Solving The Grand Challenge of Delivering Safe and Efficacious Life-Changing Medicines
SincetheeraofWorldWarII,thepharmaceutical industryhasmadesuperlativeprogressand advancementschurningoutmedications,antibiotics, vaccines,etc.thathavetransformedpeople’slivesradically. Althoughthere’snodoubtthatpharmaceuticalcompaniesare highlyfocusedoninnovation,theindustryisfacingnewchallenges thathavetobedealtwith.
Inthepast,severalpharmaceuticalcompaniesgavelessprecedencetotheiroperationsstrategywhen facedwithcompetitionfromotherplayers.Today,theyhavetoreconsidertheirchoicesinsourcing, manufacturing,andsupplychaininconsiderationoffactors,suchasinflation,therecentpandemic outbreak,newtherapeuticmodalities,geopolitics,andnewapproachestobusiness.Tosucceedunder thesenewchallenges,pharmaceuticalcompanieshavetorenewtheirfocusonoperationsstrategy.
Operationalleaderswithintheindustrynowneedtolookatthingsfromalong-termperspectiveand scaleuptheiractivitybyworkingwithtalent,operatingmodels,embracingdigitalization,andbuilding networkstrategyandresilience.Althoughthesechallengesdemandalong-termsolution,short-term responsescanbeincludedasapartofthetotalresponse.Forinstance,ifacompanyrealizesthatthey aredealingwithproblemsassociatedwithanunpredictablesupplychain,itcouldfollowashort-term approachwhereinventorycanbeincreasedwhilealsofixinguparobustend-to-endsupplychain digitalcenterforalong-termapproach.
Talkingoftherecentdisruptionsandchallengesbroughtonbythepandemic,it’sevenmorecrucialfor pharmaceuticalorganizationstoacceleratetheirwaysofworkingandbuildaconcreteactionplannow Doingthiswillensureexecutionexcellenceandnewcapabilitiestofacetheheadwindsintheindustry anddrivethenextwaveofgrowthforpharmaorganizations.
Best, DanielShelby ManagingEditor TheChief'sDigest editor@thechiefsdigest.com
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Foundedin1997,Medicureisavalue-basedpharmaceutical companycommittedtothedevelopmentandcommercialization ofinnovativeandaffordabletherapeuticsfortheU.S.market.
WaverleyPharmaInc.isaspecialtypharmacompanythatis dedicatedtothedevelopmentandcommercializationofsafe, effectiveandaffordablecancertherapeutics.Thecompany’s currentfocusisonthegenericoncologyinjectablemarketin theEuropeanUnionandNorthAmerica.
SyneosHealthisanintegratedbiopharmaceuticalsolutions organizationthatstrategicallyblendsclinicaldevelopment, medicalaffairs,andcommercialcapabilitiestoaddress modernmarketrealities.
Parexelisamongtheworld’slargestclinicalresearch organizations(CROs),providingthefullrangeofPhaseItoIV clinicaldevelopmentservicestohelplife-savingtreatments reachpatientsfaster
Merckisattheforefrontofresearchtodeliver innovativehealthsolutionsthatadvancetheprevention andtreatmentofdiseasesinpeopleandanimals.
KaneBiotechisabiotechnologycompanyengagedinthe research,developmentandcommercializationof technologiesandproductsthatpreventandremove microbialbiofilms.
CannaraBiotechisaverticallyintegratedproducerof premium‐gradecannabisandcannabis‐derivativeproducts fortheQuebecandCanadianmarkets.
ROSELifeScienceisrevolutionizingresponsiblecannabisfor QuebecersandCanadians.Wedoitbyenhancinghowcannabis grows,thencreatinganddistributinginnovativeproducts.
Pure
PureSunfarmsisoneofCanada'slargest,single-site,licensed producersofgreenhouse-grown,recreationalcannabis.
CanopyGrowthCorporationisaworld-leadingdiversified cannabiscompany.Weoperateacollectionofdiversebrands andcuratedstrainvariety,supportedmillionsofsquarefeet ofindoorgreenhouseproductioncapacity,partneredwith someoftheleadingnamesinthesector
Medicure WaverleyPharmaInc SyneosHealth Parexel JamieMacdonald CEO CanopyGrowth Corporation Merck RobertM.Davis Chairman&CEO Sunfarms KaneBiotech CannaraBiotech ROSELifeScience Dr.AlbertFriesen Founder LarryThiessen CEO MichelleKeefe CEO MarcEdwards CEO BrianStevenson CEO DavidKlein CEO ZoharKrivorot, CEO MandeshDosanjh CEO
OfftheGrounds
Followingthedevelopmentof WinRho,oneofCanada'sfirst successfulbiotechproducts,Dr.Albert FriesenlaunchedMedicureon September15,1997,asaWinnipegbasedbiotechcompanyfocusedon developingcardiovasculardrugs.
Thegoalofthecompanywastobring itsfirstproduct,MC-1fromconceptto FDAapproval.Fromthestartof developmentin1997through2008, Medicureraised$140millionand drovethedevelopmentofMC-1from anidea,throughpre-clinicalstudies, Phase1's,severalPhase2's,andthento thepivotalPhase3clinicaltrials seekingFDAapprovalforaverylarge unmetmarket:protectionagainst
ischemicreperfusioninjuryin cardiovascularpatientsundergoing bypasssurgery.
However,basedonelementsofthe studydesign,thepivotalPhase3trial ofMC-1didnotachieveitsprimary endpoint.Thesewerechallenging timesforMedicure,butthecompany wasabletosurvivethrough2008 whentherewasonlysufficientcashto carryontheexistingbusinessfor about6months.
