Partnerships in the Clinical Trial Supply Chain

1. PARTNERSHIPS
IN THE CLINICAL
TRIAL SUPPLY
CHAIN
Tony Heeley
Associate Director,
Worldwide Proposal Support Operations
May 21, 2015

2. 2
AGENDA
WELCOME • Introduction
• Identifying Partnership
• Risks
• Landscape
• Resources and Skills
• Supplier vs Partner
• Take Home Messages

3. 3
TOKYO, JAPAN
INTRODUCTION

4. 4
INTRODUCTION
• Registered and practicing
pharmacist
• PAREXEL
• Beecham
• Ciba-Geigy
– UK
– CH
– USA
• Almedica / Aptuit
– UK
– USA
• Wyeth
• Shire

5. 5
LONDON, U.K.
IDENTIFYING
PARTNERSHIPS

6. 6
WHAT IS THE DICTIONARY
DEFINITION OF A
PARTNERSHIP?
• A person who shares or is
associated with another in
some action or endeavor.
• One of two or more persons
who contribute capital to
establish or maintain a
commercial venture and who
usually share in the risks and
profits.
• A husband, wife, or lover.
• Either of two people who dance
together.
• A player on the same side or
team as another.

7. 7
TAIPEI, TAIWAN
RISKS

8. 8
DOES THIS DEFINITION FIT
THE RELATIONSHIP? • A person who shares or is
associated with another in
some action or endeavor.
• One of two or more persons
who contribute capital to
establish or maintain a
commercial venture and who
usually share in the risks
and profits.
• A husband, wife, or lover.
• Either of two people who
dance together.
• A player on the same side or
team as another.

9. 9
Sponsor Contractor
Public Safety Public Safety
Profit & Loss Profit & Loss
Shareholder Value Shareholder Value
Reputation Reputation
Long Term Stability Long Term Stability
RISKS OF GETTING IT WRONG
Research Investment

10. 10
DOES THIS DEFINITION FIT THE RELATIONSHIP?
• A person who shares or is associated with another in some
action or endeavor.
• One of two or more persons who contribute capital to establish or
maintain a commercial venture and who usually share in the risks
and profits.
• A husband, wife, or lover.
• Either of two people who dance together.
• A player on the same side or team as another.

11. 11
BERLIN, GERMANY
OUTSOURCING
LANDSCAPE

12. 12
LANDSCAPE
Outsourcing has increased over the last 20 years
and continues to increase
0
5
10
15
20
25
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Supply Chain Mgt
Logistics & Distribution
Manufacturing
Source: visiongain 2014

13. 13
LANDSCAPE
The activity mix has also changed –
but seems to be remaining constant
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Supply Chain Mgt
Logistics & Distribution
Manufacturing
Source: visiongain 2014

14. 14
Inventory Management
3PL Sourcing
Supply Chain Planning
Ancillary Supply Management
Storage / Warehousing
Transport
Import/Export
Cold Chain Services
Returns and Destruction
Drug Manufacturing
Placebo Manufacturing
Comparator Sourcing
Labelling and Packaging
LANDSCAPE
Market
Players
Market
Segment
Major
Services
Manufacturing
Storage and
Distribution
Supply Chain
Management
CMOs
Internal Divisions
Third Party Logistics Providers
CMOs
Internal Divisions
Third Party Logistics Providers
CROs
Full Service Providers
Internal Divisions

15. 15
RESOURCES AND
SKILLS
• Facilities
• Technologies
• Packaging Design
• Global Trade Compliance
• Regulations
• Project Management
• Patient / Site centricity

16. 16
BOSTON, MASSACHUSETTS
SUPPLIER VS PARTNER

17. 17
SUPPLIER VS PARTNER
• Facilities
• Technologies
• Packaging Design
• Global Trade Compliance
• Regulations
• Project Management
• Patient / Site centricity
Procedural
• Manufacturing
• Packaging
• Storage & Distribution

18. 18
SUPPLIER VS PARTNER
Intellectual
• Technical Instructions,
e.g.
• UAT …
• Project Management
• Planning & Forecasting

19. 19
AREAS REQUIRING PARTNERSHIP
Technology
• Few companies can afford to develop systems
- Core competence
- Cost
- Risk of failure

20. 20
AREAS REQUIRING PARTNERSHIP
Comparator Sourcing
• Implications of multiple sources

21. 21
AREAS REQUIRING PARTNERSHIP
Heads
• Embed within
- Sponsor project team
- Sponsor facility

22. 22
TAKE HOME MESSAGES
Partnerships are built
through a developing
relationship
• Information
• Communication
• Success
• Respect
• Trust

23. 23
THANK YOU
23