Blood breakthrough - Bio Business

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Blood breakthrough - Bio Business

U of S Scales UpBioprocessingA SustainableFUTUREAworld-class environmental monitoringsystem to track water andair quality and monitor biodiversityin the oil sands region of northernAlberta is in the works.The announcement comes on the heelsof an uproar surrounding the health ofaquatic animals found downstream fromoilsands developments.In August, University of AlbertaEcologist Dr. David Schindler published astudy evaluating oilsands pollution in connectedwaterways that was quickly disputedby the oilsands industry. The studyidentified toxic metals and other harmfulcompounds in certain Alberta waterways.In September, scientists and FirstNations representatives began a campaignto expose the environmental effects ofoilsands development. Fish with deformities,rotting flesh, tumours and a host ofother problems are becoming common innorthern communities that rely heavily onwaterways for food.A more recent study from EnvironmentCanada, chaired by Elizabeth Dowdswell,formerly Executive Director of the UnitedNations Environment Programme, foundthat current air, water and wildlife monitoringsystems in relevant areas are indeedlacking.The Environment Canada report isfound at: www.ec.gc.caThe University of Saskatchewan College of Agriculture and Bioresources opened anew bioprocessing pilot plant that will be used to study plant compounds for usein biofuels, crop development and health products.The facility, funded by the Saskatchewan Ministry of Agriculture, received a $1.2 millioninjection to acquire industrial-grade scientific equipment designed for the isolationof valuable crop components.The unique pilot plant allows researchers to look for natural products in crops withpotentially useful applications in foods, biofuels, new drugs, vaccines and nanomaterialsfor use in human and animal health. Co-operative research and development with industrypartners is a facility mandate.“This pilot plant will support Saskatchewan’s agriculture industry by bringing togetherkey pieces of equipment in one spot to help researchers continue their work on bioprocessing,”says Minister of Agriculture Bob Bjornerud.With its industrial scale-up tools, the pilot plant offers great potential for commercialization.Superchickengenetically modified “superchicken”that doesn’t spread deadlyAbird flu has been developed by Britishscientists.The British team behind the GMchicken say it is inconceivable thatthe chicken’s meat or eggs could beharmful. However, it will need rigoroussafety checks before the chickencould go into the food chain.Avian flu is a serious threat tofarmers and people. Although it doesnot easily infect humans, when it doesit can be deadly.The GM chicken was created by ateam atC a m b r i d g eUniversity andE d i n b u r g hUniversity andreported in thejournal Science.Stronger, GreenerCementAn environmentally friendly cementadditive that shows potential to significantlystrengthen concrete and reducegreenhouse gas emissions was licensed toGreenCentre Canada by LakeheadUniversity.The technology, developed by Dr.Lionel Catalan from the Department ofChemical Engineering and Dr. StephenKinrade from the Department ofChemistry, can potentially increase concretestrength by up to 40 per cent andreduce the amount of Portland cementneeded to make concrete.The production of Portlandcement involves heating calciumcarbonate and clay at extremelyhigh temperatures. This processis responsible for anestimated seven percentof all greenhouse gasesproduced annually.6 Bio Business January/February 2011


NewsPeer into the FutureFor the fifth year, researchers at the University of BritishColumbia released a series of science predictions for thecoming year.Past predictions include a 2006 claim by UBC psychologyprofessor Stanley Coren that dogs will soon be prescribed bydoctors for their therapeutic value (the U.S. government is currentlygiving service dogs to war veterans with post-traumaticstress) and a 2006 prediction from astronomy professorJaymie Matthews that we will discover a habitable planetwithin five years (a prediction increasing in likelihoodrapidly).This year’s nine predictions are:• Intelligent space: UBC researchers are leading the investigationof architecture that adapts in real time to occupants• Municipal service robots: Professors are working on a robotthat will crawl through water mains and sewers to finddefects• Personal genome analysis: Experts may soon know the genevariations that influence many aspects of our health andtraits• Restorative buildings: Researchers foresee a building thatactually restores and improves the environment• The medical tricorder: With advances in DNA sequencing,we are on the verge of having a Star Trek-like medical tricorder• Imaging genetics: Advances in brain scanning and geneticshave created a new neurotechnology that can foresee braindisease• Rare-earth dental magnets: Created for the auto industry,new magnets hold hope for denture sufferers• Magic biomarkers: Panels of novel biomarkers will helppredict risk, illness and therapies for vital organ failure• Collaborative journalism: A professor predicts we’ll soon seea raft of new tools to make sense of social mediaThe nine billion people projected to inhabitthe Earth by 2050 need not starve to preservethe environment, says a major reporton sustainability.Agrimonde describes the findings of a hugefive-year modelling exercise by the French nationalagricultural and development research agencies,INRA and CIRAD.The French team began with a goal—3000calories per day for everyone, including 500from animal sources—then ran a global foodmodel repeatedly, with and without environmentallimits on farming. The aim was to see how thecalorie goal could be achieved.“The biggest surprise was that some regionswill depend even more on imports,” says HerveGuyomard of INRA.The model suggested that realistic yieldincreases could feed everyone, even as farmstake measures to protect the environment, suchas preserving forests or cutting down on the useof fossil fuels. The key will be to tailor detailedsolutions to different regions.About 7,200 km east of the launch point ofthe French study, a pilot project to see if cashcrops can be grown in the salty ground of India’scoastal areas was launched.Marine biologists involved in the project say that saltresistantplants, or halophytes, are important for peopleliving in coastal areas, where vast tracts of land haveturned saline and unsuitable for any other form of cultivation.Field studies conducted in the U.S. and East Africa suggesthalophytes such as sea asparagus can be grown ascommercial crops.Growing Food for a Growing PopulationJanuary/February 2011 Bio Business 7


