Biotechnology Focus September 2013

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INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

SEPTEMBER 2013 VOLUME 16, NUMBER 7

TRANSFORMING OUR LIVES AND ECONOMY

CANADIAN BIOTECH

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contents September 2013 – VOLUME 16 – NUMBER 7

Canadian Biotech – The Path Forward

FEATURES

6 Readers respond

What you had to say in response to our latest Canadian biotech survey questions (Compiled by Daniela Fisher)

12 Canada’s awash in biofuels Opinion

9 Canadian Biotech – The Path Forward (By Wayne Schnarr)

12 Are we seeing the return of IPOs? (By Jacki Jenuth and Peter van der Velden)

15

22 IN EVERY ISSUE

18 Innovator

Q&A Dr. Mark Schaan, Director Life Sciences Branch, Industry Canada discusses industry trends, and the role of Industry Canada’s Pharmaceutical Sector Directorate (Compiled by Shawn Lawrence and Industry Canada)

Genome BC: Open for Business (By Dr. Gabe Kalmar)

18

Manitoban Bio Builder Dr. Albert Friesen (By Shawn Lawrence)

24 Across Canada

Changing the face of healthcare with High Performance Computing (By Allen Lalonde)

30 The Last Word

Biotech Innovation: the New Ecosystem (By Andrew Casey)

DEPARTMENTS 26 new products 27 Calendar of events

www.biotechnologyfocus.ca

September 2013 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S NOTE

PUBLISHER/ EDITOR-IN-CHIEF SENIOR WRITER STAFF WRITER Editorial Interns

National Biotech Week: public and private align

The countdown is on, for the biggest biotech celebration of the year. As we enter September, it’s again time to celebrate Canada’s achievements in biotech. From September 20 to 27, thousands of participants are taking part in Canada’s National Biotechnology Week.

The seven days are devoted to raising awareness for Canada’s biotech industry.

Hosted by BIOTECanada and its national accord partners, the cross Canada event will see activities being held across the country, devoted to education and networking.

The week is also important for raising awareness for an industry that is transforming Canada’s economy. We’ve been writing about the bioeconomy for many years now, as biotech applications are being used in a number of industries, including manufacturing, forestry, energy and agriculture. Collectively, our industry is working to position Canada as a leader in the emerging global bioeconomy.

An important next step, and part of what National Biotech Week is about, is getting the general public to see the potential of Canada’s bioeconomy. The more we educate people on the benefits of the life sciences, and its positive impact on our daily lives, the better we’re able to promote our industry. And with more public support, the biotech sector is better able to attract federal and provincial interest and investment.

In that regard, another crucial component of National Biotechnology Week is advocacy to government. Biotech in Canada is a diverse industry, spread across multiple sectors and provinces. And in such a diverse industry, government policy can at times be disjointed, with biotech companies running into overlapping or duplicated policy regimes, making regulatory affairs a challenging hurdle to surpass. To that end, industry and government have to work together, to create a unified public policy framework in support of Canada’s biotech sector, its products and investment.

National Biotechnology Week provides opportunity for that collaboration, and brainstorming on how to implement changes. It also gives us a chance to celebrate what’s going right in Canada’s bioeconomy, from innovations in research to bringing products to market and fulfilling unmet needs.

To see how you can participate, and for a full calendar of the exciting events happening during National Biotechnology Week, go to www.imegenenation.ca.

Happy September!

Terri Pavelic Shawn Lawrence Daniela Fisher Kayla Sippel

Anan Rahman

CONTRIBUTING WRITERS

Allen Lalonde

Andrew Casey

Jacki Jenuth

Gabe Kalmar

Peter van der Velden

National Account Manager GRAPHIC DESIGNER CONTROLLER MARKETING MANAGER

Wayne Schnarr Marcello Sukhdeo Elena Pankova John R. Jones Mary Malofy

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

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

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

4 BIOTECHNOLOGY FOCUS September 2013

CSPC 2013 HIGHLIGHTS • 30+ informative panels, 150+ speakers • Inauguration of the Awards of Excellence in Science Policy - a first in Canada • 3 Pre-Conference Workshop Symposiums Canadian Science Policy Conference

Compiled by Daniela Fisher

Readers Respond

What you had to say:

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ar seats made of soy foam, biofuels powering jets and easy-application clamps that can stop blood hemorrhaging in a matter of minutes. All are examples of the great work going on in Canada’s biotech sector and of the positive impact biotech has on our lives.

They’re also the kind of success stories that are being celebrated during Canada’s tenth National Biotechnology Week. With events scheduled across the country, National Biotechnology Week plays an important role in introducing the public to the positive aspects of biotech. It also acts as an advocate for success stories in an industry that’s still recovering four years after the global financial crisis.

Every year, in line with National Biotech Week in September, Biotechnology Focus does its part to help raise awareness for the Canadian biotech sector. In the months leading up to September, we run a Readers Respond survey, to get your feedback on what is and what isn’t going right in Canada’s biotech and life sciences sector.

6 BIOTECHNOLOGY FOCUS September 2013

Some of the questions we asked included how you felt Canada measured up on the international biotech scale, as well as what the major issues were that you wanted raised before government. Our goal was to find out what you want to change, and to generate ideas for how we can improve biotech in Canada.

To simplify things, this year we had one main survey for everyone in the life sciences field, whether on the research or business end, to fill out. Respondents ranged in sectors from drug discovery and therapeutics, to biomedical devices, diagnostics, bio-agriculture, environmental and industrial.

From your responses, a general theme emerged: Canada needs to get interested in biotech. We need to do a better job of championing our successes to the general public, as well as to investors. In an industry that’s traditionally reaching for the bucket and getting ready to bail, we need to advertise more effectively our success stories – the examples of how funding biotechs can be highlyattractive instead of highly-risky.

How does Canada’s bio-economy measure up?

First off, we asked our readers what the most compelling stories were in the biotech sector for 2013, including the biggest hits and misses. Answers varied, and many were of the opinion that 2013 has so far been a fairly dull year for biotech, especially in terms of financing. While 2012 saw a resurgence of biotech’s venture capital ecosystem, readers were quick to point out most of that money is going towards larger, well-established companies instead of start-ups or smaller companies still developing their products. So far, the largest financing announced this year has been the federal government’s $400 million Venture Capital Action Plan. Readers say this is a step in the right direction, but much more is needed in terms of government support for biotech.

In terms of ‘hit’ stories, the most mentioned were Paladin Labs’ growth and BioAmber’s $80 million IPO. Other big stories included the IPO window opening in the U.S., and Valeant Pharmaceuticals $8.7 billion acquisi-

READERS RESPOND tion of American company Bausch & Lomb.

Readers also highlighted Medicago being acquired by Mitsubishi Tanabe Pharma in a deal valued at $357 million. Concerning ‘miss’ stories, readers pointed to the ‘downgrading of the National Research Council (NRC) to a business support model,’ as well as the downturn in the pharma sector, with major products coming off patent resulting in pharmaceutical companies seeing large drops in revenue.

In answer to the question is Canada keeping pace internationally in your field, answers were divided. In all, 43 per cent of you thought that Canada was keeping up with the competition, while 57 per cent feared for our position on the global map.

As for how we can improve our position in the global bioeconomy, readers had many suggestions for making Canada more competitive. Most of you called for more money put towards basic research, as well as on the other end of the spectrum more funding for commercialization. One respondent suggested reducing the bureaucratic hold ups in public institutions such as the CIHR and NSERC, describing the process of applying for funding as ‘time-consuming and disheartening.’ Readers also wanted to see more mean-

ingful collaboration between the public and private sector. As another reader put it, the emphasis should be on “creating a Canadian science and innovation ecosystem that breaks down the silos between sectors, disciplines, levels of government, etc.” The new formula moving forward needs to be collaborative on all levels – between public and private sector as well as across the provinces.

Making Canada more welcoming to capital Here in Canada, we’re in a new normal when it comes to access to capital – or lack thereof. According to Ernst & Young’s Beyond Borders – matters of evidence report, in 2012 the amount of capital raised in Canada’s biotech industry was US $733 million.

This number was slightly lower than 2011’s US $739 million raised. As we move forward in an economy where financing is most likely to remain limited, companies need to adapt and develop a new model for the future.

Concerning the all-important question how can we make Canada more welcoming to capital, feedback favoured basic reform and increased tax incentives for investors. What Canada needs is a new investment regime to encourage biotech investment, a regime

that can foster a culture of investment, in an alternative risk-based industry. Or as one reader suggested, we need to be more risk-tolerant, creating incentives and rewards for individual wealthy investors to risk their capital into Canadian companies.

Another general theme that emerged was that investment was lagging in the biotech sector. The money is here, but not the interest to invest. In Canada, money often goes to more appealing investments, with shorter deadlines and less risk. Canadian investors need to realize that investing in biotech can help transform and strengthen Canada’s economy.

There were also calls for removing the regressive changes to the SR&ED program, and making SR&ED less restrictive, with more focus on smaller emerging companies instead of giving money to larger MNEs. Readers also wanted tax breaks for angel investors, and generally de-risking investment for venture capitalists, by getting government to assist small companies in getting to a fundable stage with initial investments.

Readers suggested that industry partner with government on investment programs, to help Canada’s large number of start-ups get off the ground.

September 2013 BIOTECHNOLOGY FOCUS 7

Readers Respond

Top priorities to get before government You had many great suggestions for what you want changed in Canada’s biotech industry. Ideas such as enhanced SR&ED tax credits and expanding IRAP were strongly favoured. Also popular was the idea of creating tax or monetary incentives for innovative R&D. There were also calls for making investment capital more easily accessible, and widening the venture capital pool. Another hot button issue – one that’s mentioned every year in our surveys – is the expansion of flow-through tax credits to investors in small biotech firms. As one reader explained, we need to “create an environment where you unlock the financial capital from risk-averse investors. We are passive investors in Canada and the incentives are a must to get them to move off their comfort zone.”

