tlp insight

TLPINSIGHTIssue 1 - 2013

The Logistics Portal magazine

AIR CARGO - RFID - TEMPERATURE CONTROLLED - CLINICAL - BIO PHARMA - LOGISTICS

STANDARDSTransportation of Time and Temperature Sensitive Products

TLP Insight: a journal for the life science logistics industry

LOOKING AT ACTIVE VERSUS PASSIVE IN THE DISTRIBUTION SUPPLY CHAIN

ASSESSING THE OPTIONS

A BACKGROUND ON CLINICAL LOGISTICS IN THE UKRAINE

Popular Ukraine

IATA

SWISSWORLDCARGO.COM

I am Peace of Mind

Mambio RavezziSales Manager Cargo Italy

Of course, Swiss WorldCargo is a hallmark for quality, precision and a dedicated global team. But all you really need to know is this: the moment you hand over your cargo to us, you can stop worrying. This is the true meaning of: We care for your cargo.

SWC Mambio_EN_203x280.indd 1 11.07.12 14:00

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3. TLPINSIGHT 3.SWISSWORLDCARGO.COM

I am Peace of Mind

Mambio RavezziSales Manager Cargo Italy

Of course, Swiss WorldCargo is a hallmark for quality, precision and a dedicated global team. But all you really need to know is this: the moment you hand over your cargo to us, you can stop worrying. This is the true meaning of: We care for your cargo.

SWC Mambio_EN_203x280.indd 1 11.07.12 14:00

MANAGING DIRECTORLee Atkinson

MANAGING EDITORBridget Langston

SENIOR DESIGNERJoey Graham

EDITORIAL ASSISTANTSNicholas RidgmanJamie Ward

CIRCULATION MANAGERTony Williams

SALESRakesh Makwana, Lee Atkinson

ADMINISTRATIONKatie Galelli

WEBSITE DESIGNKnut Henriksen

PRINTED BYCBF Cheltenham Business Forms Ltdwww.cbfnet.co.uk

CONTACT USSales:[email protected]:[email protected]

TLP INSIGHTIs published 4 times a year February, May, July, October by Intensive Media Ltd Send address changes to:145 - 157 St Johns StreetLondonEC1V 4PWUnited Kingdom

The opinions and views expressed by the authors in this book are not necessarily those of the Editor or the Publisher and, whilst every care has been taken in the preparation and design of this book, the Editor nor the Publisher are not responsible for such opinions and views, or for any inaccuracies in the articles.Whilst every care is taken with artwork supplied, the Publisher cannot be held responsible for any loss or damage incurred, The entire content of this publication is protected by copyright. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form, by any means – electronic, mechanical, photocopying or otherwise – without prior permission of the Publisher.

Copyright© 2013 Intensive Media Ltd

TLPINSIGHT//MAIN CONTENT

Cool chain logistics for the pharma industry to Japan and AsiaAdrian Rayner of Japan Airlines talks about Cool Chain Logistics for the pharmaceutical industry to Japan and Asia, and the ever-growing customer requirements.

14

American Airlines looks into the strict requirements that air cargo handlers are

placed under. They also tell us how they have implemented a high-visibility,

multi-layered tracking program for ExpediteTC, which guarantees all temperature-

sensitive shipments.

Read the full article on page 18 »

Integration of dangerous goods management solutions into existing software environmentsHerman Teering, Managing Director of DGM Software Development Group A/S offers dangerous goods logistics solutions that can be added to back office systems and describes the benefits that can be achieved from these as well as the associated pitfalls.

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//MAXIMIZING CONFIDENCE IN TEMPERATURE-CONTROLLED PHARMACEUTICAL SHIPPING

IATA Standards: Transportation of Time and Temperature Sensitive ProductsAndrea Gruber, Manager Cargo Business, Process & Standards is responsible at IATA for the regulations related to the transport of Live Animals, Perishables and Healthcare Cargo and for delivering the standards and processes for the air cargo supply chain. Dave Brennan, Assistant Director Cargo Safety and Standards, is responsible for coordinating the activities of the Cargo team who are jointly responsible for the IATA standards publications and products that address dangerous goods transported by air. Together they detail the framework in which the Life Science Logistics industry needs to work, and the ways in which IATA are responding to challenges presented by transporting time and temperature sensitive products.

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Contents continue on page 4 »

TLPINSIGHT www.the-logistics-portal.com4.

//CONTENTS

China Continues to Attract BiopharmaCold Chain IQ look into growth in temperature controlled pharmaceutical shipments from emerging markets and how much of the expected growth is attributed to China’s growing importance in the global pharmaceutical industry.

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//MANAGING YOUR RISK IN THE SAFE TRANSPORTATION OF LIFE-SAVING PHARMACEUTICALS. ACTIVE VERSUS PASSIVE IN THE DISTRIBUTION SUPPLY CHAIN

Kavita Somaroo at DS Smith Plastics Cool Logistics looks at

the decision on whether to use an active system or passive

packaging to transport temperature-sensitive products.

RFID and Cold Chain ManagementAlex Guillan, currently CEO of Escort Cold Chain Solutions SA (ECCS) looks forward with optimism to the day when the technology mix used in the Cold Chain can bring assurance of the product to everyone concerned, not least the patient.

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The Need for Inference: Impacts on Anti-counterfeiting, Serialisation and Product TrackingPeter Norton, Supply Chain Consultant at Intelleflex Corporation and with over ten years experience of working in the pharmaceutical cold chain and logistics industry argues for the need for inference, ‘the method of identifying the contents of a shipping container to confirm its contents without actually opening the container’.

