Capgemini-建設(shè)下一代制藥實(shí)驗(yàn)室-數(shù)字化連接環(huán)境可持續(xù)（英）-2024

Buildingthe

next-genpharmalab

DIGITALLYCONNECTED,

ENVIRONMENTALLYSUSTAINABLE

#GetTheFutureYouWant

RESEARCHINSTI

TUTE

Executive

Summary

Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

:

Mostlabsareatthepilotorproof-of-concept(PoC)stageof

transformation

Themajorityoforganizationsarestillintheearlystagesof

transformation,withonlyonein10ofthosesurveyedhavingpartiallyorfullyscaledtheirefforts.Whenweassessed

themagainstthecriticaldimensionsoflabtransformationmaturity,only15%couldbecategorizedas“l(fā)eaders."Labscontinuetoconfrontchallengesindata,technology,people,andprocessesastheystrivefortransformation.

Leadersarealreadyreapingbenefits

Ourassessmentmodelshowsthatleaders,thatarestrong

onbothfoundations(includingtools,technologies,data,

architecture,andconnectivity)andenablers(includingvision,strategy,people,processes,culture,andskills)arereaping

benefitsatscale.Almosthalfarealreadyreducingtimeto

market,humanerror,late-stagefailures,andcostsasaresultoftheirefforts.

Investmentsinlabtransformationaresettoaccelerate

Acutting-edgelaboratoryenvironmentisatthecoreofaninnovativeandcompetitivepharmaorganizationandis

criticaltomeetindustrydemandforinnovativetherapies,reducedtimetomarket,increasedapprovalrates,reducedcosts,andregulatoryrequirements.Mostpharma

organizationsarerethinkingtheirapproachtolabstructureandoperationwithanemphasisonaccelerating

digitalization,leveragingAI,improvingprocesses,and

buildingtherightskillsandculture.Ourresearchrevealsthatlargerorganizationsplantoinvest6.5%oftheirrevenuein

labtransformationinitiativesby2025,upfrom4%today.

CapgeminiResearchInstitute2024

3

Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

Howtobuildanext-genlab

Basedonourresearchandexperience,webelievethefollowingarekeyconsiderations:

?Strategizeyourtransformationapproach:Assessthecurrentmaturityofyourlabsanddevelopaclearvision,roadmap,andKPIsfortransformation.

?Designafuture-readyarchitecture:Legacy

technologiesandinfrastructurearemajorbarriers

tolabtransformationfor90%oforganizations.

Prepareablueprintoflabreferencearchitecture,

tools,andtechnologiestoguideandhelpinachievingcontinuousimprovement.

?Buildintelligencethroughstrongdatafoundations:

FocusonFAIR(findable,accessible,interoperable,andreusable)dataprinciplestoeradicatedatasilos,enableglobalcollaboration,andincreaseefficiencyofwork

performedinlabs.

?AugmenthumanintelligencewithAI:Fromtargetidentificationduringdrugdiscoverytoautomatedin-processtestingforqualitycontrol,AIand

generativeAIwillplayasignificantroleinassistinglabsincriticalprocesses.

?Optimizeyourprocesses:Ensureefficientoperationalcontinuitythroughharmonized,automated,and

integratedprocessesandworkflows.

?Collaboratewiththeecosystem:Fostertherightcultureandmindsettostrengthencollaborationandfacilitateopeninnovationinnext-genlabs.Aninterconnectedecosystemofindustryplayerstoconnectdata,insights,platforms,andinstrumentshelpsacceleratedrugdiscoveryanddevelopment.

?Strengthentalentcapabilities:Virtuallyall(97%)oforganizationsinoursurveyfindhiringscientistswithamixofdomainaswellasdigital/dataexpertisea

challenge.Helpplugtheskillsgapbyhiring,upskilling,reskilling,andpartneringtocapitalizeonthe“l(fā)ab-as-a-service”model.

?Embedsustainabilityacrossproducts,processes,

andoperations:Adoptagreenchemistryapproachtoreducewaste,conserveenergy,andeliminateuseofhazardoussubstances.

CapgeminiResearchInstitute2024

4

Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

Whoshouldread

thisreportandwhy?

Thisreport,packedwithactionable

recommendations,empowerspharmaandbiopharmaorganizationstobuildnext-gen,future-readylabs.

Itprimarilycaterstobusinessandtechnology

executivesacrossstrategy,innovation,R&D,pre-clinicaltrials,clinicaltrials,analyticalmethod

development(AMD),manufacturingprocess

development,regulatoryaffairs,pharmacovigilance,productsafety,pharmacology,quality,digital,data,analytics,andtechnologyfunctions.

