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November/December 2011 www.labbusinessmag.com

The definitive source for lab products, news and developments

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Portable Labs

Dying Bats

Cohen Commission

Canada challenged to compete for clinical trials

On Trial

Full page journal ad BioBusiness and Lab Business - BBU and LBU

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Lab business November/December 2011 3

Nov./Dec. 2011 www.labbusinessmag.com


standards5 EDITOR’S NOTE

6 NEwS

18 TECh waTCh

20 LaB waRE

whERE haVE aLL ThE CLINICaL TRIaLS GONE? Canada’s ranking as a place to conduct clinical trials has dropped steadily over the last five years with the number of clinical trials and trial sites dropping 30 per cent. Canada is now the most expensive country in the world in which to perform a clinical trial. Labs face significant challenges in bringing future trial work home. will government buy into industry’s action plan?

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November/December 2011 www.labbusinessmag.com


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ON TRIAL

inside

8 Saving the SalmonDavid Suzuki says we must address the structural challenges that plague fisheries management in Canada, in order to save the salmon.

9 North american Bats Ravaged by DiseaseAs a mysterious fungus commonly associated with White Nose Syndrome continues to spread, there is still little known about the disease because funds to further research are lacking, especially in Canada.

16 Portable Freezers Preserve Research Portable freezers can save time and money in the field and lack the drawbacks of other methods.

22 CERC Offer Lures Top ScientistDoug Wallace, new CERC in Ocean Science and Technology, and Technology and Science Director, Halifax Marine Research Institute, arrives from Germany and initiates collaborations.

21

10th Annual BioPartnering North America™

Growing Life Science Business in the Pacific Rim

www.techvision.com/bpn

10th Annual BioPartnering North America™Vancouver Convention Centre | Vancouver, BC, Canada26-28 February 2012

Now in its 10th year of success, BioPartnering North America (BPN) will build on strong relationships focusing more clearly on the Pacific Rim. Vancouver is well placed to provide these crossroads, where companies from around the world can access new business opportunities. With strong support from trade associations in Asia, Europe, North America, and elsewhere, together with creative input from our Advisory Boards, we are poised to take BPN to a higher level. BPN is a focused event for serious dealmakers and attracts participants from the highest levels of global organizations.

PRODUCED BY: POWERED BY: HOSTED BY:

Growing Life Science Growing Life Science

12bpn_biobusiness_122111.indd 1 12/22/11 11:56:14 AM


Serving Canadian Laboratories and Lab Suppliers since 1985

Publisher Christopher J. Forbes & CEO [email protected]

Executive Theresa Rogers Editor [email protected]

Managing Robert Price Editor [email protected]

Staff Writer Julia Teeluck [email protected]

Editorial Intern Justyne Yuen-Lee

Contributors Chelsea ShimDavid Suzuki Teri Theoret

Art Tammy Malabre Director [email protected]

Secretary/ Susan A. Browne Treasurer [email protected]

Director of New Business Jacquie Rankin Development [email protected]

Account Paul Rankin Manager [email protected]

Marketing Heather Kerr Manager [email protected]

Marketing Keri LaPlante Co-ordinator [email protected]

VP of Roberta Dick Production [email protected]

Production Crystal Himes Manager [email protected]

Production Joanna Forbes Co-ordinator [email protected]

Lab Business is published 6 times per year by Jesmar Communications Inc., 30 East Beaver Creek Rd., Suite 202, Richmond Hill, Ontario L4B 1J2. 905.886.5040 Fax: 905.886.6615 www.labbusinessmag.com One year subscription: Canada $35.00, US $35.00 and foreign $95. Single copies $9.00. Please add GST/HST where applicable. Lab Business Subscription and circulation enqui-ries: Garth Atkinson, [email protected] Fax: 905.509.0735 Subscriptions to business address only. On occasion, our list is made available to organizations whose products or services may be of interest to you. If you’d rather not receive information, write to us at the address above or call 905.509.3511 The contents of this publication may not be reproduced either in part or in whole without the written consent of the publisher. GST Registration #R124380270.

PUBLICATIONSMAILAGREEMENTNO.40063567RETURNUNDELIVERABLECANADIANADDRESSESTOCIRCULATIONDEPT.202-30EASTBEAVERCREEKRDRICHMONDHILL,ONL4B1J2email:[email protected]

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LabbusinessMagazinebiobusinessMagazine

Printed in Canada

editor’s note

Thescene:arepresentativefromamultinationaldrugfirmspeakstoasmallgroupofCanadianresearchersandbusinesspeopleataconferenceinToronto.sheexplainsthecompany’splantoprovidethebestcustomerservicepossible

to the contract research organizations it hires to conduct itsclinicaltrials.aftershefinishesherpresentation,amanatthefrontoftheroomraiseshishandandsays,“Whatdoyoumean,customerservice?You’retheclient.Weworkforyou.”

Therepresentativerepliesthathercompanywantstodevelopacultureofcus-tomerservicewhenitcomestodealingwithitsvendors.it’simportant,shesays,that the multinational be responsive to the small CRos it hires. so they’vedecidedtotreattheirvendorslikecustomers.

Theconferencebreaksforcoffee.Delegatesbreakintosmallergroupstosiptheircoffeeandtradebusinesscards.Puzzled,onegroupinthecornerwhispersaboutwhattherepresentativesaid.“Whatdoesitmeantocallvendorscustom-ers?”theyask.andwhatdoesitreallymean?

Canada’srankingasaplacetoconductclinicaltrialsisfallingdrastically.asweexplain inour cover story (p. 12), otherdeveloped countries are able to recruitmore people to clinical trials than Canada, and they can do this cheaper thanCanadianlabscan.Yearafteryear,developingcountries,noneofthemknownasbastionsofscience,attractmoretrialbusinessthanCanada.

now,notallislost.inspiteofitssize,Canadastilloutperformsmanyothernations.butthisadvantageisdisappearing.ThereasonswhyCanadahasslippedarestraightforward.Forone,it’shardtofindvolunteersinCanada.Canadahasasmallpopulationspreadovervasttractsofland.ourlargestcentresarepuddlestothehumanoceansofCalcutta,Tokyo,andbangkok.

