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How to effectively manage your clinical trial
CHAMPIONING THE BUSINESS OF BIOTECHNOLOGY IN CANADA
March/April 2008
Leading
Change
Canadian Publications Mail Product—Sales Agreement 40063567
One year after taking the helm, Æterna
Zentaris’ president and CEO David J.
Mazzo reflects on his company’s
renewed strategy
Going public
Financial experts consider
the critical success factors
DNA barcoding
Canadian researchers use
genetics to redefine the
natural world
www.biobusinessmag.com
reply online at www.biobusinessmag.com
reply online at www.biobusinessmag.com
Contents
Bio Business
CHAMPIONING THE BUSINESS OF BIOTECHNOLOGY IN CANADA
Going public—
critical success
factors
16
Financial experts consider the
current state of the Canadian
IPO market for biotechs, options
available on the TSX for earlystage companies, and how to sustain
fiscal stability after going public
36
also inside
13
Q&A
standards
5
7
36
EDITOR’S NOTE
NEWS
NEW PRODUCTS
Æterna Zentaris Inc.’s president and CEO
David J. Mazzo, Ph.D. on his 25 years in the
industry and his first year with the Quebec
biopharmaceutical company
22
Discoveries
Using genetics to redefine the natural world:
a look at the Canadian researchers at the
forefront of DNA barcoding efforts
27
IP&Patenting
Can two really be better than one?
Commercializing IP through collaborative
arrangements
31
Business Management
Clinical trial design: Health Canada and
PharmaPros offer their takes on effectively
managing your clinical trial
38
In Person
“…I’ve realized that there really is no shortcut to doing it right.
Companies that take the shortcuts because they run out of
money or think they can find a way to the end faster than
anybody else often end up getting someplace that turns out
to be a dead end.”
- David J. Mazzo, Ph.D., president and CEO, Æterna Zentaris Inc.
Dr. Ivar Mendez is making dreams of brain
repair a reality
March/April 2008 Bio Business 3
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Bio Business
Editor’s Note
Championing the
Business of Biotechnology in Canada
Publisher
& CEO
Christopher J. Forbes
cforbes@jesmar.com
Executive
Editor
Bernadette Johnson
bjohnson@jesmar.com
Editor
Art
Director
Tammy White
twhite@jesmar.com
Contributors
Pierre-Paul Henrie
Catherine Muir
Trevor Newton
Peg Regan
Erica Tennenhouse
Secretary/
Treasurer
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bkukkonen@jesmar.com
Account
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Co-ordinator
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Manager
Production
Co-ordinator
Money, money, money
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Roberta Dick
robertad@jesmar.com
Crystal Allen
callen@jesmar.com
Bio Business is published 5 times per year by Jesmar
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Bio Business is a proud member of
BIOTECanada and the Toronto
Biotechnology Initiative (TBI).
Publisher of
LAB BUSINESS Magazine
LAB BUSINESS Cards
BIO BUSINESS Magazine
nce again this year I had the
pleasure of attending BioPartnering in Vancouver (see
page 12 for coverage), and once again,
my main topic of conversation with
attending companies was fundraising
and financing. Competition for dollars
continues to grow within the biotechnology sector among companies themselves, as well as
with other sectors such as
mining and energy. And by
many accounts, it isn’t
going to get easier—at
least not in the short term.
Earlier this year in a
posting on the MaRS blog,
Peter Tolnai, special advisor to MaRS (on the formation of capital pools)
and the MaRS Venture
Group, cited PricewaterhouseCoopers,
NVCA, Thomson
Financial Money Tree and the Dow Jones
Ernst & Young’s VentureSource, which
reported that the amount of venture capital (VC) invested in the U.S. during
2007 increased to US$29.5B and the
amount of VC raised by U.S. VC funds
increased to $34.7B in 2007. This represents the strongest year in VC investing
since 2000 and the largest amount raised
by VCs since 2001, writes Tolnai.
Although full-year data is not yet compiled, he continues, based upon three
quarters of data (see Q3 2007 VC
Industry Overview from Thomson
Financial), the amount of money raised
by Canadian VC firms declined in 2007
from 2006, and the amounts invested in
Canadian companies by Canadian VCs
was essentially flat during 2007 relative to
2006, and not rebounding like in the U.S.
Tolnai believes U.S. VC funds are
O
increasingly A: investing in Europe,
India and China, and yes, Canada (during the first three quarters of 2007, 41%
of the VC investment in Canada came
from U.S. VCs); and B: implementing
large and global investing strategies. “If
Canadian VC funds want to ride the
wave and raise additional capital, they
would be well advised to
consider the implications
of these trends, as the best
entrepreneurs in Canada
will increasingly have
direct access to U.S. VCs,”
he writes.
In our main feature
story this issue (page 16)
author Catherine Muir
looks at another route for
biotech financing—private
placements and the IPO
market—and
considers
Canadian companies making the leap to
become public entities. In “Going
Public–critical success factors” our experts
agree there is reluctance on the part of
investors—driven by an immediate return,
they are currently warm to medical devices
and clean tech companies. While the picture is not terribly rosy, all is not lost,
according to one VP: “[There are]
not many IPOs, since valuations are
extremely low right now, but there is still
money available.”
Thanks,
Bernadette
Printed in Canada
March/April 2008 Bio Business 5
reply online at www.biobusinessmag.com
News
BIOTECanada analyses the
2008 federal budget
T
he conservative government’s 2008 Federal budget held some encouraging news for the
biotechnology industry, according to industry association BIOTECanada. In particular, the
association highlighted significant traction with respect to the Scientific Research and Experimental
Development (SR&ED) program. Some of the important changes of interest to its members and the
biotech community:
• Significantly more companies now qualify for refundable tax credits on R&D spending;
• The expenditure limit for refundable credits increased 50 percent—offering companies
an additional $350,000 per year;
• The benefits of the LLC changes can be fully realized with the resolution
of the administrative section 116 certificate issue for foreign investors.
The budget analysis by BIOTECanada states: “The beginning of the changes to the SR&ED
program is extremely positive for Canada. It sets the stage for BIOTECanada’s continued efforts
to see additional improvements.” BIOTECanada plans to continue its lobbying efforts with respect
to removing the current Canadian-controlled private corporation (CCPC) restriction on SR&ED for
refundable credits, while maintaining eligibility requirements (taxable income and taxable
capital thresholds).
The 2008 federal budget also contained the following initiatives of significance to the
biotechnology sector, according to BIOTECanada:
1. Investments in Research: University granting councils ($80 million); Canadian Institutes
of Health Research ($34 million); National Sciences and Engineering Research Council
($34 million); Genome Canada ($140 million); supporting doctoral students with $25
million over two years for a new Canada Graduate Scholarship award; and the creation
of the Canada Global Excellence Research Chairs ($21 million) working on the government’s four priorities identified in the S&T strategy.
As well, additional financing for the operations of the Canadian Light Source
Synchrotron in Saskatoon ($10 million) was proposed.
2. Venture Capital for Innovative Growing Companies: Budget 2008 sets aside $75 million
for the Business Development Bank of Canada (BDC) to support the creation of a new
privately run venture capital fund.
www.biotech.ca and www.budget.gc.ca/2008
Canadian CEOs lose confidence
in short-term growth
C
EOs’ confidence about prospects for
short-term business growth dropped
by almost half since last year and fears of a
global recession is a major threat according
to the PricewaterhouseCoopers (PwC)
11th Annual Global CEO Survey. The
current uncertainty being played out in
global financial markets echoes this drop
in confidence among global CEOs. The
annual survey is based on interviews of
1,150 CEOs in 50 countries including 30
from Canada. According to the survey this
year, only 33% of Canadian respondents
are very confident about revenue growth
over the next 12 months—a pronounced
drop of 27 points from 60% last year, and
compares to 50% of CEOs globally.
Canadian CEOs however, remain confident about longer-term growth and their
competitive strengths, with 46% indicating
they are very confident in revenue growth
over the next three years, compared to 42%
globally. Coupled with the lack of business
confidence, Canadian CEOs are most
concerned about a lack of key labour skills
(83%), over-regulation (64%), followed by
downturns in major economies (63%).
Similarly, global CEOs indicated that a
downturn in major economies (61%) and
lack of key labour skills (61%) are their
main concerns, followed closely by overregulation (59%).
$46 million for creation of new research networks
T
he federal government is calling
for applicants for the Business-led
Networks of Centres of Excellence (NCE)
program. This $46-million initiative, part
of the 2007 federal budget, is established
to fund large-scale, collaborative net-
works that support private sector
innovation. It will create up to five new
Business-led NCEs and support them
for four years, starting in 2009. The
networks will be led by private sector
consortia and will focus on research in
five priority areas: environmental science
and technologies, natural resources and
energy, health and related life sciences
and technologies, information and
communication technologies, and
business, management and finance.
March/April 2008 Bio Business 7
News
Ambrilia Biopharma
appointed Philippe Calais,
Ph.D. Pharm., as president
and CEO.
BioTalent launches new Web site
ART Advanced Research
Technologies Inc. welcomed Matthew
Smith, Ph.D., and Sean Pitts as senior
area sales manager and area sales manager respectively, for the North American
preclinical imaging market segment.
ioTalent Canada rolled out a reengineered Web site—designed to
ensure better access to HR information, projects, research, courses and
tools. The site now boasts: the new
PetriDish employment bank; a new
BioCurrents section for easier access to
the latest BioTalent news and reports;
easier course registration through a new
B
BioSyent promoted Alfred D’Souza to
VP and CFO. D’Souza is a CMA and
MBA who joined BioSyent as controller
and director of finance in 2006.
$28 million awarded to 193 researchers in Canada
Covalon Technologies appointed
Francis K. Lindayen as CFO. Former CFO
William Jackson will continue
at Covalon as CBO.
Emerillon Therapeutics recruited
Dr. Lisa McKerracher to lead Emerillon’s
management team as CEO, and a new
company focus on drug development
for treatment of infectious disease.
