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Wehavewitnessedthediscoveryofthescientific
industrythroughouttheagesthathasled humanstoinventandachieveanyfeat, includingthedevelopmentofthemedicalandresearch industrythatprovidesastrongfoundationforhealthcare resources.Today,somemedicinescandelaythespreadof cancerwithgeltechnology,whichisamassivetestamentto thepharmaceuticalindustry.Companiesworkinginthe pharmaceuticalnicheareconstantlydevelopinginnovative methodstoacquireandbetterpeople'slives.Their comprehensiveservicesrangefrombiotechnology,drug testing,manufacturingofmedicines,bioanalysisthatgo throughclinicaltrialsbeforebeingdeployedforpublic usage.
Althoughtechnologyoffersoptimizationtothe pharmaceuticalindustry,havingavisionaryleader throughoutthepharmaceuticalprocessisvital.Therefore, servinginsuchaninventivefield,pharmaceuticalleaders dotheirbesttoanalyzethecompletepharmaceutical process.Withtheirdiverseexperienceandstudies,these leadersofferussafetyinthepre-clinicalandpost-clinical operations.Theyidentifythegoodandbadeffectsofthe newermedicationdedicatingtheirlivestothebettermentof theprocess.
Theyaresurroundedbyrisksandchallengesandwork closelywiththeteamtosolveallthechallenges.Beinga professionalinthefield,theyhandleallthesituationsofthe pharmaceuticalprocess.Theirhigh-qualityservices, knowledge-base,andtechnicalexpertisemakesolvingthe customers'issuesandbuildingstrategicrelationshipswith theclientsanintegralpartoftheirwork.
Withnewscientificdiscoveries,technologies,and innovativesolutions,pharmaceuticalnicheleadersreadily faceeverychallengingproblemsituationandchallenge.
Theyarecommittedtoimprovingthequalityoflife anddisplayingtheirexcellenceinthedevelopmentof thepharmaceuticalindustry
Asoftoday,unfortunateconditionshaveprevailed duetothepandemic.Manypharmaceuticalleaders areworkingtogethertocurbtheriskofthisdeadly virus.Withvisionarypharmaceuticalleadersaround us,wecansoonseetheeradicationofthepandemic withtheirscientificknowledge.Asthevaccinesare alreadyavailabletothepeopleandtheresultsshow optimistichopes,puttinganendtothepandemic.
Thecontributionofsuchleadersisundoubtedly worthwhile.Theirimpactonthefoundationofthe pharmaceuticalindustrymakesabigdifferenceinthe livesofthepeople.
Focusingonsuchpharmaceuticalleaders,Insights Successbringsitsnewedition-The10Most EminentLeadersinPharmaceuticalIndustry, 2021.Weappreciatetheeffortsandportraythe successjourneyofthepharmaceuticalleaders throughthisedition.Atthecoverofthiseditionisthe inspiringjourneyofonesuchpharmaceutical leader-JohnThero.HeistheCEOofAmarin Corporation-arapidlygrowing,innovative pharmaceuticalcompanyfocusedondevelopingand commercializingtherapeuticstoimprove cardiovascularhealthcost-effectively.
Youwillalsodiscoverthebusinessjourneysofother pharmaceuticalleadersinthisedition,alongwith CxOstandpointsbytheindustryexpertsandthe ingeniousarticleswrittenbythein-houseeditorial team. Step
AdarPoonawalla CEO
SerumInstituteofIndia seruminstitute.com
AnnetteSäfholm CEO
Dr.SongLi Founder&CEO
GregSavino Founder
GedeaBiotech gedeabiotech.com
FrontageLaboratories frontagelab.com
SerumInstituteofIndiawasfoundedwiththeaimof manufacturinglife-savingimmuno-biologicals.
GedeaBiotechisworkingtoreflecttheprogressbeingmadein healthcaretowardsamoresustainablefuture.
FrontageLaboratories,Inc.isaCROthatprovidesintegrated, science-driven,productdevelopmentservices.
BaybridgePharmacy baybridgepharmacy.com
JohnThero CEO
JosephKim President,CEO, Director
JennyLin ChiefOperatingOfficer &BoardMember
AmarinCorporation amarincorp.com
BaybridgePharmacyaddressestherisingcostofmedication andthechanginglandscapeofpharmaceuticalservices.
AmarinCorporationisfocusedondevelopingand commercializingtherapeuticstocost-effectivelyimprove patienthealth.
INOVIO Pharmaceuticals inovio.com
CMICInc. cmicgroup.com
MichaelZahigian SVP,CIO
Amgen amgen.com
NazliAzimi CEOandFounder
BionizTherapeutics bioniz.com
INOVIOisabiotechnologycompanyfocusedonrapidly bringingtomarketpreciselydesignedDNAmedicines.
CMIC’sskilledresearchersprovidecutting-edgeexpertisein smallandlargemoleculebioanalysistooptimizedrug development.
Amgenhasgrowntobeoneoftheworld'sleadingindependent biotechnologycompanies,hasreachedmillionsofpatients aroundtheworld.
Bionizisaclinical-stagetherapeuticscompanytransforming drugdevelopmentforimmune-drivendiseases.
Howell CEO Arecor arecor.com
Arecorisabiopharmaceuticalcompanytransformingpatient carebybringinginnovativemedicinestomarket.
Sarah FeaturedPersonAmarin'sproduct developmentprogram leveragesitsextensive experienceinlipidscienceand thepotentialtherapeutic benefitsoficosapentethylto helpaddresspersistent cardiovascularrisk.
Impactfulleadershipbeginswithastrategythatisclear, compelling,supportedbythoughtfulanalysisand designedtodelivercompetitiveadvantages,andis followedbyanunwaveringfocusonexecution.Strong executionreliesonfindingtherightpeopleandcreatingthe rightenvironmentforthemtosucceed.Greatleaders believethatitispivotaltothecompany’ssuccesstoplace confidenceintheirteam,empowerthemandletexpertsin relevantfieldsbeoutinfrontoncriticalinitiativesorin conversationswithstakeholderstosolveproblems.
