Trends, Issues and Developments in Canadian Life Science ...Account Kirsty Tamaki M an ger kt a mi@jes r.co Promotion Nancy Sim Manager [email protected] Production Roberta Dick Manager

SPRING 2006

T r e n d s , I s s u e s a n d D e v e l o p m e n t s i n C a n a d i a n L i f e S c i e n c e

BIO BUSINESSBIO BUSINESSwww.biobusinessmag.com

CanadianPublicationsMailProduct—SalesAgreement40063567

Canada strengthens itsleadership in infectious

disease researchpg 14

IP protection of humangenetic material in Canada

pg 28

Italy’s bio sector connectsacademic and business worlds

pg 34

+Canada strengthens itsleadership in infectious

disease researchpg 14

IP protection of humangenetic material in Canada

pg 28

Italy’s bio sector connectsacademic and business worlds

pg 34

+Generex Biotechnology’s

ANNA GLUSKINGenerex Biotechnology’s

ANNA GLUSKIN

reply online at www.biobusinessmag.com

Spring 2006 BIO BUSINESS 3

��

also inside25 QUESTION & ANSWERAnna Gluskin, president and CEO of Toronto-based Generex Biotechnology discusses her 10-year-old company’s progress

28 IP & PATENTING A look at Canada’s intellectual property regime with respect to humangenetic materials—making it work for the health of Canadians

38 IN PERSONAward-recipient, and University of Guelph Ph.D. candidate Jamie Doran focuses his entrepreneurial efforts on launching an innovative company

BIO BUSINESS

standards5 EDITOR’S NOTE

7 NEWS

12 BUSINESS BRIEFS

36 NEW PRODUCTS

Contents

20 Business ManagementThe HR Challenge: Canada’s to-do list includes developing the sector’s employee base by easing the financial—thus recruiting—constraints faced by most of Canada’s small companies; eliminating regulatory hurdles; increasing mentoring opportunities; and helping students acquire the skills in demand by industry. Addressing these hurdles is key to achieving sustainable growth and international competitiveness, say pundits.

DISCOVERIESInfectious disease research emerges as a Canadian strongsuit. Witness this sampling of achievements and innovations

Cover photo credit: Yanka Van der Kolk Imaging & Photography

14

34REGIONAL PROFILEStronger ties between academia and business are transforming Italy’s burgeoning biotech sector

freply online at www.biobusinessmag.com


BonVoyage

s we wrap this issue, it almostfeels like we’ve been around

the world and back…from Italy toVancouver, and now Chicago. I had the pleasure of attending the

4th annual BioPartnering NorthAmerica Conference (BPN) Feb. 5-7 inVancouver. This year, 900 delegates(and almost 70 representatives of majorpharmaceutical companies) convergedto discuss and foster partnership oppor-tunities. The two-day event, producedby California-based Technology VisionGroup LLC and hosted by BC Biotech,BIOTECanada and Bio Alberta, spot-lighted several key areas includingstrategic research collaborations; merg-ers and acquisitions; deal (and technolo-gy) valuation and negotiation; and thegrowth of the specialty pharma industry.BC Biotech’s executive director,

Karimah Es Sabar says several key dealswere indeed initiated. “We had 50%more big pharma attend this year, andmuch more senior people—those whomake the deals,” she says, adding,“About 20 Japanese companies partici-pated. They are hungry for pipelines.And they are realizing that BC has allthis talent and innovation. We’re gettinga lot of interest from Europe and Japan.”Only weeks before BPN, Es Sabar

travelled to Italy on a biotech trade tour(see Regional Profile, page 34).Spearheaded by the B.C. Ministry ofEconomic Development, the missionleveraged the Olympics as a businessdevelopment event, and showcased theB.C. biotech sector to about 26 NorthernItalian biotech companies.“It was very well-received,” says Es

Sabar. “People were amazed becausethey don’t know what we do in Canada,let alone what we do in B.C. Many knewabout our strong science and academiabut didn’t realize the success of our com-mercialization and business. There areuntapped opportunities for Canada. We

need to build on our presence.”I suspect that’s precisely what is on

the minds of many of those headingdown to Chicago shortly for BIO 2006.According to Peter Brenders, presidentof BIOTECanada, the Canadian con-tingent is as strong as ever. TheSignature event and even theCanadian pavilion itself have basicallysold out, he says. “Canada should beable to quite comfortably keep its pro-file up there as the second-largestbiotech region in the world.”For our part, BioBusiness has been

busy lining up interviews and schedul-ing meetings with various state agen-cies and country representatives as partof our effort to bring you glimpses ofvarious biotech strongholds in the com-ing issues. Not only is it interesting tosee what others are up to, but perhapsthere’s a thing or two to be learnedfrom other jurisdictions. So sit back and relax, as we dim the

cabin lights…

Cheers, Bernadette

Editor’s NoteBIO BUSINESS

Trends, Issues and Developments in Canadian Life Science

Publisher Christopher J. Forbes& CEO [email protected]

Managing Bernadette JohnsonEditor [email protected]

Art Tammy WhiteDirector [email protected]

Contributors Nancy DorranceLaura EggertsonSarah FischerMitch RitterAmie Sergas

Sales Beth KukkonenManager [email protected]

Account Kirsty TamakiManager [email protected]

Promotion Nancy SimManager [email protected]

Production Roberta DickManager [email protected]

Production Sara ForgetCo-ordinator [email protected]

Bio Business is published 4 times per year by JesmarCommunications Inc., 30 East Beaver Creek Rd., Suite202, Richmond Hill, Ontario L4B 1J2. 905.886.5040Fax: 905.886.6615 www.biobusinessmag.comOne year subscription: Canada $35.00, US $55.00 andforeign $95. Single copies $9.00. Please add GST whereapplicable. Bio Business Subscription and circu-lation enquiries: Garth Atkinson,[email protected] Fax:905.509.0735 Subscriptions to business address only.On occasion, our list is made available to organizationswhose products or services may be of interest to you. Ifyou’d rather not receive information, write to us at theaddress above or call 905.509.3511 The contents of thispublication may not be reproduced either in part or inwhole without the written consent of the publisher. GSTRegistration #R124380270.

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NewsB.C. boasts best return on R&Dspending in North AmericaFirst-of-its-kind study compares output of venture capital across technologysectors in Canada and the U.S.

British Columbia technology companies are deliveringthe best return in North America for every dollar invest-

ed in research and development, according to a new UBCSauder School of Business study. The study also found B.C.is number one in Canada and fifth in North America for cre-ating value from each dollar of venture capital invested. Thestudy, funded by Leading Edge BC, is the first of its kind tocompare output, or “exits” of venture capital across majortechnology jurisdictions in Canada and the United States. During the period 1997 to 2004, 509 exits of Canadian

venture capital backed companies generated a total exitvalue of US$30 billion, while 3047 American companiesgenerated US$381 billion. Overall the research found theCanadian market performed surprisingly well when the dif-ferences—mainly size—between the U.S. and Canadianeconomies and venture markets were taken into account.When the total exit values from both countries were com-pared on a GDP basis, Canada outperformed the U.S. by3%. And when compared against the amount of ventureinvestment, Canada outperformed the U.S. by 15%.“Our results challenge the notion that the Canadian ven-

ture capital market is significantly behind the U.S.,” saysThomas Hellmann, UBC business professor and author ofthe study. “While it is true that total and average exit valuesare smaller in Canada, once we account for the different sizesof the two economies, the Canadian venture market per-forms surprising well, and if anything, better than the U.S.”

Other highlights from the report include:• B.C. is eighth in exit value in North America on per GDP basis• Exits occur faster in Canada than in the U.S.• Alberta is fastest from founding to exit in North America. B.C.is second and Ontario is third

• Ontario is the fifth largest market in North America, with atotal exit value of US$14 billion

• Exits in Quebec (US$5 billion), B.C. (US$4.2 billion) andAlberta (US$3.7 billion), demonstrate strong venture capitalmarkets in these regions

• B.C.’s strong performance is driven by successful exits in threemain sectors: information & communications; technologies,energy & sustainable technologies, and life sciences

TSX Venture Exchange announced theTSX Venture 50, the first-ever rank-

ing of Canada’s top emerging public com-panies, in each of five major industry sec-tors—life sciences, mining, oil & gas,technology, and diversified industries—based on a ranking formula with equalweighting given to one-year revenue (lastreported 12 months), return on invest-ment, market cap growth and trading vol-ume. All data was as of August 31, 2005.

The top company in the life sciencesindustry sector was CV Technologies Inc.(CVQ), of Alberta, which also emerged asthe top company overall. The company’slead product, COLD-fX, is the number oneselling cold and flu remedy in Canada.

The 2005 TSX Venture 50 companiesincluded the following companies in the life sciences sector: ImagingDynamics Company; Pyng Medical;MedMira; Prism Medical; Miraculins;ARIUS Research; Protox Therapeutics;DTI Dental Technologies; and BurconNutraScience Corp. (BU).

CV Technologies tops the TSX Venture 50 list

Ryan RadkeBioAlberta named RyanRadke as president effec-tive January 2006. Previously Radkeheld the position of VP, operation andprograms with BioAlberta. Prior to join-ing BioAlberta, Radke held internation-al trade, technology and bio-pharma-ceutical positions within theGovernment of Alberta in the depart-ments of Economic Development andInnovation and Science.

Don EnnsCANTEST Ltd. appointed Don Enns tothe position of CEO. Enns has beenwith the company since the early1980’s and has served as its presidentfor the past ten years. He will continueto hold the office of president. Ennsalso sits on the CANTEST Board ofDirectors as well as the Boards of sev-eral other companies involved in thelife sciences industry.

Elizabeth WilliamsLorus Therapeutics Inc. announced thedeparture of the following senior man-agers as part of a reorganization of the company: Shane Ellis, VP legalaffairs and corporate secretary; BruceRowlands, SVP planning and publicaffairs; and Paul Van Damme, CFO. InNovember 2005, the company reducedits staff by approximately 35%. PaulVan Damme’s responsibilities will beassumed by Elizabeth Williams, CA,presently Lorus’ Controller and newlyappointed director of finance.

Launa AspesletIsotechnika Inc. appointed Dr. LaunaAspeslet, RAC to COO. DuringAspeslet’s nine years with the company,she has held numerous positions in thediagnostic, medical, and regulatorydepartments. Most recently, Aspesletheld the position of SVP, regulatoryaffairs, where she was responsible forthe overall management of investiga-tional new drug applications and relat-ed correspondence with the U.S. andCanadian Health Authorities.

Terry VanderkruykCoastal Contacts Inc. appointed TerryVanderkruyk as vice-president, corpo-rate development.

News

The Saskatchewan Pulse Growers (SPG) andthe Crop Development Centre (CDC) at the

University of Saskatchewan have entered into anew long-term pulse breeding agreement worth$21 million over 15 years. This funding, alongwith the recently opened, $3-million state-of-the-art pulse research lab on the University ofSaskatchewan campus, is expected to meet thecrop breeding and research needs of the pulseindustry for many years to come. The SPGresearch agenda is funded through a check-off onall pulse crops sold in the province.Saskatchewan produces 99% of the country’slentils and 70% of its peas. Pulses are now plant-ed on four to five million acres annually, makingthem the province’s third most important cropexport and accounting for about 15% of incomeat the farm gate. The university has played anintegral role in the development of theprovince’s pulse industry: Fewer than a dozenSaskatchewan farmers had tried growing lentilswhen a breeding program was established at theCDC not long after the centre’s inception in1971. Since then, the CDC has released 92 pulsecrop varieties including 32 lentil, 20 pea, 22bean, 13 chickpea and five fababean varieties.