One reader cited that the CIHR grant approval rates are critically low, and that there is a disconnect between federal, provincial and local institutions. Even at the national level, the lack of coordination between the CIHR and the CRC (Canada Research Chair) programs was pointed out, and flagged as a problem in the recent international site review of the CIHR: “It behooves the federal government to step in and somehow moderate local hiring practices, as the country is currently training and hiring more research scientists than it is actually willing to fund operationally. This is very inefficient and demoralizing for many in the field. The recently announced changes to CIHR grant review procedures do NOT really address this problem and should not be thought of as an improvement in that sense.”

Readers wanted better coordination between government entities, such as the federal Department of Foreign Affairs, Trade and Development (DFAIT) and Health Canada, with the various provincial health ministries, saying they are too silo’d and need to better work together, to better create jobs and drive our economy.

In terms of what Canada’s government is doing right, answers point to some of the life science clusters, as well as life science incubators, as a way to foster innovation.

You sang the praises of SR&EDs and IRAP, saying that while they might need some tweaking, they’re still an example of the one thing government is doing right, along with continued support for academic research.

Regions that you identified as doing a lot of 8 BIOTECHNOLOGY FOCUS September 2013

Whether it’s in the healthcare, biopharmaceutical, agriculture or clean tech field, Canada’s public and private sectors are doing their best to compete on the global stage. From the results of this survey, it’s clear that biotechnology does have an important role to play in our daily lives as well as our future.

things right in biotech included the U.S. and Israel for their governments’ emphasis on R&D in small companies. You also pointed to China and again the U.S. for investing the majority of their capital in their own economies, as well as the innovation going on in Holland’s medical development sector. Also mentioned were Germany, Boston, New Zealand and Finland for their innovation and financing systems. Regions within Canada that got the thumbs up included Sarnia for its bio-based chemicals cluster, and Québec for leading the reinvesting-in-biotech charge.

Getting the public involved Along with improving our venture capital system, raising public awareness of biotech can help send funding towards the life sciences. And if you can get public support, you just might be able to attract government funding as well. The general public needs to learn more about the useful applications of biotechnology, and how biotech is

transforming our every day lives. In turn, scientists and researchers need to learn how to present their discoveries to the public in a non-threatening way, talking about the benefits as well as firmly outlining the potential risks and benefits. By having a more open dialogue, the hope is to increase public awareness of biotech.

To that end, we posed the question to readers what would you tell the public about the potential of biotech on a larger scale. Answers were unanimous: biotechnology has the potential to affect all of us in positive ways. Or as one reader explained, “we are on the cusp of a new age of controlling and directing naturallyoccurring organic materials and molecules, to drive the next wave of the industrial revolution.”

In broad strokes, biotechnology has the potential to create jobs, a healthier society, a cleaner environment and a sustainable future. On this note, Canada’s bio-agriculture sector has a large role to play in helping sustain our future.

Readers suggest that as we face the inevitable effects of climate change, as well as an expanding and increasingly affluent global population, biotech’s role in food production is especially important for the future: “Traditional crop breeding procedures probably will not be able to work quickly enough to improve or modify plant growth properties in the face of continued general warming of Canada. This cannot be left purely to the private sector which probably cannot take an adequately long-term view.”

Whether it’s in the healthcare, biopharmaceutical, agriculture or clean tech field, Canada’s public and private sectors are doing their best to compete on the global stage.

From the results of this survey, it’s clear that biotechnology does have an important role to play in our daily lives as well as our future.

Canada’s biotech industry is doing its best to compete globally. To this end, we all have to work together to advance innovation in biotech and the life sciences. This includes attending National Biotechnology Week, which runs from September 20 to 27. We hope you join us in celebrating Canada’s biotech sector.

To see this story online visit http://biotechnologyfocus. ca/?p=8669

by: Wayne Schnarr

INDUSTRY ANALYSIS

canadian biotech – the path forward

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anadian biotech cannot return to the good old days because its old business environment is gone.

Capital markets, global healthcare systems and the pharmaceutical industry now live with the daily change and volatility that have always been part of biotech. There are good times in the future for Canadian biotech, although they will look substantially different from the good old days. Canadian biotech must now chart a path forward to those good times.

Most Canadian biotech companies focus on healthcare and the companies developing novel therapeutics get the majority of the attention and funding. Using a sports analogy, these companies are realistically part of the farm team system for the pharmaceutical industry and their future is dependent upon the success of the international pharmaceuti-

cal industry. While some may think that the pharmaceutical industry controls its own fate, its future is in turn dependent upon the ability and increasingly, the willingness of the global healthcare systems to pay for the new drugs which sustain the pharmaceutical industry.

Global healthcare systems are adjusting to financial constraints which may continue for many years. While they will attempt to increase funding, their real focus is on controlling expenses in three broad areas – wages, facilities and consumables (including drugs). In many nations, Canada included, politicians focused on the next election are rarely willing to fight in public with healthcare professionals about salary, scope-ofwork and staffing levels, while the opening of new hospitals are merely great photo-ops for election advertising. As a result, the cost containment focus becomes restrictions on

services and consumables. Rational reform to create a more efficient and effective system seems almost hopeless when all participants adopt narrow self-interest positions.

The drug purchasing process has generally been a one-way ‘seller pushing’ process, with pricing being whatever the market will bear. Imagine the following scenario with a ‘buyer pulling’ process. Healthcare systems decide that for five years they will not buy any new drugs (with some exceptions), but will actually run studies to determine how to properly use and define the clinical benefit derived from the huge basket of currently approved drugs. Once the unmet therapeutic needs have been defined and prioritized, the healthcare systems will then say to the pharmaceutical companies that they will pay reasonable prices for new drugs for the following medical conditions which provide a September 2013 BIOTECHNOLOGY FOCUS 9

Industry Analysis

clinical benefit that reaches a specific hurdle rate. It is highly unlikely that a scenario this broad and extreme will ever occur, but payers in a growing number of countries are now refusing to reimburse new drugs which do not pass a cost-benefit assessment.

The pharmaceutical industry is dominated by publicly-traded international companies.

As with similar companies in many other industries, the primary focus of the C-level management and directors of a pharmaceutical company is the sustainability and growth of the share price and the dividend.

Consider the following numbers from the

is full when you consider that the pipeline includes the products under development at thousands of smaller companies, universities and research institutes, which they can license or buy as needed.

The path forward for biotech has to consider the unmet medical needs of the healthcare systems. This should not be a factor in funding basic academic research. However, at the stages of applied research, product development and company formation, the unmet needs defined by the healthcare system must be considered. Investors would be unwise to fund the development of products

Figure 1

Stock repurchases

US$8.2 billion

R&D

US$7.9 billion

Dividends

US$6.5 billion

Pfizer 2012 annual financial statements (shown in Figure 1), which are used strictly to illustrate an industry trend.

Pharma companies as a group have cut staff and expenses, increased prices, bought and sold product lines and acquired other companies and products in response to the recent patent cliff decimation of the sales of their lead products. I believe that the global pharmaceutical industry has already successfully adapted to this major challenge. While there may be pipeline gaps at individual companies, the industry pipeline 10 BIOTECHNOLOGY FOCUS September 2013

for which there are no buyers.

The path forward for biotech also has to consider the unmet portfolio needs of the senior pharma companies, who will be major investors, partners and buyers. Most novel therapeutic products will fail during preclinical or clinical development. For those few clinical successes, investors have to ensure that they will also be market successes so there will be multiple pharma buyers.

Where does Canada fit in the global pharmaceutical industry? Canada’s pharmaceutical sales are about 2.5 per cent of the global

total, which ranks Canada eighth among individual countries. This ranking is likely to decline as developing nations spend more on healthcare. There are no head offices of international R&D pharma companies in Canada. Valeant Pharmaceuticals has a Canadian head office for tax purposes, but its key management is in the U.S. and its R&D expenditures in 2012 were only US$79 million. There are also no Canadian R&Dbased companies with billion dollar market caps that currently have the valuable ‘acquire or be acquired’ options. Several companies have failed to make this transition after an initial successful product development when internal pipelines failed (BioChem Pharma), acquisitions did not work (QLT, Angiotech) or sales of an approved product were insufficient to support growth (Cardiome, Theratechnologies).

My vision of a successful Canadian biotech sector is a continuously evolving pyramid of technologies and companies. The base of the pyramid is comprised of the academic research programs, which have to be adequately funded by government or the whole pyramid collapses. The potential commercial technologies and products are the next level of the pyramid, which is where nongovernment investment starts. Each successively higher level of the pyramid will be one step closer to commercialization and involve greater non-government investment.

To have companies reach the top of the Canadian biotech pyramid would take an incredible combination of a major successful product, patient investors, timing and luck.

Reaching the top is not protection against pipeline or acquisition failures, or being acquired. An important benefit for the sector would be the attention these successful companies would attract from potential investors.

However, I don’t think we need a company at the top in order to have a successful Canadian biotech sector. I think a successful industry would have a continuous flow of technologies, products and companies

INDUSTRY ANALYSIS

moving up this pyramid, with an appropriate balance of successes and failures.

A successful Canadian biotech sector does need adequate funding, which I am convinced is available. However, asking for funding from the same potential sources in the same way that has been unsuccessful in the last few years is sure to lead to failure. Instead of saying ‘I need $X million’ to potential investors, maybe companies and bankers need to ask investors ‘what types of products, companies and risk profiles would you like to see.’

