centralization of technical service provider...
TRANSCRIPT
23August2016
CentralizationofTechnicalServiceProviderPrequalification:TheAvocaDiligentCentralRFIProgram
Thissessionisbeingrecorded
JuneWhite,Bristol-MyersSquibbJamesMcSweeney,ICONDennisSalotti,TheAvocaGroupJanisHall,TheAvocaGroup
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• JuneWhiteMBA,AssociateDirector,CentralClinicalServices,R&DOperations,Bristol-MyersSquibb
• JamesMcSweeney,PhD,MBA,VicePresidentandGlobalHeadforProposalsandBusinessInformation,ICONplc
• DennisSalottiMBA,VicePresidentofOperations,TheAvocaGroup
• JanisHallMBA,SeniorConsultant,TheAvocaGroup
WebinarSpeakers
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AvocaQualityConsortium(AQC)
TheAvocaGroupIntegratedResearch
&Consulting
PharmaIndustryFocus:ClinicalResearch/ClinicalOutsourcing
• TheAvocaGrouppillars:IntegratedResearchandConsulting, theAvocaQualityConsortium,andthenewDiligentPlatform
• AvocadevelopmentofDiligentPlatformtosupportIndustrywithcentralizedapproaches toprequalificationoftechnicalserviceproviders
DiligentPlatform(NEW)
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TheAQCbringstogetherquality,outsourcingandoperational professionalsfromMembercompaniestoacceleratethe developmentofleadingpracticesandindustrystandardsforproactivequalitymanagementandriskmitigation inclinicalresearch.
AvocaQualityConsortium(AQC)
● AvocaResearch:GatheringofquantitativeandqualitativedatafromMembers;provisionofaggregatedataandindividualbenchmarkingreports.
● LeadingPractices:Developmentofguidelines,tools,approaches,standardsandtemplatesfocusedonproactivequalitymanagement.
Collaboration|ProactiveApproaches
AvocaResearch
IndustryLeadingPractice
AvocaQuality
Consortium
>60MemberCompanies(Sponsors,CROs,ClinicalServiceProviders)
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2016AQCMembers:PharmaandBiotech
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2016AQCMembers:CROsandAssociateMembers
Longboat
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• TheAvocaQualityConsortium(AQC)Membersexpressedinterest(2012)inresearchanddevelopmentofcentralizedapproachestoProviderPrequalificationtominimizerisk,lowercosts,andreduceinefficiencyandduplicationofeffort
• AvocadeliversAvocaResearchReport:Prequalification/RoutineAuditsofProvidersanddatatoindustry(2013)
• AQCPrequalificationAdvisoryBoarddeliversPrequalificationIndustryStandardsandTools (2013-2014)forCoreand7TechnicalServicerequirements
• DiligentCentralizedPrequalificationPlatformoperationalized(2015-2016)
• CentralRFIRepository(cRFI)–2016launch- Throughcollection andcentralstorageofcompletedRFIsrequesterswillhaverapidaccesstoRFIinformationtoenablebaselineproviderevaluationwithoutchangestotheirinternalprequalificationprocess
• CentralizedPrequalificationAudits(cPQA)- 2016Piloting- AQCMember’sinterestinothercentralizationoptionstriggerscreationofasharedplatformforcentralizedprequalificationaudits
ExecutiveSummary:ProviderPrequalification
Benefits:Efficiency,Flexibility,Quality,LowerRisk,LowerCost,Shortenedtimetoonboardproviders
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FocusonPrequalificationVisitsandRoutineAudits- 30pagereporttoindustry
AvocaQualityConsortiumand2012IndustryResearch
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Prequalification:Essential,yetDysfunctional
• Prequalificationisanareaofdysfunctionintheindustry; itisinefficient,inconsistentanditsrelationshiptoqualityoutcomesisnotwellunderstood
• Thevolumeofproviderqualificationandrequalificationauditscontinuestotrendupward,fueledbyincreasedoutsourcing, increasedinnovationandgrowthinthepipelineofmedicinesindevelopment
• ProvidersandSponsorssuffernegativecostandresourceimplicationsduetoduplicativeefforts,andrealizeanopportunitycostintheabsenceofabettermodel
• AvocaresearchindicatesSponsors,CROsandProvidersareinterestedinimproving thecurrentstate1
1ResultsoftheAvocaQualityConsortium’s assessmentofPrequalificationvisitsandroutinesystemsaudits;MAY2013
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SurveyQuestion:TheAvocaQualityConsortiumisconsideringthepotentialtoestablishamechanismtoshareinformationregardingtheprequalificationofancillaryprovidersaspartofaninitiativetoreducecosts,introduceefficienciesandmitigateriskintheprequalificationoftheseproviders.Wouldyousupportthisinitiative?