Inspiringleadersoftenworkhardandletsuccessbetheir voice.Theyleadbyexampleandresults. JohnThero, CEOofAmarinCorporation,isonesuchexemplary leader.JohnandhisteamatAmarinCorporationlookfor peoplewhohave“cando”attitudes,whoaresmart,and havesuccessfultrackrecords.Theyfocusonoutputsmore thaninputs.Theycreateenvironmentswherepeoplehave roomtobecreative,solveproblemsandflourish.
AmarinCorporationisarapidlygrowing,innovative pharmaceuticalcompanyfocusedondevelopingand commercializingtherapeuticstocost-effectivelyimprove
cardiovascularhealth.Amarin’srootstracebackto1993, withmostofitsearlyworkinIrelandandtheUnited Kingdom.Thecompany’sinitialfocuswasonrare neurologicalconditions,butthatwasintheprocessof changingwhenJohnjoinedthecompanyin2009.Laterthat yearAmarinstartedtwoclinicalstudiesaspartofamultistepstrategytodevelopthecompany’sleadinvestigational assetforcardiovascularriskreduction.
Afterclinicalstudysuccessesinitsinitialstepstoproving theabilitytolowercardiovascularrisk,asasmallcompany withlimitedresources,Amarinhadtomakechoices.The companycouldgo‘allin’andmoveasquicklyaspossible towardbecomingacommercial-stagecompany,butwith morelimitedpotential;oritcouldremainpredominantlyan R&Dcompanyandstaytightlyfocusedondemonstrating thatitsleadproductsignificantlyreducescardiovascular eventsinat-riskpatients–aneedthathadnotbeen addressedbypriorpatienttreatmentoptionsfromany company.Amarinchosethelatterpath,andthathasproven tobesuccessful.
AmarinCorporation’searlyemphasiswasondemonstrating impactinreducingtriglyceridelevelsprimarilytoprevent pancreatitis.Hightriglyceridelevelswerealsoanidentifier
ofincreasedcardiovascularrisk.TheeffectsofAmarin’s leadproductwentbeyondtriglyceridelowering.Theseand otherscientificinsightsmotivatedAmarintocontinueon decade-longjourney,whichinturnledtoapprovalofits ® leaddrug,icosapentethyl(VASCEPA ),forcardiovascular riskreductionindicationsintheU.S.,CanadaandEurope. Alongtheway,17leadinginternationalprofessional societieshaverecommendedicosapentethylor incorporateditsuseforriskreductionintotheirguidelines–inanumberofcasesevenbeforetheproductwasapproved foruseintheirregion.
WhenJohnfirstarrivedatAmarinin2009,theU.S.wasin themidstofamajorrecession.Itwasn’tthebesttimefora companytoseekfundingandafootholdinanew therapeuticarea.
Amarindid,however,havesomeveryencouragingscience, andadozenorsodedicated,talented,andexperienced professionalswhobelievedinitsvisionandpotentialto helppeopleavoidthedevastatingimpactsofheartattacks, stroke,andotherseriouscardiovascularconditions. Johnwasrecruitedtobepartofanewlyconstructed managementteam,inpartbecauseofhisexperienceinthe cardiovascularcategoryandinturnaroundsituationslike thisone.Havingworkedfurther“downstream”inthespace –intherecoveryofpatients after majorcardiovascular complications--andwithahistoryofheartdiseaseinhis ownfamily,Johnwaseagertohaveanimpactin preventativecardiovascularcare.Then,asistruetoday,in theindustrializedworld,CVdiseasewasthemostdeadly andexpensiveconditioninhealthcare,whichwasanother motivatingfactorforhim.
AmarinCorporationfinished2020withrevenuegrowthof 43%tomorethan$600million.Itnowhasmorethan1,000
employees,anditsvisionisbecomingareality.Ithascome alongwaysincethoseearlydays,andJohncouldn’tbe prouderofwhatAmarinhasaccomplished.
Mostimportantly,Amarin’sdrug,inadditiontobeing clinicallyeffectiveandsafe,isaffordable.Itlowersthe significantriskthatremainsformanypeopleeventhough they’reonconventionaltherapiesforcholesterol management.Itiscurrentlyapprovedbymultiple regulatoryauthorities,includinginCanada,Europe,andthe UnitedStatesandispoisedforapprovalinothercountries. Thedataonitsproducthasbeenbroadlypublishedin leadingpeer-reviewedmedicaljournalsandisouttherefor anyclinician,orpatient,tosee.Andtheycantakecomfort inknowingthat,basedonthatdata,theproduct’sclinical resultshavebeenbroadlyreviewedandrecommended. Whilethereisnoothercardiovasculardrugapprovedfor thesameindicationasAmarin’s,ofallbranded cardiovasculardrugsintheUnitedStateswithpositive outcomesstudyresults,thelistpriceofitsproductisthe lowest.Amarinwantsitsproducttobeaccessibletoas manyat-riskpatientsaspossible.
Surveysofpatientsandhealthcareprofessionalsemphasize theimportanceofmedicaltherapywhichispreventative (helpsavoidmajornegativehealthconsequences), outcomes-based(proventoworkinmanypatientsover extendedstudy),cost-effective,readilyavailableandeasily administered.Technologiesthataresupportiveof preventativeapproaches,andareaccessibleandusefulto patientsinhelpingtotrackandenhanceoutcomescanbe helpful--especiallyifandwhenthey’reintegratedwiththe
rightclinicalinterventionsalongsideapproachesdesigned toconsistentlyengagepatientsinrisk-modifyingbehaviors.