The other reason Canada can’t compete involves regulation. You can sayCanadahashighstandardsoryoucansayCanadahastoomuchredtape.eitherway,gainingapprovalsforatrialinCanadaislaboriouscomparedtoPeruorspain.

andanotherreason:Canadiansarewell-educatedandwealthy.notmanyofusvolunteertotakeaneedleorpeeinacup.You’llfinduniversitystudentswillingtoeatpillsforaday’spaybutyouwon’tfindmanyotherCanadiansvolunteeringtheirliving bodies to science. The scene is different in developing nations, whererecruitingtrialvolunteersfromthepoor,illiteratemassesisconsiderablyeasy.

TheassociationofCanadianacademicHealthcareorganizationsisdevelop-inganactionplantoaddressCanada’ssituation.Theactionplanhastofindawayto ease regulations without sacrificing standards and to motivate reluctantCanadianstoparticipateinclinicaltrials.Therealityofourglobalizedeconomymay preclude whatever recommendations the action plan makes. Competingnationscanalwaysloosentheirregulations.Labscanalwaysfindanothervolun-teeracrosstheoceanandbeyondthedesert.

The Challenge of Trials

RobertPrice,Managingeditor

10th Annual BioPartnering North America™

Growing Life Science Business in the Pacific Rim

www.techvision.com/bpn

10th Annual BioPartnering North America™Vancouver Convention Centre | Vancouver, BC, Canada26-28 February 2012

Now in its 10th year of success, BioPartnering North America (BPN) will build on strong relationships focusing more clearly on the Pacific Rim. Vancouver is well placed to provide these crossroads, where companies from around the world can access new business opportunities. With strong support from trade associations in Asia, Europe, North America, and elsewhere, together with creative input from our Advisory Boards, we are poised to take BPN to a higher level. BPN is a focused event for serious dealmakers and attracts participants from the highest levels of global organizations.

PRODUCED BY: POWERED BY: HOSTED BY:

Growing Life Science Growing Life Science

12bpn_biobusiness_122111.indd 1 12/22/11 11:56:14 AM

6 November/December 2011 Lab business

news beat

Labs in Maryland face huge shortages of trained lab workers, according to a survey conducted by COLA, a U.S.-based clinical laboratory education, con-sultation, and accreditation organization. The survey found 62 per cent of labs face first-hand labour shortages and problems with retention and recruit-ment. The situation is not unique to Maryland, with more than 40,000 lab jobs across the U.S. sitting vacant, according to the Bureau of Labor Statistics.

We Have Good Chemistry Canada’s chemistry sector showed strong growth and profits in 2011, according to the Chemistry Industry Association of Canada (CIAC). Sales of basic chemicals and resins totalled $25 billion in 2011. Low-to-modest growth is forecast for 2012. CIAC members expect their sales to increase two per cent in 2012, as a result of global economic uncertainty, feedstock availability, the strength of the Canadian dollar, and rising electricity and labour costs. To read CIAC’s 2011 Year-End Survey of Business Conditions, go to www.canadianchemistry.ca.

Canada’s new $100 bill celebrates thecountry’shistoryofmedical innovation.

“This $100 note is a tribute to Canadianresearcherswhohavelefttheirmarkinmanyareas,” said Governor Mark Carney at thebill’s unveiling at the MaRs DiscoveryDistrictinToronto.Thebackshowsafemalescientistlookingintoamicroscopeandaviallabelledinsulinintheforeground.Thereleaseof the bill coincides with the 90-yearanniversary of the discovery of insulin byCanadianFrederickbantingandhisassistant,Charlesbest.

Thenewbill,madefrompolymer,issafer,cheaperandgreener,saysCarney.itisprintedon“Guardian,”abiaxial-orientedpolypropyl-ene substrate manufactured by securencyinternational of australia. Polymer is lesssusceptible to damage than paper and willbring cost savings, as the bills should lastat least two-and-a-half times longer thanpapernotes.

The$100notesarenowincirculationandthe$50notewillbereleasedinMarch2012.The$20billwillbeissuedinlate2012.The$10and$5billswillbeissuedin2013.

New $100 Bill Celebrates Innovation

Used with the permission of the Bank of Canada

U.S. Experiences Lab Labour Shortages

This isn’t a picture of a mouse, even though it looks strikingly similar toMickey Mouse. it’s actually a rotifer, a microscopic aquatic creature.

CharlesKrebscapturedtherotiferusingaspecialflashtocapturetherapidmotions of the rotifer’s cilia.Krebswon the2011 theolympusbioscapesDigitalimagingCompetition,acompetitionthathonoursimagesandmoviesofhuman,plantandanimalsubjectstakenthroughlightmicroscopes.

all the award-winning images and movies may be viewed online atwww.olympusbioscapes.com

Mouse Underwater

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Thenew$36millioniDaPTCentreforRehabilitation Research in Toronto is

oneof themost technologically advancedrehabilitationresearchcentresintheworld.Researchersnowhaveaplacetostudyhowadults with disabilities interact with theirenvironment. The iDaPT Centre isequipped with 12 labs, workshops andother research spaces such as stakeholderrooms where researchers can interactwithconsumers.

TheiDaPTCentre’sstarfeatureistheChallenging environment assessmentLab.ThislargesubterraneanresearchlabislocatedbeneathTorontoRehab’suniversityCentre.The lab features the world’s first

hydraulicmotionsimulatorthatcanmimiceveryday environmental challenges facedbytheelderlyandthosewithdisablingill-nessandinjury.Thesimulatorhasdifferentchambersthatcanbeliftedonandoffthebase to generate snow and ice, motion,slopesandterrain.

other labs in the facility include theControlled Climate Performance Lab,wheretemperaturescanrangefrom-20Cto35C.Here,scientistscanstudyhowthebodyrespondstoheatandcold.Theyalsoconductstudiestodesignfootwearthatcanpreventslipsinwinter.

in the three-bedroom sleep lab,researchersdevelopnewwaystotreatanddiagnose sleep disorders. The sleep labis equipped with state-of-the-art poly-somnographic, cardiovascular, audioandvideo-monitoring,andalertness-test-ingequipment.