CommentaryOnce a globalleader, Ontario’sbioscience sectoris in jeopardyFewer indigenous companies and fewerpublic companies operating in OntarioBy Gail GarlandIn April 2010, the Government of Taiwan announced a $1.9billion bioscience “Mega-Fund” to grow and support biomedicaldevelopment and commercialization. That same month,Ontario’s Ministry of Research and Innovation announced a $161million Life Sciences Commercialization Strategy. Of the $161million, approximately $57 million was new money. $7 millionwas for a one-time investment in the province’s bioscience sector.Taiwan and Ontario possess world-class research institutions,intellectual property protection and national healthcare programs.Unlike Ontario, Taiwan is making a substantive financial commitmentto ensure successful commercialization of human therapeuticsand medical devices.Ontario’s economy faces the loss of traditional manufacturingjobs. Add to that a prolonged recession, a recovering UnitedStates trading partner, aging baby boomers with increasinghealthcare demands, and necessary rationalization of services torein in the deficit. To regain prosperity, Ontario must movebeyond its manufacturing roots and invest strategically in its economicfuture.Strategic imperativeOntario needs to recognize, as Taiwan has, that support for bioscienceis a strategic imperative.Approximately 80 Ontario companies are developing andcommercializing human-health products. Capital is the lifebloodof these companies. Lengthy, obligatory regulatory timeframesdrive this need for funding. Since the onset of the recession, biosciencecompanies, like other businesses, have faced reducedaccess to capital. Many are struggling with less than one year ofoperating cash.Ontario once was home to the world’s third largest cluster ofbiotech companies. No more. A 40 per cent drop in the numberof indigenous health-science companies and a 20 per cent drop inthe number of public biotech companies over the past two yearsplaces Ontario’s biotech sector, once a world leader, in jeopardy.In July 2009, CEOs of Ontario bioscience companies formedOntario Bioscience Industry Organization to advocate for theirindustry’s survival.In November 2009, OBIO presented its recommendations tothe Ontario government in the report Industry-GeneratedRecommendations for Sustainability and Growth of Ontario’sBioscience Industry. Demonstrating how increased access to existinggovernment programs would help move product developmentfrom invention to innovation and commercialization, OBIOaccomplished its first goal of immediate financial assistance: aone-time $7 million fund to support early stage, Ontario-basedbiotechnology companies.$7 million is woefully inadequate to support a capital-intensiveindustry. Still, it’s a start.In December 2010, OBIO completed the industry’s second setof recommendations for presentation to the Ontario government.Among its key findings:• 91 percent of CEOs said their biggest issue continues to beraising external financing—up from 51 per cent in 2009.• Government programming continues to be blocked by issuesof both design and implementation.The larger challengeOntario’s bioscience CEOs are acutely aware the innovative productsthey are developing can improve healthcare outcomes forOntarians, Canadians and global citizens. Products manufacturedin Ontario and sold globally create jobs, improve health outcomesand raise our standard of living.The larger challenge is for Ontario’s bioscience sector to createa vibrant industry that is a dynamic economic engine for theprovince and global competitor.To that end, OBIO and industry experts implemented a systematic,coordinated strategy: the Ontario Bioscience EconomicStrategy Team. OBEST engages the entire Ontario bioscienceecosystem in a collaborative, iterative and democratic process tobring forward the best ideas with which to build a vibrant bioscienceindustry.Historically, high amounts of research dollars have been spentwithout much commercialization success. OBEST unites stakeholdersto solve industry problems and create solutions. Thiseffort is timely so Ontario does not miss the chance to capitalizeon the crown jewel of its societal achievement: its universal healthcare system, great universities and research centers, world leadingscience, highly educated populace, global microcosm of people,and history of successful risk taking. All can be encapsulated in astrong, world-beating life sciences economy.As noted in a recent issue of The Economist, “An innovativesociety is one that hedges its bets by having as many thoughts—and thinkers—as possible.” BBGail Garland is President and CEO of Ontario Bioscience IndustryOrganization.8 Bio Business January/February 2011


IP & PatentingThe Patent WatchInventions of Contraception and Other Intimate InterventionsBy Kathleen E. Marsman, Ph.D.Innovations to control pregnancy and fertility are in demand,not only for livestock production and wildlife control, but alsoto permit humans to manipulate their own reproductive capacity.Interesting developments abound in the areas of reducing andenhancing fertility, some of which are reviewed here.United States Patent No. 7,192,607, entitled Formulations forthe prevention or the treatment of diseases affecting mucosae or skin, orfor pregnancy prevention, and an applicator for the delivery of topicalformulations into mucosal cavities and issued on March 20, 2007,names Infectio Recherche Inc. of Quebec as assignee. The technologydescribed relates to a formulation with a film-formingcomponent and an active ingredient, such as one used toprevent pregnancy. Other active ingredients, such as onesto prevent sexually transmitted diseases, may be includedin the formulation. The formulation acts as a film-formerwithin a body cavity, and prevents invasion by externalagents such as sperm or pathogens. The formulation containsa poloxamer, which is a thermoreversible gel, such aspoloxamer 407. The poloxamer promotes formation of afilm-like barrier at body temperature.Technologies for contraception based on immune response areof interest, and researchers are exploring options employing vaccination.United States Patent No. 7,824,686, entitled Vaccineswith enhanced immune response and methods for their preparation,was issued November 2, 2010 to Immunovaccine Technologies,Inc. of Halifax, Nova Scotia. The technology described in thispatent relates to a method for potentiating an immune responsein a subject. A vaccine composition is described which includes acarrier having a continuous phase of a hydrophobic substance,liposomes, an antigen, and an adjuvant. The hydrophobic substancemay be an oil such as mineral oil or nut oil. By forming thevaccine composition in an oil-based carrier, an oil-in-water emulsionis formed, which seems to enhance the efficacy of the antigenwhen compared to the response seen with conventional aqueouscarriers. The document envisions use of this technology for deliveryof a single-dose, long lasting immunocontraceptive vaccineeffective in a variety of species, which would use adjuvantsapproved by the Food and Drug Administration. Exemplary usesin rabbits, cats and deer are provided.Among the events of fertilization, few are more important ormore enigmatic than interactions between the sperm and eggmembranes. A number of sperm proteins that bind to oocyteshave been identified, but identification of oolemmal receptors forsperm ligands remains elusive. International Patent ApplicationNo. PCT/US2009/0063540, was published as WO2010054187A3and is entitled Compositions and methods for regulating SAS1R. Theapplication, owned by the University of Virginia PatentFoundation, was published on December 14, 2010. The technologydescribed relates to inhibiting fertilization by inhibiting animmunogenic oocyte stage specific metalloprotease sperm proteinreceptor. By contacting an egg with Sperm Acrosomal spermlysozyme-like protein Receptor, likelihood of fertilization of theegg is reduced. An oocyte specific protein, Sperm AcrosomalSLLP1 Receptor (SAS1R), has been found to act as a spermInnovations to control pregnancy andfertility are in demand, not only forlivestock production and wildlife control,but also to permit humans to manipulatetheir own reproductive capacity.protein receptor. Purified recombinant SAS1R illustrated proteaseactivity, inhibited fertilization in vitro, and induced animmune response in females. SAS1R appears to be a proteolyticallyactive, oocyte and early embryo specific receptor for sperm,and may be an effective target for regulating fertilization. A contraceptivevaccine is envisioned.United States Patent No. 7,384,913, entitled PT32 spermprotein, sperm c-Yes, oocyte cytoplasmic c-Yes, and uses thereof issuedon June 10, 2008, names Queen’s University at Kingston, ofKingston, Ontario, and Oregon Health Sciences University, ofPortland, Oregon as co-owners. The patent describes an isolatedperinuclear theca 32 polypeptide that interact with activated tyrosinekinase c-Yes, for enhancing fertility, or for treating and diagnosingdiminished fertility and abnormal spermiogenesis. Oocyteactivation is enhanced in the presence of this polypeptide. Theowners envision using the technology to provide contraception.In raising livestock, it is often desirable to raise female asopposed to male populations. For example, dairy farmers wouldfind it advantageous to enhance the likelihood of breeding afemale calf by enriching sperm prior to embryo formation orartificial insemination. United States Patent Application No.2009/0325217 was published December 31, 2009 and namesMicrobix Biosystems Inc., of Mississauga, Ontario as owner. TheJanuary/February 2011 Bio Business 9