Oneofthecomplicationsofpreventingheartattacksand strokesisthatriskfactorsareoftenunnoticeable.Over time,technologymaybedevelopedtobetteridentifyand helptoaddresscardiovascularriskfromabehavioral perspective.Amarinhaspursuedapragmaticpathtohelp patientsby:a.)identifyingthosepatientsneeding cardiovascularriskreductionbasedonelevatedtriglyceride levels,ameasurewhichiscommoninstandard(widely accessible)lipidbloodtests,andb.)makingaclinically effectivetherapyavailabletothemthatiseasily administered,accessible,andhasbeenshowntowork acrossabroadpopulationofpatientswithsimilarrisks.
Fourkeystoinnovationarepeople,data,resourcesand time.Timeisavaluablebutlimitedcommodityfor innovatorsand,whileitneverexpandsasneedsgrow,itcan bemademoreproductivewithacollaborativeandtalented team.Resources,inturn,arealwaysavailableforgood ideas,steeredbycompellingdata,andwiththerightpeople behindthem.
AtAmarin,ourpeoplefoundcompellinginsightsindataon aparticularcompound,whichledtoanidea,andultimately amissiontolowercardiovascularriskinacategorywhere manyothershavefailedtodemonstrateimpact.Theidea alonewasnotenough.Developingthisidearequiredyears ofhardworkandfocusfromtalentedpeopledrivento innovateandtohelpimprovepatientcare.
Thepathtogettherewasn’teasy,orstraightforward,and JohnexpressesthatAmarinwouldnothavebeenableto overcomemanyofitschallengesifitwerenotfora
dedicated,“family-like”culturewhichemphasizes teamwork,quality,integrityandresults.AsAmarinhas grown,proactivestepshavebeentakentoensurethatthe mostpositiveelementsofitscultureareretained.Asa result,Amarinhasbuiltateamofpeopleandaculturethat hasallowedJohnTherotopursuehisplanstoretirein2021 withknowledgeandconfidencethatwhathehashelpedget underwaywillcontinuetobeadvanced.
Johnbelievesthatfocusandaccountabilityarethemost importantqualitiestohaveasaCEO.Hesays, “When you’re trying to improve healthcare, and there are so many unmet needs, it’s tempting to try and do everything you can rather than doing the most important things really well. Without adequate focus, much less gets accomplished.” Amarinisfortunatetohaveagreatteamthatbelievesin whatitisdoingandisremarkablyfocusedonitsendgoals, despitethemanychallengesanddisruptionsthecompany hashadtoovercomealongtheway
Inthenearfuture,Amarin’sprioritiesaretocontinueto growitsbusinessintheU.S.,successfullyintroduceitslead productinEurope,anddirectly,orwiththehelpof commercialpartners,expandglobally,includingsecuring regulatoryapprovalforthedruginChina.
Amarinhassomeincredibleopportunitiesinfrontofthe organization–notonlywiththerecentapprovalofitsdrug inEuropeandpotentialapprovalinChina,butalsothrough otherassetsitmaydeveloporbringintotheorganizationin theyearsahead.Ithasbuiltanincrediblecommercial organizationintheU.S.andiscreatingasimilarlystrong commercialteaminEurope.Thecompany’soutreachto leadingcardiologists,GPsandotherhealthcare professionalsgivesitastrongfoundationtocontinueto
growbasedonitsleadproductwhileconsidering opportunitiesfordiversificationintoothertherapeuticareas andindications.
Thepharmaindustrytodaytendstoprioritizeinnovation aroundspecializedconditionareaslikerarediseases.Such innovationiscertainlyneededandworthwhile.
Unfortunately,otherconditionsthatareprevalentandcostly inoursocietyareconsequentlygettinglessattention. Chronicconditionssuchascardiovascularandpulmonary disordersareespeciallyneglectedgivenlengthytime framesneededtodeveloptherapiesandlimitationson patentprotection,whichcombinetodisincentivizedrug development.Thesecircumstancescanalsoleadtohigher pricesandcostsassociatedwithproductsandprocedures foracutemedicalconditions(ratherthanlowercostsand reducedsufferingwhenthefocusisonearlierinterventions andpreventiveapproaches).
Manyofthelargecompanieswhichwerepioneersin developingcardiovascularsolutionsdecadesagotodayhave verylimitedornofocusoncardiovasculardisease.When Amarinenteredthecardiovasculardiseasemarketalittle overadecadeago,relativelyfewcompanieswere continuingtoinvest--andfewerstilllikeAmarinwere focusedexclusivelyontheproblemofheartdisease. Amarinsawthisgrowingvoidasanopportunityformajor impact.
Webelievedinthescience,westayedtruetoourstrategy, andnowhaveastrongfoundationforglobalgrowth–while alsobeingaleaderinaddressingrisksassociatedwithone oftheworld’smostcostlyanddeadlydiseases.Withsmart peopleandusingscientificdataasaguideandimproving patientcareasmotivation,Amarinelectedtonotfollowthe herdand,toparaphraseRobertFrost,followingthepath lesstraveledhasmadeallthedifference.
Withanambitiontobuildacustomer-focused organizationtohelppharmaceuticalcompanies overcometheircomplexdrugdevelopment challengesthroughanoutsourcedsolution,Dr.SongLi formedFrontageLaboratories,Inc.Today,Frontage LaboratorieshasgrowntooneoftheleadingCRO’swith over850employeesinbothNorthAmericaandChina.
PriortoFrontage,Dr.Liheldmanagementpositionsat GreatValleyPharmaceuticalsandWyeth.Duringthistime, helednumerousprojectsrelatedtothedevelopmentof pharmaceuticalproducts.Besides,Dr.Lihasauthoredmore than15scientificpublicationsspanningawiderangeof topics,includingchiralseparations,drug-proteininteractions,pharmacokinetics,andanalyticalchemistry.Importantly,hehasbeentherecipientofnumerousawards,most recentlyHealthcareCEOawardfromPhiladelphiaAlliance forCapitalandTechnologies,Ernst&YoungEntrepreneur oftheYearAward,the“RealizingtheAmericanDream” awardfromthePennsylvaniaWelcomingSociety,andthe Outstanding50AsianAmericansinBusinessAwardfrom theAABDC.
