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Toronto • San Diego • Mark Poznansky<br />

Championing the <strong>Business</strong> of <strong>Bio</strong>technology in Canada January/February 2013<br />

Canadian Publications Mail Product—Agreement 40063567<br />

www.biobusinessmag.com<br />

A lifeline<br />

<strong>for</strong> <strong>biotech</strong><br />

Medical Devices: a spark of<br />

hope <strong>for</strong> a changing industry


Contents<br />

Championing the <strong>Business</strong> of <strong>Bio</strong>technology in Canada<br />

12<br />

Investigating Canada’s<br />

Medical Device Sector<br />

Canada’s not a big global player in the medical<br />

device sector. It comprises about three per cent of<br />

the market but there’s potential <strong>for</strong> so much more.<br />

<strong>Bio</strong> <strong>Business</strong> explores the industry: what we do<br />

well, what we could do better and what needs to<br />

happen <strong>for</strong> Canada to take a step <strong>for</strong>ward.<br />

17 Starting from scratch. Neovasc absorbed<br />

the crash of 2008 and has rebuilt into one<br />

of Canada’s most exciting device companies.<br />

19 Is your chemo working? Rna Diagnostics<br />

has developed an assay that will tell doctors<br />

whether the treatment course a patient is on<br />

is working.<br />

20 Profound prostate steps. Profound Medical<br />

is developing novel technology that could<br />

change the way prostate cancer is treated.<br />

also inside<br />

8 Regional Profile: San Diego<br />

Companies like Hybritech are the bedrock on<br />

which the strong San Diego <strong>biotech</strong> cluster was<br />

built. Now a focus on collaboration is helping the<br />

Cali<strong>for</strong>nian powerhouse remain an industry<br />

benchmark.<br />

10 Regional Profile: Toronto<br />

What more can you ask <strong>for</strong>? Toronto boasts<br />

access to everything a <strong>biotech</strong> company needs,<br />

making it a growing life sciences power.<br />

Visit<br />

us at<br />

www.biobusinessmag.com<br />

<strong>for</strong> extended articles of this issue<br />

of the magazine.<br />

10<br />

standards<br />

5 Editorial<br />

6 NEWS<br />

22 <strong>Business</strong><br />

Leadership<br />

“<br />

There are sparks of hope. There’s work being done<br />

to look at this earlier and earlier which is really...<br />

cutting innovation that puts us ahead of the rest<br />

of the world in terms of the development and<br />

evaluation of products.<br />

”<br />

-Brian Lewis, MEDEC CEO<br />

Read more on page 12.<br />

www.biobusinessmag.com 3


BB_JanFeb13_Issue4.indd 1<br />

www.biobusinessmag.com<br />

January/February 2013<br />

www.labbusinessmag.com<br />

The definitive source <strong>for</strong> lab products, news and developments<br />

2/21/13 2:58 PM<br />

<strong>Bio</strong> <strong>Business</strong><br />

Championing the<br />

<strong>Business</strong> of <strong>Bio</strong>technology in Canada<br />

Publisher<br />

& CEO<br />

Executive Editor<br />

Associate Editor<br />

Editorial Intern<br />

Christopher J. Forbes<br />

c<strong>for</strong>bes@jesmar.com<br />

Theresa Rogers<br />

trogers@jesmar.com<br />

Nicolas Heffernan<br />

nheffernan@jesmar.com<br />

Shayan Jaffer<br />

Contributor Talbot Boggs<br />

Art<br />

Director<br />

Secretary/<br />

Treasurer<br />

Tammy Malabre<br />

tmalabre@jesmar.com<br />

Susan A. Browne<br />

Director of New Jacquie Rankin<br />

<strong>Business</strong> Development jrankin@jesmar.com<br />

Marketing<br />

Manager<br />

Marketing<br />

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VP of<br />

Production<br />

Production<br />

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Production<br />

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klaplante@jesmar.com<br />

Roberta Dick<br />

robertad@jesmar.com<br />

Crystal Himes<br />

chimes@jesmar.com<br />

Joanna Forbes<br />

j<strong>for</strong>bes@jesmar.com<br />

<strong>Bio</strong> <strong>Business</strong> is published 6 times per year by Jesmar<br />

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Editorial<br />

Making Devices Succeed in Canada<br />

Why not Canada?<br />

We rank near the top of high school, college and university completion rate with other<br />

OECD countries. Our researchers are publishing world class research but when it<br />

comes to health innovation we’re simply not good enough, ranking 14th out of 17<br />

countries.<br />

In putting together this issue of <strong>Bio</strong> <strong>Business</strong> I spoke with numerous people on the<br />

front lines of Canada’s medical device industry and the one thing theme that kept<br />

coming up was the desire <strong>for</strong> this sector to succeed in Canada.<br />

Seeing all the world class research that is coming to fruition through companies<br />

such as Neovasc, Rna Diagnostics and Profound Medical is extremely encouraging<br />

but when you stop to think about the trouble these companies face to attract financing<br />

and the difficulties in trying to commercialize their innovations, you can’t help but<br />

think of what might have been <strong>for</strong> all the other companies that have failed <strong>for</strong> lack of<br />

venture capital.<br />

“We’re one of the successful ones but there’s relatively few of us at this level and<br />

there could be more and there should be more,” says Rna Diagnostics CEO Ken<br />

Pritzker. “So the point we’d like to make is the various kind of supports <strong>for</strong> commercialization<br />

are being put in place at this level and the opportunities are increasingly<br />

better than they were a couple of years ago. We’re heading in the right direction but<br />

if one looks at how to attract capital and keep the development in Canada and keep<br />

the ownership in Canada… as we grow, it becomes quite problematic. That’s our challenge<br />

and the challenge <strong>for</strong> companies like us.”<br />

One of the main issues that stops Canada from being a bigger player in the<br />

device market is we can’t keep our good ideas in the country and give them the support<br />

and money they need to grow so either they’re taken to other countries or they<br />

just fold entirely.<br />

Various supports and programs are being implemented and are starting to bear<br />

fruit, such as MaRS’ Excellence in Clinical Innovation and Technology Evaluation<br />

(EXCITE), The Ontario Health Technology Advisory Committee (OHTAC) and<br />

the recently announced R&D MEDTEQ Consortium in Quebec.<br />

We hope to see you at the <strong>Bio</strong> International Convention.<br />

Follow us on twitter <strong>for</strong> live updates from Chicago.<br />

On Twitter at biolabmag<br />

Nicolas Heffernan<br />

Associate Editor<br />

<strong>Bio</strong> <strong>Business</strong> is a proud member<br />

of <strong>Bio</strong>teCanada and<br />

Life Sciences Ontario.<br />

Publisher of<br />

Lab <strong>Business</strong> Magazine<br />

<strong>Bio</strong> <strong>Business</strong> Magazine<br />

Printed in Canada<br />

Toronto • San Diego • Mark Poznansky<br />

Championing the <strong>Business</strong> of <strong>Bio</strong>teChnology in Canada January/February 2013<br />

Canadian Publications Mail Product—Agreement 40063567<br />

A lifeline<br />

<strong>for</strong> <strong>biotech</strong><br />

Canadian Publications Mail Product Sales Agreement 40063567<br />

Medical Devices: a spark of<br />

hope <strong>for</strong> a changing industry<br />

Science Policy<br />

Microscopes<br />

Kimberly Strong<br />

Speed is of the<br />

Essence<br />

Princess Margaret’s Maria Amenta<br />

trans<strong>for</strong>ms the lab<br />

Do the flip!<br />

Visit Princess Margaret’s rapid response<br />

lab.<br />

www.biobusinessmag.com 5


Photo Credit: National Research Council of Canada<br />

<strong>Bio</strong>fuel Test Flight Reveals<br />

Reduction in Emissions<br />

Results from the world’s first civil flight powered by 100 per cent<br />

biofuel released by the National Research Council of Canada<br />

(NRC), show that the biofuel used in the flight last October is<br />

cleaner than and as efficient as conventional aviation fuel.<br />

In<strong>for</strong>mation collected in-flight and analyzed by a team of experts<br />

revealed an important reduction in aerosol emissions (50 per cent)<br />

when using biofuel compared to conventional fuel. Furthermore,<br />

additional tests per<strong>for</strong>med on a static engine show a significant reduction<br />