IP & Patentingapplication is entitled Method and apparatus for sorting cells anddescribes using a sorting flow cytometer to separate labeled cellsof interest from a mixed population using an excitation energysource, diverting labeled cells with reduced harm to the cell populationof interest. With this method, there is no use of the conventionalparabolic reflectors or orthogonal detectors to detectand categorize cells, as with conventional flow cytometry. Thesorting of sperm cells is carried out in such a way that sperm cellswith the X chromosome can be distinguished and separated fromWhere patentability meets profitability.Blakes IP lawyers and patent agents have significant experiencein developing IP protection and commercialization strategies forCanadian biotechnology companies.To learn more about how you can put our IP expertise to work foryou, please contact:Santosh ChariDirect: 416-863-3166santosh.chari@blakes.comLeah Begleiter RodinDirect: 416-863-5830leah.rodin@blakes.comMONTRÉAL OTTAWA TORONTO CALGARY VANCOUVERNEW YORK CHICAGO LONDON BAHRAIN AL-KHOBAR* BEIJING SHANGHAI* blakes.com* Associated Office Blake, Cassels & Graydon LLPthose with the Y chromosome while sperm cell viability, relativeto conventional flow cytometry methods, can be enhanced. As aresult, an enriched and viable sperm cell population can beobtained with a higher chance of creating a female offspring.Another approach to improving the viability of flow cytometrysorted sperm populations is described in United States PatentNo.7,838,210 issued on November 23, 2010. The patent is entitledSperm suspensions for sorting into X or Y chromosome-bearingenriched populations and names Inguran LLC of Navasota Texas asowner. The patent describes a sperm cellsuspension for use in sorting sperm cellsinto enriched population of X or Y chromosomes.The suspension maintains spermviability by down-regulating carbohydrateuptake, thereby reducing sperm motility.The sperm cells contained in such suspensionstend to have a greater capacity forenduring the various process steps typicallyassociated with the sorting of sperm cellsinto gender enriched populations. Thus,post-sort compositions should have anincreased number of viable or motile sperm.The sperm cells are rendered immotileusing a source of carbonate within the incubationmedium and are stained with aDNA-selective dye for sorting.United States Patent Application No2007/0077545, published April 5, 2007and entitled Sperm protective polypeptidesand uses thereof, is assigned to LavalUniversity of Laval Quebec. This documentdescribes polypeptides capable ofbinding chaperone receptors, which canimprove the physiological properties ofsperm cells. The motility, survival, fertilitycapability, resistance to cooling, freezing,and thawing of sperm cells can be enhancedwhen put in contact with chaperone polypeptidesdescribed. Exemplary polypeptidescapable of acting in this way are heatshock protein, glucose related protein,stress shock protein, and others. In variousreproductive technologies, whether relatingto human or animal application, frozensperm or fresh sperm, which is transportedor manipulated prior to use, may be susceptibleto physiological changes. BBAbout the Author:Dr. Kathleen Marsman is a patent agent andpartner in the Ottawa office of Borden LadnerGervais LLP, specializing in the life sciences.10 Bio Business January/February 2011


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Big pharma retreats fromMichiganHundreds of small businesses replace thousandsof lost jobsMetabolic Solutions Development Company sprung out of the remnants of Pfizer’soperation in Kalamazoo. The company now employs 11 full-time staff.By Jason HagermanAfunny thing happened when Pfizer closed down itsKalamazoo, Michigan, research and development centre in2003. The announcement eliminated more than 1,200 jobsand yet, with those jobs gone, the life sciences industry persistedand even prospered. Those who had dedicated their lives toMichigan’s well-established biotech industry weren’t about to letit go.“If you take a look at the history, we had a strong automotivepresence and we lost it,” says David Zimmerman, CEO ofKalexsyn, a contract research organization operating 200km westof Detroit in Kalamazoo.“We had a strong paper presence and we lostit. We also had more than 100 years of pharmaceuticallegacy, and we were not going to losethat.”That pharma legacy stretches back to 1866,with the founding of Parke-Davis, followed byUpjohn Company two decades later. The firstdissolvable pill, a staple of pharma, was designedand manufactured by William Upjohn, founderof Upjohn Company.“People will always associate us with theautomotive industry,” says Michael Hagen of theMichigan Economic Development Corporation.“But just as much, we are definitely life sciences.”When Pfizer began to withdraw fromKalamazoo in 2003, and from Ann Arbor in2007, the state had already developed infrastructureto retain the newly jobless.OpportunityIn the early 2000s, Southwest Michigan First, aprivately held economic development firm inKalamazoo, decided to build the SouthwestMichigan Innovation Center, a 69,000 sq. ft. lifescience centre.Aside from companies spinning out of thethree major universities, Michigan StateUniversity, the University of Michigan andWayne State University—which collectivelybring in around $1.3 billion in federal researchand development dollars, landing it fourth in thecountry for federal research funding—there was uncertainty as towho would fill the space. But once the Innovation Centre wasbuilt, businesses emerged to fill the space.“Literally days after Pfizer’s announcement back in 2003, thelife science center was opening its doors,” says Zimmerman.This meant that recently unemployed, highly skilled scientistshad an option far more appealing than the obligatory job hunt.“It dawned on me that I would never have this opportunityagain in my life,” Zimmerman says. “I get to define who I am andI get to focus on what I’m passionate about.”Zimmerman decided to use what he’d learned over the last 1012 Bio Business January/February 2011