Dr.LiearnedaDoctorofPhilosophydegreeinanalytical chemistryfromMcGillUniversityandaBachelorof SciencedegreeinchemistryfromZhengzhouUniversityin China.
Inourendeavortofind “The 10 Most Eminent Leaders in Pharmaceutical Industry, 2021” wecrossedourpathswith Dr.Litoknowmoreabouthisleadershipjourneyandhow FrontageLaboratoriesisaddressingthemostsignificantand complexdrugdiscoveryanddevelopmentchallengesof pharmaceuticalcompanies.
Below are the highlights of the interview:
DescribeFrontageLaboratories,Inc.anditscuttingedgeserviceswhichaddressalltheneedsofits customers.
FrontageLaboratories,Inc.isaCROthatprovides integrated,science-driven,productdevelopmentservices throughoutthedrugdiscoveryanddevelopmentprocessto enablepharmaceuticalandbiotechnologycompaniesto achievetheirdevelopmentgoals.Comprehensiveservices includedrugmetabolismandpharmacokinetics,analytical testingandformulationdevelopment,preclinicaland clinicaltrialmaterialmanufacturing,bioanalysis, preclinicalsafetyandtoxicologyassessmentandearly phaseclinicalstudies.
Drug Metabolism and Pharmacokinetics (“DMPK”)
Weofferstandardandcustomizedinvivoandinvitro DMPKservices.Thisincludespharmacokinetic(“PK”)and pharmacodynamics(“PD”)studiesthroughoutthe developmentprocess.WealsoofferADMEstudies.Forthe discoveryphase,wealsoofferPKscreeningand characterizationtoenablestructureoptimization.Wealso offermetaboliteidentificationindifferentanimalspecies, MetabolitesinSafetyTesting(“MIST”),drug-drug interaction,andradiolabelingstudies.
Safety and toxicology
Weofferclientsandextensiverangeofsafetyand toxicologyservices,includinglargeanimaltesting,toour customersforthefirsttime.TheseservicesincludenonGLPandGLPtoxicologystudiestosupportregulatory
submissionssuchasINDs.Additionaltoxicological assessmentsincludepathology,ophthalmologyand cardiovascularstudies.Wealsoofferchronictoxicityand investigativetoxicologystudies,carcinogenicitystudiesand supportforadditionalindications.Wealsoassistwiththe developmentofsafetyandtoxicologytestingplans,mainly forthepre-clinicalstage,withthegoalofidentifyingthe pharmacologicalandtoxicologicaleffectsofdrug candidates.
Ourbioanalyticalservicesincludenon-GLPresearchbased andGLPassays(bothinvivoandinvitro)forsmalland largemoleculedrugsandbiomarkersthroughoutthedrug developmentprocessaswellasimmunogenicityand neutralizingantibodyassessments.Theseassayssupport first-in-humandosejustificationsandInvestigationalNew Drug(“IND”)packagesforpharmaceuticaltherapeutics. Weprovidemethoddevelopmentandvalidationservicesin additiontosampleanalysisservicestoassess pharmacokinetics,immunogenicityandpharmacodynamics effect.
Chemistry, manufacturing and controls (CMC)
OurportfolioofCMCservicesspansdrugdiscoverytothe postapprovalphase,includingleadcompound quantificationandanalyticaltestingforthediscoveryphase, formulationdevelopment,GLPtoxicologybatchstudies, releaseandproducttesting,stabilitytesting,CTMand GoodManufacturingPractice(“GMP”)manufacturing, extractabilityandleachabilitystudiesandcommercial productreleasefollowingapprovalofanapplication.
Withover20years’experienceintheexecutionof comprehensivePhaseI-IIastudies,theFrontageClinical teamcollaboratescloselywithourclientstodevelopa uniqueapproachtoovercomethechallengesofeachstudy, whilemaximizingefficiencyandmitigatingrisk.We leverageourbestpracticesinstudydesignandexecutionto advanceinvestigativecompoundstodrugcandidates. LocatednearNYC,wehaveaccesstooneofthemost diversestudypopulationsandacclaimedmedical professionalsandfacilitiestohelpsupporteachstudy.
Weprovidebioequivalence(“BE”)andrelatedservices (suchasmedicalwritingandregulatorysupport)inChina.
Bioequivalenceisthetermusedtoassesstheexpectedin vivobiologicalequivalenceoftwopreparationsofadrug. Bioequivalenceisgenerallydefinedastheabsenceofa significantdifferenceintherateandextentofwhichthe activeingredientoractivemoietyinpharmaceutical equivalentsorpharmaceuticalalternativesbecomes
Ourcommitmentto investinginhighly trainedandexperienced scientists,state-of-theartfacilitiesand instrumentations,anda strongcommitmentto operationalexcellence willallowustodeliver resultsthatmeetor exceedourcustomers' needs. ‘‘
‘‘
availableatthesiteofdrugactionwhenadministratedatthe samemolardoseundersimilarconditionsinan appropriatelydesignedstudy Theseservicesarecurrently providedbyusinChinafromourfacilityinZhengzhou, Henan,and17clinicalresearchcentersinourcollaborating hospitalsinChina.Focusonproductdevelopmenton clients’needsthentheservicesareonestopshop–list servicesinproductdevelopment
Asaleadinglaboratoryandagrochemicalservices provider,whatcontributionhasbeenmadebyyou?
Weareavalue-addpartnerwithafocusonsolvingour customers’mostsignificantandcomplexdrugdiscovery anddevelopmentchallenges.Ourscientificknowledge base,technicalexpertiseandreputationforhighquality serviceshavebeenintegraltoourabilitytoenterintostrong long-termstrategicrelationshipsandpartnershipswithour keycustomers.
Overtheyears,Frontagehasenabledmanybiotechnology companiesandleadingpharmaceuticalcompaniesof varyingsizestoadvanceamyriadofmoleculesthrough developmentandfileregulatorysubmissionsglobally.
