Download - Outsourcing: challenges and successes
Outsourcing
Challenges and Successes
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Outline
BackgroundWhy would you contract out?What to contract out?Who should contract out?Laboratory selectionHow to manage itRoad to success
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Background
~50% of R&D expenditures is external<% early research, >% later stagesIn development small number of preferred partnersPre-clinical bioanalytical at 3 sites in EU. Internal ↔ external about 60:40Clinical bioanalytical at 2 sites in EU and 1 in US. Internal ↔ external about 10:90
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Global Bioanalytics11 People
2 Ph.D.3 M.Sc.5 Analysts1 Vacancy (academic lvl)
3 SitesNL: 100% contracting outFR: partly → 100% contracting outUS: routine work is contracted out
InvolvementCore business: PK sample analysisPD sample analysis (biomarkers)Metabolism in humans (ADME)DNA sample analysis (genotyping)Central lab activities
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Why contract outBecause your boss tells you toCorporate strategy
Science in houseOperational external
Flexible workforceCope with peaks in workloadNobody needs to get laid off in slow periods
Excess or shortage of moneyR&D expenditures as % of sales
Design your contracting out strategy on corporate goals
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Why contract outImprovement of deliverables
Better then own labsBetter equippedGLP compliantMore experienced employees
Faster then own labsLarger workforceMore instrumentsHarder working
Specific expertise
Be honest and realistic: your own lab is not the best in the world
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Why contract outOther
Flying to work is more fun then drivingBlame the failures on somebody elseHelping friends/ex-colleagues setting up their own businessKeep the interesting parts you like and get rid of the boring stuffYou like doing business better then running samples Managing projects rather then managing people
Yes it is also fun
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What to contract outStrategy
Type by type(analyte by analyte)
Study by studySpecies by speciesPhase by phaseProject by project
Full packagePartnership
Your choice of lab and how to do it should depend on what you need to contract out
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What to contract outAspects
MethodsTransfer of sponsor method (+validation)Development (+validation)
Stability studiesAs part of validationLong term, special conditions
Chemical synthesis(Internal) standardsMetabolites
What can you deliver, what are you willing to pay for and trust to others
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What to contract outAspects
TroubleshootingStabilitySelectivity/specificity
Sample analysisOnly (very) large studiesOnly non-proprietary assaysEverything
How far do you want to go
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Who should contract outTechnical / scientific focus: BioanalystsOutcome focus: CliniciansTimelines focus: Project managersFinancial focus: BU / contracting out
ConsultantContract partner
If you are not in the drivers seat you can not take responsibility
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Who should contract out?
Content ↔ Goals ↔ Timelines ↔ Costs
In the end (=during submission) it is only the quality (technical, scientific, GLP,
regulatory) of the work that counts.
Bioanalytical !
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Who should contract outBioanalytical:
Head of department or groupScientists / study directorsDedicated person(s)Whoever has time
Key competencies: well experienced bioanalyst, cultural awareness, customer awareness, integrity, interpersonal sensitivity, communicator, decider, persuasiveness
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Contract lab selection
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Contract lab selection
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Contract lab selectionLocation
Close to home or close to clinicNear airportNear major cityNear university /science parkSame countrySame continent
At least: good communication & reliable and timely sample shipments
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Contract lab selectionTechnical
Number (type) of LC-MS/MS systemsOther: immuno assay, GC-MS, LC-xyQuality system - GLPNon proprietary assaysBiomarker panelsBA = core business or …Tox or Clin BA labSize & new/old building
Go there to have a look (include QA)
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Contract lab selectionPeople & skills
Number of peopleStrictly hierarchical or breederAcademics or seasoned lab techiesWizards or ‘work horses’Serious & formal orgood for a laugh
You need some chemistry
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Contract lab selectionPeople & relationships
Like or dislikeTrust or distrustRespectHonestyCommunicationLanguage skillsCorporate & national culture
Trust is a crucial factor in contracting out
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Contract lab selectionCulture
Yes means yes (or no?)Loosing faceFeminine ↔ masculineLevels of communication‘corruption’
(strictly) adhere to the lawrelationships are more important then the law
http://www.geert-hofstede.com/
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Contract lab selectionCosts
Per sample (including QCs & cals)Per study / validation‘paper’
Protocol, reportArchivingProject management
‘other’Sample handlingSample storageRepeats
Do not forget your own costs: monitoring, travel, shipments
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Contract lab selectionQuality
GLPCSVBMVQAQC
Do not forget thescience
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Contract lab selectionOther
Met at a symposium / exhibitionKnow the guy/gall (friend)Friend of a friendFriend of your boss (dangerous!)Recommended by othersSame universitySpecific equipmentNational regulationsGood looking website
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How to manage it
do not overdo it
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How to manage it
and this might be a bit too relaxed
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How to manage itSecrecy AgreementMaster Service AgreementOutline / work order / scope of workQuotation / contractQA visitsProtocol / study planTeleconferencesMonitoring visitsControl samples / cross lab COMMUNICATE
Be and stay in contact and build a relationship
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How to manage itHuman factors
Human errorAdmitting mistakesBe forgivingBe honestRealize that they may
Dislike youLove your projectsHate your QAFind you over demanding
Socialize: diner, drinks, photo’s
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Road to success
Know WHY you want to contract outDecide WHAT you want to contract outPick the right persons to do and manage itSelect one or more candidate laboratories based upon your criteriaNew lab(s)? Start small & go thereKnown lab(s)? Pick up the phone (or e-mail)
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Road to success
Do all the required paper workSupply relevant information, materials, etcBe honest, open and frankBuild and maintain a relationshipAppreciate good workCOMMUNICATE
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AcknowledgementsGlobal Bioanalytics
Brian BissellOdylle BrockhoffLéonarda BrunetKoos DroogerCaroline DurandLeonie LeferinkJosé MarengoTanya MyersLydie RossyeTony Testino
Contract labs● ● ● ● ● ● ● ● ● &●