Regional Profileyears and founded Kalexsyn with Dr. Bob Gadwood, formerAssociate Director of Medicinal Chemistry at Pharmacia.“The last decade I worked at Pharmacia [Pfizer] I outsourcedchemistry, I was a client,” Zimmerman says. “Leaving there, Iknew what the client wanted.”What the client wants, Zimmerman explains, is qualitymedicinal chemistry, a service group that can problem-solve anda contract research organization that communicates effectivelyback to clients. Zimmerman and Gadwood set out to meetthat need.Dr. Jerry Colca, President and Chief Scientific Officer ofMetabolic Solutions Development Company, capitalized in asimilar fashion.“[Michigan] was a Mecca, and you can’t lose track of that,”says Colca. “A lot of that expertise is still here.”Metabolic Solutions took advantage of intellectual propertythat Colca and Dr. Rolf Kletzien worked on while in the employof Upjohn Company.Formed in 2005, Metabolic Solutions now works on developingthat intellectual property to create effective treatments fortype-2 diabetes.“Being in Michigan helps because of the expertise that is here,”says Colca.Layoffs“Pfizer started downsizing with Pharmacia in Kalamazoo back in2003,” says Dr. Stephen Rapundalo, President and CEO ofMichBio, Michigan’s bioscience industry organization. “They dideven more in 2007 when they closed up a facility in Ann Arbor.In 2007 alone about 3,300 people lost their jobs.”Fortunately, he says, Michigan regained about one-third ofthose immediately.Like Zimmerman and Colca, many of these highly-trainedscientists launched their own enterprises in contract research,drug development, and clinical trials.“All told, around 125 companies formed between 2002 and2003, and of those I believe 120 or so are still in business,” saysRapundalo.What allowed the proliferation of so many small life sciencecompanies was the exit of Pfizer. Pfizer’s exit didn’t just forceMichigan’s science workers to seek alternative forms of employment,but provided the means for them to do so when Pfizer soldoff the equipment in its empty Kalamazoo facility.Shortly after he stopped working in the lab at Pfizer,Zimmerman was back working on the same equipment in hisown facility and under his own rule.Staffing and contracting other resources became a cinch aswell, as companies appeared from every facet of Pfizer’s business.“Before, everybody was sort of depending on the big company,on parts of the big business,” says Rapundalo. “Once peoplestarted their own companies in Michigan, after the exit of Pfizer,people in the community began to depend on each other, and thatstrengthened the community.”Community in Kalamazoo“When we set out with Kalexsyn, there were a lot of things wedidn’t know,” says Zimmerman. “But the community steppedforward and brought us those things.”Zimmerman had no previous experience with business operations,no idea how to even write a business plan. Several economicleaders from the community donated their time to showhim how.When he didn’t have the funding available to incorporate hisbusiness, a group of lawyers offered to do it for free.“We even had an accounting firm handle all of our books forfree for an entire year,” says Zimmerman.For some, entrepreneurship was more difficult.“I thought it would be easier,” says Colca. “Once we put upsome of our own money, it made a huge difference. But wecouldn’t pass up the opportunity. We were right there, the timingwas right and it was something we had to do.”Michigan Life Sciences by the Numbers• More than $2 billion in research and development fundingdrive Michigan’s 525 life sciences companies, organizationsand institutions.• More than 79,062 Michigan residents now work in thestate’s life sciences industry. About 75 per cent of lifesciences jobs are in biological fields including medicalproductmanufacturing, chemical preparation or researchand development. Another 18 per cent are medical andseven per cent are in an agricultural-related field.• Life sciences contribute a total economic impact of $9.5billion to the state.• Life sciences account for 2.1 per cent of the jobs inMichigan and 4.4 per cent of total payrolls, bothgreater percentages in Michigan than the United Statesas a whole.Today, Metabolic Solutions employs 11 full-time workers andworks with more than a hundred consultants and part-timeworkers, many of whom are united by Michigan’s big pharmabloodletting.Pfizer still operates an animal health research and developmentfacility in Kalamazoo and a massive pharma manufacturingfacility outside the city. Perrigo Company, the world’s largest overthe-counterdrug manufacturer, and Dow Chemical still employthousands. The big companies are still there. But if they were tomove on, chances are the state would be just fine.“Michigan has spent over a decade growing an infrastructureto strategically support business development efforts of early stagelife science companies,” says Hagen. “Infrastructure is the mostimportant thing, and we have it in abundance.” BBJanuary/February 2011 Bio Business 13


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Industry ReportLife ScienceIndustryAppeals toGovernmentAforecast published by PricewaterhouseCoopers andBIOTECanada shows that Canadian life sciences businessesare counting on more government support at a timewhen funding is hard to find, as access to capital remains theindustry’s top concern for the fourth year running.According to the survey, access to capital from any source,increased Canadian venture capital, and more success stories fromexisting Canadian firms are required to ensure the proliferation ofCanada’s life science industry.“While the turnaround in the Canadian economy has helpedthe longer-term confidence level of survey participants, raisingcapital is still the number one issue,” says Gord Jans, PwCCanada’s national life sciences leader. “Eighty per cent of respondentssay that unfavourable industry and market conditions is thetop challenge to successfully raising capital—that’s why especiallyin the short term the industry feels the government needs domore to help.”According to the survey, the number of companies seekingmore than $10 million in funding totals 47 per cent, compared to39 per cent in 2009, and the total funding sought by surveyrespondents exceeds $1 billion.A quarter of companies not earning revenue believe it will takemore than five years to turn a profit, and of respondents currentlyoffering no products, three quarters will remain without a productfor at least two years.“Because there are scarce sources of capital to support funding,there is a strong view by respondents that government can help bycreating incentives for risk capital and more favourable tax incentives,”says Peter Brenders, President and CEO of BIOTECanada.The survey says 30 per cent of respondents are consideringrelocating part of all of their business, and almost 40 per cent ofthem look to foreign government incentives as a deciding factor.The majority of respondents, 53 per cent, believe effectivegovernment lobbying is the most important initiative industrycan undertake to maintain a competitive position in the globalmarketplace. Spreading news of Canadian success stories andrecruiting experienced senior management are also importantindustry activities.Most respondents, 72 per cent, say research and developmentand other tax incentives are the most important assistance governmentcan offer. Employment subsidies, according to one-third ofrespondents, significantly improve chances of success, and 66 percent say government grants or related funding contribute to businesssuccess.According to 90 per cent of respondents, acquisition is thelikely endgame for a typical, successful life science business,followed by licensing or selling intellectual property and codevelopment/partnerships.Both Jans and Brenders are optimistic about the industry’sfuture in Canada, but believe Canada’s role in the future of the lifesciences relies on how effectively the country sustains its companiesthrough to commercialization today.The report, titled Inflection Point: Canadian Life SciencesIndustry Forecast 2011, contains responses from 100 sources.The sources represent public and private life sciences andbiotechnology businesses with combined revenues of approximately$2 billion. BBJanuary/February 2011 Bio Business 15


The Myriad DecisionWhat does the patent dispute mean to Canadian biotech?KarenTownsendRichardStobbeLeahRodinIn March 2010, a U.S. districtcourt ruled that isolated DNAand inventions that use isolatedDNA are not eligible for patenting.The ruling resulted from a lawsuitagainst Myriad Genetics, acompany that patented the BRAC1and BRAC2 genes, genes associatedwith increased risk of breast cancerand ovarian cancer.The decision is currently underappeal to the Federal Circuit and adecision is expected in 2011. Myriadhopes to secure ownership of theisolated genetic sequences it hadpatented. The biotech communityin the States and the rest of theworld are watching this case carefullyfor the ramifications thatmight follow from a failed appeal.If business cannot patent genesand isolated DNA—as it has fordecades—what might happen tobusiness and to science?We discuss the issue with LeahRodin, a patent agent at Blakes,Cassels and Graydon LLP, RichardStobbe, an associate at Field LLP,and Karen Townsend, an associateat Torys LLP.Bio Business:What happens if the District Court’s decision is upheld and businesscan’t patent isolated DNA?Rodin:We can’t know what’s going to happen. If the decision is overturned,business goes on as usual and we continue doing what wehave been doing. If the appeals court decides that patents thathave been granted up until now have been too broad and are notstatutory subject matter, then the question will be: to what leveldoes the court indicate that? Which of the claims are found to benot patentable? And which of the claims are still allowed? Thebiotech industry will have to go back and determine the boundariesof what we can claim and what is now off limits.BB:How should Canadian biotech businesses look at the Myriaddebate?Townsend:From a purely patent point of view, nothing is going on as far asthe Canadian Intellectual Property Office is concerned. It is not,as far as I know, re-evaluating whether it should be allowing genesto be patented. Canada marches to the beat of its own drum whenit comes to what the CIPO decides is patentable subject matterand what isn’t.There is, of course, the business side of things, and what happensin the United States is crucial to Canadian businesses for acouple of reasons. One, because all Canadian companies aspire tohave their products made and sold not only in Canada but also inthe United States. So if you’re going to enter the U.S. market youneed U.S. patent protection. And two, from a funding perspective,Canadian companies are always looking for additional funding.There’s no such thing as too many opportunities for funding.They’re looking south of the border for opportunities and the firstthing anybody doing their due diligence is going to say is, “Let’ssee your patent portfolio.” U.S. patents will be key for that.16 Bio Business January/February 2011


