BB OctNov07 Issue

Talent Wanted: Biotech industry challenged by talent shortages
CHAMPIONING THE BUSINESS OF BIOTECHNOLOGY IN CANADA
October/November 2007
Agents of Biodefense
Twinstrand president Thor Borgford on advancing biodefense research in Canada Biotech in Florida Southern state vies to become major life sciences hub Adequate Support? Assessing support requirements for selection patents
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Canadian Publications Mail ProductSales Agreement 40063567
Our look back at National Biotechnology Week 2007
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Bio Business
CHAMPIONING THE BUSINESS OF BIOTECHNOLOGY IN CANADA
Contents
Recruitment for the Canadian life sciences industry

20
Experts weigh in on how the sector is dealing with a shortage of experienced management
20
also inside
14 19 26
Post-National Biotech Week
A look back at some of the many events that happened across the country during National Biotech Week 2007
36
standards
5 7 36
EDITORS NOTE NEWS NEW PRODUCTS
Q&A
Thallions Lloyd M. Segal on his business strategy, challenges and plans for the companys future
IP&Patenting
Supporting Your Selection Has the Federal Court of Canada increased the support requirements for Selection Patents? Licensing Your IP How can companies exploit and protect their resources?
30 32 38
Discoveries In Canada we have a smaller life sciences industry, and a smaller labour pool to draw from. There arent as many people whove had biotech experience. Thats why Canadian companies covet people whove worked with a medium to large biotech company and taken products to marketpeople with experience in business development, financing, and commercialization. But it will come in timewere still a very young industry.
Mark Gregory, vice president, Pharmahorizons
Agents of biodefense in Canada
Regional profile
Building Floridas life sciences hub of the future
In Person
Computational biologist Melanie Huntley has been honoured with the Academies of Arts, Humanities and Sciences of Canada Alice Wilson Award for 2007 Cover photo: Darren Cardinal
October/November 2007 Bio Business 3
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Bio Business
Championing the Business of Biotechnology in Canada Publisher & CEO Managing Editor Assistant Editor Art Director Contributors Christopher J. Forbes cforbes@jesmar.com Bernadette Johnson bjohnson@jesmar.com Catherine Muir cmuir@jesmar.com Tammy White twhite@jesmar.com Mark D. Penner Pierre-Paul Henrie Erica Tennenhouse Susan A. Browne Beth Kukkonen bkukkonen@jesmar.com Sandor Nyman snyman@jesmar.com Nancy Sim nsim@jesmar.com Jessica Forbes jforbes@jesmar.com Roberta Dick robertad@jesmar.com Crystal Allen callen@jesmar.com
Editors Note
A Benefit to Boasting
had the pleasure of attending the National Biotechnology Week kick-off event in Winnipeg in September. Though the Manitoba weather left a little to be desired, the luncheon event was worth the trip. Headliner Dr. Moira Gunn was highly entertaining, and provided much food for thought. BIOTECanada president Peter Brenders, who delivered the results of a BIOTECanada and Pollara annual poll at the launch event, said the industrys challenge is to inspire people to understand the breadth of biotechnology. Time and time again, it comes up at events across the country: Canadian biotechnology players and companies need to educate and build awareness around biotechnology, in general, and around their companies and discoveries, in particular. The industry is always being urged to boast a little more; talk it up; sell yourself. It occurred to me in reading this issues cover story (Talent Wanted, page 20) that the positive auxiliary benefits of selling yourself may indeed be in areas such as recruitment, workforce development, and talent management. If we can start to boast ourselves and the industryboth domestically and globally perhaps we can ultimately attract and retain key scientists and management executives. According to PriceWaterhouseCoopers Canadian Life Sciences Industry Forecast 2007, recruiting experienced senior management is seen as the most important action industry can take to improve
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Canadas ability to compete globally. The survey cites the senior management positions that are particularly difficult to hire include directors of regulatory affairs, CEOs, VPs of business development and directors of clinical development. As Catherine Muirs story states, pundits agree the size of our industry, as well as its relative age, are contributing to the challenge. Sources also point to a new trend: while recruitment strategies are indeed crucial, retention is increasingly growing in importance. Our sister publication LAB Business conducts a salary survey each yearwere currently working on the 2007 edition. Without revealing too much of the good stuff, one thing I can say thats pertinent to this particular discussion is that monetary and non-monetary incentivesall designed to keep people around longerare increasing year over year. Its all about the package youre willing to offer, says Thallion president and CEO Lloyd Segal. Compensation opportunities are global, he says, indicating key employees can do business development, for instance, anywhere in the world. You have to create a competitive package that ensures they have upside in the success of the company. Heres to getting out there and boasting a little.
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News
Innovation gets low grade in Conference Board of Canada report
he Conference Board of Canada (CBC), a notfor-profit group in Ottawa, recently gave a report card to Canada that examined six domainseconomy, innovation, environment, education, health and society. The report, called How Canada Performs: A Report Card on Canada, is a detailed comparison of Canadas socioeconomic performance with that of other leading industrialized countries. In the report, Canada received mixed results, with one A, three Bs and two Ds. According to the board: [Canadas] mediocre overall standing confirms the message the Conference Board has been reiterating for the last decade: Canada is not keeping up with the top performers in the new global economy. Canada showed a particularly poor performance in innovation, which received an overall grade of D. Canada ranks fourth to last in the 17-country comparator group for innovation. The report states: We lag in investment in R&D and in machinery and equipment, and we produce a lower share of graduates in science, engineering and the trades. We are not keeping up either in the creation or in the commercialization of knowledgeCanada needs the energy that will come from a national vision to encourage innovative behaviour. Canada also needs a strategy to focus our investments in commercialization where we can create and sustain a globally competitive advantage. In response to the findings of the report, the Conference Board has created a Leaders Panel on Innovation-Based Commerce (LPIC) to propose national paths and priorities for the investments of businesses, governments and academic institutions in innovation. Canada earned its best gradean Ain the Education and Skills domain. However, says the report, Canada does not produce enough post-graduates in the disciplines that support innovation, and it fails to meet the basic skills and literacy needs of its adult population.
BIOTECanada seeks overturn of anti-IP ruling
IOTECanada is seeking intervener status in an upcoming case to overturn a ruling by the Federal Court that would establish new super sufficiency requirements for Canadian improvement patents. The patent in question is a classical improvement/selection patent, a commonplace patent recognized throughout the world in the chemical, materials, pharmaceutical, biotechnology, pulp and paper, and agrifood industries. Improvement/selection patents are granted when an inventor elucidates that one or more members of a previously known class has some previously unknown advantage. According to BIOTECanada, due to the incremental nature of research and development in the biotechnology industry, the need for selection patent protection is significant. The organization says if selec-
tion patents are invalid without the inclusion of comparative data, its member companies may find themselves holding invalid patents and may be required to incur unnecessary time and expense to prepare and include data in their future patent applications though no such disclosure is required under the Canadian patent regulatory framework. According to BIOTECanada, Novopharm has sought to dismiss the appeal in this case and if that effort is successful the Canadian patent system will likely become more uncertain for innovative companies in all sectors. BIOTECanada will be arguing on the importance of the issue and seek to have the ruling overturned.
CIHR unveils new policy for open access to research publications
he Canadian Institutes of Health Research (CIHR) unveiled a new policy to promote public access to the results of research it has funded. CIHR will require its researchers to ensure that their original research articles are freely available online within six months of publication. The policy will apply to all grants awarded after January 1, 2008 that receive funding in whole or in part from CIHR. Grant recipients must make every effort to ensure that their peer-reviewed research articles are freely available as soon as possible after publication. This can be achieved by depositing the article in an archive and/or by publishing results in an open access journal. Additionally, grant recipients are now required to deposit bioinformatics, atomic, and molecular coordinate data, as already required by most journals, into the appropriate public database immediately upon publication of research results.
News
Acrongenomics appointed Dr. Dimitri Goundis as CEO. Dr. Goundis has almost 20 years of international experience in science, business and management.
Canadian VC funding declining from Q1 to Q2

total of $426 million in venture capital was invested across the country during the second quarter of 2007, down approximately 30% from the $606 million invested in the first quarter, and down 12% from the second quarter of 2006, says a recent report. However, Canadas Venture Capital & Private Equity Associations (CVCA) quarterly statistical report by the CVCA and research partner Thomson Financial says that due to strong showings in the first quarter of 2007, total venture capital investment of just over $1 billion through the first half of 2007 was up 21% over the $853 million invested during the same period last year. During the second quarter of 2007 there was continued growth in market share from foreign (principally U.S.) investors, now at more than 40% of all
terna Zentaris appointed Jrgen Ernst as chairman of the board of directors and David J. Mazzo, Ph.D., president and CEO, to the board. Jrgen Ernst has served as vice-chairman since November 2005 and succeeds executive chairman Eric Dupont, Ph.D. terna Zentaris also appointed Paul Blake, M.D., as senior vicepresident and chief medical officer.
Allon Therapeutics appointed Dr. Annette Kleiser as VP of business development. Dr. Kleiser joins Allon from Epigenomics in Seattle where she held a similar position and prior to that worked for Amgen.
venture capital investment in Canada this far, as well as a steady decline in fundraising by Canadian venture capital firms. Biopharmaceuticals and other life sciences sectors were lower than comparable figures from 2006. $127 million went to 27 life sciences companies in the second quarter of 2007, 10% less than the prior years $141 million. Consequently, life sciences activity secured 30% of total capital invested, which matches its share in 2006 overall.
Genome Quebec Biobank opened

Axcan Pharma announced Mr. Nicholas Franco joined the company as senior vice-president, International Commercial Operations. In his new role, Franco will oversee Axcans business outside of North America.
IntelGenx Technologies appointed James Wittenberg, R.Ph., M.S., as vice-president of business development. Wittenberg has over 20 years of experience providing market research and business development to pharmaceutical companies. Most recently he served as director of business development at Schwarz Pharma.
enome Quebec, in partnership with the Centre de sante et de services sociaux de Chicoutimi, a hospital centre affiliated with the Universite de Montreal, opened a biobank as part of the previously announced P3G/CARTaGENE project. Primarily created for storing and managing biological samples collected by the CARTaGENE project from 20,000 citizens of Quebec, it will also support other key projects. The biobank will also receive financing of $9.6 million over three years.
New name for Health Care Products Association of Manitoba

