Significance of Outsourcing and its...

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

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


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


How can we manage PV deliverables efficiently

People

Technology

Outsourcing


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 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


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?


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?


Road Map

Significance of outsourcing for Pharmacovigilance

The questionnaireWhat do we outsource

Effectiveness of outsourcing

Positive experiences

Challenges when outsourcing

Lessons learned


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


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


Outsourced activities by company size


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%)


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


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


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


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


Most positive experience with outsourcing


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


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


How can we meet these challenges

Requires well-designed selection process with

detailed agreement and strict and permanent

oversight


Life is a challenge…Meet it!-Sai Baba

Choosing a vendor


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


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


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


29

To the attendees and the members of the EU PV Working Group who took the time to

complete the questionnaire


Thank you!

30PV Zone 2017 Berlin - Significance of Outsourcing and its Effectiveness – Mariska Kooijmans-Coutinho

Significance of Outsourcing and itsEffectiveness

[email protected]

uk.linkedin.com/in/mariskakooijmans

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