No pharma company, stock analyst or fund manager can consistently pick the winners in biotech. The high failure rate requires a disciplined approach to product development, which was absent during the 2000 biotech boom when funding was handed out without performance criteria and a surplus of corporate infrastructure was created for what should have been academic research.

Most funding is now tranched, with defined measures of success before the next tranche is distributed. Major investors in private companies and boards of public companies have to be prepared to say ‘stop when a program is unlikely to succeed within acceptable budgets and timelines.’

The high failure rate and probable acquisition of the successes creates a management and staffing problem. The concept of the serial entrepreneur may be valid at well-paid C-level positions, but staff at the lower levels

would like some job security rather than searching for new jobs every two to five years. Combined with the difficult funding climate, creation of virtual companies for product development is essential. This concept requires a core group of highly skilled professionals who will design the strategy and manage the contract services. The result would see stable employment at contract services companies with multiple clients.

There are other important pyramids in the Canadian healthcare sector, including ones for specialty pharma, medical devices and diagnostics, and healthcare services.

The base for the specialty pharma pyramid is very diverse, and includes drug delivery technologies and niche products. This pyramid actually has a company at its apex, Paladin Labs, which is profitable, wellfinanced and has many growth options. This pyramid also has companies that are part of the technology base (IntelliPharmaCeutics), some which have moved up over the years (Cipher Pharmaceuticals) and some which have failed during that climb (Labopharm).

A valuable tool in assessing the path forward would be an honest SWOT analysis of the Canadian biotech sector and one for the broader healthcare sector. An honest analysis is not simply a list of all the biotech assets in Canada, but rather, includes an assessment of their quality and whether or not there is the critical mass to be competitive. An honest assessment should also be

free of political and scientific bias, perhaps too much to expect when government will be paying for the study. Because the pharmaceutical industry is constantly changing, any SWOT analysis must be regularly updated for the analysis to be useful in crafting government policy.

I believe there are good times ahead for Canadian biotech if it adjusts to its new business environment. Scientific discoveries are made in Canada on a daily basis that could impact the delivery of healthcare. However, once a scientific discovery is made, product development is a series of business decisions guided by science and the regulatory process. Quality and innovation in those business decisions will be the key factor in the future success of Canadian biotech.

Wayne Schnarr is a mostly-retired healthcare consultant with over 30 years of experience in the biotech and financial industries. He is currently an advisor to Bloom Burton & Co. and TMX Equicom.

The opinions expressed in this article are strictly personal and do not reflect the opinions of any current or past employers or consulting clients.

To see this story online visit http://biotechnologyfocus. ca/?p=8672

The Voice of

Life Sciences

in Ontario

Life Sciences Ontario (LSO) is a member-driven organization that represents and promotes the province's vibrant and diverse life sciences sector. LSO collaborates with governments, academia, industry and other life science organizations in Ontario, across Canada, and globally to promote and encourage commercial success throughout this diverse sector.

Strengthening our industry through: • • • • • •

Advocacy & Policy Development Facilitating Economic Development Networking & Education Mentorship & Professional Development Marketing & Promotion Representing Ontario’s Life Sciences industry in key partnerships

Are you on the Map??

Ontario Life Sciences Asset Map is an interactive online directory of life sciences organizations across the province visit www.lifesciencesontario.ca

"Diversity of Members, Unity of Voice”

For more information on becoming an LSO Member or Partner, please contact us: admin@lifesciencesontario.ca

P: 416-426-7293

109-1 Concorde Gate, Toronto ON M3C 3N6

www.lifesciencesontario.ca September 2013 BIOTECHNOLOGY FOCUS 11

by Jacki Jenuth and peter van der Velden

PUBLIc MARkETS

are we seeing

the return of ipos?

The big story for the first half of the year has been the opening of an IPO window for the biotech industry.

12 BIOTECHNOLOGY FOCUS September 2013

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fter a dry spell of nearly five years, more money was raised in the first half of this year than in any one year since 2007. For the first half of the year, nearly $1.4 billion was raised by 14 companies. If the second half of the year is anything like the first, we’re looking at the best market for IPOs in over a decade! (see Figure 1).

So, of course we have to ask: a) what fac-

tors are driving this? b) who is investing? c) what type of companies are getting funded? and d) what if anything does this mean for the industry overall?

The answer to the first question is multifaceted. The first part is simply pent up demand. There have been a great number of really good companies formed during the past six years (funded mainly by VCs), that have not yet achieved liquidity via acquisition (for the most part by design) and that until recently had not been able to access the public markets. Secondly, on the buyer side there has been a lot of good news to support increased participation in the sector. On the regulatory front there were 39 new drugs approved in the U.S. in 2012, the most in over 16 years. The public biotech sector along with the IPOs that have priced over the past several years have performed well for investors with the sector up 27 per cent this past year.

The biotech sector has outperformed the broader NASDAQ by a whopping 11 per cent (27 per cent vs. 16 per cent) and since 2011 the NASDAQ biotechnology index has increased 88 per cent vs. a paltry 29 per cent for the S&P. Finally, many earlystage public companies have proven to be good acquisition targets for large pharma and biotech, providing investors with outsized returns. Examples include the recent acquisitions of Optimer and Trius by Cubist (both north of $800 million), AstraZeneca acquiring Omthera Pharmaceuticals for up to $443 million just three months after going public, and larger deals over the past couple of years including Gilead’s purchase of Pharmasset for $11 billion.

Responding to this performance we have seen the mix of investors change substantially. A few years ago, the IPO call list was pretty short and really only populated with a few highly focused healthcare specific investors (in the high single digits). Today, there are many more investors participating in IPOs that are getting completed and included in this group, a far greater number of generalists as they look to catch the biotech wave.

As to who is getting funded, it is pretty clear that overall, the industry has learned from the early 2000s how to be much more selective. Of those companies that have successfully passed through the IPO window, the most common characteristic seems to be that they have significant partnerships with corporate partners. Virtually continued on page 14

by Ontario Genomics Institute

ScInTELLIGEncE:

Helping industry tap into life science solutions

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ompanies in a variety of sectors are facing increased economic, social and regulatory pressures. Businesses need to stay ahead of the curve in order to be competitive. Governments are frequently evaluating regulatory requirements to support improved safety and sustainability. Increased competition has made buyers more selective about the products they purchase, where and how they are produced, and how they impact the environment and society.

Life science technologies represent a significant opportunity for various sectors to find solutions to the challenges they face. Life science solutions can optimize business processes to save time and money, while improving sustainability and corporate responsibility.

However, in many industries there is a lack of awareness about how life science solutions can optimize business processes.

Scintelligence, a new division of the Ontario Genomics Institute, is helping industry tap

into the potential of life sciences. This team of business development experts works directly with industry, academia and other key stakeholders, bringing prospective partners together to transform challenges into opportunities and outcomes.

Scintelligence is currently working in three major sectors: agriculture, natural resources including mining, water and forestry, and health and informatics. In agriculture, life science technologies can accelerate crop and animal yield, increase nutritional value and food quality, make products more resistant to disease, drought and temperature, detect invasive pathogens, insects and weeds, and improve sustainability, safety and food traceability. Life science advances can pinpoint the cause of disease and improve human health by developing targeted therapeutics tailored to genetic profiles, outline actions to treat or prevent illnesses, and use health informatics to understand population-wide trends or

enhance daily physician-patient interactions.

Life sciences could also increase the sustainability of our natural resources and improve our environment. Understanding biological processes could increase yield, lessen environmental impact, and mitigate risks such as invasive species in forestry, acid mine drainage in mining, and remediate water contamination. Ultimately, life science solutions can save companies money, improve regulatory compliance and enhance corporate social responsibility and consumer confidence.

Scintelligence’s network of hundreds of life science resources in Ontario and globally has resulted in numerous spin-out companies, hundreds of jobs, millions of dollars in revenue and countless successful partnerships. These free services are supported by the province of Ontario and the federal government.

For more information visit www.scintelligence.ca.

Connecting you.

Scintelligence works in a variety of sectors, bringing prospective industry and academic partners together to transform challenges into ideas and outcomes.

Learn more about how we can help your business: www.scintelligence.ca Scintelligence is a division of the Ontario Genomics Institute

September 2013 BIOTECHNOLOGY FOCUS 13

Public Markets Figure 1: IPO Proceeds. U.S. Venture Backed Life Science Companies

From the Canadian perspective, all this activity is still mainly south of the border and as such means little to the life sciences ecosystem here. The majority of companies we see in the Canadian ecosystem are at a stage where they are still focusing on establishing relationships with industry partners and attempting to attract capital from investors with deep domain knowledge. Having said that, there are probably a couple dozen companies that will be able to benefit from this re-emergence of biotech investing. We suspect that the majority of these companies will not be private companies looking to transition to the public markets, but rather a handful of public companies that have gone through the process of getting their houses in order. This includes strengthening management teams, cleaning up capital structures, consolidating intellectual property portfolios, having reasonable valuations and articulating clean value milestones for the capital they are seeking to raise from new investors. If these companies are successful, then hopefully the next generation of private Canadian companies will enjoy the same access to the public markets as their peers south of the border at some point in the future.

continued from page 12 all of the recent IPO candidates had at least one meaningful partnership and many had multiple high value partnerships (one of the characteristics that probably made them better IPO candidates than acquisition targets at the current time). These partners are important as they provide investors not only with the comfort that these industry partners who fully understand the risk are willing to ante up, they also signal to investors that these companies are not “desperate” and that the IPO is not a last stand for survival cash. In fact, many of the companies that have completed IPOs this year have come to the market with surprisingly strong balance sheets. These corporate partnerships have been especially important for earlier stage companies such as Epizyme which had previously closed a deal with Celgene receiving $65 million upfront to develop its early stage pipeline.