Duringthistransitionperiod,theteam pivotedtofocusonmarketing Aggrastat(tirofibanhydrochloride) injection:aMerck-developedproduct acquiredin2006.Despitetheodds againstthem,theygrewAggrastat salesfrom2%oftheUSglycoprotein iib/iiia(GP2b/3a)inhibitormarketto over65%.
BuoyedbythesuccessofAggrastat,in 2017,Medicuremadethestrategic acquisitionofApicorePharmaceuticals LLCandlaterdivestedthecompany forasaleof$140millionand significantprofit.Medicurethen returned$26milliondollarsinprofits fromthissaletoinvestors.
In2017,Medicureexpandedits portfoliointotheprimarycaremarket andbeganmarketingZypitamag (pitavastatin)tablets,anext-generation statin.Thiswasapharmaceutical alternativetoabrandedcompetitor withanestablishedmarketshare.
Medicureranintoseveralroadblocks asacompanytryingtogetthis medicationcoveredbyinsurance companiesandtheassociated pharmacybenefitmanagers(PBMs).
“There were times we offered remarkably high rebates of 75–80% of the listed price but we were still rejected (by PBMs). They said that while the net price was on par with generic statin pricing, the reason they (were denying) coverage was that it would 'hurt their quality metrics.”–saidDr.NeilOwens, President,andCOOofMedicure. TiredofthePBMrun-aroundand motivatedtogetZypitamagto patientswhocouldmostbenefit fromitsuse,Medicuredecidedto bypassthePBMsandselldirectlyto USconsumers.So,thecompany madeadealtopurchaseMarley Drug,anindependentpharmacy licensedtodispensemedication acrosstheUS.
OnDecember16,2020,Medicure begansellingdirectlythrough MarleyDrug,makingitoneofthe firstmanufacturerstousethisgamechangingmodel.Theynowoffer thisbrandedproduct,Zypitamag,at acashpriceofjust$1.15/day This is90%lessthananyotherbranded productavailablethroughinsurance andisjustasprofitabletoMedicure. Medicurealsooffersapproximately 1,000otherFDA-approved medicationsthroughitspharmacy andE-commerceplatform.
Medicurecontinuestoengagein researchandhasstartedanother Phase3clinicaltrialwiththesame moleculeithadstarteddeveloping in1997:MC-1,thistimeforarare pediatricdiseasethatcausesseizures inchildrenandisfatalifuntreated. [MC-1isbeingtestedtotreat pyridox(am)ine5'-phosphate oxidase("PNPO")deficiency.PNPO deficiencyisaninbornerrorof
vitaminB6metabolism,which causesanepilepticencephalopathy responsivetopyridoxal-5-phosphate (PLP).]Thisstudyisscheduledto begininearly2023. Gaining approvalcouldbeagame-changer forthecompany,asMedicure receivedorphandrugsandrare pediatricdiseasedesignationsfrom theUSFoodandDrug AdministrationforMC-1forthe treatmentofPNPOdeficiency.The approvalmakesMedicureeligibleto beawardedapriorityreview voucher,whichtypicallysellsfor USD$100-200million,whichcan helpaccelerateMedicure'sgrowthin itsnextchapter
Excerpt from The Chief Digest's interaction with Medicure
Whatroledochangingpolicies, mountingexpenses,andmargin pressuresplayinaffectingthestate ofthepharmaceuticalindustry?
Generally,lowermarginsimpactthe numberofcompetitorsenteringa particulartherapeuticspaceor manufacturingarena.Let'stakefor examplethegenericdrugarena, wherelowermarginsmayleadto drugshortages,whichisachronic concern.Oftenseveralmanufacturers enterthegenericdrugarenawhena druggoesoffpatentbutasmargins fall,themanufacturersoftenface pressuretodivertresourcesto anotherdrugthatwillbemore profitableandceaseproduction.This leadstoshortagesthatmaytakea verylongtimetocorrectitself,ifat all.Manyoftheseshortagescould alsocreatedisparitiesincompetition wherebyagenericdrug,whichin theoryshouldbelessexpensive,may bemoreexpensiveorfacenoprice
erosionduetofewcompetitors manufacturingtheproduct.Generally, thereisnoimpactonqualityfromlower marginsastherearestringent regulationsandcriticaloversightthat mustbemettoenterthemarket. However,itforcesmoremanufacturing anddevelopmentoffshoretocountries withlowerproductioncoststhus impactingthenationaldrug manufacturingeconomy.
Somelegislationsweareclosely monitoringrelatetounderstanding provisionsandimplicationssurrounding theInflationReductionAct,drug importationfromCanada,changesto the340bprogram,andrules surroundinghowPBMscanoperateand theroletheyplayindrugpricingand access.
Whatareyourofferingsand capabilitiestothepublic?Howdo youensurehighstandardsof operationalproductivityand efficiency?
Weoffermedicationwithintheinhospitalsetting,withAggrastatand sodiumnitroprusside,andinthe primarycarespace,withZypitamag.To ensureoperationalproductivityand efficiency,wesetimportantmetricsthat alignwithMedicuregoals.
Ourin-hospitaldrugs,whichareacute careinjectables,arecomplexmolecules withcriticalandnuancedmanufacturing steps.Wehavedetailedoversightinto allaspectsofthemanufacturingprocess andareinfrequentcommunicationwith ourpartnerstoensureaconstantsupply Wealsocarryoutvigilantmonitoringof oursuppliesandthemarketsweoperate intoensureenoughsupplytomeet demand.Onceourproductsare manufacturedandavailablefor
purchase,wethenensurethereisaccess tothemthroughthevarioussupply chainintermediaries,likenational wholesalers.So,thistootakesanother levelofoversighttoensurethatall stakeholdersinthesupplychainare adequatelysuppliedandthatno hospitaleverexperiencesastock-outor waitsforalongtimetoreceiveour products.Asimilaroperational oversightandmetricslevelisemployed forourprimarycaredrug,althoughthe manufacturingprocessisnotas complex.Overall,weemploya watchfuleyenotonlyonthe manufacturingprocessbutalsoonthe marketforcesthatmayimpingeonthe supplychain.