he Health Care Products Association of Manitoba has been renamed the Life Science Association of Manitoba (LSAM). The association has also added a communication and marketing specialist to the LSAM team, who will be the liaison between organizations, industry and government. With the launch of the association came a comprehensive Web site, featuring member profiles and members Web site links, as well as event listings with on-line registration
and payment. In addition, employment listings and links to relevant government and industry sites will be available on the LSAM Web site.
Med BioGene announced Dr. Nathan Yoganathan, Med BioGenes founder, president and CSO, has transitioned to a senior advisory role as chief scientific advisor. Dr. Bradley McLean, a senior scientist with the company, was appointed CSO.
8 Bio Business October/November 2007
Canada at the top in canola research
he National Research Council of Canada (NRC) and Agriculture and Agri-Food Canada (AAFC) released the single largest number ever of DNA sequences for Brassica napus (Canola) and related species. These sequences have been added to the global repository for DNA sequence informationGenBank (http://www.ncbi.nlm.nih.gov/). As part of a long-standing cooperative research effort between the AAFC Saskatoon Research Centre (AAFC-SRC) and the NRC Plant Biotechnology Institute, Canadian researchers have been working with Expressed Sequence Tags (ESTs) to understand how specific genes within Canola react to their environment and create compounds important in biofuels and healthy oils for foods. In conjunction with two Genome Canada projects, Enhancing Canola through Genomics (managed by Genome Prairie) and Designing Oilseeds for Tomorrows Markets (managed by Genome Alberta), NRC and AAFC have been using ESTs to examine how gene expression is involved in Canola seed development. The submission of this joint collection marks the most significant DNA sequence contribution to the global Brassica research community, representing nearly 90% of all submitted Brassica ESTs.
$14.7M for Thunder Bays Molecular Medicine Research Centre
Neuromed Pharmaceuticals appointed Mario Orlando to the newly created position of vice-president of marketing. Orlando has over 25 years of marketing and sales experience of major medicines with Wyeth, Genentech, Glaxo and Eli Lilly.
he federal government is investing $14.7 million in the Thunder Bay Regional Health Sciences Centre (TBRHSC) for the establishment of a Molecular Medicine Research Centre where cancer, cardiac and neurology research will take place. The $44.1 million project will be managed as a joint venture partnership between TBRHSC and Sunnybrook Health Sciences Centre, with active involvement of private partners, led by Philips Medical Systems (a division of Philips Electronics Ltd.). FedNor will administer the funding for the centre over the next five years. Specifically, the investment will support the salaries of a scientific director, career scientists and technical support staff; help purchase core research, IT and laboratory equipment; and support contracted professional services to assist with the establishment of the Molecular Medicine Research Centre. The economic impact of the Molecular Medicine Research Centre on Thunder Bay and area is estimated to be between $92 million and $110 million over five years, and is projected to lead to 205 full-time knowledge-based jobs, and an additional 400 600 spin-off jobs across the region.
PharmEng International named David G. Leonard the Keata Pharma president for the Sydney and Perth manufacturing sites. David succeeds Bernie Boudreau who will assume the new role as the vice-president of corporate development and legal affairs of PharmEng. Keata Pharma is a wholly owned subsidiary of PharmEng.
Dr. Michael Mayne, Ph.D., director of research at NRCs Institute for Nutrisciences and Health (NRC-INH) in Charlottetown, accepted a secondment to the province of Prince Edward Island as deputy minister of the new office of Biosciences and Economic Innovation. Dr. Jeffery Zidichouski will assume the duties of director of research for NRC-INH.
Theratechnologies named Pierre Caudrelier, M.D. as chief medical officer, effective September 2007. For over 15 years, Caudrelier held various positions at Aventis Pasteur and was recently vice-president, clinical research & CMO at Kiadis Pharma where he led the clinical development on four proprietary products in the area of oncology.
First of its kind anthology

The Nanoethics Group has published a collection of papers addressing issues related to nanotechnologys impact on society. Published by John Wiley & Sons, the 416-page anthology, containing almost 40 papers, is directed towards students, policymakers, industry stakeholders, and the general public. Nanoethics: The Ethical and Social Implications of Nanotechnology discusses issues facing nanotechnology. www.nanoethics.org.
The University of Toronto appointed professor R. Paul Young as vice-president, research. Young begins his term on November 1. Young is currently chair of the department of civil engineering and holds the Keck Chair of Seismology and Rock Mechanics, and is a fellow of the Royal Society of Canada.
News
Simplified compliance to substances notification regulation sought
BIOTECanada, Environment Canada and Industry Canada are working together on issues affecting new substances notification. Under the New Substances Notification Regulations (Organisms) of the Canadian Environmental Protection Act (CEPA), companies must report any new or modified organism or product of a new or modified organism to Environment Canada. If a company uses any genetically modified bacteria in their manufacturing process, including commonly used organisms such as E. coli K12, CEPA requires the company to notify Environment Canada. According to the organizations involved, regulations should be efficient, competitive and not cause a substantial burden to manufacturers. Representatives highlighted the need to expand the current list of common workhorse organisms on the Domestic Substances List in order to simplify compliance with the regulation. www.ec.gc.ca/substances/nsb/eng/biotech_e.shtml
$76M to combat disease in hog sector

he feds are contributing $76 million over four years to combat disease and enhance prosperity and stability in the hog sector, as Porcine Circovirus Associated Diseases (PCVAD) are severely affecting the Canadian swine industry, with incidences increasing across Canada and new outbreaks in Western Canada. Following the recommendations of an industry-government task team, the fouryear program will focus on assisting producers and the industry in four areas: herd inoculation, research, bio-security best management practices and finding longterm risk management solutions.
he Ontario government is committing $10 million to a new Bioindustrial Innovation Centre in the Sarnia-Lambton region, located at the University of Western Ontarios SarniaLambton Research Park. The centre will connect researchers and the local petrochemical industry to create and commercialize new sources of clean fuel. The centre will include a retrofit of 60,000 sq. ft. of existing laboratory space that will provide a commercialization centre with incubator suites, laboratory equipment, pilot plant space, and growth space for start-up companies. The project is also receiving support from the University of Western Ontarios Sarnia-Lambton Research Park, the City of Sarnia and Lambton County.
Resverlogix Receives Excellence in
Technology Award
esverlogix won the 2007 North American Excellence in Technology of the Year Award by Frost & Sullivan. The award is given to the company that has pioneered the development of an innovative technology that has the potential to impact several market sectors. Resverlogix NexVas PR technology is a best-in-class technology for therapeutic drug development. The enhancement of ApoA-l has the potential to revolutionize how cardiovascular diseases are treated in the future, writes Frost & Sullivan.
Counter terrorism research at U of Ottawa receives $6.8 million
hree research projects at the University of Ottawa have received a total of $6.8 million in funding from the Chemical, Biological, Radiological-Nuclear and Explosives (CBRNE) Research and Technology Initiative (CRTI). Richard Davies, from University of Ottawas Department of Medicine and Heart Institute will lead the deployment of a system that monitors information from various sources to provide an early warning system for disease outbreaks. Louise Lemyre, from University of Ottawas Department of Psychology, will develop a bilingual, user-friendly training tool
to assist responders and planners in the event of CBRNE threats or attacks. Also, the faculty of science will lead the development and adaptation of software for maintaining a comprehensive database of chemicals, standardizing the management of chemical inventories across institutions, and improving tracking of chemicals in Canada.
New bioindustrial innovation centre planned
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News
Protocol amending income tax treaty welcome news for Canadas biotechnology industry
protocol amending the income tax treaty between Canada and the United States was signed on Friday, September 21, 2007. We are modernizing a long-standing treaty for the betterment of individuals and businesses on both sides of the border, including manufacturers, said the Honourable Jim Flaherty, minister of finance. Today we have signed an agreement that will stimulate further trade and investment and make our tax systems more efficient. The fifth update of the Canada-U.S. Tax Treaty eliminates withholding taxes on cross-border interest payments; extends treaty benefits to limited liability companies; allows taxpayers to require that certain key double tax issues, such as transfer pricing, be settled through arbitration; ensures that there is no double taxation on emigrants gains; gives mutual tax recognition of pension contributions; and clarifies how stock options are taxed. After nearly 10 years of negotiations, we are delighted that the government has signed an updated Canada-U.S. Tax Treaty, said Perrin Beatty, president and CEO of the Canadian Chamber of Commerce. The economic benefits to Canada... will result in a substantial increase in capital and foreign direct investments in Canada. As biotech companies require a significant amount of capital to
take their ideas through the regulatory and development process to turn them into commercial products, some of the changes were welcome news to BIOTECanada. Todays signing is a tremendous accomplishment for the investment climate in Canada and our international colleagues will take notice, said Peter Brenders, president and CEO, BIOTECanada. A BIOTECanda National Biotechnology Week poll revealed 87% of Canadians were looking to the federal government to find ways to support Canadian biotechnology companies. The tax treaty amendments answer this call and help with Canadas advantage, continued Brenders.
Thanks for coming!

