connecting cell and gene therapies to patients

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Connecting Cell and Gene Therapies to Patients Regenerative Medicine UK: Sweden London delegation Simon Ellison 13 th May 2019

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Connecting

Cell and Gene Therapies

to Patients

Regenerative Medicine UK: Sweden – London delegation

Simon Ellison

13th May 2019

How significant is the cost of logistics?

Logistics has same cost impact as staff and facility costs !

6/21/20192

Chimeric antigen receptor–T cell therapy manufacturing: modelling the effect of offshore production on aggregate cost of goods

Richard P. Harrison, Ezequiel Zylberberg*, Simon Ellison, Bruce L. Levine. Cytotherapy, In Press

World Courier – global capability & understanding

6/21/2019 CONFIDENTIAL4

ARM Quarterly Reports

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Company Growth

Total NORTHAM EMEA LATAM APAC

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Shipping Locations Growth

# countries #sites

World Courier Internal Data

Clinical Trial Growth

PhI PhII PhIII

World Courier - Trust and Consistency

6/21/20195

EXPERIENCEDeliveries to >2000 clinical sites

SCALABILITYManaging clinical trial and commercial

projects

QUALITYFully GDP compliant throughout

global network

GLOBAL SUPPORT140 offices in 50 countries

TEMPERATURESupporting +37 to -190C shipments

DEDICATEDCustomer Service teams for advanced

therapies

Logistics Platform Developer, managing Time Sensitive / Temperature Critical

Shipments for the Advanced Therapy Industry

World Courier - Advanced Therapy Integrated Support

6/21/20196

Do

na

tio

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Patient recruitment Tumor Collection

Kit OrderDonation Collection Donation Transport Manufacturing Receipt

Vecto

r

Vector TransportVector CMO Manufacturing Receipt

Th

era

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Specialty DistributionCryo store Therapy Transport

Donation Transport

Patient receipt

Auto

logous

Allo

geneic

Storage

Sa

mp

les

Specialist Laboratory

Reta

ins

Sample Transport

Monitorin

g

Disposal

Retu

rns

Short term

cryo store

World Courier – Managing Logistics

6/21/20197

Platform Partners Therapy Innovator World Courier

Building a logistics platform

Temperature controlled shipping

Real time tracking

Commercial scale operations

Dedicated customer service

Customs brokerage

Global capability

6/21/20198

Order to cash

Storage & distribution

Direct (to)from Patient

BioSphere transport

Supply Chain Orchestration

Shipping technology

Effective Therapy

Commercial Therapy

Logistics Platform in Operation

6/21/20199

Global LN2 Charging Capability

• 12 charging centres, and capability throughout global network

• Driven by a single quality system and underpinned by established SOPs

• Supporting over 10,000 cryo shipments annually

Integrated platform development

(Announced 28th May @ ISCT)

• Relationship with key manufacturing infrastructure organisation

• Support therapy developers in scaling up through clinical into commercial operations

• Integrate Logistics & Manufacturing Platforms

ATTC Collaborator

• Developing seamless supply chain

• Integrate and apply learnings throughout global network

World Courier’s people, operational expertise, and office

locations will support the success of your therapy

Focus on Communication: Automated updates; 24/7 dedicated Customer

Service and Clinical Trial teams; GPS tracking; unparalleled emergency response

Pro-Active Chain of Custody: Thorough SOPs and Work Instructions to

maintain chain of custody; shipment tracking through systems and GPaS

Own Office Network: 98% percent of all activity takes place in countries where

we have offices (including pick up, drop off, and transhipments)

Contingency Planning: Pre-arrangements with emergency services

(ambulances, local police escorts, helicopter); WC office dry shipper supply

State of the Art Training: Proprietary Training Resource Center and Agent

Resource Center; Site training plan

Scalable Processes: Training infrastructure; Packaging Management Hubs

(PH1); extensive network; Technology (Biostar); Quality Management System

Preferred Partner: FCPA compliant; regular local and global audits; constantly

investing to support client needs; resourced to overcome any challenge

6/21/201910