McKerracher has over 20 years
experience in science leadership
and biotechnology.
secure online registration system; and
the ability to create a BioTalent Canada
account. www.biotalent.ca
researchers (50 of which
were recruited from outside
Canada) were given a $28-million
investment by the Canada Foundation
for Innovation (CFI). The money is
193
going toward 35 institutions in 30
municipalities, divided among 149
projects and 193 researchers in areas
ranging from environmental science to
health, information and communication
technologies, to the social sciences and
humanities. The funding falls mainly
under the CFI’s Leaders Opportunity
Fund (LOF), a program designed to
provide infrastructure to attract
researchers to Canadian institutions
at a time of intense international
competition for knowledge workers.
www.innovation.ca
Ontario pharma, research industries get boost
Job and research funds among latest Ontario government initiatives
Neurochem Inc. welcomed Gary
Schmid as CEO of Neurochem’s new
nutraceuticals business. Schmid joins
from Santé Naturelle A.G. Limited,
the international manufacturers and
marketers of Quebec’s market-leading
Adrien Gagnon natural health brands.
Neuromed
Pharmaceuticals appointed
Jeffrey Arcara as VP of
business development and
Gene Wright as VP of project
leadership. Both are newly created positions.
8 Bio Business March/April 2008
T
he Ontario government launched
several initiatives to support the
provinces science and technology sectors. The $150-million Next Generation
Jobs Fund is designed to encourage
research-based pharmaceutical companies
to invest in Ontario. The money is
designed to create jobs in the biopharmaceutical research community by enabling
companies to apply for grants, loans, forgivable interest loans and funds for building infrastructure, research and training.
For its part, the $115-million Ontario
Research Fund plans to help Ontario’s top
researchers develop new ideas and turn
these ideas into products and services
that can be marketed to the world.
Government funding will be matched
by 107 partners including industry.
Other recent Ontario initiatives include
launching the $160-million Ideas-toMarket strategy that supports emerging
companies, which includes the Ontario
Venture Capital Fund.
www.ontario.ca/innovation
UTI and BioAlberta partner to
strengthen Calgary’s bioindustry
niversity Technologies International
(UTI) and BioAlberta announced a
partnership that focuses on creating
stronger technology-based companies
within the Calgary region and improving
the technology commercialization
process for early-stage technologies. The
Memorandum of Understanding outlines areas of mutual interest and potential collaborative projects.
UTI is the University of Calgary’s
technology transfer, commercialization
and incubation centre for inventors,
innovators and entrepreneurs. The intention of the partnership is to support companies in strengthening their intellectual
property and product pipelines so they
can achieve higher valuations, revenues
and success, according to BioAlberta.
technology to reach $9.5 billion
Federal spending on science and
U
T
he federal government’s
spending on science and
technology is expected to reach
$9.5 billion in the fiscal year
2007/2008, after surpassing $9
billion in 2005/2006, according
to a recent report by Statistics
Canada. Research and development will be the main beneficiary of this federal investment.
A survey of the science and
technology activities of federal
departments and agencies shows that
intended spending on R&D for
2007/2008 will be an estimated
$6.1 billion. Related scientific
activities, such as scientific and
general data collection and information services, will receive $3.5 billion.
As a result, science and technology
will account for about 4.5% of the
total federal government budget in
2007/2008, compared with 5.1%
two years earlier.
Growth expected for Canadian pharmaceutical market for 2007
T
Patheon Inc. named Terry
Novak as president, North
American operations and chief
marketing officer. Novak will be
responsible for managing and growing
Patheon’s North American network of
commercial manufacturing operations,
which includes three plants in
Canada, three in Puerto Rico and
one in Cincinnati.
he Canadian pharmaceutical market is expected to grow 6.0% to 6.5% for 2007 to
$19 billion in drug store and hospital sales, according to IMS Health. Last year’s
market growth was slower than the 8.4% average rate achieved from 2002 to 2006.
In 2007, growth in the generics and innovative sectors was 20.1% and 3.3%, respectively. Excluding biotechnology products, the growth of innovative therapies was only 1.6%.
According to IMS Health, this disparity in growth between the two sectors is primarily the result of the large number of patent expirations experienced during the year.
In addition to the strong growth experienced in the generics sector, sales of biotechnology products are up 17.2%. Biotechnology therapies represent 10% of total pharmaceutical sales in Canada, but are responsible for approximately 24% of the market’s
overall growth last year. Also contributing to more moderate pharmaceutical market
growth overall is the low number of new products last year. New medicines (new
molecular entities and line extensions) launched in Canada in 2007 account for less
than 0.3% of total drug store and hospital sales this year as their sales continue to be
affected by market-access delays.
PharmEng International Inc.
appointed John Carkner the Keata
Pharma president for the Arnprior manufacturing site. Keata Pharma is a wholly
owned subsidiary of PharmEng with
pharmaceutical contract manufacturing
facilities in Ontario and new facilities in
Sydney, Nova Scotia.
Simon Fraser University welcomed
Dr. Robert Young as the new Merck Frosst
BC Leadership Chair in Pharmaceutical
Genomics in Drug Discovery. Previously
vice-president of Medicinal Chemistry at
Merck Frosst Canada, Young brings
almost 30 years of pharmaceutical industry research experience to SFU.
WEX Pharmaceuticals appointed Dr.
Bin Huang as president and CEO.
Huang’s spent two years as CEO of
GeneHarbour Technologies (Hong Kong)
and five years as president and CEO of
Cytovax Biotechnologies Inc.
Xenon Pharmaceuticals Inc.
appointed Charles J. Cohen as vice-president, discovery research. Cohen has spent
the past approximately 25 years in the
pharmaceutical/biotechnology industry
with positions at Bayer Pharmaceuticals,
Merck & Co and Vertex Pharmaceuticals.
March/April 2008 Bio Business 9
News
$5M to boost food safety
expected to create up to 135
new jobs. The production facility will use an innovative technology to produce a vaccine
designed to significantly reduce
the levels of E. coli bacteria in
cattle and their manure, which
will help reduce potential con-
Study examines
compensation and
entrepreneurship
in the life
sciences industry
T
he compensation trends of senior executives within privately-held therapeutic, diagnostic, medical device,
instrumentation and platform companies were explored
in a recent report by Ernst & Young; executive search firm
J. Robert Scott; and the law firm WilmerHale; in collaboration with professors from Harvard Business School. The
2007 Compensation & Entrepreneurship Report in Life
Sciences looks at compensation data for 13 top management
positions and examines the evolution of executive pay as
companies advance from start-ups to fully developed private enterprises (166 privately-held life sciences and medical device companies throughout the U.S. took part in the
survey). The study found that in terms of salary, the total
target cash for the CEO rose 2% year over year, most
notably in base salary, an increase of $11,000. Average base
salary rose by 5.9% across the executive positions surveyed
from 2006 to 2007. With regard to equity holdings, incentive stock options account for just over half of the equity
grants to the management team in 2007, down from 62%
in the 2006 report. As companies evolved from the early
stage, with one or fewer rounds of funding, to becoming
more mature companies with four or more rounds of funding, the number of founders remaining in the CEO position declined from over one-half to under one-third. The
study also found that 72% of non-founding CEOs have
some form of a severance package, with the average severance period being 12 months. The study includes data on
cash compensation, equity holdings, base salaries and
bonuses for private, venture-backed life science companies
as well as public biotechs. www.compstudy.com
10 Bio Business March/April 2008
Study says Canadian drug
T
he federal government is
contributing $5 million to
establish an animal health
and food safety vaccine production facility in Belleville, ON at
the Bioniche Life Sciences Inc.
campus. The new facility—the
first of its kind in Canada—is
tamination of E. coli in the
environment, ground water,
and cattle processing plants.
The $25-million project, which
is phase one of a larger scale-up,
is funded under Agriculture
and Agri-Food Canada’s AgriOpportunities program.
policies offer no cost advantage over U.S.
G
overnment policies surrounding the pricing and reimbursement of prescription drugs in Canada do not produce
lower costs for Canadians compared to Americans, according to
a new study from independent research organization The Fraser
Institute. The Cost Burden of Prescription Drug Spending in
Canada and the United States says on average Canadians
are spending about the same percentage of their incomes on
prescription drugs as Americans. Canadians spent 2.5% of
their personal disposable income on prescription drugs compared to only 2.2% for Americans. The study also found that
the number of prescriptions dispensed per capita in each
country is approximately the same. In 2006, 13 prescriptions were dispensed per person in Canada versus 12.3
prescriptions per person in the United States. Even though
Canadian prices for brand name drugs are lower than U.S.
prices for identical drugs, consumers in both countries spend
roughly the same percentage of their personal income on
drugs because the price of Canadian
generics is more than double U.S. prices
for identical drugs, reports the study. The
study author suggests the root causes of
high generic drug prices in Canada are
government policies that shield retail
pharmacies and generic drug manufacturers
from competitive market forces.
Media preferences of life scientists in applied markets
F
@
aced with modest growth in the traditional life science market,
suppliers are turning their attention to opportunities in agricultural, biodefense and molecular diagnostics. BioInformatics LLC’s
Marketing to Life Scientists report highlights the importance of effective marketing in capturing mindshare in markets where product differentiation can be hard to achieve. Scientists surveyed also ranked
the effectiveness of their suppliers’ marketing programs in terms of
best Web site, print catalog, exhibits, print advertising and sales force.
Approximately 570 scientists from North America and Europe participated in this survey, conducted between Oct. 18 and Dec. 3, 2007.
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News
Photos by Daniel deRegt
BioPartnering North America
concludes in Vancouver
T
he 6th Annual BioPartnering North
America (BPN) Conference, held
early February in Vancouver, attracted a record number of 933 participants
attending from 545 companies, and representing 27 countries.
Co-hosted by LifeSciences British
Columbia,
BIOTECanada,
and
BioAlberta, BPN is now the 2nd largest
life sciences partnering event in the U.S.
and Canada (after the annual BIO meeting), according to Robert Kilpatrick,
partner at Technology Vision Group
LLC, the conference organizer. This year,
the conference boasted 130 new companies (over last year), of which 67 were
pharmaceutical (up 14% from 2007).