See you again soon
The Life Science Association of Manitoba (LSAM) was proud to host the 2007 National Biotechnology Week launch in Winnipeg. A very special thanks to BIOTECanada and all of our national partners!
LSAM is the premier association promoting Manitobas dynamic life science industry. We are proud to represent the Biotechnology, Pharmaceutical, Healthcare and Medical Device sectors.
Visit us at www.lsam.ca
National Biotechnology
A look back at NBW 2007 events across the country
he fourth annual National Biotechnology Week was launched in Winnipeg on September 20. Many events took place across the country during the intensive week of biotechnology advocacy, from September 22 to 29. Individual provinces and cities hosted events such as regional advocacy days, conferences, career fairs, and tours of biotech facilities. Biotech CEOs also meet with senior federal decision makers in Ottawa to discuss issues relating to biotechnology in Canada. Across the country, other industry leaders hosted meetings with Members of Parliament in their respective hometowns, providing guided tours of their facilities and outlining the importance of biotech to their communities and constituents. Heres a sampling of National Biotech Week happenings held from coast to coast:
NBW Winnipeg launch engages Canadas business leaders The capacity crowd at the Winnipeg National Biotechnology Week launch featured leading industry players and also the broader business community. It proved to be an excellent opportunity to demonstrate the importance of biotechnology in peoples everyday lives. The theme of the NBW Launch spoke to how items we use everyday are biotech products and hold the potential to benefit almost every aspect of our lives, from our health to the food we eat and how we travel. Dr. Moira Gunn, host and author of Biotech Nation, delivered the keynote address. She was introduced by the master of ceremonies, Mr. David Asper, chairman of the National Post. Peter Brenders, president of BIOTECanada, delivered the results of the organizations annual poll conducted in partnership with POLLARA. The results showed that 93 percent of Prairie
residents support biotechnology. Canadians see an opportunity for governments to make sure Canadians have access to treatments for rare diseases and illnesses, as well as to provide tax incentives to encourage innovation in Canada, said Brenders. Thats part of our on-going discussions with federal and provincial decision makers. Winnipeg was proud to host the launch of this truly national celebration of Canadian innovation, said Dawson Reimer, chair of the newly re-branded Life Science Association of Manitoba. In the past decade, Manitoba has experienced a significant increase in activities within the life science and health products sector. Several major publicly financed research centers exist and the number of new companies and employees continues to grow. It was a natural fit to host National Biotechnology Week in this province. For more information visit www.lsam.ca or www.biotech.ca
NBW 2007
Week 2007
Photos courtesy of Kevin Kennefick
Dance exploring genetics connects science and art Perhaps the most unusual of all National Biotech Week activities in 2007 was Ferocious Beauty: Genome. The Canadian premiere of a multimedia, dance based work was presented by the Ontario Genomics Institute, in association with Harbourfront Centre, in Toronto. The work aimed to help people develop an understanding of biotechnology, an often-misunderstood subject. The work is the result of a unique collaboration between several leading American genetic scientists and the Liz Lerman Dance Exchange, based in Takoma Park, Maryland. The production used dance, video, text and music to illuminate some of the fundamental concepts of genetic science.
Biotech national advocacy day A cornerstone event of National Biotechnology Week, National Advocacy Day in Ottawa (Sept. 25) began with a Newsmaker Breakfast hosted in partnership by BIOTECanada, National Press Club Canada and Association of Canadian Academic Healthcare Organizations (ACAHO). Participants heard from 100 Years of Biotech Know How with established researchers, an industry executive and an up-and-coming industry leader. Panelists (l-r): Dr. Francisco Diaz Mitoma, CEO, Variation Biotechnologies Inc.; James MacLeod, student and second place recipient, Sanofi Aventis BioTalent Challenge (Canada); Dr. Brian Barber, director of technology development and commercialization, University Health Network, Toronto; Dr. Lori Frappier, professor, University of Toronto, Department of Medical Genetics and Microbiology
When it comes to life sciences in Montral its all about vitality Since its creation in 2002, Montral InVivo, in collaboration with its partners, has been creating over 2000 jobs annually in the Greater Montral area. To continue to grow and to be competitive globally we have decided to focus on seven key priorities after consultations with our members, says Mr. Carl Viel, the new general manager of Montral InVivo.We now know what we have to focus on, and our members are ready to work together and ensure that the cluster continues to be at the forefront of the life sciences industry. The first half of 2007 has been quite rewarding with some major investments from big pharma and partnerships between biotech companies and pharma companies. We were also successful in attracting BIO VentureForum East for the first time outside of the U.S., with 60 VC firms coming to hear about our Canadian biotech companies. Mr. Viel concludes in saying that the international quality of research happening, both private and public, and the talent pool in Montreal, along with provincial measures are just a few reasons Montral InVivo and its members are ready to face the opportunities that present themselves.
NBW 2007
MP roundtable and tour of Halifax, Nova Scotia-based ImmunoVaccine Technologies (IVT) [l-r] Marli MacNeil (BioNova), Cate McCready (BIOTECanada), Stephen Duff (Precision BioLogic), Alexa McDonough (MP, Halifax) Hermes Chan (MedMira), Mike Savage (MP, Dartmouth-Cole Harbour), Robert Thibault (MP West Nova), Brian Lowe (IVT), Scott Brison (MP Kings-Hants), Jean Paul Deveau (Acadian Seaplants)
Dr. Roberta Bondar, Canadas National Biotechnology Champion, speaks to 240 high school students at the Sanofi-Aventis BioTalent Challenge launch eventGateway to Biotechnologyat BCIT in Vancouver on Sept. 26.
The Guelph Partnership for Innovation (GPI) golf tournament on Sept. 26 brought together industry representatives for a day of fun on the golf course. The winning foursome were (l-r) Dr. John Kelly, MaRS Landing; Dr. Bruce Archibald, OMAFRA; Grant Tipler, RBC; and Paul Truscott, AFMNet.
ABIC 2007 explores the evolution of ag-biotech (l-r) Dr. Ashley OSullivan, president and CEO of Ag-West Bio Inc, Dr. Abdul Jalil, director of agriculture research for Saskatchewan Agriculture and Food, and Dr. Robert Tyler, acting associate dean (research) College of Agriculture and Bioresources for the University of Saskatchewan at the Saskatchewan Networking Reception during ABIC in Calgary. The Agricultural Biotechnology International Conference (ABIC) 2007, the largest agricultural biotech conference in the world, was held from September 23 to 26, 2007 in Calgary, Alberta. The four-day event offered scientists, investors, industry leaders and policy makers the opportunity to exchange ideas and hear from a line-up of internationally acclaimed speakers addressing issues and challenges being met by the global biotechnology industry. The conference, which had the theme of Harnessing Science for the Evolving Consumer: The Fit of Agricultural Biotechnology, highlighted Alberta and Canadas leadership role in the world of agricultural biotechnology.
BioPort Atlantic conference looks at going glocal Members of the life sciences industry from Atlantic Canada and abroad took part in the BioPort Atlantic conference in Halifax, Nova Scotia on September 26-27. This years theme, Going glocal, focused on how local industries can achieve global success. Speakers discussed the issues and opportunities faced by local Atlantic Canadian companies in the world marketplace. Phillip Blake, president and CEO, Bayer Inc. Canada and chair, Rx&D, and Dr. Scott Kennedy, executive director, global research & development, Pfizer Inc., spoke at the conference about big pharma and life sciences partnerships. Local life sciences companies gave pitch sessions and a number of panels addressing such issues in the life sciences as accessing capital and getting products to market were held throughout the day. A proclamation was made by the province of Nova Scotia, declaring the week of September 23-29 as Biotechnology and Life Sciences Week in Nova Scotia, coinciding with events being held across the country during National Biotech Week.
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C6001-A105D 2002, 2006 Brinkmann Instruments, Inc.
NBW 2007
BIOlymics brings biotechnology to elementary students Our Lady of Lourdes Catholic School was the champion of this years BIOlympics in London, Ontario. But winning was not really the goal for the 14 elementary schools that participated in the BIOlympics challenges. Were trying not to be too competitive, says Amar Singh, a team leader for the event, and the general manager of the Biotron Institute for Experimental Climate Change. Rather, the challengeswhich included solving a crime by translating the genetic code, building a human skeleton, and
identifying plant species commonly used in biotech research were designed to fuel interest in biotechnology among elementary students. Many people made it out to the event, including mayor Anne Marie DeCicco-Best, chief Murray Faulkner of the London Police Service, and the president of Fanshawe College, Howard Rundle, all of whom volunteered as team leaders. The morning was buzzing with activity as the seventh and eighth grade students experienced the challenges, and the excitement, of biotechnology.
Q&A
Question and answer with Thallion president and CEO, Lloyd Segal
In March of this year, Ecopia Biosciences Inc. and Caprion Pharmaceuticals Inc. amalgamated to form a new corporation called Thallion Pharmaceuticals Inc. Former president of Caprion Lloyd M. Segal has taken on this new entity as president and CEO. Having raised $45 million in the merger between Caprion and Ecopia, Thallion appears to be off to a prosperous start. The company is working on developing new treatments in oncology and infectious diseases. Its product pipeline includes three pre-clinical drugs. Below, Segal discusses Thallion, and provides insights into doing biotech business in Canada.
Q
A
: How and why did you get started in biotech?
Q
A
: What is your personal business strategy?
: I was a consultant at McKinsey & Co. and I was recruited to the role of the CEO of a true start-up founded in the mid-90s and funded by angel investors. That was Bioconcept, and the business was essentially research discovery tool. That was my entry into biotech. Martin Leblanc and I left McKinsey & Co. and started this company, or commercialized the company, and we sold it two years later to whats now Perkin-Elmer. That was our trial by fire in this industry.
: In this business, you need to focus on doing the right things that are going to get drugs to market in the long run; your strategy has to be a long-run play. You have to do the right things in the short term, even if it means taking pain, because drugs arent developed in a quarter, or a year, or even five years. The typical timeline for drug development is 10-15 years from conception, so you cant possibly win with a short-term strategy in the drug development game.
who could suffer from very serious cancers could have a substantial change to their quality of life.Those are outcomes that will provide not only attractive returns to our shareholders, but a sheer form of joy for our entire team and board, and thats a very nice mix of aspirations because theyre perfectly aligned.
Q
A
: What are your plans for the future?
Q
A
: Can you give a brief overview of Thallion?
: What have been your major challenges?
: Thallion is a drug development company focused on oncology and infectious disease. We have three phase II or later clinical programs and our sole focus is on developing later stage drugs in oncology and infectious disease. We raised $45M in March of this year on the back of a merger of the two companies that created ThallionCaprion and Ecopia. Our mandate was to use the cash we raised together with the critical mass and economies of scale that we got from putting together two very synergistic companies for a scale play in oncology and infectious disease.
A: I think for anybody developing laterstage drugs, the biggest challenge is always a regulatory and cost one. Those two thingsthe sheer cost and complexity of doing human clinical trials combined with the current challenges of the regulatory environmentmake for a particularly special brand of CEO pain. But we have an advantage in thinking about that pain that most CEOs in most other industries dont get, and thats that we have an absolutely noble purpose. If were successful in what we do, kids who might otherwise die or spend months in the hospital could be cured, and that has its own very special rewards. With our cancer drugs, people
: Five years from now we hope to have two important things done, and all the caveats that come with forward-looking statements apply. Our aspiration is to have our Shigamabs product registered in at least its first jurisdiction, if not more, and to be treating kids with E. coli infections five years from now. Second, [we aim] to be seen as a serious player in the cancer space, where we [currently] have two phase II clinical programs.
Q
A:
: What advice would you provide a growing biotech?
Get as much cash as you can, and dont take any short cuts. Because short cuts, whether they be getting to the clinic before youre ready or avoiding key preclinical tests that could tell you whether or not your drug deserves to be in the clinic, inevitably come to bite you on the behind. This is not a short-term game.
Experienced biotech professionals apply here
By Catherine Muir
ndustry watchers will not be surprised that in PriceWaterhouseCoopers (PwC) Canadian Life Sciences Industry Forecast 2007, financing is ranked number one as a critical success factor for companies in the life sciences arena. What may come as a surprise, however, is the factor close at its heels in importance: in second place is accessing, attracting and retaining the right employees. The PwC survey asked stakeholders from corporate, academic, government and other organizations involved in the life sciences and biotechnology industries about a variety of issues impacting the industry today and in the future. Over one-third of respondents named attracting and retaining key employees as within the top three challenges for their
companies within the next three years, only below accessing venture or other types of capital and above finding a partner, managing the regulatory process, product development and six other factors. Access to experienced talent pool was ranked within the top three critical success factors for the Canadian life sciences and biotechnology industry by half of respondents, the largest factor below increased Canadian venture capital. The 2005 Statistics Canada Biotechnology Use and Development Survey (BUDS)results of which were released in 2007offers similar findings. More than 70% of respondents indicated that lack of experience has a medium-low to mediumhigh impact on filling biotech-related jobs, as does a lack of qualified candidates.
Business Management
Experts from Canadas life sciences industry weigh in on how the sector is dealing with a shortage of experienced management
