The horizon pharma case

Horizon Pharma / B. Blumer

January 29th, 2013

NASDAQ: HZNP

12th annual Coolchain Logistics Europe 2013

Best Practice for End to End Visibility on your international Cold Supply Chain using RFID Technology

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Topics • Embedding monitoring and visibility strategies from the outset • Thorough qualification and briefing of suppliers to ensure full transparency throughout distribution • Effectively designing and setting up your supply chain • Successfully qualifying the whole supply chain to ensure it is robust • Reporting and documentation, merges event and temperature data • Always keeping in mind GDP guidelines

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Horizon’s Vision Embedding monitoring and visibility strategies from the outset The target of the project was to prepare and secure a timely and seamless transfer of the temperature sensitive drug product from the Packaging site Germany to the distribution partners in Tennessee, USA respectively Ohio, USA.

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Horizon’s Vision To Dos:

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Identify a flexible and reliable forwarding partner for the supply of the product to the USA

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Research and identify regulatory hurdles for the importation (customs, permits, storage) and ensure that these hurdles can be overcome

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Definition of the framework to successfully design the supply chain together with the selected partner

Horizon’s path

March 2012 Project start with RFQ

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April 2012

RFQ Feedbacks

Selection

July 2012 August 2012 Supply Chain Design

Audits SOPs

1st Shipment Launch Quantities

Horizon’s Project How did we identify the correct partner?

1) 2) 3) 4)

Nomination of possible partners with a Pre-RFQ Questionnaire Selection of Candidates for a quotation Face-to-Face presentations by the Candidates Final decision for one partner

And then?

Let‘s start to design the supply chain considering all aspects related to product stability, GDP, timelines, etc.

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Horizon’s Design How did we jointly design the supply chain?

1) 2) 3) 4) 5) 6) 7)

Involve all stakeholders in a timely manner Clarify all governance and compliance requirements Conduct Risk Analysis based on various modes and routes Establish, discuss and fine-tune the workflow and SOPs Determine deviation management and contingency Plan route qualification and timing.

H Inform and train all stakeholders O

It is of substantial importance to have a clear and common understanding of what is expected from each involved party.

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R I Z O N

3PL Supplier

C U S T O M E R

Horizon’s Deviation Alert System Full control over loading

Airport / Port Distribution Center

Airport / Port Defined Reicing process

Consolidation Hub Temperature cells

Consignee / Pharmacy

Real-time Visibility

Reefer Trucking

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Supplier

Temperature device

Horizon’s Deviation Alert System – cont.

How and when do we know if something went wrong?

1) 2+ RFID/ temperature/humidity loggers on every skid – Door/Door 2) One managed web-based monitoring system with RFID router interchange at every handover point in the supply chain Door/Door 3) Clear communication matrix and action measures in case of deviation.

4) Immediate data (event, location and graph) availability for review 5) Decision process in case of deviation alerts 6) CAR/CAPA process to follow final report It is of great advantage to have unlimited access to the shipment at all times. This beneficially influences the deviation process and time.

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Horizon’s 1st shipment Key Figures 6 Envirotainer RAP T2 30 Pallets Germany – USA Distance: 7758 km Transit time: 73 hours Ambient temperature: +28 C to +35 C Wheels-up customs clearance (Pre-clearance process)

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Product Routing

H O R I Z O N

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3PL Supplier

C U S T O M E R

Horizon’s GDP Guideline Mapping How do we ensure GDP compliance?

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Quality Management

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Qualified Staff Premises, Installations, Equipment

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Documentation Operations Complaints, Returns

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Contract Operations Self Inspection Transportation

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Quality System, SOP, Integrity Accountability, Trainings, Assessments Controlled Environment, qualified equipment Door - Door Documented, available, traceable Compliant, transport and storage Traceability of transport records on item level Service Level Agreement, Audits According GDP Guidelines Proactive Exception Management, at GDP certified transit points.

Q&A

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