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Clinical Logistics in UkraineSergii Pomerantsev, Head of Logistics at Centre of Clinical Research (CCR), who has managed the clinical supply chain for more than fifty clinical projects in Ukraine and Sergii Myronenko, Quality Assurance Manager at CCR give us practical background information on clinical logistics in Ukraine; an increasingly popular venue for international clinical trials.

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Cool Chain and Clinical TrialsBiocair explains the ever-increasing importance of the Cool Chain in Clinical

Trials, where different phases often take place on different continents and

samples need to be in the right place at the right time and in the right condition.

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Read the full article on page 45 »

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//TLP INSIGHT FORWARDThe first of its kind

We would like to wish you all a Happy New Year for 2013 and a warm welcome to the first issue of TLP Insight.

2012 has been a tough year in a long line of tough years for everyone in the Life Science Logistics industry, but here at TLP

Insight we have remained optimistic from the outset that with a lot of hard work and a desire to bring the very best to market

we could buck the trend.

TLP Insight has grown out of our online presence, The Logistics Portal, a Pharmaceutical Logistics B2B directory, which provides an

informed and comprehensive information hub for the Life Science Logistics industry. Our publication is our response to the needs of the

industry for a book to compliment the online portal and we are very pleased to have been able to bring it to fruition.

We have set out to create a publication that is unique in the Life Science Logistics industry and delivered in a format unlike any other.

It is unique in that it is the only book in the industry, the first one, to complete the whole market from technology and software to bulk

shipment and air cargo.

And unlike any other publication, it will not be split into sections; rather our approach is to present content in a more integrated, holistic

format.

The aim of this is to encourage the flow of information between all the different parties involved in Life Science Logistics, promote

discussion on all topics and nurture a cross-fertilisation of ideas. And in so doing, promote understanding of the different problems and

challenges faced by different elements that can ultimately impact on the industry as a whole.

In this issue we cover IATA Standards: Transportation of Time and Temperature Sensitive Products. IATA’s Andrea Gruber, Manager Cargo

Business, Process and Standards and Dave Brennan, Assistant Director Cargo Safety and Standards provide our main feature which gives

an in depth insight into the framework within which our industry needs to work and the ways in which IATA are rising to the challenges

presented in the transportation of time and temperature sensitive products.

Issues around documenting the authenticity of pharmaceuticals are a very hot topic, with many people working in the industry trying to

anticipate changing or new directives from governments. Peter Norton a Supply Chain Consultant from Intelleflex Corporation argues the

need for inference in his article The Need for Inference: Impacts on Anti-Counterfeiting, Serialisation and Product Tracking.

Alex Guillen the CEO of Escort Cold Chain Solutions SA (ECCS) gives us thought-provoking perspectives on the current state of play of

RFID and Cold Chain Management and why he believes that long-awaited progress will be made in this area of our industry.

Over the course of the coming year, in what looks to be a full and busy schedule for TLP Insight, we will be focused on covering a variety

of topics: from Green Packaging and the various packaging regulations, reusable packaging and labelling associated with it to discussing

global regulatory issues within air cargo, within emerging markets and within clinical trial logistics as well as touching further on anti-

counterfeiting.

I would like to thank the contributors and our staff for all their efforts and hope you enjoy the publication. I hope too that you will stay

with us as we move from strength to strength.

All the best for 2013

Lee AtkinsonManaging Director and Founder of Intensive Media Ltd

www.the-logistics-portal.com TLPINSIGHT 7.

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Air cargo delivering the modern worldThe global economy relies on air transport to deliver high

quality products at competitive prices to consumers worldwide.

International trade is now estimated at over USD 15 trillion and

about 35% of that value is transported by air.

With the healthcare market becoming a key engine of the global

economy, pharmaceutical and biomedical industries are facing new

challenges in adapting to globalization. Air cargo is an essential link

in the consumer supply chain ensuring continual access to quality

and choice but it cannot work on its own.

The International Air Transport Association (IATA) is the industry’s

global trade association and represents some 240 airlines comprising

84% of global air traffic. Its mission is to represent, lead and serve the

air transport industry. In Cargo, IATA takes a supply chain approach

to all its initiatives, with an aim to benefit all parties (airlines,

forwarders, governments, Customs and shippers).

IATA delivers standards and solutions to ensure a safe and

harmonised air transport system. IATA’s vision for Cargo is to foster a

safe, secure, reliable, efficient and profitable air cargo supply chain.

Specialist drugs, vaccines and emergency aid rely on air cargo to get

where they are needed.

The market for healthcare products continues to grow and shows

strong resilience to global economic downturns. An increasingly

ageing population requires access to new products and spending

on national healthcare programs is an important part of many

government social policies. The emergence and expansion of Brazil,

Russia, India, China and South Africa as major consumer markets

will shift demand and lead to more balanced trade flows in the air

cargo industry. This is already seen in China and to an extent in India.

The growing middle classes in emerging economies are discerning

high end consumers who will continue to sustain air freight growth

in the years to come. Understanding customer needs, anticipating

them and adding value in delivery is key to achieving an effective

supply chain. In particular the healthcare industry is concerned

with ensuring the integrity of sensitive products is maintained

when transported by air. IATA in collaboration with supply chain

stakeholders and partners has undertaken collaborative actions to

address these concerns.

Speed to market is essential and the healthcare industry is

increasingly dependent upon air cargo. It is vital to address the

challenge of keeping products at the correct temperature range

to ensure the quality of the product is not affected in transit.