ing in Canada, says Ryan Radke, president, BioAlberta. In Canada we have a smaller life sciences industry, and a smaller labour pool to draw from. There arent as many people whove had biotech experience, echoes Mark Gregory, vicepresident with life sciences recruiting agency Pharmahorizons Inc. Thats why Canadian companies covet people whove worked with a medium to large biotech company and [who have] taken products to marketpeople with experience in business development, financing, and commercialization. But it will come in timewere still a very young industry. The people most in demand are those individuals with a solid understanding of both the science and business sides of the industry, according to Barry Gee, director, operations and communications with LifeSciences British Columbia. Particularly those with a track record of successfully managing a product through the full drug development process and negotiating the regulatory systems. A lack of time-proven business acumen is perhaps most evident in the province of Alberta. In Alberta, [the life sciences management personnel] dont have the same depth and level of experience as executives that have been through the trials and tribulations that many energy companies go through. For this sector, we are still missing that senior management to executive type level, says Radke. The relative old age of the Canadian population may also have something to do with this need as well, especially in the technical arena. Were faced in Canada, and in the wider industrial world, with an aging population. Were seeing the
around talent management versus talent recruitment.
I think moving forward, focus will be more
Business skills needed Its no secret that money is number one on the list of worries for Canuck life sciences firms, but with Canadas top research and science reputation, top-notch schools, and active R&D environment, why do employment and recruitment rank a close second? The answer may lie in the relative youth of the Canadian life sciences industry, say some authorities. In comparison to larger and more established life sciences arenas such as the United States, Canadian executives often pale in comparison to their more experienced counterparts. The more experience people have working in life sciences, clearly the more skills they develop in terms of bringing a product to market. The reality is its the senior level that were miss-
labour pool shrink, and that is particularly affecting companies in the area of technical skills. For example, employees with experience in clinical and quality assurance are becoming harder and harder to find. Theres the demand both for seasoned managers in the area of business development, regulatory affairs, financing, operationsand also on the technical side, says Gregory. According to the PwC 2007 forecast, recruiting experienced senior management is seen as the most important action industry can take to improve Canadas ability to compete globally. The idea that people make the difference in effectively accessing capital and executing business plans was also shown in the PwC 2006 forecast. Both the 2006 and 2007 surveys indicated that the senior management positions that are particularly difficult to hire are directors of regulatory affairs, CEOs, VPs of business development and directors of clinical development.
Business Management
The 2007 survey also shows VP of manufacturing being a position that is most difficult for Canadian life sciences firms to fill. The current issue of gaining skilled and experienced employees seems to grow in importance when the growth of the industry is taken into account. The 2005 BUDS details a 13% increase in the number of employees with biotechnology-related responsibilities from about 11,900 employees in 2003 to over 13,400 in 2005. Colette Rivet, executive director at BioTalent, a non-profit national organization dealing with human resource issues in Canadas life sciences industry, has seen the gap between what is needed and what exists in terms of talent in the industry widen in recent years, and predicts it will only get wider in the next few years. Were not talking about just needing research scientists. Our companies are evolving, and getting bigger. Theyre definitely going to need people in manufacturing, and commercialization. Rivet names a number of challenges facing recruitment practices and employment in the life sciences sector in the coming years. Its become much more competitivewe now have to compete globally. There are more companies than in the past. Also, technologies in this sector can change overnight, she says. We still have a long ways to go. We definitely have a big shortage of skilled and experienced workers coming up. Rich Pennock, business unit leader at Kelly Scientific Resources, agrees. Were going to be seeing a talent crunch in the next couple of years. The number of recent scientific and engineering grads is going to be declining over the next few years, and the number of people retiring over the next few years is going to be increasing, so well have more and more companies looking at how they create and manage talent. Gregory cautions against blanket statements about the state of employment within the industry. The sector is growing, and there are opportunities, he says. However, he adds, there are a number of factors that affect this growth. He explains changes to the pharmaceutical industry within the past few years such as mergers and acquisitions, the expiry of patents, and the shortage of new discoveries means that big pharma companies around the world are shrinking, especially in the sales and marketing and operations areas. So in some ways there is even a contraction in the industry, Gregory says. I think there are opportunities in the sector, but on the recruitment side, both in the industry and those looking to get into the industry have to be pragmatic and really do their homework to focus in on where the opportunities actually are. Like his colleagues, Gregory sees the areas of commercialization, business development, and regulatory affairs as key places to seek job opportunities. Managing growth and talent Pennock sees several ways companies can manage talent. He suggests retiree pools or contingent labour opportunities (like using a company like Kelly Scientific) can add additional labour to a companys current talent pool. I think moving forward, focus will be more around talent management versus talent recruitment. George Adams, president and CEO of Amorfix, says, We are looking for a vice-president of research and development, and weve gone to a service to help us identify people, because we really havent been able to find anybody whos available. Each player in the life sciences industry arguably has a role to play in the talent management issue. According to Pennock, matching education with the industrys needs makes sense. At the university level, industry needs to work closer with academia to make sure that the training thats being offered at the BSc and the MSc level is developing the skills that industry is going to need moving forward. Some of these programs were developed thirty years ago, and while the fundamentals havent changed, the industry has really shifted in techniques required within the industry, he says.
The reality is its the senior level that were missing in Canada.
-Ryan Radke, president, BioAlberta
According to Gregory, there has been a greater awareness in recent years of the changing needs of the industry, and educational institutions are starting to pay attention. He says organizations such as Montreal In Vivo are already working closely with technical schools in the Montreal area to encourage the development of graduates in the areas that they know the industry specifically needs. They are also trying to get the message out to universities that they need to generate more graduates with business skills in the life sciences. Professional development for those already in the workforce is also important, says Gregory. At pharmahorizons, we have about 25 industry-specific programs and a number of them are specific to management skills. Another initiative Gregory places importance on is the development of internships and mentorships for students within life sciences companies, so we see more managerial skills moving into the industry. Similarly, Pennock has also been following this industry trend: Were seeing more and more companies looking at how they manage talent, instead of how they recruit talent. And weve seen more and more of our clients look at creating internships to give recent grads and current students the opportunity to gain skills. Foreign-trained professionals A recent study by BioTalent Canada looked at a problem specific to talent management in Canadas life sciences industry. Recognizing Talent: Capitalizing on the Skills of Foreign-Trained Professionals for a Vital Bio-Economy, explored the human resource realities of Canadas biotechnology sector, and presented initiatives for supporting the entry of foreign-trained professionals into the Canadian life sciences industryan issue upheld by BioTalent as a pressing one in todays industry. The study states that to fuel the process of biotechnology research, development, manufacturing and commercialization, Canadian institutions and companies require an abundant supply of qualified, skilled talenta demand that cannot be met by those trained in Canada aloneand that can be satisfied by looking to the abundant talent of professionals trained abroad. According to the 2005 BUDS, the demand for foreigntrained professionals within Canadian biotech companies is there: 1,668 employees were hired from outside Canada to work in innovative biotechnology firms in Canada in 2005. Internships are one tool suggested by BioTalent to help harness the talent of foreign-trained professionals, in order to provide these professionals with Canadian experience, English and business competency, and evaluation of skills and experience. Rivet says BioTalent has secured funding from the Foreign Credentials Program Department of Human Resources Skills Development Canada (HRSDC) for an internship model that would help to get internationally trained professionals integrated into the sector. Funding has also been secured for a way of practically assessing skills such as lab techniques in a prior learning and recognition sort of model that would allow prior
Q& A
Q&A with Lloyd Segal, president and CEO of Thallion Pharmaceuticals, on his success at recruiting and retaining top employees
Q: How do you recruit top talent? Recruiting talent is easily the most important thing that a CEO has to do once a good strategy is in place and [his strategy] is aligned with his board and his investors. I think there are a couple of things you can do to recruit top talent. First, you need to give it the time required, to go after the best possible people in any given senior leadership role, and that means constantly having an eye open for great talent and people who can help the company meet its goals. Secondly, you have to be prepared to compensate people in a world-class way. Q: How do you compensate employees? Great people who can develop drugs or who can do business development for our technologies can work anywhere: they can work in Boston, they can work in San Francisco, they can work in London, they can work in Geneva. If theyre truly world-class people you cant ignore the fact that their compensation opportunities are global, and you need to make sure that your package reflects that. Even though it means short-term pain, [it works] towards a very long-term view when you get the right people. You have to reward them not just in the short-term, but in the long-term as well, and make sure they have upside in the success of the company and in their own personal missions in the context of the corporate mission. Q: How do you retain talent? Finally, once you get them, its not just attracting great talent, its retaining them. You have to do a package of things that ensures that youve got a great team for the long-run. That means giving them great challenges, giving them the freedom to meet those challenges, giving them the encouragement and the tools they need to get the job done, and support and resources and the environment thats going to keep them motivated. That all sounds like very rudimentary stuff, but when you lose great people, inevitably youve dropped the ball on one or more of those things.
Business Management
experience in the biotech or even other sectors to be transferred into the Canadian life sciences sector. Other BioTalent projects under way include a labour market information survey that will assess employment figures within the life sciences industry with regard to foreign trained professionals. On-line self-assessment modules (funded by the Ontario government and the University of Guelph) for internationally trained professionals allow them to look at some typical examples of what they are going to be facing, then rate themselves. BioTalent is also trying to get funding to do an instructional language course relating to the life sciences sector to help in communications with regulatory bodies. Another initiative underway is BioTalents career focus program, where the organization subsidizes a third of the salary of a new graduate from university or college, to go and work for the first time in the biotechnology sector. Out of the people that finish the program, almost 100% get employed. So we need to take that model and use it for internationally trained professionals and Canadian graduates. According to Rivet, BioTalent is trying to be a broker between industry and federal or provincial/territorial governWere seeing a bit of a reversal of the brain drain, where expatriates in the U.S. are expressing a little greater interest in returning to Canada, says Gregory. Most of them are in the 45-55 age range and are looking at coming home for retirement because of the differences in quality of life and healthcare in Canada. There are some things in our favour. Gregory also states that 10% of Pharmahorizons candidates are outside of Canada, mainly in the U.S. Of this, we mostly get U.S. talent looking to emigrate to a Canadian company. Radke offer a unique perspective on where to look for talent to fill employment gaps in the Canadian life sciences industry, especially given Albertas recent surge in employment due to growth in the energy sector. I think there are people with the needed skillsthey might just be involved in other sectors of our economy. Perhaps there is someone with business development, marketing, or regulatory skills that is working in the energy industry, or the agriculture industry. As these sectors become more integrated with growth in the life sciences industry seen in such areas such as biofuels and bioenergy, people in these sectors may have experience to bring to the table. For example, people who have been involved in the ICT industry. People who have been involved in other technology companies can be adaptable into the realm of health biotech or drug development. Revisiting Growth The life sciences industry in Alberta will indeed have talent gaps to fill in the near future, if growth statistics are any indication. According to BioAlberta, the number of jobs in the provinces life sciences industry increased an astounding fortyfive per cent from 2004 to 2006. For 2007, it is expected that an additional 212 jobs will be createdan increase of approximately six percent from 2006. With todays labour market, it is no surprise that attracting new, skilled employees proves to be of concern for this sector, says Radke. Figures in other regions across the country echo consistent growth in the industry, and therefore, a need to fill biotech positions. Montreal International is projecting a growth of 2000 jobs per year for the next few years for the city, one of the largest biotech clusters in the country, with the skills needed ranging from technical to know-how in IP and patenting. The Life Science Association of Manitoba estimates an increase of 150200 new jobs in the sector within the next year. Change is inevitable, as those in the biotech industry know. How this change is managed is perhaps the most crucial factor in the future of the industry. Gregory is positive about employment issues in the industry as a whole now and in the future: Life sciences companies continue to be attractive employers of choice. Within the life sciences industry, we have some worldclass employers in this country. Many of the companies are extremely well respected and in their hunt for talent they are not just prepared to pay for itthey are trying to create a culture for BB the workforce of the future, so that they hold on to and retain
important thing that a CEO has to do