Legal RoundtableRodin:Many Canadian biotech companies view the U.S. as their maintarget market. Canadian biotech companies will need to monitorthe Myriad case as it progresses through the court system and willneed to adapt to changes in the U.S. patent law that may resultfrom this case. Companies may need to revise their patentingstrategy and even their business model if the courts put morerestrictions on the types of patent claims that are available.In particular for smaller biotech companies and for start-ups, ifthere is inadequate protection for innovations in this field thenthere may not be enough incentive to invest in the research.Another issue that may arise that is more specific to theCanadian biotech industry, is if the law in Canada becomessignificantly different than the law in the U.S. with respect topatenting genes. If you look at the CanadianMyriad patent applications and granted patentsthey are somewhat similar in scope and in somecases somewhat different. There are still claims inCanada to the isolated DNA itself. The process inCanada has been not so different than the processin the U.S. However, if the U.S. decides that isolatedgenes are not patentable and free for everybodyto use, and if Canada says they are patentable,we see some limitations. In some respects, it mayhurt the prospect of certain types of research beingdone in Canada if the genes were open for all to use in the U.S.but were not in Canada. It will be interesting to see howCanadian courts and the Canadian patent office will react whenthings are sorted out in the U.S.BB:Is there a potential for this argument about Myriad’s right to patentgenes to spill over into other areas of science?Stobbe:Certainly in the field of agriculture a similar debate is going on. Ithink this will have some fallout there. And certainly the principlesof what’s patentable will be used. If a decision comes downfrom the U.S. Court of Appeals, or it goes all the way to theSupreme Court, that will be applied to many fields both insideand outside of biotech.Their analysis of what business methods should be patentableand when software should be patentable, as that debate settles andthis one settles, both will affect each other. There will be overlap.Townsend:It is a fine line. The U.S. District Court was of the opinion thatDNA is special. It is not. Genes have typically been characterizedin patent law as a type of chemical, which, once isolatedfrom the body, is patentable because it is distinctly differentfrom what is found in nature. But now the District Court hasmade this argument that the fact that DNA carries geneticinformation makes it special. The Court said that the real valuein DNA is that it’s a carrier of information—and that characteristicdoes not change even when the DNA is isolated from thebody. So that’s why it’s not patentable. Now, they did make apoint in the District Court decision to say that the conclusionsreached in this decision are limited to the patentability of isolatedDNA, because, I think, the court recognized that this is aslippery slope. Are proteins patentable? What’s the differencebetween a protein and a chemical? Where do you draw the line?And it would be a pretty scary day if it was decided that proteinsare not patentable. I mean, proteins are very commonly thesubject of FDA approval these days.I think the District Courtrecognized that and said, “Okay, we’re only talking about isolatedDNA here.” But who’s to say the next challenge won’t beto some protein or chemical that’s in your body?Researchers are encouraged to rush off tothe patent office when they come up withsomething. But then you get a Myriad situationwhere that’s exactly what happened andeverybody turns around and cries foul becausethey did so. We can’t have it both ways.BB:Why do you find this worth discussing?Stobbe:One of the interesting things to me is the whole debate on therole of research centres and research universities. The Myriadtechnology spun out of a U.S. university and in Canada we’ve gotthe same kind of system in which universities are encouraged tocommercialize something. Researchers are encouraged to rush offto the patent office when they come up with something. But thenyou get a Myriad situation where that’s exactly what happenedand everybody turns around and cries foul because they did so. Wecan’t have it both ways. We can’t tell researchers they’ve got torush out and commercialize and then jump up and down andcomplain when they patent something we don’t think should bepatentable but, by law, is.That’s sort of a whole other debate though.I think the other thing that goes along with that is that weneed some guidance from Parliament. We get some pieces fromthe courts, but we need full-on amendments to the law to seewhat’s patentable and what isn’t. That debate would be greatto have.I think it’s unlikely that we’ll have it. For political reasonsnobody wants to tackle that for fear of losing a political edge.Ultimately, what we can hope for is the court in the Myriadsituation coming up with some clear guidance in the U.S. whichmay help inform what we do in Canada. BBJanuary/February 2011 Bio Business 17


Photo Credit: Christopher CampbellRyan Mitchell (l), a graduate student,Mick Bhatia (m), Scientific Director ofMcMaster’s Stem Cell and CancerResearch Institute, and ShravantiRampalli, a postdoctoral fellow.18 Bio Business January/February 2011


BreakthroughsSKINDEEPCanadian discovery holds the promise of ending blood shortagesBy Jason HagermanOn a Sunday in November 2010, Dr. Mick Bhatia firstreported the results of his work. Across the Pacific lessthan 48 hours later, organizers of a stem cell symposiumin Japan rushed to prepare a section dedicated to reviewing anddiscussing Bhatia’s paper. The work—which demonstrates how toturn skin cells into adult blood cells—was too important for theconference organizers to overlook.And for good reason. In 2008 the Canadian Blood Servicesissued a nationwide warning that reserves of blood had droppedby about 40 per cent. As the winter approached in Halifax, hospitalsbegan rationing blood supplies by the hour. In early 2010, theAmerican Red Cross declared a major blood shortage with barelymore than a three-day supply on hand. Kuwait rallied citizens todonate blood. And hospitals in China continue to appeal to thepublic for new donors while putting off non-essential surgeries.Imagine having one blood donor for each patient awaitingsurgery, or even more than one donor per patient. That’s exactlywhat Bhatia’s research might offer. In the not-too-distant future,patients will become their own donors, trading a coin-sized bit ofskin for a vat of blood. Blood donors may become what they aretoday—rare.Mick Bhatia opens a cell storage container.In the detailsOther scientists have produced blood cells from stem cells. Thiswasn’t exciting.“The big excitement came when we realized the blood wewere producing was adult blood,” says Bhatia, Scientific Directorof McMaster University’s Cancer and Stem Cell BiologyResearch Institute.“It wasn’t so much the making of blood, but the fact that it wasadult hemoglobin red cells was what made this so unique.”For a few years now, scientists have been able to generateembryonic blood from both embryonic stem cells and inducedpluripotent stem cells, a type of cell that acts like an embryonic cell.The challenge has been to create adult blood cells becauseembryonic blood—which binds oxygen to hemoglobin withgreater efficiency than adult blood—is unsuitable for treatingadult humans.January/February 2011 Bio Business 19