Describeindetailabouttheworkcultureandthevalues thatdriveFrontageLaboratories,Inc.
Our Purpose: Toimprovequalityoflife
Our Vision: Tobethepreferredpartneroflifescience leadersinproductdevelopment
Quality:Wearecommittedtoexcellenceintheresultswe achieve,andhowweachievethem.
Integrity:Webelieveinhonesty,reliabilityand accountabilityinourwordsandbehavior
Innovation:Weemploynewscientificapproaches, technologiesandprocessestoprovideinnovativesolutions tochallengingproblems.
WhatarethefutureaspirationsofFrontage Laboratories,Inc.?Whatstrategiesareyouundertaking toachievethosegoals?
FrontageLaboratorieswillcontinuetogrowitscapacity andcapabilitiesbothorganicallyandthroughmergersand acquisitionsasappropriate.Injustthelastsixmonths,the companyhasexpandeditsfootprintinbothNorthAmerica andChina,acquiringamajoritysharepositionofaCMC groupinChinaandsettingupnewlabsinbothChinaand NorthAmericatoaccommodategrowthintheCMCand Bioanalyticalareas.Alongthesamelines,Frontage Laboratorieswillcontinuetolookforopportunitiesthatwill enhanceitsend-to-enddiscoveryanddrugdevelopment services.
Theroleofthepharmaceuticalindustryishugeinthe
livesofallpeopleintheworldfortheirbetter healthandwell-being.Goodhealthandwell-being isoneofthemostimportantsustainabledevelopmentgoals bytheUnitedNations.Theleadersinthepharmaceutical industryhavegreatresponsibilitytoensurethegoodhealth andwell-beingofpeopleworldwide.Thegreatertheleaders inthepharmaceuticalindustry,thegreatersolutionscanbe foundtoresolvealltheissuesinthissectorandensure people'sgoodhealthandwell-beingsustainably.
Thequesttolivehealthyforalongerperiodoftimeis foreverinhumanbeings.Theleadersinthepharmaceutical industrycontinuouslystrivetocomeupwithinnovative treatmentsandmedicationsthathelppeopleimprovetheir overallhealthandwell-being.Undertheleadershipofa competentpharmaceuticalleader,pharmaceutical companiesdevelop,manufacture,market,anddistributethe advancedtherapiesthatcanbenefitpeopleinmaintaining theiroverallhealth.
Pharmaceuticalleaderscontributegreatlytoincreasingthe lifeexpectancyforpeopleallovertheworld.Ifweseethe statistics,wecanunderstandthelifeexpectancyofpeople hascertainlyincreasedwithinnovationsinthe pharmaceuticalsector.Advancementsinmedicinesnotonly helppeopleliveforalongerperiodoftimebutalsolive efficientlyandfunctionwiththehighestproductivityfora longerperiodoftimeintheirlives.
Theroleofpharmaceuticalleadersinhelpingpeople battlingwithdifferentdiseasescannotbeappreciated
enough.Especiallypandemichashighlightedthe importanceofleadersinthepharmaceuticalindustrytoa greatextent.Thepharmaceuticalindustrycomesupwith unprecedentedsolutionsinunprecedentedtimes,and pandemicisonesuchexample.Undertheexpertleadership ofpharmaceuticalleaders,thepharmaceuticalindustry strivesitsbesttoeradicatethediseasesandillnessesin societywithitsadvancedmedicationsandtreatments.Many pharmaceuticalleaderscomewithsolutionsthatplayahuge roleinrelievingpatientsfrompainandsuffering.
Theleadersinthepharmaceuticalindustryminimizethe anxietyanddepressionofpeopletoagreatextentwiththe solutionstheyprovidethroughtheirorganizations.These leadersprovidequalitytreatmentstogiveadequatecomfort topatientsandhelpthemfighttheillnesstheygothrough. Suchleadersimprovethequalityoflifeofpeopleand facilitatethemthefreedomtolivehealthyandfulfilling lives.Theseleadersutilizealltheresourcestheyhaveto deliverefficientservicesthroughtheirpharmaceutical organization.
Thebusinessleadersinthepharmaceuticalindustrydo justicetoallthestakeholdersinvolvedintheirbusinessand theindustry Theseleadersdrivemedicalprogressby researching,bringing,anddevelopingnewmedicinesthat improvehealthaswellasthequalityoflifeforpeopleall overtheworldwiththeirinnovativesolutions.Allthe developmentsinthemedicalfieldbyleadersinthe pharmaceuticalindustryalsocontributesignificantlytothe world'seconomicgrowthandleadstothestableand balancedlifeofthepeople.
Forthepastfewyears,thepharmaceuticalindustry haswitnesseddrastictransformations.Itisdueto thesignificantcontributionsofleaderswhoare poisedtonavigatechangingthefaceofthepharmaceutical industry.OnesuchleaderweatInsightsSuccess,came acrossisGregSavino,theCo-Founder&BoardMember ofInfinityRxandFounderofBaybridgePharmacy
Withhis15+yearsofpharmacyexperience,Gregspentsix ofthoseyearsbuildingBaybridgePharmacy2015–2020. Developingabusinessmodelinaspecifictherapeuticclass exposedhimtothemanychallengespatientsencounter afterbeingprescribedmedication.Heexpressesthatpatient adherenceandcompliancewerepartoftheproblem,while initiationoftherapycarrieditsownchallengesandis secondarytovariousfactors;costofmedication, availabilityofmedication,coveragelimitationsand restrictions,etc.Evenafterthoseobstaclesareovercome, patientsmayexperiencesideeffectsorneedconsultation throughouttheirmedicationjourney,especiallywithmore complexspecialtymedications.Theseareasofhealthcare arebeinginadequatelyaddressed,andthepatientsarethe onessuffering.