Supporting its partnering mandate,
attendees to BPN 2008 scheduled 3,076
meetings: a 40% increase from 2007.
There were 62 Open House podium
presenters and eight pharmaceutical
sponsors, including, ITD Hungary,
California’s SuperGen Inc. and Sloning
BioTechnology GmbH of Germany, as
well as Canada’s own Kane Biotech Inc.,
Stem Cell Therapeutics, ASKA
Research, and Patheon Inc.
This year also highlighted specific
12 Bio Business March/April 2008
global regions, with the Italian Trade
Commission hosting a workshop entitled
“Italian Life Sciences: Growth and
Opportunities.” Overall 16 Italian companies and 20 delegates participated in
the conference—with 10 companies participating in the workshop, among them:
Menarini Biotech; Alfa Wassermann
SpA; MolMed SpA; and Pharma &
Biotech Advisors.
“Last year at this show we had six participating companies,” said Paolo Ponti,
Italian Trade Commissioner in Toronto
who helped open the session. “This year,
we have more than double. That’s evidence of how important the sector is and
how relationships between Italy and
Canada are growing.”
This year’s event also featured the
inaugural Asia Pacific Pitch on February
6th, the day after BPN concluded. The
special one-day meeting organized by
Technology Vision
Group
and
LifeSciences included speakers from
China, India, and Japan, and drew 165
delegates interested in learning more
about the exciting new opportunities
available in the leading Asia-Pacific bioregions of China, Hong Kong, India and
Japan. Karimah Es Sabar, president of
LifeSciences British Columbia, commented, “We were extremely proud to
have been the co-host of what proved to
be another incredibly successful event. It
was particularly great to have our colleagues from India, Japan, China and
Hong Kong come and present as part of
the inaugural Asia-Pacific Pitch Day.”
Next year’s BPN conference will take
place February 8-10, 2009.
www.techvision.com/bpn BB
Q&A
Question and answer with David J. Mazzo, Ph.D.,
president and CEO of Æterna Zentaris
terna Zentaris is a biopharmaceutical company
focused on endocrine therapy and oncology. Its
broad pipeline encompasses products from the preclinical
stage through to marketed products. The lead value driver for the company is an LHRH antagonist, cetrorelix.
This compound is already marketed under the trade name Cetrotide for in vitro fertilization and is currently
being studied in an extensive Phase 3 clinical development program for the treatment of benign prostatic hyperplasia (BPH). Æterna Zentaris’ lead oncology program is AEZS-108 a targeted cytotoxic conjugate, currently in
Phase 2 for the treatment of ovarian and endometrial cancers.
The company, headquartered in Quebec City, has two wholly-owned subsidiaries: Æterna Zentaris Inc. based
in Warren, New Jersey where the majority of the executive team resides, and Æterna Zentaris GmbH, based in
Frankfurt, Germany where the discovery and preclinical activities are conducted.
In April 2007, David Mazzo was appointed president and CEO of the company. He has more than 25 years
of experience in the pharmaceutical industry and has worked in the U.S., Europe and Asia. His experience
includes management positions at Chugai Pharma, Merck, Baxter, Rhône-Poulenc Rorer, Hoechst Marion
Roussel and Schering-Plough. Bio Business spoke with Dr. Mazzo about Æterna Zentaris’ recent strategic management review, the company’s new global business strategy, and his advice for growing Canadian biotechs.
Æ
Q
: What is the most important thing
you’ve learned over the years?
A: Based on many years of experience in
big pharma, a number of years in small
pharma and serving on public company
boards, I’ve realized that there really is no
shortcut to doing it right. Companies that
take the shortcuts because they run out of
money or they think they can find a way to
the end faster than anybody else often end
up getting someplace that turns out to be a
dead end. We are being careful to do only
those things which are necessary, and to do
them in such a way that they are done
right the first time and with the right qual-
ity and the right outcome. Our strategy
now is to not just get a filing in, but get a
filing in that will be rapidly approved and
will lead to a successful and sustained
commercial launch.
Q
: Last year Æterna Zentaris
undertook a management
review of the company’s
pipeline and business operations to identify strategies for
achieving short- and long-term
success. What would you say is
the most important change
coming out of the review?
A
: The review allowed us to prioritize
our pipeline, so rather than presenting a
very broad pipeline, which I feel we still
have, we presented it as a pipeline that is
focused, and one which allows effort to
be focused on those products which are
going to have the highest probability of
medical success coupled with the greatest
commercial
viability.
We
now
have…clear development plans that
identify what needs to be done in order
to get us to a successful and sustained
launch of a product. Most companies at
our stage don’t have the breadth of experience to understand that it’s really the
launch and the sustained launch that are
March/April 2008 Bio Business 13
Q&A
the most important long-term goals of
the company. It’s not filing or even
approval—so many companies file and
then don’t get an approval or get an
approval for something that they can’t
really sell in the market effectively. I think
we’ve constituted the appropriate team,
the resources, and the financial means to
move forward.
development strategies are global. In this
way, it allows us to take the greatest
advantage of all the possibilities that exist
without having to duplicate everything in
every region in order to get approval.
in recent years. Now we have not only
one, but with our partners we could have
as many as three products in phase three
by the end of 2008.
Q
: Are there any internal strategies that have helped lead to the company’s success?
Q
A: There are a couple of challenges. The
: What is the company’s new
business strategy?
: Up until recently, the company really
had a mixed strategy when it came to partnering and addressing the world. When it
came to partnering, there was a vestige of
the strategy that required the company to
do a number of small deals early in the life
of a product in order to maintain a certain
cash flow within the company—which is
an admirable trait. On the other hand,
when you do that, you often devalue for
your own shareholders the actual product.
Basically, if you were able to chart on
the X-axis the timeline, phases from preclinical to phase one, two and three in the
clinical development area, and then on the
Y-axis, just general value, you would see
that compounds increase significantly as
they move from one stage to another, but
the big jumps come in two places. They
come after proof of concept in man, and
then upon regulatory approval and launch.
Up until those, any of the other intermediate milestones still create additional
value, but in relatively minor proportions.
And so what the company was doing was
often selling its products prior to hitting
those big milestone jumps.
Now we’ve made the strategy that we
will, to the best of our abilities, develop
our products at least through proof of
concept in man, and for those that fit
nicely within our niche, in terms of therapeutic focus and capabilities, we’ll take
those through to launch ourselves, to get
the second, much larger boost in value for
our shareholders.
The other thing we’re doing is we’re
looking at the company globally now. Our
partnering strategies are global, our commercial strategies are global, and our
A
14 Bio Business March/April 2008
: What challenges has the company faced recently?
first one is of leading change. We have
instituted an enormous amount of change
in a short period of time. It was necessary
to do that in order to keep the company
competitive and keep its lead products
competitive. So the first challenge is to
get people to first understand, then to
accept, then to embrace these changes.
“We have a common set of
goals that gives us strength
of character that a lot of
companies don’t have.”
It’s also a challenge for us to convince
the market, the world, and the investment
community that we are a biopharmaceutical/biotech company like every other
biopharma company in the U.S. or North
America. We have an enormous amount
of potential, in many ways a much lower
risk profile and a much higher upside
than many of our peer group. But we are
a company that doesn’t generate revenues
right now, in any significant form and
won’t generate profit until after we launch
our first major product in 2011. People
need to understand that as a biotech company, we will burn money in the short
term in order to provide a big upside in
the long term.
Also, for quite a long time the company has not had a product in phase 3.
Phase 3 is by far the most important and
expensive phase of development, and that
puts a bigger strain on the company from
a financial perspective than has been seen
Q
A
: We consciously have constituted a
team at the leadership level who has
multinational experience and are from all
over the world. We have a group of comfortable, competent, courageous, and successful people; they know how to get
things done and they do so in a humanistic way. We discuss things openly. We
approach our problems from the perspectives of people educated and brought up
in various countries in North America
and in Europe, with different backgrounds and specialties, and we respect
each other’s expertise, and also respect
each other’s intelligence. We challenge
each other. That creates a richness of discussion and eventually of decision-making and planning that’s not found in a
homogenous culture. We have fun, we
enjoy our work, we’re committed, passionate, and we know how to treat people.
We respect contributions at every level.
We have a common set of goals that really gives us strength of character that a lot
of other companies simply don’t have.
Q
: Do you have any advice or
insights for a growing biotech company in Canada?
A
: First and foremost, I would recommend that any biotech company would
be in a much better and stronger position for sustained growth and sustained
existence if they had more than one
product in their pipeline.
We have a completely full pipeline
from a discovery engine through preclinical all the way up to two marketed products. Having that breadth of possibilities
and that mitigation of risk really helps a
biotech company. BB
©2008 Thermo Fisher Scientific Inc. All rights reserved.
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reply online at www.biobusinessmag.com
Going public—critical
success factors
Financial experts consider the current state of the Canadian IPO market for biotechs, options available on the TSX for early-stage companies, and how to sustain fiscal stability after going public
By Catherine Muir
T
he IPO, or initial public offering, has long been a vehicle for
companies to raise funds to fuel their growth. The first sale of
stock by a private company to the public is a rite of passage
for many companies, allowing the company to tap into a much
wider pool of investors than they previously could and giving access
to large volumes of capital without the accumulation of debt.
But biotech companies are unique compared to most firms
that undertake an IPO financing, according to Wayne Schnarr,
senior VP, life sciences, with investment relations firm The
Equicom Group. “Compared to most other junior companies—
tech, mining, and oil and gas companies—[biotech firms] don’t
have revenues.” Also, life sciences companies often need to raise
large amounts of money to pay for lengthy R&D and testing
phases before the commercialization stage is even reached and a
return on an investment is seen.