WithourDirect-to-Patientpharmacyecommerceplatform,weofferallFDAapprovedmedicationand approximately1,000ofthese medicationsareofferedataverycosteffectivepricewhichenablesaccessby allAmericans.Mostofthese medicationsareamongthemost prescribedmedicationsinthecountry Towardsoperationalproductivityand efficiencywithournationalpharmacy, weemploypatient-focusedmetrics.In thiscase,weareaffordingaccessto medicationwedon'tmanufacturebut areprovidingaccessto.Therefore, sourcingtheseproductsatan acquisitioncostwherewecanpasson thesavingstoourclientsisaprimary metricforus.Weworkwithmany partnerstoacquirethelowest acquisitioncostwhilenot compromisingsafety.Wearealso constantlysurveyinge-commerce competitorsinseveralsectorswithan eyetowardimprovingefficienciesin orderingandcustomerservicesothat theoverallprocessmeetsandexceeds industrystandards.Finally,delivering
PosttheCOVID-19pandemic, howhasyourbusinesschanged?
Thepharmaceuticalindustryhas reallyreliedonin-person communicationwithhealthcare providersoverthepastfewdecades. TheCOVID-19pandemicdefinitely changedthat,andwe'reseeingmore andmorehealthcareproviders willingtomeetwithusvirtuallyto learnaboutourproducts.Thisisa realadvantageforus,especiallyasa smallerpharmaceuticalcompany Wecanspendlesstimetravelingto meetwithhealthcareprovidersand moretimetalkingwiththem,but virtually.
We'vealsoseenalargeincreasein thewillingnessofhealthcare providerstolearnonline, particularlythroughsocialmedia. We'veadaptedourmarketing strategiestomakesureweare gettinginfrontofhealthcare providersastheirhabitshave changed.
Anotherkeyparametertoconsider fromtheCOVID-19pandemicis budgetaryconstraints.Withboth AggrastatandZypitamag,we'vehad arealadvantage-we'vebeenableto sellbothproductstohealthcare providersasnotonlyaclinical benefittotheirpracticebutalsoasa financialbenefit.WithAggrastat, thosecostsavingsappliedto hospitals,andforZypitamag,those costsavingsappliedtopatients,in thattheywerepaying90%lessfor brandedpitavastatin,andtoclinics, inthattheywerespendingwayless administrativetimefightingwith insurancecompaniestogeta brandedproductapproved.
medicationtopatientsinatimely manneracrossthecountryisalso anotherimportantmetricwemonitor andimproveuponwhennecessary
Doyoufeelthereisfierce competitioninthepharmaceutical space?Howwouldyouhighlight yourcompany'scompetitive advantages?
Thepharmaceuticalspaceisvery competitive,bothintheinnovationof newproductsandinthegenericspace. Medicurehasbeensuccessfulby focusingonourvaluepropositionto physicians,pharmacists,andpatients. Wefindthatbeyondafleeting transactionalexperience,our stakeholderswantinformationand support.Wehavealwaysfocusedon robustclinicalevidenceanddatainour conversations,aswellashowwecan savehospitalsandpatientsmoney, whichhasbeenasuccessful combinationforus.
Inyouropinion,whatdoyouthink arethekeychallengesinthepharma sector?Isthereapossiblesolutionto that?
Whenitcomestopromotingbranded FDA-approvedproductsintheUSa keychallengerightnowispatient access.Companiesaregoingtohaveto getsmarterandbecomemorecreative todevelopsolutionsforpatientsto accesstheselife-savingmedications.
Couldyoushedsomelighton upcomingproductsandpatents,if youhaveany?Whichproductsare thekeyhighlightsofyourcompany?
Weareveryexcitedaboutthree excitingavenuesforusrightnowZypitamag(pitavastatin)tablets, MarleyDrug,andMC-1.
Zypitamag(pitavastatin):Wehavethis greatproductthatwebelievecanhelpa lotofpeople,butthismolecule, pitavastatin,hasneverbeenaccessible toAmericansbecauseoftheoutrageous costs.WefeelthatwithourDirect-toPatientmodel,sellingZypitamag throughamanufacturer-owned pharmacyisgame-changing.Thebest partisthatthismodelisjustas profitableforusasthetraditionalPBM route.Theonlydifferenceispatientsare paying90%lessforthemedication, prescriptionsareneverabandoneddue tocost,andthereisalwaysproduct availability.It'sawin-winforpatients andthere'sanaddedbenefitfor providersinthattheydon'thavetofight withinsuranceanymoreandgothrough step-therapiesorpriorauthorizations whichisahugeadministrativeburden forhealthcareprovidersrightnow.
Second,MarleyDrug.MarleyDrugisa nationwidepharmacywithhuge potential.Wearesellingmedicationat affordablecostinall50states.Weusea veryfairpricingmodel.Wepriceour medicationsbasedonwhatitcostsusto buythem.It'sthatsimple.Webuy medicationsfromwholesalers,cutout thePBMmiddlemen,andpassonthose savingsdirectlytopatients.Thereisa growingunderstandingintheU.S.that forginginsuranceandpayingcashfor yourmedicationsisactuallyabetter dealandMarleyDrugisagreatresource forpatientstogetaccesstothese medications,regardlessofwherethey live.Wealsoofferlongerfillsthanother pharmacies,upto12months,whichcan savepatientsalotofmoney,andthereis datatosuggestitalsoisbetterfor patientcomplianceandadherence.