in particles (up to 25 per cent) and in black carbon emissions (up<br />

to 49 per cent) compared to conventional fuel. These tests also show<br />

a comparable engine<br />

per<strong>for</strong>mance, but an<br />

A second aircraft trailed the Falcon 20 improvement of 1.5<br />

to measure engine emissions.<br />

per cent in fuel consumption<br />

during the<br />

steady state operations.<br />

The jet’s engines<br />

required no modification<br />

as the biofuel tested<br />

in-flight meets the<br />

specifications of petroleum-based<br />

fuels.<br />

“We are pleased with these positive results. The flight went<br />

smoothly and the data collected enables us to better understand the<br />

impact of biofuel on the environment,” says John R. McDougall,<br />

President of the National Research Council of Canada. “We will<br />

continue to work with our partners Applied Research Associates,<br />

Chevron Lummus Global and Agrisoma <strong>Bio</strong>science Inc. to bring<br />

this effective energy solution to market. The final product will be a<br />

sustainable option <strong>for</strong> reducing aviation emissions.”<br />

New R&D Consortium For Quebec<br />

Medtech Sector<br />

Canada’s Medical Technology<br />

Companies (MEDEC) couldn’t<br />

hide its delight with the<br />

announcement of Quebec Government<br />

funding <strong>for</strong> the MEDTEQ Consortium.<br />

Brian Lewis<br />

MEDEC is a founding member of the<br />

new medical technology industrial R&D<br />

consortium, together with more than 30 companies, universities<br />

and providers.<br />

By building upon the strengths of representatives<br />

of these three key pillars, this open innovation initiative<br />

will facilitate the development of leading edge<br />

solutions <strong>for</strong> patients and address unmet needs of healthcare<br />

providers.<br />

“MEDEC will continue to support the consortium as it<br />

stimulates the vibrancy of our industry and the leadership<br />

of our partners,” says Brian Lewis, MEDEC’s President and<br />

CEO. “It highlights our commitment to the sector’s innovation<br />

agenda and to the sustainability of healthcare.”<br />

While the MEDTEQ Consortium will facilitate increased<br />

collaboration between companies of all sizes, it will also<br />

provide small to medium size companies the opportunity to<br />

highlight their capacity <strong>for</strong> innovation, both incremental<br />

and breakthrough, positioning them directly on the critical<br />

path to global markets.<br />

For more on medical devices, turn to page 12.<br />

6 <strong>Bio</strong> <strong>Business</strong> January/February 2013


News<br />

Historic $50 Million Gift to Princess Margaret Cancer Centre<br />

Dr. Benjamin Neel has 50<br />

million reasons to smile.<br />

The Research Director<br />

of the Princess Margaret<br />

Cancer Centre will have $50<br />

million to spend on research<br />

thanks to Canadian philanthropists<br />

Emmanuelle<br />

Gattuso and Allan Slaight.<br />

“This unprecedented<br />

‘superfund’ allows us to<br />

build and support research<br />

teams focused on precision<br />

genomics, advanced tumour<br />

biology, immune therapy<br />

and molecular imaging,”<br />

says Neel. “I truly believe that we can conquer<br />

cancer.”<br />

The donation is the biggest ever private<br />

gift to cancer research in Canadian history<br />

and will advance the Princess Margaret<br />

Cancer Centre’s Personalized Cancer<br />

Medicine initiative. The Princess Margaret<br />

Cancer Centre, one of the top five cancer<br />

Left to right: Paul Alofs, Dr. Bob Bell,<br />

philanthropist Emmanuelle Gattuso,<br />

Geoffrey Ogram, Dr. Benjamin Neel<br />

and Dr. Mary Gospodarowicz.<br />

research centres in the world, is revolutionizing<br />

cancer care by creating and<br />

delivering its own distinct model of<br />

personalized cancer medicine encompassing<br />

four key themes: detect, diagnose,<br />

target and support. Personalized<br />

cancer medicine will help detect cancers<br />

earlier, diagnose cancers more precisely,<br />

provide targeted treatment, and better<br />

Provinces and Territories Seek Significant Cost Savings <strong>for</strong><br />

Canadians on Generic Drugs<br />

Provinces and territories are working together through a co-ordinated approach to<br />

price setting <strong>for</strong> six widely used generic drugs, which represent approximately 20 per<br />

cent of the publicly funded spending on generic drugs in Canada.<br />

This joint approach will leverage combined purchasing power to obtain the lowest<br />

generic prices achieved to date in Canada, and consistent with the price <strong>for</strong> these<br />

drugs on the international market.<br />

It is expected that when fully implemented, this initiative could produce savings of<br />

up to $100 million <strong>for</strong> provincial and territorial drug plans.<br />

Participating provinces and territories have agreed to establish a price point <strong>for</strong><br />

six of the most common generic drugs at 18 per cent of the equivalent brand name<br />

drug. Currently, individual provinces and territories pay between 25 and 40 per cent<br />

of brand name prices. The new prices are to be in effect by April 1, 2013.<br />

“Drug plan costs are increasing <strong>for</strong> all Canadians,” Saskatchewan Premier Brad<br />

Wall says. “In recent years the generic drug industry has worked with provincial and<br />

territorial drug plans to lower generic drug prices in Canada and with today’s<br />

announcement, we will realize savings that will ensure more dollars <strong>for</strong> provincial<br />

healthcare systems across Canada.”<br />

Prince Edward Island Premier Robert Ghiz says, “this<br />

is just a starting point—we are committed to continuing to<br />

work together on a long-term strategy to further improve<br />

value <strong>for</strong> Canadians.”<br />

Photo credit: Marko Shark<br />

support patients and their<br />

families through their cancer<br />

journey.<br />

Gattuso and Slaight’s gift<br />

to The Princess Margaret<br />

Cancer Foundation’s Billion<br />

Dollar Challenge is pledged<br />

over 10 years, and is an investment<br />

in human capital. It will<br />

create an unprecedented<br />

“superfund to support superstars”<br />

that will provide longterm,<br />

sustainable funding to<br />

attract, support and retain<br />

researchers whose sole focus is<br />

to eradicate cancer.<br />

For more on Princess Margaret,<br />

flip to LAB <strong>Business</strong> and turn<br />

to page 10.<br />

New Study Says Government<br />

Policies Misin<strong>for</strong>med<br />

Canada-Europe trade negotiations are<br />

being influenced by false assumptions<br />

about the impact of drugs on the cost of<br />

healthcare according to new research published<br />

today by the Canadian Health Policy<br />

Institute (CHPI).<br />

Canadian negotiators are reluctant to<br />

adopt European standards on intellectual<br />

property rights <strong>for</strong> new drugs because of<br />

allegations by special interest groups that<br />

those standards will lead to significantly<br />

higher healthcare costs in Canada.<br />

The CHPI study suggests that the federal<br />

government might be risking an opportunity<br />

to secure Canada’s economic future over<br />

worries about drugs costs that are exaggerated,<br />

because the actual scale of government<br />

drug spending is small and its impact<br />

on healthcare costs over the last 38 years<br />

has probably been close to neutral.<br />

Brett Skinner, the author of the study<br />

says, “The trade agreement will reduce barriers<br />

<strong>for</strong> Canadians to do business with<br />

nearly 500 million people—almost 15<br />

times the size of our domestic market.”<br />

www.biobusinessmag.com 7


Critical Mass<br />

San Diego’s rich history of <strong>biotech</strong> propels industry today<br />

By Talbot Boggs<br />

Denise Garcia still remembers with enthusiasm the years<br />

she spent working in the operations and regulatory divisions<br />

of Hybritech in San Diego, doing everything from<br />

conducting tours of the compounding laboratory to managing<br />

and training employees. She worked with Hybritech through a<br />

series of mergers and acquisitions in the mid-1980s and beyond<br />

that have been credited with helping turn San Diego and southern<br />

Cali<strong>for</strong>nia into one of the world’s leading <strong>biotech</strong>nology<br />

clusters on the planet.<br />

“It was a time of great energy and passion in the company and<br />

the industry in San Diego,” recalls Garcia, who co-founded a nonprofit<br />

resource network group <strong>for</strong> Life Sciences and Technology<br />

professionals in Palm Beach, Fla., after leaving Hybritech. “The<br />

company grew very quickly. When Eli Lilly took over it had a very<br />

different culture and a lot of people left and started their own<br />

companies. Everybody in the area was connected with everybody<br />

else, which gave you great career mobility. You only had to decide<br />

what you wanted to do and more than likely you could find it.”<br />

San Diego has had a significant concentration of biomedical<br />

research institutions such as the Salk and Scripps institutes and<br />

the University of Cali<strong>for</strong>nia San Diego (UCSD) <strong>for</strong> half a century,<br />

but the region’s <strong>biotech</strong> industry began in the late 1970s<br />

when two researchers from UCSD, Ivor Royston and Howard<br />

Birndorf, founded Hybritech.<br />

In 1986, Eli Lilly purchased Hybritech <strong>for</strong> $400 million, and<br />

many of the company’s entrepreneurs, with the appropriate financial,<br />

scientific and business connections, went off and started their<br />

own pharmaceutical and medical-device companies, including the<br />

city’s biggest success story, Idec, which now is part of <strong>Bio</strong>gen-<br />