Breakthroughs“Once you reset cells to their most primitive form [theembryonic stage], the cells are hardwired at a genetic level tomake fetal hemoglobin,” says Bhatia. “Why wouldn’t it? That’swhat makes sense.”“I figured the best way to get what we wanted was to not resetthe cells to that most primitive form,” says Bhatia. “In our view, itisn’t stem cells that you want, but the things that stem cells make.”Bhatia’s innovation was to alter the process of converting skincells to stem cells. For months on end, Bhatia’s team createdvariations within the bath of proteins used to generate the cells.They looked for the combination of environment and timing thatcould yield a direct conversion from skin cells to adult blood cells.A stem cell scientist circumventing stem cells in stem cell researchis a strange approach, but it worked.“When we were finally convinced that we were getting bloodout of these skin cells, we weren’t actually convinced,” says Bhatia.McMaster Stem Cell and Cancer Research Institute stem cell isolationexpert, Marilyne Levadoux-Martin, operating the FACS Aria II, ahigh-speed cell sorter used to isolate human stem cells“There was probably a 10 second period where we just looked ateach other. To this day, we know that we have a system allowingus to do this but, as grumpy scientists, we want to know preciselyhow this works because we want to improve it.”And improving the process means scaling up.The next stepBhatia’s process of generating adult blood cells from skin cells isin its infancy. Bhatia can take a few skin cells and create a slightlylarger quantity of blood cells. To make the process useful to thepublic, Bhatia must scale up.“If we are able to expand the program by 10 fold, we won’tneed many skin cells to make a large quantity of blood cells,” saysBhatia. “However, if we are only able to expand two fold, we willcontinue to require more skin cells.”Yet, even with media around world heralding the significanceof this discovery, Bhatia is troubled by the potential struggle toscale up.“Can we take it to the next step?” he asks. “This is my singleworry today, the chasm between basic discovery and application.”The academic question has been answered. Yes, it is possible tocreate adult blood cells through direct conversion from skin cells.“The thing is, scaling up costs way more than asking an academicquestion in a few Petri dishes with a relatively small groupof students,” says Bhatia. “Everybody asks me about clinical trialsand the truth is, until we have a grasp on how exactly we can scaleup and what our safety regulations and requirements are, I can’ttruly answer that question.”Several media outlets have cited early 2012 as a marker forclinical trials to potentially kick off, but Bhatia is loath to committo setting a timeframe.Shortly after the word got out, Bhatia began to receive phonecalls from people who were battling severe illnesses. They wantedto know when this could help them, what he could do for them.Bhatia is not, however, in the business of false hope. For now, hesays, it will have to be left open-ended.“In journals and in the media this is all very impactful,” saysBhatia. “But to me, if we don’t get somebody out of the hospitalearlier or prevent them from coming to the hospital again, it hasbeen insignificant, meant nothing. If we can’t help somebody inthe end then we didn’t have any impact at all.”What Bhatia does offer at this point is a physical target.“The immediate application we look at with this technology isin leukemic patients,” he says. “This is not just about applicationfor ease. This is where the clinical need is.”Leukemic patients who require bone marrow transplants areoften frustrated by the challenges of finding matching, willingdonors. Blood created by Bhatia’s technique could be a boon forthese patients as well as other cancer patients who must undergorigorous therapies. Once a first-in-man trial has been completedon leukemic patients, the information gathered can provide thefoundation for expansion beyond leukemia.Funding for innovationAtop a lengthy bookshelf in Bhatia’s office rest 17 empty champagnebottles, one for each major paper Bhatia and his researchpartners have published.A magnum of “whatever was cheap at the time” at the end ofthe shelf sports newly minted signatures scrawled across thelabel. A hint of sugary residue resides in the deeps of the bottle,a casualty of this most recent success.“The champagne symbolizes a finish or a culmination, solidifyingto the lab that the long hours, stress and near-misses wereworth it,” says Bhatia.The fate of this most recent bottle was sealed nearly a decadeago, before Bhatia took up his position at McMaster in 2005.“We started out looking or alternative sources of blood and wewere focused on embryonic stem cells,” says Bhatia.Induced pluripotent stem cells became the focus of hisresearch as an alternative source for embryonic stem cells, but20 Bio Business January/February 2011


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Breakthroughsneither of the cells were making the blood he wanted. As theresearch evolved, so did the question he was asking. He went fromasking “Where can we find alternative sources of blood?” to “Whydoes that source have to be stem cells?”Asking these sorts of questions, or having the ability to pursueanswers to them mid-research, would not have been possiblewithout the type of funding Bhatia’s lab receives.“This work that we have here wasn’t directly written. It’s notlike I came up with the idea a few years ago and applied for aMAGAZINE BIOPOLE BUSINESS 2010:Layout 21 10/12/10 8:41 AM Page 1The Laval BIOPOLE: a place, a passion,a vision, and a scientific business communityThe Laval BIOPOLE is a driving force in the scienceeconomy of Greater Montreal.With 85 biopharmaceutical, biotechnology and human health companies,the Laval BIOPOLE continues to grow and build on its academic, research,start-up, expansion and promotional infrastructures. Since 2001, theBiotech City has been part of this infrastructure and a contributor tothe growth of the Laval BIOPOLE. Become a part of this force, and joinour leaders.INRS – Armand-Frappier research CentreJewish Rehabilitation HospitalNational Experimental Biology CentreQuebec Biotechnology InnovationCentre – QBICActelion pharmaceuticals CanadaBoehringer IngelheimGSK BiologicalsRoche DiagnosticsSanofi-aventisServier CanadaAccelLABAlgorithme PharmaCIRION BioPharma ResearchCorealis PharmaElucid PharmaLAB ResearchWarnexLaval: a technopole that continues to grow.w w w. l a v a l t e c h n o p o l e . c o mAllosteraBELLUS HealthBio-K + InternationalLabopharmNew World LaboratoriesVertex pharmaceuticals(Canada)EmoviErgorechercheKlox TechnologiesValeant Canada1555 Chomedey Boulevard, Suite 100, Laval, Quebec H7V 3Z1 CANADATelephone: 450-978-5959 | Fax: 450-978-5970 | E-mail: info@lavaltechnopole.comgrant,” he says. “It was something that emerged. Although wedo have a lot of supporters, they are funding the lab and not thisspecific application. A huge chunk of our money comes fromdonations, from people who aspire to support innovative science.”It comes as little surprise that Bhatia is a proponent of openendedfunding for basic research.“If it’s truly innovative, then it’s not hypothesis driven,” he says.“This type of funding, with the flexibility it provides, is absolutelykey if you’re going to do innovativescience.”Innovative science leads to all sorts ofthings. Currently, Bhatia is working ondevelopment of other types of human cellsfrom skin and has a solid base of encouragingevidence. He also wants to developcell lines to use as mechanisms for drugdiscovery.“Imagine turning skin cells into cellsthat could be used for drug testing,” saysBhatia. “We’d have clinical trials in a dish.”This could also lead to an unprecedentedpersonalization of medicine. Drugsinteract with individuals in different ways,and the ability to test therapies on individualpatient cells to determine the mostsuitable therapy would be invaluable.But for now, Bhatia’s discovery that skincells can be reprogrammed as adult bloodcells means that eventually patients may beable to benefit from readily available, perfectlymatched blood. Elective surgerieswill not require hospitals to dig in toreserves. Instead, the patient may visit thehospital prior to surgery to have a sectionof skin harvested from the bum, a simpleprocedure commonly used with burn victims.When they return for whatever procedurethey might be set to undergo, a fewpints of what is essentially their own bloodwill be waiting to help them through.Cancer patients may be able to continuewith chemotherapy or radiation therapylonger, as the damage to the blood systemin the body could be negated.It also means that scientists have newevidence of how far the boundaries of theircraft can be pushed. Scientists across thevast span of disciplines can begin to ask, “Ifthis is possible, what else?”Bhatia’s discovery makes a case for theassertion that we may one day be able toproduce anything from anything else. BB22 Bio Business January/February 2011


