23August2016

CentralizationofTechnicalServiceProviderPrequalification:TheAvocaDiligentCentralRFIProgram

Thissessionisbeingrecorded

JuneWhite,Bristol-MyersSquibbJamesMcSweeney,ICONDennisSalotti,TheAvocaGroupJanisHall,TheAvocaGroup

22

• JuneWhiteMBA,AssociateDirector,CentralClinicalServices,R&DOperations,Bristol-MyersSquibb

• JamesMcSweeney,PhD,MBA,VicePresidentandGlobalHeadforProposalsandBusinessInformation,ICONplc

• DennisSalottiMBA,VicePresidentofOperations,TheAvocaGroup

• JanisHallMBA,SeniorConsultant,TheAvocaGroup

WebinarSpeakers

3

AvocaQualityConsortium(AQC)

TheAvocaGroupIntegratedResearch

&Consulting

PharmaIndustryFocus:ClinicalResearch/ClinicalOutsourcing

• TheAvocaGrouppillars:IntegratedResearchandConsulting, theAvocaQualityConsortium,andthenewDiligentPlatform

• AvocadevelopmentofDiligentPlatformtosupportIndustrywithcentralizedapproaches toprequalificationoftechnicalserviceproviders

DiligentPlatform(NEW)

4

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)

5

2016AQCMembers:PharmaandBiotech

6

2016AQCMembers:CROsandAssociateMembers

Longboat

77

• 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

8

FocusonPrequalificationVisitsandRoutineAudits- 30pagereporttoindustry

AvocaQualityConsortiumand2012IndustryResearch

9

Prequalification:Essential,yetDysfunctional

• Prequalificationisanareaofdysfunctionintheindustry; itisinefficient,inconsistentanditsrelationshiptoqualityoutcomesisnotwellunderstood

• Thevolumeofproviderqualificationandrequalificationauditscontinuestotrendupward,fueledbyincreasedoutsourcing, increasedinnovationandgrowthinthepipelineofmedicinesindevelopment

• ProvidersandSponsorssuffernegativecostandresourceimplicationsduetoduplicativeefforts,andrealizeanopportunitycostintheabsenceofabettermodel

• AvocaresearchindicatesSponsors,CROsandProvidersareinterestedinimproving thecurrentstate1

1ResultsoftheAvocaQualityConsortium’s assessmentofPrequalificationvisitsandroutinesystemsaudits;MAY2013

10

SurveyQuestion:TheAvocaQualityConsortiumisconsideringthepotentialtoestablishamechanismtoshareinformationregardingtheprequalificationofancillaryprovidersaspartofaninitiativetoreducecosts,introduceefficienciesandmitigateriskintheprequalificationoftheseproviders.Wouldyousupportthisinitiative?

AQCPulseCheckSurveyonPrequalification(2013)

89%

11%

Yes No

N=38 AQC Companies (Sponsors and CROs)

1111

Transformationinthewaytheindustryprequalifiestheirtechnicalproviderstoimprovequalityandefficiencyinclinicaltrials.

TheVisionfortheFuture

Standardize

Centralize

Optimize

StandardizationIndustryStandardsandTools

Centralization:CollectandcentrallystorecompletedRFIsandauditreports

Optimization:Builduponcentralsharingusingdataanalytics

12

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)

1313

• CoreRequirements

• CentralLaboratories

• IxRSServices

• CentralECGServices

• MedicalImagingServices

• BiomarkerLaboratories

• BioanalyticalLaboratories

• ClinicalOutcomeAssessmentProviders

EightstandardizedPrequalificationPackages*:

AQCPrequalificationInitiative

*EachincludesasetofIndustryStandards,RFItemplate,ScoreCard,andVisitCheckList

1414

AQCPrequalificationInitiativeandDiligentPrequalificationPlatform

AQC• PrequalificationStandards

• PrequalificationTools

• UpdatestoPQStandardsasRegulationsChange

Diligent• CentralizedPrequalificationAudits

• DataRepositoryandDataAnalytics

CentralRFIRepository*

• AQCFocus:PrequalificationStandardsandTools• DiligentFocus:CentralizationofPrequalificationActivities

1515

AchievingtheVision

2016Launch-DiligentCentralizedRFIsStatus*

• BuildingtheDiligentRepository– 42CompletedRFIs

– 14ParticipatingProviders

• PipelineofAdditionalPotentialProviderParticipants– 36additionalProvidersatvariousstagesofdiscussionorexecution

– Potentialtoaddupto95additionalcompletedRFIs

• DistributionofCompletedRFIstoRequestingCompanies– 12companiessubmittedrequestsforcompletedRFIs

– 128RFIsrequested

– 31RFIssentout

*asof19Aug2016

16

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

17

IndustryPerspective:(SponsorandProvider):

JuneWhiteatBristol-MyersSquibb

JamesMcSweeneyatICONplc

1818

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?

1919

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?

2020

SponsorOrganizationalChallengesandNeeds

SponsorPerspective:Bristol-MyersSquibb

• Onesponsorrepresentative:Mychallenges– “Agroupofone”foroversightofallScientific/analysingLaboratory

ServiceProviders(>20PreferredLaboratoryServiceProviders)

– Changingtechnologies(especiallybiomarkers)

– Increasingexpectationsforsupportingdevelopmentprograms

– Managingtime;Managingrisk

– Establishingandmaintainingpositiveproviderrelationships

– Supportinginternalteamstonavigateproviderperformanceandqualitychallenges

2121

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

2222

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

2323

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

2424

SponsorMeetingtheseChallenges

SponsorPerspective:Bristol-MyersSquibb

• MembershipintheAvocaQualityConsortium(AQC)– Collaborationwith60+othercompaniesfacingthesamechallenges.