The federal government committed an extra $80 million in funding to theNational Research Council over five years, and a major portion of thisfunding will be used to help launch the National Centre for Biomedical

Innovation (NCBI). The centre is a partnership of the University of Torontoand the National Research Council that has been in development for approx-imately two years. It is designed to enhance the possibility of practical appli-cation from biomedical discoveries made in Canadian university labs. Its goal is to ensure that more of these made-in-Canada breakthroughs canbe applied to improve the lives of Canadians and create new economicopportunities across the country. Canadian universities are world leaders inbiomedical discovery; indeed, the Greater Toronto Area is ranked amongthe top five biomedical research clusters in North America. But manyCanadian discoveries are actuallyfirst applied as commercial and clin-ical products outside of Canada.NCBI will focus on creating applica-tions for six areas of biomedical dis-covery: chemical biology, computa-tional biology, imaging, nano-biotechnology, personalized medi-cine, and regenerative medicine.

National Centre for BiomedicalInnovation gets funding boost

8 BIO BUSINESS Spring 2006

$21M long-term pulse breeding agreement signed

Peter QuickMedicure Inc. appointed Peter Quick,former president and CEO of Quick &Reilly Inc.—one of the first and largestdiscount brokerage firms in the U.S.before being acquired by Bank ofAmerica—to its Board of Directors.Most recently, Quick was president ofthe American Stock Exchange (July2000 to April 2005).

Suzanne FortierThe Natural Sciences andEngineering ResearchCouncil (NSERC) wel-comed Dr. SuzanneFortier as its fifth president. Fortier wasformerly VP (Academic) at Queen’sUniversity, and a full-time professor at the university in both the depart-ments of chemistry and computing and information science. She is a crystallographer by training.

Arnout Ploos vanAmstelWyeth Pharmaceuticalsappointed Arnout Ploosvan Amstel to the positionof president and manag-ing director of Wyeth Canada effectiveSeptember 1, 2005. Ploos van Amstelreplaces Jim Connolly, who has takena position as executive vice presidentand general manager of the WyethGlobal Vaccines Business Unit.

Life Sciences Research Instituteunder development in Halifax

Montreal is about to become a major centre for pharmacogenomics research,thanks to the creation of a new centre dedicated to this advanced medical

science. A personal donation of $5 million from Michel Saucier and his wife GisèleBeaulieu to their alma mater, theUniversity of Montreal will fund theconstruction of the Beaulieu-Saucier Pharmacogenomics Centreon Montreal Heart Institute proper-ty. Pharmacogenomics is a verypromising branch of drug researchthat uses a patient’s genetic profileto select appropriate medicationsand fine-tune drug therapies. TheBeaulieu-Saucier Pharmacogeno -mics Centre is expected to openofficially in the Summer of 2007.

Christopher J. Waddick, Paul J.Van Damme, Jacqueline H.R.Le SauxVasogen Inc. promoted Christopher J.Waddick to the position of COO, andappointed Paul J. Van Damme as VP,Finance and CFO, and Jacqueline H.R. Le Saux as VP, corporate andlegal affairs. The company also namedRonald M Cresswell, former senior VP and CSO of Warner-Lambert, and Calvin R. Stiller, co-founder andformer chairman and CEO of theCanadian Medical Discoveries Fund, to its Board of Directors.

Edge WangWEX Pharmaceuticals Inc. named Dr. Edge Wang president and CEO.Dr. Jean Bourgouin, CMO, wasappointed EVP. Trevor Sinclair, CA,was also appointed as interim CFO as WEX searches for a permanentCFO. Dr. Don Qiu, MBA, PhD, wasappointed VP operations.


A new centre forPharmacogonomics

A$34-million research facilitycalled the Life Sciences Research

Institute (LSRI) is one step closer to real-ity with the unveiling of architecturaldrawings. The facility will provideresearch and incubator space for theNova Scotia’s life sciences andbiotechnology sectors. The lead tenantwill be the Brain Repair Centre (BRC).

WHW Architects of Halifax designedthe $34-million, five-storey LSRI.Fundraising for the project is stillunderway, and the construction datedepends on sufficient funding. Theproject is a joint project of CapitalHealth, Dalhousie University and theIWK Health Centre.

Using proprietary indexing and standardizationtechnology, IFI Patent Intelligence, a Wolters

Kluwer business, issued its annual compilation ofthe top U.S. patent winners. According to the analy-sis, the total number of U.S. patents issued in 2005declined 12 % compared to 2004. This is the secondyear in a row to show a decrease—2004 posted a2.7% drop. The total number of pharmaceutical-related patents granted in 2005 decreased by 8%,while the number of applications publisheddecreased by about 2%. In the biotech industry,while there was a slight increase in the number ofapplications published, the number of actualpatents granted declined by more than 10%.www.ificlaims.com.

Toppatent U.S. companies

2005 reveals a 12% decrease in patents granted; pharma and biotech also down

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The 2006 BIOTECanada-TVGStudent ScholarshipBIOTECanada, in partnership withTechnology Vision Group LLC,announced the winners of the 2006BIOTECanada-TVG Student Scholar -ship. The awards offered the uniqueopportunity for graduate students witha background and demonstrated inter-est in the biotechnology industry toattend BioPartnering North Americain Vancouver (held Feb. 5-7).

Congratulations to the 2006Scholarship recipients:Alexis Braun, University of BritishColumbiaJennifer Chan, University of VictoriaWilliam Chow, University of CalgaryHannan Fleiman, McMaster UniversityFred Garcia, Richard Ivey School ofBusiness

UBC Life Sciences Centre hon-oured for green featuresThe UBC Life Sciences Centre (LSC)has been awarded the prestigiousLeadership in Energy andEnvironmental Design (LEED) Goldcertification by the United StatesGreen Building Council for its inno-vative sustainability features. The$125-million, 52,165-sq. metrebuilding is the largest building atUBC. The Institute comprises 25,000sq. metres of interdisciplinaryresearch space, which enables morethan 80 faculty investigators andapproximately 600 trainees andresearch staff to conduct innovativeresearch in many areas of the lifeand biomedical sciences.

Anand Kapur, Richard Ivey School ofBusinessLianne Kark, Richard Ivey School ofBusinessCharles Otieno, Simon Fraser UniversityJoseph Patton, University of AlbertaDenise Prindiville-Kirby, Simon FraserUniversityFredrick Rook, Simon Fraser UniversityAmie Sergas, Queens UniversitySarah Elaine Serl, University ofCalgaryIvan Waissbluth, University of BritishColumbia

News

Canada’s Top 10 The Ottawa Life Sciences Council (OLSC)unveiled this year’s finalists in Canada’s Top 10Life Science Companies Compe tition (Canada’sTop 10). “Canada’s Top 10 has consistentlyproven to be a highly accurate indicator of the

likely success stories in Canada’s life sciences sector,” saidKen Lawless, president and CEO, Ottawa Life SciencesCouncil. “The ensuing investment and partnership activityobserved among the alumni is a testament to the quality ofthe finalists and the expertise of our jury.”

Finalists are selected from a pool of entrants by an inde-pendent international jury of life science venture capitalists.Based on their expert knowledge of investment in the lifesciences sector, the jury selected the companies that theyfelt offered the best investment and partnership prospects.

The 2005/2006 finalists are:

Early Stage• Axela Biosensors Inc. (Toronto, ON)• iCo Therapeutics Inc. (Vancouver, BC)• Innodia Inc. (Laval, QC)• Trillium Therapeutics Inc. (Toronto, ON)• Variation Biotechnologies Inc. (Ottawa, ON /Gatineau, QC)

Emerging and Late Stage• Allon Therapeutics Inc. (Vancouver, BC)• Bioaxone Thérapeutique Inc. (St. Laurent, QC)• Inimex Pharmaceuticals (Vancouver, BC)• YM Biosciences Inc. (Mississauga, ON)• Zelos Therapeutics Inc. (Ottawa, ON)

The 2005 BioAlberta Achievement AwardsBioAlberta recognized several individuals and organizations that have made outstanding contributions tothe development of Alberta’s bioindustry at its annual BioAlberta Achievement Awards Gala. “We are veryproud to be honouring these outstanding achievers from Alberta’s bioindustry”, said Ryan Radke, Presidentof BioAlberta. “The leadership, entrepreneurship and innovation displayed by these award winners is anindication of the excellence that we have right here in our own province—Alberta is a success story”.• Dr. Chris Bleackley, faculty of biochemistry, University of Alberta, Edmonton, for Scientific Achieve -ment and Innovation

• Mr. Kevin Giese, president and CEO, BioMS Medical Corp., Edmonton, for Entrepreneurship• Mr. Andrew Baum, president and CEO, SemBioSys Genetics Inc., Calgary, for Industry Leadership• Dr. Lorne Tyrrell, CEO, ViRexx Medical Corp., Edmonton, for Lifetime Achievement• Dr. Antoine Noujaim, chairman, ViRexx Medical Corp., Edmonton, for Lifetime Achievement

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AAnnggiiootteecchh PPhhaarrmmaacceeuuttiiccaallss,, IInncc..,Vancouver, and its corporate partner,BBoossttoonn SScciieennttiiffiicc CCoorrppoorraattiioonn havejointly received the Canadian AmericanBusiness Council (CABC) 2005Achievement Award, which recognizesinnovative and successful alliancesbetween Canadian and American firms.

BBiioommiirraa IInncc.., Edmonton, arranged afinancing totaling approximatelyUS$16.1 million with Rodman &Renshaw, LLC of New York acting asexclusive placement agent. The financ-ing is subject to regulatory approval.

BBiioovvaaiill CCoorrppoorraattiioonn plans to spin offroughly all of its branded off-patentpharmaceutical products to its share-holders on a pro rata basis. The transac-tion—to be completed in 2006—is sub-ject to a number of conditions. Biovail’slegacy assets include Cardizem inCanada. The products are not activelypromoted by Biovail and representnon-core assets for which patent protection has expired.

CCaapprriioonn PPhhaarrmmaacceeuuttiiccaallss IInncc..,, Montreal,announced a research collaboration withBerlex Inc., a US affiliate of ScheringAG Germany. The collaboration will useCaprion’s CellCarta proteomics platformto support biomarker discovery.

HHeelliixx BBiiooPPhhaarrmmaa CCoorrpp.., Aurora, ON,completed a private placement inEurope for gross proceeds of CDN -$5,523,750. Helix issued 3,156,428 common shares and 3,156,428 commonshare purchase warrants in theEuropean placement.

IInneexx PPhhaarrmmaacceeuuttiiccaallss CCoorrppoorraattiioonn,Vancouver, will complete a spin-out ofits targeted immunotherapy assets intoa new company, Tekmira Pharmaceut -icals Corporation. Shareholders alsoapproved a stock option plan forTekmira.

Montreal’s MMeetthhyyllGGeennee IInncc.. andPPhhaarrmmiioonn CCoorrppoorraattiioonn, of the UK,announced a license and collaborationagreement for the research, develop-ment and commercialization ofMethylGene’s histone deacetylase(HDAC) inhibitors in North America,Europe, Middle East and certain othermarkets.

MMiissttrraall PPhhaarrmmaa IInncc.., Montreal, closedits private placement with DynexCapital Limited Partnership for a non-broker private placement of $500,000at a price of $0.05 per common share.

NNeeuurroocchheemm IInncc.., Montreal, enteredinto a sale and leaseback transactionwith an affiliate of Alexandria RealEstate Equities, Inc. The transactioninvolves the Neurochem campuslocated in Laval, Quebec, including itshead office and research facility, fortotal proceeds to Neurochem of C$32million.

PPaatthheeoonn IInncc.., Toronto, entered into afive-year master supply agreementwith Merck & Co. Inc. to providecommercial manufacturing and phar-maceutical development services toMerck. Merck also selected Patheonas a strategic partner for commercialmanufacturing and pharmaceuticaldevelopment services.