FinancingPicasso in the atticEstablishing a patent litigation strategyis a smart business decisionBy John Norman, PhDThe best strategy for patent holders and infringers alike is toknow the patent landscape and prepare for patent litigationbefore it starts. This sounds obvious, but many companiesdo not know the value of their own patents or that of their competitors.Understanding the patent landscape can uncover hiddenassets. It can also allow companies to make quick and reasonabledecisions in enforcing patent rights, mitigating against being suedfor patent infringement or being ready for litigation if it happens.Patent auditsThe challenge to any company is uncovering patent assets alreadyin existence. This phenomenon has been likened to finding aPicasso in the attic. Patent audits may help determine untapped,unrealized and forgotten assets such as licensing opportunities,bargaining-chips in negotiation with suppliers or purchasers,potential alliances or partnerships, and even the sale of patentedtechnology and patents that are no longer part of the company’sbusiness plan.Mitigation is another important part of a successful patent andbusiness strategy. The most important factor in mitigation is tounderstand the patent rights owned by competitors. This alsosounds obvious, but those sued for patent infringement oftenadmit they did not know they infringed a patent in question.Knowledge of patents owned by competitors can also lead to noninfringingwork-arounds. Another mitigation strategy is to obtaina license for patented technology prior to use. In most cases, it ischeaper to obtain a license than pay legal fees and damages forinfringement. Mitigation planning will also highlight areas ofresearch and development that have been underexploited by thecompetition opening up previously untapped markets.Litigation proceduresAnother important litigation strategy is to put a plan in place thatsets out the procedures to follow if patent litigation occurs. It ismuch easier to interview and retain qualified patent litigationlegal counsel when there is no pressure to defend against patentinfringement. It also allows the company to evaluate litigationrisks and prepare legal strategies prior to being sued. This is crucialbecause once patent litigation starts, the patent infringer mustmake decisions quickly.The mere allegation of patent infringement can send stockprices tumbling. The biggest and most immediate threat to acompany is an injunction. Although difficult to get, an injunctioncan force the infringer to stop selling, making or usinginfringing products. This can have a negative impact on the bottomline especially in circumstances where the infringer has onlyone product or has a large amount of capital tied up in productsthat cannot be sold. Often tied to injunctions are orders requiringthe infringer to destroy or give to the patent holder allinfringing products.Damages and royaltyDamage awards can also negatively impact the bottom line.These awards can run in the tens or even hundreds of millionsof dollars. Damage awards are calculated based upon how muchprofit the patent holder has lost, not on how much money theinfringer has made. Thus, if an infringer sells an infringingproduct for bargain basement prices making little or no money,they may still be liable for damages based on the higher price thepatent holder would have charged for its product. A patentholder will typically elect this method if its losses are greaterthan what the infringer made. A patent holder can choose anaccounting of profits to calculate how much money an infringerowes. Under accounting of profits, the infringer is liable for allprofits it made on the sale of infringing products. A patentholder may prefer this option if it does not want to disclose itscost of production information to a competitor.Reasonable royalty is another possibility for assessing liabilityfor infringement. The court may impose a reasonable royalty if itfeels the infringer only received a partial benefit by using patentedtechnology. For instance, the court may impose a reasonable royaltyon the sale of a car that contains an infringing carburetor.Under this scenario, the court may require the infringer to pay apercentage of the sale price of each car sold. BBJohn Norman is a partner in Gowlings’ Ottawa Office. John may bereached at 613-783-8848 or by email, john.norman@gowlings.com.Visit us online at www.gowlings.com.January/February 2011 Bio Business 23


Know the lawHiring the right legal representation is important to thesuccess of a burgeoning biotech company. But with hundredsof firms across North American providing specializedbiotechnology expertise, the trick is finding the one mostsuited to your technology and goals.“A very important service for biotech companies is intellectualproperty,” says Micheline Gravelle, head of the Biotechnologyand Pharmaceutical Practice Group at Bereskin & Parr LLP.“The only asset they have in the beginning is the intellectualproperty, so developing a relationship with an IP firm is criticalright from the start.”Intellectual property law is often addressed before the detailsof the company are worked out. An innovation can take years tomove through the regulatory process and expert guidance is necessaryto get through those years comfortably.Is it patentable?The golden question a biotech should ask an intellectual propertylawyer, according to Charles A. Gaglia, a biotech and pharmaintellectual property lawyer with Gibbons P.C., is, “Is what I havepatentable?”Finding an answer to the question requires an in-depth searchof existing or pending patents and a side-by-side examination ofrelated patents by the intellectual property attorney.The technical nature of the biotech industry makes an experiencedattorney or firm invaluable, says Gravelle.Almost all of the members of the Biotechnology andPharmaceutical Practice group at Bereskin & Parr LLP have agraduate degree in a related scientific discipline, the majority ofwhich have PhDs.“The benefit is that they understand the scientists, which is acritical thing because if you don’t understand the invention, theprotection can be weak,” says Gravelle.Intellectual property is just one of many legal considerations.Biotech companies also require expertise in regulatoryaffairs, as industry regulations can be hazy and challenging tounderstand.“The regulatory side is highly complex,” says Gravelle.Biotech companies will want to make sure they ask prospectivefirms if they are registered to work in the U.S.Go big or go small?There are two options when seeking legal representation—the biglaw firm and the small, specialized firms.A big firm may have the capacity to work with a biotech onmultiple scientific fronts. Depending on the goals of the biotechcompany, this may be the most effective option. Larger firms alsooffer advice on tax law, employee benefits, immigration andlitigation, the mainstays of business operation.Smaller firms tend to have more focused expertise and mayhave more intimate knowledge of a particular subject.“It’s good to shop around to get an idea of what will work bestin the situation,” says Gravelle.“A company needs all kinds of information that they might beable to get from one lawyer, but more than likely they’ll have totalk to many different lawyers,” says Gaglia.Shopping around allows the biotech to get a feel for therapport that could develop with a law firm.Since the relationship between business and legal representationis a long and continuing process, good rapport is essential. BBLaw firms active in biotech and intellectual propertyALSTON & BIRD LLPIntellectual Property, Food, Drug andDevice Planning, Finance, Litigationwww.alston.comBERESKIN & PARR LLPIntellectual Propertywww.bereskinparr.comBORDEN LADNER GERVAIS LLPBusiness Law, Commercial Litigation,Intellectual Propertywww.blg.comEDWARDS, ANGELL, PALMER &DODGE LLPIntellectual Property, Mergers andAcquisitions, and Public Offeringswww.eapdlifesciences.comFROMMER, LAWRENCE & HAUGLLPIntellectual Propertywww.flhlaw.comGIBBONS P.C.Intellectual Property, Litigation,Corporate, Tax and Antitrustwww.gibbonslaw.comGREENBERG TRAURIG LLPIntellectual Property, Corporate andSecurities, Litigation, Regulatory,Compensation and Benefits, GlobalTrade, Immigration and Real Estatewww.gtlaw.comKENYON & KENYON LLPIntellectual Property and Patentswww.kenyon.com24 Bio Business January/February 2011


