PV Zone 2017
Significance of Outsourcing and itsEffectiveness
Mariska Kooijmans-Coutinho MD PhDHead of Drug Safety and Pharmacovigilance International
and EU QPPVAmicus Therapeutics UK Ltd.
PV Zone 20175th Annual Pharmacovigilance Forum
Berlin 02-03 March 2017
Road Map
Significance of outsourcing for Pharmacovigilance
The surveyWhat do we outsource
Effectiveness of outsourcing
Positive experiences
Challenges when outsourcing
Lessons learned
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Road Map
Significance of outsourcing for Pharmacovigilance
The surveyWhat do we outsource
Effectiveness of outsourcing
Positive experiences
Challenges when outsourcing
Lessons learned
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Pharmacovigilance is under pressure
Internal Pressures e.g., company growth, mergers and
aquisitions; more complex products; global expansion; use
of third parties and oversight thereof
External Pressures: changing and more demanding
regulatory requirements; data privacy; demand for
transparency
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Key components for PV operating models
Manage Core Activities
ICSR management
Aggregate reporting
Signaling activities
Benefit-Risk Management
Ensure Optimal Benefit-Risk Product Profile
Provide Global Coverage
Ensure Oversight and governance
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
How can we manage PV deliverables efficiently
People
Technology
Outsourcing
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Reasons for outsourcing
Meet regulatory obligations
Fit for purpose models to meet varying workloads
Instant expertise when needed
Increasing efficiency and capacity in a cost-effective manner
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
PV Outsourcing possibilities
‘Everything’
Activity specific
QPPV/Local Contact for PV/out of hours coverage
PSMF
Case related Core activities
Aggregate reporting
RMP
Signaling and literature review
Quality Management
SOP
Audit planning/CAPA management/Inspection readiness training
PV Systems
Global Safety Database
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Case study 1
Large Biotech company with 5 products on the market – global reach
Increasing number of partnerships
Growing pipeline – expanding number of clinical programmes
Solution:
Unique partnership with one service provider
Aim to include provider in strategic and product lifecycle planning
Joint processes and procedures – true partnership
Outcome?
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Case study 2
Small USA based Biotech – orphan disease space
First product approval in EU mid 2016
Support needed for PV and regulatory
One preferred (large) CRO for clinical operations, clinical trial drug safety andPostmarketing PV
Initially everything outsourced including EU QPPV
At approval EU QPPV hired
Path forward?
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Road Map
Significance of outsourcing for Pharmacovigilance
The questionnaireWhat do we outsource
Effectiveness of outsourcing
Positive experiences
Challenges when outsourcing
Lessons learned
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
What is our joint experience – the questionnaire
Thank you to all who participated:
Colleagues here in the audience
Colleagues from the EU PV Working group
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Questionnaire Results N = 21 completed
Questionnaire completed by*:
Head of Drug Safety/PV N = 6
EU QPPV N = 7
Deputy QPPV N = 5
Safety surveillance manager N = 1
Lead safety team not at hq N = 1
Medical director global patient safety N = 1
Not mentioned N = 2
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Outsourced activities by company size
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
0
5
10
15
20
25
1 to 20 (N=4) 21 to 100 (N=4) >100 (N=12)
Outsourced activities by company size (normalised to 100%)
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
0
5
10
15
20
25
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 to 20 (N=4) 21 to 100 (N=4) >100 (N=12) Total
Other outsourcing
Safety variations N = 1
Commercial PSP vendors N = 1
GSD application maintenance N = 1
Call center for out of hours coverage N = 5
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Sponsor experiences with outsourcingPositive experience N = 9 of 21
Vendor provides services sponsor does not have internal resources for
Vendors are OK for immediate workload problem solving
Vendor helps manage volume increase and fluctuations in case load at
reasonable cost and quality
Specialised vendors for specific tasks allows for internal staff to focus on
higher priority work
Cost-saving on core activities
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Sponsor experiences with outsourcingMixed experience N = 7 of 21
Steep learning curve and re-training needed, but good service once
trained
Close oversight needed
Variable quality and intensive resource need for oversight
Routine activities outsourcing is OK under strict control
Local vendors are knowledgeable about local requirements but over
time the quality of work suffers and cultural and language
differences may cause mistakesPV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Sponsor experiences with outsourcingNegative experience N = 3 of 21
Long learning curve makes task take longer
High turnover at CRO and continued need for oversight
Although outsourcing ensures flexibility and quick scale-up it is hard
to maintain quality and requires a large resource to manage the
vendor
Small company using large vendor who appears to not take pride in
deliverables and also has a high staff turnover – quality of work
therefore not adequate and huge oversight effort needed
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Most positive experience with outsourcing
Small competent consultancy no supervision needed and
good result
A one person consultancy:flexible, knowledgeable and
helpful, taking initiative to improve
Vendor takes accountability and reacts pro-actively
Strategic partnership with PV vendor– mutual ownership –
challenges are tackled together
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Most positive experience with outsourcing
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Long-standing relation developing into broad-scale strategic
partnership based on mutual confidence
Consultants working on-site and hence in close relation with
internal people
Using a preferred vendor for multiple activities to manage
internal resource issues
Ad hoc request for PASS protocol with short timeframe – used
niche vendor who was familiar with the company and the product
and agreed on scope of project
Biggest challenges in outsourcing
Finding the right vendor and agree on responsibilities
Setting up a good contract
Managing cost and quality
Maintaining the standard of service and oversight
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Biggest challenges in outsourcing
Set up period and training followed by oversight
High staff turnover at vendor – close oversight and re-training
needed
Time zone and language differences between Sponsor and
Vendor
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
How can we meet these challenges
Requires well-designed selection process with
detailed agreement and strict and permanent
oversight
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Life is a challenge…Meet it!-Sai Baba
Choosing a vendor
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 to 20 (N=4) 21 to 100 (N=4) >100 (N=12)
Capabilities Global reach Cost Other
Auditing of vendor
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 to 20 (N=4) 21 to 100 (N=4) >100 (N=12)
Sending out a questionnaire By phone In person audit
Vendor oversight
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 to 20 (N=4) 21 to 100 (N=4) >100 (N=12)
PV management Plan agreed Defined KPIs in PV Plan Project Manager at Sponsor Regular reports from vendor Regular meetings with vendor Vendor auditing
Lessons learned
Outsourcing requires well-designed selection process
with detailed agreement and strict and permanent
oversight
Choose the vendor who is fit for purpose for the job
and the stage your company is at
Work hard to make it work
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
29
To the attendees and the members of the EU PV Working Group who took the time to
complete the questionnaire
PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Thank you!
30PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho
Significance of Outsourcing and itsEffectiveness
uk.linkedin.com/in/mariskakooijmans