Idec, a manufacturer and researcher specializing in drugs <strong>for</strong><br />

neurological and autoimmune disorders and cancer.<br />

In the ensuing years, the cluster began to spread to surrounding<br />

communities and counties while the National Institutes of<br />

Health (NIH) began to increase funding <strong>for</strong> basic science<br />

research. Today, more than two dozen research institutes, universities<br />

and colleges in southern Cali<strong>for</strong>nia conduct basic scientific<br />

research or train future generations of scientists, entrepreneurs<br />

and life science workers.<br />

As the industry grew, so did the infrastructure to support it,<br />

and the area now is home to numerous support services that specialize<br />

in the life sciences. That critical mass of research, entrepreneurs,<br />

support services, and private investors savvy about the risks<br />

and long incubation periods <strong>for</strong> life science products acts as a<br />

magnet to attract even more life sciences activity to the region.<br />

“The industry in San Diego is very robust and is growing in all<br />

sectors,” says Kevin Lustig, founder and CEO of Assay Depot, an<br />

online marketplace <strong>for</strong> pharmaceutical research services. “There<br />

are more than 320 life science contract research organizations and<br />

some 81 research institutions all within a five-kilometre radius as<br />

well as big pharmaceuticals like Johnson and Johnson, Pfizer, and<br />

Merck plus hundreds of start-ups like us. We all have common<br />

roots, and now with the internet everyone can stay connected and<br />

network. It’s a community, a great place to get going with access<br />

to financial support and many brilliant people.”<br />

The <strong>biotech</strong> cluster is comprised of six major sectors: biopharmaceuticals,<br />

research and lab services, medical devices and diagnotics,<br />

industrial <strong>biotech</strong>nology, whole sale distribution and wireless<br />

communication.<br />

8 <strong>Bio</strong> <strong>Business</strong> January/February 2013


Regional Profile<br />

“There is a real culture of collaboration here based on the belief<br />

that what is good <strong>for</strong> one is good <strong>for</strong> all,” says Steve Hoey, director<br />

of business creation and development with CONNECT, a<br />

regional program designed to facilitate the creation of technology<br />

and life sciences products by linking inventors and entrepreneurs<br />

with the resources they need <strong>for</strong> success. Since 1985 it has been<br />

credited with assisting in the <strong>for</strong>mation and development of more<br />

than 3,000 companies.<br />

What can other municipalities learn from San Diego’s experience?<br />

“This is a bottom-up process,” says Lustig. “It’s a matter<br />

of putting all the right elements in place to ensure that you can<br />

grow organically.”<br />

Those elements include identifying a core group of early development<br />

companies like Hybritech that have good growth potential.<br />

Get the different people and organizations together, foster<br />

belief in a goal and then develop the infrastructure and support<br />

systems. And finally, use technology to create good communication<br />

among all members and bring all these elements together.<br />

“You can’t mandate success, you can’t make the lighting strike,<br />

but you can bring together all the elements to create an environment<br />

that gives the lighting a chance to strike,” Lustig adds. “It’s<br />

like rolling a snowball down a mountain: it keeps getting bigger<br />

bit by bit until it reaches a critical mass, and then it just takes off<br />

on its own.” BB<br />

San Diego <strong>biotech</strong> at a glance<br />

• The life sciences employ about 42,000 people in<br />

San Diego and generate approximately $22 billion<br />

in direct, indirect and induced economic activity.*<br />

• 42 per cent of San Diego county residents possess<br />

an associate’s degree or higher compared with<br />

35 per in the rest of the United States.*<br />

• 312 new technology companies started up in 2011,<br />

an increase of 14 per cent over 2010, leading to<br />

the creation of 1,100 new jobs.**<br />

• Merger and acquisition activity doubled in 2011<br />

to $6.6 billion from $3.8 billion in 2010**<br />

• Venture capital investment increased almost 25 per<br />

cent in Q4 2011 over the previous quarter.**<br />

• A record number of 1,215 patents were granted<br />

in Q4 2011, up from 940 in Q4 2010.**<br />

*2012 Southern Cali<strong>for</strong>nia Economic Impact Report,<br />

BIOCOM, Hendershot Economics<br />

**CONNECT Innovation report 4th quarter 2011<br />

and 2011 year summary<br />

The Voice of<br />

Life Sciences<br />

in Ontario<br />

Life Sciences Ontario (LSO) is a member-driven organization that represents and promotes the<br />

province's vibrant and diverse life sciences sector. LSO collaborates with governments,<br />

academia, industry and other life science organizations in Ontario, across Canada, and globally<br />

to promote and encourage commercial success throughout this diverse sector.<br />

Strengthening our industry through:<br />

• Advocacy & Policy Development<br />

• Facilitating Economic Development<br />

• Networking & Education<br />

• Mentorship & Professional Development<br />

• Marketing & Promotion<br />

• Representing Ontario’s Life Sciences industry<br />

in key partnerships<br />

Are you on the Map??<br />

Ontario Life Sciences Asset Map; An interactive online<br />

directory of life sciences organizations across the province<br />

"Diversity of Members, Unity of Voice”<br />

For more in<strong>for</strong>mation on becoming an LSO Member or Partner, please contact us:<br />

admin@lifesciencesontario.ca<br />

P: 416-426-7293<br />

109-1 Concorde Gate, Toronto ON M3C 3N6<br />

www.lifesciencesontario.ca<br />

www.biobusinessmag.com 9


Everything you Need<br />

Access to resources, financing, markets, and an educated and diverse population,<br />

mean Toronto has everything a <strong>biotech</strong> needs, mostly within a few kilometres<br />

By Talbot Boggs<br />

Although most of his business is in the United<br />

States, Greg Hines thinks Toronto is one of the<br />

greatest cities in which to own and operate a<br />

<strong>biotech</strong>nology company. And he should know. He’s<br />

been doing it <strong>for</strong> 12 years and continues to make<br />

Toronto his headquarters.<br />

Between 2000 and 2007, Hines was president of a<br />

DNA diagnostic testing company now called Luminex<br />

Molecular Diagnostics, when he left to start up his<br />

own company, Arctic DX. He rented “a cubicle of an<br />

office” from MaRS in downtown Toronto, then a<br />

fledgling organization dedicated to helping bring<br />

incubator companies in the <strong>biotech</strong>nology and life sciences<br />

sectors to life.<br />

Over the next three and a half years MaRS supplied<br />

Hines with office space at a subsidized rate and<br />

helped him develop a business plan and network with<br />

finance companies, regulatory authorities and other<br />

groups he needed to successfully develop his product<br />

and bring it to market. Last year, Life Sciences<br />

Ontario named Arctic DX its Emerging Life Sciences<br />

Company of the Year.<br />

Arctic DX’s main product, Macula Risk, identifies<br />

people who will lose their sight to age related macular<br />

degeneration so the disease can be managed to prevent<br />

blindness. It also helps in supporting the selection of<br />

intraocular lens implants <strong>for</strong> cataract patients. Macula<br />

Risk currently is being reimbursed by Medicare in the<br />

U.S. Hines has sales agents across the U.S. and a laboratory in<br />

Grand Rapids, MI, but still considers his company Canadian.<br />

“MaRS was just an incredible help,” says Hines. “There are so<br />

many things that are needed to successfully bring something like<br />

this to market, and they’re all right here in Toronto.”<br />

The reason <strong>for</strong> Hines’ love of Toronto as a place to do business<br />

can be summed up in one word: access—access to resources like<br />

MaRS, access to financing, access to great technical minds, access<br />

to an ethnically diverse population, and access to markets.<br />

“Only in a city like Toronto with world-class universities, hospitals<br />

and organizations like the Fields Institute (<strong>for</strong> Research in<br />

This photo: An artist’s rendering of the new phase two MaRS building in downtown<br />

Toronto. Below: Labs at the Centre <strong>for</strong> Commercialization of Regenerative<br />

Medicine (CCRM).<br />

Mathematical Sciences) could you find technicians and people<br />

who can design DNA assays and conduct up to 100 chemical<br />

experiments in one test tube at one time,” says Hines. “DNA testing<br />

also has a lot of ethnicity related to it and Toronto has people<br />

from all over the world. It’s fantastic.”<br />

A lot of organizations and people share Hines’ enthusiasm<br />

<strong>for</strong> the city. Toronto has the largest combined biomedical and<br />