AQCPulseCheckSurveyonPrequalification(2013)
89%
11%
Yes No
N=38 AQC Companies (Sponsors and CROs)
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Transformationinthewaytheindustryprequalifiestheirtechnicalproviderstoimprovequalityandefficiencyinclinicaltrials.
TheVisionfortheFuture
Standardize
Centralize
Optimize
StandardizationIndustryStandardsandTools
Centralization:CollectandcentrallystorecompletedRFIsandauditreports
Optimization:Builduponcentralsharingusingdataanalytics
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PrequalificationAdvisoryBoardCompanies:2014- 2016
Advisory BoardMemberCompanyRepresentation
Amgen Merck
Astellas Nektar
Baxalta Novartis
Baxter PPD
BMS Premier
Chiltern Purdue
DaiichiSankyo Quintiles
Endocyte Sanofi
ICON SeattleGenetics
INC Takeda
Lilly Theorem
Participationby22AdvisoryBoardMemberCompanies(15Biopharm,7CROs)
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• CoreRequirements
• CentralLaboratories
• IxRSServices
• CentralECGServices
• MedicalImagingServices
• BiomarkerLaboratories
• BioanalyticalLaboratories
• ClinicalOutcomeAssessmentProviders
EightstandardizedPrequalificationPackages*:
AQCPrequalificationInitiative
*EachincludesasetofIndustryStandards,RFItemplate,ScoreCard,andVisitCheckList
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AQCPrequalificationInitiativeandDiligentPrequalificationPlatform
AQC• PrequalificationStandards
• PrequalificationTools
• UpdatestoPQStandardsasRegulationsChange
Diligent• CentralizedPrequalificationAudits
• DataRepositoryandDataAnalytics
CentralRFIRepository*
• AQCFocus:PrequalificationStandardsandTools• DiligentFocus:CentralizationofPrequalificationActivities
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AchievingtheVision
2016Launch-DiligentCentralizedRFIsStatus*
• BuildingtheDiligentRepository– 42CompletedRFIs
– 14ParticipatingProviders
• PipelineofAdditionalPotentialProviderParticipants– 36additionalProvidersatvariousstagesofdiscussionorexecution
– Potentialtoaddupto95additionalcompletedRFIs
• DistributionofCompletedRFIstoRequestingCompanies– 12companiessubmittedrequestsforcompletedRFIs
– 128RFIsrequested
– 31RFIssentout
*asof19Aug2016
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DiligentParticipatingProvidersandCompletedRFIs
Strongpipelineofadditionalparticipatingproviders
Companies/Services Core CentralLab
BioAnalyticalLab
BioMarkerLab
IxRS/IRT Imaging ECG COA TotalRFIs
Almac 1 1 2Banook-Cardiabase ** ** ** 0Agreementpending* 1 1 2Agreementpending* 1 1 2Bracket ** ** 0CancerGenetics ** 1 1Covance 1 1 1 1 4ClinicalReferenceLab(CRL) 1 1 2Eurofins 1 1 ** ** 2ExcoIntouch ** ** 0FlowMetric ** ** 0iCardiac ** ** ** 0ICON 1 1 1 1 1 1 1 7IntrinsicImaging 1 1 2IXICO 1 1 2Kayentis ** ** 0NewYorkGenomeCenter 1 1 2PacificBiomarkers ** ** 0PPD 1 1 1 1 1 5PrecisionforMedicine ** ** 0Q2Solutions 1 1 1 1 4WorldwideClinicalTrials 1 1 1 3WriteResult ** ** 0YPrime 1 1 2TotalRFIs 14 6 5 8 4 4 0 1 42*RFIsreceived,agreementpending
Pipelineof36companiesatvariousstagesofreview(potentialfor>75moreRFIs)**10additionalagreementssignedleadingto23incoming
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IndustryPerspective:(SponsorandProvider):
JuneWhiteatBristol-MyersSquibb
JamesMcSweeneyatICONplc
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Challenges
IndustryPerspective:SponsorandProvider
• Meetingexpectations– Whataretheregulatorsexpectingofsponsors?– Whatareseniorleadersexpectingoftheirstaff/teams?(SponsorsideandProviderside)– Whataresponsorsexpectingofproviders?