Drawingonacomprehensivesurveyof702

seniorexecutives(fromR&D,quality,andprocessdevelopmentlabs)atlargepharmaandbiopharmaorganizationsexceeding$500millioninannual

revenue,thisreportprovidesatoolfor

organizationstoassesstheirmaturityoncritical

transformation“foundations”and“enablers”.

Beyondoutliningthe"why",thisreportalsodivesintothe"how"ofsuccessfullabtransformation,exploringpracticalstepsandconsiderations.Therecommendationsspanlabtransformationvisionanddesign,talentandstructure,partnerships

andmethodologies,technologies,and

architecture,andarecorroboratedbyin-depth

qualitativeinsightsfromover10industryleaders.

CapgeminiResearchInstitute2024

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Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

“Next-genlabswilldeploydigitaltechnologiessuchasautomation,predictiveanalytics,

andAIacrossthelifecycle.People,processes,tools,andtechnologieswillcometogethertoprovideaseamlessexperience”

JIGESHADHOLAKIA

AssociateDirector,AnalyticalMethod

Development,Bayer

CapgeminiResearchInstitute2024

Introduction

6

Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

Pharma1companiestodayfacearangeofissues,including

lowdrugapprovalrates,risingdrugdiscoverycosts,

pressuretoacceleratetimelines,ever-evolvingregulatory

requirements,andsupplychainuncertainties.Labs(including

R&Dlabs,qualitylabs,andprocessdevelopmentlabs)are

vitaltothe“molecule-to-medicine”valuechain.Byleveraging

digitalization,automation,robotics,andnext-generation

analytics–supportedbytherightsetofstrategies,processes,

people,culture,andpartners–future-readypharmalabs

willplayacriticalroleinaddressingtheseglobalhealth

challengeswithgreaterspeed,accuracy,andimpact.

Organizationsarelookingtocreatefuture-ready“next-gen”

labstodrivescientificbreakthroughs.However,asidefroma

fewhighperformers–whatwecall“l(fā)eaders”–ourresearch

showsthatlabtransformationprogressisgenerallypatchy.

So,whatisitabouttheseleadersthatallowsthemtocreate

moreagile,efficient,collaborative,flexible,andsustainable

labs?Andhowcanothersemulatethemtocreateandscale

next-genlabs?

Toanswerthesequestions,weconductedaglobalsurveyofmorethan700respondentswithinR&D,quality,andprocessdevelopmentlabsfrom235pharmaceutical(producing

chemicalorsmall-moleculedrugs)andbiotechnology

(producingbiologicsorlarge-moleculedrugs)organizationsacrosstheUS,UK,Switzerland,France,Germany,Japan,andIndia.

Wealsoconductedin-depthinterviewswithlifesciences

executivestocomplementthequantitativeinsights.Formoredetailsonthesurveysample,pleaserefertotheresearch

methodology.

CapgeminiResearchInstitute2024

Introduction

3

2

4

5

7

Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

Basedonourresearch,thereportfocusesonthefollowingquestions:

1

Whatarethekeyforcesdrivinglabtransformationinitiativestoday?

Whatisthestateofcurrentandplannedinvestmentinlab

transformation

initiatives?

Whereare

organizations

nowintheirlab

transformation

journey?

Whatarethekey

data-,technology-,

people-,andprocess-relatedbarriersto

transformation?

Whoaretheleadersandwhatarethe

benefitstheyachieve?

6

Howdoyoubuild

anext-genlaband

whatcanwelearn

fromtheleadersin

thisfield?

CapgeminiResearchInstitute2024

。

Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

01

LABSPLAYAKEYROLEINTHE

“MOLECULE-TO-MEDICINE”

VALUECHAIN

CapgeminiResearchInstitute2024

9

Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

acceleratedtimelinesisdrivingchange

Pharmacompanies,onaverage,spend$2.8billionperdrugapproval.2Onlyaround12%ofdrugsenteringclinicaltrialsareultimatelyapproved.3MountingR&Dcosts,lowapprovalrates,andlead-timechallenges,aswellastheincreasing

complexityofnewgeneandcelltherapies,areforcingpharmaorganizationstorethinktheirapproach.