Temperature control in transport is therefore an important

component of the industry and is continuously rising in line with

international trade. The most important issue for the industry and

its logistic providers is to clarify mutual expectations to minimize

risks and challenges for airfreight within the cool chain. Temperature

deviations and temperature excursions throughout the journey

require the establishment of a complete logistical process to

IATA STANDARDSTransportation of Time and Temperature Sensitive Products


Manager Cargo Business Process & StandardsInternational Air Transport Association

Assistant Director Cargo Safety & StandardsInternational Air Transport Association

Andrea Gruber

//BIOGRAPHY

David Brennan

Mrs. Gruber joined the International Air Transport Association (IATA) in 2008 as Manager

Business Process & Standards in the Cargo Division and is responsible for delivering the

standards and processes for the air cargo supply chain.

Mrs. Gruber is responsible for the IATA regulations related to the transport of Live

Animals, Perishables and Healthcare Cargo. She is secretary to the IATA Live Animals and

Perishables Board and the Time and Temperature Task Force.

Prior to working with IATA, Mrs. Gruber worked at the International Road Transport Union

(IRU) as head of a division implementing, at the Customs and business level, tools to

assist the application of risk management.

Mrs. Gruber studied in Geneva at the University and at the Graduate Institute of

International Studies (I.U.H.E.I.) and holds a Master of Sciences in International Relations.

David joined IATA in May 2002 as the Manager, Dangerous Goods Technical Services. In

April 2004 David was appointed Assistant Director Cargo Safety & Standards.

David is responsible for coordinating the activities of the Cargo team who are jointly

responsible for the IATA standards publications and products that address dangerous

goods transported by air. David is the Secretary of the IATA Dangerous Goods Board and is

also the Panel member nominated by IATA to the International Civil Aviation Organization

(ICAO) Dangerous Goods Panel.

Before joining IATA David worked for Australia Post as a consultant on Aviation Security /

Dangerous Goods compliance. Prior to that David worked for Ansett Australia for a period

of 26 years holding a number of supervisory and management positions

maintain the shipment integrity. Quality, reliability and

performance are crucial, and to achieve this dialogue, joint

strategy and standardization throughout the complete

supply chain is needed. The shipper is ultimately responsible

for ensuring the product (and any necessary packaging)

is preconditioned to the required temperature, and will

remain within a temperature range for a certain period of

time, using the appropriate refrigeration method adapted

to the shipping circumstances. However the accountability

is shared by all of the stakeholders within the healthcare

supply chain. Meeting the challenges can only be achieved

by cooperation between all stakeholders involved in the

supply chain, who recognize the need for guidelines.

BackgroundTo address the challenges in transporting healthcare

products, IATA established a dedicated working group: the

IATA Time and Temperature Task Force (TTTF) under the

supervision of the IATA Live Animals and Perishables Board,

a governance body comprised of 12 Airline members,

endorsing healthcare standards for the air cargo industry

recommended by the Time and Temperature Task Force

members. The work undertaken by this healthcare industry

subject matter expert Task Force composed of airlines,

ground handling agents, freight forwarders, shippers,

international and national organizations, airports, and

equipment manufacturers led to the inclusion of a specific

chapter in the existing IATA Perishable Cargo Regulations

(PCR). Today the air cargo industry is using the IATA PCR

as the essential reference guide for all parties involved in

the packaging and handling and distribution by air of time

and temperature sensitive healthcare products. Chapter 17

“Air Transport Logistics for Time and Temperature Sensitive

Healthcare Products” in the PCR specifically addresses the

IATA STANDARDSTransportation of Time and Temperature Sensitive Products


temperature control management issues identified by the industry

and sets out recommended standards such as the use of the IATA

Time and Temperature Sensitive label, developed together with the

air cargo supply chain, and first introduced on July 1st, 2010.

Mandatory Shipping LabelThe Time and Temperature Sensitive label came about as a result

of standardizing the nearly endless parade of labels applied by

shippers throughout the industry. It is a shipment label, specific

to the healthcare industry, that must be affixed to shipments

transported as time and temperature sensitive cargo. Regarded

as a recommendation, the air cargo industry recognizes this label

as a best practice. Therefore, effective July 1st, 2012 the IATA

Time and Temperature Sensitive label became mandatory for

the transportation of healthcare cargo shipments transported as

temperature sensitive cargo. The decision to implement this step

resulted from a collective recommendation supported by the Time

and Temperature Task Force and Working Group members and

endorsed by the IATA Live Animals and Perishables Board.

IATA’s aim is to ensure the integrity of the time and temperature

sensitive healthcare cargo shipments and that the air cargo supply

chain is prepared to handle the demands of these healthcare

shipments. The application of this new requirement will enhance

the transport and handling of specific healthcare commodities with

the aim to ensure the highest quality through effective cold chain

distribution. Therefore, it is imperative that airlines, ground handling

agents and other stakeholders in the supply chain – including freight

forwarders, terminal operators, ULD manufacturers, packaging

and tracking and tracing companies – are familiar both with the

regulations and the appearance of the label.

The PCR Chapter 17 requirement mandates the lower half of the

label to indicate the external transportation temperature range of

the shipment. The responsibility to apply and complete the label for

time and temperature sensitive healthcare cargo shipments booked

as such rests with the shipper (or designated shipper’s agent by

service agreement). Though transportation begins with the shipper,

IATA, together with its members, is putting an emphasis on the initial

booking, which is the key step to successful cargo transportation and

which triggers the appropriate handling and operational processes

associated to healthcare transport. The label only supports the

booking, thus the transportation temperature range specified on the

label must match the transportation temperature range stated on

the Air Waybill, Service Level Agreement (SLA) or Standard Operating

Procedures (SOP).