<strong>biotech</strong>nology cluster in North America and is home to more<br />

than 11,000 principal researchers and technicians operating out<br />

of the University of Toronto’s faculty of medicine, 100 hospitals<br />

and research institutions and nine teaching hospitals. Toronto-<br />

10 <strong>Bio</strong> <strong>Business</strong> January/February 2013


Regional Profile<br />

based researchers have earned a world-class reputation <strong>for</strong><br />

medical and technological breakthroughs in cancer, central<br />

nervous system disorders, genomics, stem cells and cardiovascular<br />

and respiratory diseases.<br />

The Discovery District boasts Canada’s largest concentration<br />

of research institutes, business incubators and business support<br />

services, spanning 2.5 kilometres in the heart of downtown<br />

Toronto, making it the densest geographical centre <strong>for</strong> research in<br />

the world.<br />

“The whole development cycle is here,” says Sonia Sanhueza,<br />

a MaRS adviser and leader of its life sciences and health care<br />

practice. “Organizations realize Toronto is the place to be because<br />

it offers great opportunities to develop licensing agreements and<br />

partnerships and get the investment, marketing and other advice<br />

to move toward commercialization.”<br />

“All the pieces of the puzzle are here: hospitals,<br />

research institutes and large pools of capital all<br />

within a few blocks of each other.”<br />

Founded in 2000 and opened in 2005, MaRS works with<br />

companies in life sciences and health care, in<strong>for</strong>mation technology,<br />

communications and entertainment, clean technology and<br />

social innovation. It provides education, advisory services, market<br />

intelligence and access to talent, customers and capital to help<br />

organizations launch, grow and develop into market leaders.<br />

Every day more than 2,300 people from the scientific, business<br />

and finance communities come to work at MaRS, which is undergoing<br />

a $350-million expansion that will double its space and<br />

make it one of the world’s largest urban science, technology and<br />

research destinations.<br />

The major thrust of the Ontario government’s economic<br />

development and innovation strategy <strong>for</strong> the <strong>biotech</strong>nology and<br />

life sciences sectors has been to bring research and technologies<br />

to commercial fruition through organizations like MaRS, the<br />

Centre <strong>for</strong> Commercialization of Regenerative Medicine<br />

(CCRM) and MaRS Innovation, the commercialization agent<br />

<strong>for</strong> new research and discoveries emerging from 16 leading<br />

Ontario academic institutions.<br />

“Everything is here in one place” says MaRS Innovation<br />

President and CEO Raphael Hofstein. “You’ve got top-rated<br />

research activity, teaching hospitals promoting the concept and<br />

practice of transitional research (taking research from the bench<br />

to the bedside), and the capability to conduct clinical trials in our<br />

own backyard. The icing on the cake is the global medical technology<br />

and pharmaceutical companies.”<br />

The Toronto region is a hub <strong>for</strong> medical devices. Sixteen of the<br />

top 25 global medical device companies now operate in the<br />

Toronto region, and Sanhueza estimates that about 70 per cent of<br />

clients in MaRS’ health care and in<strong>for</strong>mation technology practice<br />

are involved in designing and producing medical devices.<br />

As well, Toronto is at the epicentre of the recently created<br />

Ontario-Quebec Life Sciences Corridor, which brings together<br />

the life sciences research, business and investment communities in<br />

the two provinces, with government partners, to achieve worldclass<br />

innovative discoveries and successful commercialization.<br />

Toronto’s <strong>biotech</strong>nology business has continued to boom, even<br />

during the economic downturn, with hundreds of millions of dollars<br />

in new buildings and infrastructure projects, the <strong>for</strong>mation of<br />

new strategic partnerships and the commercialization of new<br />

processes, products and technologies.<br />

“The sector has continued to be very strong and has thrived<br />

during the recent difficult economic times, primarily because the<br />

companies involved in it are well-managed and financially secure,”<br />

says Matt Buist, Vice President of Life Sciences Ontario. “Sure,<br />

there might have been some cutbacks, but they haven’t stopped<br />

the growth.”<br />

Buist says the only weak link in the Toronto <strong>biotech</strong>nology<br />

chain at the moment is in pharmaceuticals because patents on<br />

some of the world’s largest drugs such as Lipitor and Viagra have<br />

already, or are about to come off patent. “This can mean a big loss<br />

in revenues,” says Buist.<br />

While much of the public funding of the sector comes from<br />

the Ontario Ministry of Economic Development and Innovation<br />

(MEDI), private-sector collaboration among the various areas has<br />

in the past been mostly in<strong>for</strong>mal. However, the sector now is<br />

beginning to create a better “culture of collaboration.”<br />

“All the pieces of the puzzle are here: hospitals, research institutes<br />

and large pools of capital all within a few blocks of each<br />

other,” says Dr. Michael May, Chief Executive Officer of the<br />

CCRM. “When intellectual property is identified it is passed on<br />

to organizations like ours which then incorporate it into a project<br />

and then assign people to the task of bringing it to commercial<br />

fruition. It’s something we can brag about because there aren’t<br />

many cities or countries that can do it as easily as we can.” BB<br />

Toronto <strong>biotech</strong> at a glance<br />

• Largest combined biomedical and <strong>biotech</strong>nology<br />

cluster in North America.<br />

• Annual revenues of $4 billion, employing 140,000<br />

people.<br />

• 11,000 principal researchers and technicians, 100<br />

hospitals and research institutions, and nine teaching<br />

hospitals.<br />

• More than $1 billion a year in private medical<br />

research investments.<br />

• Home to nearly 50 global pharmaceutical and<br />

<strong>biotech</strong>nology companies.<br />

• Home to more than half of Canada’s major<br />

pharmaceutical companies. Of the 17,000<br />

pharmaceutical jobs in Canada, 11,000 are based<br />

in the Toronto area.<br />

www.biobusinessmag.com 11


Trans<strong>for</strong>ming Medical<br />

Improvements in science and technology has seen the industry<br />

flourish in Canada but there is still a lot of room <strong>for</strong> growth<br />

By Nicolas Heffernan<br />

With the Canadian medical device sector it’s what might<br />

be rather than the reality that gives hope <strong>for</strong> the future.<br />

In 2008, the Canadian medical device market was<br />

valued at $6.4 billion, or less than three per cent of the world<br />

market, but growing faster than the global drug market. By comparison,<br />

the American market was valued at more than $100 billion;<br />

approximately 42 per cent of the global market. In 2009,<br />

medical device sales reached $220 billion in Canada.<br />

“I think our members are well aware that the world around<br />

them is becoming more complex so the ability to be able to influence<br />

it and deal with it all takes time,” says Brian Lewis, CEO of<br />

Medical Technology Companies (MEDEC), the national association<br />

created by and <strong>for</strong> the Canadian medical technology<br />

industry. “The whole thing now is doing the right things to get<br />

there and that’s where we need to focus on. It’s about being ready<br />

to deal with the situation as it comes <strong>for</strong>ward in the future.”<br />

But Lewis sees the desire that will help Canada move out of<br />

the current “tough environment”.<br />

“It’s the idea that it can thrive,” Lewis says. “We just have to<br />

be able to pull it all together. There’s a desire to make it want to<br />

work and if we position it properly I believe we absolutely can get<br />

the growth that’s required or the processes modified to make<br />

Canada more competitive on the world stage.”<br />

The state of the industry<br />

Currently, Canada is a modest player on the global medical<br />

device stage, primarily as a purchaser and small exporter to the<br />

U.S. market. While the U.S. remains Canada’s primary partner<br />

<strong>for</strong> exports, Germany, the United Kingdom and the Netherlands<br />

are gaining a bigger share. There has also been a shift in the<br />

source of Canada’s medical device imports since 2000. The<br />

United States still accounted <strong>for</strong> 51.1 per cent but China,<br />