Asshowninfigure1,pressuretoreducetimetomarket

impacts77%ofpharmaorganizations.SylvainDemanze,

SeniorAnalyticalScientistatAstraZenecasays,“Typically,thedesignmaketestanalyze(DMTA)cyclecantakeanything

fromafewweeks,ifyouarelucky,toseveralmonthsper

integration.Withinadrugdiscoveryproject,youneedtogothroughthiscycle10,20or30times.…ifyoucangothroughthisiterationmorequickly,youcanprogressyourpipelineofprojectsquicker.”4Only48%oforganizationsfeelpreparedforthisacceleration.

While58%oforganizationssaynewtherapeuticplatforms(suchascellandgenetherapies5,etc.,)areakeytheme,only42%arepreparedforthistrend.NovoNordiskFoundationhasrecentlyinvested$136millioninthedevelopmentof

anewclinicalcelltherapymanufacturinghubinDenmark.Thehubincorporatesbothprocess-developmentlabsandamanufacturingbase.6

Thedemandfor

FIGURE1.

Theneedforfasterdrugdevelopment,digitalization,andashifttowardsinnovativetherapiesareimpactingpharmaorganizationsglobally

PERCENTAGEOFORGANIZATIONSAGREEINGTOTHESTATEMENTSBELOW

77%

48%

66%

Dataanddigitalization

37%

58%

42%

54%

Regulatorycompliance

35%

48%

37%

isakeythemeforwhichourorganizationisprepared

Source:CapgeminiNext-GenPharmaLabSurvey,October2023,N=235pharmaandbiopharmaorganizations,N=702respondentsfrompharmaandbiopharmalabs.

Newtherapeuticplatforms(suchascellandgenetherapies)

isatopthemeimpactingpharmaandbiopharmaorganizations

Pressuretoreducetimetomarket

Drivetoincreasee?ciency

CapgeminiResearchInstitute2024

10

Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

Labecosystemscan

addressindustry

pressuresandemergingtrends

Pharmaorganizationsarerethinkingapproachestolab

structureandoperation,withanemphasisonaccelerating

digitalization.AstraZenecaisstronglyfocusedondigitizingitslabsthroughdata-drivenscience,artificialintelligence

(AI),digital-enabledlabworkflows,andconnectedlab

instruments.Forinstance,thecompanyisusingAItodeducethebestmoleculesacross70%oftheirsmallmolecule

chemistryprojects.7

FIGURE2.

Acceleratingtimelines,reducingcosts,improvingapprovalrates,andincreasingefficiencyarethetopdriversoflabtransformationinitiatives

PERCENTAGEOFORGANIZATIONSRANKINGTHEBELOWAMONGTOPDRIVERSFORLABTRANSFORMATIONINITIATIVES

Tocutdownthetimetomarket

Toreducethecostofdrugdiscovery,development,and

manufacturing

Toimprovesuccessrateofnewdrugdiscovery

Toenablecost-e?ectiveande?cientpharmacovigilance

Toenablefasterscaleupofthemanufacturingprocesses

Toaidinbetterregulatoryandauditcompliance

Toreducelate-stagefailures

Toenablebettercollaboration

Source:CapgeminiNext-GenPharmaLabSurvey,October2023,N=702respondentsfrompharmaandbiopharmalabs,N=235pharmaandbiopharmaorganizations.

92%

90%

87%

85%

83%

71%

76%

75%

CapgeminiResearchInstitute2024

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Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

Thetopdriversoflabtransformationcloselyalignwiththekeythemesimpactingtheindustry:

?Reducedtimetomarket:92%ofpharmaorganizationssurveyedrank“acceleratingtimetomarket”inthetopfivedriversforlabmodernization,digitalization,and

transformationinitiatives.Bycountry,96%ofpharma

organizationsheadquarteredinIndia,93%intheUS,and93%intheUKrankthisasatopdriver.

?Reducedcosts:Reducingcostsateverystageofthe

lifecycleisparamountfor90%oforganizationssurveyed(95%inSwitzerland).

?Improvedsuccessrates:87%ofsurveyedorganizations(96%intheUK,92%inFrance,and88%inJapan)

lookingtodigitalizationandtransformationtoimprovesuccessrates.

?Inaddition,83%aimtoscaleupmanufacturingfasterthroughlabtransformationinitiatives,especially

thosetargetedatimprovingtheefficiencyofprocessdevelopmentandqualitylabs.