To strengthen the overall supply chain a 24-hour contact telephone

number of a person knowledgeable about the shipment will have

to be provided at the time of booking on the Air Waybill as well as

in the SLA or SOP, to allow contacting the appropriate person in

the event of a significant delay or disruption to the shipment that

may impact on the viability of the contents of the shipment. More

information can be accessed on the IATA website using the following

link: http://www.iata.org/whatwedo/cargo/pharma/Pages/index.aspx

Monitoring devicesIn addition to the label and new healthcare requirements, IATA is

working on a number of other projects to help tackle difficulties

in pharmaceutical transportation. IATA by means of an industry

working group, the Cargo RFID Working Group (RFIDWG), will be

focusing on temperature monitoring devices and their use, as

currently there are no clearly defined standards that exist that permit

the use of electrically active devices in cargo shipments.

The healthcare industry is increasingly using monitoring systems,

which may be placed in individual packages, to track temperature

or other parameters through the whole distribution chain. These

track and trace devices, such as electronic temperature data loggers,

are used on or in passive packages but different types of active

containers with advanced monitoring and tracing devices are

also arriving on the market. These active devices such as Global

Positioning System (GPS) systems raise security concerns and also

issues with the potential interference with aircraft navigation and

electrical systems.

*(The temperature indicated on the lower half of the label must match the

approved transportation temperature range, e.g. +15ºC to +25ºC)

+15ºC to +25ºC

www.the-logistics-portal.com TLPINSIGHT 11.www.the-logistics-portal.com 11.

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In addition, it is critical to understand that most temperature

monitoring devices contain lithium batteries (commonly lithium

metal batteries), which are dangerous goods. Lithium batteries

represent a significant safety concern. Incorrectly manufactured and/

or tested lithium batteries pose a fire risk in transport. All lithium

batteries must be transported in accordance with the provisions

set out in the IATA Dangerous Goods Regulations (DGR) (and ICAO

Technical Instructions). Guidance material on the transport of lithium

batteries is available at: www.iata.org/lithiumbatteries

In addition active devices must comply with the appropriate air

worthiness standards regarding electromagnetic interference

of aircraft systems. The responsibility to comply with these

requirements is with the shippers of such devices. To determine the

requirements shippers are advised to make contact in advance with

the applicable airline to determine the suitability of including such

active devices in shipments.

Training

Supply chain excellence is achieved as a result of applying

fundamental principles that answer customer’s needs. Training

therefore becomes paramount. Training of staff handling sensitive

cargo is crucial to ensure the integrity of the cold chain is

maintained. For the stakeholders involved in Time and Temperature

Management, it is a prerequisite for the implementation of the PCR

and the air transport logistics of healthcare products. The success of

a program like Chapter 17 is based on how well it is implemented. It

is essential that each member of the supply chain understands what

their specific requirements for compliance are, as well as those of

others in the supply chain. This allows for greater understanding of

the entire supply chain process and smooth integration. As a result,

the IATA Training and Development Institute leads training in time

and temperature sensitive cargo handling to ensure compliance with

the Perishable Cargo Regulation Chapter 17.

IATA is working with the industry and for the industry, and therefore

such initiatives are carried out in cooperation with the appropriate

cold chain stakeholders in the healthcare industry. This is only the

start: there will be continuous development of the standards to

reinforce IATA’s vision for a safe, secure and profitable air transport

industry that sustainably connects and enriches our world.

Contact: Cool Chain Logistics Team c/o Adrian Rayner　Tel: +44-(0)1784-422-637

[email protected]　www.jal.co.jp/en/jalcargo/

-SOLUTIONS PHARMA

[RELIABILITY]

Constant Temperature Control Dedicated Logistics Team

COOL CHAIN LOGISTICS

Provide the best solution

for the transportation of

pharmaceuticals.


An introduction to air cargo systems There is a growing demand for transport by air from Europe of

temperature sensitive cargo to Japan and various countries in Asia.

The airlines are called upon to be able to provide various cool

transport products to the European air freight market in order to

send temperature sensitive cargo securely and timely to Japan and

other Asian destinations by aircraft without risking the quality of the

pharmaceuticals.

The main commodities transported tend to be in addition to

pharmaceuticals: life science samples, bio samples, chemicals,

medicals, life saving drugs, clinical trials supplies, diagnostics.

Customer RequirementsCertain commodities such as pharma require temperature control

and monitoring throughout the transport process. Common

temperature ranges requested are -20deg C deep-frozen and 2~8

deg C or avoidance of fluctuations and extreme temperatures

whether high or low.

Pharma shippers are often looking for written evidence of items

such as validation report of cool container condition, check sheet of

handling, temperature graph of storage room, written information

to prove standards or explanation of procedures to handle pharma.

These are items that can be prepared by the airlines for air transport

and which provide for individually tailored standard operation

procedures (SOPs), which can be agreed with the shippers.

EquipmentThere are various types of cool equipment which can be used

inside the cargo holds of aircraft such as thermal blankets, use of

Envirotainer e1 and t2, Ice Battery System (IBS) which are used by

airlines and forwarders. Airline staff are trained to handle these

products and follow carefully made SOPs agreed in advance with

the shippers. The choice of equipment depends upon the degree

performance needed to maintain the quality of the cargo.

The IBS is able to control temperature with an accuracy of +/-2 deg

over 200 hours. Using special coolants so that there is no need for

dry ice, the temperature required is pre-set and a data logger can be

attached to monitor the temperature.

The Envirotainer e1 has been used for pharma on many occasions to

maintain strict temperature control and the popular Envirotainer t2

model can be set at a wide range of temperatures.

