides grants for up to $2 million, for a maximum period of three years. The Focus program is designed for academic research institutions as well as for private companies. Multidisciplinary collaborations between public and private sectors are also strongly encouraged in this program. Thus far, CQDM has financed 11 research projects for a total of $19.2 million disbursed amongst 17 research entities (nine academic research centers and eight private companies). Even though the first projects financed with this program will end in August 2012, several deliverables with high impact have already been generated.

Three years later the CQDM has performed beyond expectations. And not surprisingly, it continues to grow.

For starters, the number of pharma partners that have signed on with the CQDM has increased to six with the additions of Boehringer Ingelheim andGlaxo Smith Kline Inc. in February, and

the addition of Eli Lilly Canada in June.

With the arrival of the new partners, the CQDM also took another forward step launching a new initiative aimed at building unconventional and highly innovative research projects geared towards impacting the drug discovery process. This new program is called Explore.

CQDM vice president, Research and Business Development Diane Gosselin said there are many difference between the two programs.

“Explore covers projects that aren’t possible in the Focus Program model.

With Explore, we’re trying to fund something that is not possible to fund right now in Canada. Whereas the Focus program focuses on large-scale, multi-disciplinary, multi-institutional public-private partnership types of projects, Explore is more small-scale.

It can be just one lab and the projects themselves are more out of the box thinking,” she said.

While different in nature, the goals of the two programs remain the same.

“Both programs are geared towards funding tools that can help increase the productivity in general or facilitate the discovery of new drugs but with Explore it’s on a smaller scale yet with more risk and higher rewards. Explore is also geared toward talented researchers who wouldn’t otherwise have access to support from industry both in terms of funding and in an advisory role,” she said.

The Explore program is not only intended for research fields directly related to drug development, but also for all sectors that can provide solutions to the challenges faced in biopharmaceutical research (for example, engineering,

CQDM nanotechnology, medical instrumentation, diagnostic products, translational medicine, imaging tools, etc.). The three new pharma companies joined CQDM for this one program specifically, but the three original partners will also support the program.

The CQDM has already selected four projects for the Explore Program and they are: 1. Terence Hebert (McGill University): This project aims to generate a library for G-protein coupled receptor sensors to analyze the conformational mapping of receptor dynamics upon binding and activation.

2. Rafael Najmanovich (Sherbrooke University): The aim of this project is to develop and validate a computational program to detect similarities in the binding sites of drugs.

3. Enrico Purisima (National Research Council, Biotechnology Research Institute): The aim of this project is to develop a novel platform to design antibodies using an innovative computational technique allowing to model and virtually optimize the interactions of antibodies with their target molecules.

4. Brent Richards (McGill University): The aim of this project is to identify somatic mutation sufficient for the development of autoimmune diseases.

Alsace BioValley is a France-based competitive health cluster dedicated to therapeutic innovation. The two sides signed an agreement last November for a bilateral partnership for the benefit of Alsatian and Québec research centres and industries in the life sciences and health sector.

“The CQDM always had the intention to partner at the international level so we did some work last year identifying clusters and potential partners all

around the world and Alsace BioValley was a logical fit because they shared the same objectives, they were flexible, they knew a little bit about Québec,” explained Gosselin.

The main goal of the CQDM/Alsace BioValley program is to strengthen biomedical research in Québec and Alsace by the alignment of international resources. Once again, at its core is the development of novel enabling technologies or tools to facilitate the

québec

In all, the CQDM Explore competition received 51 proposals that were evaluated by the Explore Advisory committee made up of representatives of the consortium’s member pharmaceutical companies.

“This is something that is quite impressive with six pharma companies together working and selecting a project that they will finance. They all agreed that Explore should be really dedicated to small, very novel, disruptive technology. Risky things and because we have this leveraging of funds behind the program they’re ready to take those risks,” said Gosselin.

“The active involvement of six strong pharmaceutical members creates a very powerful leverage effect for all our members, and will benefit the whole scientific community,” said Dr. Fehlmann.