Mexico and Ireland have more than doubled their share of the<br />

Canadian market, while Germany and Switzerland also posted<br />

higher growth rates.<br />

Canada’s device manufacturing industry consists of about<br />

1,500 facilities and 35,000 employees. In the United States there<br />

were nearly 5,300 medical device companies in 2007, employing<br />

more than 365,000 people. Most medical device manufacturing<br />

and development facilities in Canada are small and medium<br />

sized enterprises (SME), with 57 per cent employing fewer than<br />

25 employees and 37 per cent having 25 to 49 employees. Only<br />

four per cent employ 50 to 150 workers and less than one per<br />

cent is considered large with more than 150 employees. About<br />

90 per cent of Canadian medical device facilities are Canadianowned,<br />

although <strong>for</strong>eign-owned facilities tended to be larger as<br />

21 per cent had 50 or more employees.<br />

12 <strong>Bio</strong> <strong>Business</strong> January/February 2013


Medical Devices<br />

Technology<br />

Canadian clusters<br />

The industry has a presence throughout Canada, but is concentrated<br />

in Ontario and Quebec where the majority of all facilities<br />

were located.<br />

Out west, B.C. specializes in interventional and implantable<br />

cardiology, diagnostic testing and analysis, in addition to orthopedic<br />

devices. More than 60 medical device companies are operating<br />

in the province and Simon Fraser University supports the cluster.<br />

Winnipeg is also home to a cluster with expertise in MRI, which<br />

is supported by the University of Manitoba, Winnipeg’s Health<br />

Sciences Centre and the Centre <strong>for</strong> the Commercialization of<br />

<strong>Bio</strong>medical Technology. More than 60 medical device firms are<br />

located around Edmonton and Calgary; Alberta is supported by<br />

the National Institute <strong>for</strong> Nanotechnology and the National<br />

Research Council Institute <strong>for</strong> <strong>Bio</strong>diagnostics West.<br />

The two biggest clusters in Ontario are located in Ottawa and<br />

Toronto but there are pockets of advanced activity elsewhere in<br />

the province, especially in diagnostic imaging in London. Ontario<br />

is supported by 24 colleges and 20 universities, as well as research<br />

institutes and the MaRS Centre <strong>for</strong> Technology and Innovation.<br />

About 675 companies are based in Ontario.<br />

Quebec’s centre of the device industry is Montreal, with the<br />

province playing host to more than 350 companies with a strong<br />

B.C.<br />

60<br />

Alberta<br />

60<br />

Manitoba<br />

60<br />

Ontario<br />

Quebec<br />

675 350<br />

▲ B.C. (specifically Vancouver) has more than 60 medical device<br />

companies operating in the province. Winnipeg, Calgary and<br />

Edmonton boast more than 60 medical device firms. In Ontario<br />

device clusters are currently focused in Ottawa and Toronto with<br />

675 companies. Montreal is at the centre of Quebec's medical<br />

device industry, hosting more than 350 companies.<br />

optic-photonic sector, partnering with a number of universities<br />

with access to national research centres and support available<br />

through Canada’s Networks of Centres of Excellence.<br />

Regulation<br />

Devices are regulated by Health Canada using a four-tiered classification<br />

system, with the device manufacturer, importer, or distributor<br />

responsible <strong>for</strong> classification. Class one devices are low<br />

risk and are exempt from licensing and do not need to obtain<br />

Health Canada approval to market. Class twos are low-to-medi-<br />

www.biobusinessmag.com 13


Devices<br />

Imports<br />

um risk devices and require that applicants assert the safety<br />

and efficacy of their device without having to submit evidence<br />

to support this conclusion. Class threes are medium-to-high<br />

risk devices that are surgically invasive and<br />

intended to be absorbed into the body and remain there<br />

<strong>for</strong> at least 30 consecutive days. Class four devices are highrisk<br />

and surgically invasive that diagnose, control or correct<br />

a defect in the central cardiovascular system. Class three and<br />

four devices require more documentation and provision of evidence<br />

proving the safety and effectiveness of their device.<br />

On average, medical devices in Canada take two to five years<br />

to progress from concept to commercialization depending on the<br />

complexity and regulatory classification. The lifecycle of a device<br />

in the marketplace tends to be a maximum of five years but a<br />

competitor will usually move in with a competing product<br />

between 18 months to three years. “There is not the same degree<br />

of reliance on patents as you see in pharmaceuticals just because it<br />

is so easy to be able to change a product just slightly,” says Lewis.<br />

“So you would think that this would mean it would be less competitive<br />

but it is actually... because of your ability to develop products<br />

and improve upon something that’s there.”<br />

Strengths<br />

Canada brings numerous strengths to the global medical device<br />

market. Canada can boast a well educated population. Canada<br />

ranks second out of 17 OECD countries in high-school completion<br />

rate, first in college completion and fifth in university completion.<br />

Canada is ranked eighth in the quality of research published<br />

by its universities, ahead of both the U.S. and the U.K. But<br />

despite the high rankings in these categories, Canada ranks only<br />

14th in health innovation. “The quality of the research being done<br />

in Canada is second to none,” says Lewis. “It really is high-quality<br />

research but it’s not just research, it’s being able to take that<br />

research and commercialize it and apply it and adopt it.”<br />

Canada also brings an emerging capacity <strong>for</strong> collaboration<br />

among companies, university researchers and health sector partners<br />

with aid from government-sponsored programs and policy.<br />

Another strength is Canada’s strong track record <strong>for</strong> conducting<br />

clinical trials, currently ranking<br />

fourth in the world in trial<br />

capacity and hosting 4.1 per<br />

cent of the world’s trial<br />

sites. Canada also boasts<br />

global leadership in<br />

health technology assessment<br />

(HTA), a decisionmaking<br />

strategy that<br />

compares the cost and<br />

effectiveness a new technology<br />

with competing<br />

existing technologies.<br />

Finally, Canadian policy<br />

has begun to support the<br />

3%<br />

3%<br />

3%<br />

5%<br />

21%<br />

Other<br />

Italy<br />

$48 million<br />

U.K.<br />

$50 million<br />

China<br />

$57 million<br />

Germany<br />

$85 million<br />

65%<br />

United<br />

States<br />

$1,195 million<br />

Devices<br />

Exports<br />

Japan<br />

$274 million Mexico<br />

$280 million<br />

4% Germany<br />

4% $424 million<br />

26%<br />

7%<br />

China<br />

Other<br />

$469 million<br />

7%<br />

52%<br />

United<br />

States<br />

$3,404 million<br />

device sector through tax incentives <strong>for</strong><br />

research and development, with<br />

Canada offering some of the most generous<br />

scientific research and experimental<br />

development (SR&ED) tax incentives<br />

among G7 countries. But the incentives don’t<br />

support bigger and more successful companies.<br />

Issues<br />

Despite these advantages, Canada is still a relatively modest<br />

player in the global arena in part because of the numerous challenges<br />

the industry faces. Today, nearly 10 per cent of Canadian<br />

medical device companies are spin-offs from universities, laboratories<br />

or other firms and on average, a medical device exceeds five<br />

years be<strong>for</strong>e it begins recuperating initial investments. But <strong>for</strong><br />

many small firms and start-ups, stable and sustained financing<br />

through the initial prototype phases can present a huge barrier to<br />

innovation. The device industry in Canada is very dependent on<br />

partnerships with other institutions to research, develop, innovate<br />

and validate new technology, but the large and bureaucratic<br />

nature of these institutions makes it difficult <strong>for</strong> some companies<br />

to access the system to achieve collaboration. Without access to<br />

venture capital partnerships and/or universities small companies<br />

can’t access the external government research funding, which is<br />

concentrated in academic institutions, making both private and<br />

public funding scarce.<br />

Venture capitalists invested nearly $4 billion in Canada’s<br />

device industries in 2001. At this time, Canada held approximately<br />

10 per cent of the total North American venture capital<br />

<strong>for</strong> the industry. But in each of the last three years, venture<br />