PPrrooccyyoonn BBiioopphhaarrmmaa IInncc.., Monreal, andFrench biotech CCeellllppeepp SS..AA.. enteredinto a definitive acquisition agreementunder which Procyon has offered toacquire all of the outstanding securitiesof Cellpep in exchange for a number ofcommon shares equal to $39.1 million invalue to be issued to the Cellpep share-holders. A $18.1 million concurrent pri-vate placement of special warrants andunits has also been completed. Procyonalso announced that it has made asecured loan of $1.9 million to fund theoperations of Opep Pharma Inc., theCanadian manufacturing subsidiary ofCellpep S.A. This will allow the newlyformed entity to substantially increaseits future gross margin in the manufac-turing area. Following the completion ofthe transaction, the strategic combina-tion of both companies will form a newentity: Ambrilia Biopharma Inc., a glob-al, publicly-listed biopharmaceuticalcompany (TSX ticker symbol: AMB)specialized in the development of inno-vative therapeutics in the fields of oncol-ogy and infectious diseases.

Montreal’s PPrrooMMeettiicc LLiiffee SScciieenncceess IInncc..announced a reorganization plan underwhich the business will be structuredas a parent company with four pure-play operating units. Within the newstructure, each distinct unit will func-tion independently in terms of man-agement, funding its operations,attracting investment, and developingspecific products and services.

QQLLTT IInncc.. announced a restructuringplan that includes cutting its workforce by up to 46%, selling Atrix’s non-core assets, chopping expenses forR&D and general overhead by 20%and streamlining the company’s focusto ophthalmology and one other to-be-determined therapeutic area. Thecompany also intends to double thesize of a continuing share buybackprogram to $100-million.

BusinessBriefs

UN CATALYSEUR POUR LA COMMERCIALISATIONLes Instituts de recherche en santé du Canada (IRSC) sont en train de créer les outils et programmes qui faciliteront les activités decommercialisation au sein de la communauté de la recherche en santé du Canada.

Une stratégie axée sur la réussite• Recherche – réaliser des investissements stratégiques dans des secteurs ciblés afin de concrétiser le potentiel des découvertes de la recherche

fondamentale.

• Talent – constituer un bassin de professionnels talentueux de la commercialisation combinant esprit d’entreprise, savoir-faire en rechercheet expertise en gestion.

• Capital – stimuler l’investissement dans ce secteur à haut risque en aidant à préciser le potentiel commercial des technologies naissantes.

• Liaisons – faciliter les interactions et les partenariats avec le secteur privé ainsi que les milieux de la finance et de la recherche en santé, etce, à toutes les étapes de la chaîne de l’innovation.

Programmes de commercialisation des IRSC

CATALYST FOR COMMERCIALIZATIONThe Canadian Institutes of Health Research (CIHR) is creating the tools and programs that will help build successful commercializationactivities within Canada’s health research community.

A Strategy for Success• Research – Make strategic investments in targeted research to realize the promise of discoveries reached through basic research. • Talent – Build a talented pool of commercialization professionals, people with a combination of entrepreneurial drive, research

know-how and management expertise.

• Capital – Stimulate investment in this high-risk sector by helping clarify the commercial potential of early-stage technologies.• Linkages – Facilitate interactions and partnerships with the private sector, finance and health research communities at all stages of

the innovation pipeline.

CIHR Commercialization Programs

Validating and refining research discoveries • Proof of Principle Program

Putting PhDs in health research on the MBA track

• Science to Business ProgramHelping identify promising new compounds

• Drug Development InitiativesStrengthening capacity of tech transfer offices

• Intellectual Property Mobilization Program (tri-agency partnership)

Seeding technology transfer offices with recent MBA grads

• Commercialization Management Grants

Fostering cross-disciplinary research• Collaborative Health Research

Projects Program (partnered withNSERC)

Developing future leaders in trials research• Randomized Controlled Trials

Mentoring Program

For more information on CIHR programsand opportunitiesCall 1 888 603-4178E-mail [email protected] www.cihr-irsc.gc.ca

Valider et raffiner les découvertes issues de la recherche • Programme de démonstration des principes

Inciter des titulaires d’un doctorat dans la recherche en santé à suivre un programme de MBA.

• Programme des sciences aux affairesAider à identifier les nouveaux produits prometteurs

• Initiatives de mise au point de médicamentsRenforcer la capacité des bureaux de transfert de technologie

• Programme de mobilisation de la propriété intellectuelle (partenariat des trois Conseils)

Fournir aux bureaux de transfert de technologie de récents diplômés du programme de MBA

• Subventions de gestion de la commercialisation

Encourager la recherche transdisciplinaire• Programme des projets de recherche concertée

sur la santé (en partenariat avec le CRSNG) Former de futurs chefs de file dans la recherche clinique

• Programme de mentorat des essais contrôlésrandomisés

Pour de plus amples renseignements sur les programmesdes ISRC et les possibilités de financementComposez le 1 888 603-4178Envoyez un courriel à [email protected] le site www.irsc-cihr.gc.ca

CIHR2.qxd 3/7/06 3:23 PM Page 1



If Jonas Salk had Rafick-Pierre Sékaly’s knowledge andequipment, the doctor who pioneered the polio vaccinemight not only have known that his vaccine worked

before he tested it on himself and his family, he might alsohave known how and why it worked.Like Salk, Sékaly and other members of the Université

de Montréal’s Canadian Network for Vaccines andImmunotherapeutics (CANVAC) are dedicated to findingvaccines that will curb the outbreaks of diseases that aredevastating populations around the globe. Instead of polio,their targets are HIV, Hepatitis C, SARS, cancer, and pan-demic influenza. Unlike Salk, who in 1952 could only make an educated

guess about his vaccine’s efficacy, Sékaly and his team con-centrate on deciphering the mechanisms of the body’s pro-tective immune response. Before today’s researchers testvaccines on human subjects, they need to know how andwhy those vaccines will create immune responses. Salk tested his vaccine on children who had already recov-

ered from polio, and on volunteers who had never had thevirus—including himself, his wife, and their children. Today,that kind of testing would be deemed unethical, especiallywhen working with live viruses. Researchers must knowmore before proceeding to human trials with new vaccines.“For HIV, Hepatitis C, and many other chronic viruses,

nobody knows the nature of the protective immuneresponse and how to measure it,” says Sékaly, a professor ofmicrobiology and immunology at the Université deMontréal, and the scientific and program director of CAN-VAC. “In order to know, you need to develop tools to meas-ure and identify that response.”What Sékaly needs to measure is the way cells react to

whatever vaccine he is testing. It’s a process that can involvethousands or even tens of thousands of cell samples. “One ofthe problems that has slowed down the field [of vaccinedevelopment] is the fact that there was very little standard-ization between different sites and validation of the assays(method, procedure, or test for determining how much of asubstance is in a sample) that were being used to measureimmune responses,” Sékaly says.Sékaly hopes to overcome that roadblock by using robot-

Infectious Disease ResearchA Canadian Forte

CANVAC researchers use robots to measure immune responsesfor new vaccines

P R O J E C T

DISCOVERIES

By Laura Eggertson

Government labs, academic institutions and private sector com-panies across Canada are at the forefront of combating infectiousdiseases—from SARS and BSE to Norwalk, C. difficile and HIV.Indeed the nation trains and employs many of the world’s lead-ers in infectious disease research, celebrating highly acclaimedorganizations like Canadian Network for Vaccines and Immun -otherapeutics in Montreal, Saskatoon’s Vaccine and InfectiousDisease Organization, British Columbia’s Centre for DiseaseControl, and the not-for-profit International Centre for InfectiousDiseases in Winnipeg. Canadian industry also boasts many leaders including Cangene, GSK (which recently acquired IDBiomedical, a leading producer of vaccines in Canada) and SanofiPasteur, among other smaller pioneers. Here is a sampling ofsome of the country’s recent achievements and innovations.



ic technology. This will allow researchers to standardizetheir tests and process thousands of samples at a time.Within 18 months, Sékaly will work in tandem with a

robotic arm that will ensure consistently high standards andeasy-to-reproduce results, and permit better characterizationof the markers of immune protection that are critical in mod-ern vaccine development. Standardized tests to measureimmune responses will allow researchers to assess vaccinesto see if they are creating the desired immune responses.Once researchers can predict how the body’s immune

system is likely to respond to a particular vaccine, they canthen forge ahead with clinical trials.Working with other researchers in the vaccine network,

like Dr. Frank Plummer at the University of Manitoba,Sékaly and his team also study the immune responses ofpeople who appear to be naturally protected against someviruses, like HIV. They hope to be able to compare naturalimmune responses with the responses induced by initialforms of a vaccine. That would enable them to develop asecond vaccine that would “fill up the gaps” or create aneven stronger immune response.

Vaccines are the most cost-effective way to treat infectiousdisease, because they are preventative. The smallpox vaccine enabled the medical profession to wipe out the disease; Salk’s polio vaccine has nearly eradicated the virusin many parts of the world, including North America. (India and Indonesia are among the countries still strugglingwith polio.)At the Université de Montréal, Sékaly and other mem-

bers of CANVAC are developing tools to measure the

New research by Dr. Wilfred Jeffries, supported withfunding from the Canadian Institutes of Health

Research, has demonstrated the possibility of develop-ing effective vaccines that would require drasticallysmaller dosages—100-times less than normal. Potentlow-dose vaccines could help ease concerns about vaccine shortages for possible pandemic situations suchas the avian flu. Such an approach also raises the possibility of creating live vaccines for high-riskpathogens because of the minimal amount of materialrequired to generate an immune response. Dr. Jefferies is a professor in the Departments of

Zoology, Microbiology and Immunology and MedicalGenetics working in the Michael Smith Laboratories andthe Biomedical Research Centre at the University ofBritish ColumbiaDr. Jeffries research addresses the use of adjuvants

to boost immune system response, focusing on the studyof a gene family specific to the immune system, themajor histocompatibility complex (MHC). Proteinsexpressed by these genes play a key role in movingantigens to the surface of the cells, provoking animmune response that attacks and eliminates the invading virus and other pathogens. The strategy successfully used by Dr. Jefferies involves the overex-pression transporters associated with antigen process-ing (TAP) to help boost the immune response.The result, documented in experiments with mice, was

that the immune system responded as if it had encoun-tered a major viral infection. Large numbers of antigenswere dispatched to help trigger an immune responseeven though the actual amount of virus introduced in thevaccine was 100 times less than normal. In animals,despite the lower levels of vaccine, the immune responsestill provided effective protection against infectious diseases such as measles and smallpox.“We’re excited by the possibility that this discovery

could change the face of vaccines as we know it,” Dr.Jefferies says.“Smaller doses of some vaccine formulations with

potential toxicity may be better tolerated by those withweaker immune systems,” adds Dr. Bhagirath Singh,Scientific Director of the CIHR Institute of Infection andImmunity. “This unexpected finding suggests that delivery of TAP gene boosts the immune response of thevaccine. This new technique could increase vaccine efficacy and potency.”

Source: CIHR/IRSC, www.cihr-irsc.gc.ca

LESS IS MORE


B E N E F I T S


duction gives us not only a competitive edge at developingnew vaccines, but also ensures that if there is an epidemic,we have our own vaccine infrastructure [to effectively com-bat it],” says Sékaly.