ments and the universities and institutions: an organization that can facilitate relations between these groups and the people who are trying to work in the industry. Pennock sees managing talent as a global issue across political boundaries separating life sciences sectors. One of the things were starting to look at is the concept of global mobility of talent, and how we can ease talent across borders. We need to continue to work with different regulatory bodies to make sure that were really addressing key scientific issues, versus worrying about where talent is coming from. This could mean a person actually coming to a country or being able to harness that talent through the use of websites or other types of collaborative systems. Typically, companies are leery about the length of time it takes to bring people here and the cost, adds Gregory. Its much easier to focus on areas where there might be less of a communications gap, less of a cultural gap, and look at North America and Central America. Pennock concurs. We do see quite an influx going back and forth between Canada and the U.S. with the NAFTA agreement, which has made it easy for talent to move across borders. Gregory offers another reason for life sciences talent heading north. Theres also a lot of Canadians who have gone to school in the U.S. and are working in the U.S. Some Canadian companies are always looking to connect with Canadian expatriots, especially if they have in-demand skills.
Recruiting talent is easily the most
SUPPORTING YOUR SELECTION

HAS THE FEDERAL COURT OF CANADA INCREASED THE SUPPORT REQUIREMENTS FOR SELECTION PATENTS?
invention is directed to a new process, compound, use thereof or an improvement thereto. The second more narrow patent type is where the patent covers one or more previously unknown compounds that have been selected from a group of known compounds based on some unexpected advantage of the selected members over the previously known group members. This second class of patents can be referred to as selection patents. In other words, the invention in a selection patent relates to the discovery of a new compound or subgroup of compounds having improved characteristics over the previously existing group of compounds. In order to avoid objections that any such invention would be obvious in view of the previously existing group of compounds, patentees must establish that this selection of the new subgroup has unidentified characteristics and based on such characteristics, these compounds provide some advantage over the existing group members. The inventive step in a selection patent lies in the identification that one or more members of the previously known class possess some advantage that could not be predicted. Selection patents exist, therefore, to reward and encourage researchers to invent new second generation compounds that are, for example, more effective or exhibit less clinically significant side effects than those of the larger previously known class of compounds. By requiring this special advantage (e.g. improved activity, less clinically significant side effects, etc.), potential patentees are stopped from obtaining a selection patent merely by ascertaining the properties of the members of a group or class of compounds. By allowing patent protection for such compounds that do have such a special advantage, on the other hand, the public benefits through the availability of an ever-improving panel of available drugs. Until recently, however, there has been little judicial consideration of selection patents in Canada. The few Canadian cases dealing with the validity of selection patents have relied heavily on more developed U.K. law. More attention will likely now be paid to selection patents and the decisions related thereto as many of the patents covering important blockbuster drugs may soon be expiring in Canada; many of the patents directed to the second generation of these pharmaceutical compounds are protected via selection patents. As such, the Eli Lilly decision could have a significant impact on the validity of many of these patents. The Eli Lilly Decision As with many pharmaceutical patent cases in Canada, the
recent decision of the Federal Court of Canada has caused a ripple of dissent throughout the pharmaceutical and biotechnology world. The cause of this dissent relates to an aspect of the decision that may impact the disclosure requirements for patentees trying to obtain patent protection for newly invented chemical compounds. As a result of the decision, the validity of many Canadian patent specifications that are directed to such selection inventions may be in question. While this is only a decision of the trial division of the Federal Court, it could have significant ramifications for those trying to obtain such patent protection in Canada if unchallenged on appeal. If the decision is left to stand, it may be necessary for patentees to reconsider whether there is adequate support in their Canadian patents for pharmaceutical and/or biological inventions. Background In the June 6, 2007 decision in Eli Lilly v. Novopharm, the Federal Court was faced with considering whether the Canadian patent directed to the drug olanzapine, an antipsychotic sold in Canada under the brand name ZYPREXATM, was valid. More specifically, the Court was tasked with trying to determine whether the patent directed to olanzapine constituted a valid selection patent. In very general terms, there are two broad types of chemical patents in Canada. The first class relates to patents where the
IP & Patenting
Eli Lilly case involved a dispute between Eli Lilly Canada Inc. and the generic drug manufacturer, Novopharm Limited under the Patented Medicines (Notice of Compliance (NOC)) Regulations. While a detailed discussion of the NOC Regulations is beyond the scope of this article, they can be summarized as follows. In order for a generic manufacturer to obtain a NOC to market its drug product in Canada where that drug is covered by a patent, the generic manufacturer (i.e. Novopharm) must argue that the patent covering the drug will not be infringed and/or is invalid. In the Eli Lilly case, Novopharm argued, inter alia, that the patent covering the drug olanzapine was an invalid selection patent. Olanzapine was selected from a genus of previously known compounds and the patent was directed to the selection of olanzapine based on it having special properties, and [lacking] certain detrimental properties that make it useful in the treatment of disorders of the central nervous system. In essence, olanzapine was a better drug candidate because in a clinical situation it had a better profile than prior known antipsychotic agents (e.g. flumezapine, haloperidol and clozapine) since it had a higher level of activity in humans and, it was alleged to have less clinically significant side effects. Olanzapine, while not specifically disclosed in earlier patents and therefore novel, would have been encompassed by earlier patents directed to drugs having the same general chemical backbone. In comparison to those previous compounds, however, olanzapine provided improved characteristics. On this basis the Canadian patent was granted. the specification. The important aspect of the Eli Lilly decision focused on this second aspect. The Court in Eli Lilly found that [w]here you have to rely on the presence or absence of an effect or an advantage, it must be clearly stated in the specification. Eli Lilly provided in its patent specification that there were advantage(s) and specifically enumerated the advantages, namely greater activity and reduced side effects. The question in the Eli Lilly case was whether this disclosure sufficiently described and supported the selection of olanzapine and the basis for it. The more specific question for the Court to consider in Eli Lilly, therefore, was to what extent does a patentee need to support the advantage obtained or disadvantage avoided by the selection. Comparative Data Required to Properly Support Selection Patent In order to properly determine whether the advantages have been properly stated, it is necessary to first determine what the advantages, namely what could not be predicted by a person skilled in the relevant art, are. The evidence in Eli Lilly provided that in the 1980s, Eli Lilly was concerned with identifying compounds that were as effective as previously known and used compounds, without the known clinically significant side effects. According to Justice Hughes, no comparative data was given to support Lillys statement that olanzapine has surprising and unexpected properties by comparison with flumezapine and other related compounds. Hughes went on to say that rhetoric in the use of adjectives such as mild and lower is all that is given.
side effects is not sufficient according to Justice Hughes.

Criteria for Selection Patents Under Canadian patent law, it is required to fully describe the invention in such a manner that a person skilled in the relevant art can operate or perform the invention. While it is generally not required to state the advantages of a particular invention within the patent, Canadian patent law requires that if the patentee is trying to obtain patent protection for a selection, the basis of this selection, namely the advantages, must be disclosed. When, however, is the advantage(s) adequately described and supported in the patent specification? According to Justice Hughes in Eli Lilly, the criteria for a valid selection patent are more specifically defined as follows. First, a valid selection patent may be obtained where the invention lies in selecting a member or members from a previously disclosed group where the member or members selected possess a particular advantage or avoid a particular disadvantage not previously found or predicted in a large number of members of the class by a person skilled in the art. Second, the advantage or avoided disadvantage must be clearly set out and supported in
Simply stating that there is a high level of efficiency and mild and transient and lower
In conclusion, the Court found that the patent failed to provide sufficient support in the patent specification on what basis olanzapine should have been selected from a previously disclosed group of compounds. The invention in selecting olanzapine is the so called surprising and unexpected properties of olanzapine in comparison with flumezapine and other related compounds. No such comparison is made anywhere in the patent and no data was given to support the claims of the advantages. Simply stating that there is a high level of efficiency and mild and transient and lower side effects is not sufficient according to Justice Hughes. According to the Court in Eli Lilly, some kind of comparative data establishing the special advantages would appear to be required in order to adequately support the claimed selection. More importantly, this support must be provided in the specification itself. Evidence provided by way of affidavit or other material external to the patent specification per se appears to be insufficient. While Lilly provided the patent examiner further data to support its patent claims during prosecution of the patent
IP & Patenting
before the Canadian Intellectual Property Office, this was inadequate in the Courts view since the prosecution history, also known as the file wrapper, is not admissible in construing a patent in Canada. What was at issue was the sufficiency of the disclosure in the patent itself, not any disclosure to the patent examiner. Federal Court of Canada may have raised the bar as to what is now required in Canadian patent disclosures for selection patents. If patentees wish to obtain patent protection for so-called selection patents, it would appear necessary that when drafting these cases, the full advantages and the basis for these advantages should be provided (e.g. evidence supporting the Going Forward selection, for example, in the form of comparative data). While Eli Lilly has appealed the decision of Justice Hughes, it For example, it may now be necessary to clearly and explicwould appear that until that appeal is finally determined, the itly define how the new product meets the requirement of the special advantage. If the new drug avoids certain side effects or shows superior results, it will be necessary to provide substantive examples in the way of actual data. It may no longer be sufficient to indicate that there is such a special advantage. That special advantage may have to be defined in relation to members of the previously known class of compounds. It is therefore necessary to state (a) what the advantage(s) are, namely what could not be predicted by a person skilled in the relevant art; and (b) provide support, such as, for example, by way of comparative data. Investing in Saskatchewan gives you Merely providing statements in the ready access to more assets and raw nature of the advantages appear to be no product than any other province. longer sufficient. Our province offers a young and While the Eli Lilly decision has been vibrant workforce, ready and willing appealed, it may be necessary to now to take on new challenges and build consider further whether there is careers. adequate support in current patent The Saskatchewan government specifications for any such selection offers attractive incentives such patents. Given, however, that amendas the SaskBIO program, an 80 ments to add additional matter into the million dollar program for new and specification (e.g. comparative data) is expanding biofuel facilities. not possible, the validity of many of Saskatchewan is a leader in biofuels. Canadian patent specifications that are In fact, we were the rst province directed to such selection inventions in Canada to mandate 7.5 per cent ethanol blend in gasoline. may be in question if they do not meet the requirements provided in the Eli Lilly case. BB
Four Excellent Reasons Why Saskatchewans Biofuel Potential is Worth Your Consideration
1 2 3 4
To learn more about biofuels investment opportunities in Saskatchewan, visit www.saskatchewan.ca
Mark D. Penner is a partner with the Technology and Intellectual Property Group of Fasken Martineau DuMoulin LLP. He has an M.Sc. in Immunology, a B.Sc. in Biochemistry and is a registered Canadian patent and trade-mark agent with expertise in the acquisition and enforcement of intellectual property rights in the chemical, pharmaceutical and biotechnology fields. He can be reached at 416-868-3501 or via e-mail at mpenner@fasken.com.
LICENSING: THE GOOD, THE BAD, AND THE IP
IP & Patenting
By Pierre-Paul Henrie
ffective protection and commercialization of IP strikes a balance between objectives, yielding a resource that cannot be utilized by others without providing benefit to the owner. There are numerous ways in which a company can allow for both protection and exploitation of IP: the IP may be sold to a third party, joint ventures, collaborations, joint-development, strategic alliances and licensing. A licensing arrangement may be appropriate and desirable. Indeed, licensing arrangements are common and widely utilized, but they do come with their own host of challenges. About Licenses At its most basic level, a license is an authorization by one person (licensor) to another (licensee) allowing such person to use a right which, without the license, they would not have. In exchange for such right, the licensee pays a fee, often in the form of a royalty. However, at a more sophisticated level, licenses take various forms and typically include common fundamental provisions, including the following: grant rights, including scope and geographical range; restrictions on use; term of license; termination of license and effect of termination on rights granted; fees payable; representations and warranties relating to the licensed product, including IP ownership; indemnities and limitation of liabilities; confidentiality. It should be noted that the license may and can include other provisions.The licensor should pay particular attention to the scope of the grant rights and limitations of use. Indeed, the balance must be achieved between the rights that the licensor wishes to grant and the rights the licensee wishes to receive. Whether the rights granted are exclusive, sole or non-exclusive may have a material impact on the licensors business. Exclusive licences ensure that only the licensee can use the IP. Under an exclusive licence not even the licensor, the inventor of the IP, can commercially exploit their ideas. Employing an exclusive license has the advantage for the licensee that he will not have to compete with the licensor within the market place. These types of agreements will usually be employed where actually harnessing the licensed IP for commercial benefit will require a substantial capital outlay. However, when contemplating the use of an exclusive license, a company may wish to include a clause which sets out a minimum royalty requirement. A clause of this nature should be included to anticipate a situation where the licensee does not effectively commercialize the IP. In this way, if the licensee cannot make the minimum royalty payments required under the license, they would have to contribute to reach the minimum level.
Companies that create IP find themselves in an interesting predicament. They possess an intangible resource with value, but how do they protect and exploit it?
By way of contrast, sole licenses allow both the licensor and licensee to use the licensed property, to the exclusion of all others. These types of licenses are used relatively infrequently. Non-exclusive licenses, on the other hand, are extremely common. A nonexclusive license allows the licensor to employ the IP and license the property to third parties as well. In this way, any potential licensee should factor into account potential competition from both the licensor and other parties. Moreover, a potential licensee would be well advised to ensure that the license agreement contains a most favoured clause. The inclusion of one of these clauses ensures that if ever the licensor grants more favourable licensing terms to another licensee then those terms would be extended to the licensee wielding a most favoured clause. As a result, a licensee can ensure that the competition does not gain any unfair advantage when it comes to using the licensed property. The Advantages and Disadvantages of Licensing IP For the licensor, one of the greater advantages of licensing is the creation of a royalty base, resulting in a steady or defined revenue stream. In addition, the licensor may avoid or reduce the costs of further developing the IP, although often times retaining the right to use the IP further developed by the licensee. Further, the licensor does not invest the time and resources in the commercialization and sale of the IP. Finally, and more importantly, the licensor continues to retain ownership of the IP, continues to have the ability to leverage such IP as an asset of his business and often has the ability to further develop his IP and other related technology. While royalties provide a continuing system of payments, in contrast to a sale, the profit generated by the licensed property will necessarily be limited to the income generated from those payments. As a result, if the licensed property becomes widely successful, the main beneficiary will ultimately be the licensee, not the licensor. As a corollary, when issuing a license, the licensor effectively loses control of its property. This raises concerns over an increased potential of pirating and the consequences of this for the licensor. About the Author: Pierre-Paul Henrie is a partner in the business law group of Ogilvy Renault LLP, and is based in the firm's Ottawa office. The author would like to acknowledge the contribution to this article made by Aaron Shull of Ogilvy Renault.
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 author.
By Erica Tennenhouse
was September 11, 1978. Georgi Markov, a Bulgarian communist defector, was walking across Waterloo Bridge in London when a man passing by lightly jabbed his thigh with the tip of an umbrella. Markov passed this off as an accident and continued to his home, where he developed a fever later that evening. Three days later, he was dead. This was one of the most notorious Cold War assassinations planned by the Soviet Unions KGB. The tip of the umbrella had actually held compressed gas, which shot a tiny pellet laced with approximately 0.28 milligrams of the deadly ricin toxin directly into Markovs bloodstream. One of the many problems with the ricin toxin is the fact that it is readily available to almost anyone. The toxin is easily extracted from the waste left over from processing of castor beans, and millions of tons of castor beans are processed annually worldwide. Its toxicity and availability make it a significant bioterror threat. In 2003, the Canadian government contracted Twinstrand Therapeutics, Cangene, and Defense Research and Development Canada (DRDC) Suffield to develop an antidote to ricin. The project wrapped up about two years ago, but Twinstrand has continued to receive funding from the U.S. Department of Defense and U.S. National Institute of Allergy and Infectious Disease for programs to develop medical countermeasures to ricin. Twinstrand is expecting to begin a human clinical trial concerned with one of these programs this fall and anticipates that some of the drugs they are working on will be available for emergency use towards the middle or end of 2008. For Twinstrand Therapeutics, biodefense research is simply a spin-off of the companys main program, which is the development of therapeutics for cancer and infectious disease. They have been working with genetically engineered versions of ricin, which they have targeted for diseased cells. In that sense, were very narrowly focused on molecules such as ricin and abrin (a similar toxin to ricin), which are two potential bioterror agents, explains Thor J. Borgford, president and CEO of Twinstrand. Developing therapeutic ricin-like molecules has given Twinstrand the ability to control the toxicity of these molecules.
It
Agents of biodefense in Canada