Thermal blankets are used to avoid extremes of temperatures and

sudden fluctuations of temperatures.

Ice Battery System

coolant plates placed inside

the IBS

Temperature can be set

between +5deg C and -20deg C with an accuracy of +/- 2deg C. The

internal loading space of the box is 41x36x31cms.

A typical handling procedure would look like this:-

1. The carrier makes the box ready with coolants based on agent’s requirements.

2. Agent picks the box up at Departure Airport.3. Agent or shipper sets cargo in the box.4. Agent delivers the box to the airline after Customs clearance.5. The box is handled by the airline based on the SOP.6. Agent picks up the box after Customs clearance and delivers it

to consignee.7. Agent returns the empty box with coolants to Airport for return.

An example from LHR (London Heathrow) needed -20deg C. The

Unit was prepared and handed over to the designated forwarder in

Cheshire close to Manchester, the cargo loaded inside the IBS and

returned to LHR. As the unit can be kept cool for over 200 hours or

kept frozen for 100 hours this allows for sufficient time that covers

duration of delivery to the airport and the flight to Tokyo, the final

A SEAMLESS COOL CHAINCool Chain LogisticsCOOL CHAIN LOGISTICS FOR THE PHARMA INDUSTRY TO JAPAN AND ASIA


destination in Japan and time for collection from the airport and

delivery to the consignee in Japan.

Envirotainer e1 E1 container performance is stable for precise set temperatures

over many hours and airline staff have training to handle shipments

requiring stable temperatures. Internal temperatures can be set

between 0 dec c and +20deg C with an accuracy of 1deg C. Upon

request checks can be made of the temperature inside and outside

the units and detailed checks recorded on a check sheet. This unit

does not require dry ice.

Envirotainer t2This popular cool container is often to be seen on flights from

European gateways with the latest units from the manufacturer

Envirotainer.

Temperature can be set from -20 to +20 deg C and is powered by

batteries and dry ice.

Thermal Blanket Used widely, the Thermal Blanket is able to minimise temperature

fluctuations with no extremes of heat or cold. The build up of the

blankets and cargo is done under airline staff supervision making

certain of secure handling. With

shipping temperatures of between

1 and 30 deg C direct sunlight is

avoided and extreme cold too.

Blankets are available in 2 sizes, LD3

Long Lasting

(146x136x145cms) and LD7 (292x200x162cms). There are good

quality and re-usable blankets but also other disposable sheets are

available.

HandlingA seamless cool chain by is provided by the staff of airlines based on

standard operation procedures (SOP).

• Individual SOP for each shipment is prepared, reflecting the customer’s requests.

• SOPs are based on international guidelines such as IATA PCR Chapter 17 and GDP etc.

• Staff who are well-trained handle pharmaceutical products.

SOPThe SOP set up by an airline in agreement with the shipper and cargo

forwarder and will include the following type of items to meet the

needs of the shipper and consignee:-

Training programme Trained staff in both origin, transit and destination airports. ■ Handling

Confirm the shipment and document is compliant with carrier /country regulations and procedure

■Priority serviceHonour the flight schedule, ensure space onboard is available

■Contact listCommunicate delays or problems to the forwarder

■ Check sheetUpdate any temperature log sheets

Over 200 Hours


■ Storage areaStore the product in conditions that are within a defined temperature range

■ On tarmac Limit the time between the warehouse and aircraft loading/unloading

■ EquipmentHandle active cooling containers in accordance with the supplier’s instruction

■ DurationMaintain recommended cargo hold temperature setting

■ Loading positionRefrain from loading temperature sensitive freight near the aircraft cargo door, when possible

Customer feedback and satisfactionAn increasing number of pharma shippers are requiring temperature

control and monitoring for their transport. Airlines are able to meet

those requirements even including at transit points in Asia when the

final destination is beyond the airline hub.

Especially appreciated by the customers is the personal check by

airline staff and monitoring with the check sheet to ensure all parts

of the chain are being carefully followed. In cases where any issues or

problems are noted then it provides an opportunity for the process

to be re-examined and strengthened in light of that feedback and

agreement between the parties involved to be made.

ConclusionIn order to serve the cool transport market by air cargo, airlines offer

various categories of service and equipment which are available

according to the preciseness of temperature control and monitoring

of the air transport process required and airlines are able to provide

that service to pharma shippers and their forwarders by use of

carefully agreed SOPs covering handling, checks and providing

special cool equipment.

This can encompass the whole air cargo chain from the shippers’

premises, acceptance at the origin airport up to the destination

airport by the airline and then delivery to the consignee.

Contacts:JAL Cargo Cool Chain Logistics c/o Adrian Rayner

Tel +0044(0)1784 422 283 [email protected]

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please visit www.aacargo.com.

DID YOU KNOW? Our Cold Chain Solutions Speak Multiple Languages


Pharmaceuticals Require Strict Temperature Controls Pharmaceutical products are considered one of the fastest growing

and most valuable cargo commodity categories handled by air

carriers. It is estimated that biotech and pharmaceutical products

represent the highest value per air-lifted pound of any cargo shipped

by the airlines. And taking into account that many temperature-

sensitive pharmaceutical products will at some point during the

distribution process travel by air, the significance of maximizing

shipper confidence in every aspect of the quality and reliability of

the shipping process is of utmost importance.

Pharmaceutical industry confidence in air cargo can be further

gained by using state-of-the-art equipment packaging and

containers, tracking systems and highly-trained personnel. Processes

that provide detailed documentation or proof that these sensitive

products have been well maintained throughout the shipping

process allow pharmaceutical companies the control they need to

manage their products effectively.