Researchers focus on the development

of communication technologies in theCommunication Function Lab.They testand assess the effectiveness of devicesdesigned to help those with communica-tion disabilities understand or producewords in difficult environments. Thelab is equipped with clinical audiometers,and middle ear, brainstem, andotoacousticemissionanalyzers.

UBC Heads to india

The University of British Columbia recently announced

it will open offices in Bangalore and New Delhi. Since 2000, the university has quadrupled the number of international students from India with close to 290 Indian students at both its campuses.

The Bangalore office is led by the University’s Sauder School of Business. The school will partner with the Indian Institute of Management Bangalore and the Indian Institute of Technology Madras to increase student exchange, research partnerships and collaborative program devel-opment. The goal is to deepen connections within the Indian business community to increase job opportunities for the universi-ty’s students and alumni.

The New Delhi office will be opened in partnership with the University of Toronto. “India is a leading global innovator with many excellent scholars and stu-dents,” says University of Toronto President David Naylor. India is expected to be the fifth-largest economy in the world by 2050.

MottLab.indd 1 8/16/10 4:11 PM

aerospace Technology Meets rehab research


More Than a Commodity

By David Suzuki

In2007and2008,aviruswipedoutmillionsofsalmononfishfarmsinChile,slammingthecountry’saquacultureindustrywith$2billioninlosses,farmandprocessing-plantclosures,

and layoffs of 2,000 workers. now that same virus, infectioussalmon anemia, has been found in wild salmon from b.C.’sRiversinlet.

Thevirusnormallyaffectsatlanticsalmon,whichiswhatmostsalmonfarmsonb.C.’scoastraise,butitcanspreadandmutatequickly. scientists confirm that the virus found in the sockeyesalmonfromRiver’sinletwastheeuropeanstrain,whichmeansitalmostcertainlycamefromafishfarm.Wedon’tyetknowwhatitseffectonPacificsockeyesalmonwillbe,butitcouldbecata-strophic, especially considering all the other threats b.C.’s wildsalmonarefacing.Thereisnovaccineortreatment for infectious salmon anemia(whichdoesnotaffecthumans).

salmonaremorethanjustacommod-ity; they are an integral part of WestCoastecosystemsandculture.Theypro-videfoodformarinepredatorsandbears,eagles,andotheranimalsalongtheriversand lakeswhere they spawn.Thenitro-genandothernutrientstheybringfromtheoceanarespreadtothecoastalforestsbyanimalsthat feedonthefish.salmonalsoprovideahealthysourceofnutrition forpeople andhavebeenan important ele-mentofFirstnationsculturesformanygenerations.Losingthemwouldbedevastatingtolocaleconomiesandwouldhaveapro-foundimpactoncoastalecosystems.

infectioussalmonanemiaisjustthelatestinalistofthreatsidentified during the Cohen Commission of inquiry into theDeclineofsockeyesalmonintheFraserRiver.it’salsooneofseveral thathavebeen linked toopennet-pen fish farms.Theproblem of declining salmon populations is obviously biggerthan the sum of its threats. overfishing, habitat destruction,pollution,andfishfarmsareallissuesthatcanonlybedealtwithbyaddressingthelargerstructuralchallengesthatplaguefisher-iesmanagementinCanada.

TheCohenCommissioniswrappingupitshearingsandwillreporttogovernmentattheendofJune2012.TheDavidsuzukiFoundation,aspartoftheConservationCoalitionrepresentedbyecojustice,submittedrecommendationsonoctober17.oneof

the coalition’s main conclusions was that we can’t protect wildsalmonuntilwechangethewaygovernmentandFisheriesandoceans Canada operate. To begin, Fisheries and oceans ischarged with promoting the fish-farming industry, which isabsurd. it should focuson itsprimarymandateofusing strongscienceandmonitoringandenforcementtoconservefish.

CanadahasastrongconservationtoolwithitsWildsalmonPolicy.buteventhoughitwasreleasedin2005,ithasyettobeimplemented. Without the policy, and with conflicting man-datesandbudgetcutbacks,theDFohasnotbeenabletodoitsjobproperly.Thegovernmentshouldrestoretheindependenceand transparencyof scienceby re-establishingan independentfisheries research board. instead of cutting budgets, it should

providemoneyandresourcestomoni-tor and enforce regulations to protectfishandhabitat. itcouldstartbyput-ting money now used to promoteindustryintoscienceandconservation.

Thegovernmentshouldalsoaddressmajorthreatstowildsalmonbygettingopen net-cage salmon farms off wildsalmon migration routes and makingsure endangered stocks are not over-fished.butthat’s justastart.Weneed

tomovefromopennet-penfishfarmingtoclosed-containmentsystems that eliminate interaction between farmed and wildsalmon.Thegovernmentshouldalsodomore toconfrontcli-matechange,whichwillhaveanimpactonallmarinespecies.

The problems may seem overwhelming, but with strongpoliciesandregulations,adequateresources,andaFisheriesandoceansdepartmentfocusedonprotectingfish,wecanstarttoaddressthem.JusticebruceCohenhasheardfrommanypeopleandgroups,andwe’reconfidentthathisreportwillbethorough.ofcourse,wehopeandexpectthathewillincludetherecom-mendations of the Conservation Coalition as well as otherenvironmentalgroups,Firstnations,andall stakeholderswhocareaboutthesurvivalofwildPacificsalmon.itwillthenbeuptothegovernmenttoactquicklyontherecommendations.Thesalmondependonit.andwedependonthesalmon.LB

With contributions from Jeffery Young, David Suzuki Foundation aquatic biologist.

The government should restore the independence

and transparency of science by re-establishing an independent fisheries

research board.

Virus is another sign of failure to protect wild salmon

suzuki comment

research spotlight

Hundredsofdeadbatslitterthefloorsofbatcavesacrossnorthamerica.Dismemberedwingsandlegsarescat-teredthroughoutthedarkchamber.alloftheremains

haveonecommoncharacteristic:amysteriouswhitefluffgrow-ing along the corpse, most apparent on the muzzles of thesewingedrodents.