Cenkündey,PhD,HeadofPharmaceuticalTechnical

DevelopmentDataandDigitalOrganizationatGenentech,anindependentsubsidiaryofRocheadds,“Thebenefits

ofdigitalizationincludeenablingseamlessdataand

informationflowacrossthedevelopmentvaluechainandintomanufacturing.Thisincreasesdevelopmentteams’productivitywhileadvancingthepipelineactivities.”8

CapgeminiResearchInstitute2024

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Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

Investmentsinlab

transformationaresettoaccelerate

Increasingly,aconnected,cutting-edgelabenvironment

isregardedasthecoreofaninnovativeandcompetitive

pharmaorganization.ArecentsurveyfromForrester

highlightsthat69%oflabheadsbelievetheywilllose

competitiveadvantageiftheyfailtoconnectandautomatetheirlabs.9

Ourresearchshowedthatnearly75%ofrespondentssay

theyhavebegunlabmodernizationandtheremaining

25%arestrategizingtheirapproach.Thesenumbersare

consistentacrossallthreetypesofpharmalabsinthesurvey(R&D,processdevelopment,andquality),underliningthe

universalnatureofthisimperativetotransform.

Onaverage,in2022organizationsspent2.7%ofrevenue

oninitiativesrelatedtomodernization,digitalization,and

transformationoftheirlabs.Theyplantospendnearly4.5%ofrevenueonthisby2025(seefigure3).Organizations

withrevenueof$500million–$1billiontypicallyspent

around1.8%inlabtransformationin2022,whereaslargerorganizations($10billion+revenue)spentaround3.7%.

FIGURE3.

Largeorganizationsplantoinvestnearly7%ofrevenueinlabtransformationinitiativesby2025

TOTALINVESTMENTINLABTRANSFORMATIONASA%OFORGANIZATIONALREVENUE

6.5%

5.4%

4.5%

4.1%

3.5%

2.7%

2.4%

1.8%

$5billion–lessthan

$10billion

20222025(E)

Source:CapgeminiNext-GenPharmaLabSurvey,October2023,N=702respondentsfrompharmaandbiopharmalabs,N=235pharmaandbiopharmaorganizations,N=35organizationsintherevenuerange$500million–lessthan$1billion,N=126

organizationsintherevenuerange$1billion–lessthan$5billion,N=28organizationsinrevenuerange$5billion–lessthan$10billion,N=46organizationwithrevenuemorethan$10billion.

$1billion–lessthan$5billion

$500million–

lessthan$1billion

Morethan$10billion

Overall

3.7%

2.8%

CapgeminiResearchInstitute2024

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Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

Nearlyhalf(48%)oforganizationsanticipatethattheywill

requiretwotofiveyearstotransformtheirlabs.Asignificantminority(17%)feeltheywillrequireatleastfiveyears,

whereas35%believetheycancompletetransformation

withinthenextcoupleofyears.

RocheisdevelopingtheIntegratedCoreLab,withcentralizedautomationthatwillincludeasingleuserinterfacethatcanruntheentiresystem.Theaimistoeliminatehumanerror

fromtaskswherehumaninteractionisnotrequired,improveefficiency,andreduceturnaroundtime.10

%

ofrevenueoflargeorganizationsisexpected

tobeinvestedinlabtransformationinitiatives

by2025

“DigitaltransformationledbyAIisakeycontributortoour

successandwillhopefullyhelpbringsolutionsfasterto

patients.”

NIVETHAPATERSON

HeadofScientificServicesfor

NorthAmerica,Sanofi

CapgeminiResearchInstitute2024

14

Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

02

MOSTORGANIZATIONSAREIN

THEEARLYSTAGESOFLAB

TRANSFORMATION

CapgeminiResearchInstitute2024

15

Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

MostlabsareatpilotorPoCstage

Manyorganizationsareyettoadvancebeyondpilotsand

proof-of-concept(PoC)intheirlabtransformationjourneys,asfigure4shows.

SophieBailes,Director,DigitalTransformationAstraZenecasays,“Whenwetalkaboutdigitaltechnologies,it's10%

technologyand90%people…Ifyou'redoingasmallpilotorPoCwhereyoumaybehaveonelaboroneproject,how

doyouthenscalethat?That'spartoftheengagementpiece,changemanagementandthatpeer-to-peersupport.[By

usingthiscollaborationpiece]we'vemovedtonowhavingVRtechnologyinthelabforinstance.Youhavetodeliver

digitaltransformationthrougheverybody–notthroughourleaders,notthroughonegroup.”11

FIGURE4.