GrowingBaybridgefromateamoftwotowhatitistoday wasataskthatrequiredconstantnurturing.Leadingby exampleandbeinginvolvedineveryaspectofthebusiness, fromhiring,productacquisition,patientcare,andeven cleaningupatnight,isintegralinproducingculturefor success.Takingtimetolearnabouteachemployeeand discovertheirstrengthsandambitionsempowersthemto developnewskillsandoccasionallyenterareasof discomfort,oftenproducinggrowth.Buildingateamof highlyskilledoperativesprovidedGregtheopportunityto continuebusinessdevelopment,leadingtoexponential year-over-yearincreasesinrevenueandprofit,allwhile ensuringthepatientwasattheforefrontofhiscompany’s efforts.Withthisgrowthcamerecognition.Fortwo consecutiveyears,BaybridgelandedaspotontheINC 5000list,beingthe#46fastestgrowinghealthcarecompany inthecountryin2019.Despitethat,thepaceatwhichGreg wasgrowingprofessionallyoutweighedtheabilityofhis
ownbusinesstokeepup.Hehadtotransitionthebusiness intoanotherowner’shandsinorderforhimtotakethenext stepsatagreaterobjectivewithabroaderreach.
UponthesaleofBaybridgePharmacyin2020toaprivate equityfirm,alongwithitsbrandingandmarketingarm, SpartaRxPrograms,Gregnowhadthetimeand opportunitytoformanewcompanywithaclearvisionand broadreach.Thus,InfinityRxwasfoundedin2021byhim, actingasaBoardMemberandanotherindustryleader, YuriyDavydov.
InfinityRxisaPatientServiceProgramsproviderfor pharmaceuticalmanufacturerswithamissiontomake medicationsmoreaffordableandaccessibleforpatientsby simplifyingtheprocessforallpartiesinvolvedinthe dispensingofmedication;includingphysicians, manufacturers,pharmacies,andpatients.Thecompany deliversprogressive,efficient,andcost-effectivepatient serviceprogramsandadvancedtechnologysolutionsto healthcareorganizationsthatenablethemtoempower prescribersanddrugserviceproviderstofurnishvalueaddedservicestotheirpatients.
Gregasserts, “Creating an all-encompassing, end-to-end solution for the life cycle of medication was a priority for us at InfinityRx.” Heexplainsfurther, “We begin our relationship with manufacturers during late-stage clinical trials to gain market access, which is essentially formulary coverage on various insurance plans. Simultaneously, we develop an affordability program (aka coupon program) for their medication, allowing patients to obtain the product at a lower cost. Next, we assist physician specialists with the triage of prescription orders through our white-glove service hub, a facility designed to increase speed to therapy and increase patient compliance/adherence.”
Ifdesiredbyamanufacturerandappropriateforthepatient circumstance,InfinityRx’sownnon-commercialpharmacy,
eScript360,candelivermedicationnationwideatnocostto thepatient.DuringthedispensingprocessateScript360, patientscanhavefullvisibilityintothestatusoftheir prescriptionthroughthecompany’spatientportal,available onthedesktoporthroughitsmobileapplication.Withan interactiveinterfaceandappealingdesign,patientscan trackexactlyatwhatstageineScript360theirmedication is.Despitethevaluethesesolutionshaveinandof themselves,thedatacollectionandreportingprocessis extremelycriticalforpharmaceuticalmanufacturers,and InfinityRxalwaysprovidesreal-timeaccesstoinformation. Bestofall,eachPatientServiceProgramisuniqueand custom-designedforitsclients.
It'snosecretthattechnologyisthewayahead.InfinityRx dovedeepintosoftwaredevelopment,creatingsomething new,itsownproprietaryclaimsprocessingsystemthatis farmoreadvancedanduserintuitivevsthecompetition. “Giving our clients (pharmaceutical manufacturers) the ability to make changes to their affordability programs on the front end/user side was a great accomplishment and a step ahead of industry standards.” Comparedtoother vendors,InfinityRx’ssystemcanmakechangesinrealtime,takingonlyminutestoaccomplish,whereitwould takeanothervendorweeks,ifnotmonths.Givingits customersthistypeofaccessandcontrolputstheminthe driverseatoftheirownaffordabilityprogram,anaïveand
empoweringpositionforthem.Additionally,InfinityRx providesremittanceandreimbursementsolutionsforall sitesofcare.
GregbelievesthatInfinityRx’svisioncannotbecomea realitywithouttheoutstandingpeoplebehindthemission. ItsteamofdisruptorsandinnovatorsisledbyitsCEO, NicholasOpalich,a30+yearindustryveteranandno strangertosuccess.Nickhasbuiltmulti-millionandmultihundred-milliondollarcompanies,includinganinfusion pharmacy,specialtypharmacy,mail-orderpharmacy,and pharmacybenefitmanager.Hisexperienceandexpertiseare secondtonone.AbbeyChakalisisInfinityRx’sCIOandshe bringsawealthofdiversitytotheteam.Sheisalsoan activememberofNCPDPandNASP,whereshecontinues toaddresstheimportanceofaffordablehealthcareservices.
InfinityRx’sCo-founderandChairmanoftheBoard,Yuriy Davydov,foundedDermSource,dermatology’sfirstonline grouppurchasingorganization(GPO),nowwithover800 independentpharmacymembers.GregandYuriyalso operateasbusinessdevelopmentpartnersinaprivateequity firm’snationalspecialtypharmacychain.Itsthirdmember oftheboardisArthurGukasyan,aNursePractitionerby professionandanexperiencedbusinessgrowthexpert. Arthuralsoco-foundedanon-profitorganizationthat enablesunderprivilegedhighschoolstudentstoobtaina collegedegree.
InfinityRxhasgainedanumberofpharmaceutical manufacturerclientsandhasbeenthetopicofmany discussionsintheshorttimesinceitsformation.Gregsays, “As we continue to progress our technology and perfect our services, InfinityRx will be the vendor of choice across the spectrum. Ensuring that we create the right solutions, it’s important to discuss the problems, something that many in the industry brush under the rug.” InfinityRxisnothereto comply;it’sheretodefyanddosoinawaythatpromotes patientaccesstomedicationsandtherapy,drivenby technologyandeaseacrossthecontinuumofcare.