Lastly,we'rereallyexcitedaboutMC-1. ThisproductwaswhatstartedMedicure, andwhiletheoriginalindicationfailed
itsPhase3trial,we'resoexcitedto belaunchinganewPhase3trialfora rarepediatricconditioncalledPNPO deficiency.Manyfamiliesoutthere canreallybenefitfromthat,asthere isanunmetneedforpharmaceuticalgradevitamintherapyforthis condition.Inaddition,orphandrugs andrarepediatricdisease designationsfromtheFDAenable Medicuretobeeligibleforapriority reviewvoucher,whichtypicallysells forUSD$100-200million.
Howdoyouseethecompany changingoverthenextfewyears, andhowdoyouseeyourself creatingthatchange?
Theworldismovingonline.We expectaboomintheonline
pharmacyindustry,andwebelieveour E-Commercepharmacy,MarleyDrug willbeakeypartofthat.We're currentlyworkingonimprovingthe workflowsoourcustomerscanhavea smoothandtrustworthyexperience onlinewhenitcomestoorderingtheir medications.
Withthesuccesswehaveseenwith Zypitamag,wearealsohopingtofind similarproductsthatcouldreallybenefit fromaDirect-to-Patientmodel. Whetheritbethroughapartnership,or purchasingaproduct,weseerealvalue inthismodelasawaytopropelproduct growth.
Dr AlbertD.Friesenisthefounderand hasservedasCEOandBoardChairof MedicureInc.since1997.Heisalsoa founderandservesasPresidentof GenesysVentureInc.(GVI).Dr.Friesen hasbeeninstrumentalinthefounding anddevelopmentofseveralhealth industrycompanies,including DiaMedicaInc.andABIBiotechnology (whichbecameApotexFermentation andnowCronosFermentation), Canada'sfirstprofitablebiotech company,andtheWinnipegRh Institute,whereheledthedevelopment ofCanada'sfirstbiotechproduct, WinRho.Dr.Friesenhasalsoplayeda keyroleinanumberofregionaland nationalorganizations,includingasa founderandfirstBoardofDirector ChairoftheIndustrialBiotechnology AssociationofCanada(now BIOTECanada).Dr.Friesenreceived hisPh.D.inproteinchemistryfromthe UniversityofManitoba.
“Our vision is to become a leading pharmaceutical company within the U.S., offering a growing portfolio of products that improve patients' lives.”
Dr. Albert D. Friesen, Founder & CEO
Formorethan130years,we havebroughthopeto humanitythroughthe developmentofimportantmedicines andvaccines.Weaspiretobethe premierresearch-intensive biopharmaceuticalcompanyinthe world—andtoday,weareatthe forefrontofresearchtodeliver innovativehealthsolutionsthat advancethepreventionandtreatment ofdiseasesinpeopleandanimals.We fosteradiverseandinclusiveglobal workforceandoperateresponsibly everydaytoenableasafe,
sustainable,andhealthyfutureforall peopleandcommunities.
Ourvaluesrepresenttheverycoreof ourcharacter Theyguideevery decisionandactionwetake.
Patientsfirst:Weareallaccountable fordeliveringhigh-qualityproducts andservices.Weaspiretoimprove thehealthandwellnessofpeopleand animalsworldwideandtoexpand accesstoourmedicinesandvaccines. Allofouractionsmustbemeasured
againstourresponsibilitytothose whouseorneedourproducts.
Respectforpeople:Ourabilityto exceldependsontheintegrity, knowledge,imagination,skill, diversity,safety,andteamworkofour employees.Weworktocreatean environmentofmutualrespect, inclusion,andaccountability.We rewardcommitmentandperformance andareresponsivetotheneedsofour employeesandtheirfamilies.
Ethicsandintegrity:Weare
Aspiring to Be the Premier Research-Intensive Biopharmaceutical Companycommittedtothehigheststandardsof ethicsandintegrity.Weareresponsible toallofourstakeholders:employees, patients,customers,distributorsand suppliers,shareholders,andthe communitiesweserveworldwide.We donottakeprofessionalorethical shortcuts.
Innovationandscientificexcellence: Wearededicatedtothehigheststandard ofinnovationandscientificexcellence. Ourresearchisguidedbya commitmenttoimprovinghealthand qualityoflife.Westrivetoidentifyand meetthemostcriticalneedsofpatients andcustomersthroughcontinuous innovationacrossallareasofour business.
We'reproudtodeliverbreakthrough innovationsinoncologythatarehelping toextendthelivesofpatientswith certaintypesofcancer We're continuingtoacceleratewhatwecan achieveforthepatientsweserve, becauseeveryoneneedsmorewaysto treattheircancerand,hopefully,more time
Ourteamofresearchersandscientistsis pushingtheboundariesofcancer researchtodiscovermoreeffective anticancertherapies.
• Cell-basedtherapiesandT/NKcell engagers:UtilizingallogeneicT andNKcellsandT/NKcell engagersthataimtoattacktumors.
• Immuneagonists:Molecules designedtostimulateimmune systemfunctions,suchas enhancingtheactivityofanti-tumor immunecells.
• Inhibitionofnegativeimmune regulators:Designedtoblock theactionofmoleculesthat suppresstheimmunesystemto potentiallyenableamore robustanti-tumorresponse.
• Personalizedcancervaccines: Therapeuticvaccinesbasedon patients'specificcancerthat couldpotentiallyprimethe immunesystemtorecognize certaincharacteristicsand attackthecancercells.
• Tumormicroenvironment modulators:Seektoregulate theenvironmentaroundtumors toinfluencehowtumorsgrow andinteractwiththeimmune system.
Ourworkinvaccinesfocuseson makingcertaindiseasesathingof thepast.