For a pure R&D company, an IPO is generally completed in
order to fund a phase of a clinical trial. The scope of that trial can
expand significantly as successive phases are reached, both in
terms of the number of people and the geographic spread and
“Compared to most other junior companies,
tech, mining, and oil and gas companies,
[biotech firms] don’t have revenues.”
therefore the costs associated with the trial. In contrast, for medical device companies the timeline for raising funds through an
IPO can be relatively short. Medical device firms are usually
looking to bring a device to commercialization fairly quickly and
so the capital raised may be both for the continued research and
development of the device but also to raise production capacity to
get the product into the market as fast as possible.
16 Bio Business March/April 2008
In both cases, funds are ultimately needed by life sciences
companies to progress to the next level in their development. But
says Schnarr: “there is a lack of private funding for earlier stage
companies.” Private sources of financing that companies typically turn to, such as venture capital (VC) or angel financers, are
sometimes reluctant to invest in early-stage companies.
With VC investors putting money into companies with laterstage products or reinvesting in their current portfolio of companies, and angel financing generally being very localized with a cap
on the amount of money that can be raised, many early-stage life
Financing
Q&A
with Ron Sabourin,
executive VP finance and
administration and CFO, IMRIS
Q: What factors made the company choose to use an IPO as
a vehicle to raise funds?
A: The most important consideration for IMRIS was the cost of
capital. From our perspective, while taking the company
public at the time was perhaps a little sooner than we might
have originally planned, we believed that the success of our
products to date in the market would lead to the company
being well received by the public, and that the resulting
valuation and dilution would be favorable when compared
with other financing alternatives. More importantly
perhaps, we believed that as a company we had the ability to deliver against the more onerous expectations that the
public investment community would impose on us. It is one
thing to be able to raise the capital, but the public market
will demand that the company perform well after the IPO,
and the company needs to be ready to meet this challenge.
In our case, and while we are still on the road to profitability, our products have received very strong acceptance from
our customers, and we have put in place a very capable
and experienced management team with the ability to
execute against our plans.
Q: What were the main challenges of going public?
sciences companies that are looking for capital choose to go public.
Schnarr says the IPO gives a company access to markets it
wouldn’t have otherwise, such as the public markets, institutions,
and retail investors who invest only in public companies.
Completing an IPO also provides a share that can be valued or
easily used in transactions such as M&As.
A: The most significant challenge is just the process itself. It is a
fairly all-consuming process and requires a lot of time from
the management team, in particular the CEO and the CFO
of course. Managing this process while trying to run a
growing business is a challenge.
Q: What is the $40 million directed toward?
A: Roughly one third of the proceeds of the offering will be
Current state of the IPO market
The sub-prime mortgage debacle, where many financial institutions around the world were forced to significantly write down
used to fund the company’s research and development and
...continued on page 19
March/April 2008 Bio Business 17
incurring losses, has caused many investors in Canada, the U.S.
and around the world to take a close look at where they are going
to be putting their investments going forward, says Raymond
King, senior manager, listings business development at the
Toronto Stock Exchange (TSX).
He points out that what that has meant for companies in the
pure R&D life sciences space is that there is a preference at the
moment for companies that are in later-stage clinical trials and
are listed on a senior exchange.
On the TSX Venture Exchange, a public venture capital marketplace for junior companies who have not yet met the requirements for listing on the TSX, King says there still is an appetite
for financing earlier-stage companies, but whereas in the past
pre-clinical companies were often financed on the venture
exchange, now the phase one companies are more likely to get
financing. “Funding pre-clinical is now falling back into the
realm of private venture capital.
“Everybody’s being very cautious about where they are investing their money, and they want to see a more immediate guaranteed return,” says King.
Having said that, medical devices, he says, are “flying off the
shelf, in large part because you can see the more immediate poten-
tial return on the investment.” He also says that anything with a
clean tech focus to it is performing particularly well at this time.
There are certain times when more IPOs are done than others, says Schnarr. These IPO windows include: 1991 when many
initial product approvals were happening for some of the big
companies in the U.S; 1995-1996 when fund managers were
seeking more investment opportunities; and in 1999-2000 when,
after the tech boom, investors were looking for another space
where comparable returns could be made.
Schnarr says that although there is no IPO window open at this
time, IPOs are still getting done. “Not as many, since valuations are
extremely low right now, but there is still money available.”
The venture exchange
In King’s opinion, the TSX Venture Exchange is really the equivalent of public venture capital. His advice for early-stage life sciences companies looking to raise funds is to utilize all available
options. “In many cases what you will see on the Venture
Exchange is companies tapping into private placements on the
public markets as well as continued investments from VCs.”
For earlier-stage companies, King says the benefit to listing on
the TSX Venture Exchange is that they can continue to go back
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Financing
to the market on a regular basis and receive financing in a timely
manner. “When a company needs to go back to the market for
more financing, it will most likely be as a private placement,
which can be completed fairly quickly in comparison to raising
private venture capital where talks and lengthy road shows can
cause the process of raising capital to take months.” Also, listing
on the Venture Exchange allows the company’s management to
retain a fair amount of control over the company, as opposed to
giving it up to private investors.
“Everybody’s being very cautious about where
they are investing their money, and they want
to see a more immediate guaranteed return.”
King says there is a grey area between private and public financing that many companies are tapping into. Some VCs are establishing private investment and public equity (PIPEs) where they’ll
invest into publicly traded companies on the Venture Exchange or
the more senior TSX. “A smart company is tapping into both the
private and the public capital pools to help fund its growth.”
An alternative to the traditional IPO
The traditional IPO may not always be the optimal choice for an
early-stage company looking to raise funds. One alternative is
raising capital through Capital Pool Companies (CPCs). CPCs
can be effective vehicles for raising financing, especially for a
company looking to raise only $5 to $10 million, says King. For
this amount of money, a pure IPO can incur high costs on the
another third to fund our sales and marketing for the next
two years respectively. The balance will be retained for
working capital purposes.
Q: What was IMRIS’ message or investor relations strategy?
How much of a role does investor confidence play in a
public offering?
A: Investor confidence is pivotal to the success of an IPO. This
means not only investor confidence in the company seeking
to become public, but investor confidence in the investment
market as a whole. Since you cannot affect the latter, you
must focus on the messaging of why the market should
invest in your company. IMRIS did not have an IR strategy
or media strategy pre-IPO that was geared towards the
investment community. Our first contact with the financial
community came about as a result of the IPO. In undertaking the IPO, we worked with a very capable syndicate of
investment bankers and an investor relations consultant with
significant roadshow experience to help us to explain our
story to the investment community.
Q: What role does leadership play in the IPO process?
A: You must have a credible management team in place during the IPO process. Investors invest in businesses because
they believe in the management team. If you have weaknesses on the management team you will be well served to
fix them in advance.
Q: Given
your experience, what factors are the most
important for life/health sciences companies to consider
when undertaking an IPO?
A: There are a number of factors that any company needs to
consider in taking the company public:
• Is the company ready to become a public company? Being
a public company will place significant new demands on
management time, and will result in a much higher degree
of transparency across all facets of the business. How well
is the company prepared to take on these new challenges,
or would it be better served to remain private with venture
or private equity investors?
part of investment banking firms, whereas a CPC, sometimes
done in conjunction with a private placement, can raise that
amount of capital in a cost-effective manner.
The CPC program enables seasoned directors and officers to
form a company with no assets other than cash and no commercial operations, list it on the TSX Venture Exchange, and raise a
pool of capital to use for investment. The CPC acquires an operating company which meets Exchange listing requirements and
lists on the Exchange.
• Does the management of the company have the time to
take on being a public company? The IPO process is
lengthy and requires a full time commitment on the part of
the CEO and the CFO. Post-IPO, the management team
will need to devote a portion of their time to investor relations. Can these individuals devote the effort required
without losing momentum in other areas of the business?
• How confident is the company in its ability to deliver
against expectations? Does the company have a history of
meeting its business objectives? The public market will be
much more punishing in the event that the company is not
successful in meeting expectations, so all companies need
to manage these expectations well. BB
March/April 2008 Bio Business 19
Financing
“The CPC is becoming an increasingly strong vehicle for good,
strong earlier stage growth companies that are looking to fund at
the level they need to move their concepts forward,” says King.
Sustaining growth
For companies that have never undertaken a public offering,
going public can be a daunting experience. Especially for life sciences firms, where “in many cases, we’re talking about brilliant
scientists that are not necessarily the most business-savvy people,”
says King. “But the minute a scientist has to go out for that first
round of capital, this endeavor ceases to be a scientific endeavor
and it becomes a business.”
King believes communication is fundamental to the success of
an IPO, and says it is up to life sciences companies to communicate their story to the marketplace, to ensure that capital is available when they need it. “You have to attract a lot of sustainable
market momentum. You can’t just put a story out every few years
once the next round of trials is completed. You need to be more
consistent in your communication on a quarterly, semi-annual and
annual basis to bridge those big milestone communication gaps.”
Equicom’s Schnarr says this communication needs to evolve as
the company grows into the public space. His advice is that prior
20 Bio Business March/April 2008
to going public a company should start to look at the new audience it will be communicating information to, including retail and
institutional shareholders, stock analysts, investment bankers, and
the entire public markets community. “It’s something that you
want to start to consider many months prior to going public.”
An area that companies can tend to overlook but is an integral
part of how a company functions and thus how it raises financing
is management itself. King advises that as a company goes out for
each subsequent round of financing, and moves through its development, realistically there needs to be
a change of management at every
one of those stages.
“By the time a company goes
public, it should have had at least
three to four changes in senior
management, reflecting the different stages of its growth,” he says.
“The CEO who was also the scientist at the beginning should not
necessarily be the same person running the company as it goes public
at phase three.”
King suggests a company that is
looking at going public also speak
to a reputable investor relations
firm: “People out there that understand the market can help you craft
your message.”
This message is especially important to cultivate early on, says
Schnarr. “Your next financing starts
the day your IPO closes,” he says.
“You really don’t want to go below
one to two years of cash before you
do your next financing. You are continually raising money in order to
fund the burn rate of the company.”