We are passionate about inspiring pharmaceutical companies, healthcare service providers, and all others who share our commitment to join us in changing the future.
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JennyLin,theChiefOperatingOfficerandBoard
MemberofCMICInc.,holds27yearsofexecutive/lab managementexperienceinbio-analyticaland analyticallaboratoryoperationsinsupportofdrug discovery,pre-clinicalandclinicaldrugdevelopment. Moreover,sheisproficientinGLP,GMP,GCP,OECD, ICHand21CFRpart11regulationsandinbusiness strategicplanningandexecution.Herexpertiseincludes buildingorganizationalqualitysystem,stafftraining, bioanalytical/analyticalmethoddevelopment/validation, bioanalyticalsampleanalysis,analyticaldevelopmentfor CMCsubmission,chromatographypurification,stability studies,referencestandardcertification,QCsupportfor GMPmanufacture.Shehasbeenalsoaselectedmemberfor GlobalBioanalysisConsortium(GBC)making recommendationsforglobalBioanalysisharmonization. Sheservesaseditorialboardmemberforpeerreviewed journalandchairforinternationalconferences.
Moreover,sheisanauthorandco-authorforapproximately 40publications,whitepapersandpresentationsandisthe inventorof7issuedUSpatents.JennyearnedherBSin AnalyticalChemistryatPekingUniversityandherMSin MedicinalChemistryatUniversityofConnecticut.Sheisa memberoftheAmericanSocietyofMassSpectrometry (ASMS),AmericanAssociationofPharmaceutical Scientists(AAPS),AmericanChemicalSociety(ACS), NationalAssociationofProfessionalWoman(NAPW)and GlobalCROCouncil(GCC).
APioneerintheCROBusiness
CMIC,Inc.,isasubsidiaryofCMICGroupandaleading CRO(ContractResearchOrganization)specializedin bioanalyticalservices,whosecutting-edgecapabilitiesand
sophisticatedexpertiseinvariousaspectshelpeditachieve agreaterstatureinthebusiness.Itsbioanalyticalservices areinsupportofTK/PK/PDBiomarkerstudiesforpreclinicalandclinicaldevelopments.Itfirmlyfocusesand holdsexpertiseinbioanalyticalmethoddevelopment, methodvalidation/qualificationandstudysampleanalysis forsmall,largemoleculesandOligonucleotide.CMIC Groupwasfoundedin1992asJapan’sfirstCRO.The “CMIC”namestoodfor“CurrentMedicalInformation Center”,andthecompanyremainscommittedtothe advancementofmedicinesandhealthcarerevolution. CMICInc.,asoneoftheCMICGroup’ssubsidiariesinUS, helpssponsorsovercomechallengesinbioanalysiswith expertise,rapiddataturn-around-time,andhigh-quality customerservices.
CMICGroup’scorevaluesinterceptedthrough,W&3C; Ÿ WELLBEING:FullyLiveEveryMoment Ÿ Challenge:Liberateopportunitybychangingour vantagepoint Ÿ Change:Transformwithoutseekingrefugein conventionalwisdom Ÿ Communication:Proactivelyreachouttopeopleand society
CMICInc.,aCMICGroup’snon-clinicalservicesubsidiary inChicago,IllinoisisaglobalCROwithover30years’ experience.Thelaboratoryoffersbioanalysisfornonclinicalandclinicalprojects,bothGLPandnon-GLPwithin astate-of-the-artfacilitythathasthecapacityto accommodatequickturnaroundforhigh-volumeprojects. CMIC’sskilledresearchersprovidedeepexpertiseinsmall andlargemoleculebioanalysis,biomarkerservicesand
oligonucleotidebioanalysisexpertise.Purposebuiltin 2010,CMICInc.’scontractbioanalyticalandbiomarker laboratoryislocatednearbyChicagoO’HareInternational Airportandisoneoffourglobalcontractlaboratoriesinthe CMICHoldingsgroup.
Currentlargemoleculecapabilitiesincludeanalysisof oligo,peptide,orantibodytherapeuticsusingstandard ELISAorMSD-ECLligand-bindingplatforms.Avarietyof formatsareavailableincludingbutnotlimitedtodirect, indirect,sandwich,competitive,andmultiplexwhichcanbe performedwithoff-the-shelfassaysordevelopedin-house. Foroligonucleotidedetectionbyhybridizationassay,CMIC Inc.bringsawealthofexperiencewithcaptureand detectionprobe-basedassaysforquantitationofantisense orsiRNAbasedtherapies.
CMICInc.’sflowcytometerhastheabilitytodetectupto 13colors,andisequippedwitha96-wellplateloaderto handlehigh-throughputapplications.Thesoftwareis21 CFRPart11compliant,anddisplayseasilyvieweddata. Immuno-phenotypingonwholeblood,PBMC,orbone marrowcanbeperformedwithageneralpaneltodetermine thepercentageofT-andB-cells,NaturalKiller,and monocyte/macrophagelineagewithintheleukocyte population.Alternatively,specializedpanelssuchas
regulatoryT-cells(Tregcells)canbecharacterized.Treg cellsplayaroleinregulatingorsuppressingothercellsin theimmunesystem,andcanbedefinedbythecellular markersCD25,FoxP3,andCTLA4,andtheintracellular cytokinesIL4andTGFβ.AnotherspecializedtypeofT-cell (onethatisimportantforbattlingforeigninvaders)isthe CD4+memoryT-cell,whichcanbeidentifiedbystaining CD45RAandCCR7todeterminethepercentageofnaïve, centralmemory,andeffectormemoryT-cellswithinthe overallT-cellpopulation.Otherflowcytometryapplications includeconfirmationofgeneexpressioninorderto establishpotencyofgenetherapy,ortheefficacyofa treatmentregimen.