• Experienceinvaccines:We've beendiscovering,developing, anddeliveringvaccinestohelp preventdiseasearoundthe worldforover100years.Itis nosecretthatinventingand developingvaccinesis complex,time-intensive,and carriesnoguarantees.Tokeep pacewiththeever-evolving diseaselandscape,wecontinue toresearchcandidatesto addresssignificantunmet needs.
• Collaborationandprogressin vaccines:Ittakesactive collaborationbyourteamswho partnerwithgovernments, academicresearchers,andnongovernmentorganizations aroundtheworld.Ourworkin researchingandproducing
vaccinesisguidedbyscienceand fueledbyhumanneeds.
• Programsinvaccines:Inspired bytherichlegacyandinnovative spiritofthelong-timescientist, Dr.MauriceHilleman,weare proudtobeengagingwiththe globalhealthcommunitythrough theMSD-WellcomeTrust HillemanLaboratories.The missionoftheLaboratoriesisto pursueinnovationinvaccine scienceandtechnologythathelps makeaccesstovaccinesmore affordableandequitableinlowerincomemarkets.
Ourdecadesofresearchininfectious diseaseshaveledtoprofound scientificadvances.We'vebeen combatingglobalhealththreats causedbyinfectiousdiseasesfor morethanacentury.Fromdeveloping oneofthefirstantibioticsto pioneeringresearchinHIVscience, ourfocushasalwaysbeenonthe preventionandtreatmentofdiseases thatthreatenpeopleandcommunities aroundtheworld.Butourworkisfar fromdone.
Everyyear,millionsofpeopledie frominfectiousdiseases.Theworldis countingonustobringforwardnew approachestohelpeasehuman suffering.
• HIV:WerememberwhenHIV wasoneofsociety'smost dauntingchallenges,when millionsofpeoplelosttheirlives tothedevastatingAIDS epidemic.Ourscientists embarkedonanurgentmissionto unravelandunderstandthevirus, whichledtogroundbreaking researchinHIV
• Wearestilldriventodomore. Wearepushingtheboundariesof HIVsciencebecauseunmet medicalneedstillendures. Eradicationofthevirusisour ultimategoal.
• Antibiotics:Whileother companiespullawayfrom antibioticresearchand development,westandoutfrom thepack.Wecontinueourefforts becauseweknowtheworldneeds it.
• Ebola:Sincetheemergenceof theEbolavirusin1976,periodic outbreakshavebeenaglobal healthchallenge.Weareproudto bepartoftheglobalpublicprivatepartnershipthathasunited thegovernment,industry, communitygroups,scientists, healthcareworkers,andordinary people,tocometogethertohelp fightthisdeadlydisease.
Wehavealonghistoryofmakingan impactoncardio-metabolicdisorders, suchastype2diabetesand cardiovasculardisease.
Morethan60yearsago,we introducedourfirstcardiovascular therapy–andourscientificeffortsto deeplyunderstandcardio-metabolic disordershavecontinued
Cardio-metabolicdisordersinclude cardiovasculardiseasesandmetabolic diseases,suchastype2diabetes. Theserepresentsomeofthemost serioushealthchallengesofthe21st century.
Advancementsincardio-metabolic researchcanmakeanimpactful differenceforpatients,andthereis stillmuchmoreworktobedone.We
striveforscientificexcellenceand innovationinallstagesofresearch, fromdiscoverythroughapprovaland afterward.
RobertM.Davis,Chairman,and chiefexecutiveofficer
RobDavisischairmanoftheboard andchiefexecutiveofficerofMerck. Previously,RobservedasMerck's president,responsibleforthe company'soperatingdivisions— HumanHealth,AnimalHealth, Manufacturing,andMerckResearch Laboratories.Priortothat,hewas executivevicepresident,ofGlobal Services,andthecompany'schief financialofficer.
Robjoinedthecompanyasachief financialofficerin2014with additionalresponsibilityforrealestate operations,corporatestrategy,and businessdevelopment.In2016,his rolewasexpandedtoinclude responsibilityforinformation technologyandprocurement,forming GlobalServices.Hebecamepresident inApril2021,CEOandamemberof theboardofdirectorsonJuly1,2021, andchairmanoftheboardon December1,2022.
RobreceivedhisJ.D.from NorthwesternUniversitySchoolof Law,hisM.B.A.fromNorthwestern University'sKelloggGraduateSchool ofManagement,andhisbachelor's degreeinfinancefromMiami University
“Everythingwe do,inandoutof thelaboratory,is basedonourdeep appreciationfor life.That'sthe reasonwecome togetheracrossthe businesswithone purpose—touse thepowerof leading-edge sciencetosaveand improvelives aroundtheworld.”
Parexelisamongtheworld's largestclinicalresearch organizations(CROs), providingthefullrangeofPhaseIto IVclinicaldevelopmentservicesto helplife-savingtreatmentsreach patientsfaster.Leveragingthebreadth ofourclinical,regulatoryand therapeuticexpertise,ourteamofmore than19,000globalprofessionalsworks inpartnershipwithbiopharmaceutical leaders,emerginginnovators,andsites todesignanddeliverclinicaltrialswith patientsinmind,increasingaccessand participationtomakeclinicalresearch
Dr. Albert D. Friesen, Founder & CEO
acareoptionforanyone,anywhere.
Ourdepthofindustryknowledgeand strongtrackrecordgainedoverthe past40yearsismovingtheindustry forwardandadvancingclinical researchinhealthcare'smostcomplex areas,whileourinnovationecosystem offersthebestsolutionstomakeevery phaseoftheclinicaltrialprocessmore efficient.Withpeople,insightand focusonoperationalexcellence,we workwithHeartTMeverydaytotreat patientswithdignityandcontinuously learnfromtheirexperiences,soevery trialmakesadifference.
