Partnerships in the Clinical Trial Supply Chain by Tom Heely

PARTNERSHIPS IN THE CLINICAL TRIAL SUPPLY CHAINTony HeeleyAssociate Director, Worldwide Proposal Support OperationsMay 21, 2015

2

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.





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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.





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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

5

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


• Patient / Site centricity

Procedural

• Manufacturing

• Packaging

• Storage & Distribution

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SUPPLIER VS PARTNER

Intellectual

• Technical Instructions, e.g.

• UAT …


• 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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Comparator Sourcing

• Implications of multiple sources

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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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Partnerships in the Clinical Trial Supply Chain by Tom Heely

Healthcare