• Whatarewedoing?– Howhavewebeendoingit?– Whatwasworkingwell?– Whatwasnotworkingsowell?
• Resourcechallenges– Howdoweoperateinacostcuttingenvironmentand“domorewithless”?– Howdoweimproveproductivityandremainheadcountneutralenvironment(orcutbackon
resources?)?
• Balancingpriorities– Wheredoweprioritizeourlimitedresources?– Shouldouroperationalresourcesfocusonimplementingclinical trials?– Howmuchcanweexpect themtodivertfocustoassessproviders/respondtoRFIrequests?
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Challenges
IndustryPerspective:SponsorandProvider
• Assessor’sexpertise– Dosponsorshavetechnicalexpertiseforallserviceareas?– Aresponsorsabletostaycurrentwithevolvingandnewtechnologies(technicaland
regulatoryknowledge)?– Doprovidersfindthatsomesponsor’sassessorsdon’thavesufficientknowledgeof
thetechnicalrequirements?
• CriticalCompetenciesvs.CoreCompetencies– WheredoSponsorsWANTtobuildandmaintainexpertise?
– Wherecan/shouldSponsorsrelyonusingexternalsourcesofexpertise?– WhatcanProvidersdotosupportneedforandsupplyexternalexpertise?
• Pre-competitivecollaboration– Canchallengesbemetbyleveragingindustryleadingpractices?– Wherecanwepartnertoshareandlearnleadingpractices?– Wherecanwepartnerwithotherstoavoidduplicationofeffort?– Isriskaversionpreventingadoptionofnewapproaches?
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SponsorOrganizationalChallengesandNeeds
SponsorPerspective:Bristol-MyersSquibb
• Onesponsorrepresentative:Mychallenges– “Agroupofone”foroversightofallScientific/analysingLaboratory
ServiceProviders(>20PreferredLaboratoryServiceProviders)
– Changingtechnologies(especiallybiomarkers)
– Increasingexpectationsforsupportingdevelopmentprograms
– Managingtime;Managingrisk
– Establishingandmaintainingpositiveproviderrelationships
– Supportinginternalteamstonavigateproviderperformanceandqualitychallenges
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SponsorOrganizationalChallengesandNeeds
SponsorPerspective:Bristol-MyersSquibb
• CoreCompetency/CriticalCapability/Non-CoreCompetency– Corecompetency- researchanddrugdevelopment,launch,lifecyclesupport
– Criticalcapability– criticalassupporting functiontocorecompetency;totalcompliancewithFDA/HAregulations;criticalfunctiontomaintainleadingedge
– Non-corecompetencies– potentialtouseavailableexpertiseoutsideBMSi.e.typicaloutsourcingmodel
• LargeSponsorcompanyunits/functions– Sharedresponsibility forscientificlabselection
• Scientificcommunity
• Clinicalteam
• Operations• QualityAssurance
• Regulatory
• Procurement/Finance
• Outsourcing/AllianceManagement
– Emphasisdependsongoalororganization
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ProviderOrganizationalChallengesandNeeds
ProviderPerspective:ICONplc
Oneproviderrepresentative:Mychallenges• Volumeandrangeofrequestsforinformation
– Volume>1000requestsperyear– Networkacrosseachbusinessunittogetaccesstoexpertinput
• TraditionalCRO(Trialsetup,execution,dataanalysisandreporting)
• Central,BiomarkerandBioanalytical Laboratory
• IxRS,MedicalImagingandeCOAServices
• Variabilityofrequestsforinformation– TypesofRequests
• Emailrequestforbasiccapabilityanddemographicinformation
• Highlystructuredcomprehensive(>20page)questionnaires.