Protecting these valuable assets with proven, precise handling and

strict temperature-control can literally save companies millions of

dollars in lost inventory. This is also ultimately essential for protecting

patients and end-users of the pharmaceutical products.

Therefore, it is imperative for pharmaceutical companies, freight

forwarders and air carriers alike to understand and overcome the

challenges of cost effectively delivering high-value, temperature-

sensitive pharmaceuticals across widely varying climates to their

customers worldwide.

Requirements-Driven Approach

The International Air Transport Association (IATA), which promotes

safe, reliable, secure and economical air service practices, has

developed additional regulatory requirements for the handling of

temperature-sensitive pharmaceutical products. Effective July 1,

2007, the IATA published a separate chapter to its 7th Edition of the

Perishable Cargo Regulations, specifically addressing air transport

logistics for temperature-sensitive healthcare products, changing

its previous passive guidelines to a more strict requirements-driven

approach.

The IATA regulations for the air transport of temperature-sensitive

pharmaceuticals were carefully developed using the following

information:

• Scientific data from research institutions, and field experience

from major airlines and freight forwarders

• International and local regulations for goods shipped and

stored under optimal conditions in on and off airport locations

from key pharmaceutical companies

• Comprehensive classification of perishable commodities,

including temperature/humidity requirements, packaging

references and incompatibility/segregation information

• Airlines contact information, dedicated websites, and specific

rules regarding perishable cargo

• Pharmaceutical product information based on World Health

Organization (WHO) guidelines.

Additionally, pharmaceutical and biotech materials are closely

governed by specific federal requirements that must be observed,

including growing requirements for more advanced equipment,

permits, and training in order to move medical material and

pharmaceuticals.

With the growth of pharmaceutical manufacturing internationally,

it is increasingly common for a drug to start as an active

pharmaceutical ingredient (API) and go to a finished product

in multiple steps across multiple countries. As a result, the

requirements have increased for packaging, storing, transporting

and distributing pharmaceutical ingredients and finished products.

The shipping process must be as reliable and sophisticated as the

manufacturing process for these products.

Proven Reliability in Handling of Pharmaceutical Shipments

Built on the proven service reliability of American Airlines Cargo’s

Expeditefs℠ express freight product, American’s ExpediteTC℠ service

was developed to deliver a highly reliable, temperature-controlled

service. Successfully tested in 10 U.S. and international cities before

its worldwide launch, ExpediteTC offers customers specialized

handling, monitoring and tracking of sensitive pharmaceutical

shipments. Americans ExpediteTC service is available at more than

100 cities throughout its worldwide cargo network.



Multi-Layered, High-Visibility System

American Airlines Cargo has implemented a high-visibility, multi-

layered tracking program for ExpediteTC , which guarantees all

temperature-sensitive shipments are closely monitored. ExpediteTC

is a program that delivers the specialized air cargo expertise needed

by the pharmaceutical industry with all system layers supported by

a team of highly trained professionals that have the commitment to

deliver ongoing superior service.

American has also developed innovative internal systems that ensure

efficient and reliable handling of temperature-controlled ExpediteTC

shipments. These systems enable cargo teams to thoroughly monitor

temperature compliance.

With this system, American is able to provide high-visibility

monitoring and unique tracking of the high-value shipment. Because

the pharmaceutical industry is facing more regulation than ever

before, American Airlines Cargo has implemented standardized

processes and procedures that support customers with their

regulatory requirements of tracking shipments to ensure that they

have been transported under the correct conditions.

Meeting or exceeding their needs, shipments are closely tracked and

supervised by knowledgeable service teams. Customer-prescribed

Standard Operating Procedures are put in place, which involve

high-visibility watch and proactive tracking from end to end. The

teams closely monitor the temperature and provide for maintenance

services such as re-icing and battery replacement when needed.

Careful handling also includes blue special tags that make these

crucial shipments easily recognizable to personnel loading the

aircraft.


THE STRENGTH OF AMERICAN’S QEP ACCREDITATION IS BOLSTERED BY THE EXTENSIVE HANDS-ON TRAINING OF MORE THAN 2,400 CARGO TEAM MEMBERS GLOBALLY. CUSTOMERS

ARE ASSURED THAT QEP CERTIFIED PERSONNEL HAVE A THOROUGH UNDERSTANDING OF ALL ASPECTS OF ENVIROTAINER CONTROL, OPERATION, MAINTENANCE AND TROUBLESHOOTING.

Certified Training of Personnel Worldwide Enhances Service Reliability and Accessibility

The strength of American’s QEP accreditation is bolstered by the extensive hands-on training of more than 2,400 cargo team members

globally. Customers are assured that QEP Certified personnel have a thorough understanding of all aspects of Envirotainer control, operation,

maintenance and troubleshooting.

This includes the complete operation of the control panel all the way to the handling and changing of dry ice, cooling fans and container

batteries. Achieving QEP status in multiple key locations and cities worldwide demonstrates American’s commitment to providing the

highest standard of service and shipment reliability to its temperature-sensitive cargo customers.

Summary

American Airlines has made significant capital investments in our cargo facilities to accommodate temperature-senstive shipments in the

various cities we serve. Every station is equipped with an environment area for temperature-senstive cargo and several of our key locations

(including New York, Chicago, Miami, Dallas and San Juan) will be outfitted with dedicated CRT rooms, specifically designed to accommodate

passive packaging. CRT rooms will be added in additional locations worldwide in the near future.