invested roughly $1 billion. Only 6.6 per cent of total venture<br />

capital invested in North America was invested in Canada in<br />

2009. But over the past decade, annual U.S. venture capital investments<br />

in the device industry averaged nearly $2.5 billion. The<br />

value of venture capital investments in medical technology<br />

increased by 40 per cent in the U.S. and by almost 60 per cent in<br />

Europe and Israel from 2000 to 2009.<br />

Improvements also have to be made to the regulatory process,<br />

as the timelines are a bit of an unknown, a lot of the fees<br />

are prohibitive given the size of the market and Health Canada<br />

doesn’t recognize approvals from other respected regulators like<br />

the FDA and the European Union. “It’s more of a process thing<br />

than a quality thing because Health Canada’s quality is really<br />

good,” says Lewis.<br />

Procurement is also a major challenge in Canada because<br />

many professionals favour short-term cost savings to participating<br />

members. Today, it is estimated by industry insiders that only 20<br />

per cent of supply chain officers are well-trained and only five per<br />

cent are professionally qualified as procurement professionals who<br />

14 <strong>Bio</strong> <strong>Business</strong> January/February 2013


Medical Devices<br />

Theranostics<br />

Drug-device combos make sense but path to success<br />

is paved with stumbling blocks<br />

Dr. Paul Walker, CEO of<br />

Spectral Diagnostics Inc.<br />

By Nicolas Heffernan<br />

Combining a drug and a device<br />

seems like a no-brainer but there<br />

are few companies who have<br />

found success with both.<br />

“The idea seems so obvious. The actual<br />

practicality of it is sort of the stumbling<br />

block,” says Paul Walker, President and<br />

CEO of Spectral Diagnostics Inc.<br />

Spectral is one of the few companies<br />

who have found success as a theranostics<br />

company. Spectral’s Endotoxin Activity<br />

Assay (EAA) is paired with a therapeutic,<br />

Toraymyxin, to help treat sepsis, with a<br />

specific focus on endotoxemia.<br />

Walker and a colleague developed<br />

the assay in the 1990s and it is currently<br />

being used in more than 200 hospitals.<br />

“We recognized that the major financial<br />

payback <strong>for</strong> our shareholders would<br />

be associated with matching [the assay]<br />

with a therapeutic so we licensed what<br />

we considered to be the best therapeutic<br />

on the market,” says Walker.<br />

Companies that develop a companion<br />

diagnostic might think they are limiting<br />

the size of their market, “although it<br />

also contributes very highly to the success<br />

of the product because now you<br />

know exactly who to give it to,” says<br />

Walker. “So I would say that’s the direction<br />

we’ve taken. We’ve said, ‘No, we<br />

don’t want to treat everybody. We want<br />

to treat the people that are going to be<br />

dramatically improved by this therapeutic<br />

intervention.’”<br />

Technicians<br />

working at<br />

ProMetic Life<br />

Sciences Inc.<br />

Walker believes more companies will<br />

find success with combination devices<br />

but it’s a difficult process. “I believe it<br />

will continue, it’s just these things are<br />

time consuming and expensive to develop—a<br />

really good diagnostic or a really<br />

good biomarker,” says Walker.<br />

Another company to find success with<br />

a combination device is ProMetic Life<br />

Sciences Inc. ProMetic’s technologies are<br />

used to remove pathogens from blood,<br />

and extract and recover valuable proteins<br />

from plasma, while its therapeutics<br />

treat blood-related disorders. Prometic<br />

also offers enabling technology that other<br />

companies can license to develop their<br />

own therapeutics.<br />

The technology was developed at<br />

Cambridge University and the company<br />

is now headquartered in Laval, Quebec.<br />

“Combining this basically is a means<br />

<strong>for</strong> us to retrieve a higher value <strong>for</strong> our<br />

core competency, core technology. And<br />

we’re not fighting <strong>for</strong> those types of<br />

agreements; they actually fit with the strategic<br />

understanding and focus of our<br />

partners,” says President and CEO Pierre<br />

Laurin. He says plenty of similar businesses<br />

are out there and more might<br />

follow suit.<br />

“These are companies that started<br />

enabling others and all of a sudden<br />

they’re saying, ‘Hang on a minute, I can<br />

keep on enabling others but I’m to develop<br />

a pipeline of our own and license out<br />

something more valuable down the<br />

road.’ So I don’t think it’s unique but I<br />

think people don’t get to see the benefit<br />

of this because they end up being bought<br />

out by big pharma,” says Laurin.<br />

understand how to best identify total value of the products and<br />

technology they procure. “Our hospitals are running on such a<br />

tight budget. Our health care system is essentially running on<br />

fumes in some ways and what’s happening there is decisions about<br />

adoption of new technology in terms of bringing that into the<br />

hospital and the procurement process ends up being challenged<br />

because the focus is on cost minimization,” says Lewis.<br />

In the device sector, the singular focus on the cost of devices<br />

has resulted in decisions to acquire new devices, often with little<br />

attention to quality of patient care outcomes and limited, if any,<br />

involvement of physicians or other health professionals. “So it’s<br />

about looking at it more broadly, being able to budget more<br />

broadly. It’s looking at short-term price minimization. It’s not<br />

looking at cost-effectiveness; it’s looking at price minimization<br />

rather than looking at longer cost impact.”<br />

Lewis also wants to see product purchasing that supports<br />

Canadian innovation with an emphasis on SME growth and the<br />

connectors to MNE growth. There needs to be a demonstration<br />

of the value of medical technology with MNEs creating the<br />

foundation. “It is about what are the patient outcomes, what are<br />

the cost outcomes and what are the true benefits, and the measure<br />

has to be different <strong>for</strong> devices than it is <strong>for</strong> pharmaceuticals,”<br />

says Lewis.<br />

Another issue <strong>for</strong> small companies is launching their products<br />

in Canada. Canada must work on developing the environment<br />

that will allow research to stay in Canada beyond the development<br />

stage. “Because of the regulatory and procurement environment in<br />

Canada is such that a lot of these companies tend to go to the<br />

United States or Europe first to market their products and to get<br />

them approved,” says Lewis.<br />

www.biobusinessmag.com 15


What needs to be done<br />

In order to get to where industry leaders like Israel and the U.S.<br />

are, input from all the stakeholders in Canada is essential.<br />

“Sometimes things get developed in isolation and then they are<br />

launched upon the industry,” says Lewis. “Possibly if they got into<br />

a conversation with the industry as well as the doctors, they could<br />

possibly come up with a solution that would achieve the same end<br />

without limiting the utilization or adoption of a new technology.”<br />

Also the Ontario Health Technology Assessment Committee<br />

(OHTAC), a standing advisory subcommittee of the Health<br />

Quality Ontario (HQO) Board that makes recommendations<br />

about the uptake, diffusion, distribution, or removal of health<br />

interventions in Ontario and MaRS EXCITE, the premarket<br />

evaluation of products in terms of health technology assessment<br />

—looking at broad health outcomes rather than looking just at<br />

price must gain traction and be the spur <strong>for</strong> MNEs to invest in<br />

Canada are showing promise. “I think if those large organizations<br />

invest in Canada more, it helps create a stronger medical device<br />

community,” says Lewis. “It actually causes those biomechanical<br />

engineering individuals to cluster and begin to work on stuff. I<br />

think you need that external investment to come into Canada to<br />

really help build the foundations that will actually help the smaller<br />

organisations as well.”<br />

Lewis would also like to see government help companies<br />

through the regulatory process with cost recovery help and enable<br />

new technologies to be “onboarded” more easily. “And by easily<br />

I’m not talking about safety and efficacy,” says Lewis. “I’m talking<br />

about the ability to have funds and the ability to look at something<br />

new that’s coming along and onboard it because there just<br />

isn’t enough expense budgets available in the hospitals.”<br />

Reasons <strong>for</strong> hope<br />

Lewis sees reason <strong>for</strong> hope because of the interest from governments<br />

across Canada, industry’s desire to work through the tough<br />

environment and the strong research done that creates a strong<br />

foundation.<br />

“There are sparks of hope—I shouldn’t say hope because it’s<br />

even a little stronger than that. There’s work being done to look<br />

at this earlier and earlier which is really... cutting innovation that<br />

puts us ahead of the rest of the world in terms of the development<br />

and evaluation of products,” says Lewis. “It’s just tweaking a few<br />

other things and there’s openness and understanding. We’ve just<br />

got to be able to get parties in the room and get into open dialogue<br />

and trust to be able to make those few adjustments that we<br />

need to make it a better environment. I think we can move up the<br />

chain significantly if we play our cards right.” BB<br />

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The Human Pathogens and Toxins Act is designed to protect<br />

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accidental or deliberate release of human pathogens and toxins<br />

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Under the Human Pathogens and Toxins Act, if you are handling<br />