What does this activity mean for the industry? Well thankfully it appears that the days when companies with poor products or platforms could be funded are gone. It also appears the recent changes in the rules for marketing companies to investors as a result of the JOBS act is having the desired effect. Companies are now able to pre-file in the U.S. allowing additional time for companies to meet and build deeper relationships with investors over multiple meetings while at the same time allowing investors to complete more thorough and thoughtful due-diligence processes. Our sense is that this window is likely to remain open until at least the end of the year with many high quality companies still in the queue. Hav14 BIOTECHNOLOGY FOCUS September 2013

These corporate partnerships have been especially important for earlier stage companies such as Epizyme which had previously closed a deal with Celgene receiving $65 million upfront to develop its early stage pipeline.

ing said that, the window will eventually close at some point. The only question is whether it will be a function of investors’ appetite simply becoming satiated, too many second tier offerings beginning to enter the process or some other unforeseen trigger arising. In the meantime we believe that the recent activity will place some pressure on pricing for pharma looking to partner or outright acquire biotech companies. This in turn will benefit investors and entrepreneurs.

Jacki Jenuth is a principal and key member of the senior management team with Lumira Capital.

Peter van der Velden is the Managing General Partner at Lumira Capital and President of Canada’s Venture Capital and Private Equity Association.

To see this story online visit http://biotechnologyfocus. ca/?p=8676

Compiled by Shawn Lawrence

Industry Canada

Q&A

with

Mark Schaan, Director of Industry Canada’s Pharmaceutical Sector Directorate

1.

Photo: Blair Gable

What is the Pharmaceutical Sector Directorate, Manufacturing and Life Sciences Branch and what is its mandate?

Industry Canada’s mandate is to help make Canadian industry more productive and competitive in the global economy, thus improving the economic and social well-being of Canadians. More specifically, the Department works to ensure that the Canadian market is efficient and competitive; that science and technology, knowledge, and innovation are effective drivers of a strong Canadian economy; and that competitive businesses are drivers of sustainable wealth creation.

Within this, the Pharmaceutical Sector Directorate (PSD) provides industry analysis and policy advice to encourage innovation and to increase the competitiveness of Canada’s life science industry. In particular, PSD contributes to policies to advance commercialization for life science products and therapies and to retain and grow the life sciences footprint in Canada, including manufacturing, partnerships with academia and research centres, research and development, and small-and-medium-sized enterprises (SMEs).

2.

Tell us a bit about your role as director, pharmaceutical sector directorate, manufacturing and life sciences branch?

PSD works with other groups within Industry Canada, with other federal departments, and with provincial governments on issues that affect the sector. We aim to be the centre of expertise on the industry in Canada, working to understand both global and domestic trends and their implications for industry in order to provide strategic advice to government on sectoral and industrial policies.

Our position within the Manufacturing and Life Sciences Branch (MLSB) provides a unique platform for us to understand the linkages between life sciences and other industries. The breadth of MLSB’s scope, including steel, aluminum, machinery and equipment, pharmaceuticals, medical devices, business services, textiles, apparel, consumer products and emerging technologies, allows us to understand the shared opportunities and challenges between our sector and others.

As well, we help drive a policy agenda that broadly supports general industrial competitiveness, including work on global value chains, and supports for commercialization.

3.

Is it wrong to assume your function is somewhat like a go-between for government and industry?

As public servants, one of our core roles is to provide professional, candid and frank advice to political decision-makers. This requires significant outreach to industry and other stakeholders in order to be informed and knowledgeable on the wide purview of sectoral issues – everything from overall industry trends to the technicalities of the impact of a specific regulation. We work September 2013 BIOTECHNOLOGY FOCUS 15

Industry Canada The study finds that successful firms need to consistently have an innovation that can be put into practice, is patentable, has a commercial market, and is something for which someone is willing to pay.

closely with colleagues within the Department, and within the broader Government arena to understand how their policy work will impact the industry and to identify areas to use policy levers to meet broader policy goals while also stimulating growth of this important sector.

4.

What are some of the key issues industry wants to get before government? Likewise what are some of the productivity and competitiveness issues facing the Canadian life sciences sector?

The sector has been undergoing a significant transition, both worldwide and in Canada.

Each sub-sector within the larger life sciences industry is facing unique shifts: declining research and development productivity and the “patent cliff” hitting innovative pharmaceutical firms; a new pricing model and increasing complexity in product development for generics; and a continued challenge in accessing financing and increased selectivity in pursuing new drug candidates for small and medium-sized enterprises. At the same time, there is an increased focus on safety and quality from regulators, cost-containment on the part of drug plans, increased complexity in the science of new medicines, and a growing focus on emerging markets.

This has placed an increased emphasis on partnerships across the sector – whether with small firms on product development, with academia on research, or with contract service providers in looking for new models for innovation and manufacturing.

As a result, the competition for investment is even greater, highlighting the need for Canada to remain internationally competitive.

This shift and its implications for Canada is an issue industry has worked hard to articulate to the Government of Canada. This includes highlighting the changing nature of R&D, the importance of partnerships with Canadian institutions and firms, the growing nature of the contract manufacturing and contract research sector, the continued importance of venture capital and early-stage financing, and the role of intellectual property in shaping business decisions.

All of these issues speak to the changes 16 BIOTECHNOLOGY FOCUS September 2013

underway in life sciences and the shared effort to position Canada for success in new and emerging business models.

5.

Part of your mandate has been improving conditions for investment and innovation performance in the sector, are we on the right path? What needs to happen to get there?

Guided by the 2007 Science and Technology (S&T) Strategy, the government has taken action through successive budgets to support knowledge creation, develop and attract top talent, and promote business innovation. In fact, since 2006, more than $9 billion in new resources has been committed to support science, technology and the growth of innovative firms. These investments keep the Canadian economy strong, create high-quality jobs and ensure that Canada is a premier destination for the world’s brightest minds and leading companies. However, while Canada is now globally recognized for its research excellence, there remains great opportunity for growth in productivity, private sector investment in R&D and the commercialization of new products and services.

In light of this, and informed by the Review of Federal Support to Research and Development (Jenkins Panel), the federal government has shifted its business innovation approach to one that emphasizes demand-driven initiatives and the growth of innovative firms, including those in the life sciences sector. The government is doing that by doubling support for SMEs through the National Research Council of Canada’s (NRC) Industrial Research Assistance Program and by using procurement to build demand for innovative products and services. The government is supporting access to venture capital by investing $250 million to establish private-sector-led national funds of funds, $60 million to support business incubators and accelerators, and a further $100 million through the Business Development Bank of Canada (BDC) to invest in firms graduating from business accelerators. The government is also deepening partnerships by transforming the NRC into a business-oriented research and technology organization, creating a new

credit notes program to help SMEs access research and business development services, and establishing a concierge service to ensure businesses can easily access federal innovation support programs.

In essence, the path to innovation success is about setting the right conditions for the growth of Canadian companies and helping them bring new ideas to market. Recognizing the efforts of competing countries to grow knowledge-based economies, our strategy involves optimizing federal investments, facilitating partnerships, and targeting areas of strength and opportunity. The focus is on finding ways to further incent the private-sector to drive innovation and growth.

In doing so, we will continue to work with Canada’s life sciences sector to improve its global competitiveness.

6.

The PSD-MLSB has published several reports and case studies with examples of international best practices. What findings did you make that might serve as examples for how to do things here in Canada? i.e. International Patent Strategies for Biopharmaceutical SMEs in Canada. Can you expand on some of the messages in these reports, i.e. recommendations, or some of the key findings?

Industry Canada

to align Canada’s specialities with the needs of emerging markets, the rich capacities of Canadian scientific centres of excellence, the diverse and solid manufacturing footprint Canada retains in phamaceuticals, and the niche areas where Canada may have a comparative advantage for new investments.

All of this underscores the changing business model and its driving trends are offering opportunities for the pharmaceutical industry in Canada. We continue to factor these findings into our work with firms and on policy files that impact the sector.

7.

In November 2012, at the OBIO AGM you made the statement that Canada is now a mature pharmaceutical market, can you expand on this thought?

It simply means that Canada is a developed economy with a lucrative and well-established pharmaceutical market.

8.

The Directorate aims to be a centre of expertise on the life sciences sector. To do that, we’ve continued to pursue research and analysis that broadens our understanding of the actual operations of the sectors and the trends that are emerging.

Our study on International Patent Strategies for Biopharmaceutical SMEs in Canada, for which we partnered with a leading Intellectual Property (IP) firm, underscored the importance of appropriate patent protection in companies’ success.

The study finds that successful firms need to consistently have an innovation that can be put into practice, is patentable, has a commercial market, and is something for which someone is willing to pay. Successful patent strategies require management in their formation and execution, seek to find consistent alignment between the patent strategy and the business strategy, ensure rigour in cost control, and anticipate answers to difficult questions from potential investors and partners.

At a roundtable with industry in January 2013, a group of leading analysts from across the life sciences sector outlined a number of key trends, including the growing importance of biologics and biosimilars, the opportunities

Firms are exploring new ways to increase revenues and de-risk drug development, including increasing collaborations, can you comment on this? For example, at the OBIO AGM you also spoke about partnerships and acquisitions as well as the growing number of multinational enterprise (MNE)-led venture capital funds, is this a trend that has continued in 2013?

As indicated earlier, the pharmaceutical sector is experiencing rapid change in the face of emerging global trends. Globally, pharmaceutical R&D productivity has been in decline with fewer and fewer new molecular entities coming to market and receiving approval compared to 10 years ago. Declining research productivity has led to thinning product pipelines and has necessitated a solid rethink of the pharmaceutical R&D model of many large firms. Many analysts indicate that large pharmaceutical companies can no longer rely on the traditional business model where major blockbuster drugs were developed and manufactured in large in-house facilities. In order to de-risk drug development, improve productivity and increase revenues, pharmaceutical firms are increasingly moving away from the vertically integrated model and adopting new strategies focused on diversification, open innovation, R&D networks, risk-sharing partnerships and outsourcing.