Little is known about Geomyces Destructans (G.Destructans), the fungus that leads toWhitenosesyndrome(Wns) and eventually death for so many bats. The fungusgrowsintemperaturesunder20Candistypicallyfoundonthemuzzles,wingsandearsofinfectedbats.

“imaginehavingyourwingsbeingdigestedwhileyousleep.itwouldbequitedisturbing.Thebatsaredisturbedoutoftheirsleepbydiscomfort.Theyalsoexperiencewaterlossfromtheirtissues and wake up cold, hungry and thirsty,” says Dr. GregThorn, associate biology professor at the university ofWesternontario.

G.Destructansdisruptsthenormalpatternsofhibernation,causing bats to awaken prematurely during their slumber at atime where their main food source, insects, are not as easilyaccessible.asaresult,therehasbeenanincreaseindeathsfromsymptomssuchasbodyfatlossandstarvation.

as White nose Syndrome ravages the bat population, researchers struggle to find a curePh

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Cluster of hibernating little brown bats with evidence of WNS.

By Chelsea Shim

Dying FundsDead Bats


research spotlight

an epidemicThefirstcaseofWnswasdiscoveredfiveyearsagoinacavenearalbany,nY.sincethenithasspreadto16statesintheu.s.andthreeprovincesinCanada:ontario,newbrunswickandQuebec.Todate,therehavebeenmorethanonemillionbatdeathsassoci-atedwithWnsinnorthamerica.

a2010study ledbybostonuniversity researcherspredictsthatthelittlebrownmyotis,oneofnorthamerica’smostcom-monbatspecies,willbeextinctinthenortheastin20yearsdueto thespreadof the fungusamonghibernatingbats ineasternnorthamerica.

astheepidemiccontinuestospread,thereisstilllittleknownabout the disease as funds to furtherWns research is lacking,especiallyinCanada.

Dr.brockFenton,anemeritusprofessoroftheuniversityofWesternontario,specializesinthebehaviourandecologyofbats.Hesaysneitherthefederalnorprovincialgovernmentsaremak-ingasignificantefforttoaddresspotentialsolutionstopreventthespreadofWns.

Fenton says the government has little to no care about thethreat facing thebatpopulation and silences the scientistswhospeak up and challenge the government. and he says thatalthoughscientistsneedthemoney,theyhavenocredibleideaofwhattheymaydotoalleviatethesituation.“nobodyknowsmuchabout the disease. scientists are literally chasing the unknown.Thisiswhythereisahesitationtoprovidethefunds,”hesays.

Six years onWhite nose syndrome, first identified in north america in2006, is often referred to as the “poorly understood disease”affectingbats.ithasbeennearlysixyearssincethediseasewasidentified,andalthoughthecauseofG.Destructansfungushasbeendiscovered,notreatmentsormeansofpreventingfurthertransmissionisknown.

Dr JianpingXu, associateprofessor of biology atMcMasteruniversityandamemberoftheinstituteforinfectiousDiseaseResearch,saystwofactorscontributetothislackofsupport.

Thefirstfactorislimitedresourcesandfundingingeneralforemergingandre-emerginginfectiousdiseases.Thesecondisthatmost,ifnotall,ofthefundingforinfectiousdiseaseshasgonetotheveryfewhigh-profilediseaseagents(flu,HiV,e.coli).Thelesser known ones, especially fungal pathogens, get very littleattention from granting panels within the infectious diseaseresearchcommunity.

Xu says fungaldiseasesdeservemore attentionbecause theyare“verycommonandcauseanincreasingproportionofemerginginfectionstoforests,crops,wildanimals,andhumans.”

studies have suggested thatWns was introduced to northamerica fromeurope. ineuropeanbat caves,hibernatingbatshavebeenfoundwiththeGeomycesfungusontheirbodies,butwithoutassociatedmortality.

evidence suggests the spread of Geomyces is likely human-assistedasnobatspeciesmigratebetweentheeuropeandnorth

america. because of this, many bat caves have been closed tohumansinordertopreventfurtherspreadofthedisease.

othereffortsthatarecurrentlyinplacetoprotectthespecies,suchasloweringthehumidityincavestoslowthefungalgrowth,are desperation measures. although they may have success insomeinstances,Thorncallsthemimpracticalaslong-termsolu-tions.Thesemeasurescanprovidetemporarysupportforinfectedpopulations,butwillprovidenoaidasalong-termsolution.

Thorn says a permanent solution can be devised fromresearchbutresearchevolvesfromfunding,whichisveryscarceforscientistswhowanttostudyWns.“Formanyofus,thisisgrant application time and the need for science funding inCanadaishigh.”

Thornsaysinrecentyearstherehasbeenapeakingovernmentsupportforindustriallyrelatedresearch,andadramaticdeclineinsupportfornaturalsciences.“Whitenosesyndromeisnotindus-triallyrelated,somoneytosupportbasicfungalecologyandbatresearch is hard to come by, it has been less and less over thedecade,”saysThorn.

alackofinterestinthematterisnotanissue.Thornsaysthenumberofbiologygraduatestudentsandpost-doctoratefellowsareontherise,butthefundingtosupportthesestudentsisdeclin-ing.Hehasnoticedtherehasbeenasubstantialdropinthenum-berofscholarships,grantsandawardshandedtothosewhostudynaturalsciencesinCanada.

active research in CanadaintheWillisbatLabattheuniversityofWinnipeg,Dr.CraigWillis,associateprofessorinbiology,focuseshisresearchoncur-


rentwildlifeconservationandmanagementissues,specificallyonWns.ResearchersintheWillisbatLabtesttheoriesinvolvingthe body temperature and oxygen consumption of bats undervariousconditions,andthroughthis,theyrecordtheeffectsthesefactorshaveonthesurvivalofinfectedbats.

Willis and his team captured bats during the fall matingperiodinthewinterof2010tostudythechangeintheirbodyconditions.Thispastsummer,theresearchteampublishedthefindings.

Theworkwasconductedinthefieldatagroupofcavesabout50 km north of Grand Rapids, Man. Research showed adultfemales entered hibernation with greater fat reserves and con-sumedthosereservesmoreslowlythanadultmales.ThefindingsledtothehypothesisthatadultfemalesmaybemorelikelythanmalestosurviveWns.