The CQDM and Europe Another new initiative at the CQDM is the CQDM /Alsace BioValley joint funding program.

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BER BioFocus_Mar2011_OUT.indd 1

2/9/11 10:00:13 AM

Biotechnology Focus / October 2011

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quéBec

cqdM

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biopharmaceutical research.

“Through this program, we are promoting the partnership between private companies and academic institutions.

The projects are for the equivalent of $1.4 million, to be split by both CQDM and Alsace BioValley,” stated Gosselin.

On how the projects were selected, priority was given to enabling technologies that were designed to encourage the development of new diagnostic tools, imaging tools and technologies for the discovery of new drugs, instruments and medical devices platforms. The first actual competition was completed and two projects were selected involving two small private companies based in Québec.

The first project will be focused on visualization and monitoring of receptoreffector complexes activity in vivo, and involves a private-public partnership between Michel Bouvier (IRIC, Université de Montréal), the organization

Biotechnology Focus / October 2011

Mispro of Montreal and two Alsatian collaborators.

The second project will focus on the development and validation of two synergistic platforms based on imaging and biosimulation to visualize the action of drug candidates at the subcellular and molecular levels and involves collaboration between the private organizations Photon etc. (Québec) and Rhenovia (Alsace) and Université Laval.

LooKiNG AheAd To 2012: cqdM’S pLANS For The LiFe ScieNce corridor With the establishment of the QuébecOntario Life Sciences Corridor in June, organizations are racing to facilitate cross-border partnerships between the two provinces. CQDM can be counted as one of those organizations.

“We are now working on a new initiative to fund collaborative projects between Québec and Ontario specifically

to start to fund collaboration projects within the corridor,” stated Dr. Fehlmann. “Already, we have identified two projects with the help of MaRS Innovation and MaRS Discovery District that could be funded by CQDM. Like with the Alsace BioValley partnership we have initiated two pilot projects to see how the process will work and thus far we are happy with the results.”

The end goal or intention according to Dr. Fehlman is to launch a formal competition in 2012. Before this can happen, the CQDM will need to find a partner in Ontario.

“The CQDM is looking for a partner to share such a competition with the partner in Ontario taking charge of expenses in Ontario and CQDM taking charge of the expenses in Québec,” Dr. Fehlmann said. “It will be a lot smaller than the Focus Program but the general aim is the same. Hopefully we will have something to announce in November.”

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oBio

By Gail Garland, President & CEO OBIO

BioScieNce iNduSTrY LeAderS diScuSS iSSueS ThAT MATTer At oBio’s 2nd Annual québec and ontario Bioscience ceo dinner event

quéBec

On May 31, 2011 OBIO together with event sponsors, Sanofi, Torys, BDC and PWC hosted the Second Annual Québec/Ontario Bioscience CEO dinner.

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The tradition started in 2010, to provide bioscience industry leadership with a unique opportunity to connect and discuss industry issues in a relaxed interactive setting while enjoying a fine meal and refreshments. Building on last year’s positive word of mouth, the 2011 event was over-subscribed. This year, over 50 guests from across Canada came together at, ‘The Rosewater Supper Club’ in downtown Toronto for a cocktail reception before joining tablemates and embarking on the evening’s agenda.

The conversation was enriched by the perspectives of guests from British Columbia and Manitoba in addition to Québec and host province, Ontario.

Attendees included industry leadership from therapeutic, device, diagnostic and healthcare IT companies, lawyers with sector and IP expertise; accountants with industry experience in programs such as SR&ED (Scientific Research and Experimental Development Tax Incentive Program) and financial and capital market executives.

This year’s gathering was designed to build on conversations that started

Biotechnology Focus / October 2011

at the 2010 Québec/Ontario Bioscience CEO Dinner. Each table of guests was asked to choose three questions from a list of seven prepared by Helen Findlay, OBIO director. Questions were designed to provoke discussion on a range of industry-relevant topics including: branding; industry sustainability and growth; government policy and opportunities for collaboration across country-wide networks.