– Purposeofrequests• Simpleinformationneedstoconsiderforastudy
• Applicationforstrategicalliancepartnerships
– Requestscovermanyofthesametopics,butofteninslightlydifferentways- limitedopportunityforefficienciestorecycleRFIresponses
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ProviderOrganizationalChallengesandNeeds
ProviderPerspective:ICONplc
• ProviderChallenges-Billablevs.Non-Billableresources– IndividualsassignedtorespondtoRFIrequestsarenotbillable(SG&A)
– Timetorespondtorequestsiscostofdoingbusiness(expensehitsbottomline)
– Imperativetodriveefficiencies
– RFIsmayrequireinput/supportbyinternalexperts(i.e.billablestaff)(impactsrevenue- hitsthetopline)
– InternalSeniorManagementpressureto
• reduceexpenses(SG&A)
• maximizeleveragingbillablestaff
• ClientexpectationsandProviderVALUE– Clientswantproviders(outsourcing) tobeacostefficientstrategicoption
– Clientsexpectproviderstobeexpertsinmaximizingefficiencies
– Providers(andSponsors)wanttoreducethetimeandcostofclinicalresearch
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SponsorMeetingtheseChallenges
SponsorPerspective:Bristol-MyersSquibb
• MembershipintheAvocaQualityConsortium(AQC)– Collaborationwith60+othercompaniesfacingthesamechallenges.
– Networkingandlearningfromeachother
• MemberrepresentationonPrequalificationAdvisoryBoard– BMSrepresentativeinvitedtojoinAdvisoryBoard
– Attendedmeetings;builtawarenessofsourceofindustrystandards
– AccesstoleadingpracticetoolsandindustryexpertsonAdvisoryBoard
• EvaluationofDiligentCentralRFIProgram– Workinginternallytoevaluateandadoptwhereappropriate
– EvaluateAQCstandardsforCorerequirementsvs.BMSrequirements
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SponsorMeetingtheseChallenges
SponsorPerspective:Bristol-MyersSquibb
• EarlyadopteroftheAvocaDiligentProgram– UsedAvoca“IntroductoryEmailMessage”foroutreach(firstsetof4providers)
– SentDiligentCoreRFI(forcorerequirements)andBiomarkerLabRFI
– SentBMScustominternalcapabilityquestionnaire
– Avoca-heldWebExmeetingswith3ofthesecompanies
– Outreachexpandedto4moreproviders
– AvocaheldoneWebExmeetingwith1company
– AvocametatDIAwith2companiesonBMSlist
– BMSadded2moreprovidersviaDiligentagreement
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ProviderMeetingtheseChallenges
ProviderPerspective:ICONplc
• MembershipintheAvocaQualityConsortium(AQC)in2013– Collaborationwith60+othercompaniesfacingthesamechallenges.
– Networkingandlearningfromeachother
• MemberrepresentationonPrequalificationAdvisoryBoard– ICONrepresentativeinvitedtojoinAdvisoryBoard
– Attendedmeetingscontributedtodevelopmentofindustrystandards
• ICONinvitedbySponsortoparticipateinDiligent– “BigPharmaCo.”askedICONtoparticipateinDiligent
– “BigPharmaCo.”sentoutDiligentRFIsforcentrallabcategoryrefresh
– ICONsignsDiligentParticipationAgreement
– ICONcompletesCoreRFI(corerequirements)andCentralLabRFI
– ICONapprovesDiligentreleaseofCoreandCentralLabRFIsto“BigPharmaCo.”