Business ServicesMAYER-BROWN LLPIntellectual Property, Transactions,Dispute Resolution and Antitrust,Government and Global Trade,Tax and Regulatorywww.mayerbrown.comMINTZ, LEVIN, COHN, FERRIS,GLOBSKY AND POPEO P.C.Antitrust, Litigation, CorporateGovernance, Intellectual Property,Licensing, Mergers and Acquisitionsand Venture Capitalwww.mintz.comLIST OF ADVERTISERS & WEBSITESBereskin & Parr.................................................. Page 25.....................................www.bereskinparr.comBiotalent............................................................. Page 21..............................................www.biotalent.caBlake Cassels..................................................... Page 10.............................................. www.blakes.comChemical Abstracts Services (CAS)..................... Page 11.................................................... www.cas.orgErnst & Young..................................................... Page 28................................................www.ey.com/caEppendorf.......................................................... Page 14, 27...................................www.eppendorf.comLAVAL TECHNOPOLE........................................... Page 22................................ www.lavaltechnopole.comTherapure.......................................................... Page 4.......................................www.therapurebio.comVWR................................................................... Page 2.....................................................www.vwr.comMORRISON & FOERSTER LLPFinance, Intellectual Property, Litigation,Regulatory and Internationalwww.mofo.comOGILVY RENAULT LLPBusiness Law, Litigation, IntellectualProperty, Employment and Labourwww.ogilvyrenault.comROPES & GRAY LLPIntellectual Property, Corporate Law,Litigation, Tax and Benefits, Labourand Government Relationswww.ropesgray.comSMART & BIGGAR/FETHERSTONHAUGHIntellectual Property, Technology Lawwww.smart-biggar.comVinson & Elkins LLPLitigation, Intellectual Property,Regulatory, Labour, Finance and Taxwww.velaw.comWIGGIN & DANA LLPMergers and Acquisitions, CorporateFinance, Intellectual Property,Real Estate and Licensingwww.wiggin.comWILMERHALECorporate Finance, Licensing, Mergersand Acquisitions, Intellectual Property,Real Estate and FDA Regulationswww.wilmerhale.comJanuary/February 2011 Bio Business 25


Business LeadershipRogerDumoulin-WhiteEngineer who turns prototype laser into a tool for destroyinglisteria bacteria—and now wants to blast cancer—discusses hiscompany and the importance for new businesses to fill a need.By Robert PriceIn 1993, Roger Dumoulin-White met his parents for dinner.His father, a jeweller, wanted to show Roger a laser he pickedup in Europe.“It’s a laser that heals tissue,” his father said.Roger, an engineer by training and an employee of the FordMotor Company, didn’t believe his father. Lasers don’t heal—theyburn. He told his father this.“No,” his father said. “It’s for real. This laser is an invisible laser.”“Even better,” Roger said. “You can’t see it. Look, I have toget going.”“It’s for real. I’ll show you.”Then Roger’s father clicked on the prototype and shot is ownarm.Roger quickly pulled the laser awayfrom his father. “What are you doing?” hesaid. “You’ll burn yourself.”The laser didn’t burn his father. Forfurther proof of the laser’s healing powers,Mr. Dumoulin-White gave his son a onepageanecdotal study, translated fromFlemish, that showed that the invisible laserlight increased the cellular mytosis rateof fibroblasts, the basic building blocksof tissue.The laser and the one-page study activated Roger Dumoulin-White’s curiosity for understanding how things work. He askedhimself: “How can light impact a biological system?”“We’re not plants. This isn’t photosynthesis,” he says. “Youcan’t go lie in the sun and cure all your ailments.”After a year-and-a-half of research and planning, Dumoulin-White resigned his position from Ford, purchased the worldwiderights to the laser technology, and went into business for himself.Years later, Dumoulin-White purchased the rights to a setof photodynamic compounds. In trials in late 2010, Theralasedeveloped an application for destroying liseria monocytogeneswith the photodynamic compounds and lasers. Dumoulin-White aims at turning his lasers and photodynamic compoundson cancer.“Small companies aretoo small to create amarket,” saysDumoulin-White. “Theyhave to fulfill a need.”Starting a business“From what I’ve seen in building any type of company, there aredifferent skill sets required at different levels of the corporation,”says Dumoulin-White. “Why ninety per cent of companies fail inthe first ten years is very hard to find an individual who has allthose skills sets all the time.”Dumoulin-White’s advice to biotech entrepreneurs: “Knowwhat type of individual you are and what skill sets you possess, andbetter, what your weaknesses are.”“Surround yourself with the people who fill in your weaknesses.”Entrepreneurs should also set their sights on needs, not markets.An engineer by trade, Dumoulin-White didn’t invent thelaser technology but worked hard to understandthe technology and what the laserscould do for people.“Small companies are too small to createa market,” says Dumoulin-White. “Theyhave to fulfill a need.”Research the idea, says Dumoulin-White, and ask: What’s the unaddressedneed that this science fulfills? Why wouldsomebody buy my product? Who are mycompetitors? Why aren’t my competitors doing the job?“The more you dig into it, the more you find that those areasare already filled,” says Dumoulin-White. “There are people thathave addressed it.”Start-up funding“Making money is like scooping water out of a pool,” Dumoulin-White says. “As soon as you do it, everybody else comes rushinginto fill the void.”But developing a product that generates revenue is the problemfor biotech.“It’s a catch-22 in building a company because you’re a young,unproven entity, you’re a one man show that needs capital and allthe support to get moving but nobody wants to give it to youbecause you’re an unproven entity.” BB26 Bio Business January/February 2011


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Looking to driveinnovation?Our Life Sciences team can help.We bring deep industry experienceand insight into market trends foremerging biotech or med-techfirms and global pharmaceuticalcompanies. Whether you’re forminginnovative alliances, improvingoperations or exploring newmarkets, we can help you find theglobal edge you need to win intoday’s competitive economy.What’s next for your business?ey.com/ca© 2011 Ernst & Young LLP. All rights reserved.

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