The first topic of discussion at most tables was branding – the ongoing effort to create a clear understanding of human health bioscience and its potential to deliver innovative health care solutions and therapies from Canada. Branding was seen as an important objective, both locally and nationally, to ensure a common understanding throughout the ecosystem that supports and benefits from the indigenous health science biotechnology industry. Beyond branding, guests described the need to articulate industry’s ability to generate value while reducing system healthcare costs and creating both direct and ancillary jobs.

Next, discussion turned to industry advancements over the last year. Several companies were able to discuss financings that had closed in recent months enabling development pipelines to continue to move forward. Many of the evening’s guests had participated in OBEST™ (Ontario Bioscience Economic Strategy Team) over the last several months and expressed the view that OBEST represents a much needed framework to develop and implement a strategy for a commercially viable human health bioscience industry. Daniel Billen, PhD., chair of the OBEST Advisory Board was present and recognized

for his leadership and for encouraging industry to develop goals and strategies that industry will implement while partnering with government to develop supportive policies.

Participants then spoke to the need for effective deployment of existing government programs and put forward ideas for future policy. Participants referenced examples of effective and highly competitive programs in other global jurisdictions where governments support health science biotechnology by creating an environment with favourable conditions for growth and sustainability. Programs that provide non-dilutive options for early stage companies were presented as being particularly attractive.

Programs that provide funding while de-risking technologies were recognized as particularly important by increasing follow-on investment opportunities.

One such program was the Small Business Innovation Research Program (SBIR) funded by US federal agencies.

The SBIR provides small businesses with feasibility and pre-commercial research funding for ideas that meet high priority research and development needs detailed by the US government and which have potential for commercialization. The SBIR program is highly competitive and focuses on performance and go/no-go decision points which results in the early termination of non-viable projects. Depending on the type of program, companies in the SBIR program are eligible for either grants (supply side) or procurement contracts (demand side). It has been shown that companies which successfully pass through the SBIR program

OBIO pre-revenue public companies possessare able to attract angel and venture ing undeducted SR&ED expenditures capital funding. and tax credits that could be passed on Referencing the SBIR program, a to FTS investors. Investors would then proposal was advanced for a Canadian benefit from the tax credits – and future program which would be funded using capital gains. a similar model. As with the US SBIR Participants emphasised the improgram, a Canadian program would portance of maintaining the SR&ED enhance university-company collaboraprogram and recommended expanding tion, attract follow-on investors and creeligibility and increasing expenditure ate sustainable spin-off companies and levels. As recommended in OBIO’s 2009 jobs. One suggestion would stipulate that and 2010 industry reports (found at government funded organizations such www.OBIO.ca) industry experts again as, Genome Canada focus on high risk felt that the OITC (Ontario Innovation early stage companies for a specified Tax Credit) should increase the altime period. lowable portion of qualifying SR&ED When asked about government creexpenses from 10 per cent to 37.5 per ated fund of fund programs guests noted cent to ‘level the playing field’ with the lack of investments to date made by Québec operating companies.

Québec’s Teralys Capital Fund (2008) and Industry CEOs advancing products the Ontario Venture Capital Fund (2008) along commercial pathways and other into local venture capital firms with bioexperts at the dinner emphasized the science technology portfolios. The group need for a shift in government procureproposed a number of alternative funding ment policy away from a single minded vehicles including providing tax incenfocus on cost containment. Instead stratetives to encourage direct investment by gic procurement should take into account institutional investors or pharmaceutical the value created when adoption of innocompanies. One table of guests put forvative technologies addresses healthcare ward a particularly innovative proposal needs, contributes to economic growth for a themed lottery managed by the and increases global competiveness of Ontario Lottery Corporation as a way indigenous companies. This concept to provide a pool of risk capital for the also forms one of the OBEST strategies to health science and biotech sectors. address the vital role of procurement in Guests also discussed the role of an enabling innovation. The ongoing stratequity-based financing alternative such egy engages government and industry as, flow-through shares (FTS) to fund stakeholders in identifying healthcare research and development activities. priorities and enhancing industry’s reA FTS program similar to what is cursponsiveness so that procurement and rently available in the resource sector, AxSourceMagAd_FINAL__ 11:33 AM Page 1 commercial development become two would be most attractive 02/08/2011 to early-stage,

sides of the same coin.