“A smart company is tapping into both the
private and the public capital pools to help
fund its growth.”
Perhaps the most important factor for a company to be aware
of is the receptivity of the public markets – a factor that can affect
how easy it is for a company to raise the funding they need. “You
have to keep your finger on the pulse of the public markets,” says
Schnarr. “From quarter to quarter, the appetite for IPOs may
change. And year to year, it definitely changes.” BB
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Using genetics to redefine
the natural world
Canadian researchers at the forefront of DNA
barcoding efforts
By Catherine Muir, with files from Erica Tennenhouse
T
Throughout recent history, the practice of taxonomy has
allowed scientists to classify species of living things, bringing
order to the wildly diverse world of biological organisms.
Since the first classification systems emerged—dividing life
forms into different groups depending on certain characteristics—scientists have struggled to keep classification in step with
scientific evidence.
Over the past century, rapid advances in evolution, genetics,
molecular biology and other scientific fields have constantly
reshaped our understanding of how organisms are related to one
another.
At the forefront of these scientific developments is a new technique that uses recent advances in genetics research. DNA barcoding uses a short genetic marker in an organism’s genome to
identify it as belonging to a particular species.
Dr. Mehrdad Hajibabaei, the associate director of the Canadian
Centre for DNA Barcoding (CCDB, www.dnabarcoding.ca) at
University of Guelph says the idea of using DNA for identifying or
classifying organisms is not new, but “DNA barcoding basically
argues that we need to standardize and systematically approach this
issue to address unknown biodiversity.”
The Canadian Centre for DNA Barcoding is the first and
largest high volume research and production facility for DNA barcodes in the world, and Hajibabaei says its main job is to build
DNA barcode libraries for different groups of life. The Guelph
facility is part of a network of facilities doing DNA barcoding
work in Canada and around the world.
In Canada the research is focusing on the Canadian Barcode
of Life network, a research network funded by NSERC, Genome
Canada, and several other funding agencies. Approximately 50
different Canadian researchers form the network, with the hub for
the organization found in Guelph. Internationally, the
Consortium for the Barcode of Life is responsible for promoting
barcoding as a standard tool for species identification.
Hajibabaei says CCDB has a series of barcoding projects called
22 Bio Business March/April 2008
“We still find new species when we do
barcoding. Sometimes one species turns
into five or six species.”
campaigns, to build barcode libraries: “You could say a campaign
is equivalent to a genome project. But we gather DNA sequences
from a small portion of a genome from many species, whereas in
regular genomics you sequence all the genes in one genome. You
can therefore call barcoding a horizontal genomics approach.”
The centre coordinates several campaigns in collaboration with
more than 200 scientists across Canada and internationally. These
Discoveries
DNA barcoding uses a short genetic marker in an organism’s genome to identify it as
belonging to a particular species. Scientists at the Canadian Centre for DNA Barcoding
have barcoded 260,000 individuals from about 30,000 species.
collaborators often use CCDB’s high-throughput platform and
database and bioinformatics software to barcode their samples and
contribute to barcode campaigns. The CCDB is now building
momentum to launch a large-scale global barcoding project called
the International Barcode of Life project (iBOL,
www.dnabarcoding.org) in collaboration with scientists from 25
countries. This project will raise $150M to gather barcode records
from 0.5 million species in 5 years.
CCDB currently has 35 employees, including four investigators, eight post-doctoral fellows and a number of technicians and
bioinformatics experts that are involved in data analysis and software building, along with a number of graduate students. The centre has an imaging facility; a high throughput core lab containing
multiple PCR machines, DNA sequencers, and DNA isolation
robots; an R&D methodology lab, and a bioinformatics group.
The centre is at the forefront of DNA barcoding work internationally. In fact, researchers at the CCDB have developed a
database and bioinformatics platform that is used as standard barcoding software around the world. Called Barcode of Life Data
March/April 2008 Bio Business 23
Systems, or BOLD (www.barcodeoflife.org), it’s an online database and data management system, with analysis tools and integrated visualization modules.
Though the CCDB is not a specimen and DNA collection
bank, it does have a collection facility to keep 0.5-1M specimens
and their DNA samples. After the barcoding work has been done
and a barcode is in the database, the specimen is sent to a museum for long-term storage, but the DNA samples are kept in the
DNA archives of CCDB in -80 degrees freezers. These DNA
samples provide an excellent source for future genetic studies.
DNA barcoding has wide implications beyond the obvious one
in evolutionary biology of being able to organize biodiversity more
precisely than ever before. For example, in other fields, such as the
medical sciences, DNA barcoding could lead to diagnostics for
disease-causing agents. “That’s a real world situation in which you
need robust identification,” says Hajibabaei.
For example, animals can often be disease-carriers, and if a
quick way of species identification could be found, it would help
in disease control. Another real-world application for DNA barcoding is in border control. Sometimes, goods or containers that
cross the border into Canada are infected with invasive species,
species that are not native to a certain area and have been
brought there by human activity, and whose introduction is likely to cause economic, environmental or human harm. Stopping
a single invasive species, such as zebra mussel, can save our economy millions of dollars.
Hajibabaei says the current method employed by border control agents is to send samples to agriculture or food inspection
lion species from different domains of life in existence. DNA barcoding seeks to facilitate the identification of known species and
the discovery of new or cryptic ones.
Before any barcoding work can be done though, a standard
gene region needs to be identified. The standard DNA barcode for
animals is part of a mitochondrial gene called the cytochrome c
oxidase 1, or CO1. According to Hajibabaei, in the mitochondria
of eukaryotes (organisms whose cells contain a distinct membrane-
“If you have a portable device that can read
the barcode sequence of an unknown speci-
men and compare it to a database, you can
achieve identification in minutes.”
agencies, to be examined by a specialist taxonomist, a time-consuming process that sometimes can take several months. “If you
have a mobile lab or a portable device that can quickly read the
barcode sequence of an unknown specimen and compare it to a
database of barcoded species, you can achieve identification in
minutes or seconds.” The technologies to build such a device are
available and the integration can be done in a decade.
Fundamentally DNA barcoding is based on the fact that when
you start comparing fragments of DNA between two species, you
find enough variation, or positions in the code that enable you to
distinguish these species from each other.
Although taxonomic work has been done for hundreds of
years, scientists guess that only about 1.7 million species of
eukaryotes have been described out of an estimated 10 to 100 mil-
24 Bio Business March/April 2008
(Above) In the lab: the CCDB is the first and largest high volume research and production
facility for DNA barcodes in the world; (Below) Dr. Mehrdad Hajibabaei’s butterflies and
moths studies in Costa Rica identified many species that had not been classified before.
Discoveries
bound nucleus), there are only two genes that are common in all of
them, one of which is the CO1 gene. Composed of 650 base pairs
of the 5’ region of this gene, this portion of the gene was tested and
proposed as a DNA barcode by University of Guelph’s evolutionary biologist and CCDB’s Director, Paul Hebert in 2003.
“Since then, we have been looking at the rate of divergence of
this barcode fragment in different groups of animals,” says
Hajibabaei. “What we’ve found is we usually see about 5-10%
divergence between species, but when you look within species,
there is not much variation. So the ratio
of this difference of within a species and
between species enables a robust identification system.” The centre’s scientists
have barcoded 260,000 individuals so far,
from about 30,000 species.
Though animals, plants, fungi, and
protists are all eukaryotes, when divergence levels are looked at, the CO1 barcode gene does not evolve at the same rate
in all groups of life. In plants, for example,
the variation in the CO1 barcode region is
not sufficient to enable species identification in the same way it does in animals.
Thus, in plant science, scientists are currently looking at possibly using more than
one gene, and they are looking at chloroplast genes for DNA barcoding.
DNA barcoding is still a relatively new
technology, and thus the bugs are still
being worked out. The front end of the
process is really about finding ways of
accessing samples, and streamlining samples into the facility, says Hajibabaei. A
DNA barcoding centre has to deal with
many different types of tissue, from insect
legs to fish muscle tissue to bird feathers to
cultures of fungi. At the front end scientists are focused on finding better ways of
sampling, or getting these tissue samples
from different collaborators or from the
field. CCDB has just started a new
research program that uses next generation
parallelized sequencing machines to gather barcode records directly from mixed
environmental samples. This so-called
environmental barcoding approach will
lead to quick biodiversity scans of any
environment. This technology will also
enable efficient monitoring of the species
that are indicators of environmental
health, currently a stiff challenge for environmental agencies.
According to Hajibabaei, one of the
most interesting and important aspects of DNA barcoding is that
“when you start doing barcoding in high-throughput fashion, you
will find cryptic diversity, things that have been overlooked, or
haven’t been identified at all.”
Hajibabaei’s butterflies and moths studies in Costa Rica in collaboration with American biologist Daniel Janzen identified many
species that had not before been classified. “We still find new
species when we do barcoding. Sometimes one species turns into
five or six species.” BB
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IP & Patenting
CAN TWO REALLY BE BETTER THAN ONE?
Commercializing IP through collaboration
By Trevor Newton and Pierre-Paul Henrie
B
iotech companies face a disproportionately high demand for resources when compared to companies in other
sectors, and frequently grapple with the question of how to find the resources needed to commercialize, and
ultimately exploit their IP. While licensing and sale agreements are both common and useful modes of
commercializing IP, collaborative arrangements—such as joint ventures, strategic alliances, and partnerships—provide
an avenue by which a party can fully exploit and maintain control over IP assets. Collaborative arrangements
essentially allow parties to combine their resources to produce a result that would otherwise not be feasible or efficient.
What is a collaborative arrangement?
A joint venture is an agreement by two independent companies
or institutions to contribute resources toward, and share profits
from, a specific project or undertaking. A joint venture may take
various forms, involve different structures and may be carried
through partnerships, corporations or other vehicles. Given that
a joint venture is not a legally recognized structure, but is rather
a term used to connote a relationship between parties in the context of certain projects, the preparation of the underlying agreement is crucial at identifying and protecting the interests of the
parties to the joint venture.