– Networkingandlearningfromeachother

• MemberrepresentationonPrequalificationAdvisoryBoard– BMSrepresentativeinvitedtojoinAdvisoryBoard

– Attendedmeetings;builtawarenessofsourceofindustrystandards

– AccesstoleadingpracticetoolsandindustryexpertsonAdvisoryBoard

• EvaluationofDiligentCentralRFIProgram– Workinginternallytoevaluateandadoptwhereappropriate

– EvaluateAQCstandardsforCorerequirementsvs.BMSrequirements

2525

SponsorMeetingtheseChallenges

SponsorPerspective:Bristol-MyersSquibb

• EarlyadopteroftheAvocaDiligentProgram– UsedAvoca“IntroductoryEmailMessage”foroutreach(firstsetof4providers)

– SentDiligentCoreRFI(forcorerequirements)andBiomarkerLabRFI

– SentBMScustominternalcapabilityquestionnaire

– Avoca-heldWebExmeetingswith3ofthesecompanies

– Outreachexpandedto4moreproviders

– AvocaheldoneWebExmeetingwith1company

– AvocametatDIAwith2companiesonBMSlist

– BMSadded2moreprovidersviaDiligentagreement

2626

ProviderMeetingtheseChallenges

ProviderPerspective:ICONplc

• MembershipintheAvocaQualityConsortium(AQC)in2013– Collaborationwith60+othercompaniesfacingthesamechallenges.

– Networkingandlearningfromeachother

• MemberrepresentationonPrequalificationAdvisoryBoard– ICONrepresentativeinvitedtojoinAdvisoryBoard

– Attendedmeetingscontributedtodevelopmentofindustrystandards

• ICONinvitedbySponsortoparticipateinDiligent– “BigPharmaCo.”askedICONtoparticipateinDiligent

– “BigPharmaCo.”sentoutDiligentRFIsforcentrallabcategoryrefresh

– ICONsignsDiligentParticipationAgreement

– ICONcompletesCoreRFI(corerequirements)andCentralLabRFI

– ICONapprovesDiligentreleaseofCoreandCentralLabRFIsto“BigPharmaCo.”

2727

SponsorFeedbackonDiligentProcess

SponsorPerspective:Bristol-MyersSquibb

• Outcome:FeedbackonDiligentProcess– QualityofDiligentRFItemplates(alignmenttoBMSneeds/expectations)

– Firstoutreachwasquickandeasy(prepopulatedemailtemplate)

– Addressingquestionsfromproviders(BMSvs.Avocainvolvement)

– DiligentAgreementchallenges(version1)

– DiligentAgreementrevision(toaddresschallenges)

• Outcome:ResponsefromBMS’Providers– ReceiptofcompletedRFIs

– Timingofreceipt

– QualityofproviderinformationwithinRFIs

2828

ProviderFeedbackonDiligentProcess

ProviderPerspective:ICONplc

• ICONexperience– Initialexposure

– Internalevaluation

– Decision-makingonparticipation

– Respondedtobeapartof“BigPharma”categoryrefresh

• ICONexpandedparticipationforotherservices– BiomarkerLab

– BioanalyticalLab

– IxRSServices

– ImagingServices

– COA/eCOAServices

2929

SponsorValuePropositionandPlansfortheFuture

SponsorPerspective:Bristol-MyersSquibb

• ValuePropositionofDiligentforSponsors– AccesstoverycomprehensiveRFItemplates

– Avocasupportwithoutreach

– Avocasupportwithproviderquestions(WebExsessions,emailfollowup,etc.)

– Timesaved;moreefficient

– Utilizingexistingtoolsvs.usingmytime

• LeveragingDiligent– SharingapproachwithothersatBMS

– Possibilitiesforexpansionforotherservicesoutsidespecialtylabs

– ContinuedparticipationinAvocaQualityConsortiumforsharedbestpractices

– ContinuedparticipationinPrequalificationAdvisoryBoard

“Itjustmakessense”

3030

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”

31

Diligent:FutureVisionandOpportunities

DennisSalottiVPofOperationsTheAvocaGroup

32

OurSharedReality

Adaptedfrom:ProtocolComplexityasaFactorinClinicalComplianceRisk,MartaFields,SeattleGenetics

33

OurSharedReality

34

ASharingEconomy

Outsideofourindustry,varioussharedapproachestoeconomicorsocialpressureshaveemerged.

FindingThings LearningAboutThings GettingThingsDone

35

OurSharedReality

Adaptedfrom:ProtocolComplexityasaFactorinClinicalComplianceRisk,MartaFields,SeattleGenetics

36

ASharingEconomy

Withinourindustry,encouragingexamplesexistandcontinuetoemerge.

3737

Diligent:AVisionforOptimizingPrequalification

• Collaboration amongallStakeholders

• Transformationintheprequalificationprocessfortechnicalprovidersforimprovedqualityandefficiency.

38

Thankyou

ContactAvocaat:(609)252-9020

www.theavocagroup.com

info@theavocagroup.com

diligent@theavocagroup.com

179NassauStreet,Suite3A

Princeton,NJ08542