FundersforthestudywerenseRC,CanadaFoundationforinnovation, Manitoba Research and innovation Fund and batConservationinternational.Willis’labisonlyoneamongthefewbatlabsinCanadaactivelyresearchingWns.othersincludetheuniversity ofWesternontario,Theuniversity of Guelph, andMcMasteruniversity.

Dying bats, dying bees The american association for the advancement of sciencereportsthatthelossofbatsinnorthamericacouldleadtoagri-culturallossesestimatedatmorethan$3.7billioneachyear.batsserveasanaturalpestcontrolbysuppressingtheinsectpopula-tion;theyfeedonnocturnalinsectsthatdamagecropsandforests.abateatsupto60to100percentofitsbodyweightininsects

daily,whichlessenstheneedforexpensiveandpotentiallyharm-ful pesticides to protect crops. This also helps to prevent thespreadofinsect-bornediseases.ifthebatpopulationcontinuestodecline,itmayresultinanincreaseindiseasescarriedbymosqui-toes,suchasWestnileandmalaria.

specificbatspeciesalsoplayanimportantroleinplantpolli-nation. Like the honeybee, another dying species, they eat thenectar and transfer seeds. over 300 species of fruit, includingbananas,mangoesandguavas,dependonbatsforpollination.

The Canadian federal government recently announced itwouldprovide$1.19millioninfundingtobuildanewresearchfacility, the national bee Diagnostic, in beaverlodge, alta., inresponsetothebillionsofdeathsassociatedwithdiseasesaffect-ingthehoneybeepopulation.

The question is: Why the bees and not the bats? it comesdowntomoney.Whiletheeconomicvalueofbatsis$3.9billionperyearduetopestcontrol,theannualvalueofthehoneybeefaroutweighs the economicworthof bats.Due topollination andcropproduction,thevalueofhoneybeesisapproximately$20bil-lioninnorthamerica.

Canada falls behindWnsresearchintheu.s.ismoreprominent.DuetothelackofresearchgrantsfromtheCanadiangovernment,XusaysCanadaisfallingfarbehind.Hesaysthefundingforsurveys,monitoring,andresourcesismainlyprovidedbyamericanconservationagen-cies.“ThereisnotenoughgovernmentsupportforWnsresearch.indeed,therehasbeenlittleformalgovernment-sponsoredfund-ingforbasicresearchonWns,”saysXu.

Willisagrees.“MillionsofdollarshavebeenspentonWnsresearch in the u.s. For example, the experiments we’ve beendoing tounderstandwhat the fungusGeomycesDestructans isdoingtothephysiologyofthebatsarefundedbytheu.s.FishandWildlifeservice,”Willissays.

althoughtheprovincialMinistriesofenvironmentaredoingwhattheycantomonitorWnswiththelimitedsupport,Willissaysitwillnotbeenoughunlessthereisresearchdollarsspecifi-callytargetingbasicquestionsaboutthedisease.Willissayswhatwereallyneedarededicatedfederalandprovincialresearchfundstosupportbasicresearchonthisemergingwildlifedisease.

Last year, the united states Fish andWildlife service pro-vided a total of $1.9 million in grant awards to investigate thecauseofWnsandways tomanage it.anoctober2011pressreleasefromtheu.s.FishandWildlifeservicestateditantici-patesmoreawardswillbeannouncedinFebruary2012.upto$1millionmaybeavailableforhighpriorityresearchprojectscon-cerningWns.

CanadianresearchersinvolvedinthestudyofWnsareurgingothersinthescientificcommunitytobevocalandhighlighttheneedforfundingtofurtherresearch.TheyurgeCanadianstocallonthefederalgovernmenttoaddressWnsbeforetheproblemescalates.but asFenton says, itmaynotbe enough.“scientistswhodospeakupareoftensilencedbythegovernment.”LB

Little brown bat with fungus growth on muzzle.

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clinical trials

WithCanadaalreadyoneof the leastpopularplaces intheworldtoconductclinicaltrials,Canadianlabsfacesignificantchallengestobringfuturetrialworkhome.

Canadafacescompetitionfromdevelopedeconomiesanddevel-oping countries, where the costs of conducting trials is lower,findingpatientstovolunteerfordrugtestingiseasier,andregula-tionissimpler.

lowly rankedCanada’srankingasaplacetoconductclinicaltrialshasdroppedsteadilyoverthelastfiveyears.between2006and2010,thenum-

ber of clinical trials and trial sites inCanadadropped approxi-mately30percent,withclinicaltrialapplicationsfornon-genericdrugsdecreasingto596from777.

This flight of research from Canada sparked industry, aca-demiaandgovernmenttogatherinottawainseptember2011forthefirstCanadianClinicalTrialsummit.There,industryandpolicy-makers discussed Canada’s downward trend and workedonanactionplantoimproveCanada’scompetitiveness.

TheissueofCanada’sweakenedcompetitivenessisnotanewone. according to an article in the January 2009 Canadian Medical Association Journal,manypeopleinvolvedinclinicaltrials

TheLostDecadeCanada’s decline in clinical trials means profits for developing countries

By Julia Teeluck


believedthatcostandconflictingrequirementswereamongthecausesfortheCanadiansystem’sdisarray.inthearticle,RonaldHeselgrave, chair of the ethics board at the university Healthnetwork, said there is the fear that once clinical trials leaveCanadatheywillbedifficulttogetback.Thisfearmaybethenewreality.Clinicaltrialscontinuetodecline,andthereislittleincen-tive for companies to come to Canada except for a history ofexcellenceinresearch.“Whatwe’retalkingaboutisalostdecade,”saysJackCorman,President,institutionalReviewboardservices.“sonowwe’retryingtoplaycatchup.”

Corman says that how Canada proceeds depends on what

governmentwantstoaccomplish—torearrangethefurnitureortomakefundamentalchangetotheclinicaltrialsysteminCanada.“Talkischeap,andit’snotcheaptalk.Therearemillionsthathavebeenspent—andideliberatelydonotusetheterminvested—ongovernments constructing schemes to bring more research [toCanada],toharmonizeorcentralizeethicsreviewsinagovern-mentrunsystem,andthey’vebackfiredeverytime.somaybethistime it’ll work, but i’m not counting on it based on the pastrecord,”saysCorman.