It is impressive how much ground the group covered in just a few hours. As part of the evening’s wrap-up, guests emphasised the benefits of the evening’s discussion and encouraged OBIO to continue to use these dinner events to capture innovative thinking and the best ideas across geographical and sector boundaries.

About OBIO™ The Ontario Bioscience Industry Organization (OBIO) is a private sector, membership-based organization that is Ontario’s leading advocate for the life science sector. OBIO is engaged in advocacy to enable the successful development and commercialization in Ontario of life science technology through investment, strategic alliances, stakeholder engagement and industry promotion.

Our goal is to build a leading bioscience cluster in Ontario to deliver innovative products / services to a global market.

About OBEST™ The Ontario Bioscience Economic Strategy Team (OBEST) was developed by OBIO following consultation with leaders of Ontario’s bioscience companies who provided the impetus for developing a province-wide strategic vision to support the growth and viability of Ontario’s bioscience industry. OBEST includes all stakeholders in the Ontario bioscience community who want to create the conditions for sustainable growth of Ontario’s bioscience industry.

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By Patricia Folkins and Michael Fenwick

ACROSS CANADA

IS YOUR DRUG “OBVIOUS TO TRY”?

When a pharmaceutical or biotechnology company brings a profitable new medicine to market, one can safely wager that the validity of the patent which protects the drug will be challenged in court.

Whether the medicine is obvious, or lacks inventiveness, in view of any known prior art is one of the main avenues for attack in an impeachment proceeding. Asserting that the patent’s claims are obvious allows the challenger to combine prior art references, and argue that a person skilled in the art could have arrived at the particular medicine without any inventive skill. Assuming that a patented drug will be challenged in court, companies conducting pharmaceutical research should, from the onset of a research program, record any and all indicia of inventiveness in their work.

26 BIOTECHNOLOGY FOCUS October 2011

In 2008, the Supreme Court of Canada addressed the law of inventiveness with respect to clopidogrel bisulfate (Plavix®) (Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 [Sanofi]). One issue in Sanofi was whether a patent claiming the S-enantiomer of clopidrogel could be inventive over a prior patent which specifically disclosed the racemate. The Court held that the S-enantiomer of clopidrogel was indeed inventive over the prior art, and that the separation of the racemate was not “selfevident” from the disclosure in the prior patent. The Court reasoned that a skilled

person would not know if the properties of the S-enantiomer would be different from the racemate or the R-enantiomer, even though methods to separate and isolate enantiomers were known. The fact that enantiomer separations were labour-intensive at the time the application was filed, at least for this class of compounds, was an important consideration in the Court’s finding of inventiveness. Due to advancements in the area of enantiomer separation, were a patent application claiming a specific enantiomer filed today, it would be much more difficult to establish inventiveness without some other indicia of non-obviousness.

In Merck-Frosst-Schering Pharma GP v.

Teva Canada Ltd., 2010 FC 933, the patent which claimed Merck’s drug Ezetimibe was attacked for lacking inventiveness in view of certain prior art. One of Teva’s arguments centered on the structural similarities between Ezetimibe and compound (8F) which was disclosed in a prior patent.

To arrive at Ezetimibe, a person skilled in the art would have to substitute a fluorine atom in place of a hydrogen atom, add a hydroxyl moiety, and replace a methoxy group with another fluorine atom. The skilled person would also have to address the stereochemistry of Ezetimibe. Teva argued that it was a simple ten-step process to arrive at Ezetimibe from compound 8F, each of the steps being taught or suggested in a prior patent. The Court rejected Teva’s argument stating that the ten-step process was unpredictable and therefore not obvious to try.