At Thermo CRS Ltd., Grace Mangialardi and her colleaguesspecialize in finding automation solutions for laboratories.That’s why the Burlington, Ontario-based company is a nat-ural fit to work with Sékaly and his team at the Universitéde Montréal to create a robotic platform that will helpresearchers process tens of thousands of cell samples quick-ly, accurately, and consistently. That’s particularly importantwhen researchers are trying to develop vaccines quickly inresponse to developing epidemics like SARS.“Humans just can’t mentally schedule everything to start

all at the same time, and process things as accurately as arobot can,” says Mangialardi, Thermo CRS’s area manager.Thanks to the fully automated robotic system, Sékaly

and other researchers will move closer to their goal ofunlocking human immune responses to disease and devel-oping vaccines to generate protective responses. They will also be able to work with live viruses in a

“clean” or containment room safely


human immune response to infectious diseases. Their workis a critical step in developing vaccines that could save mil-lions of lives. In the case of HIV/AIDS, it would also savebillions of dollars in health care costs, along with social andeconomic costs that countries coping with epidemics incur.“Diseases like AIDS are killing millions of people,” says

Sékaly. Although drug cocktails can slow or stall the disease,the antiviral medication that patients need is too expensivefor most developing countries. Those who need the drugsdon’t always get them.“We know that we’ll never be able to provide [these pop-

ulations] with therapies because the therapies are extremelycostly. The only way to intervene effectively is to providevaccines that can prevent the disease,” says Sékaly.Sékaly’s laboratories will be linked to cell-processing

facilities at McMaster University in Hamilton and at privatefacilities at MDS Pharma in Montreal. Eventually, Sékalyand the CANVAC team also want to build a vaccine produc-tion plant that would be available for academic collabora-tions. “That would give us the complete picture [in the fieldof vaccinology],” Sekaly says.Canada must rely on its own production facilities and

researchers in the event of any outbreak of epidemic, suchas the cyclical in.uenza pandemic the World HealthOrganization has been warning is overdue.” Having a strongset-up that goes all the way from pre-clinical to vaccine pro-

AQueen’s University expert in studying the transmis-sion and evolution of infectious diseases such asSARS and avian flu was the 2005 winner of the pres-

tigious Steacie Prize, presented annually to a young scientistor engineer for outstanding research in Canada.Troy Day, Canada Research Chair in Mathematical

Biology, studies the evolution and causes of infectious dis-eases through the use of mathematical models. Hisresearch examines how and why diseases appear whenthey do, as well as the reasons some diseases becomedeadly while others remain relatively benign.“Troy Day is an exemplary model for our new genera-

tion of researchers, many of them working at the frontiersof interdisciplinary science,” says Queen’s Vice-Principal(Research) Kerry Rowe. “The Steacie Prize is a well-deserved recognition of his ability to navigate difficultmathematical problems to find solutions to compelling bio-logical questions, and his potential to enrich our knowl-edge in the future.”Most emerging diseases in people, such as SARS and

avian influenza, arise from cross-species transmission ofan infectious agent to humans. “In order for such cross-

species transmission events tospark a substantial outbreak,typically there must first be somelevel of evolutionary adaptationby the infectious agent to the newhost,” explains Day. “But not all cross-species transmissionleads to such adaptation, followed by outbreaks. We areattempting to predict the kinds of cross-species infectionsthat are most likely to give rise to evolutionary adaptation.”Awarded annually to an outstanding science or engi-

neering researcher under the age of 40, the $15,000Steacie Prize honours the memory of Edgar WilliamRichard Steacie, a physical chemist and former presidentof the National Research Council of Canada. It is support-ed from the income of the E.W.R. Steacie Memorial Fund,which was established in 1963 through contributions fromfriends, associates and former colleagues of Dr. Steacie.

Top award goes to expert in evolution ofinfectious diseases

For more information on the Steacie Prize please visit:www.steacieprize.ca Original article by Nancy Dorrance,Queen’s News & Media Services, Queen’s University,Kingston, Ontario, Canada www.queensu.ca

P A R T N E R S

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as the robotic arm will handle the samples. “You need to prepare samples quickly because you want to

reduce the amount of time any infectious substances are opento the environment,” says Mangialardi. “If they can develop avaccine [more ef.ciently] because they have the capabilities todo it with a robotic platform, that’s all the better.”Using cutting-edge automation and equipment is necessary

to keep Canada on the forefront of vaccine research and devel-opment. “It’s also important to retain high-quality researcherslike Dr. Sékaly and his team [of more than 40 researchers] inCanada,” Mangialardi says. “Just being associated withthem...ensures that we will be able to continue to offer newand leading-edge technology solutions in the future.”

• To learn more about Rafick-Pierre Sékaly’s work and aboutCANVAC, the Canadian Network for Vaccines andImmunotherapeutics, go to: CANVAC. http://www.canvac.ca/• For information about Thermo CRS, check out:Innovation Leaders, Thermo CRS. http://irap-pari.nrc-cnrc.gc.ca/success/thermo_e.html

SSoouurrccee:: Reprinted courtesy of the Canada Foundation forInnovation. Read about more exciting research taking place

across Canada at www.InnovationCanada.ca.

BB

The International Centre for Infectious Diseases(ICID) in Winnipeg serves as a catalyst forprogress and collaboration in infectious diseasesresearch, training and applied science.Established last year, the not-for-profit ICID isworking with pre-eminent medical research andhealth training facilities, drawing togetherresources from government laboratories, aca-demic institutions and private sector companiesacross Canada.

Since you launched just over a year ago, what have beensome of your major milestones?We’re still finding our way. We’re in a new world with

respect to infectious diseases—just ten years ago there wasthe occasional outbreak, and twenty years ago we thoughtwe’d conquered infectious diseases, but they have roaredon the scene with a vengeance. It’s now a priority of gov-ernments, the private sector and communities.As such, laboratories are being built all over the

world—in the U.S. alone there are 5 or 6 level 3 and level4 facilities going up. So we’ve become very active in thebiosafety training field. There’s a great competition to fillthese facilities with talented people and scientists, butthere’s also a training demand on how to run these facili-ties safely. We’re trying to meet that demand with ourBiological Risk Management Program (www.biosafety.ca).We feel this will be a growth area for us. We have twocourses that are being offering in May: the ContainmentLaboratory Workshop in Design, Operation andManagement; and the 5th Annual International HighContainment Biosafety Workshop. One of the unique things that we’re able to do with our

courses, is bring public and private sector together—the lat-ter course is being offered by partners that include ourselves,

the PHAC’s Canadian Science Centre for Human andAnimal Health, and the Rollins School of Public Health atEmory University. So we’re bringing public and private insti-tutions together—even across the border.The ICID has three pillars: there’s a research compo-

nent, a training component, an innovation component(business development), and then we’re establishing afoundation to help with funding the other three pillars. Sothe whole idea is of ICID as a flexible, nimble organizationthat can do things that government finds impossible or dif-ficult to do. And working with the private sector is often aproblem for government.We are also quite engaged with the National

Microbiology Laboratory—we are looking at things likevaccine candidates, and their commercial potential. We justcompleted a market and IP assessment of some vaccinecandidates and we think there is significant market poten-tial in some of these discoveries in our federal laboratories.We hope to play a role, as a non-profit, in helping that IPout of the lab and into the marketplace, where it can bothassist public health goals as well as perhaps give Canadaa return on investment for many public health dollars spent.Canada is poised to be the global leader…to play a

very special role in the world—the leadership role in har-nessing the research and applying it to fight infectious dis-eases. Infectious disease is ravaging communities andeconomies around the world. And a pandemic could poten-tially have a dramatic effect on the global economy. Theone thing that we do have to do is come together as aninfectious diseases community to pool both are thinking andresources to make that happen. The ICID is very involved inthat and wants to continue to be a facilitator in that so thatthere is an identifiable Canadian initiative, rather than 20or 30 disconnected or independent initiatives. That’s a rolewe think we can play. But everyone has to join hands.

with Terry Duguid, president and CEO, ICIDQ&A

L E A R N M O R E


Cover Story

By Bernadette Johnson

Growth and competitiveness

of biotech hinges on Canada’s

ability to address skills shortage

and regulatory hurdles

Toronto-based Generex Biotechnology isn’t unlike manyCanadian biotechs, at least in terms of its struggle toeffectively managing the often limited financial and

HR resources. In Canada, it employs roughly 30 people,though it works with many contractors and partners acrossthe border and globally. The company has come a long way since it was launched 10

years ago by Mark Perri, Rose Perri and Anna Gluskin.Generex developed a platform technology for the buccal deliv-ery of drugs that historically have been administered only byinjection. The first application for its proprietary platform drugdelivery technology RapidMist is an insulin formulation,Generex Oral-lyn, which is now commercially approved inEcuador and is in late clinical stages around the world.“Back then, we never thought in a million years that we

would be involved in marketing and distribution, but herewe are now, doing it, and establishing a bit of a differentprecedent in Canada,” says president and CEO Gluskin (seeQ&A, page 25). Of course the company’s growth had to be managed very

carefully, and in keeping within its financial confines. Assuch, it was necessary to take up specific, sometimes cre-ative, HR practices, not least of which was wearing many

HRTHE

Challenge


different hats over the years, she says. But naturally Generexhas hired both temporary and permanent staff, and plans tohire more, she says. And in some cases, it has turned to stu-dents to round out its employee base. “We get a lot of resumes from students, and have hired

some of them. When people are young I believe that’s whenthey are able to get by on very little, but learn a lot,” saysGluskin. “A lot of people we employ learn on the job. Noamount of education is going to help you as much as experi-ence. And though you might get paid very little initially,there are exciting possibilities in a life sciences career.” In so far as middle- and upper-management positions,

Gluskin says many Canadian companies—hers included—draw som expertise from the U.S., mostly because Canadianmanagers with to-market strengths and experience are hardto find. “Our successes all leave. Brain drain is still an issue.” “The situation is more buoyant in the U.S. We do have

some healthy management candidates in Canada. But eitherway, management is expensive. What we’re trying to do, andhave always done, is get by with what we have, so we’ve oftenlooked to contractors and consultants because you don’t haveto deal with issues like immigration. It’s a lot cheaper thatway. We are still watching our pennies,” says Gluskin.Generex’s challenges underpin the HR issues currently

facing the Canadian biotechnology industry overall. Thehuman resources to-do list includes developing and expand-ing the sector’s employee base (currently at about 250,000skilled workers, according to the BHRC) by easing thefinancial—thus recruiting—constraints faced by most ofCanada’s small companies; eliminating regulatory hurdles,such as taxation and immigration; increasing learning andmentoring opportunities for executives; and helping stu-dents acquire the skills in demand by industry, among oth-ers. Pundits agree attracting, developing and retaining ahighly-skilled Canadian workforce will be paramount to thenation’s and the sector’s sustainable growth and internation-al competitiveness. “Our infrastructure needs tweaking,” says Colette Rivet,

executive director of the Biotechnology Human ResourceCouncil, the not-for-profit organization dedicated to sup-porting and growing Canada’s biotechnology talent. “Howdo you explain that biotechnology is growing and that thereare employment opportunities, when it’s so precarious all ofthe time?”

FINANCINGOne of the key elements, according to Rivet, is the financeissue: “Most of our companies are small to medium-sizedand they have no revenue. They’re trying to retain andrecruit staff with no money in the bank.” On top of that, shecontinues, when a company grows—from laboratory toindustry—all of a sudden a whole pile of new competenciescrop up that they don’t have, or didn’t realize they needed. “When financial companies look at you, they want to

make sure you have the ‘scars’ as they call them. How doyou get those scars? A company often can’t survive without

the person with the scars because it won’t get financing. It’sa very vicious circle,” she says. Rivet believes such cash-starved organizations need job-

ready people in order to survive, and suggests, in addition tofunding and training assistance initiatives, HR packages becreated—based on industry research—so that small compa-nies wouldn’t have to worry about processes and procedures. Rivet and the BHRC currently have a host of priorities on

their collective agenda. She would like to develop a process orstandard for assessing expertise from experience, and outlinesome best recruitment and retention practices in the sector,among other things. “I want to build momentum in the indus-try and I want to see results. But it’s a systematic process.”

MANAGEMENT Typically, many of Canada’s small organizations have alsobeen criticized for not having the required business acumento succeed. Witness the March 01, 2006 National Post articleentitled “Scientists don’t always make the best CEOs”,which reported the lack of business basics (marketing, regu-latory affairs, and financing/investment knowledge) in mostscientifically-driven Canadian biotechs. “Chief scientists who started their own companies will

need soft skills. And they don’t have time to go back toschool,” contends Rivet, who recently asked the govern-ment to put up the funding for a pilot project to provide HRcoaching—one-on-one time that would allow actual prob-lems to be assessed and learned from.