Expensive researchCanadaisnowthemostexpensivecountryintheworldinwhichtoperformaclinicaltrial.althoughcostisonlyoneofthemanyfactors a company takes into consideration when choosing aclinicaltriallocation,thepricetodoresearchinCanadaisalmostdoublethatofspainandtheunitedKingdom.incomparingtheper-patient cost for the same trials, Canada is nearly twice ascostlyasFranceandGermany.

PatientrecruitmentaddstotheexpenseofconductingclinicaltrialsinCanada.Canadahasasparsepopulationandmarketingneededtoreachthesepatients isnotasplentifulorassophisti-catedasinothercountries.Researcherswhocan’trecruitalargesamplewon’talwaysgetsuperiordatafromthetrial.

“Thenameofthegameinclinicaltrialsisgettingthedata,”saysnormandLaberge,VicePresident,RegulatoryandscientificaffairsatRx&D.ifacountry is slowand inefficientatgettingresults,whythen,asksLaberge,wouldacompanytaketherisktoinvest there? “Canada went down significantly to the profit ofothercountries,”saysLaberge.

LabergeexplainsthatothercountriesarebeatingCanadaonthesesimpleadministrativeelements.“[othercountries]startupfaster so theycan recruitpatients longer.Trialswill start at thesametimearoundtheworld,butifwespendthreemonthsorsixmonths doing ethical reviews while the other countries arerecruiting,attheendofthetrialwewillhaverecruitedonlyhalfofthepatientsweweresupposedtorecruit,whiletheothercoun-triesrecruitedmaybe140percent.andthat’sthecaseofspain.Theyrecruit120percent,andthey’rehalfourcost,”saysLaberge.

Labergealsonotes thatbureaucracyat the startofaclinicaltrialcontributestoalossinperformance.Currently,forexample,ifatrialhas20sitesinCanada,thesponsorcompanymustsign20contractswitharepresentative(amanagerorcontractnegotia-tor)fromeachsite.Labergebelievesthecontractshouldbestan-dardized.Thesamegoesforethicalreviews.“Theotherthingisifwe’regoingto12differentsitesinCanada,whydo12differentethicalreviews?There’snoreason,”saysLaberge.

Laurelevans,associateDirector,Researchethics,officeofResearch services university of british Columbia, addressedthe issue of complicated administrative systems at the 2011annual Clinical Trials in Canada conference. she says theCanadianassociationofethicsReviewboardsviewsthestan-darddevelopedbytheCanadianGeneralstandardsboardasfartoodetailed.


clinical trials

“Wealsohavedifficultieswiththestandardbecausefromourperspectiveit’spartlystandardoperatingprocedure,andit’sfartoodetailedinmanyinstanceswhichconstraintheflexibilityofourresearchethicsboards,”saysevans.shesaysthatwhileguidelinesandrulesareuseful,researchethicsboardsmustmakedecisionsinrelation to a specific project site andinvestigator.“Theyneed tohavecertainflexibility around what they’re doing inthatrespect,”saysevans.

Cormanadvocatesharmonizedstan-dardsacrossCanada’smanyjurisdictions.Healsosaysresearchersneedaverifica-tion system for ethics committees inCanada.There isno federalornationalinspection system for ethic reviews.HealthCanadadoesnothavetheauthor-itytoinspectresearchethicsboardsnoristhereaCanadianaccreditationbodyforresearchethicsboards.itisthesponsor’sresponsibilitytoensureaclinicaltrialisconductedaccording to the regulations andgoodclinicalpractice.“Tomyknowledge,we are theonly country in theWesternworld thatdoesnothavesomekindofanoversightsystem,verificationsys-temforethicscommittees.ithinkthat’sahugeholethatneedstobefixed,butharmonizationalonewithoutastandarddoesn’tcut

it,”saysCorman.

Taking it elsewhere TherehasbeenrapidgrowthofclinicaltrialsinLatinamericaand eastern europe. The reason for outsourcing is complex.

Many companies choose to conducttheirtrialsdownsouthoroffshorewherecosts are low, the population is plenty,and the laws are “streamlined.” one ofthe reasons companies leave Canada,accordingtoCorman,isthatthequalityof research is improving in developingcountries.“oftenthequalityofthedatais as good, if not better than in theWest,”saysCorman.

While the data may be comparable,the level of regulation is not. a 2001

report from the Human Health Department, the u.s. govern-mentagencyresponsibleforhealthcare inamerica,notedthatthe pharmaceutical industry, national regulatory agencies, thenationalbioethicsadvisoryCommission,andtheWorldHealthorganization,allhadconcernsoverforeignreviewboardsandalackofexperienceandpoormonitoringpracticesinsomeclinicaltrials.althoughtheseconcernsarewelldocumented,thenumber

If a country is slow and inefficient at getting results, why then would a

company take the risk to invest there?


ofclinicaltrialstoLatinamericahascontinuedtogrow.The u.s. Federal Drug administration does not require

sponsorsofforeign-basedresearchtoconductresearchunderaninvestigational new Drug application, and does not requireforeign investigators to sign an attestationthat they will protect their human subjects.accordingtoa2010reportby the inspectorgeneraloftheDepartmentofHumanHealthservices, which outlines the challenges theFDa has in monitoring and inspecting for-eigntrialsites,sponsorsareincreasinglycon-ducting early-phase clinical trials at foreignsites without investigational new Drugapplications.Theapplicationsarenotrequiredfor trials conducted outside of the unitedstates, but are required for those conductedwithin the united states. The applicationinforms the FDa about the protocol of theclinical trial, about the qualifications of thestaff conducting the trial, and assures theFDa that the subjects involved in the trialwillbeprotectedandthatthesubjectswillnotbeexposedtoany“unreasonablerisk.”

Language barriers and a lack of intellec-tualpropertyprotectionmaypresentaprob-lemforresearchorganizationsthatchoosetodo research in developing countries. ManyLatinamericancountries,suchasargentina,Venezuela, brazil and Mexico, are on theunited states Trade Representative special301Report’sPriorityWatchList.Thereportis an annual review of the global state ofintellectual property rights protection andenforcement.

