Factors to be considered when contracting out bioanalytical services to contract laboratories.

1. Outsourcing
Challenges and Successes

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Outline
Background
Why would you contract out?
What to contract out?
Who should contract out?
Laboratory selection
How to manage it
Road to success

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Background
~50% of R&D expenditures is external
<% early research, >% later stages
In development small number of preferred partners
Pre-clinical bioanalytical at 3 sites in EU.
Internal ↔ external about 60:40
Clinical bioanalytical at 2 sites in EU and 1 in US.
Internal ↔ external about 10:90

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Global Bioanalytics
11 People
2 Ph.D.
3 M.Sc.
5 Analysts
1 Vacancy
(academic lvl)
3 Sites
NL: 100% contracting out
FR: partly → 100% contracting out
US: routine work is contracted out
Involvement
Core business: PK sample analysis
PD sample analysis (biomarkers)
Metabolism in humans (ADME)
DNA sample analysis (genotyping)
Central lab activities

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Why contract out
Because your boss tells you to
Corporate strategy
Science in house
Operational external
Flexible workforce
Cope with peaks in workload
Nobody needs to get laid off in slow periods
Excess or shortage of money
R&D expenditures as % of sales
Design your contracting out strategy on corporate
goals

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Why contract out
Improvement of deliverables
Better then own labs
Better equipped
GLP compliant
More experienced employees
Faster then own labs
Larger workforce
More instruments
Harder working
Specific expertise
Be honest and realistic: your own lab is not the best in the world

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Why contract out
Other
Flying to work is more fun then driving
Blame the failures on somebody else
Helping friends/ex-colleagues setting up their own
business
Keep the interesting parts you like and get rid of the
boring stuff
You 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 out
Strategy
Type by type
(analyte by analyte)
Study by study
Species by species
Phase by phase
Project by project
Full package
Partnership
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 out
Aspects
Methods
Transfer of sponsor method (+validation)
Development (+validation)
Stability studies
As part of validation
Long term, special conditions
Chemical synthesis
(Internal) standards
Metabolites
What can you deliver, what are you willing to pay for and trust to others

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What to contract out
Aspects
Troubleshooting
Stability
Selectivity/specificity
Sample analysis
Only (very) large studies
Only non-proprietary assays
Everything
How far do you want to go

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Who should contract out
Technical / scientific focus: Bioanalysts
Outcome focus: Clinicians
Timelines focus: Project managers
Financial focus: BU / contracting out
Consultant
Contract 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 out
Bioanalytical:
Head of department or group
Scientists / study directors
Dedicated 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 selection
Location
Close to home or close to clinic
Near airport
Near major city
Near university /
science park
Same country
Same continent
At least: good communication & reliable and timely
sample shipments

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Contract lab selection
Technical
Number (type) of LC-MS/MS systems
Other: immuno assay, GC-MS, LC-xy
Quality system - GLP
Non proprietary assays
Biomarker panels
BA = core business or …
Tox or Clin BA lab
Size & new/old building
Go there to have a look (include QA)

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Contract lab selection
People & skills
Number of people
Strictly hierarchical
or breeder
Academics or
seasoned lab techies
Wizards or
‘work horses’
Serious & formal or
good for a laugh
You need some chemistry

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Contract lab selection
People & relationships
Like or dislike
Trust or distrust
Respect
Honesty
Communication
Language skills
Corporate & national culture
Trust is a crucial factor in contracting out

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Contract lab selection
Culture
Yes means yes (or no?)
Loosing face
Feminine ↔ masculine
Levels of communication
‘corruption’
(strictly) adhere to the law
relationships are more important then the law
http://www.geert-hofstede.com/

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Contract lab selection
Costs
Per sample (including QCs & cals)
Per study / validation
‘paper’
Protocol, report
Archiving
Project management
‘other’
Sample handling
Sample storage
Repeats
Do not forget your own costs: monitoring, travel, shipments

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Contract lab selection
Quality
GLP
CSV
BMV
QA
QC
Do not
forget the
science

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Contract lab selection
Other
Met at a symposium / exhibition
Know the guy/gall (friend)
Friend of a friend
Friend of your boss (dangerous!)
Recommended by others
Same university
Specific equipment
National regulations
Good 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 it
Secrecy Agreement
Master Service Agreement
Outline / work order / scope of work
Quotation / contract
QA visits
Protocol / study plan
Teleconferences
Monitoring visits
Control samples / cross lab
COMMUNICATE
Be and stay in contact and build a relationship

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How to manage it
Human factors
Human error
Admitting mistakes
Be forgiving
Be honest
Realize that they may
Dislike you
Love your projects
Hate your QA
Find you over demanding
Socialize: diner, drinks, photo’s

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Road to success
Know WHY you want to contract out
Decide WHAT you want to contract out
Pick the right persons to do and manage it
Select one or more candidate laboratories
based upon your criteria
New lab(s)? Start small & go there
Known lab(s)? Pick up the phone (or e-mail)

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Road to success
Do all the required paper work
Supply relevant information, materials, etc
Be honest, open and frank
Build and maintain a relationship
Appreciate good work
COMMUNICATE

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Acknowledgements
Global Bioanalytics
Brian Bissell
Odylle Brockhoff
Léonarda Brunet
Koos Drooger
Caroline Durand
Leonie Leferink
José Marengo
Tanya Myers
Lydie Rossye
Tony Testino
Contract labs
● ● ● ● ● ● ● ● ● &●
Contact
peter.vanamsterdam@solvay.com