Their ability to control the activity of the molecules means they are able to also create very benign or inactive forms of the molecules. According to Borgford, they are able to create molecules that look like ricin, have all the immunological properties of ricin, but have none of its toxicity. As a consequence, Twinstrand makes toxoidsthe inactive versions of molecules such as ricin and abrin. Those toxoids can then be used as vaccines or immunogens in humans and other animals. Administration of the toxoids can protect people either by virtue of the immune response elicited by the proteins, or immunoglobulins that recognize ricin could be collected from the animals or humans and transferred to affected people. Cangene is undergoing a variety of biodefense R&D programs
to almost anyone.
toxin is the fact that it is readily available
One of the many problems with the ricin
with the Canadian and U.S. governments, involving Burkholderia bacteria, Ebola and Marburg viruses, acute radiation syndrome, and ricin toxin (it has created humanized anti-ricin monoclonal antibodies). According to president and CEO John Langstaff, in terms of its dealings with the U.S. government, Cangene is currently the largest contractor in the biodefense arena in the world. Although smallpox might not conjure the same ideas about bioterrorism as anthrax or ricin, in 2002 the U.S. government considered launching a smallpox vaccination program in the United States, due to the danger that Iraq posed for using smallpox in germ warfare. Cangenes first biodefense product to be licensed by the FDA was intended to treat potentially life-
Discoveries
left: Thor J. Borgford, president and CEO, Twinstrand Therapeutics right: John Langstaff, president and CEO, Cangene
threatening reactions that some people have to the vaccinia virus (the virus used to make the smallpox vaccine). The Vaccinia Immune Globulin (VIG) product, which is rich in antibodies against vaccinia, is currently the only known antidote to complications of the smallpox vaccination. The potential threats of botulism, anthrax, and SARS, to name a few, are also addressed by Cangenes extensive biodefense product pipeline. Within the Biotechnology Section at DRDC Suffield, vaccines for a number of biological agents are being examined. Les Nagata, head of the biotechnology section at DRDC Suffield says they have had promising results using recombinant adenovirus vector systems against alphaviruses. The alphaviruses are an interesting group of viruses that include the western encephalitis virus, which was responsible for major epidemics of mosquito-transmitted encephalitis (acute inflammation of the brain) in western Canada and the western United States in the 1940s. The viruses can also be transmitted through an aerosol route, making them potential agents of bioterrorism. A second area of research at DRDC Suffield focuses on broad-spectrum and virus-specific nucleic acid-based therapeutics. One of these products, Oncovirs Hiltonol (poly-ICLC), induces broad-spectrum protection against a number of viruses including influenza, ebola, and the alphaviruses when tested in animal models, says Nagata. Dr. John Cherwonogrodzky, a researcher at DRDC Suffield, conducted the test and evaluation of the anti-ricin antibodies produced by Cangene in a mouse model. The results were promising, but further research is still required before a treatment for ricin intoxication is ready for the market. The CBRN Research and Technology Institute (CRTI), which is sponsored by the Canadian government, is responsible for seeding many biodefense projects (such as the ricin project) that would not otherwise get off the ground. Nonetheless, it is a difficult area to work in, since there is not the same marketplace for products as exists for a therapeutic. With a therapeutic, you can establish the breadth of use of the molecule youre developing by virtue of how many people have a particular disease, explains Borgford. In the case of these bioterror agents, you typically dont have very many customers, and those customers are government agencies. Unfortunately, government agencies dont always know their own requirements ahead of time. It is very important for a small company like Twinstrand that the government agencies, which would eventually procure these molecules, also provide funding to allow their development. Nagata also expresses that the Canadian biotechnology
industry has been hard-pressed to find the resources necessary for the transition from research to products: Cutting-edge equipment and facilities in the biotech field are expensive to acquire and maintain, but are essential [if we are to remain] a player in this arena. He adds the CRTI initiative has been a welcome addition to providing funds for projects in this area. For Langstaff, the main problem with Canadian biodefense has been the absence of a program to stockpile products: Where they would agree to fund some of the research and development, they did not have a plan in place to stockpile these products afterwards. In many cases, this meant the research and development would be done in Canada, and the stockpiling would be done in the United States. However, he explains that there have been talks about this changing in the near future. The 21st century has seen biological warfare pose a growing threat to public safety. However remotely some people perceive the danger to themselves, preparedness remains essential. As the biotechnology sector continues research and development of new vaccines, people become safer against the very real threat of bioterror. BB
Building Floridas life sciences hub of the future

Southern biotech cluster gaining momentum
ith the location of world-class life sciences research institutions, Florida is poised to become a major market for the life sciences industry, said Brenda Workman, director of business retention for Enterprise Florida Inc., the states lead economic development organization. Floridas life sciences sector is growing, and people are beginning to take notice. The momentum generated by The Scripps Research Institute in 2004 accelerated the building of a life sciences cluster that led to other distinguished life sciences organizations coming to Florida. Among them are the Burnham Institute for Medical Research and Torrey Pines Institute for Molecular Studies. The foundation is in place for a strong longterm position in the life sciences industry, with Florida becoming more competitive against leading states such as California and Massachusetts. Florida is interested and motivated and they seem to really get it, said Richard Houghten, president and CEO of San Diego, Calif.-based Torrey Pines, in a May 2007 interview with the St. Petersburg Times. The message is: Florida is ready to go. As a result of advanced research capabilities, a collaborative environment and pro-business climate, Floridas life sciences businesses are thriving. Their contributions represent innovations in a variety of fields, such as neuroscience and degenerative diseases. Furthermore, the state has earned a notable reputation in marine biotech, bioinformatics, medical devices and clinical trials. And, on the local and regional as well as the state level, Florida is building an environment that will enable life sciences companies of the future to innovate and succeed. Florida universities and research centers continuously are expanding the breadth and depth of their scientific investigations in the life sciences fields. In fact, Florida universities took top honours in the Milken Institutes research study Mind to Market: A Global Analysis of University Biotechnology Transfer and Commercialization. The University of Florida was named as one of the top five tech transfer and commercialization universities in the U.S. and Canada, and also among the top universities in the world for biotechnology patents. Florida is also home to nationally recognized university-based tech incubators. The University of Floridas Sid Martin Biotechnology Development Incubator is ranked number one for technology in the United States according to the National Business Incubation Association. Floridas life sciences industry has the potential to develop a robust innovation
The Clinical Research Building which houses the Miami Institute for Human Genomics. Photo courtesy of the Beacon Council
pipeline that links universities and research institutions with incubators, intellectual property firms, and venture capital. Biotechnology is large component of life sciences. Ranking second in the nation for number of bioscience start-ups and third for number of new bioscience branches, Florida is the number one region for effective economic development initiatives for the biotechnology industry. One of Floridas success stories is the Scripps Research Institute, one of the worlds largest non-profit research institutes, which opened its second major research facility in Florida in 2005. Located in Palm Beach County, the facility focuses on basic biomedical science, drug discovery, and technology development. Xcovery, Scripps Floridas first private drugdiscovery start-up, has been named one of the worlds most promising biotech companies.
The message is: Florida is ready to go.
In addition, Florida has one of the countrys largest medical device sectors. More than 20,000 Floridians work in this industry where a majority of the companies are located along the Florida High Tech Corridor in Central Florida, the Jacksonville area, and in the South Florida region. Mako Surgical Corporation, based in Fort Lauderdale, developed a revolutionary robotic medical device for knee-surgery. Medical device manufacturers are able to maintain a competitive edge in product development through industry organizations such as Florida Medical Manufacturers Consortium and resources such as
Regional Profile
Floridas commercialization offices and technology incubators to help them succeed. Pharmaceuticals are another important sector. The state is home to developers of treatments for cardiovascular and respiratory diseases, generics, nutraceuticals, over-the-counter drugs, and a wide array of other products. Organizations such as BioFlorida, the Florida High Tech Corridor, and the South Florida Bioscience Consortium provide support for the more than 90 companies that manufacture, fabricate and process medicinal substances into finished pharmaceuticals. Florida is home to Nanotherapeutics, which was voted Most Promising pharmaceutical company by the American Society of Mechanical Engineers. Florida has a large and vibrant health care sector as well. More than 626,000 employees work in the sector, which includes one of the largest and most sophisticated health care systems in the country. Some of the world-renowned research hospitals and centers in Florida include the Cleveland Clinic, Florida Hospital, H. Lee Moffitt Cancer Center and Research Institute at USF, M.D. Anderson Cancer Center, Mayo Clinic, Mount Sinai Medical Center, Shands Healthcare, and University of Miami Jackson Memorial Hospital. Given all the life sciences-related excitement and activity around the state, it is evident why Ernst & Young ranked Florida as a Top 10 State for Biotechnology. Florida is the right place for
A Scripps Florida scientist. Photo courtesy of the Business Development Board of Palm Beach County
both the science of discovery and the promise of business growth. We got a terrific reception, Ed Schons, director of economic development at the University of Central Florida, told the St. Petersburg Times in May. We are beginning to get noticed. ... People are saying, My goodness whats happening there? Source: Enterprise Florida, www.eflorida.com
Life Sciences Workforce