Despite these concerns, Corman says acountry’sabilitytorecruitlargenumbersofsubjectsquicklyintoclinicaltrialsisanimportantfactorforresearchsponsors.CormantellsthestoryofatopCanadianrecruiterwhowasabletorecruit150 patients for a trial.The sponsor was very pleased at theseresults.atalatermeeting,thetopCanadianrecruiterspokewithapersonwhohadparticipatedinaresearchsiteinTaiwan.Theresearcher had recruited 1,500 patients in one week for theTaiwan trial. More than 23 million Taiwanese live on the 36thousand-square kilometre island compared to the 34 millionCanadiansspreadovernearly10millionsquarekilometres.

What’s happening here WhenitcomestohealthcareinCanada,patientcarestealstheagenda. Clinical trials, an important part of patient care, are asecondaryconcern.Thisdividedmentalityshouldn’texist,Labergesays. if Canada wants to improve patient care, then attentionneeds to shift to clinical trials. Countries that conduct clinicaltrialsbenefitfromtheknowledgetransfer,thekeytoanyinnova-

tion policy in this country. “if the trials aren’t done here inCanada,whenthemedicineisgoingtobeapproved,wewillhavenoknowledgebaseonhowtoappropriatelyuseit,”saysLaberge.

Canadahasareputationforexcellenceinresearchandcontin-ues to attract clinical trials, in spite of lowpatientrecruitmentandhighcosts.Forexam-ple,inoctober2011,HealthCanadaapprovedCytonet, a biotechnology company based inGermany and the united states, to extend aphasethreetrial,currentlybeingconductedintheunitedstates,intoCanada.TheseLiCaiiitrialwillevaluatethesafetyandefficacyofliver cell therapy in children with urea cycledisorders, a genetic disorder of the liver thatcan lead to brain and nerve damage. ThealbertaChildren’sHospitalinCalgaryandtheHospitalforsickKidsinTorontowillpartici-pateinthetrial.

Cytonet’s decision to extend to CanadawasbasedonitsexistingrelationshipwithDr.aneal Khan at the alberta Children’sHospital,whosaidhewouldbeabletosecurepatientsforthetrial.“TheCanadianscientistthatwewereworkingwithhadalsocontactedus and said that they had the capability torecruit the patients—we’re dealing with anextremelyrarediseaseandi thinkthat’soneofthethingsyouhavetokeepinmind,”saysRodney Monroy, senior Director, northamerican Clinical operation at Cytonet.“We’relookingatgeneticdefectsinacertainsetofchildren,and[Khan]saidthatheoftenseeschildrenwiththistypeofdefect.andsohecontactedusandthey’recurrentlygettingready to pass through their review ethics

boards,sotheclinicalsite’sready,”saysMonroy.Dr.Khanexplainsthereisaneedforinnovativetreatmentsfor

ureadisorderandbringingthetrialtoCanadawouldallowthosefamilies whose children suffer from this disease an alternativetherapy.“We’rehopingthistechnologycanchangethisnumberaround,”saysDr.Khan.

The future of trials in CanadaGlenn brimacombe, President and Ceo of the association ofCanadianacademicHealthcareorganizations,sayshehopestheactionplan,which is indevelopmentbytheassociation,willbeavailablebytheendof2011.itwillincludesuggestionsmadebyparticipantsattheClinicalTrialsummitinottawaandwillserveasaroadmapforgovernment,industryandacademiatoaddressthebarrierstoclinicaltrialsthatarecausingCanadatofail.WhileCanada retains a reputation for excellence in research, thereremains competition from developing countries that can offeraccesstomorehumansubjects.LB

Top countries of growth in clinical

trial sites (2005-2010)

Japan

India

China

Russian Confederation

Argentina

Poland

Brazil

Australia


portable labs

Ensuring the integrity of critical samples collected in thefieldisbestdescribedasahassle.Dryice?itisunreliableatbestasthecontainermustbeventedtoallowthegasto

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Yetthedemandfordeepfreezingsamplespersists.Dr.PeterCranford,MarineecologistattheecosystemResearchDivision,Fisheries and oceans Canada, and adjunct Professor in theDepartmentofoceanographyatDalhousieuniversity, explainsthat“samplesprocessed in the field for flowcytometry analysisneedtobemaintainedatultra-cold temperatures.”For thepastthree years, Cranford has headed a study into mussels at thebedfordinstituteofoceanography.

“Theresearchwasconductedaspartofouroverallobjectivetounderstandcoastalecosysteminteractionswithextensivemusselaquaculture,”hesays.Heexplainsthatmusselshavearemarkablecapacitytofilterfoodparticlesfromlargevolumesofwater,andifenough mussels are present, they can deplete their food supplyandaffectwildspeciesthatalsorelyonthesamefood.

Cranford’s team collected water samples at a number ofremotefieldsites(withandwithoutmusselculture)forenumera-tionofphytoplankton types and sizespresent.Thedeep freezetemperatures(-40C)oftheFreePistonstirlingengine(FPse)Portable Freezer provided a uniform running temperature pre-servingthephytoplanktonpigmentsforflowcytometryanalysisatthe“home”lab.“Liquidnitrogenanddryiceshippingcontain-erswereinitiallyusedtotransportsamplesbyvehiclefromfieldsites, but required attention and ongoing costs. a one-timeinvestmentinaportablefreezerprovedtobeaneffectivealterna-tivethatsavedustimeandmoneyoverthecourseofthestudy,”heclaims.

The FPse Portable Freezer used by Cranford is one-of-a-kind inmoreways thanone. if you coulddeep freezeprecioussamples collected in the field, your firstwishmightbe for trueportability.Weighingjustunder15.4kgandhavinga25Lcapac-ity,itislightweightandyetsizeableforsufficientsamplestorage.Tobetrulyportable,youwouldwishfortemperatureuniformityfromthe“home” labtothe fieldandback.TheFPsePortableFreezerincludesa12VDCcordtopowertheunitinavehicle.Timespentinthefieldisnolongerdeterminedbythelimitationsofthemeansoftransport.

