partnerships in the clinical trial supply chain by tom heely
TRANSCRIPT
PARTNERSHIPS IN THE CLINICAL TRIAL SUPPLY CHAINTony HeeleyAssociate Director, Worldwide Proposal Support OperationsMay 21, 2015
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AGENDA
WELCOME • Introduction
• Identifying Partnership
• Risks
• Landscape
• Resources and Skills
• Supplier vs Partner
• Take Home Messages
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TOKYO, JAPAN
INTRODUCTION
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INTRODUCTION
• Registered and practicing pharmacist
• PAREXEL
• Beecham
• Ciba-Geigy– UK
– CH
– USA
• Almedica / Aptuit– UK
– USA
• Wyeth
• Shire
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LONDON, U.K.
IDENTIFYINGPARTNERSHIPS
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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.
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TAIPEI, TAIWAN
RISKS
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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.
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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
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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.
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BERLIN, GERMANY
OUTSOURCINGLANDSCAPE
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LANDSCAPE
Outsourcing has increased over the last 20 years and continues to increase
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 20250
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10
15
20
25
Supply Chain MgtLogistics & DistributionManufacturing
Source: visiongain 2014
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LANDSCAPE
The activity mix has also changed – but seems to be remaining constant
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 20250%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Supply Chain MgtLogistics & DistributionManufacturing
Source: visiongain 2014
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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
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RESOURCES AND SKILLS
• Facilities
• Technologies
• Packaging Design
• Global Trade Compliance
• Regulations
• Project Management
• Patient / Site centricity
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BOSTON, MASSACHUSETTS
SUPPLIER VS PARTNER
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SUPPLIER VS PARTNER
• Facilities
• Technologies
• Packaging Design
• Global Trade Compliance
• Regulations
• Project Management
• Patient / Site centricity
Procedural
• Manufacturing
• Packaging
• Storage & Distribution
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SUPPLIER VS PARTNER
Intellectual
• Technical Instructions, e.g.
• UAT …
• Project Management
• Planning & Forecasting
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AREAS REQUIRING PARTNERSHIP
Technology
• Few companies can afford to develop systems- Core competence- Cost- Risk of failure
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AREAS REQUIRING PARTNERSHIP
Comparator Sourcing
• Implications of multiple sources
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AREAS REQUIRING PARTNERSHIP
Heads
• Embed within
- Sponsor project team- Sponsor facility
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TAKE HOME MESSAGES
Partnerships are built through a developing relationship
• Information• Communication• Success• Respect• Trust
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THANK YOU
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