While large pharmaceutical companies have adopted various approaches to R&D in this new model, firms are increasingly

looking at external partners including biopharmaceutical SMEs for new sources of innovation. They are creating formal divisions that can directly partner with external collaborators at a very early development stage, and creating translational research partnerships with academia to bridge the gap between scientific discovery and the delivery of promising candidates to the pharmaceutical MNE pipeline.

This has led to a number of large pharmaceutical firms developing research and commercialization partnerships through the support of the Networks of Centres of Excellence suite of programming, an initiative of the three federal granting councils: the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council (NSERC) of Canada and the Social Sciences and Humanities Research Council of Canada (SSHRC). For example, the Québec Consortium for Drug Discovery, a Business-Led Network of Centres of Excellence, has worked with firms to develop research platforms to aid drug discovery. Similarly, the Centre for Drug Research and Development (CDRD), a Centre of Excellence for the Commercialization of Research (CECR), supports partnerships in the development of particular technologies and therapies. In addition to these programs, pharmaceutical companies have also made a number of investments in Canada’s academic sector including in basic research by funding research chairs in universities and projects in institutions such as the Montreal Heart Institute.

While large pharmaceutical firms have a long history of partnering with Canadian biopharmaceutical SMEs, they are also starting to participate in venture capital funds within Canada as another means to more easily access R&D opportunities in Canada.

Outsourcing has also led to considerable growth of the contract service provider subsector, including opportunities for contract manufacturing and services related to all forms of research, including clinical trials.

All of this highlights the unique opportunities these trends hold for Canada in all subsectors of the broader life sciences industry.

To see this story online visit http://biotechnologyfocus. ca/?p=8679

September 2013 BIOTECHNOLOGY FOCUS 17

By Shawn Lawrence

INNOVATOR

Former Canadian Minister of State for Science and Technology Gary Goodyear, presents Dr. Albert Friesen with the Gold Leaf award for INDUSTRY LEADERSHIP at Bio 2013 held in Chicago, IL .

manitoBa’S Bio BuilDer

Dr. Albert Friesen: A Legacy of Leadership

M

anitoban bio-entrepreneur Dr. Albert Friesen has devoted his entire career to building the biotechnology sector in both the province of Manitoba and by extension Canada. With more than 40 years of experience in the industry, Dr. Friesen’s name is linked to some of Canada’s biggest biotech success stories, among them, the creation of Canada’s first profitable biotech company ABI Biotechnology (now Apotex Fermentation), and playing a prominent role in the development of Canada’s first biotech product WinRho®. Moreover, Dr. Friesen has been an advocate for the industry, both at the regional and

18 BIOTECHNOLOGY FOCUS September 2013

national level, co-chairing the Manitoba Innovation Council and serving as a member of the Premier’s Economic Advisory Council in Manitoba.

On the national stage, he was instrumental in the launch of the Industrial Biotechnology Association of Canada, now BIOTECanada in 1986, where he served as chair and founding director.

Over the course of his career, he has also founded or co-founded numerous other bio-ventures, including Novopharm Biotech Inc., Genesys Pharma Inc. and KAM Scientific Inc. In all, some 16 life science companies owe their existence to Dr. Friesen.

He is in every sense of the term a pioneer on the national biotech stage and few can match his many achievements or the impact he has had as a builder for the sector.

“In a way I’ve always had that entrepreneurial spirit, creating and growing companies is something I’ve always been comfortable with and liked doing,” says Dr. Friesen. “As an entrepreneur, you’re

the one putting in the hard work, taking the risks, doing the things needed to grow the business from the ground up, planning ahead and simply trying to achieve success.”

Dr. Friesen found his way to the entrepreneurial life in a unique way. The seeds of his entrepreneurial spirit were sowed many years before, not in the lab or an academic setting, but rather, as a teenager on his family’s farm.

“I was born and raised in Kane, Manitoba, a very small town. There were six kids in our family — three boys, three girls. My father had a unique way of teaching my siblings and I the value of money and hard work, the farmer’s mentality so-to-speak. When I was 10-years-old, he gave each of us the income from an acre of land as our allowance and we had to learn to manage that allowance for the entire year. In farming you live from year-to-year, you rely on weather and nature to succeed. So, there’s obviously risk involved, and a need to plan ahead and work hard. I discovered much later that biotech had similarities in that it is high risk and there are cycles of good years and bad. To be successful one has to manage the successes of

INNOVATOR

making the most of an opportunity. It was a new and exciting venture and one that would reward me tremendously going forward.”

Taking on the role of president of the company, he oversaw the development of an Rh immune globulin and eventually the creation of what would be Canada’s first biotech product, WinRho®. Today, the product is used in hospitals all over the world.

“It’s quite exhilarating for me to have been able to use the chemistry and bio information which I had, to develop a drug which actually prevents an important disease.

Young people today aren’t even aware of the disease and kind of take for granted that we now have prevention for it.”

Dr. Friesen is equally as proud of the fact that he was able to run the company (which eventually became Cangene) for 20 years, and that he achieved such business success without an MBA. “Like many other scientists who find themselves in a similar position, I was tasked with learning the business side of things on the fly, and I have to say I enjoyed it, trying to understand the business and marketing side of things.” the good years to be able to sustain the lean years. So you have to learn to manage your money and assets over the long term and to plan for unforeseen circumstances. You’re in it for the long haul, just like biotech where it takes typically 13 years to develop a drug.”

Tragically, his father passed away in a farming accident when he was just 17. At that point, the lessons he had learned grew all the more meaningful as the responsibilities of looking after the farm fell to the children, which included his brother, brother-in-law and him. They were lessons he never forgot, and they shaped the rest of his life.

WinRho®: A landmark discovery in Canadian biotech The next life altering event in Dr. Friesen’s life came not long after, when in his Grade 11 year he found he enjoyed chemistry.

“As of then, I knew I wanted to be a chemist, so I took the necessary steps and it wasn’t long (six years) before I found myself working on my PhD in protein chemistry, trying to understand the biological impact of the chemical structure of proteins.”

Like his choice to be a chemist, the realization that he wanted to become an entrepreneur came not long after, when two physicians (one being Dr. Bruce Chown) came into his lab and expressed that they were looking for a new way of making a Rh antibody, a product that prevented Rh disease, or the destruction of fetal red-blood cells, in newborns.

“At the time, if an expectant mother was Rh negative, and the father was Rh positive, the baby could be Rh positive and this was quite a concern for couples getting married.

In fact, many couples were being blood typed to see whether they were even Rh compatible. So to do the research, they felt they needed a protein chemist and a lab to do the research, and so Dr. Chown asked me to get involved. I was a year or so into my PhD, and it was a tremendous opportunity.”

In 1971 he became the first employee of the Winnipeg Rh Institute.

“Although non-profit originally, it was operated like a business. As such, I was involved in the research, but also managing the business. I was 23-years-old, simply

Serial entrepreneur Today, Dr. Friesen serves as president of Genesys Venture Inc. (GVI), a company he founded which provides the expertise for launching and managing emerging health and biotechnology ventures. The GVI concept he explains is that it acts as a technology-based business incubator, developing a partnership with the technology holders and/or investors and provide an avenue for researchers and entrepreneurs to build successful start-up companies.

“The idea behind GVI came about as a result of the experience I had with WinRho® and other start-ups and the fact that I was frequently asked to help researchers try to commercialize their discoveries. So, I formed GVI in the mid-90s as a business. How it works, for example, is a scientist comes to me and says I’ve got an idea to cure cancer, or some other disease, or they might have an idea for a great new technology. If we (the GVI team) like the idea, we take the next steps and actually form a company. In doing so we fund the company and manage all of its development as the business accelerator.”

September 2013 BIOTECHNOLOGY FOCUS 19

INNOVATOR

“It’s quite exhilarating for me to have been able to use the chemistry and bio information which I had, to develop a drug which actually prevents an important disease. Young people today aren’t even aware of the disease and kind of take for granted that we now have prevention for it.”

— Dr. Albert Friesen

In addition to incubation, GVI provides consulting services to industry and public organizations on issues related to health technology and bio-industry development.

He estimates that GVI has been responsible for the creation of a number of life science companies in Manitoba.

One such company is Medicure Inc., a Winnipeg-based cardiovascular drug discovery and development company that Dr. Friesen took a personal interest in. Subsequent to its creation, he has served as CEO and chair of Medicure Inc. since its formation in 1997.

“My involvement in Medicure came about from a simple phone call. The scientist phoned me up and said “I’ve made a discovery that could lead to a drug treatment for acute ischemia and ischemic-reperfusion injury, would you be interested in commercializing it?” So I started the company, funded the research and remained involved as the CEO, because while I enjoyed starting companies, I wanted to stick with it and take it much further this time, to try and carry forward the idea, create the product, and get involved potentially in marketing the product. We managed to raise $142 million and take the product to Phase 3 which in itself I think was an accomplishment.”

Ultimately, the Phase 3 trial didn’t work out, but the company in the meantime made several other key moves including purchasing the US commercial rights to AGGRASTAT (tirofiban HCl), a cardiovascular drug, in 2006 from Merck. AGGRASTAT, in 20 BIOTECHNOLOGY FOCUS September 2013

combination with heparin, is indicated for the treatment of acute coronary syndrome.

Already on the market, the drug has carried the company financially, providing a necessary revenue stream to continue work on other drugs in various stages of development in its pipeline.