While the structural differences between the compounds may have been sufficient to establish inventiveness, Merck was further able to rely on teachings in the prior patent which taught away from Ezetimibe. Compound

ACROSS CANADA Figure 1:

8F, for example, had low biological activity.

Significantly, the judge also appeared willing to extend a higher threshold for a finding of obviousness due to the arduous nature of drug discovery, “[g]iven that what is being developed is a drug for human ingestion.”

In Eli Lilly Canada Inc. v. Novopharm Limited, 2010 FCA 197, the Federal Court of Appeal was asked to review a finding of non-obviousness of Eli Lilly’s antipsychotic drug, Olanzapine, in view of a prior patent which disclosed flumezapine. The two compounds differ simply by the replacement of a fluorine atom with a hydrogen atom.

Though the structural modification is minor, Olanzapine is a superior antipsychotic drug due to its lower incidence of liver enzyme elevations and lower muscle enzyme creatine phosphokinase levels. The Court found that there was simply no disclosure of the specific beneficial properties of Olanzapine in the prior patent, and therefore, the claims of the patent were held to be inventive.

Likewise, in Hoffman La Roche Limited v.

Apotex Inc., 2011 FC 875, the court found that Hoffman La Roche’s drug mycophenolate was inventive over the prior art.

Mycophenolate (MMF) is a prodrug of mycophenolic acid (MPA), which has been simply esterified with a morpholinoethyl moiety. MMF has improved bioactivity Figure 2:

compared with MPA, due to its increased solubility. Apotex argued that the addition of an ester to improve gastric solubility would have been obvious to try in view of the fact that ester derivatives of MPA were known, and that prodrugs were known to improve solubility. Hoffman La Roche relied on the fact that though many ester prodrugs of MPA were known, no ester derivative in the prior art had better activity than MPA alone. Essentially, the prior art taught away from using an ester prodrug of MPA. The Court ruled that the prior art merely showed “a possibility that an ester derivative of MPA might deliver enhanced bioavailability”, which was not sufficient to establish obviousness.

The ruling in Ratiopharm Inc. v. Pfizer Limited, 2009 FC 711 (affirmed by the Federal Court of Appeal; 2009 FCA 204) is illustrative of a drug that was found to lack inventiveness. Pfizer asserted that the selection of the besylate salt for the known drug Amlodipine was inventive because the selection of the besylate salt improved the stability of the formulation. The judge rejected Pfizer’s arguments on the basis that experimenting with different salt formulations was a “routine task”, and that “[w]hile besylate would not be everyones’ first choice, it was not an unreasonable choice”.

Also, in Bristol-Myers Squibb Canada Co. v. Apotex Inc., 2009 FC 137, the Court held

that a claim to a temperature stable crystalline form of the antibiotic cefepime hydrochloride monohydrate lacked inventiveness.

A prior patent disclosed a crystalline form of cefepime hydrochloride, but did not disclose or suggest the monohydrate. The Court reviewed the data in the patent and found that there was no unexpected benefit in using the monohydrate, and that “it is more-or-less evident that within a group having ‘excellent’ properties one member, tested once, would be better than another”.

The Supreme Court’s decision in Sanofi attempted to clarify the law with respect to obviousness. In its application, subsequent courts have stated that for an invention to be found obvious, it must be “self-evident” or “very plain”, with more than just a possibility of finding the invention in the prior art. Though the question of obviousness is largely a factual inquiry, the case law demonstrates that courts will often find non-obviousness in a pharmaceutical context, where: • there are significant structural differences between the claimed compounds and the prior art compounds; • unexpected or unknown advantages exist, even with seemingly insignificant structural alterations to prior art compounds; or • prior art which teaches away from the claimed invention.