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Destinataires : Personnes manipulant des agents pathogènes<br />

humains et des toxines<br />

La Loi sur les agents pathogènes humains et les toxines vise à protéger<br />

la santé et la sécurité de la population contre les risques associés au<br />

rejet accidentel ou délibéré d’agents pathogènes humains et de<br />

toxines par un centre de recherche ou un autre établissement.<br />

Selon la Loi sur les agents pathogènes humains et les toxines, si vous<br />

manipulez des agents pathogènes humains ou des toxines, vous<br />

pourriez avoir à remplir certaines obligations. La meilleure façon de<br />

savoir si la Loi s’applique à vous consiste à vous inscrire auprès de<br />

l’Agence de la santé publique du Canada en consultant notre site Web.<br />

To register or to obtain more in<strong>for</strong>mation about<br />

laboratory biosafety in Canada, please visit<br />

www.publichealth.gc.ca/pathogens<br />

Pour vous inscrire ou pour en savoir plus sur la biosécurité<br />

en laboratoire au Canada, veuillez consulter le site<br />

www.santepublique.gc.ca/pathogenes<br />

16 <strong>Bio</strong> <strong>Business</strong> January/February 2013


Medical Devices<br />

Out of the Ashes<br />

Neovasc ressurects as a Canadian device leader<br />

By Nicolas Heffernan<br />

It’s not very often you hear the CEO of a small startup cite the<br />

market collapse of 2008 as one of the best things to happen to<br />

his business, but Alexei Marko is convinced Neovasc wouldn’t<br />

be thriving now if it wasn’t <strong>for</strong> the crash.<br />

Marko had recently been appointed CEO of Medical Ventures<br />

Corp. and shortly into his tenure he completed the acquisition of<br />

two Israeli companies, B-Balloon Ltd. and Neovasc Medical Ltd.<br />

The newly <strong>for</strong>med company rebranded itself as Neovasc. But<br />

shortly after that “all hell broke<br />

loose” on the capital markets <strong>for</strong>cing<br />

Marko and his CFO Chris Clark to<br />

re-evaluate their company. Neovasc<br />

was fairly well capitalized but it was<br />

also a fairly big company, with multiple<br />

projects on the go, facilities in<br />

Israel and 10 different product<br />

development programs.<br />

“In some ways it gave small companies<br />

such as ourselves the licence<br />

to just <strong>for</strong>get about what people<br />

thought about what we were doing<br />

and just do what we thought the right thing was,” Marko says.<br />

For Marko and Clark, the right thing was stripping the company<br />

to its bare bones and starting almost from scratch, cutting<br />

staff down from to 25 from 75 people, and cutting any programs<br />

that weren’t showing immediate promise or potential <strong>for</strong> cash<br />

flow. The business was pared down to a tissue program and<br />

reducer and refractory angina (RFA) product that had been<br />

acquired out of the Israeli Neovasc.<br />

“It was a very difficult thing to do but it was absolutely the<br />

right thing to do,” says Marko. “It’s never easy to fire people. It’s<br />

never easy to lay people off. I don’t think we had any choice and I<br />

look back on it now and it was really one of the keys that allowed<br />

us to get to where we are.”<br />

Now things are looking up <strong>for</strong> the Vancouver-based company.<br />

At the moment, the basis <strong>for</strong> Neovasc’s work is its tissue business,<br />

which is focused on the transcatheter heart valve industry. “That<br />

business is cash flow positive and what it’s allowed us to do is<br />

really pay <strong>for</strong> the whole company and the overheads and actually<br />

start to underwrite the vast majority of our R&D and pipeline<br />

projects. So while as a whole the company is not a cash flow<br />

positive company, we have a very, very low burn,” Marko says.<br />

The reducer is a device that treats RFA by snaking a catheter<br />

through the jugular vein and restricting the venous outflow, creating<br />

back pressure on the blood flowing in <strong>for</strong>cing it into areas it<br />

wouldn’t normally go.“It’s a little like pinching off the end of a<br />

garden hose,” says Marko. “If you have a leaky garden hose, the<br />

blood or the water will take the path of least resistance down the<br />

middle of the hose if you let it run freely. But if you pinch off the<br />

end of the hose a little bit so there’s some back pressure, that water<br />

or blood will start squirting into areas of high resistance where it<br />

wasn’t going be<strong>for</strong>e.” The<br />

blood is <strong>for</strong>ced into these<br />

The Tiara. aschemic or non-oxygen<br />

receiving territories of the<br />

heart which provides a lot<br />

of relief from symptoms<br />

from aschemia from lack of<br />

blood flow to these areas.<br />

The reducer can be sold in<br />

The Reducer complete with delivery system.<br />

Europe. It’s also running a randomized pivotal trial that’s nearing<br />

completion. The company plans to launch the product soon after<br />

the clinical trial is finished.<br />

The other product in the pipeline is the Tiara transcatheter<br />

mitral valve. Currently, the approach <strong>for</strong> most transcatheter valve<br />

replacement has been with the aortic valve but Neovasc is trying<br />

to tackle the much more complicated mitral valve.<br />

Progress was accelerated because of the experience and knowledge<br />

gleaned from Neovasc’s tissue and reducer programs. “I don’t<br />

know if we are the leading but certainly if somebody were to<br />

throw out a list with all the promising programs, we’re credited<br />

with being one of them,” says Marko.<br />

Neovasc is now implanting its valves into a sheep model with<br />

a view to doing a first human trial in late 2013. This has never<br />

been done successfully. BB<br />

www.biobusinessmag.com 17


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First Real Time Breast Cancer<br />

Chemotherapy Guidance Tool<br />

Medical Devices<br />

Test can accurately predict whether treatment will work<br />

By Nicolas Heffernan<br />

The RDA is a test that allows doctors to know with 99 per<br />

cent certainty whether a patient with breast cancer will not<br />

achieve full pathologic complete response (pCR) to the<br />

chemotherapy they are receiving early in treatment, so they can be<br />

considered <strong>for</strong> another <strong>for</strong>m of treatment.<br />

“The patients will benefit because they will have reduced toxicities<br />

from various kinds of ineffective therapies,” says Ken<br />

Pritzker, CEO. “Because there will be decreased chemotherapy<br />

this will reduce cost from the complications of chemotherapy and<br />

it will reduce the cost in terms of keeping the amount of facilities<br />

that are required to provide chemotherapy. So there’s a patient<br />

savings and there’s a cost saving.”<br />

For breast cancer, chemotherapy is given in six to eight cycles<br />

over four to five months. Currently, patients get the full treatment,<br />

and most patients’ tumours will shrink at least 50 per cent, however<br />

less than 25 per cent will get a survival benefit. But almost<br />

half the patients who have breast cancer will get chemotherapy as<br />

part of their treatment.“So what it means is we’re over treating<br />

these patients with drugs that have severe and serious side effects,”<br />

says John Connolly, VP Corporate Development.<br />

And that’s where the RDA comes in. The test can accurately<br />

predict, through the analysis of a patient’s ribosomal RNA,<br />

whether the treatment path they’re on will help that patient<br />

achieve full pCR.<br />

“We have the first real time chemotherapy guidance tool to<br />

address this problem,” says Connolly. “It’s the first test on the<br />

market that measures response to chemotherapy early during<br />

therapy—early enough so that the clinical pathway can be adjusted<br />

depending on whether we can detect that the patient is<br />

responding or not.”<br />

After the patient has had her infusion of chemotherapy, she’ll<br />

be back to see her physician—about two weeks after the treatment<br />

—and a fine needle aspiration biopsy will be taken of the tumour.<br />

After the biopsy is taken it’s immediately put in an RNA stabilization<br />

reagent and a test tube is then sent to a central lab. The<br />

RNA is isolated and analyzed to produce an RDA score. Rna gets<br />

the tally by looking at the ribosomal RNA of the patient’s tumour.<br />

If there is a high level of ribosomal RNA disruption it means that<br />

the therapy is working and that the patient should continue along<br />

that regimen. If there is an inadequate level of RNA disruption it<br />

means that the therapy is not working and that continued cycles<br />

will not lead that patient to success. The results are then sent back<br />

to the ordering physician.<br />

“This is a very strong diagnostic tool to identify non-responders.<br />

It’s not as strong to identify—we can’t say categorically that<br />

you are responding,” says Connolly.<br />

Rna is hoping to be able bring its product to market by the end<br />

of 2013 in part because it isn’t selling the device as a product, but<br />

as a service.<br />

Pritzker believes the RDA has the capacity “at its ultimate to<br />

increase survival of breast cancer by 10 per cent.”<br />

“Our [key opinion leaders] are saying we prove this out this<br />

should become a standard of care in treating breast cancer patients<br />

with the range of<br />

breast cancer<br />

drugs available,”<br />

adds Connolly.<br />

With the<br />

number of new<br />

chemotherapy<br />

drugs hitting the<br />

market, the test<br />

is timely. “The<br />

whole idea is to<br />

give the appropriate<br />

therapy,<br />

not the most<br />

therapy,” says<br />

Pitzker. “So this<br />

is truly personalized<br />

medicine.<br />

We’re talking<br />

now, individual<br />

patients and the<br />

outcomes of<br />

individual<br />

patients as seen<br />

as guided by<br />

individual<br />

response to this<br />

test on their own<br />

tumour.” BB<br />

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www.biobusinessmag.com 19


Making Profound Steps in<br />

Prostate Cancer Treatment<br />

By Nicolas Heffernan<br />

Steven Plymale believes Profound Medical can revolutionize<br />

prostate cancer treatment.<br />

The Toronto-based company is bringing to human trials<br />

a device it says will allow practitioners to precisely eliminate<br />

cancer by ablating the entire prostate gland, removing the tissue<br />

but without causing the side effects that current treatments are<br />

grappling with.<br />

“The potential <strong>for</strong> a big success here exists and the potential<br />