Patientsfirst:Eachofus,nomatter whatwedoatParexel,contributesto thedevelopmentofatherapythat ultimatelywillbenefitapatient.We takeourworkpersonally,wedoitwith empathyandwe'recommittedto makingadifference.
Quality:Fromthesmallestdetailto thelargest,wetakequalityseriously Wefocusonthedetailwhilenever losingsightofthebigpicturetodrive thebestpossibleoutcome.
Respect:Werecognizeandupholdthe importanceofallpeople,thewaywedo things,ourquestforinnovation,and mostimportantly,ourpatients.
Empowermentandaccountability:We followourhearts;wedotherightthing andwehavethecouragetoownthe outcome.
Mostserviceprovidersputtheirback intoresearch.Weputourheartsinas well.
Wedon'tjustthinkdifferentlyaboutyour project,wefeeldifferentlyaboutit,too. Whenyoufacethecomplexproblems involvedintransformingscientific discoveryintoanewtreatment,then gettingthattreatmentintothehandsof patients,youneedaclinicalresearch organization(CRO)partnerwhois investedateverylevel.Ateamofpeople whokeepsolving,improving, optimizing,andcaringjustasmuchas youdo.Nomatterhowlongittakes,no mattertheobstacles.
Togetnewtherapiestothosewhoneed themasquicklyaspossible,weresearch asefficientlyaspossible.Fromfinding therightpatientstooperatingin locationsthatsuitthem,weputour heartsintodoingthemostgoodatevery pointinthedevelopmenttimeline.
Overtheyears,we'velearnedathingor twoabouthowtonavigatethe developmentandapprovallandscape. That'swhywe'reabletothoughtfully guideorganizationsthroughregulatory strategy,compliance,andpartnerships. Together,weidentifywaysyoucan improve,thenequipyouwiththetoolsto getthere.
Whetheryouneedahandwitha singlepartofaclinicalstudyorwith anentireportfolio,wecandevelop anoutsourcingmodeltofitthetask athand.
Withmorethanthreedecadesof experience,Parexel'smedical communicationsserviceshelpensure thatyourproductsbenefitfrom insightfullyconveyeddataand communicationsexcellence.
Parexel'sinnovationengineaspires tobethevanguardinretoolingthe waythattherapiesaredevelopedand ultimatelydeliveredtopatients.
Intoday'slandscape,regulatory approvalisn'ttheendofthedrug developmentprocess,it'sjustthe beginning.That'swhy,weprovidea customizedapproachthatisdesigned tohelpyougetfit-for-purposedata andtheinsightsthatyouneed-not justterabytesofdatatosupportvalue demonstrationforpayers,providers, andpatients.
MeetTheCEO
JamieMacdonald,ChiefExecutive Officer
JamieMacdonaldistheChief ExecutiveOfficerofParexel.Hehas morethan25yearsofexperiencein leadingglobalbiopharmaceutical servicescompanies.
PriortojoiningParexel,Mr MacdonaldservedasChief ExecutiveOfficerofINCResearch, nowknownasSyneosHealth,from January2013throughSeptember 2016,whereheledthecompany throughasuccessfulInitialPublic Offeringin2014.Mr.Macdonald
alsoservedasINC'sChiefOperating OfficerfromJuly2011through December2012,andpreviouslyheld severalleadershippositionsinthe biopharmaceuticalservicesindustry, includingSeniorVicePresidentand HeadofGlobalProjectManagementat Quintiles,nowknownasIQVIA.Prior tothis,heheldvarioussenior operationalandfinancerolesat Quintiles.Hehaspreviouslyservedon theBoardofDirectorsforthe AssociationofClinicalResearch Organizations(ACRO)andasits Chairmanin2015.Mr.Macdonald's recentexperiencealsoincludesserving asChairmanoftheBoardforCertara,a drugdevelopmentconsultancywith solutionsspanningdiscovery, preclinical,andclinicaldrug development,from2017to2018.
Mr.Macdonaldbeganhiscareerinthe pharmaceuticalindustrywithSyntex Corporation(acquiredbyRoche Holdings,Inc.).AnativeofScotland, heholdsaB.A.inEconomicsfrom Heriot-WattUniversityinEdinburgh, Scotland,andisaqualifiedChartered ManagementAccountant(ACMA).
“Throughoutouryears helpingdiscoveriescome tomarket,onethinghas remainedconstant–the morepatient-focusedthe process,thebetter.That's whyallourservicestake patientinputtoheart before,during,andaftera clinicalstudy.”
SyneosHealth®istheonlyfully integratedbiopharmaceutical solutionsorganizationpurposebuilttoacceleratecustomersuccess.The firmleadswithaproductdevelopment mindset,strategicallyblendingclinical development,medicalaffairs,and commercialcapabilitiestoaddress modernmarketrealities.
SyneosHealthcallsthisnewwayof collaborativeworkingthe BiopharmaceuticalAcceleration ModelorBAM™.
Dr. Albert D. Friesen, Founder & CEO
SyneosHealthistheonlycompanyin thebiopharmaceuticalservicesindustry purpose-builttocreatetremendous successforitscustomers.AtSyneos Health,clinicalandcommerciallive underthesameroofandconstantlyshare real-worldknowledgeandinsightsthat leadtogettingthejobdonebetter, smarter,andfaster.
Howdoesitwork?BAMisanendto-endconcept,workingacross SyneosHealth'sclinicaland commercialcapabilitiesanddrivenby eachandeveryoneofits approximately28,000employees. Importantly,italsoincorporatesmany uniqueSyneosHealthdisciplines includingtheTrustedProcess®, SyneosOne®,theSyneosHealth DataLakeEcosystem,RealWorld Evidence,anditsdeeptherapeutic expertise—eachprovidinga constantstreamofinsightsfocusedon twocriticalareas:patientbehavior andprocessacceleration.