Generex Biotechnology’s Anna Gluskin

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Many reports over the last several years have cited Canada’sdearth of experienced senior-level executives, says PeterBrenders, president of BIOTECanada. “There’s no questionwe have a lot of great talent in Canada—but we’re always look-ing for more. Companies are growing their senior executives.But typically they’re importing that skill base. That’s withinany industry. I don’t necessarily think it is unique to us.”Brenders says his association is spearheading various initia-

tives to help executives be more successful, including launch-ing an executive workshop series, and partnering with BIO tobring up its CEO boot camp, a more hands-on workshop forexecutives that tackles things like presenting to investors andworking with partners. BIOTECanada is also developing adeal valuation executive workshop series which will be imple-mented in May. Christian Lortie, project manager, life

sciences, at Montreal International /Montreal InVivo, which representsMontreal’s life sciences cluster, has alsobeen involved with several initiatives andpartnerships to encourage the growth anddevelopment of its executives. He high-lights the MBA program specifically forbiotechnology management at theUniversité de Québec à Montreal, andmentoring programs he has helped devel-op at the university level.Lortie adds that many of the small

Quebecois and Canadian companiesthat have survived because ofgood science and manage-ment are now moving up.“This will help. I think we’vebrought up a good bunch ofmanagers. And these successstories will encourage others.” While it is typical for

Canadian organizations to look south of the border for topmanagement, he contends it is not necessarily a bad thing.“We’re still very happy when we get someone from outside.It’s a good deal for them: people who come realize it’s a greatindustry up here and the financial incentives are great (per-sonal tax breaks for 5 years). Ultimately it creates leadershipand mentoring opportunities for the people under them.”Adds Brenders: “There have been many successes with

Canadian companies bringing people up here, and there aresome creative ways that companies are managing talent.Because a lot of work can be done electronically, you’ll findsome executives will be hired and stay in their home state,for instance, and might only be on site a couple days perweek. There are other ways to work your business model.”

REGULATORYThe fact is, there are also a lot of Canadians working in thestates that would love to come home, though unfortunately it’sgenerally not the promise of money that lures them, says Rivet.Those who do return, she adds, generally do so for either per-

sonal reasons like family, or for more entrepreneurial motives. Money permitting, recruiting south of the border is neces-

sary. “We don’t have enough Canadians to do our work. By2010—according to the government—a large part of our work-force will be from immigration. And often, they have the scarsand the experience we need,” she says.That being the case, something has to be done about

Canada’s immigration policies and procedures, urges KarimahEs Sabar, executive director of BC Biotech. “We’ve heard sto-ries about very senior people turned away at the border becausetheir VISA or paperwork wasn’t processed, or because the bor-der rep didn’t understand the person’s qualifications or special-ty. Work Visa’s are typically taking from six to nine months toget—who can be bothered by that? These individuals are in

demand. They have opportunitieseverywhere else in the world. There’s ahuge reputation issue now amongst pro-fessionals that Canada is not necessarilythe place to come. It’s a big issue.”She says she has also heard of

instances where people come to Canada,having seen promotions for jobs in theirhome countries, only to find that thereisn’t the expected number of opportuni-ties available. Or if there are, their for-eign credentials aren’t recognized.Es Sabar suggests looking to what

other regions and countries are doing insuch instances: how are they handling

accreditation? What are theirimmigration procedures?“Our immigration processneeds to be streamlined, andbecome much more efficient.If we want to attract top tal-ent, we’ve got to work at it,and develop a process to facil-

itate their entry into the country—one that’s fast, and prob-lem-free,” she says, adding that though it isn’t well-known orunderstood, programs like B.C.’s Provincial NomineeProgram—whereby the province nominates the person andexpedites the paperwork—may hold some promise.Brenders says challenges like immigration and taxation

are out of the ability of the company to manage and more arole for his association as an advocacy group. The associationrecently set up a joint human resources committee with theMedical Device Association of Canada with a mandate tohelp resolve some of the HR challenges facing the industry.Montreal International, for its part, has a specific

International Mobility department to address the immigra-tion challenges of its member companies. It employs immi-gration experts—some of whom used to work at Immigra -tion Canada—who know exactly how the process works, andcan provide guidance, says Lortie. “Once you’ve chosen acandidate, you give the file to us and we do all the paper-work. Often within a week we have all the papers ready andthe folder set up. Because there is a level of trust that the

“Chief scientistswho started their own

companies will need soft skills. And they

don’t have time to go back to school.”


information is complete and accurate, it is accepted rightaway almost 99% of the time,” he says. Montreal International also helps people relocate and can

even help spouses find jobs. On arrival, it also provides new-comers with custom-made booklets on how to live inMontreal. Lortie believes because of these efforts, luringpeople from outside is in fact a strength of the Montreal, andthe Quebec biotech region.

STUDENTSChallenges also exist in the biotech space when it comes tofinding placements for new university graduates and ensur-ing that they are job-ready (see Student sidebar below).“We have a ton of young graduates coming out in the

biotech field, but we don’t have the entry level jobs,” says EsSabar. Unfortunately, especially in BC, companies areyounger and smaller, and don’t have the infrastructure or thenumbers, she says, adding that in contrast, Montreal and per-haps even Toronto, might be in slightly better positionsbecause of the presence of big pharma and more head offices.“Many young graduates will have to go out-of-province or

out-of-country looking for jobs,” says Es Sabar. “Now that’snot altogether a bad thing—to get experience and thencome back—but I’d like to see a situation that improvesover time. We’ve got to get to a point where we have biggercompanies and anchor companies that can recruit these stu-dents as they come out of our great universities.” Because landing that first job can be so challenging, the

BHRC launched its Career Focus Program—which subsi-dizes one third of a graduate’s wage up to a maximumamount, leaving the company with the remaining two thirds.The program is designed to give unemployed or underem-ployed professionals under the age of 30 with work experi-ence in biotech. She says BHRC is also looking at compe-tency development at the university level and outlining whatis still needed within the learning systems—not only theknowledge and competency, but the skills and the attitude.According to Lortie, there is a huge gap between what’s

taught at the university level—in a grad or undergrad pro-gram—and the skills required in the actual market. “Manystudents a few years ago didn’t know about the biotech busi-ness model. That’s very important, so we’re trying to createcareer and sector awareness by enlisting industry people togive talks, etc.—a kind of a student mentorship program.” Montreal International also created a guide to help post-

doc students get out of university and into the industry thatincludes tips like how to find a position, negotiate salary,manage expectations. Last year, the organization, in partner-ship with BioQuebec, AITS, Pharmahorizons andL’Evénement Carrières, held its first life science career fairas part of Biotechnology Week. The two-day event hosted1600 candidates and 16 industry booths—Lortie plans todouble the latter number at this year’s event. Interestingly,most of the candidates were professionals. Based on a surveyof a sample of the participants, he says, 60% defined them-selves as professional, while the remainder were students, orhad just finished their degree.

Where do MBAs belong?By Amie Sergas

As a career-searching MBA, finding a fit in thesmall circles of Canadian biotech has been adaunting task. To paint a rosy picture of industryexcellence and potential for growth does not reflectthe actual job market for an MBA in this field. Unemployment jitters are expected as my classmates

and I approach spring convocation. But unlike them, Iwill not be recruited by an established firm or bank. Acareer posting or ad that fits my profile will be found bychance. If I do encounter an opportunity, it will likely ariseout of seren dipity—speaking to the right individual at theright time, and creating a position that benefits both of us.Knowing this, it has been crucial to remain current with

the biotech community. The opportunities to attend industryconferences have been key to my career education and inreceiving information first-hand. More importantly, that’s whereI have been able to meet and speak with industry professionals.Many have been optimistic that a science/business hybrid suchas me would be in demand. But realistically, it has becomeapparent that our biotech industry is not hiring young profes-sionals poised for middle management positions.The void of such positions in Canadian biotech may be

attributed to the large number of small, undercapitalizedfirms. Service and support industries defer from specializingin biotech due to sporadic financing activities, and so profes-sional opportunities also diminish. Public sector positions aredependent upon whether adequate funding can be raisedand maintained, and so are often temporary. But what Ibelieve is the greatest career challenge for a biotech-MBA is overcoming the hurdle of such firms’ hiring behaviours.Our career interests, such as business development, productmanagement, or VC financing for example, are rarelyavailable as positions in Canada. When they are we aredeemed unqualified. It is the industry veterans who are “inbetween projects”, or the PhDs who wish to leave acade-mia who are selected out of the applicant pool. Fresh talent, enthusiasm, diversity and business acumen loseout to industry history and research expertise.I do not regret that I pursued my MBA. I am opti-

mistic that the right opportunity will come, but am un-sure if it will be in biotech in Canada. It is unfortunatethat I feel I am unable to apply and further developthese skills in this business environment, and thatthis facet of professional development is not sup-

ported by an industry that I am pas-

AAbboouutt tthhee aauutthhoorr:: Amie Sergas is completing the MBA for Science & Technology at Queen’s School of Business.Previously, Sergas worked in research for Kinetek Pharma-ceuticals and in marketing and business development for

StemCell Technologies. She holds a BSc. in biotechnology from BrockUniversity. Sergas recently attended BioPartnering as a recipient of this year’s BIOTECanada-TVG Student Scholarship competition.

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Q: How did you get started in theindustry?

A: From the ground up. My partners,Mark and Rose Perri, and myself start-ed the company—it was the only way tomaintain control. We decided we want-ed a different kind of company.Typically a smaller biotech acquires atechnology, develops it and immediate-ly licenses it to big pharma. We wantedto do it differently and preserve theintegrity of our development—throughthick and thin. And believe me, it has-n’t been easy. Ours is a David andGoliath story: our competitor is Pfizer—can you get any bigger than that? But in2005 we celebrated our first 10 years.There were three of us when we

started—sadly there are only two of usleft. Mark Perrie, then chairman andchief financial officer, had a debilitat-ing disease (multiple myeloma) anddied in 2002. We’re actually workingon a book that will depict his life. His

Question and Answer with Anna Gluskin, president and CEO of Generex Biotechnology Corporation

ust over 10 years ago, Anna Gluskin helped found and launchToronto-based Generex Biotechnology Corporation (NasdaqSC:GNBT). The company is focused on developing a platform tech-

nology for the buccal delivery—delivery to the oral cavity for absorp-tion through the inner mouth mucosa—of drugs that historically havebeen administered only by injection.

The first application for its proprietary platform drug delivery tech-nology RapidMist is an insulin formulation, Generex Oral-lyn. It wascommercially approved in Ecuador in 2005 and is in late clinicalstages around the world.

In August 2003, Generex acquired Antigen Express, a platformand product-based company developing proprietary vaccine formu-lations and focused on stimulating critical members of the immuneresponse, known as T helper cells. It continues to seek and identifyopportunities and acquisitions in the areas of diabetes, drug delivery,cancer, H5 avian influenza, HIV, generic and branded prescriptiondrugs, 505(b)2 product candidates, and late stage developmentopportunities. Below, Gluskin discusses the company’s evolution sinceinception.

J

sister Rose and I are continuing in hisname, and we will get it done.We started as a small biotech, we

incorporated the company, and acquireda technology, and have since devotedour lives to developing better lifestyleproducts for patients with debilitatingdiseases and diseases that have no cure.

Q: Any diseases in particular?

A: Diabetes is one of them. The dis-covery of insulin is 85 years old, and westill don’t have an understanding of howdisease happens. Today, according to thelatest data, diabetes affects 600 millionpeople around the world. It is a true pan-demic. In fact it shares the number oneand two causes of death: 80% of all heartattacks are due to diabetes. People don’trealize that. Cardiovascular disease andmetabolic disease syndrome are thenumber one killers, and diabetes is ahuge part of that.And now we’re seeing children—

kids 8 to 18 years old are getting Type2 diabetes. And it’s because of theirlifestyle. Unfortunately the disease inthese children is very serious, andoften much more severe than in anolder individual.

Q: And your flagship productGenerex Oral-lyn hopes to tackle thispandemic?