One such drug is Tardoxal™, a naturally occurring small molecule drug that is in development for a neurological condition known as Tardive Dyskinesia (TD). Tardoxal has demonstrated activity on a number of biological factors believed to be responsible for TD. Medicure has conducted extensive research and development activity with the molecule and established its safety profile in clinical trials enrolling over 4,000 patients.

The product is currently being evaluated in a Phase 2 proof-of-principle clinical study.

In addition to growing sales for AGGRASTAT, Medicure is also currently developing a transdermal delivery formulation of AGGRASTAT for which the product is undergoing a clinical trial right now to broaden its label. The transdermal delivery has several benefits over intravenous delivery to offer patients and to optimize patient care, including ease of administration, possible reduction in costs and potential for new indications.

Giving back to the sector In addition to operating these two companies, Dr. Friesen continues to mentor and work with dozens of entrepreneurs. He be-

lieves mentorship is integral to developing the industry, and it’s a role he has embraced.

“For a mentorship to work, it requires more than just checking in with people. By that I mean there’s a line of thinking that good mentorship is simply hiring a number of experienced CEOs to come and meet with a young entrepreneur once a month for an hour and I’m not a big fan of that. Mentorship is more than just meeting once a month for an hour to share some war stories, you really have to walk people through, to take them through the challenges.”

In his 40 years in the business, he’s learned many lessons and has plenty of war stories to tell. The advice he gives entrepreneurs is that they need to be brave, work hard and be tenacious in order to succeed.

“I think it takes four things to be successful in starting a company. One is you need good technology. Good management is also quite critical, particularly having experienced management. It also takes a lot of capital and that’s probably been the biggest hurdle I’ve faced as an entrepreneur. Lastly you have to have the ability to sustain the hurdles that will be encountered. This fourth item is what I call either luck or staying power, you have to have the ability to sustain ups and downs in any kind of business.

There are going to be problems that you encounter that are unforeseen. The question is do you have the management skills or financial resources to overcome those hurdles. Sometimes it’s just about making the most of your opportunities.”

Adding to the many accolades that already honour his status, including: Distinguished Alumni of the University of Manitoba and the Order of Manitoba, Dr. Friesen was presented with the Industry Leadership Gold Leaf Award by BIOTECanada at this year’s BIO International Convention. Yet, out of all his accomplishments, what he is most proud of is his family.

“My wife, three daughters, son-in-laws and grandchildren are the most important parts of my life. I mentioned earlier that the development of WinRho was very rewarding to me. When we started clinical trials in 1975 for WinRho, one of the first 1,200 patients was my wife and it protected one of our babies. Now my three daughters, who each had three babies, each received WinRho to protect their babies. For that, I’m truly thankful.”

To see this story online visit www.biotechnologyfocus. ca/?p=8716

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By Dr. Gabe Kalmar, Genome BC

GENOMIcs

genome BC:

open For BuSineSS Secrets uncovered What does a mighty red cedar in Vancouver Island’s Cathedral Grove have in common with a miniscule microbiota floating in the drainage water of a Cape Breton mine? It is simple: they both have a genome. Genomes have no secrets - they are an open book but until recently they have been written in an alien language.

T

oday, with the help of advanced tools and technologies, we are decoding genomes and more importantly, using this information to address challenges facing the agri-food, aquaculture and fisheries, energy and mining, forestry, and healthcare sectors. Within these sectors there are challenges associated with complex biological systems. A better understanding of these systems at a molecular level will provide the groundwork for developing effective solutions.

Meeting unmet needs Genome BC integrates its program design with feedback from industry to ensure that the research it funds is addressing genuine problems within realistic timelines. While some issues such as climate change will require more time to integrate genomics strategies into solutions, other problems like wait times for cancer screening need to see real-time results. The recently launched User Partnership Program (UPP) is designed to directly address the challenges defined by users and the imbalances between academic research ‘push’ and needs of industry ‘pull.’ By engaging industry, government regulators, health authorities, not-for-profit organizations and other users early in the implementation process, Genome BC is proactively managing the translation of research innovations to products, services and policies.

partnerships and Outcomes: Hitting all the Targets Nothing Fishy Here An example of UPP is the Strategic Salmon Health Initiative (SSHI) that addresses concerns outlined in the final report of the Cohen Commission Inquiry into the Decline of Fraser River Sockeye Salmon. This report noted that a deeper examination is needed to make accurate assessments about the range of possible impacts on wild fish stocks. The SSHI project, which was already underway when the report came out, is concentrating on the specific recommendations related to fish pathogens and diseases.

22 BIOTECHNOLOGY FOCUS September 2013

Our current knowledge about salmon comes primarily from observations of cultured fish (both in hatcheries and in aquaculture). Consequently, there is a fair understanding of pathogens and diseases that impact salmon in freshwater hatcheries and sea-water net pens. However, we know less about pathogens affecting wild Pacific salmon.

Genome BC and the Pacific Salmon Foundation are spearheading a five-year project that is utilizing more than a decade of research and $37.5 million worth of past investments to be the largest ever evaluation of the distribution and impact of potential disease agents conducted on BC salmon (wild and hatchery).

While identification of a specific microbe won’t necessarily indicate the presence of disease, it will provide a critical baseline for future monitoring activities. And rigorous analysis and categorization could determine which microbes have the potential to cause disease in salmon.

A public interest panel comprised of key government, aquaculture industry, sport fishery, salmon gillnetters and environmental experts also plays an important role in determining disease agent information that is important to them and other end-users. Ongoing engagement with these vested groups will assist in the development of an effective strategy for communicating research outcomes and help identify applications that may assist in the management of wild and cultured salmon resources.

Clean Water Just over a decade ago, a small Ontario town was the epicentre of a drinking water-related disaster. Close to half of Walkerton’s 5,000 residents fell ill and seven people lost their lives due

GENOMIcs The journey leading to scientific discovery is never direct or easy to navigate. It’s filled with leaps of intuition, false starts, happy accidents and unexpected results. But, however it zigs or zags; the path to discovery and innovation is propelled by the need to make an impact. to the highly dangerous strain of E. coli bacteria found in their drinking water.

A team at the BC Centre for Disease Control (BCCDC) is working to prevent another such disaster. Genome BC is enabling their research that aims to develop a better way to identify the presence of fecal pollutants in watersheds and provide new tools to track sources of water contamination.

Current drinking water testing collects samples from the tap, rather than the watershed source and testing for bacteria contaminants, such as E. coli, often takes more than two days to complete.

Additionally, these tests do not always reflect contamination of water by non-bacterial pathogens such as parasites or viruses. By applying metagenomics, a much more robust method that can identify many pollutants at once, future analysis methods will become much faster as testing can occur at the watershed level. This simplified process will reduce testing time from days to hours and provide profiles of all microbes present in a water sample.

The BCCDC, responsible in BC for investigative water analysis around microbiological threats, will be an early adopter of this testing method and the research project is partnering with the Canadian Water Network in the near future to pilot the watertesting prototype in watersheds across Canada.

Forest Health Invasive species pose a significant threat to Canadian forests. The evidence is all around us— blighted leaves, spotted needles, bare branches, cankered stems—all proof that increasing numbers of trees are succumbing to invasive pests.

Traditional techniques used to isolate and identify pathogens take weeks to perform, requiring precious time that forest professionals just don’t have when dangerous pathogens like sudden oak death are detected in a foreign shipment. And, by looking only for known pathogens, unknown ones can slip through. Genome BC-funded research in this area has morphed to application and is now providing tools to detect known and novel pathogens in real time, preventing an imported, infectious sapling from finding its way into a Canadian nursery or forest.

Research outcomes are making inroads in the forest sector and anticipate generating significant economic benefits from a reduction in losses due to forest diseases.

For example, one research project ran approximately 10,000 tests on samples for several end-users, including the BC Ministry of Forests Lands and Natural Resource Operations (MFL), the Québec Ministry of Natural Resources, and the cities of Victoria and West Vancouver. These tests detect and map pathogens, and provide risk assessments. Based on the results generated by this project, the MFL is considering options of how the exotic poplar canker pathogen could be eradicated to protect planted and natural poplars on the West Coast.

Cancer Screening If a woman inherits a mutation in the BRCA1 or BRCA2 gene, her lifetime risk to develop both breast and ovarian cancer is greatly increased over that of other women in the general population.

The Centre for Clinical Diagnostic Genomics (CDG) at the Provincial Health Services Authority (PHSA), in partnership with the PHSA Cancer Genetics Laboratory, is the first clinical laboratory in Canada to develop and use a revolutionary “NextGen” DNA sequencing process for routine clinical testing. With funding from Genome BC, the new technology has reduced the time to detect BRCA1 and BRCA2 mutations from six months to two months, which means therapy decisions are made more quickly.

An additional benefit of the work done by the CDG is the potential for growth of the service. With the capacity of the CDG for inherited cancer testing being four times that of current provincial demand within BC, the province is well-poised to expand services across Canada and provide testing for other provinces to become a national centre for inherited cancer sequencing. The CDG will continue to expand its services to include new tests for both cancer and other chronic diseases.

Beyond the scope The journey leading to scientific discovery is never direct or easy to navigate. It’s filled with leaps of intuition, false starts, happy accidents and unexpected results. But, however it zigs or zags; the path to discovery and innovation is propelled by the need to make an impact. And impact cannot be made without support from our funders and partners. Investment in Genome BC is something of a self-fulfilling prophecy: dollars from the provincial government allow BC researchers to compete for federal and international funds which in turn draw new investments into the province.

Genome BC is an essential cog in Canada’s Science & Technology Strategy, and our unique co-funding model attracts millions in international funding and valuable collaborations. With help from our funding partners we invest in the very best people, the very best genomics research programs, and the most advanced technologies because we are propelled by a single desire: to pave the way for research to have a direct impact on our lives and our future, and to deliver critical benefits to people in British Columbia, Canada, and beyond.