However, where routine tests merely confirm expected properties, a finding of inventiveness is unlikely, even if the properties are unknown. Accordingly, before filing a patent application, inventors should be aware of the relevant prior art in order to focus their research on obtaining data in support of inventiveness, so that it can be argued that their invention is not merely “self-evident”.

Patricia Folkins, B.Sc., Ph.D. (Chem.) is a partner with Bereskin & Parr LLP and a registered Canadian and U.S. patent agent. She can be reached in Mississauga at 905.817.6101 or pfolkins@ bereskinparr.com.

Michael Fenwick, B.Sc., M.Sc. (Org. Chem.), LL.B. Is an associate with Bereskin & Parr LLP and a registered Canadian and U.S. patent agent.

He can be reached in Toronto at 416.957.1665 or mfenwick@bereskinparr.com.

For more TO MARKET information visit our COMMERCIALIZATION Web Portal at www.bioscienceworld.ca

October 2011 BIOTECHNOLOGY FOCUS 27

By: Mehrdad Hariri

FEATURE

CSPC 2011

A MUST ATTEND FORUM FOR PHARMA AND BIOTECH

T

he 3rd annual Canadian science policy conference (CSPC) is coming soon, this time in the nation’s capital, Ottawa, Ontario. With 17 panels and one workshop, more than 70 speakers, two receptions, an award ceremony, and hundreds of participants, CSPC 2011 is going to be the biggest event on science and innovation policy of the year. Indeed as a grassroots initiative with high level of success, CSPC in becoming the most comprehensive annual national forum on science, technology and policy issues, and has been able to change the discourse and scene of a habitually steady and relatively quiet science and innovation policy community. Science Policy community was caught off-guard in 2009, by a grassroots push from various sectors, for an urgency of a national dialogue.

This was, of course, met with a high level of support and unprecedented participation of various organizations.

Since then it seems there has been a huge level of mobilization in the research and development community which has been reflective in various national efforts such as the Equinox conference on energy, various public policy forum seminars on innovation, sciencepages initiative, which involves publishing brief notes on science issues aimed for parliamentarians and student seminars on science policy and public science website.

Finally launch of a science media centre, the state of the nation report 2010, published by Science Technology Innovation Council and the Review Board panel report on Business 28 BIOTECHNOLOGY FOCUS October 2011

R&D, to be published in October, are among the community’s excitement this year. All these are certainly helping promote a more collaborative, cohesive, and flourishing community with the prospect of establishing better cross-sector dialogue. Particularly the R&D review will open set the tone for quality discussions and reflection by industry at CSPC, which adds to the significance of this year’s science policy conference being held in Ottawa.

CSPC has established an excellent relationship with the biotechnology and life science industry. BIOTECanada has been a community partner, Biotechnology Focus as its Media Partner for the past three years. This, combined with having at least one life science sponsor and several speakers from the life science industry ensures that CSPC continues to be plugged in to this important sector.

Canadian Business Expenditure Research and Development (BERD) has been pointed as law among OECD countries. In order to have improvement in this, there is a need for active participation of industry at the national dialogue around various science and innovation policies. In fact, without an enduring dialogue among the various stakeholders, the expectation of a fully efficient and collaborative system resulting in policies tailored around an innovative environment is not realistic. A dynamic and effective innovation system will be established only when the proper channels of communications have been put into place. This requires a common language and understanding of the four sec-

tors involved in science policy: academia, government, NGOs, and the private sector.

The Canadian Science Policy Conference has been paving the way for the formation of such a network. CSPC 2011 promises to continue working towards these goals. Last year, there was a focus on life science and biotechnology. This year’s Conference has a special focus on chemistry, in recognition of this year being the international year of Chemistry. The Chemistry Institute of Canada is the driving force behind this initiative and the organizer of a plenary session in which many industry leaders will be involved as panelists, including one panelist from Pharmaceutical industry. Additionally there is a focus on private sector innovation titled: “Enabling Private Sector Innovation” which will include three panels. There will also seven panels exploring innovation with a strong private sector presence from various disciplines. Finally this year CSPC will be the host of one of Genome Canada GPS series: “Where Genomics, Public Policy and Society Meet”.