Theseinsights,alongwithunique approachestodataanddigital,whichwe callDynamicAssembly®,allowthe organizationnotonlytosolveproblems, butalsosolvethemmorequickly, increasingthelikelihoodofregulatory approvalandmaximizingcommercial success.SyneosHealthbelievesthat BAMisthefutureofbiopharmaceutical development.Andmoreimportantly,itis thekeytoshorteningthedistancefrom labtolifeforitscustomers.
Everycustomerhasuniqueclinical developmentneeds.Ourfit-for-purpose CROsolutionsaretailoredtoyour productandrequirements.Whatever yourneeds,wecanadoptnewprocesses
“We help our customers improve and accelerate the delivery of therapies that impact health worldwide”
Michelle Keefe | Chief Executive Officer
andtechnologies,diversetherapeutic expertise,andaccesstocommercial insightsthatcanfacilitateshorterandmore efficienttrialsdesignedtoimprovethe likelihoodofregulatoryandcommercial success.
AtSyneosHealth®,weareableto enhancebrandperformancebyleveraging dataandinsights,accumulatedbest practices,anddeepaccesstotherapeutic expertise.Servingcustomersofallsizes, ourCCO(ContractCommercial Organization)capabilitiesarethebroadest andmostrobustintheindustrydelivering flexible,targeted,multi-channelprograms designedtoproduceahigherlikelihoodof launchsuccess.Atthesametime,our commercialandmarketinsightsalongwith proprietarydataaccesscanimprove clinicaltrialdesignandacceleratepatient recruitment.It'sapowerfulplatformfor themodernbiopharmaceuticalworld.
BuiltonthecombinationofCampbell AllianceandKinapse,SyneosHealth Consultingisaleadingmanagementand consultingfirmspecializinginthelife sciencesindustry.Weprovidedeepsubject matterexpertiseovertheentirelifecycleof anorganization,portfolio,orasset,andour uniqueabilitytoleverageend-to-end capabilitiesandglobalfunctionaland therapeuticexpertsresultsinhighly customizedsolutions.Deeppre-andpostlaunchexpertisegeneratesstrategic insightsthatyieldimplementation-focused recommendationsdesignedtoreducerisk, speedtimetomarket,andincreaseoverall assetandportfoliovalue.
TheTrustedProcessisSyneosHealth's proprietary,metrics-drivenmethodology initiallydevelopedtomanageallaspectsof clinicalstudies.Thisunique,four-step approachdeliversfasterresultswhile maintainingdataintegrityandreducing operationalriskandvariability
• Averagestudystartsup-timefour weeksfasterthanindustry average
• Patientenrolmentcompletedas planned
• Databaselockfasterthanindustry average
SyneosHealth®isalsoapplyingthe TrustedProcesstoCommercial Solutionstodrivegreateroperating efficienciesandimprovedtimesto market.
Oncewereceiveyourrequestfora proposal,ourtherapeuticexperts createacustomizedstudydelivery plan.Combiningqualitywitharobust feasibilityevaluation,wedevelopa solidstrategytodeliveryourprotocol.
Webegintheselectedserviceswith ourbest-in-classprojectmanagement methodologies.Experiencedproject teamsturnstrategyinto comprehensiveplans,focusingon yourpriorities.Wemeetwithyouata week-longcamptoreviewallaspects oftheproject,whereweagreeon goals,establishstudyownershipand clarifyresponsibilities.Thisreduces cycletimesandthepotentialforfuture strategyrevisions.Attheendofthe week,everyonehasthesamevision andhasagreedtoaplanthatcovers projectmilestones,deliverables,key risks,andresponseplans.
Thisisthepointatwhichstudysites areactivatedandbegincontributingto enrollmentanddatageneration.The projectteamfocusesondeliveryby overseeingtheprojectactivitiesand managingrisks.Theproject's performanceismonitoredtoresolve issuesimmediatelyandkeepyou informed.
Assoonasthefirstenrolledpatient completesthestudy,webeginthenext phaseofintenseplanning.We reassembletheprojectmanagementteam toreviewthedeliverablesandevaluate projectperformance.Thisunique approachreducesoperationalrisk, variability,andcycletimes.
MichelleKeefe,ChiefExecutive Officer
Michellehas30+yearsoflifesciences expertiseandaproventrackrecordof creatingcross-collaborative,agileteams thataccelerateproductdevelopment success.Mostrecently,Michelleserved asSyneosHealth'sPresidentofMedical AffairsandCommercialSolutions, whereshedrovethetransformationof theCompany'sCommercialbusiness.
Hersuccessesacrosstheproduct developmentcontinuuminclude launchingKinetic™,SyneosHealth's moderncustomerengagement capability;buildingintegratedsolutions suchasFull-ServiceCommercialand MedicalAffairs;andcollaboratingto drivegrowthinSyneosOne,the Company'suniqueend-to-endoffering.
Shehasalsospent20yearsatPfizer, withincreasinglevelsofresponsibility culminatingasaRegionalPresidentand ledmarketdevelopmentfortheVisiting NurseServiceofNY.Priortothat,she servedasGlobalGroupPresidentand ChiefDevelopmentOfficeratPublicis Health,overseeingtheContractSales Organization,medicalaffairs,and specialtyagencyfunctions.
SheistheExecutivesponsorofthe SyneosHealthDE&ICouncilandsitson theHealthcareBusinesswomen's Association's(HBA)GlobalBoardof Directors.
WaverleyPharmawas foundedin2014and becameapubliccompany inOctober2017.Thecompanytrades underthesymbolWAVEontheTSX VentureExchange.Asanoncologyfocusedpharmacompany,Waverley Pharmacarefullymonitors opportunitiesandpossibleacquisitions ofrelatedpharmaceuticalproductsin ordertorealizelong-termvalue.