American has implemented a multi-layered, high-visibility system that combines state-of-the-art Envirotainer containers with accredited,

highly-trained cargo personnel in major cities worldwide. All are designed to provide shipper confidence in the end-to-end shipping process

for pharmaceutical products. A testament to the success of this multi-layered, high-visibility approach is that customers who started with the

air carrier’s pilot program have continued to use American Airlines Cargo for their temperature-controlled shipments.

AmericanAirlines Cargo, Expeditefs and ExpediteTC are service marks of American Airlines, Inc.



INTEGRATION OF DANGEROUS GOODS MANAGEMENT SOLUTIONS INTO EXISTING SOFTWARE ENVIRONMENTS

Biography of Heman TeeringManaging Director DGM Software Development Group

Before coming to DGM in 1997, he was a logistics expert in the Dutch army. He worked for 5 years

as a logistics coordinator for Explosives and Fuel distribution and 5 years as expert on international

movement of equipment, ordnance and personnel.

Herman first joined DGM as a member of the Special Project team at DGM NL. In the years that

followed he held senior management positions in DGM Systems and DGM Support, the head office of

the international DGM network.

Since 2003 he has been Managing Director of DGM Software Development Group, an IT company

specialized in databases, tools and solutions for all modes of transport, production, storage, handling

and waste of Dangerous Goods.

Production, handling, storage and

transporting of dangerous goods

are subject to many regularly changing,

national and international rules and

regulations. Most of these rules and

regulations have a direct impact on

logistic processes, related documentation

and reporting requirements.

As these rules and regulations can differ

between countries, and in some cases

even between states or communities, the

challenges for the industry are numerous.

On the one hand you would like a minimum

impact on your processes, and on the other

hand you want to be in compliance with

the applicable rules and regulations. This

means you must be able to prepare all the

required reports and transport documents,

have all article-related documentation – like

a material data safety sheet (MSDS)– up to

date and on hand, and make sure that you

have your workplace instructions, product

labelling and safety measures in place.

On top of that, you have to be aware of

differences between the various regulations

as, for instance, goods can be dangerous

according to the Globally Harmonized

System of Classification and Labeling of

Chemicals (GHS), but not dangerous for

transport under one of the regulations for

the Transport of Dangerous goods. Likewise,

you can have goods which are dangerous for

one transport modality but not for another.

For the purposes of this article, the focus

will be on the logistics and related transport

documentation.

Adding dangerous goods logistics solutions

to existing back office systems like

warehouse management systems (WMS),

customer relation management (CRM) or

enterprise resource planning (ERP) solutions

can create a lot of additional value to these

systems, but can also cause a lot of problems

– both financial and operational – if the

options are not clear and integration is not

managed well.

From experience, we have learned that there

are basically three options to implement

these solutions, and in this article description

– as well as positive and negative aspects of

each option – will be given.

The separate solution

In this setup there is basically no connection

between the back office system and

the dangerous goods solution. The user

processes the orders as usual in the back

office system and then switches to the

dangerous goods solution. This solution

can be a software package offered by

several suppliers either locally installed on

computers, on the company’s intranet, or

accessed via the internet. Also, the good old

‘copy and paste’ solution is still used on many


Dangerous Goods Management is all about

safety and minimizing risk. In air transpor tation,

staying compliant with all of the many rules

and regulations is not an easy task. However,

supported by DGOffi ce.net with its specifi c

modules for air transportation, it becomes a

clean cut operation. From Packing Instructions

to Shipper’s Declaration and ‘NOtifi cation TO

Caption’: it’s all in the software and highly

Safety fi rstin Dangerous Goods Management

DGM SDG A/S, Kokholm 3b, DK 6000 Kolding, +45 75 575 790,[email protected], www.dgoffi ce.net

automated where possible to save you time

and to reduce error rate to a minimum.

DGOffi ce.net was developed as an on-line

application, meaning you can access it anytime

from anywhere in the world. Alternatively,

run it as you see fi t: within your own network

or on a stand-alone computer.

014016_DGOffice_adv_203x280.indd 2 11-12-12 16:56


occasions whereby a Word or Excel template

is completed with information typed in from

the regulations.

The order data is entered in the solution and

documents are generated accordingly.

Depending on the solution, there are options

for checking several issues like segregation

requirements, mixed packing provisions,

verification of required information,

emergency response information etc.

Also depending on the solution, prepared

documents are stored within the solution

and/or exported in printed and digital format.

Options may be available to export the

document data for re-use in the back office

system, or creation of statistical information

to fulfil reporting requirements which may

be required by some rules or regulations.

The benefit of a separate solution is the speed

of implementation: for instance, a solution

that can be accessed via the internet can be

set up in a very short time without the need

of IT staff to interfere as long as access to the

internet is possible. The costs are also known

in advance

The negative side of a separate solution is

the double work in data entry, the different

locations where data is stored, and the issue

of connecting, for example, shipment data

from the back office system to the dangerous

goods solution and vice versa.

A separate solution could well work

in situations where a small number of

dangerous goods shipments a week are

processed, or in situations where IT support

is not at hand or too expensive to realise one

of the other solutions. It could also serve as a

basis to realise the connected solution in due

time.

The connected solution

This setup connects a dangerous goods

logistics solution to the back office systems.

The actual shipments are

prepared as usual in the

back office system, but the

required documentation

and/or dangerous goods-

related information is processed in the

separate remote dangerous goods logistics

solution.

The interface connecting the two systems is

running in the background and is triggered

by user-initiated actions on the back office

system. This can be anything from a new

order to a simple change in the status of a

shipment. The user does not have to take

additional actions, other than collecting the

processed documents from the printer, the

email system or any specified file location.