<strong>for</strong> having an impact—a major impact on this disease—exists,”<br />

says Plymale. “We’re not doing something that’s a small incremental<br />

add to a long list of treatments. This therapy has the<br />

potential, I believe, of becoming the new gold standard <strong>for</strong> how to<br />

treat prostate cancer.”<br />

The issue with prostate cancer isn’t the mortality rate, as the<br />

five-year survival rate is nearly 100 per cent. After 10 years it<br />

drops to 98 per cent and after 15 years it falls to 91 per cent. “The<br />

issue with prostate cancer isn’t mortality, its morbidity,” says<br />

Plymale. “And by that we mean the quality of life that comes with<br />

the side effects of treatment because once you intervene, men are<br />

being almost guaranteed that they will be cured. But, and it’s a big<br />

but, many men are experiencing significant quality of life issues<br />

which is really what we’re trying to resolve with our technology.”<br />

The side effects include short-term constipation, incontinence,<br />

erectile dysfunction, infertility and urinary problems. Currently,<br />

Profound Medical’s<br />

mimimally invasive<br />

device will treat<br />

prostate cancer.<br />

Steven Plymale, CEO<br />

there are number of different treatment options including surgery,<br />

radiation therapy, brachytherapy, radical prostatectomy, HIFU<br />

(high-intensity focused ultrasound), and cryotherapy. Many of<br />

these techniques are time-intensive and invasive.<br />

“We find ourselves in the sweet spot. The actual energy delivery,<br />

the actual time it takes to ablate your prostate with our device<br />

is only 30 minutes,” says Plymale.<br />

“We just want to have the ability to bring an alternative to the<br />

table that would reduce side effects and we believe we’ll be able to<br />

accomplish that.” The only critical side effect, he says, is that the<br />

patient will be unable to have children. “Beyond that... it’s a gland<br />

that can be sacrificed and if it’s a gland that’s become cancerous,<br />

any man would quickly step up and volunteer to take it out and<br />

do everything [they could] to eliminate their risk of that cancer<br />

metastasizing.”<br />

Preclinical trials were done in a nine-canine study at the<br />

University of Western Ontario and the results should be published<br />

soon. Human trials will follow.<br />

Plymale sees this procedure as a simple outpatient procedure.<br />

After a patient is prepped a probe is inserted into the penis,<br />

snaked through the urethra into the prostate and lined up with<br />

images that have been taken and monitored via computer. A software<br />

algorithm controls 10 transducers which emits a rotating<br />

beam of energy that can be contoured, heating to the edge of the<br />

prostate at 55 degrees—the point where cell death occurs.<br />

The MR images show the diagnostic in<strong>for</strong>mation and thermometry<br />

in real time. Every five seconds the MR relays how hot<br />

20 <strong>Bio</strong> <strong>Business</strong> January/February 2013


Medical Devices<br />

the tissue is and when the target boundary reaches 55 degrees, it<br />

moves. Unlike some other treatments that don’t have this feedback,<br />

the surgeons are pointing and shooting and don’t know until<br />

sometime in the future whether or not they were successful in<br />

achieving the result they wanted.<br />

“We will know in real time how we heated the tissue and that<br />

allows us to precisely deliver energy where we want but more<br />

importantly, it allows us to precisely not to deliver the treatment<br />

where we don’t want to,” says Plymale.<br />

“The potential <strong>for</strong> a big success here exists and<br />

the potential <strong>for</strong> having an impact—a major<br />

impact on this disease—exists.”<br />

Once the tissue is heated to the point of cell death it sloughs<br />

off and is absorbed into the body. Eventually, it shrivels up, scars,<br />

and is no longer cancerous.<br />

Following the procedure, the patient would be monitored to<br />

ensure any pain, discom<strong>for</strong>t or bleeding is being managed. “To be<br />

quite honest, we need to learn a lot about this through <strong>for</strong>mal<br />

clinical studies and that’s the objective of our safety study... to<br />

demonstrate that we can insert this device to treat safely and then<br />

send these patients home,” says Plymale.<br />

Profound Medical began as a six-person team and did much<br />

of the proof of concept work out of Sunnybrook Hospital. The<br />

company was tight on funds so in late 2010 started an ef<strong>for</strong>t to<br />

raise money and add staff. Plymale joined the board late in<br />

2008 as an independent director and was named CEO in<br />

November 2011.<br />

Profound should have the device—at least an early version of<br />

it—ready in two to three years. Plymale is planning <strong>for</strong> the initial<br />

launch to take Profound through Canadian and European markets<br />

be<strong>for</strong>e the U.S. because of the long and labour intensive<br />

regulatory path. BB<br />

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www.biobusinessmag.com 21


<strong>Business</strong> Leadership<br />

Mark<br />

Poznansky<br />

President and CEO of the Ontario Genomics Institute credits his<br />

success to his team’s abilities, not just his ideas<br />

By Nicolas Heffernan<br />

After being awarded the Order of Ontario and the Order<br />

of Canada, there’s not much room <strong>for</strong> improvement, but<br />

Mark Poznansky, President and CEO of the Ontario<br />

Genomics Institute (OGI), couldn’t hide his pride at being<br />

awarded a lifetime achievement award from Life Sciences<br />

Ontario.<br />

“It’s different,” he says. “First of all, it’s pretty Toronto-centric<br />

and I’m not from Toronto so that was kind of neat. And it’s more<br />

of an industrial award so it probably a little more directly answers<br />

what my objectives are here at OGI. My objectives were never to<br />

get an Order of Canada or to get an Order of Ontario but my<br />

objectives are <strong>for</strong> making life sciences strong in the province. So if<br />

these folks associated with it decide to give<br />

me this honour I’m absolutely tickled. The<br />

other thing is to think that I’m even in<br />

similar shoes to people like Joe Rotman and<br />

Lou Siminovitch and Cal Stiller I think<br />

well maybe they made a mistake.”<br />

Poznansky has been involved in the life<br />

sciences <strong>for</strong> decades, in public, private and<br />

teaching capacities. Retired from his position<br />

as President and Scientific Director of<br />

Robarts Research Institute, in 2007, he<br />

started his own consulting company, G2G<br />

Consulting Inc. He served on the board of<br />

the OGI but when the <strong>for</strong>mer president<br />

stepped down, Poznansky jumped at the<br />

opportunity to work with “a bunch of<br />

really bright young people with PhDs and MBAs who wanted<br />

to make things happen and specifically business happen in the<br />

province,” he says.<br />

And the president and CEO cannot put enough emphasis on<br />

“The potential is enormous<br />

and we’re really at the<br />

cusp; we’re really at the<br />

start of this revolution.<br />

Some people call it the<br />

genomics revolution. I call<br />

it the life sciences<br />

revolution.”<br />

the change genomics will have on health care, agriculture and<br />

food, and the environment. “The potential is enormous and we’re<br />

really at the cusp; we’re really at the start of this revolution. Some<br />

people call it the genomics revolution. I call it the life sciences<br />

revolution.”<br />

Poznansky’s main goal is to make Ontario a major <strong>for</strong>ce in the<br />

life sciences industries. “We are currently a <strong>for</strong>ce in academia in<br />

life sciences—one of the best in the world,” he says. “But we have<br />

not translated much of that into real jobs, real wealth creation.<br />

So… virtually everything I do now is aimed at job and wealth<br />

creation in the life sciences sector.”<br />

Poznansky has a depth of leadership experience at both public<br />

and private institutions where he learned<br />

there is no difference in terms of how they<br />

should be run. “There’s a huge difference in<br />

terms of the products but running an institute<br />

and running a business and running a<br />

department, it should be the same: basically<br />

getting people to be productive and effective.”<br />

Poznansky takes a lot of his leadership<br />

strategy from the “type five leader” described<br />

in Jim Collins’ book, Good to Great. “A<br />

leader who has a huge ambition <strong>for</strong> the<br />

cause or the company or the institute… that<br />

ambition is really hot… It’s passion <strong>for</strong> the<br />

organization and the cause, and not <strong>for</strong> him<br />

or herself.”<br />

He believes the quality of the team dictates the success you will<br />

have. “It doesn’t matter how good a ‘team manager’ or ‘leader’ you<br />

are,” he says. “If your kids can’t play hockey, you’re not going to do<br />

well.” BB<br />

22 <strong>Bio</strong> <strong>Business</strong> January/February 2013

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