CSPC is striving to build a national dialogue across sectors on the basis of the belief that Canada deserves an annual national forum on science and innovation policy in which all players participate, provide insights and are engaged in mapping the future of the research and development community in Canada. CSPC as the most comprehensive forum on science, technology and innovation policy in Canada, and being in Ottawa this year, is well deserved even greater level of private sector participation.

CALENDAR NOVEMBER 2011 November 1-2 MEDEC 2011 MedTech Conference Venue: Toronto, ON Tel: 416-620-1915 Email: bpayne@medec.org Web: www.medec.org/en/content/medec-2011-medtech-conference

Québec Regional Spotlight Continued from page 18

Sherbrooke: proving size doesn’t matter when it comes to innovation

November 1-3 Market Access Canada 2011 Venue: Toronto, ON Tel: +44 (0) 207-375-7592 Email: lanre@eyeforpharma.com Web: www.eyeforpharma.com/macanada/index.shtml

The city of Sherbrooke represents Québec’s third largest life science cluster and while it is much smaller than its counterparts in Montréal or Québec City, it is rich in its innovative capacity.

November 7-8 Agrivulture 2.0 Global Investments Venue: Toronto, ON Tel: 1-888-670-8200 Email: reg@ibcusa.com Web: www.ibclifesciences.com/globalaginvesting/home.xml

November 8-11 ALMA Conference Venue: New Orleans, LA Tel: 505-989-4683 Email: alma@labmanagers.org Web: www.labmanagers.org

November 15 BioConnect 2011 Venue: Montréal, QC Email: bioconnect2011@gmail.com Web: www.bioconnect2011.mcgill.ca/registration.html

November 16-18 Canadian Science Policy Conference Email: info@CSPC2011.ca Web: www.CSPC2011.ca

November 16-19 Medica-World Forum for Medicine Venue: Dusseldorf, Germany Web: www.medica.de

November 28-30 Canada Renewable Fuels Summit Venue: Calgary, AB Web: www.greenfuels.org

DECEMBER 2011 December 4-6 BioPartnering China Venue: Shanghai, China Tel: 1-831-464-4230 Fax: 1-831-464-4240 Web: www.techvision.com/bpc/

Backed by Sherbrooke Innopole, the regional development organization overseeing this cluster, the city is reaching out to attract new businesses to the area.

“Our role is to promote Sherbrooke to the world as a world class life science cluster and attract companies to the city, as well working with existing local companies to help them grow and collaborate with other organizations. The vision is to make Sherbrooke a hub for innovation,” explains Josée Blachard, director, business development, Life Sciences, Sherbrooke Innopole.

For a city of its size Sherbrooke already has a lot of things going for it.

Firstly, there is a high concentration of companies and researchers that already exists in the city. In all, there are 35 life science companies that call Sherbooke home. Some of the more larger of which are Neptune Technologies and Bioressources Inc., Baxter, Charles River, and Tranzyme Pharma. According to Blanchard this sizable industry footprint provides plenty of collaborative opportunities for foreign companies interested in relocating to Sherbrooke.

The city is also home to two universities (University of Sherbrooke and Bishop’s University) that together generate more than 1,000 graduates in life science related programs.

“Sherbrooke brings many assets to the table, including experts in pharmacology, oncology, molecular imaging, genomics, metabolic diseases, diagnostics and medical technologies both in the public and private sectors. We also have a highly educated workforce, and a lot of good scientific research going on at both these institutions. It’s very easy to identify specialists, there is ample talent to choose from whether it is for recruitment or partnering purposes.”

Companies that operate in Sherbrooke also benefit from lower operating costs, and lower staff turnover. Moreover, Sherbrooke prides itself on being business friendly. In an effort to provide funds for innovative companies in start-up phases and to sweeten the pie for companies who might relocate to Sherbrooke, Sherbrooke Innopole partnered with Desjardins Innovatech to offer joint financing of up to $7 million over five years for start companies in the life science/biotech space.

