outsourcing: challenges and successes

Outsourcing

Challenges and Successes

21-Feb-2008 PvA - Bioanalysis in Clinical Research: Contracting Out 2

Outline

BackgroundWhy would you contract out?What to contract out?Who should contract out?Laboratory selectionHow to manage itRoad to success


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


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


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


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


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


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


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


What to contract outAspects

TroubleshootingStabilitySelectivity/specificity

Sample analysisOnly (very) large studiesOnly non-proprietary assaysEverything

How far do you want to go


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


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 !


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


Contract lab selection

http://www.covance.com/index.php

http://www.stjohns.edu/


Contract lab selection


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


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)


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


Contract lab selectionPeople & relationships

Like or dislikeTrust or distrustRespectHonestyCommunicationLanguage skillsCorporate & national culture

Trust is a crucial factor in contracting out


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/


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


Contract lab selectionQuality

GLPCSVBMVQAQC

Do not forget thescience


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


How to manage it

do not overdo it


How to manage it

and this might be a bit too relaxed


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


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


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)


Road to success

Do all the required paper workSupply relevant information, materials, etcBe honest, open and frankBuild and maintain a relationshipAppreciate good workCOMMUNICATE


AcknowledgementsGlobal Bioanalytics

Brian BissellOdylle BrockhoffLéonarda BrunetKoos DroogerCaroline DurandLeonie LeferinkJosé MarengoTanya MyersLydie RossyeTony Testino

Contract labs● ● ● ● ● ● ● ● ● &●

[email protected]

outsourcing: challenges and successes

Business

clinical research

pva bioanalysis

consultant contract

choice of lab

central lab activities

laboratory selection

seasoned lab techies

strategy type