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SponsorFeedbackonDiligentProcess
SponsorPerspective:Bristol-MyersSquibb
• Outcome:FeedbackonDiligentProcess– QualityofDiligentRFItemplates(alignmenttoBMSneeds/expectations)
– Firstoutreachwasquickandeasy(prepopulatedemailtemplate)
– Addressingquestionsfromproviders(BMSvs.Avocainvolvement)
– DiligentAgreementchallenges(version1)
– DiligentAgreementrevision(toaddresschallenges)
• Outcome:ResponsefromBMS’Providers– ReceiptofcompletedRFIs
– Timingofreceipt
– QualityofproviderinformationwithinRFIs
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ProviderFeedbackonDiligentProcess
ProviderPerspective:ICONplc
• ICONexperience– Initialexposure
– Internalevaluation
– Decision-makingonparticipation
– Respondedtobeapartof“BigPharma”categoryrefresh
• ICONexpandedparticipationforotherservices– BiomarkerLab
– BioanalyticalLab
– IxRSServices
– ImagingServices
– COA/eCOAServices
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SponsorValuePropositionandPlansfortheFuture
SponsorPerspective:Bristol-MyersSquibb
• ValuePropositionofDiligentforSponsors– AccesstoverycomprehensiveRFItemplates
– Avocasupportwithoutreach
– Avocasupportwithproviderquestions(WebExsessions,emailfollowup,etc.)
– Timesaved;moreefficient
– Utilizingexistingtoolsvs.usingmytime
• LeveragingDiligent– SharingapproachwithothersatBMS
– Possibilitiesforexpansionforotherservicesoutsidespecialtylabs
– ContinuedparticipationinAvocaQualityConsortiumforsharedbestpractices
– ContinuedparticipationinPrequalificationAdvisoryBoard
“Itjustmakessense”
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ProviderValuePropositionandPlansfortheFuture
ProviderPerspective:ICONplc
• ValuePropositionofDiligentforICON– ReducesthenumberofrequeststhatrequirecustomizedICONresponses
– ICONparticipationdemonstratestoindustryacommitmenttoquality
– ICONparticipationmayresultinincreasedexposureto60+AQCMemberCompanies
– ICONminimizesnon-billabletimespentonrepetitivequestionsfound inRFIs
– ICONcanshiftfocusofsponsordiscussionstoprotocolandtherapeuticarea/indicationspecificneeds,anddemonstratetruevalue-addexpertise
– Expectationthatitwilldrivesefficiency,lowercost,reducetimeforonboarding
• LeveragingDiligent– IfanAQCSponsorCompanyasksICONtorespondtoaRFI,ICONwilldirectthem
tothecompletedDiligentRFIs
– Ifnon-AQCsponsorssendinRFIrequests,ICONcanaskthosesponsorstoconsiderrequestingDiligentcompletedRFIs(basedonAQCIndustryStandards)
“Itjustmakessense”
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Diligent:FutureVisionandOpportunities
DennisSalottiVPofOperationsTheAvocaGroup
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OurSharedReality
Adaptedfrom:ProtocolComplexityasaFactorinClinicalComplianceRisk,MartaFields,SeattleGenetics
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OurSharedReality
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ASharingEconomy
Outsideofourindustry,varioussharedapproachestoeconomicorsocialpressureshaveemerged.
FindingThings LearningAboutThings GettingThingsDone
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OurSharedReality
Adaptedfrom:ProtocolComplexityasaFactorinClinicalComplianceRisk,MartaFields,SeattleGenetics
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ASharingEconomy
Withinourindustry,encouragingexamplesexistandcontinuetoemerge.
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Diligent:AVisionforOptimizingPrequalification
• Collaboration amongallStakeholders
• Transformationintheprequalificationprocessfortechnicalprovidersforimprovedqualityandefficiency.
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Thankyou
ContactAvocaat:(609)252-9020
www.theavocagroup.com
179NassauStreet,Suite3A
Princeton,NJ08542