A: Yes. We have files everywhere—regulatory files in Europe and the mid-dle east, and in Canada and the U.S. Atthis point in time, we are looking for-ward to an accelerated process inCanada, but we will immediately bepursuing the ones in Europe and in theU.S. However, we’re a very small com-pany and the resources are limited. I am happy to report though that we

are on the market in South America(Ecuador) already. This is importantbecause native South Americans areseverely affected by diabetes—one of

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the most affected populations in theworld. They all have the gene—it’s aquestion of who will be lucky enoughnot to develop the disease. Some havewhat’s called a pre-diabetic condition —we can treat them too. We are availablein Ecuador right now, but we are rollingout across South America. It’s just a mat-ter of time and money.

Q: How has financing shapedyour evolution?

A: We first invested our ownresources into the company, whichwasn’t easy. And then we did a privateround—not using VCs—we’ve alwaystried to stay independent. We got first-round funding, and then we went pub-lic. Since placement on Nasdaq [in1998] we’ve raised $150 million. There aren’t many public Canadian

companies that continue their exis-tence independently—that’s why sooften I find people look us over andask, ‘You’re still around?’ Canada defi-nitely has a hostile financing environ-ment. Generally Canada does not lead,we follow. And unfortunately most ofthe good developments that we haveend up going elsewhere or dying. When the venture capital industry

started years ago, during the war, theyintroduced this idea of a large pool ofmoney coming in and licensing a lot ofproducts, and it was a great thing.Unfortunately at this point in time, bigVCs don’t really exist—they look andact like banks. And that’s unfortunate.We need a revival of the entrepreneur-ial, financial initiatives—they are real-ly lacking in the business.We have to realize that Canada has

brought some fantastic developmentsto the market, and brought fantasticdevelopments into existence even, butnever took it through. A lot of Canadiancompanies are in the states trying tomake inroads. We trade on the Nasdaq,but we’re still a Canadian company. Butthe problem is that as such, we arealways a second-class citizen. Andinstead of being proud Canadians andgetting some support here, we justdon’t seem to get any attention.

Q: WWhhaatt hhaavvee bbeeeenn ssoommee ootthheerrcchhaalllleennggeess??

A: Well, let’s face it, big pharma isgenerally not very nice. Many times,I’ve heard statements like, ‘we’re justwaiting until you croak and then we’llpick up the pieces.’ Year after year, weshow up and prove them wrong. Wesurvive. And now we’ve come to apoint where they are talking to us andasking us about what we’re doing. Butnow that the whole risk is out of thesituation, it’s not necessary for us togive up 90% of our upside to them.And because our device is so simpleand user-friendly, they are saying to us

that we are too good to be true. Wecan’t win. It’s either too complicatedand expensive, or it’s too simple. It’s acatch 22 position that we’ve lived inour whole lives. Of course, the moment we become

a success story—and we will, I prom-ise you, and sooner than people think—they will say we got lucky. And I saylet them.

Q: WWhhaatt hhaass iitt bbeeeenn lliikkee ttoo bbee aawwoommaann CCEEOO iinn tthhiiss iinndduussttrryy??

A: There aren’t many women in mid-dle or upper management in thebiotechnology space in Canada…atleast not yet. But we’re breakingthrough. It’s still a big boys club.

Q: TToo wwhhaatt ddoo yyoouu aattttrriibbuutteeGGeenneerreexx’’ss ssuucccceessss??

A: Our goal is get that product tomarket. We negotiate everything—allour contracts and contract research,

and we do a lot of things ourselves. Iwear a lot of hats. We only have 28people, and about 50 consultantsaround the world, which we use spo-radically—they’re not on the payroll.Every vendor and every supplier weuse, we negotiate with. And they seemto be very understanding—someaccept shares, some allow us longer topay back (60 to 120 days sometimes).Our partners have been terrific. Iguess it’s about survival. And becausewe have a very important cause, peo-ple feel compelled to participate. The other thing is that we are

always open for business. Anytime,anywhere, an investor can call me. Wedon’t let any call or inquiry go by with-

out attention. That is a policy. Theygave us their money, so I will foreverfell indebted to them. I’m not surehow we will evolve that policy as weget bigger—and I want us to get big-ger. We are looking to launch anotherWeb site strictly for patient enquiriesas soon as we launch in Canada.Lastly, our focus from the beginning

was on the business side of the equa-tion. We knew that money was impor-tant. When people say ‘money is noteverything’ I tell them it is the onlything. We started from that standpoint,knowing how much it was going to take.We did transfer the technology from ascientist who was basically doing it outof his kitchen. Unfortunately a lot ofgood products die because there is noone there to pick it up. I have a Mastersdegree in microbiology and genetics[from Moscow State University] so Icould at least assess what we was look-ing at. But Mark Perri’s knowledge ofpublic markets and financing was cru-cial—I learned a lot from him. Thatcombination of scientific expertise andfinancial acumen was very helpful.

We knew that money was important. When people say

‘money is not everything’ I tell them it is the only

thing. We started from that standpoint, knowing

how much it was going to take.


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n August 2004, the Canadian Biotechnology AdvisoryCommittee established an Expert Working Party to assist itin conducting a study of intellectual property (IP) protectioninvolving human genetic materials (HGM) and its effects onthe health sector. CBAC undertook the study at the jointrequest of the Government of Canada’s ministries of healthand industry. The report describes particular aspects ofCanada’s IP regime as they relate to HGM and discusses theissues and impacts of these aspects in three interconnectedspheres of activity involved in making new HGM-basedproducts and services available for use in health care;research; development and commercialization; and healthservices.

IInntteelllleeccttuuaall PPrrooppeerrttyy PPrrootteeccttiioonn ooff HHuummaann GGeenneettiicc MMaatteerriiaallIntellectual property law aims to promote innovation for thegood of society and to make valuable knowledge from newinventions available to the public. IP can be protected in avariety of ways depending upon the nature of the invention,including through patents, trademarks, copyright or tradesecrets. The patent is the most common form of IP protec-tion for HGM. There are substantial similarities among the

patent regimes of Canada and its major trading partners.These regimes have similar requirements forpatentability (novelty, non-obviousness and utility)

although there are nuances of definition and interpretationthat differ amongst them. Databases of genetic informationobtained from HGM may be protected by copyright or spe-cific database protection rights.HGM as they exist in nature cannot be patented, howev-

er, chemicals isolated from nature through human interven-tion are patentable and this precedent has been applied tothe chemical sequences within HGM. Patents have thusbeen granted on processes for identifying and isolatingsequences of nucleotides in DNA that were not obviousbefore and on the isolated sequences of polynucleotidesthemselves. To obtain a patent, the inventor must be able toidentify or modify the novel genetic sequence and specifythe product of the sequence and how it functions in nature.A fundamental issue in gene patenting is whether or not

knowledge of the nucleotide sequence in a segment of DNAis qualitatively different from structural knowledge about anyother molecule and, if so, whether that difference warrantsdifferential treatment of HGM with respect to patentability of

Making Canada’s Intellectual

Property Regime Work for the

Health of Canadians

From the Expert Working Party on Human Genetic Materials, IntellectualProperty and the Health Sector to the Canadian Biotechnology AdvisoryCommittee, October 2005

HumanGeneticMaterials

IP & PATENTING

I


DNA sequences. Other issues have to do with the details ofthe criteria of patentability. There are questions aboutwhether the claims contained in patents awarded on HGMhave in some cases been unduly broad with respect to utility(“real world usefulness”) and about whether the criterion ofnon-obviousness (“inventiveness”) is being applied too loose-ly now that high-throughput DNA sequencing has been sohighly automated.The recent surge in patenting

of HGM has been accompaniedby growing public debate andcontroversy about the effects ofsuch patents and patent-relatedpractices on the health sector.Some question the propriety ofsuch patents on ethical grounds, while others are concernedabout practices that act as barriers to industrial/economicdevelopment, to research, or to ready and affordable access toproducts and services.The diffusion of patented IP in society is effected by

patent holders who make, sell or distribute the patented prod-uct or process or by licensing others to do so. To ensure that

their IP is widely used, some patent holders license it non-exclusively and readily. Others choose not to license at all or tolicense in a highly restrictive manner thereby limiting researchand impeding access to beneficial health innovations.Moreover, the profusion of patents can impede diffusion ofinnovations by creating dense thickets of intersecting property rights that make licensingextremely complex.

There is also a considerablevariability in the nature andextent to which patent holdersenforce their patents or defendthem against challenges. Bothprocesses can be time consumingand expensive and therefore morelikely to be pursued by patent

holders who have substantial resources available to them.Most, if not all, patent regimes provide for government to usea patented invention or to issue a license to others where itbelieves that greater access to a patented product or process isrequired to serve the national interest. The conditions forinvoking such provisions vary from country to country. InCanada, the provisions exist but have not been used.

The recent surge in patenting of HGM

has been accompanied by growing

public debate and controversy


EEFFFFEECCTTSS OONN RREESSEEAARRCCHHTwo factors have contributed to the rapid increase in patent-ing of HGM in Canada in recent years: significantly increasedinvestment in research involving HGM through the federalgranting councils, provincial agencies, the voluntary sector,and special entities such as the Canadian Foundation forInnovation and Genome Canada and the private sector; andan increased emphasis on commercialization of IP. Growinglinks between the public and private sectors in research anddevelopment, the increasing activity of public sector institu-tions in facilitating and sometimes participating in commer-cialization of IP, and the various roles now played byresearchers has added complexity to the debate about policiesrelated to IP protection and to the efficacy of current provi-sions in IP regimes related to research.Patents are intended to have a

positive impact on research byvirtue of the requirement thatinventors disclose fully the natureof their invention and thus add tothe store of public knowledgethat researchers use to further their work. In some instances,patents have been reported to deter or impede research.Factors that create or contribute to such deterrents or impedi-ments include: an unduly broad scope of protection, absenceof an experimental use exemption against claims of patentinfringements; refusal by patent holders to license patents;licensing fees that are too expensive; or transaction costs ofnegotiating licences within a “thicket” of overlapping patentsthat are too high.BBrrooaadd PPaatteennttssThe extent to which broad patents deter or impede researchmay depend on the type of research involved and the natureof the patented invention. With respect to HGM, broadpatents are of two main types, those that cover a geneticsequence and all homologous sequences, and those thatcover a generally applicable research technique or resource(“foundational” or “platform” technologies). Patents of theformer type may be too broad if they can be used to claimrights over any use of, or product involving, the patentedsequence not specifically identified in the patent application.Broad patents typically appear as new technologies

emerge; the scope of granted patents tends to narrow asknowledge grows and expertise in patent offices increases.Where the broad patent is on a DNA sequence, options suchas “inventing around” the patent may not be possible, sothat the impact of broad patents based on HGM may begreater than in other fields of technology.RReesseeaarrcchh TToooollssResearch tools used by scientists in the course of theirgenetic research include: laboratory techniques; consum-ables such as enzymes or reagents used in the laboratory;and DNA sequences used to identify targets for develop-ment of vaccines or therapeutic drugs.A particular product or process may serve as a research tool

when used in a research laboratory and as an end productwhen used in a diagnostic service laboratory. Access to patent-

ed research tools is determined predominantly by the avail-ability and terms of licenses granted by the patent holders.Restrictive or costly licensing can increase the difficulty ofobtaining access to research tools. Moreover, the time requiredto negotiate licences may be problematic if it erodes the timeavailable for research, delays work and reduces productivity. Insome cases, licensing may be provided with the purchase ofproducts (e.g., the purchase price of a reagent includes limit-ed, nontransferable rights to use the product for research pur-poses). In other cases, patent holders may distinguish betweenacademic and commercial researchers in applying a licensingstrategy so as to promote access for academic researchers.There has been insufficient study to determine how

widespread or quantitatively significant the effects of theforegoing disincentives are. Some suggest that, where

patents are very broad andresearch tools are not readilylicensable, most firms and uni-versities have been able todevelop “working solutions” toallow their research to proceed,

such as “inventing around” patents, using patented IP with-out a licence (assuming experimental use will be exemptedfrom claims of infringement), developing and using publictools, and/or challenging patents in court. There is evidencethat these ameliorating approaches may be less available fortools used in clinical genetic research. Providers of patentedresearch tools do not accept their use as falling under aresearch exemption. As a result, researchers report thatresearch has been hindered, certain areas of research havebeen avoided and sharing of data between researchers hasbeen hampered.