While each collaborative model is unique, several of the IP
issues that should be considered before entering into a joint venture, strategic alliance or partnership are common to these
arrangements. This article canvasses some, but by no means all, of
the elements a company may wish to consider when entertaining
the idea of a collaborative venture.
Before you commit
Before making any decisions about which type of collaborative
model is most appropriate, management must clearly define the
company’s short and long-term goals. For a successful collaboration, each party must be clear about its objectives, and the level of
engagement and contribution it is seeking from a potential partner.
Secondly, management should take stock of the value of each
of the company’s assets and liabilities. Valuation of IP is an essential part of this exercise, and generally requires the company to
undertake a due diligence investigation. This due diligence should
March/April 2008 Bio Business 27
IP & Patenting
include a search to determine where the IP is protected, an evaluation of the enforceability of any patents granted, an investigation
of market freedom, and a review of all IP-related contracts to confirm that the IP’s potential uses are not limited or constrained.
Valuation of IP is a difficult but necessary task. This is particularly true for companies and institutions that are contributing IP in lieu of cash. An accurate valuation gives the company
contributing the IP a stronger foundation upon which to negotiate certain key terms of the arrangements, including the contribution to and proprietary interest in the project, in addition to
the rights and sharing of profits.
In addition to knowing its own assets, management should
gather as much information as possible about its prospective collaborator. As such, it is advisable to conduct a full due diligence
investigation to ensure, as far as possible, that any representations
made by the prospective partner as to its core business competencies, corporate status, financial position and asset contribution
(IP, financial, human or otherwise) are accurate.
Negotiating the rules of the game
The joint venture, strategic alliance or partnership agreement will
be the document that establishes the rights and obligations of
each party. As such, it should be as comprehensive as possible so
that there are no surprises down the road.
Firstly, the agreement should define the scope of the arrangement and assign each party’s specific roles, duties, responsibilities
and contributions in all of the key areas of the project. It is also
important that each party accurately and comprehensively
describe the property, including IP, that it is contributing to the
project. These descriptions should be clearly reflected in the
agreement, to avoid confusion and prevent disagreement.
A key element of negotiations will be deciding on an appropriate division of the profits flowing from the collaboration.
Profits are often apportioned according to each party’s stake in
the venture, but may be divided equally or by way of a tailored
allocation formula.
Further, it is important to recognize that IP that is contributed
to a collaborative arrangement—also known as background IP—
is likely to be accessed, used and manipulated by others during
the course of the collaboration. To ensure background IP can be
freely used by the parties involved, it may be useful to consider
licensing provisions covering the joint use of the IP. A confidentiality agreement, either as a provision of the main agreement or
as an appended agreement, may be a helpful tool to ensure that
the disclosure of confidential information pertaining to the IP or
the business of the parties is restricted and controlled.
Developing a clearly defined exit strategy
An exit strategy is an essential element of any collaboration
agreement, as even successful collaborations usually conclude at
some point. To this end, the agreement should list the types of
events that, should they occur, would give the parties the right to
terminate the relationship.
28 Bio Business March/April 2008
When a business collaboration ends, first and foremost on the
minds of the parties is usually the division of the assets contributed to, and developed or acquired during, the collaboration.
From an IP perspective, it is vital that the agreement stipulate
which party will retain or acquire ownership of any background
IP that was developed prior to the collaboration. Often, the party
that developed the background IP will retain ownership.
More complicated is the ownership of foreground IP.
Foreground IP is IP that has been developed or created during the
collaboration. The division of foreground IP is often a contentious
area and, as such, requires a clearly defined and precise approach.
In some cases, where both parties have developed IP independent
of each other during the duration of the collaboration, the agreement may stipulate that ownership is retained by the creator.
Alternatively, where resources are co-mingled, the agreement
could require the parties to continue to hold the IP jointly.
“Management should gather as much
information as possible about its
prospective collaborator.”
Often during the term of a collaborative relationship, management of one party will become familiar with, and impressed
by, the employees of the other party. In some cases, it may be a
good idea to enter into a non-solicitation agreement to ensure
that one party does not solicit employees from its former partner
once the parties have gone their separate ways.
Conclusion
For companies considering a collaborative arrangement—a joint
venture, strategic alliance, or partnership—a few key points should
be kept in mind. Firstly, each party should thoroughly evaluate its
strengths, weaknesses and overarching objectives, as well as those
of its prospective collaborator. Once the parties have agreed to
enter into a relationship, the ownership of background and foreground IP, the division of profits, and a clearly defined exit strategy should be at the forefront of any negotiations. BB
About the authors: Pierre-Paul Henrie is a partner in the business law group of Ogilvy Renault LLP and Trevor Newton is a
patent agent in the intellectual property law group of Ogilvy
Renault LLP. The authors also gratefully acknowledge the contributions made by Linsey Sherman. All contributors are based in
the firm’s Ottawa office.
The purpose of this document is to provide information as to developments in the law. It does not contain a full analysis of the law nor does
it constitute an opinion of Ogilvy Renault LLP or any member of the
firm on the points of law discussed. The views expressed in this paper
are solely those of the authors.
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Business Management
Clinical trial design—effectively
managing your clinical trial
B
io Business recently consulted Heath Canada to take a look at
Canada’s most recent clinical trial regulations, and what effect might
they have on the industry. The following abstract is based on an
interview with Joey Rathwell, media relations officer, Health Canada.
Background
The role of the Therapeutics Products Directorate (TPD)—for
pharmaceutical drugs—and the Biologics and Genetic Therapies
Directorate (BGTD)—for biologic drugs—in clinical trial regulation and management in Canada is multifold. TPD/BGTD
conducts scientific reviews of all clinical trial applications before
a drug can be sold or imported by a sponsor of a trial (the review
must be conducted within 30 calendar days)—they are required
to evaluate the safety, efficacy and quality of information provided in a clinical trial application. The main objective of this review
is to ensure that the sponsor has the appropriate parameters in
the application such that known risks to participants are: identified and minimized; detailed and communicated via the
Informed Consent Form; detailed in the Investigator’s Brochure;
and are acceptable within the context of the medical condition to
be treated, the alternative treatments available, and study population identified in the protocol. TPD/BGTD is not responsible
for evaluating the ethics of clinical trials or conducting the trial,
however, sponsors are required to attain ethics approval for all trials from a properly constituted Research Ethics Board prior to
initiating the study. Since clinical trials are a key mechanism for
Canadians to get access to therapeutic products, TPD/BGTD
also plays a key role in activities that promote clinical trials in
Canada (e.g. workshop sessions/conferences) at a local, national
and international level.
Current situation
September 1, 2001, Part C, Division 5 of the Food and Drugs
Regulations (drugs for clinical trials involving human subjects)
came into force, with two over-arching objectives: to strengthen
protections for clinical trial subjects; to attract and sustain investment in research and development in Canada. In addition, the
regulatory framework also required a review to be undertaken in
response to the commitment made to assess the impact of the
new regulations within three to five years in the Regulatory
Impact Analysis Statement (RIAS) that accompanied the 2001
regulations. The regulatory review was launched via an e-consultation in June 2006 followed by a stakeholder workshop held on
March 26, 2007. Relevant information related to this regulatory
review was also discussed at specific events in the fall of 2007.
The review of the clinical trials regulations was also undertaken
in the context of Health Products and Food Branch’s (HPFB’s)
Blueprint for Renewal, an ongoing initiative that aims to modernize the regulatory system for health products and food. Another
important initiative under the HPFB Blueprint for Renewal is the
Progressive Licensing Framework (PLF) Project. The PLF is a
long-term policy framework that will help inform the development
and implementation of a plan to improve the drug regulatory system by providing Canada with instruments for modern and inno-
“Additional flexibility is required to address
emerging trends such as adaptive clinical
trial designs, pharmacogenomics, and the
needs of specific populations.”
vative regulation of drugs. In other words, this framework is
designed to specifically address the areas of the regulatory framework that need to be “modernized/revamped”
Based on the feedback received to date most respondents indicated that the 2001 regulatory framework has met its objectives
of strengthening protection for clinical trial subjects, and attracting
and sustaining investment in research and development in Canada,
and that these objectives continue to be relevant. However, additional flexibility is required to address emerging trends such as
adaptive clinical trial designs, pharmacogenomics and to address
the needs of specific populations. Stakeholders also suggested the
need to build upon the current process in order to have a more
March/April 2008 Bio Business 31
Business Management
effective regulatory framework by improving access to information
related to clinical trials. An example of such an approach—which
has been well received by stakeholders—was the launch of the clinical trials e-manual (summer 2007) as an online tool that provides
all the information related to the Canadian clinical trial application
process for pharmaceuticals, biologics and radiopharmaceuticals
(http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applicdemande/guide-ld/clini/cta_intro_e.htm).
Insider advice
Sponsors are encouraged to review the relevant information provided in the e-manual so that they are more aware of the
Canadian clinical trial application (CTA) process and the subsequent regulatory requirements, both pre- and post-filing of an
application. In addition, sponsors should also visit the Health
Canada site on a frequent basis in order to ensure that they are
fully aware of any recent postings. As an example, in the last quarter of 2007 Health Canada released the final version of the guidance document titled “Standards for Type II Diabetes in Canada”
and also an update related to the requirements for Tuberculosis
screening in specific Phase I trials.
“Sponsors need to be aware that they
always have the opportunity to request
a pre-clinical trial application meeting.”
Sponsors also need to be aware that they always have the
opportunity to request a pre-clinical trial application (pre-CTA)
meeting, which can be especially useful for both parties when the
sponsor is proposing something novel and some sponsors also use
this as a training opportunity for new staff that have just joined
their organization.
Finally, being more aware of the relevant International
Conference on Harmonization (ICH) guidance documents that
have been adopted by Health Canada should also help Canadian
companies who are beginning a clinical trial.