Profession/Position Total in Florida Agricultural, food and nutrition scientists and technicians 710 Biomedical and biochemical scientists and engineers 400 Medical and clinical lab technicians 20,700 Biological scientists and technicians 6,060 All other life scientists 420 TOTAL 28,290 Source: Occupational Employment Statistics, 2004
The Kalypsys robot at Scripps Florida in Jupiter, FL. Photo courtesy of the Business Development Board of Palm Beach County
Floridas Business Advantages

Florida offers an attractive business climate. One of the most tax friendly states, it has no state personal income tax and a corporate income tax rate of just 5.5 percent. Florida offers: No sales tax on R&D equipment No state-level property tax No corporate income tax on subchapter S-corporations, as guaranteed by constitutional provision No property tax on goods-in-transit for up to 180 days No sales tax on raw material purchases incorporated in a final product for resale, including non-reusable containers or packaging Source: Enterprise Florida www.eflorida.com No state personal income tax No corporate income tax on limited partnerships No corporate franchise tax on capital stock No sales and use tax on goods manufactured or produced in Florida for export outside the state
Regional Profile South Floridas up-and-coming life sciences sector
rank Nero, president and CEO, The Beacon Council (an economic development agency that oversees Miami-Dade County); James P. Tarlton, president and CEO, The Broward County Alliance; Andrew Duffell, senior vice president, The Business Development Board of Palm Beach County; and Marcy Grossman, consul general of Canada in Miami, spoke to Bio Business about the South Florida life sciences cluster, encompassing Miami-Dade, Broward and Palm Beach counties. Nero: The three counties that make up what is commonly referred to as South Florida have over the past dozen years been concentrating on developing the biosciences as one of a few targeted industries. Weve been heavily recruiting but are also trying to develop strengths within our regions. We have collaborated in our efforts through Enterprise Florida. In Miami Dade, the most exciting thing going on in the area of life sciences is what is going on at the University of Miami. The University of Miami Miller School of Medicine is in the midst of a $1 billion dollar expansion in the life sciences. What we are doing is similar to what MaRS is doing in Torontoto try to develop the commercialization of research. Were also developing a new medical school at Florida International University. Duffell: A major focus of the life sciences industry in Palm Beach County is the Scripps Research Institute, a biomedical research institute located in Jupiter, Florida on the campus of Florida Atlantic University (FAU). Researchers at Scripps Florida focus on basic biomedical science and drug discovery. Currently more than 170 researchers and support staff are working in two temporary facilities (74,000 square feet of lab space) at FAU. An expansion into a 350,000 square foot, three-building permanent complex that will house a minimum of 545 staff members is projected for early 2009. Scripps Florida has a projection of 6,500 new jobs and a $1.6 billion economic impact over the next 15 years. Also, the non-profit research organization Max Planck Institute from Germany is looking at locating a major research facility in Florida. The Max Planck Society received conceptual approval in September 2007 to establish its first U.S. research institute in Palm Beach County. It is now applying to the State for additional funds. And of course there are collaborations between the institutions in all three counties. Scripps and Max Planck are talking about relationships with the University of Miami. What were seeing is a cluster. If you look at the life sciences industry in Florida, its really located in these three counties. Tarlton: For more than 30 years, life science companies have flourished in Broward, including many start-ups that have grown to become successful businesses. For example, Sunrise-based Bioheart has developed an innovative approach to repairing damaged heart muscle by using the bodys own cells. Clinical studies are well underway on Biohearts MyoCell products. Another life science company is Goodwin Biotechnology, a fully integrated cGMP contract manufacturing organization of monoclonal antibodies and recombinant proteins for preclinical
Photo courtesy of the Business Development Board of Palm Beach County
and Phase 1, 2, and 3 clinical trials. With over 14 years experience as an independent contract manufacturer, Plantation-based Goodwin has worked with companies of all sizes, from small university spin-offs to major research institutes, government agencies and large established biopharmaceutical companies. We also have Nova Southeastern University, where a 208,000 sq ft $30 million research centre is planned consisting mainly of wet labs for use by NSUs research programs such as osteopathic medicine, dentistry, oceanography and pharmacology. I think the collaboration between the universities and also the tricounty area thats building this clusterits pretty significant. There is a lot of investment being made across the board, from Palm Beach all the way down to Miami-Dade. The life sciences activity in South Florida is supported by the public sector, but theres a lot of private sector activity as well. There are a lot of private sector parties that are really working to make sure the sector is supported both on the private and the public sectors. Nero: The current development were seeing in the life sciences industry in Florida was an initiative of former Florida governor Jeb Bush, who decided that when the state of Florida diversified its economy, one of the areas that he would concentrate on would be the biosciences area. He really created the initiative, and directly recruited Scripps (for the Scripps Research Institute). There were heavy incentives from the government to get facilities built in Florida, and that has continued with our current governor. Florida has created what is called an innovation fund, to serve as an incentive package for high-impact innovation projects. And the funds are matched by the local governments. And its not just for the big guys; its also for smaller research firms. Grossman: Establishing Canadian-Floridian partnerships in the life sciences is a natural, since the Canada-Florida connection has already been established on many levels. Canada is currently Floridas number one overall economic partner. It is the number one source of in-bound tourismover 2.2 million Canadians visits to Florida on an annual basis, many of which are long-term snowbird population, putting over 2 billion dollars into the local economy every year. Canada is also the number one source of foreign direct investment in Florida with corporate investments valued at over US$5 billion. Canada is also the number one source of real estate investmentalso valued at $5 billion, in personal residences, commercial structures, condos and construction projects.
Spotlight on Miami-Dade County

The life sciences sector of Miami-Dade is 50 years old. Home-grown companies include Beckman Coulter (developers of the blood counter, started in 1950s) and Cordis Corp (established in the 1960s, now part of Johnson & Johnson), Noven Pharmaceuticals and IVAX (now part of the Israeli company TEVA). Major life sciences companies with operations in MiamiDade County include Shering-Plough and Boston Scientific. Novartis Latin America has its Latin American Regional Headquarters in Miami-Dade County. The University of Miami Miller School of Medicine is in the midst of a $1 billion expansion on its medical campus. Newly constructed and planned buildings include a Clinical Research Building, (336,000 sq ft), a Biomedical Research Institute (182,000 sq ft), and the Miami Bioscience Center (240,000 sq ft). Major research institutions at the University of Miami are Bascom Palmer Eye Institute, the Sylvester Comprehensive Cancer Center,The Miami Project to Cure Paralysis,The National Parkinson Foundation, and The Diabetes Research Institute. New at the University of Miami Miller School of Medicine are the Miami Institute of Human Genomics, and a new Interdisciplinary Stem Cell Institute. The Miller School of Medicine has more than 1,300 ongoing research projects that are funded by nearly $200 million in external grants and contracts to University of Miami faculty. Florida International University is in the process of establishing a new medical school. Local universities and colleges, including the University of Miami, Florida International University, Miami Dade College, and Barry University train students for the life sciences field, creating a skilled workforce.
Existing Canadian-Floridian partnerships in the life sciences:

Research collaborations: Agreement between Memorial University Marine Institute in Newfoundland and the NOAA Tampa Bay Physical Oceanographic Real-Time System (PORTS) at the University of South Florida College for Marine Science. As a result of the Team Canada Atlantic Mission Ocean Technologies Roundtable held in the fall of 2006, Memorial University Marine Institute in NL signed an agreement to collaborate on future projects with the NOAA Tampa Bay Physical Oceanographic Real-Time System (PORTS) at the University of South Florida College for Marine Science. Agreement between NRCs Institute for Marine Biosciences satellite laboratory in Charlottetown PEI (NRC-Institute for Nutrisciences and Health) and Florida Atlantic University (FAU). As a result of researchers from NRCs Institute for Marine Biosciences satellite laboratory in Charlottetown traveling to Florida Atlantic University, Boca Raton Campus, and participation in a research symposium that focused on marine compounds and their benefit to human and animal health, a MOU was signed between the two organizations. The Director of the Florida Centre of Excellence for Biosciences and Marine Biotechnology based at FAU subsequently relocated to PEI. Canadian companies with investments in Florida: Haemacure Corporation, a Canadian company specializing in products for the acute surgical wound care market, markets Hemaseel, the first fibrin sealant product approved by the U.S. FDA. The company was founded in Montreal, Quebec in 1991 by Mr. Marc Paquin, President. Since the 1990s Mr. Paquin has had links with the Florida medical community, the medical devices industry and the Sarasota Memorial hospital. Haemacure first opened an office in Sarasota essentially to build a sales force in order to sell in the U.S. In 2005 the company announced that they decided to manufacture Hemaseel themselves, investing $10 million in a new manufacturing plant. They will occupy 50,000-square-feet in a building located north of the Sarasota-Bradenton International Airport. Ontario-based Allied Research International (ARI) has opened a 132-bed clinical phase 1 research facility in Miami Gardens. ARI does FDA-approved research for pharmaceutical and biotechnology companies.
There are close to 470 life sciences companies in Miami Dade County. They employ close to 9,000 people. Number of Companies Pharmaceutical Manufacturers Medical Device Manufacturers Research Institutions Medical Laboratories Total Source: The Beacon Council 84 89 133 165 471 Number of Employees 2,841 3,363 1,406 1,300 8,910
Microcentrifuges optimize airflow and reduce noise levels

Eppendorf North America introduced two microcentrifuges. Models 5418 and 5424 include standard aerosol-tight rotors that hold 18 or 24 microcentrifuge tubes, respectively. They have unique, patented lid designs for optimized airflow and reduced noise levelspractically down to background level. Operation is quiet, even for runs that do not use the rotor lid. Additional optional rotors for Model 5424 include a 4 x 8-tube PCR strip rotor and 18 x miniprep spin column/filter rotor.
Optimal ventilation for very small animals