Our vision is to advance the innovation of products and solutions that will empower people worldwide to achieve greater health and well-being ‘‘
Real-timeqPCRhasemergedasapowerfultoolfor bioanalysis,andofferstheabilitytoexploremRNAgene expression.RNAcanbeisolatedfromwholeblood,PBMC, bonemarrow,solidtissue,ormatricessuchasurine,saliva, orcerebrospinalfluidandthenaddedtoareversetranscriptasequantitativePCRtoaccuratelyquantify mRNAlevels.Alternatively,DNAcanbeisolatedand addedtoaqPCRtoidentifysinglenucleotide polymorphisms,fordetectionofknownmutations,orto determineindividualcopynumbervariation.Oneofthe morepowerfulapplicationsofqPCRistheabilityto multiplex,whichisthedetectionofmanytargetswithinthe samereaction.Thiscanbeleveragedforbiomarker screeningtodeterminewhichgenesaredifferentially regulatedinresponsetotherapeutictreatment.CMICInc.’s qPCRinstrumentsarecompatiblewithavarietyof flourophoresandarefullysupportedbythevendor, providingforseamlessdesignofspecializedpanels,thereby savingprecioustimeandcost.Yetanotherapplicationfor qPCRisdetectionofviralnucleicacidsinorderto determinetheremaininglevelsofavaccineorgenetherapy vectorinordertoestablishwashoutandallowfurther optimizationofadosingregimen.
CMICInc.planstoadddropletdigitalPCRandcell-based assaystoaugmentcurrentGLPcapabilitiesforbioanalytical supportofgenetherapyprograms.Whileindustryand regulatorycontemporariesarebuildingoutaknowledge basefornewandupdatedassays,CMICInc.willbewell positionedtosupportlargemoleculebiologicsrangingfrom monoclonalantibodies,biosimilars,anti-cancercompounds, peptide-basedtherapies,genetherapy,andvaccines.
CMICGroup’sCREEDasacorporatephilosophy,consists ofWellbeing,Challenge,ChangeandCommunication (W&3Cs).Thecompanyhasbeenapplyingthisphilosophy tocontinuouslyevolveitselfinlinewithmarketchanges, andwilldosointhefuture.Moreover,byfurtherexpanding fromthecurrent“PharmaceuticalValueCreator”(PVC) businessmodel,thecompanyhasanaspirationtobecomea “PersonalHealthcareValueCreator”(PHVC)toaddressthe up-comingpersonalizedmedicinemovementandindividual patientqualityoflife.
Whatmakesthehealthcareindustrybiologically safe,treatingalldiseasesandmakingusall healthy?Itisthepharmaceuticalindustry–the mediatorbetweenthepeopleandthehealthcareindustry.If itwerenotbecauseoftheirclinicalstudies,research, biotechnology,andfindingstocurethediseases,people wouldhavestruggledfortheirlives.Fromthebubonic plaguethatstruckinEuropeandAsiainthemid-1300sto theveryrecentCOVID-19pandemic,theeffortsofthe entirepharmaceuticalindustryareworthappreciating.
Theresearchrequiredtocureallthesedeadlydiseasesis wheretheexistenceandcontributionofpharmaceutical companiescomeintothepicture.Continuousresearch studies,findings,newscientificdiscoveries,manufacturing medicines,andmanysuchcontributionsarealways appreciatedinmakingthisworldfitandhealthy.Becauseof theirscientificdiscoveries,humanscanfollowtheirpassion andlivealongandhealthylife.Butithasfacedmany challengeslately.
Lookingattheriskthathumankindisattoday,theworld needsthepharmaceuticalindustrymorethananything today
Whenthepandemicwasatitspeak,welostenormouslives, andeveryonewasprayingforacure–vaccine.The healthcareworkerssavedmanylives,andthe pharmaceuticalindustryprovideduswiththevaccine.We couldfinally,ifnotputanendbutcouldcontrolthespread ofthishavoc.Thispandemicnotonlymadeusrealizethe importanceofhealthinourlivesbutalsohadsomeonewho canactquicklytocontrolsuchsituationsinthefuture.
Wewerealreadyawareoftheircontributiontotheworld. However,thesenewdeadlydiseasesliketheZikavirus,or covidvariants,havepharmaceuticalsaroundusthathave
becomecrucialintheseweirdtimes.Thepharmaceutical industry'snewdiscoveriesandexpertisehavebecomean intrinsicpartoftheworld.Today,withtheirexcellence,we canbereadytofaceanysuchvirusorplagueandcontinue toputsmilesonthefaceofpeople.
Wearemovingtowardsasignificanttransformationwith theadvancementsofinnovationandtechnology,andwe wouldprefertogothingssmoothly,butthefuturecannotbe predicted.Thankfully,wehavesmartpharmaceutical companiesalwaysreadytoourrescue.Theyhavedisplayed theiroutstandingresultsinthepastandwillcontinuetheir effortsinthefuture,avoidingoutburstskeepingusall healthy
Theuseofpharmaceuticalsissoextensivethatithasan impactontheentireindustry.Pharmaceuticalcompaniesare theoneswhomwelookatasabiggerpicture.So,wehave tosupportthethingsthatfavorthemandfollowanecofriendlypathtolivingahealthylifestyle.That'swhatwe expectontheindividuallevel.
Onthegloballevel,nationsneedtocometogetherto developmoreground-breakingpharmaceuticaldiscoveries. Itholdsanenormousstrengthandcanprovideincredible opportunitiesforallofus.Unfortunately,governments neglectscienceinsomenations,andgettinglessattentionto newinventionsanddiscoveriesmeansnoprotectionfrom diseases.Weshouldcomeforwardtosupportsuch countries;afterall,thatiswhatmakesushumans.Itwill helptolivelongeranderadicateeventhedeadliestdisease likeCancer
Everyoneshouldbelieveinscienceandsupportthe pharmaceuticalenvironmentaroundus;ifitweren'tforthe pharmaceuticalindustry,wehumanswouldnothavemade ourmarkontheworld.