Prep talk
There is no cost for requesting a pre-CTA meeting nor for filing
the CTA (application itself ). In addition, the review process for a
CTA is subject to a 30-day, regulatory default, which includes
weekends and holidays. Therefore, as mentioned above, knowing
the Canadian CTA process and the regulatory requirements
should not only help facilitate the filing of the submission, but
also enable a better understanding of the post-authorization, regulatory obligations/requirements (e.g. reporting of serious and
unexpected adverse drug reactions). As an example, knowing that
prior to starting the trial, the sponsor must receive authorization
from Health Canada and approval from the relevant research
32 Bio Business March/April 2008
ethics board is an aspect that the sponsor should build into their
planning phase since the risk in not doing so can result in significant delays in commencing the trial.
Looking forward Canada is now competing with India and
China to attract sponsors to conduct trials in their respective
countries. The strength of the Canadian regulatory process (e.g.
the ability to continue to have a 30-day default, not to mention a
seven-day target for bioequivalency trials) along with other established processes such as having an inspection program, a strong
scientific/clinical and research ethics board community, a diverse
population and world-renowned clinical facilities, will all play a
key role in ensuring that Canadians have and will continue to have
opportunities to access therapeutic products within a clinical trial
environment. Furthermore, by modernizing the regulatory framework, the Blueprint for Renewal is also designed to address areas
that may be considered as “weaknesses” and by continuing to have
the relevant representation, both locally and in the global market,
Canada will continue to ensure that sponsors who are interested
in conducting clinical trials are aware of the opportunities that
exist in Canada. There do appear to be certain emerging trends
such as adaptive clinical trial designs, pharmacogenomics and the
need to conduct clinical trials in specific sub-populations (e.g.
pediatrics), but in most cases these are not just specific to
Canadian clinical trials. Having said that, Health Canada has
released relevant guidance documents (e.g. Guidance Document
related to the submission of Pharmacogenomic information) and
continues to ensure that dialogue continues through relevant discussions with stakeholders, be it at specific conferences such as the
5th Annual Canadian DIA, or via pre-CTA meetings.
With respect to issues arising in the future related to pharmacogenetic/genomics, these will include issues around the use of
biomarkers within the context of a clinical trials and also having
“personalized medicine” type trials where the treatment arms are
tailored to meet the clinical trial subject’s needs based on their
genotype. While these issues may have clinical implications (e.g.
are the biomarkers validated?) they will also have ethical and privacy-related implications (e.g. who will have access to the
genomic data? how will it be stored? destroyed?). BB
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©2007 VWR International, Inc. VWR, forms of VWR and the VWR logo and/or design are either registered
trademarks or trademarks of VWR International, Inc. in the United States and/or other countries.
reply online at www.biobusinessmag.com
Business Management
CONTRIBUTED ANALYSIS
What Does the Future Hold for Clinical Data Management?
By Peg Regan, CEO, PharmaPros Corporation
C
ompanies engaged in clinical trials
are seeing a paradigm shift in the
very definition of clinical data management (CDM). What was once a
paper-based, manual process that focused
on one trial at a time, is quickly evolving
into a technology-based, automated
process that can operate across multiple
studies. We’ve seen in the industry over the
last 10 years not only an explosion of
technology and telecommunications, but
the globalization of clinical trials in
response to patient recruitment challenges
and price pressures on activities now being
viewed as commodities, such as CDM and
site monitoring.
Trends reported by the FDA show that there is a growth in the
number of studies sponsors must conduct for each product, fewer
patients from which to recruit and an ever-expanding number of
data sources being incorporated into clinical trials such as EDC,
ePRO, IVRS, CTMS, and new types of electronic lab data. As a
result, software vendors have been taking on the challenges of
managing and housing this data. This is not a tenable situation,
and will continue to be a pressing issue for sponsor companies
and CRO’s alike, until a holistic approach to electronic CDM
emerges to fill these gaps and act as the conduit through which
the lifecycle of the data becomes interconnected and seamless.
So what is this holistic approach? First, old notions of CDM
must be left behind in order to secure the future, which is Data
Lifecycle Management. With this comes changing the current
notion of what role CDM plays in clinical trials, along with the
different roles within CDM itself. What was once a “black box”,
where data went in one end and came out the other (if at all),
will become a multi-disciplinary process with open access and
visibility. Data Lifecycle Management is an approach to the
overall development lifecycle of a product, enabling adaptive
trial designs and real-time access. Through faster access and
better quality data at each step and the development of optimal
eCDM processes, Data Lifecycle Management will help remove
the silos of information that have resulted in a the lack of quality data, cost overruns, and pushed timelines that have plagued
traditional clinical trials.
What roles will be required for a Data
Lifecycle Management approach? Where
we once had Lead Data Managers, Data
Analysts, Programmers and Data
Processors, we will now begin to see
Product Data Managers working across
multiple studies and Data Project Leaders
with skills in eCDM. We will also begin to
see Data Integrators who will manage the
integration of electronic labs, EDC,
CDMS, IVRS, ePRO and CTMS and Data
Aggregators who will pull data from
across multiple studies and programs for
the executive team to be able to evaluate
feasibility, and more importantly, the
safety trends that such a comprehensive
view can provide.
What skills will these new roles need to possess to perform
their new functions? With the increased number of vendors
and diverse study teams involved in clinical research, these
new roles will need strong interpersonal skills and the ability to
manage these seemingly disparate functions as one integrated
team. And with the trend toward globalization, these new
roles will require a knowledge base in international regulatory issues and data standards. All of these roles will need to be
technology-savvy and willing to adapt in an ever changing
and complex environment, which will soon include the integration of electronic health records (EHR) and Trusted Third
Party Services (TTPS), as the healthcare and life sciences industries continue to converge in new ways.
For those who think CDM is a thing of the past, think again.
While it may look very different than it used to, we will still
have people managing data. The difference is that they will be
managing the entire electronic lifecycle of the data, and no
longer from a silo operation. They will be working along side
the other functions as part of an integrated multi-disciplinary
team. At the end of the day, the trial data is the lifeblood of
this industry and is what determines the success or failure of a
product; sometimes a company. Whether you’re a leading
CRO, or an emerging small to mid-size biopharmaceutical
company with one lead candidate, the future of CDM is Data
Lifecycle Management. BB
About the author: An expert in designing technology solutions integrated with optimized business practices, Peg Regan is the founder,
president and CEO of PharmaPros Corporation, a dynamic team of industry experts in delivering business solutions in managing
clinical trials. www.pharmapros.com
34 Bio Business March/April 2008
03.08 THE STATE OF LOUISIANA:
THE PERFECT
CULTURE FOR
GROWING BIOTECH
BUSINESSES.
Pennington Biomedical Research Center, a world leader in nutrition
and disease prevention research, is investigating genetic factors that
may c o n t r i b u t e to eating behaviors, body w e i g h t and b i n g e eating
NuPotential, located at the Louisiana Emerging Technology Center, has
developed a revolutionary approach to reprogramming somatic cells i n t o
pluripotent stem cells Esperance Pharmaceuticals is developing a unique
targeted anticancer drug that selectively kills cancer cells on contact
Embera NeuroTherapeutics, based at InterTech Science Park, has
developed patent-pending treatments for addiction and a wide array of
neuropsychiatric disorders BioFluidica Microtechnologies is developing
on-site DNA testing instruments for use in forensics, medical diagnostics
and pathogen detection Louisiana’s Angel Investor Tax Credit allows
refundable Louisiana income or franchise tax credits of up to 50% of
investments The Tulane Center for Gene Therapy is the first research facility
in the nation dedicated solely to using a patient’s own donated stem cells
To learn more or to find out about valuable Gulf Opportunity Zone Incentives, call Bob Fudickar
at 225.342.6816 or visit us at
LouisianaForward.com/BioBusiness
© 2008 Louisiana Economic Development
reply online at www.biobusinessmag.com
Blood kit for isolating genomic DNA
Invitrogen launched the iPrep PureLink gDNA Blood Kit for isolating genomic DNA from
blood. The kit produces high yields of pure genomic DNA from up to 350ul of fresh
or frozen blood, perfect for sensitive downstream applications. Designed specifically
for use with the iPrep Purification Instrument using Invitrogen’s Dynabeads magnetic
separation technology, this kit yields sufficient DNA for clinical studies or for multiple
PCR-based standardized testing assays. The kit provides reagents in pre-filled cartridges
to eliminate contamination and also includes all tips and tubes needed to isolate DNA
from blood samples in 30 minutes.
reply online at www.biobusinessmag.com
In situ adherent cell electroporation
BTX introduced the Petri Pulser for In
Situ Electroporation of mammalian
cell transfections, gene therapy or drug
delivery. The Petri Pulser is a re-usable
electrode and fits into a single well or
6-well plate or in an individual 35mm
plate. The gold electrodes are 2 mm
apart and can used with BTX
generators. The electroporation of
adherent cells avoids the need for
chemical disassociation of cells and
eliminates the problems associated
with low plating efficiencies flowing
electroporation.
reply online at www.biobusinessmag.com
Automated system for biomolecular characterization
Wyatt’s Dynapro Titan Plate reader is an automated, non-invasive dynamic light
scattering system for biomolecular characterization. The plate reader can be used
to perform fast and accurate sample analysis in a wide range of applications. These
include researching antibody formulations in a variety of solution conditions, screening
proteins prior to crystallization trials and the bioprocessing and quality control of viral
particles in vaccines. The DynaPro Plate Reader does not harm sample stability and
reduces the amount of time scientists need to spend operating and monitoring the
instrument. The DynaPro’s non-invasive technology measures the sample in the industry standard microplates
(96, 384 or 1536 well
plates), where the data are
collected automatically by
the easy-to-use DYNAMICS
software. The software can
be customized to integrate
with any of the industry
leading liquid handling
robotic systems. Once the
data have been collected,
the protein samples can
be retrieved and the plates
discarded. Only very small
sample volumes are
needed, as little as 5
microlitres per well.