The HSE-HA MicroVent, from Harvard Apparatus, provides optimal ventilation for prenatal mice, birds and other very small animals. Small in size, it can be placed close to the animal, resulting in minimal dead space volume, which is integral to proper ventilation. This is especially true in prenatal mice and other small animals, as larger volumes introduce greater system compliance and affect the accuracy of the tidal volume delivery. The unit can be connected to anesthesia for surgery, the Harvard Apparatus nebulizer and multigas adapter for aerosol drug delivery, or can be used alone for straight ventilation. The MicroVent provides breathing rates from 60 to 400 breaths/minute and has a stroke volume from 0 to 130 l. The stroke volume may be adjusted while the ventilator is running.
Neurite outgrowth neurotoxins screening kit

Millipore launched the Neurite Outgrowth Assay. Using high content screening for imaging and analysis of neurite outgrowth and neuronal cell morphology, the kit offers a complete solution for specificity labeling and neuronal cell bodies for high content imaging. The kit utilizes highquality, validated, target-specific detection reagents for profiling in a variety of species, including human, mouse and rat. Large-scale screening is simplified through the assay reagents 24-hour stability at room temperature. Its primary antibody is immunofluorescence-based to specifically label neurites and neuronal cell bodies in heterogeneous cell populations. High sensitivity-generating images with high signal-to-background ratios facilitate subsequent high content analysis, making the kit ideal for screening both inducers and inhibitors of neurite outgrowth neurotoxins.
New kit-based small RNA cloning system

Integrated DNA Technologies announced the availability of its new miRCat small RNA cloning system. The unique kit-based resources make the creation of small RNA (including miRNAs, piRNAs and endogenous siRNAs) libraries from any primary RNA source time and cost efficient with peerless flexibility and consistency. The new miRCat system permits cloning of very rare small RNAs and takes into account the natural variability in structure and sequence between species. It is compatible with most existing standard laboratory protocols for processes such as RNA extraction, purification and cloning. The miRCat cloning system consists of three sequential protocols: RNA isolation and enrichment, followed by cloning linker attachment, and ending with an amplification and cloning phase.
Products
Single-use aseptic filling system improves liquid dispensing of biopharmaceuticals
Flexicon America has a new solution for the dispensing of biopharmaceutical liquids. The DAFPA (Disposable Aseptic Filling Path) is a disposable tube set assembly system. The all-disposable USP 29 Class VI DAFPA system includes pharmaceutical grade silicone tubing and single use disposable plastic filling needles in a ready-to-use pre-assembled and gamma irradiated kit. The aseptic system features a simplified set up and go efficiency that improves process staging, raw materials management and reduces the number of steps within the filling and validation processes. The DAFPA system simplifies and speeds the validation process and reduces validated changeover protocol requirements. The pre-assembled sealed system saves on assembly component procurement, parts management and human error, and offers no equipment clean-up, no autoclaving and no risk of product cross contamination.
Fully automated system for gel electrophoresis

Lab901 launched the ScreenTape system, a fully automated, walkaway solution for gel electrophoresis. The ScreenTape system comprises the TapeStation (that carries out liquid handling, electrophoresis and imaging), ScreenTape (a consumable that contains the pre-cast, pre-packaged gel and running buffer) and bespoke software. With no gel or buffer preparation and no system priming, even untrained operators can rapidly generate accurate and reproducible data. The first ScreenTape consumables are optimised for the analysis of DNA fragments up to 800 bp, for use with multiplex or simplex PCR analysis, genotyping, QC of Q-PCR products and QC of DNA prior to microarray printing. Efficient and safe data storage is achieved through integrated bar-coding and the generation of secure file formats for the analysed data. Labs using gel electrophoresis can obtain full traceability and GLP compliance.
New high-fidelity PCR master mix

NEB, in conjunction with its partner Finnzymes, announced the release of Phusion Flash High-Fidelity PCR Master Mix. It has been designed for fast PCR, with extension times of 15 seconds per kilobase (or less). The fidelity of the polymerase is 25 times higher than Taq, and provides high yields in reduced time.
Chemistry system for high volume testing labs

Siemens Medical Solutions Diagnostics introduced the ADVIA 1800 chemistry system, offering new productivity benefits, including faster and more reliable ISE test module and easy sample and reagent loading. The ADVIA 1800 incorporates easy automation connectivity to the ADVIA WorkCell or ADVIA LabCell Network Solutions without requiring additional interface hardware. Direct sampling prevents detaining tubes at the analyzer and reduces aliquoting. Redundant sample loading is included for built-in backup and easy handling of non-routine samples. The ADVIA 1800 is capable of conducting up to 1800 tests per hour, or 200 basic metabolic panels per hour. Sample integrity checking, microvolume sampling, and short sample and clot detection, all reduce the need for manual intervention and facilitate testing routine and low-volume samples.
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In Person
Melanie Huntley
Young genetics researcher awarded with RSC honour
elanie Huntley is a computational biologist who currently holds an NSERC postdoctoral fellowship and is a postdoctoral associate at Cornell University. She recently won the Academies of Arts, Humanities and Sciences of Canada (RSC) Alice Wilson Award for 2007. The award honours the memory of Alice Evelyn Wilson, FRSC, a worldrenowned palaeontologist, one of Canadas foremost geologists, and the first woman elected to RSC in 1938. The award is given to a woman of outstanding academic qualifications who is entering a career in scholarship or research at the postdoctoral level. Huntleys research focuses on the biology, function, and evolution of amino acid repeats within protein sequences, a topic at the forefront of genetics research, as amino acid repeats within proteins were virtually unheard of when she first began research in this area. Amino acid repeats are associated with several diseases of the human nervous system (such as Huntingtons disease), making it research that could prove to be highly relevant in understanding the origin of neurodegenerative diseases. Where repeats within proteins were once thought to be the protein equivalent of junk DNA, they are now being recognized as functionally and evolutionarily significant sequence features. Huntley says one paradigm that seems to be most affect-
ed by the findings is the sequence, structure, function paradigm: amino acid repeats tend not to form consistent 3D structures, and are instead rather flexible, mobile and disordered. But what makes Huntleys research so relevant to genetic research is that this inherent mobility appears to serve a major function in the day-to-day biology of cells, and therefore, life. Huntley began her science studies at McMaster University, where she completed an Honours undergraduate degree in Biology and Mathematics in 2001 and spent summers in the universitys bioinformatics and molecular evolution research lab. A PhD at McMaster followed, under Dr. Golding, and was completed in August 2006. The postdoctoral fellow position is one Huntley has held since the completion of her PhD, at Cornell Universitys Dept. of Molecular Biology and Genetics, under Dr. Andrew G. Clark. Huntley hopes to apply her research in the broader areas of genetics, and contribute to a larger scientific understanding of the process of development. She has a vision that scientists will one day be able to trace and understand exactly how an organism goes from the genetic information and cellular composition of a single celled zygote, to a fully developed adult organism, and further through aging. This could have far reaching consequences for health related research. BB
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should be there...
end.
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.
No matter where you are in your research or production process, your supplier should be right there with you. VWR is always there with carefully developed, end-to-end solutions that are based on our long and extensive experience serving customers worldwide. Meeting the needs of the life science market is one of our priorities. VWR is consistently at the forefront with the latest products and services for efforts ranging from drug discovery to the latest stem cell research. And you can rely on our network of life science specialists for start-to-finish support. Theyll help you match the right instrument with the right consumables and the right service for your applications. In the end, theres only one choice. We call it the Power of 1 and its VWR. For more information, call 1-800-932-5000 or visit vwr.com now.
l Mastercycler ep realplex
real-time PCR system
l epMotion 5070
automated pipetting system
l Highly precise
pipetting tools
l Comprehensive software
for optimized data analysis
Automated qPCR that pays for itself.

Precision pipetting Reproducible results Affordable automation
Eppendorf Automation and Real-time Systems (ARTS) combine the most accurate and reproducible pipetting with the fastest and most sensitive real-time cycling. That means you get highly consistent and reproducible results within and across experiments. You can even perform reactions in lower volumesand with fewer replicates, so you will also save significantly on reagents! Mastercycler ep realplex Real-time PCR in less than 30 minutes l User-friendly software l Highly sensitive optical system
l
epMotion 5070 automated pipetting system Easy operation via control panel or PC l Preinstalled, validated applications/consumables l High-precision pipetting from 1 l to 1,000 l
l
Visit: www.epmotion.info or www.realplex.com
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 Your local distributor: www.eppendorf.com/worldwide Application Hotline: Phone +49 180 366 67 89
Practice of the patented polymerase chain reaction (PCR) process requires a license. The Eppendorf Thermal Cycler is an Authorized Thermal Cycler and may be used with PCR licenses available from Applied Biosystems. Its use with Authorized Reagents also provides a limited PCR license in accordance with the label rights accompanying such reagents. This is a Licensed Real-Time Thermal Cycler under Appleras United States Patent No. 6,814,934 and corresponding claims in non-U.S. counterparts thereof, for use in research and for all other applied fields except human in vitro diagnostics. No right is conveyed expressly, by implication or by estoppel under any other patent claim.
C9700-A128B 2006 Eppendorf AG

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Talent Wanted: Biotech industry challenged by talent shortages

CHAMPIONING THE BUSINESS OF BIOTECHNOLOGY IN CANADA

Our look back at National Biotechnology Week 2007

One source for spectrophotometry

One place One standard One call...

Recruitment for the Canadian life sciences industry

Agents of biodefense in Canada

Building Floridas life sciences hub of the future

October/November 2007 Bio Business 3

Model 5424 available with control keypad or knobs

Standard aerosoltight rotor and lid

18-place spin column rotor

Column rotor for filter tubes

The new laboratory standard2

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C5201-A134 2006 Eppendorf AG

October/November 2007 Bio Business 5

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BIOTECanada seeks overturn of anti-IP ruling

CIHR unveils new policy for open access to research publications

October/November 2007 Bio Business 7

Canadian VC funding declining from Q1 to Q2

Genome Quebec Biobank opened

New name for Health Care Products Association of Manitoba

8 Bio Business October/November 2007

Canada at the top in canola research

$14.7M for Thunder Bays Molecular Medicine Research Centre

First of its kind anthology

October/November 2007 Bio Business 9

$76M to combat disease in hog sector

Resverlogix Receives Excellence in

Counter terrorism research at U of Ottawa receives $6.8 million

10 Bio Business October/November 2007

New bioindustrial innovation centre planned

Less strainMore efciency.

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C5101-A132E 2003, 2006 Eppendorf AG

Thanks for coming!

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14 Bio Business October/November 2007

October/November 2007 Bio Business 15

16 Bio Business October/November 2007

In partnership with Brinkmann

Weve got your size.

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C6001-A105D 2002, 2006 Brinkmann Instruments, Inc.

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: How and why did you get started in biotech?

: What is your personal business strategy?

: What are your plans for the future?

: Can you give a brief overview of Thallion?

: What have been your major challenges?

: What advice would you provide a growing biotech?

October/November 2007 Bio Business 19

Experienced biotech professionals apply here

20 Bio Business October/November 2007

around talent management versus talent recruitment.

I think moving forward, focus will be more

October/November 2007 Bio Business 21

22 Bio Business October/November 2007

October/November 2007 Bio Business 23

important thing that a CEO has to do