WaverleyPharmaInc.isaspecialty pharmacompanythatisdedicatedto thedevelopmentand
Dr. Albert D. Friesen, Founder & CEO
commercializationofsafe,effective, andaffordabletherapeutics.The company'scurrentfocusisonthe genericoncologymarketintheUnited Kingdom(U.K.)andNorthAmerica. Thecompanyhasfivegeneric oncologyproductsontheU.K.market andisawaitingregulatoryapprovalof fouradditionaloncologygenericsfor theU.K.andNorthAmericanmarkets. Thecompanycurrentlyhasapipeline ofproductsindifferentstagesof development,throughmultiple partnerships.WaverleyPharmais committedtoprovidingpatientswith
affordableprescriptionmedicinesthat lowerhealthcarecostsandprovidea betterqualityoflife.
WaverleyPharmaisanemerging pharmaceuticalcompanyfocusedon thedevelopmentand commercializationofsafe,effective, andaffordablecancertherapeuticsin theEU,UnitedKingdom,andNorth Americanmarkets.
WaverleyPharmaisworkingin collaborationwithRelianceLife
Sciences(RLS),partofaconglomerate basedinMumbai,India,forthe commercializationofseveraloncology drugsfortheUnitedStatesandEuropean markets.
PharmaceuticalsontheEuropean Market:
• Erlotinib:Erlotinibismanufactured byRLS. WaverleyPharmahasa bindingcontractwiththeU.K. NationalHealthServiceforthe supplyofErlotinib.
• Temozolomide:Temozolomideis manufacturedbyRLS,andthe bindingcontractswiththeUK NationalHealthServiceforthe supplyoftemozolomidehavebeen transferredtoWaverleyPharma.
• Capecitabine:Capecitabineis manufacturedbyRLS,andthe bindingcontractswiththeUK NationalHealthServiceforthe supplyofcapecitabinehavebeen transferredtoWaverleyPharma. WaverleyPharmahasexclusive rightsforGermanyandseekinga salesandmarketingpartner.
WaverlyPharmaiscommittedto providingpatientswithaffordable prescriptionmedicinesthatlower healthcarecostsandprovideabetter qualityoflife.
NewDrugDiscoveryProgram:PARP1Inhibitors
Cancerisagroupofmorethan200 diseasesaffectingdifferentpartsofthe body Theyallshareonecommon characteristic;uncheckedcellgrowth progressingtowardsunlimitedexpansion andrequiringdifferentapproachesforits treatment.Bothradiationtherapyand chemotherapeuticdrugssuchas alkylatingagents,anti-metabolites,and topoisomeraseinhibitorsaredesignedto damageDNAinordertopreventcancer cellsfromgrowing.
Itispostulatedthattheeffectof chemotherapyandradiationtherapy isdampenedbyDNArepairenzymes
1Poly(ADP-Ribose)Polymerase-1 (PARP-1)belongstothePARP familyofenzymesandisinvolvedin thedetectionandrepairofDNA damage.PARP-1inhibitorsareanew classofanticanceragentstargeting DNArepairmechanisms.The inhibitionofPARP-1isofclinical importanceinvarioustypesof cancer. PARP-1inhibitorshave showngreatpotentialtotarget cancerssuchashigh-gradeovarian cancersandtriple-negativebreast cancerswhichareresistanttocurrent treatment.PARP-1inhibitorcanbe usedbothasamonotherapyto selectivelykillcancercellsandalso incombination.
WaverlyPharma'swholly-owned subsidiaryinBarbados,Waverly PharmaInternationalInc.,has acquiredtwogenericoncology products,temozolomide,and capecitabine,currentlymarketedin theUnitedKingdom,fromReliance LifeSciencesPrivateLimited (“RLS”).Theproductswere developedbyRLS,andthebinding contractswiththeUKNational HealthServiceforthesupplyof theseproductsarebeingtransferred toWaverlyPharma.
RLSwillmanufacturethetwo productsforWaverleyPharmaatits MedicinesandHealthcareproducts RegulatoryAgency-approved manufacturingfacilityinMumbai, India.WaverlyPharmaexpectsto makemodestprofitmarginsonthe productsafterpayingtransferprices toRLS,andafterdistributorand analyticaltestingchargesintheUK areaccountedfor
“Whilethisacquisitiontransforms WaverleyPharmaintoarevenuegeneratingcompany,it,more importantly,positionsuswellforthe launchofWAV-101and102,oncethey getapprovedintheEuropeanUnion,” statedtheCompany'sPresidentand CEO,Dr.GeorgeR.Thomas.
“RelianceLifeSciencesispleasedto beabletocontributetostrengthening theoncologyproductportfolioof WaverleyPharmawiththeadditionof temozolomideandcapecitabine,and, intheprocess,reinforcethe relationship,”statedMr.K.V. Subramaniam,PresidentofRLS. MeetthePresidentandChief ExecutiveOfficer
LarryThiessen,MBA
Mr.ThiessenjoinedWaverleyPharma inFebruary2020. Hehasextensive pharmaceuticalexperiencehaving workedforBauschHealthCompanies Inc.(formerlyBiovailCorporation), for28years,workinghiswayupfrom managertositedirectorofthe manufacturingoperationinSteinbach, Manitoba. Heledateamofroughly 400employeesandprovidedoverall leadershipandstrategicdirectionatthe operation. Mr Thiessenhasa BachelorofScienceinBiologyandan ExecutiveM.B.A.fromAthabasca UniversityinEdmonton,Alberta.
“Our mission is to develop and commercialize pharmaceuticals for safe and effective treatment.”
