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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 />
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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 />
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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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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