Only1in10organizationshavescaledtheirlabmodernization,digitalization,andtransformationinitiatives

FOROURLABSMODERNIZATIONANDDIGITALIZATIONINITIATIVES,WEHAVE:

2%

10%

11%

22%

39%

26%

25%

R&Dlabs

strategizedourapproachlaunchedearlyproof-of-conceptsimplementedpilots

partiallyscaledupfullyscaledup

Note:Numbersdonotaddto100percentduetoroundingoff

Source:CapgeminiNext-GenPharmaLabSurvey,October2023,N=702respondentsfrom235pharmaandbiopharmalabs,N=371respondentsassociatedwithR&Dlabs,N=311respondentsassociatedwithprocessdevelopmentlabs,N=309respondents

associatedwithqualitylabsinpharmaandbiopharmaorganizations.

ProcessdevelopmentlabsQualitylabs

10%

25%

40%

40%

26%

26%

CapgeminiResearchInstitute2024

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Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

CURRENTTECHNOLOGY-,PROCESS-,ANDPEOPLE-RELATEDCHALLENGES

Pharmaandbiotechlabsareundermountingpressureto

increaseR&Dproductivity,reducecostsandtimetomarket,andbecomemoresustainablewhilealsodevelopingnew

andpromisingcures."Throughputandspeedarethekey

challengesinachievingthevisionforthelabofthefuture,”

notesJanetNikolovskifromJanetaConsultingGroup.As

labsstrivetomeetthesegoals,theymustaddressmultiplechallenges–fromheterogeneousunstructuredhigh-volumedata,tosiloedlabequipmentandprocesses,andashortageofskillsetssuchasdatamanagement,analytics,anAI.

Data-andtechnology-relatedchallenges

Dataisthefoundationforaccelerated,cost-efficient,and

high-qualitydrugdiscoveryanddevelopment.Inoursurvey,9outof10organizationsbelievethatdealingwithhuge

volumesofdataisoneoftheirbiggestchallenges.Withtheadoptionofnewcellandgenetherapies,andwithincreasinguseofmultiomicsanalysis12,datavolumeisincreasingatanunprecedentedpace.Onehumangenomesequencealone

requiresmorethan200gigabytesofstorage.Itisestimatedthat40exabyteswillbeneededtostoretheworld’sgenomicdataby2025.Forcomparison,everywordeverspokenby

humanswouldneedjustfiveexabytesofstorage.13AseniordirectorfromtheR&Darmofaleadingpharmaceutical

companyelaborates,"Wegenerateahugeamountofdatafromomics,genomics,geneticscreens,etc.,Oftentimes

wedon'tmakethebestuseofthisdatabecauseitisnot

connectedintherightway,andweenduprunningthesameexperimentmultipletimes.”

%

oforganizationssayheterogeneityofdata

formatsisachallengefortheirlabs.

CapgeminiResearchInstitute2024

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Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

FIGURE5.

Datasizeandcomplexityisamongthekeychallengesfacinglabs

PERCENTAGEOFORGANIZATIONSIDENTIFYINGTHEFOLLOWINGASTOPDATA-ANDTECHNOLOGY-RELATEDCHALLENGES

Regulatorycomplianceissuesregardingtechnologyuse

Equipmentinteroperability-relatedchallenges

Heterogeneityofdataformats

Datavolume

Fragmenteddatasystems

Source:CapgeminiNext-GenPharmaLabSurvey,October2023,N=702respondentsfrompharmaandbiopharmalabs,N=235pharmaandbiopharmaorganizations.

95%

95%

92%

93%

92%

Theheterogeneityofdatacollectedaddsanotherlayerofcomplexityfor93%oforganizationssurveyed(seefigure5).Thisdatacanbestructuredorunstructured,manual,

ordigital,andcanrangefromreal-worlddata(suchas

electronichealthrecords,imagingandlabdata,claims

andbillingdata,genomicsdata,etc.),toclinicaltrialsdata,partnerorvendordata,researchpapers,labnotes,and

pharmacovigilancedata,aswellasoperationaldataaroundinventory,schedules,instruments,etc.Thisallneedstobeintegratedand/orcross-comparedtoallowformeaningfulanalysis.ChristosVarsakelis,teamleadinAI/ML,Janssen

PharmaceuticalCompanies,Johnson&Johnsonsays,

“IfweworkedatTargetandwerecapturingpointof

salesinformationfromacashregister,thatisallhighly

structured[data]…Inalab…wehaveamuchmore

diverseandchallengingdatasettodealwith.”14

CapgeminiResearchInstitute2024

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Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

Anynewmethodologyadoptedinthelabmustbeapprovedbytherelevantregulatorybody.

Unsurprisingly,95%oforganizationsidentified

regulatorycomplianceissuesrelatedto

technologyuseasakeychallengeandafurther

95%highlightedequipmentinteroperability.