EEFFFFEECCTTSS OONN DDEEVVEELLOOPPMMEENNTT AANNDD CCOOMMMMEERR--CCIIAALLIIZZAATTIIOONNAlthough there may be those that question the strength ofthe link between patenting and the stimulation of innova-tion, it is clear that patenting is critical to attracting invest-ment in development and commercialization in the phar-maceutical and biotechnology sector. In other industries,other strategies, such as first mover advantage, secrecy andthe existence of complementary assets, are used to protectinventions without necessarily relying on patents. Thedegree of importance attached to patents is directly relatedto the scale of investment required to bring an invention to market and the time horizon for recouping development, marketing and regulatory costs and achiev-ing an economic return.Investment decisions may also be influenced by both

reality and perceptions about the nature and operation of theIP regime. Recent court decisions in Canada have been por-trayed in the U.S. as signifying that the strength of Canada’ssystem is questionable. Moreover, the operation of Canada’sIP regime has been criticized as not being as efficient andeffective as that in some other countries.IImmppaacctt OOff PPaatteennttiinngg AAnndd LLiicceennssiinngg OOff HHGGMMMany, if not all, of the deterrent and anticompetitive effects

In some instances, patents have been

reported to deter or impede research.

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of excessively broad patents and restrictive licensing prac-tices that act as disincentives for noncommercial researchalso apply to research, development and commercializationperformed in industry. Moreover, increasing linkagesbetween academia and industry have blurred the boundariesbetween commercial and non-commercial research. As genepatenting has expanded from a focus on genes as engines forproduction of therapeutic proteins to include genes as plat-forms for generating diagnostic products, the interaction ofthese actors has become more diverse and in some casestheir interests have diverged or even come into conflict.

EEFFFFEECCTTSS OONN HHEEAALLTTHH SSEERRVVIICCEESSTo the extent that patents encourage investment in the devel-opment of new products and services of proven benefit andaccessibility, the impact is clearly positive. However, the impactcan be negative if patent holders exercise their rights in waysthat place an undue cost burden on the health system, impedeaccessibility to products and services, make integrated and highquality patient care more difficult, interfere with appropriateaccess to information, or fail to protect against inappropriate useof information. As a result of a few high profile cases involvingrestrictive licensing practices, most of the recent debate aboutthe impact of patenting and licensing of HGM on health serv-ices has been focused on diagnostic or prognostic genetic testsrather than therapeutic products.

CCoossttssConcerns about the exercise of patent rights by patent hold-ers have in part, been based on the assumption that they willuse restrictive licensing practices (e.g., exclusive licenses)and that licensees will charge monopoly prices. The overallcost impact of genetic tests depends on, among other things,the characteristics of the test (e.g. its predictive power), thescope of its application (high-risk populations or generalpopulations), and changes in health care utilization inducedby the test result (e.g., surveillance, prevention, counsellingand treatment). These considerations apply whether thetests are performed in public or private laboratories, are req-uisitioned by a health care professional or by patients them-selves stimulated by direct to consumer advertising.

AAcccceessssAccess to patented genetic inventions can be limited ifpatent holders choosing to exploit their patent rights byemploying restrictive licensing practices, exacting high roy-alty fees and charging high prices for in-house performanceof services such as genetic testing. However, restrictive exercise of patent rights is only one

of the factors that may affect access to services such asgenetic testing. Other factors include funding priorities ofhealth service providers, the technical capacity and accredi-tation status of laboratories, and the clinical and researchinterests of the laboratory. A significant proportion of clinicallaboratory directors indicate they have abandoned efforts tointroduce new genetic tests or have discontinued offeringthem because of patenting and licensing concerns.

QQuuaalliittyy AAnndd CCoonnttiinnuuiittyy OOff CCaarreeA combination of broad patent scope and unduly restrictivelicensing practices may block the improvement of existinggenetic tests and the development, validation and imple-mentation of new, possibly less expensive and/or technicallysuperior, diagnostic tests. This clearly has consequences forthe health system’s ability to offer a range of alternatives topatients, for the opportunity to expand Canadian expertiseand for the integration of clinical practice and research;should key expertise have been lost to non-Canadian labo-ratories and a particular genetic diagnostic capability lostthrough commercial instability, it will be an enormous taskto rebuild these resources.A number of privacy and access to information consider-

ations are also raised by restrictive licensing practices, par-ticularly where the facility performing the test operates out-side of Canada and is not subject to Canadian privacy lawsand regulations.

CCoonncclluussiioonnss aanndd RReeccoommmmeennddaattiioonnssThe request that CBAC undertake the present study stated:The objective of an effective and balanced intellectual prop-erty regime is to act as an important stimulus for innovation,by protecting and nourishing creativity and investment, tothe mutual advantage of producers and users of such inno-vation, and in a manner conducive to economic and socialbenefits. We concur with the view that, with respect toHGM-based innovations, Canada’s IP regime, like those inother jurisdictions, can lead to circumstances in which ful-fillment of the foregoing objective—particularly, the “mutu-al advantage to both producers and users”—may be frustrat-ed by the way in which monopoly rights are exercised or bythe opportunity costs associated with uncertainty and ineffi-ciency in the way the IP regime operates.Although there is a paucity of empirical data on the quan-

titative, system-wide effects on the health sector of currentdeficiencies in the IP regime in respect of HGM, there is, inour opinion, enough qualitative evidence to warrant con-certed action to prevent problems from escalating.

CCoonncclluuddiinngg OObbsseerrvvaattiioonnCanada’s IP regime, like those of its major trading partners,is a legislated mechanism for reconciling the objectives offostering innovation and ensuring access to its benefits. Ourfindings and recommendations are focused on identifying,and proposing modifications to Canada’s IP regime toaddress issues brought to light by recent cases involvingpatented HGM in which the particular ways in which patentrights have been exercised have frustrated the achievementof such reconciliation.The issues addressed in this report are part of the much

larger challenge of how to create the capacity to adopt ben-eficial innovations in an already heavily burdened healthcare system. Meeting this challenge fully will require morethan refinement of the IP regime. It will also require newinstitutional mechanisms and perhaps new organizations.We believe collaborative efforts involving all levels of


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government, health care and research institutions, andindustry must be intensified to ensure that a comprehensivearray of policies, procedures and practices are pursued torealize fully the health and economic benefits of innovationsbased on HGM.

Source: Canadian Biotechnology Advisory Committee,Government of Canada, October 2005, http://www.cbac-cccb.ca,

Catalog Number Iu199-5/2005E, ISBN 0-662-41898-0 Thisreport was produced by the members of an Expert Working Partyestablished by the Canadian Biotechnology Advisory Committee.

The views expressed in this report are those of the Expert WorkingParty and do not necessarily reflect those of the Canadian

Biotechnology Advisory Committee, the biotechnology MinisterialCoordinating Committee or the Government of Canada.

In our recommendations, we call for:• the enhancement, clarification, and more rigorous applicationof patentability criteria; the development of interpretive guide-lines; enhanced disclosure requirements on the part of appli-cants and application of sanctions for failure to meet them;

• significantly enhanced opportunities to challenge patents:before they are granted by a more open and responsivemechanism than exists now; and, after they are granted, bythe introduction of an opposition procedure;

• increasing the scientific expertise of the Federal Court andconsideration of establishing an Intellectual Property Divisionwithin the court in light of the speed of developments, notonly with respect to HGM, but within technology as a whole;

• amendment of the Patent Act to establish an experimental useexemption from claims of infringement;

• enhanced voluntary mechanisms to limit unduly restrictive prac-

tices and remove barriers to diffusion of HGM-based innova-tions, for example through development, of licensing guidelinesand encouragement of industry initiatives to create patent poolsand other mechanisms to remove barriers to diffusion of HGM-based innovations. With respect to HGM-based inventionsdeveloped using public funds obtained through federal grants,the granting bodies should develop licensing guidelines adher-ence to which would be a condition of funding;

• strengthened legislative provisions (e.g. competition andcopyright) to limit patent rights and copyright in cases ofabuse or where the national interest is at stake, either bymaking current provisions more effective or by introducingnew provisions to deal with these matters; and

• the Canadian Intellectual Property Office to review its opera-tions with a view to making them consistent with internationalbest practices and to improve its client services.

BB


BC Biotech Leaders Return from Successful Missionto ItalyBC Biotech and representatives from BC’s life sciencesindustry, academia, investment community, and govern-ment had the pleasure of joining Minister of EconomicDevelopment Colin Hansen in opening British Columbia-Canada Place and hosting BC Biotech Day in Turin, Italyat the end of January. The goal of the mission was to showcase BC’s R&D

infrastructure capacity, life science company opportunities,and opportunities for venture capital, private equity and cor-porate pharma investment to European biotechnology com-panies and investors.“European biotechnology clusters are looking for collab-

orations and partnerships with Canada just as we are lookingfor the same on the other side of the Atlantic”, said BCBiotech executive director Karimah Es Sabar. “Withoutpresenting our capabilities and the activities of our biotech

Biotechnology in ItalyStronger ties between the

academic and business worlds

are transforming research into

a burgeoning sector

Despite its relatively small number of biotech companies (approximately 50), many multinational

biotech and pharmaceutical companies such as AstraZeneca, Eli Lilly and Serono have chosen

Italy for their operations, and now employ10,000 people there.

Why have so many companies chosen Italy? According to InvestInItaly—the Italian organization for

investment promotion—Italy’s advantages include its infrastructure, central location within Europe, and

R&D business costs lower than Germany, France, the United Kingdom and the Netherlands. When asked

his reasons for building a new research centre in Italy, Roberto Gradnik, regional vice-president of

Serono identified cost as a major factor: “Italy has very good productivity which is comparable to any-

where else in Europe. The cost of a researcher is 50% lower than in Switzerland.”

REGIONAL PROFILE


community in British Columbia to these interested clusters,European pharma, and investors, we will not realize the fullpotential of collaborative opportunities.” Minister of Economic Development Colin Hansen

spoke to the British Columbia government’s interest in cre-ating global partnerships.“In British Columbia, we have focused our efforts on

building strong, globally-competitive companies that bringvalue to investors”, Minister Hansen told the audience fromItaly, Switzerland, Germany and the UK. “With the revital-ization of world economies underway, it is an exciting time toconsider British Columbia as a place to conduct business.”After the program and networking lunch, members of

the delegation had one-on-one meetings with several Italianbiotech companies. The following day, the BC delegationvisited the San Raffaele Biomedical Science Park in Milan.

Science Parks Bring Together Academia, Researchand BusinessDuring BC Biotech’s recent mission to Turin, members of thedelegation visited the San Raffaele Biomedical Science Park inMilan. Focused exclusively on biomedical and biotechnologyresearch, the Park is one of the largest science parks in Europe.The Park is home to the San Raffaele Scientific Institute

with over 400 scientists working in gene therapy, stem cells,and therapeutic areas such as oncology, neuroscience,

inflammation, and infectious disease. Research that resultsin patent applications, opportunities for licensing, or the for-mation of a new company is managed by the Park’s dedicat-ed internal Biotechnology Transfer Centre.Several biotech companies including BioXell S.p.A.,

which recently signed a US$150M deal with Merck for itsexpertise in TREM receptors, are located in the park.Clinical stage companies have the advantage of conductingclinical research at the San Raffaele Hospital, also housed inthe park. The hospital runs over 140 clinical trials per year.Plans are now underway for expansion of the Park with

the construction of 74,000 square meters of new laboratoryspace to boost the research capacity both for new companiesand the Research Institute. The Park is even connected tothe Milan Subway system with its own internal station.BC Biotech Executive Director Karimah Es Sabar feels

that visiting parks such as the San Raffaele Park provides agreat opportunity to learn from each other’s strengths.“Just like the University of British Columbia, the San

Raffaele Biomedical Science Park has all of the componentsfor biomedical research: a university, a biomedical researchinstitute, several biotech companies, a hospital for conduct-ing clinical trials, plus a technology transfer centre all withinone campus,” remarked Ms. Es Sabar.