“We will use this money to invest in local companies, and that number could eventually go up to $20 million if there is more demand for it. The fund is for both companies already established in Sherbrooke, or companies that wish to establish themselves here. So, that makes subsidiaries of an international company, university spin-outs or even existing biotech companies in Sherbrooke eligible for the fund,” states Blachard.

Suffice to say, all elements are firmly in place for the city to continue to support research and development in Life Sciences.

October 2011 BIOTECHNOLOGY FOCUS 29

THE LAST WORD

By John Lawson

Collaboration

or a real partnership?

C Dr John Lawson DBA, MBA,

ollaboration is a word often used in the biotechnology industry. It can mean as little as having a meeting and meaningful discussion on a subject of mutual interest with another party, or it can refer to two parties working closely together to achieve shared goals. The latter implies a much closer relationship but it is only possible when the two parties have trust in each other’s abilities and motives.

This is the basis of a true partnership. Morgan and Hunt (1994) described trust as serving a pivotal role in the commitment towards forming and maintaining a relationship.

Although in all relationships there are potential negative elements such as coercion, opportunistic behavior, conflict and potential termination costs, for a true partnership to work the positive elements of shared values, cooperation, strong communication and mutual recognition of the benefits of that relationship must dominate.

With this in mind I started to look at the relationships between the biotechnology industry, Big Pharma and the ultimate payers for the products and services that the industry generates. There is a continuum of customer intimacy that starts with strictly transactional relationships (i.e. one party sells, the other simply buys) and ends with true partnerships where each party is truly concerned that the other’s needs are being fully met. It is clear (to me, at least) that the pharmaceutical industry has an arm’s length relationship with the payer. The industry ties to maximize the price and penetration of its products. In return, the payer tries to limit its exposure by defining selected patient types for treatment and negotiating reduced prices.

30 BIOTECHNOLOGY FOCUS October 2011

The relationship is strictly transactional. At the same time, the biotechnology industry, which generally has to work in partnership with Big Pharma as their only conduit to market, inadvertently becomes an extension to those marketing efforts. Royalties to Biopharma only result if sales are generated during the patent period and this need precipitates a mutual level of urgency. This is the basis of their shared values. At the same time, Null et al (2004) reported that there were 783,936 iatrogenic deaths in the USA and around 7.5 million unnecessary surgical and medical procedures were performed. Is it not unreasonable, therefore, for the FDA and other authorities to try to perform stricter due diligence on new drugs, and for the payers to want to be sure that their money is being well spent?

So, how can the biotechnology industry tackle the situation and feed their marketing partners with the right tools that might improve this situation? My suggestion is for them to provide better diagnostic tools. When you think about it, biotechnologists already have all the right competences to make this happen. The current trend in Biopharma research is to identify cellular targets and then find small molecules or biologics to fill the gap. If the target is already known, wouldn’t it be sensible to develop a diagnostic test at the same time? Genomic profiling would be possible. This would result in the drug only being given to those patients that respond positively to the diagnostic test. Patients that are unlikely to respond, or might develop side effects, could be specifically excluded. The drug industry would get access to two patents rather than one, extending their period of exclusivity; the payer would only be paying for treating those patients that are likely to respond to the drug; fewer patients would be dying from iatrogenic causes; market access activities would be less complicated; and the regulatory authorities would have better information upon which to base their licensing decisions. At the present time physicians are compelled to give potent medications to ill patients on a suck-it-and-see basis. Let’s try to make medicine more of a science and less of an art! What a partnership opportunity!

Dr John Lawson DBA, MBA, BPharm is a business consultant with Tri:M-V Inc., a member of the BioStrategis consortium.

He assists innovative companies to define and implement their strategies. His doctoral thesis concerned the formation of partnerships and he developed a new customer intimacy model. He can be contacted on jlawson@sympatico.ca

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