Sample times are also
reduced from 15 minutes
to less than one minute.
reply online at
www.biobusinessmag.com
36 Bio Business March/April 2008
Homeothermic Blanket System
for small animals
Harvard Apparatus introduced the Homeothermic
Blanket System used to maintain animal body
temperature during surgery, or for post surgery
recovery. The Homeothermic Blanket System
can be used with mice, rats, cats and dogs.
The unit can accurately maintain an animal’s
body temperature between 68° and 122° For
20° and 50° C. The system has built in minimum
and maximum temperature alarms and a
hysterisis control to help reduce over-shoot
of the set temperature. The NEW Homeothermic
Blanket System offers a large user friendly bright
graphical display that shows the temperature
as monitored by the probe, the set temperature,
alarm settings and whether the blanket is
“floating” or “earthed”. Harvard Apparatus
is a global developer, manufacturer and
distributor of innovative and specialized
products to enhance bioresearch.
reply online at www.biobusinessmag.com
Gas controller for maintaining
O2 and CO2 gas concentrations
Warner Instruments introduced the new
Oxystreamer O2 and CO2 Gas Controller
for precise and variable selection of O2
and CO2 gas concentrations. With a
closed-loop dynamic gas control system,
this instrument maintains mixed gas concentration to within 0.2% of the selected
set-point levels. Ranges cover O2 concentration from 0.1–99.9%; CO2 concentration
from 0.1–20.0%; N2 concentration 0–100%. The
two output streams of this system are ideal for
controlling the atmosphere in a microscope stage
mount cell culture incubator/chamber and the
dissolved O2 and CO2 levels in a media or perfusate.
reply online at www.biobusinessmag.com
Products
PCR tool speeds up bacterial identification
Faster multichannel pipette calibration
Q Chip introduced a new PCR tool which speeds up bacterial
identification, with greater accuracy and less variability.
Identification using the ReaX Assay 16S beads is based on PCR
amplification of the 16S ribosomal RNA gene. With the ReaX
Assay 16S PCR beads, less manual pipetting is required, with
fewer opportunities for contamination and reduced pipetting
error. ReaX Assay 16S beads contain all the reagents required
to perform 16S rRNA gene amplification, including a high-performance Taq polymerase, dNTPs and the universal 16S rRNA
gene-specific primers 27F and 907R. Only template DNA is
required prior to running the PCR protocol. Amplification is
confirmed using end point PCR.
Mettler Toledo’s MCP series of calibration workstations provide ISO 8655-compliant calibration of
single and multichannel pipettes in a fraction of
the time required by a traditional balance. The
MCP workstations can precisely calibrate volumes
as low as 10 µl. With the MCP series, a 12-channel micropipette can be fully calibrated within just
14 minutes using the MCP5 workstation. The calibration workstations are useful in accredited calibration laboratories, for QC laboratories, and for performing a quick check before starting an experiment. The
workstations consist of from one to five automatic weighing units, each one consisting of a balance and an automated transport system that can weigh up to 12 individual liquid
samples dispensed by the pipette. Mettler Toledo’s pipette calibration software Calibry is easy to use, and allows large
amounts of data are to be easily organised, with every single
operation recorded.
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Small syringe pump for limited space applications
The KD Scientific Model KDS 310 Nano Pump is used with micro
syringes from 0.5 to 250 microliters. Small size, remote control and
a rugged mounting arm make it ideal for use with micromanipulators,
stereotaxic frames and other clamping devices. The controller can be
6 feet away from the pumping unit, which is useful for safely pumping
into reaction vessels, pumping radioactive chemicals or for mounting
in small places next to an experiment. The single syringe infusion/withdrawal pump consists of a controller and a remote pump head
designed to use microliter syringes and deliver nanoliter volumes at low
flow rates. The microprocessor-based controller uses a bright display
and membrane keypad with a simple, menuprompt system for easy setup. The pump features preset rate and volume control. The dispense volume is displayed continuously and
the pump shuts off automatically when the
preset volume has been reached.
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Purification kit for
purification of RNA,
microRNA, DNA and
proteins
Norgen Biotek introduced
the Total RNA Purification
96-Well Kit for high
throughput total RNA
purification. The all-inone purification kit
enables the isolation of
total RNA including microRNA, genomic DNA and total proteins
sequentially from a single sample using one column, without the use
of phenol/chloroform or acetone. A microRNA Enrichment Column is
also provided for optional separate purification and enrichment of
microRNA from the total RNA fraction. This procedure allows for the
efficient isolation of the four macromolecules in less than 20 minutes
with scientists no longer needing to divide their initial sample or
lysate, thus resulting in better consistency. The purified macromolecules are well suited for many downstream applications including PCR
amplifications, RT-PCR and Real-Time PCR, as
well as Southern blots, Northern blots, Western blots, and Dot blots,
cDNA synthesis, microarrays and mass spectrometry.
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Microcentrifuge offers
speed and ease
Eppendorf’s latest microcentrifuge, Microcentrifuge 5424,
following in the tradition of
Model 5415 D, was developed for increased silence,
speed, and simplicity. Model
5424 offers up to 21,130 x g
(15,000 rpm) to satisfy all
applications and is whisper
quiet—even running without
the rotor lid. Its innovative operating concept and overall design
are based on in-depth ergonomic studies, making everyday routines faster and easier.
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LIST OF ADVERTISERS & WEBSITES
Biotec Canada ..................................Page 26 ....www.goldleafawards.com
Biotalent ............................................Page 29 ..................www.biotalent.ca
Brinkmann..........................................Page 21 ............www.brinkmann.com
Buffalo Niagara ..................................Page 6 ..........www.buffaloniagara.org
Conviron ............................................Page 39 ................www.conviron.com
Eppendorf ..........................................Page 4, 11, 40 ..www.eppendorf.com
Fisher Scientific..................................Page 2, 30 ..............www.fishersci.ca
Government of Saskatchewan ..........Page 25 ........www.saskatchewan.ca
Louisiana Economic Development ....Page 35 ..............................................
......................................................www.louisianaforward.com/biobusiness
Thermo ..............................................Page 15 ..................www.thermo.com
TRIEC ................................................Page 18 ........www.hireimmigrants.ca
VWR ..................................................Page 33 ........................www.vwr.com
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March/April 2008 Bio Business 37
In Person
Dr. Ivar Mendez
Making dreams of brain repair a reality
I
var Mendez, MD, PhD, FRCSC, FACS, is Chairman of the Brain
Repair Centre, the largest and most comprehensive health
research initiative in Atlantic Canada. In addition he is Professor,
Department of Anatomy & Neurobiology, and Professor and Head,
Division of Neurosurgery at Dalhousie University in Halifax,
Director of Research for the Department of Surgery and Director of
the Neural Transplantation Laboratory.
As one of the founders of the
Brain Repair Centre (BRC), Dr.
Mendez has developed a worldclass collaboration of researchers
and physicians all working
toward treatments and innovative
solutions to diseases and injuries
of the brain and spinal cord.
From the clinician/scientist perspective, Dr. Mendez’ research
focus is in functional neurosurgery, brain repair, stem cells,
robotic neurosurgery and computerized systems in neurosurgical applications. In 2002, Dr.
Mendez and his team performed
the first long-distance robotic telementoring neurosurgery in the
world between Halifax, Nova
Scotia and Saint John, New
Brunswick—400 km away.
As a researcher, Dr. Mendez
is breaking new ground in the
field of neurotransplantation. At
Canada’s only Cell Restoration
Laboratory, he is working to
answer questions posed by neural transplantation teams around
the world—among them: how to
improve survival and how to
transplant cells without damaging
the brain.
His laboratory research has
been supported by peerreviewed funding from a number
of sources including the Canada
National Centers of Excellence,
Canadian Institutes of Health
38 Bio Business March/April 2008
Research, Nova Scotia Health Research Foundation, Atlantic
Innovation Fund, and Parkinson’s Disease Foundation of USA. Dr.
Mendez has been recognized by his peers nationally and internationally. He has won a lengthy list of awards including the
Clinical Scholar Research Award in 1997, the Royal College
Medal Award in Surgery in 1999, the Japan Neurosurgical
Society Award in 1999, the Murray L. Barr Scientist Award in
2000, and the Professional of
Distinction Award by the
Discovery Centre in 2003. In
2004, Dr. Mendez was recognized for his extensive humanitarian activities by receiving The
Paul Harris Fellowship Award as
well as the Dr. Gerald and Gale
Archibald Medical Humanities
Award. He is recognized internationally as an expert in his field
and has extensive scientific publications.
Dr. Mendez received his MD
and PhD in Anatomy from the
University of Western Ontario,
London, ON, where he also completed his post-graduate training
in Neurosurgery. After completion
of his neurosurgical residency, Dr.
Mendez was awarded the
Resident Research Prize by the
American Congress of Neurological Surgeons and the William
P. Van Wagenen Fellowship by
the American Association of
Neurological Surgeons. His
research Fellowship was done at
the Department of Medical Cell
Research, University of Lund,
Sweden. Dr. Mendez is a Fellow
of the Royal College of Physicians
and Surgeons of Canada and the
American College of Surgeons.
SOURCE: With permission from
the Brain Repair Centre
www.brainrepair.ca
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C001.A1.0115.E © 2003, 2006 Eppendorf AG
l
Reduced operating forces
l
Pipette and tip color-coding
systems
l
Comfortable fit
l
Ergonomics approved by TÜV
Fantastic fit.
Intuitive operation—Minimal user exertion
Eppendorf PhysioCare Concept pipettes.
Specially developed precision components and an optimal
design produce a pipette that is easy to use and requires
less force to operate. The results are reduced mental and
physical strain and a more efficient lab process.
®
TÜV Rheinland approved our manual pipettes as:
ergonomic, user-friendly and user-tested.
To find out more about the complete
PhysioCare Concept please visit:
www.physiocare-concept.info
www.eppendorf.com • Email: info@eppendorf.com • Application hotline: 516-515-2258
In the U.S.: Eppendorf North America, Inc. 800-645-3050 • In Canada: Eppendorf Canada Ltd. 800-263-8715
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