Source: BC Biotech, www.bcbiotech.ca

Members of the British Columbia delegation visited the SanRaffaele Biomedical Science Park in Milan

BC Biotech would like to thank Dr. Sam Abraham, Mr. DonAvison, Mr. Yad Garcha, Mr. Jim Heppell, Mr. Harry Jaako,Mr. Gordon McCauley, Mr. David Matthews, Mr. AndrewRae, Dr. Bob Sindelar, and Mr. Todd Tessier for devoting theirtime and participating in the mission. BC Biotech alsoexpresses its appreciation to Sandra Marchesi, TradeCommissioner at the Canadian Consulate in Milan for heroutstanding contribution on the ground in Torino.

Thanks...

...continued on page 36


How would you describe biotech in Italy?The Italian biotechnology sector is grow-ing. Since 1998, the number of compa-nies increased by 60%, especially thanksto the establishment of New BiotechCompanies (NBC’s). In the last fouryears; the turnover number reached 300million Euros. This represents an increaseof 10% compared to last year. Theimpact of R&D investments on sales hasgrown in the last four years by over 10%,from 34% in 1999 to 46% in 2002. Atthe same time, the impact of R&D invest-ments on sales has grown by over 10%.Italy’s performance in the European

biotech-derived drug developmentpipeline is quite remarkable, especiallywhen compared to the overall size of itsbiotech industry. In fact, Italian compa-nies have 18 innovative drugs at anadvanced stage of development, 6 ofthem were defined as Orphan Drugs bythe EMEA (most of the by FDA as well).These data clearly show that the exist-

ing bioindustry core has a great poten-tial to create new and effective drugs. Asfor products developed, the Italianbiotech industry is already well placed ina leading position. As to it’s present com-petitiveness: in fact, the position reflectsmore our rank of our pharmaceuticalmarket size rather than the currentdimensions of our “red” biotech industry

(the Italian pharmaceutical market hasreached the fifth worldwide in size, witha very strong public health system).

Different studies have shown that world-wide startups and SME’s benefit whenlocated in a cluster. What is your associa-tion doing for cluster development in Italy?

In Italy, there is a strong concentration ofbiotech companies in a specific region.Lombardy and particularly the areaaround Milan, is indeed the area with byfar the highest number of biotech com-panies as well as the highest growth rate. Furthermore, in this area the existing

companies are developing faster thanelsewhere in terms of employees. Thisconcentration of activity leads to thedevelopment of a common ground amongdifferent realities and establishes a livelyscientific and entrepreneurial network.This network is an essential factor for

the development of a ‘critical mass’ ofactivities that attract investments. In fact,the Milan area offers expert scientific andclinical expertise, with three main univer-sities and 10 research centres. Thanks tothe support of local administrations,Lombardy is the current Italian leader forresearch and innovation. The investmentsin research and development reach 2.3%of the gross product (2/3 private and 1/3

public); this is twice the National averageand represents a synergy between publicfunding and private equity investments.Lombardy’s biotech cluster is the

largest in Italy and it is the only one thatis equivalent to European medium-sizecluster. The strong presence of industrialspin-offs and the strong orientationtowards the development of therapeuticproducts are the key characteristics ofthe bioindustry in Lombardy. This clustercould be the potential driving force forthe development of the whole Italianbioindustry. We are working to furtherconsolidate the cluster and foster thegrowth of national bioindustry byspreading out Lombardy’s model to otherareas of the country.

Q&A with Leonardo Vingiani, Director, ASSOBIOTEC

Assobiotec is the National Association for the Development ofBiotechnology representing about 70 companies and science &technology parks operating in Italy in different fields: pharma-ceuticals, diagnostics, agro-foods, fine chemicals, environment,processing industry and equipment. Assobiotec’s mission is tobe the landmark for Italian biotech companies involved in R&D,production and marketing of products and services. Assobiotecprotects their interests and represents the Italian bioindustry atthe National and International level. Associotec collaborateswith both National and EU institutions, aimed at setting-up fis-cal and financial policies fostering innovation and R&D strate-gic programmes, and defining a clear regulatory frameworkfor biotech-related activities. Assobiotec’s activities include pro-moting the access of Italian companies to the EU and National

or regional funding of biotech activities, and enhancing the col-laboration between companies (particularly SMEs) andresearch organizations. Assobiotec is co-founder member ofEuropaBio, the European Association Bioindustry. EuropaBiorepresents both the National Bioindusty Associations and thebiotechnology companies across the EU.

Source: The above Q&A was originally conducted for and published in the 2005 edition of the Italian BiotechnologyDirectory: Facts and Trends Analysis. The publication is produced annually by the Province of Milan (a local govern-

ment authority) and Biopolo (a non-profit consortium dedicat-ed to promoting and supporting Italian biotech). Please visit

www.biodirectory.it for more information.

BB

ASSOBIOTEC




Produce pyrogen and nuclease-free water Millipore announced the availability of the new BioPak disposable ultrafiltration car-tridge to dispense ultrapure water for up to three months without a loss of flow rate.The cartridge connects to the outlet of any Milli-Q, Direct-Q or Synergy water purifica-tion system as a final purification step. Typically, BioPak cartridges are used in cell cul-ture, biochemistry or molecular biology applications. The cartridge has been validatedin Millipore laboratories to warrant the production of pyrogen-free (< 0.001 Eu/mL)RNase free (< 0.01 ng/mL ) and DNase-free (< 4 pg/µL ) ultrapure water, while main-taining both the resistivity and total organic carbon (TOC) of the treated water.

High-precision epTIPSEppendorf North America introduced the new generation of EppendorfPipette Tips—the high-precision epTIPS, manufactured to combine everyapplication and volume with perfect functionality, ensuring an investment inquality. The new epTIPS—Totally Integrated Pipetting System—feature finevolume graduations, a soft and flexible tip cone, and better access to awider variety of tubes and wells. The epTIPS are available in three puritylevels (Eppendorf Quality, PCR Clean, Eppendorf Biopur) and a variety ofpackaging options including bulk, autoclavable racks, refill trays, reusableboxes and individually wrapped tips. While the optimized cone geometryprovides a perfect fit with every eppendorf pipette, their universal fit meansthey can be used with pipettes from other manufacturers. They require lesstip attachment and ejection force while ensuring complete sealing.

Fast and easy processing of RNA samples Norgen Biotek Corp launched the first in its series of RNA purification productsthat are based on its patented purification technology. Norgen’s RNA PurificationKit provides a rapid method for the isolation and purification of all RNA speciesfrom cultured animal cells, bacteria, yeast, blood and small tissue samples. The kitallows for fast and easy processing of samples using a spin-column format. Bothhigh and low molecular RNAs can be isolated in a few easy steps. Total RNA hasbeen isolated and detected from as little as a single cell using this kit. The purifiedRNA is of the highest integrity, and can be used in a number of downstream appli-cations including real-time PCR, reverse transcription PCR, Northern blotting,RNase protection, primer extension and expression array assays.


High-throughput purification of mRNA Invitrogen Corporation announced the availability of The mRNA Catcher PLUS Kit which enables high-throughput purification of mRNA from cells, tissue, blood, and total RNA in a 96-well format. By taking advantage of LockedNucleic Acid (LNA) technology, the kit provides a fast protocol and improvedperformance while preserving mRNA yield and purity. In the mRNA CatcherPLUS Kit, mRNA from total RNA, cells, tissue and blood samples is hybridizedto an immobilized, single-stranded oligo(dT) 20-mer containing LNA technology.The incorporation of LNA into the oligo probe increases the hybridization effi-ciency and specificity of mRNA binding. This leads to faster protocol times andimproved performance as indicated by lower Ct values in qRT-PCR analysis.


Ready-to-use protein markersFisher BioReagents introduced theEZ-Run Prestained Rec ProteinLadder. Supplied in gel loadingbuffer, the ready-to-use proteinmarkers incorporate 10 proteinscovalently linked to a blue chro-mophore plus a 72k Da orange ref-erence protein. The EZ-Run Ladderis ideal for monitoring protein sepa-ration during SDS-PAGE, verifyingWestern transfer efficiency, andapproximating the molecular weightof blotted proteins.



IN PERSON

Aunique award that supports technological research hasled to the creation of an innovative company dedicatedto the development of leading edge technologies for the

greenhouse industry. University of Guelph Ph.D. candidate Jamie Doran, department

of plant agriculture was recently awarded the Martin WalmsleyFellowship for Technological Entrepreneurship by the OntarioCentres of Excellence (OCE). The award, valued at $100,000, isdesigned to foster entrepreneurial spirit and facilitate the transfer oftechnology. It will enable Doran and his colleague Jeff Huber, aM.Sc. candidate in the department of environmental biology, tofocus their entrepreneurial efforts on their new company, GlassOnion. The company will target technologies for the allium industry.

“Glass Onion is a broad based company that will touchmany different areas of the allium industry—from spices tonutraceuticals, from field production to a new greenhouse indus-try,” says Doran. “Developing this business allows us to mesh ouracademic research with practical application. We want theindustry to benefit from our research, and Glass Onion will helpmake sure the applications get to market.”Among other things, Glass Onion has its sights on developing

a virus-free garlic seed through tis-sue culture techniques. Currently,the majority of the Canadian garlicis imported, due to higher foreignproduction volume and a lowercost per pound. Local production islimited further by the hardships ofviruses and fungi, which reducequality and yield. Furthermore, alli-ums have been identified as candi-date species for incorporation intospace food production systems, butmore information is needed aboutgas exchange rates and environ-mental response under closed envi-ronment conditions (CES).Virus-free seed has been shown

to increase yields up to 50 per cent.A component of its developmentprocess will require growing garlicin the greenhouse and the develop-ment of the associated technologies. “People are amazed to find out

that up to 95 per cent of the garlic

consumed in Canada comes from imported sources,” saysDoran. “But Glass Onion is set up to help local growers improvethe quality and quantity of their garlic and secure a greater market share.” Glass Onion is also developing alternative methods to pro-

duce highly concentrated extracts that require less produce forthe same end result, boosting producers’ profit. Current produc-tion of allium extracts, such as garlic powder and liquid extract,results in losses of up to 80 per cent of the active ingredients. Tocompensate, extract manufacturers must use large amounts ofproduce to develop a quality product. The company will work with Bioenterprise, a non-profit com-

pany that assists scientists in the commercialization of their ideas.Doran’s research is sponsored by the Ontario Fruit and VegetableGrowers Association, Earth and Environmental Technologies, andthe Ontario Ministry of Agriculture and Food. Doran is advisedby Profs. Bernie Grodzinski and Mary Ruth McDonald.

Jamie DoranAward prompts technological innovation By Sarah Fischer and Mitch Ritter

Photo credit: Oliv

ia Brown

From left: Prof. MaryRuth McDonald, and

Glass Onion co-foundersJamie Doran, Jeff Huber

Original article by Sarah Fischer and Mitch Ritter, SPARK pro-gram, University of Guelph, Ontario, Canada. www.uoguelph.ca.For more information on Glass Onion please visit: www.glassonioncorp.com

BB

BioBus_Pierce.eps 2/3/06 2:01:23 PM



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Trends, Issues and Developments in Canadian Life Science ...Account Kirsty Tamaki M an ger kt a mi@jes r.co Promotion Nancy Sim Manager [email protected] Production Roberta Dick Manager