To see this story online visit http://biotechnologyfocus.ca/?p=8701

September 2013 BIOTECHNOLOGY FOCUS 23

By: Allen Lalonde

Across canada

Changing the Face of Healthcare with

High Performance

Computing Across the globe, researchers are focused on trying to not only cure, but to improve the diagnosis and treatment of diseases and disorders that plague the human population.

T

he results of these efforts will not only improve the quality of life for those living with ailments, but also improve patient experience during diagnosis and treatment and save healthcare systems around the world money in the process.

In Canada, and specifically in Ontario, academic and industry researchers have the potential to lead in these developments, partially due to their ability to access a set of technology-leading tools that will allow them to make advances in the healthcare field that were not previously possible. For example, when considering some of our population’s biggest health challenges – leukemia, lung cancer, neurological disorders, and diagnosis of disease – the key to addressing these issues may lie in the moun-

tains of data that has already been collected on them. The challenge, making sense of this “big data”, becomes easier when the right minds have access to the right tools: High Performance Computing (HPC).

That’s why the IBM Canada Research and Development Centre (CRDC) is offering Canadian researchers the unprecedented opportunity to access an advanced HPC infrastructure that includes the most powerful supercomputer in Canada and some of the most advanced analytics software available today. The CRDC has partnered with seven Southern Ontario universities, as well as the Ontario and Canadian governments, to form the Southern Ontario Smart Computing Innovation Platform (SOSCIP). SOSCIP is a

Brain Graph

research consortium with the mandate of pairing academic and industry researchers with HPC to analyze big data and fuel innovation leadership in Canada within agile computing, health, water, energy and cities.

IBM’s $175 million investment in the $210 million initiative recognizes the power of combining the talent of academic researchers with HPC infrastructure.

“To have this leg-up at this critical juncture is really exciting,” says Mark Daley, an associate professor of Computer Science and Biology at Western University. Daley is using the centre’s capabilities to further his research in neuroscience and modeling the brain. “This will help to make us world leaders in many disciplines by enabling us to make sense of the vast amounts of data we’re generating.”

Daley’s brain research is one of fifteen healthcare projects using the SOSCIP capabilities. Let’s take a closer look at how four of these healthcare projects, currently underway, are using HPC to transform healthcare.

Real-time Analysis of Human Brain Networks

Each filled circle represents a brain region. At the moment in time represented by this particular graph, if two brain regions have similar activity, a line is drawn between them. In this plot we can see two clusters of highly-linked brain regions, connected by more sparsely-linked regions.

24 BIOTECHNOLOGY FOCUS September 2013

An important tool in the diagnosis of neurological disorders is functional magnetic resonance imaging, or fMRI. However, fMRI can be a timely and expensive option. Results can take a week or more to be analyzed, and the current process could result in a patient requiring multiple scans to determine the proper results.

Across canada

But what if the results could be available in near real-time? Daley and his research team are working on just that, and only six months into their research, have a working prototype. Daley’s research brings together scientists from neuroimaging, neuroscience and HPC, and will result in faster, more accurate diagnoses, better outcomes, and optimal use of expensive scanner time.

Dynamically adapted brain scanning allows the test to be stopped, tuned and adjusted while it is underway. Neural functional connectivity networks have shown potential as diagnostic indicators for several brain disorders, including autism, schizophrenia, Alzheimer’s, and ADHD. “The tools IBM is providing allow us to take these colossal data sets and make sense of them in an automated way,” Daley notes.

“In neuroscience, we can often generate terabytes of data from images detailing both the structure and the function of the brain.

The new computational resources will allow us to automate that analysis so we can boil that down into simple models.”

Understanding biological processes through imaging technology and nanophotonic devices Imagine having the ability to see some of the smallest parts of us – our cells, tissues, and molecules – up close, and to be able to monitor them over time. How could this capability inform our understanding of dis-

ease? Dr. Lora Ramunno, Canada Research Chair in Computational Nanophotonics and associate professor in the Department of Physics at the University of Ottawa, and her research team are using Canada’s fastest supercomputer, an IBM Blue Gene/Q, to find out.

The team is using the supercomputer to develop powerful imaging technologies and nanophotonic devices with multiple applications including the potential to improve the early detection and treatment of diseases.

The team, which includes university research chair in Surface Plasmon Photonics, Pierre Berini, and an IBM Canada researcher, is able to capture real-time images of live cells and tissues as well as detect trace molecules using cutting-edge nanophotonic devices. Having access to this level of detail will help them better understand how diseases affect us at the cellular level, leading not only to the improved detection of disease, but also to improved treatment.

“The ability to create models of this type of device has been limited by the amount of computer power and the software available until now.” Ramunno notes. “The Blue Gene/Q will allow us to apply our computational programs, which can carry out the intensive Big Data calculations that are critical to simulating nanoscale imaging and nanophotonic device applications.”

Health Predicting Leukemia Inhibitors Have you ever wondered how drugs that treat cancers like leukemia are created? In many cases it starts by examining molecular behaviour. Chematria, a University of Toronto Bioinformatics start-up, is a great example of a company that makes software to help pharmaceutical companies determine which molecules can become medicines.

Abraham Heifets, CEO of Chematria Inc. and his research team are using a big data approach to molecular activity prediction.

In partnership with Dr. Aaron Schimmer at the University of Toronto and UHN Princess Margaret Hospital, Chematria is using the the SOSCIP HPC platform to help guide the selection of molecules for the treatment of acute myeloid leukemia. The results will enable faster drug development for a fraction of the price of wet-lab experiments.

Common Signatures in Lung Cancer Canadian cancer statistics (2012) indicate that lung cancer accounts for almost 14 per cent of all cancer cases in Canada, leading to the

highest number of deaths (27 per cent) of all cancers.

To create therapeutic solutions for the treatment of individual patients, complex and computationally intensive analysis of the patient’s biomarkers, for example, gene signatures, are required.

Dr. Igor Jurisica, professor, Departments of Computer Science and Medical Biophysics, University of Toronto and Tier I Canada Research Chair in Integrative Cancer Informatics, and his team are designing an algorithm to identify common signatures in lung cancer patients, advancing diagnosis, prognosis and treatment capabilities. Their findings will provide insights into how computational tasks as a whole can be optimized for other cancers and diseases, and could also potentially be used to re-purpose existing FDA-approved drugs for other treatments.

In total, the SOSCIP project portfolio includes close to 40 projects. Other health projects are looking at the treatment of head and neck cancers, the diagnosis and treatment of chromosome/cell-related disorders such as lymphoma, predicting the health status of premature children, as well as the prediction, control and treatment of pandemics, such as radiation exposure or the spread of an infectious disease.

The results of these research projects hold much potential – and not only for the significant advancements they will make in their respective fields. The results of this research also hold promise for the creation of skills and innovation in Canada. The power of the HPC tools being used is enabling researchers to tackle big data and grand challenges in new ways. This means, as a result of the academic/industry partnership within each project, the potential for an increase in homegrown software and engineering skills; more rapid adoption of innovative HPC technologies within Canadian businesses; and accelerated commercialization of Canadian-led research and development.

The consortium members include the IBM Canada Research and Development Centre as well as seven Ontario universities, led by the University of Toronto and Western University. Other participants include McMaster University, Queen’s University, University of Ontario Institute of Technology, University of Ottawa, and University of Waterloo.

To see this story online visit http://biotechnologyfocus. ca/?p=8682

September 2013 BIOTECHNOLOGY FOCUS 25

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precisely cosine corrected. The LED-luxmeter with integrated shutter autoranges over an eight decade dynamic measurement range. Data can be measured in nine different units using the five different measuring modes for complete accuracy.

Web: www.led-measurement.com Upright Work Bench IAC Industries introduces a new way to add storage and utility to workbenches with the company’s versatile Multi-Task System I and II (MTS-I and MTS-II). Each System features heavy gauge vertical posts with a tie beam at the

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Ethernet Switch Omega releases the OM-ESW-100 series, a range of compact IEEE 802.3 layer two network unmanaged industrial Ethernet switches with automatic speed, duplex and cable sensing. The series features a construction capable of withstanding environmental extremes for use in mission critical applications. These Class I, Division 2 switches feature redundant power inputs, hardened metal enclosures, and 16 kV port protection. Each switch is capable of auto negotiating 10/100 Mbps and half/full duplex communications. Special auto-crossing detection supports standard and crossover Ethernet cables.

Web: www.omega.ca Filtration Capsules Haffenden Consulting introduces its new Zenpure line of Filtration products, including the patented Zenpure Zero Capsules, eliminating downstream hold up volume for high value products. Look to Zenpure for a full range of filter membranes from syringe tips to full scale capsules and cartridges.