Freezing in the FieldPortable freezers give field researchers cold security

By Teri Theoret


“Thecolderwekeepthetissueaftersampling,thelesschangein chemical composition due to loss of volatiles or inducedchanges in the conifer tissue as a result of wounding,” Dr. Jonsweeneyexplains.sweeneyisaResearchscientistwithnationalResources Canada’s Canadian Forest service. To monitor thehealthofCanada’sforests,“weusedtheportablefreezertofreezesamples of conifer tissue [shoots, bark, phloem cores] immedi-ately followingcollection,aswellas samplesofconifervolatilescollectedonsolidphasemicroextractionfibres,whilewewereinthefielduntilwecouldgetthembacktothelabforprocessingorcoldstorage.Weusedthe(-18C)portablefreezerinthefieldanditworkedquitewell,”hesays.

TylerZubkowski,aquaticscienceTech,Fisheriesandoceans,salmon and Freshwater ecosystems at the Pacific biologicalstation in nanaimo, b.C., takes his portable lab to the ocean.Zubkowskiisontheteamstudyingjuvenilesalmonmetabolismand growth aboard the Viking storm, a 100-foot commercialfisheriesvessel.Thecollectionofthetissues[liver,brain,kidney,muscleandgill]isplacedintoalatersolutiontoinstantaneouslyprevent the breakdown of the mRna. “The samples are thenplacedtopreventanyfurtherbreakdownintothe-86CultracoldFPsePortableFreezer.ThesamplesrequireimmediatefreezingduetothefactthatmRnaishighlyunstable,”saysZubkowski.

ThepreviousmethodwastoplacesamplesintoaDewarcontain-ingliquidnitrogen,orwherenotpossibletouseaDewar[duetospace availability onboard research vessels], the samples wereplacedina–20Cwalk-infreezer.

Fieldresearchhasuniquechallengesandlimitationswhichareslowlybeingeliminatedwithnew,efficienttechnologiesliketheportablefreezer.Theengineinsidetheunitisunliketheconven-tionalcascadesystemsinrefrigeratorsandultra-lowtemperaturefreezersfoundinmostlabs.it’satime-tested,butunderdevelopedtechnologythathasbeenengineeredintoanefficientandreliablesolutionforpreservingsamplecollectionsinthefield.Thecoolingsystemincludesjustthreemovingparts,twointheFPse(pistonanddisplacer)andthetubeaxialfan.becausethepistonanddis-placer float on helium gas bearings, lubricants are not requiredandthesystemusesnooil.it’senergyefficientandquiet.Mostimportantly,theFPsekeepsyoursamplespreservedatthetem-peratureyouset,withoutfluctuation.

Therearemorethanenoughvariablesthatkeepscientistsupatnight.Repeatableandportablefreezinginthefieldoffersonelessvariabletoallowasclosetonearperfectconditionsforyourvaluableresearch.LB

Teri Theoret is Marketing Manager of Canadawide Scientific.

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scientist profile

DougWallaceneverthoughthe’dleaveGermany.butthen,DougWallaceneverthoughthewouldbeoffered a position as Dalhousie university’s first Canada excellence Research Chair (CeRC) in

oceanscienceandTechnologyandanappointmentasTechnologyandscienceDirectorofthenewlyopenHalifaxMarineResearchinstitute.

“being awarded the CeRC is not only a great honour, but it’s also a fantastic opportunity,” saysWallace.“itallowsmetoreturntoCanadaandhitthegroundwithmyresearchprogramrunning.”

Theappointmentcomeswith$10millioninfederalgovernmentfundingwhichwillallowWallacetodevelopnewobservationinstrumentsthataremoresensitiveindetectingbiogeochemicaloceanicchangethancurrentmethods.stationedonnumer-ousvolunteershipsandothermarinevessels,thesetoolswillgatherinformationaboutthefundamentaltransformationshappeningintheoceans.

the Canada excellence research Chairs program is an international draw.“When theCanadaexcellenceResearchChairbecamea realpossibility, itwasanoffer that was attractive enough to draw me away from the rather good Germanscientificfundingsystemandinfrastructure.”

Collaboration is essential.“TheideaoftheHalifaxMarineResearchinstituteistofindamechanismfordiffer-entgroupstoworktogethereffectivelyanddosomethingmuchbiggerthantheycandoon theirown.Theawardingof the shipbuildingcontract (inoctober,Halifax’s

irvingshipbuildingwasawardeda$25-billioncontracttobuild21Canadiancombatships)willdefi-nitely help us because we were heavily involved in helping irving shipbuilders get that contract andthey’reveryinterestedalsoingrowingmarinetechnologyhereandmarinescienceintheregion.”

Canada has some work to do.“There’s a need for more national organization for large-scale infrastructure for marine research inCanada.someoftheinfrastructureisreallyexpensive.Researchvesselsarehugelyexpensive.There’saneedtomakethediscussionandthelong-termplanningofinfrastructuremuchbroader.”

observation is essential.“Myareaofresearchisveryheavilybasedonobservationsandtheproblemwithobservingtheoceanisit’senormous,soit’sverydifficulttoobserve,especiallybeneaththesurface.Thisisabigproblembecausethat’swheremuchoftheactionis.That’sreallywhatmostofmyresearchisaimedat:observingtheoceanandtryingtofindnewandbetterwaystoobserveit.”

some of the best ideas are borne of necessity.“Whenyoumakemeasurementsatseaitsometimesrequirestakingverycomplexinstrumentationandispentmywholelifedoingthis;dismantlingequipment,puttingitinboxes,shippingitoverseas,rebuild-ingitoverseasandlearningthatyouforgotaparticularscrew.We’llhavefivecontainerizedlaboratoriesthatarepartofthelaboratoryitselfsowhenthey’renotatsea,they’llbenextdoorwithfreeaccesstomymainlaboratorysostudentscangobackandforth.ithinkthisisafairlyuniquething.usuallywhathap-penswiththesecontainersiswhenthey’rebroughtbacktoland,youunloadtheequipment,putitbackinyourlab,andtakethecontainerandstoreitinaparkinglotsomewhere.”LB

Doug WallaceBy Theresa Rogers

CERC in Ocean Science and Technology, and Technology and Science Director, Halifax Marine Research Institute

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