Skill-andculture-related

challenges

Labprofessionalsneedtherightanalyticalskills

toderiveinsightsfromdata.However,97%of

organizationsseeachallengeinfindingscientistswithamixofdomainaswellasdigital/data

expertise(seefigure6).Thevastmajority(87%)

alsomentionedtheabsenceofanagiledigital

cultureasachallenge.

FIGURE6.

Hiringpeoplewiththerightmixofskillsisachallengeforlabstoday

PERCENTAGEOFORGANIZATIONSIDENTIYINGTHEFOLLOWINGASSKILLANDCULTURERELATEDCHALLENGES

Inabilityto?ndtalentwithdomain/industryaswell

astechskills

Source:CapgeminiNext-GenPharmaLabSurvey,October2023,N=702respondentsfrompharmaandbiopharmalabs,N=235pharmaandbiopharmaorganizations.

Resistancetochangefromresearchers/scientistsside92%

Di?cultyinretainingtherighttalentandskillset93%

Leadershipnotbeingdigitalsavvy88%

Absenceofanagileculture87%

97%

CapgeminiResearchInstitute2024

"Throughputandspeedarethekeychallengesinachievingthevisionforthelabofthefuture”

JANETNIKOLOVSKI

JanetaConsultingGroup.

19

Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

Process-relatedchallenges

Labs,andparticularlythosededicatedtobiopharmaprocesses,areinherentlyheterogeneousand

pronetovariability.Thus,issuesrelatedtosample

representativeness,timedelays,operatingconditionvariations,likelychangesinsampleduringstorageandtransportation,sterileprocess,useoftoxicchemicalsandreagents,etc.,cropup.Asorganizationsdiversifyintonewadvancedtherapymedicalproducts(ATMP),processesbecomeevenmorecomplexwithnew

demandsonworkflowstosynergisticallycombinebothcomputationalandexperimentalapproaches.

Clinicalstudiestodayalsoinvolvemore

decentralization,complexprotocols,largernumbersofstakeholders,andavarietyoftechnologies,all

ofwhichmaketheexecutionmorecomplexand

lessefficient.Inourresearch,92%oforganizationsrecognizethatprocesscomplexityrankshighinthechallengeslabsface.

CapgeminiResearchInstitute2024

20

Onlyaminorityoforganizationsare“l(fā)eaders”

Tounderstandwhereorganizationsareonthejourneytowardsnext-genlabs,oursurveycoveredanumberofcriticalelements.Asseeninfigure7,theseelementsfallintotwogroups:the“foundations”andthe“enablers”oftransformation.

?Thefoundationscomprisethewhatoftransformation,includingthetools,technologies,data,architecture,andconnectivityrequiredtocreatethenext-genlabs.

?Theenablerscoverthehowoftransformation,includingthevision,strategy,people,processes,culture,andskillsrequiredforfuture-readylabs.

Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

FIGURE7.

Keyelementsofnext-genlabtransformation

01

THEFOUNDATIONS

?Architectureandsystemsintegration

?Cybersecurity

?Labconnectivity

?Intelligentdatacaptureandanalysis

?Labautomationandrobotics

?Emerginglabtechnologies(suchasAI,generativeAI,syntheticbiologyetc.)

THEENABLERS

?Laborganizationstructure

?Labprocessesandwork?owoptimization

?Labstrategyanddesign02

?Digitallabculture

?Labcollaborationandknowledgesharing

?Next-genlabcompetenciesandskills

Note:PleaseseetheAppendixformoredetailsonsub-parametersincludedforboththedimensions.

Source:CapgeminiResearchInstituteanalysis.

CapgeminiResearchInstitute2024

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MaturityofenablersoflabtransformationHigh

Low

Visionaries

10%

Leaders

15%

15%

Innovators

60%

Beginners

Buildingthenext-genpharmalab:Digitallyconnected,environmentallysustainable

Basedontheseelements,weidentifiedfourcohorts:

“visionaries”,“l(fā)eaders”,“innovators”,and“beginners”.

%

oftheorganizationssurveyedfallintothe

leaderscategory,wheretheyleadinboth

foundationsandenablers.

60%

fallintothebeginnerscategory,fallingbehind

inbothdimensions.

25%

dowellinonlyonedimension.

FIGURE8.

Only15%oforganizationsaremature(leaders)intermsoflabtransformation

High

Low

Maturityofthefoundationsoflabtransformation

Source:CapgeminiNext-GenPharmaLabSurv