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CALENDAR SEPTEMBER 2013 September 9-12 Fourth BioMarine International Business Convention Venue: Halifax, NS Email: contact@biomarine.org Web: http://www.biomarine.org/

September 15-18 ABIC 2013 Venue: Calgary, AB Tel: 403-686-8407 Fax: 403-255-4592 Email: events@irismeck.com Web: www.abic.ca/abic2013

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

Tel: +1-819-821-5577 Email: meduchaine@ sherbrooke-innopole.com Web: http://sils-sherbrooke.com/

OCTOBER 2013 October 2-3 BioContact Québec Venue: Québec, QC Tel : 418-694-8778 Fax : 418-694-0614 Email: lysbeth@biocontact.ca Web: www.biocontact.qc.ca

October 15-17 Biofibe 2013 Venue: Winnipeg, MB Tel: 204-272-5095 Fax: 204-272-2961 E-mail: biofibe@lsam.ca Web: www.biofibe.com/

October 24

2013 Gairdner Awards Receptients’ Symposium Venue: Toronto, ON Email: sheila.robinson@gairdner.org Sherbrooke International Life Sciences Summit Web: www.gairdner.org/content/ Venue: Sherbrooke, QC about-our-events OBIO Ad (Final):Layout 1 12-05-14 5:13 PM Page 1

September 26-27

October 27-31 Materials Science & Technology Conference and Exhibition combined with ACerS 115th Annual Meeting Venue: Montréal, QC Tel: 614-794-5894 Fax: 614-899-6109 Web: http://www.matscitech.org/

NOVEMBER 2013 November 3-8 AIChE 2013 Annual Meeting Venue: San Francisco, CA Tel: 800-242-4363 Fax: 203-775-5177 Email: jeffw@aiche.org Web: http://www.aiche.org/conferences/ aiche-annual-meeting/2013

November 13-14 12th Annual Market Access Summit, Canada Venue: Toronto, ON Tel: 1-866-298-9343 Fax: 1-866-298-9344 Email: customercare@strategyinstitute.com Web: www.marketaccesscanada.ca

Ontario Bioscience Innovation Organization

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

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

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

September 2013 BIOTECHNOLOGY FOCUS 27

and

es h

By the Standards Council of Canada

SPOTLIGHT

ASSESSORS PLAY VITAL ROLE in ensuring quality laboratory results

A

growing number of government regulations. Encouragement by industry peers and customers. A fiercely competitive global trade arena. These are a few of the reasons behind Canadian testing laboratories’ increasing efforts to comply with international standards.

Assessors greatly contribute to the ongoing implementation of the Standards Council of Canada’s (SCC’s) Laboratory Accreditation Program. SCC accredits conformity assessment bodies, such as testing laboratories, to internationally recognized standards.

“Having an accredited laboratory increases the assurance of the public and other regulatory authorities – including regulatory authorities of other countries – that the test results are reliable, competent and valuable,” says Chantal Guay, SCC’s vicepresident, Accreditation Services.

“In addition to the benefits SCC brings to Canadians’ health and safety, SCC is a member of the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC),” she says. “Both IAF and ILAC promote the mutual recognition of accreditations and certifications worldwide.”

Two key international standards Two key international standards that have a direct impact on citizens’ health and safety, and that testing laboratories comply with, are ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories and ISO 15189 Medical laboratories – Particular requirements for quality and competence.

ISO/IEC 17025 provides a globally accepted basis for laboratory accreditation.

The implementation of this international standard demonstrates an organization’s competence to perform specific, vital testing methods and to meet the general requirements for the quality system of a testing laboratory. The implementation of ISO 15189 provides greater accuracy of test results generated by clinical and medical testing laboratories.

28 BIOTECHNOLOGY FOCUS September 2013

“Accredited organizations, including laboratories, are distinguished from those that are not,” says Guay. “More and more, both public- and private-sector laboratories around the world are requesting that their suppliers have gone through accredited testing, inspection or certification, in order for them to do business together.”

In carrying out conformity assessment activities to determine that a process, product or service meets relevant technical standards and fulfills relevant requirements, SCC recognizes the important ways in which assessors assist the organization’s work.

Yvon-Louis Trottier exemplifies the important role that assessors play. Trottier has been the Regional Microbiology Laboratory supervisor for Health Canada’s Regional Food Laboratory (based in Longueuil, Quebec, near Montreal), and has worked for the Canadian Food Inspection Agency, for a combined total of some 20 years. The team he has managed inspects laboratories testing food safety and natural health products. As well, the team assesses inspectorate programs for drugs and medications and supports the water testing program for Health Canada’s First Nations and Inuit Health Branch.

In describing the nature of the team’s work, Trottier says, “We look at (a laboratory’s) analytical methods, at the measure of uncertainty of (its test) results, at the management of (an organization’s) whole testing program and at the confidence level of the results delivered to the client. We (also) look at how closely the lab is conforming to a standard.”

Trottier maintains that the confidence level of laboratory test results is very important.

“For instance, a false positive (test result) could end up in recalls of massive amounts of food, which would be detrimental for commerce,” he says. “Canada is recognized as a leader in terms of ensuring a high level of confidence in (its laboratory test) results, to ensure food safety for all Canadians, and also for imported products, to be sure that we’re protected from any kinds of disease or fraud.”

Yvon-Louis Trottier has been the Regional Microbiology Laboratory supervisor for Health Canada’s Regional Food Laboratory (based in Longueuil, Quebec), and has worked for the Canadian Food Inspection Agency, for a combined total of some 20 years.

Having more than 30 years of experience in the field, Trottier recently retired. He says he is extremely proud of the work he and his team have carried out and has enjoyed sharing knowledge and experience with other lead assessors. “Every time you do a technical assessment, it’s a new world, new people, new fields. It’s constantly changing.

It’s a new adventure every time.”

Learn more at World Standards Day 2013 SCC invites you to join us, and the international community, in celebrating our World Standards Day (WSD) 2013 event in Vancouver, British Columbia, on October 16.

SCC’s presentations and panel discussion will underscore how conforming to international standards ensures quality laboratory results. As well, SCC will screen its new video entitled Assessors Wanted. The video highlights the vital role Canadian assessors play in ensuring organizations’ adherence to international standards. To learn more about opportunities for becoming an assessor, please visit the Stakeholder Participation section of SCC’s website, at www.scc.ca.

This article is reprinted with permission from SCC’s website feature article (August 2013).

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THE LAsT WORd

By Andrew Casey

BIOTECH INNOVATION:

the New Ecosystem Today’s global population has surpassed the seven billion mark. By 2050, it is predicted to grow to more than nine billion people. This exponential growth brings with it enormous opportunities, as nine billion people will require more efficient and effective ways to deliver health care, grow food and manufacture goods.

At the World Congress on Industrial Biotechnology held earlier this summer in Montréal, we witnessed firsthand the interconnected ecosystem of partnerships Andrew casey, being developed and nurtured in this inPresident and CEO, dustry. Canada, having a strong foundaBIOTECanada tion in plant innovation in areas such as Saskatchewan, harnessed agronomics to develop canola into a commercial crop that is now being used to replace non-renewable alternatives for biofuels, industrial lubricants, and cosmetics.

From a human health perspective we are seeing an aging population and the rapid emergence and discovery of new diseases and illnesses. Thankfully, innovations such as the mapping of the human genome have enabled researchers to better understand these health challenges and develop targeted medicines to relieve, cure and even prevent illness. In this global challenge and corresponding solutions lies an enormous economic and social opportunity for Canada and its biotechnology industry.

Canada is home to a vibrant biotech industry of more than 500 established and emerging companies. BIOTECanada members reflect the type of biotech sector found in this country. It is an industry of great diversity with an array of entities including large, multinational brand pharmaceutical companies and small and medium sized companies. In addition to health and pharmaceuticals the biotech sector represents an important part of ensuring Canada’s industrial and agricultural sectors are competitive in the global economy. Similar to other Canadian industry sectors, Ontario and Québec are home to significant biotech clusters. However, one of the truly special features of Canada’s biotech sector, indeed one of its core strengths, is the biotech clusters found in each province stretching from coast-to-coast.

This diverse array of company types and strong regional clusters bodes well for Canada as a new biotech-pharma business model begins to take shape globally. The traditional way of developing new medicines through a ‘one-stop shopping’ kind of concept where large, brand name companies internally discover, develop, test and ultimately commercialize a medicine or therapy is becoming the Walkman in an iPad world. The new product development pipeline of today’s biopharma industry is one where large companies partner with or invest in the smaller domestic innovators. It is these partnerships and investments that are delivering gamechanging therapies and drugs. In this context, Canada represents fertile territory for innovation and product development.

Importantly, in the context of the emerging biotech ecosystem, 30 BIOTECHNOLOGY FOCUS September 2013

Canada has in place many of the components critical for global competitiveness and success. Indeed, Canada is home to worldclass universities and research institutes, biotech entrepreneurs, a significant multinational industry presence, and a highly educated and dedicated workforce. In addition, cities such as Vancouver, Toronto and Montréal are home to biotech incubators that support and grow the emerging companies and also help facilitate the partnerships between these emerging companies and the established multi-nationals. Within these city clusters there are commercialization and incubator organizations that bring together the various industry players including innovators, partners and investors.

Ultimately these organizations facilitate research, development and commercialization of new therapies and medicines.

The Centre for Drug Research and Development (CDRD), in Vancouver is a fully-integrated national drug development and commercialization centre, providing expertise, infrastructure and the capacity to partner thereby enabling researchers from leading health institutions to advance promising early-stage medicines. CDRD bridges the commercialization gap and supports the transformation of publicly funded health discoveries into viable investment opportunities for the private sector.

In Toronto, MaRS Discovery unites science, technology and social entrepreneurs. Providing research labs, offices, and event facilities, MaRS joins innovators from the private and public spheres. Accelerator initiatives (such as the $7 million life sciences fund) allow for investment into companies with the potential to be global leaders.

Montréal-based NEOMED helps drive drug discovery activities up to the stage of human proof-of-concept. Once accomplished, these de-risked projects provide significant value for NEOMED’s downstream partners. Launched in response to the changing pharma research and development business model, this publicprivate partnership with government and biopharmaceutical companies fills the gap between basic research and later stage drug development.

The regional clusters supported by organizations such as CDRD, MaRS and NEOMED are central to Canada’s ability to successfully grow a thriving biotech sector. Each of these organizations leverages the strengths of their respective regions including established and emerging companies, universities and investors, to drive innovation and strengthen the industry more broadly. All told, our growing biotech industry supported by new partnerships and pipeline development will deliver significant dividends going forward for both Canada and the world.

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