A remote server solution should be capable

of offering the following solutions:

• automatic generation of dangerous goods

declarations for shipments in any mode of

transport

•printingthedeclarationsonanyprinterdefined

in the user’s network

•preparationof thedeclarations inPDForXML

format (e-freight ready)

• adding (version-controlled) documents like

MSDS or handling instructions to declarations

based on customer requirements.

•instantorbatchorderprocessing.

In general, a typical order processing system

works with articles. These articles have a

unique identifier, such as the article number.

All other objects specified for a single article

are linked to the article number on database

level. For example the trade name, pricing,

location, stock, and so on. When a customer

orders a quantity of a specific article, the user

will only have to enter the article number

and the order quantity. Everything else is

automatically added from the connected

database.

The dangerous goods logistics system has

a similar setup, but for dangerous goods

only. The database is built around unique

identifiers. Selecting a specific ID will make all

related data available.

Article classificationKey in a connected solution is the connection

between the article number in the order

system and the ID used for the dangerous

goods data. This so-called article classification

can be done in two ways. The first option

is to maintain all information in the order

processing system, meaning a complete set

of dangerous goods information (including

the key) needs to reside in the system. The

dangerous goods key needs to be assigned

to the article based on the characteristics

of the article (see MSDS). Also, the chemical

and/or technical name (if required), type of

packaging and required quantity need to be

defined.

The second option is that the article

classification is handled entirely by the

dangerous goods logistics solution, whereby

the article numbers from the back office

system are loaded in the solution and the

article classification is completed using the

solution itself.

Connecting and processing dataOnce the order is ready and shipment

papers need to be made, the back office

system needs to generate a message to

the dangerous goods logistics system. This

message needs to be drawn up in the specific

format for the chosen solution. If there is no

message generator tool available in your

back office system, this requires additional

programming.

The message contains the shipper and

consignee information, the method of

transport required, as well as the article

information and/or the dangerous goods key.

Depending on the way article classification

is handled, additional information might be

needed.

In the message, the type of output and

where it should be delivered is specified.

For example, the declarations can be sent

to a local or a remote printer. Messages can

be processed instantly or stored for batch

processing.

Generating results

The dangerous goods


logistics system will generate the required

information or documentation as specified

in the message. If the articles are maintained

in the solution, it will take all relevant

information from there.

An interesting option is to utilise document

management modules if they are available.

Here, additional documentation like

MSDSs, handling information or workplace

instructions, can be connected to your articles

and printed along with the declarations when

required. When version control is available,

you can also make sure your customer will

automatically receive the latest version of

these documents.

Another option is the use of web services

that might be available in the dangerous

goods logistics system, which can be used

to retrieve information or checks back into

the back office system and as such create

the option to do a storage segregation check

at the moment of receiving goods in the

warehouse, present packing and labeling

information to the packers etc.

The major advantage of a connected solution

is the addition of dangerous goods-specific

information and documentation to the back

office system without the need to keep all

data in the system. Also, the user of the back

office system will not notice a difference

besides the changes that might be made

in the back office system and of course the

automatic creation of documentation and/or

information pages.

Another plus is the time that is saved with

the maintenance of the dangerous goods

data as this is handled by the supplier of

the system, and the automatic production

of documentation based on the input from

the back office system so no need for double

work.

In general, the experience is that a connected

solution can be realised in a short timeframe.

The total time required depends on the

wishes and the availability of IT support to

the back office system.

Negative points can be the need of IT support

and/or developers, as the connections need

to be made with the back office system.

Also the choice of where the actual article

classification takes place has effect on the

work to be done in the back office system.

Costs can also be unpredictable. However,

the costs for the dangerous goods logistics

solution are mostly transparent. The changes

required in the back office system can cause

some serious increase in costs if it is not clear

what the needs and wishes are before the

work starts.

The same is even more important when

talking about the third option.

The integrated solution

This is more or less the ultimate solution

whereby all data and processes, as described

in the separate and connected solutions, are

integrated into the back office system.

Some providers of back office systems offer

modules or extensions that contain (parts of )

the dangerous goods logistics solution, but

in most cases the user will have to add data

and /or functionality to realise the desired

solution.

The most important issue in this setup

is the availability and consistency of the

dangerous goods-related data which is

needed for the whole system to run on. This

requires a thorough planning and inventory

of the minimum needs, the operational

requirements, and perhaps additional wishes

that need to be incorporated in the final

solution.

Based on that inventory, the dataset needs

to be designed and structures need to be

developed. In this phase the designer should

be aware that the rules and regulations are

dynamic and can change on any particular

moment resulting in additional data or the

need for a structure change in the databases.

Also in this phase a decision will need to be

made as to who will be responsible for the

data. Will it be own staff filling the structures

or will it be a third party? In both cases, fixed

routines will be required to make sure the

data integrity stays intact.

The negative side of this setup is budgeting.

As already indicated, regulations and rules

change and do not take into consideration

that you are in the middle of designing a

solution. So during the development, changes

can be implemented which cause delays and

increases in costs. Also, changing wishes and

requests for additional functionality during

the design and development process could

drag a project on and on. Hence planning and

firm time frames are essential.

The big benefit is that the final solution can be

as perfect as possible for your situation and

can generate tremendous additional value.

Herman TeeringManaging Director

DGM Software Development Group A/S

www.dgm-sdg.com


I quite often see articles written on Cool Chain and articles written

on Clinical Trials, but there aren’t many that integrate the two

together. This piece will discuss the current problems that exist

in running a clinical trial in an emerging country such as Russia,

Brazil or India – and the Cool Chain issues that will inevitably be

encountered in these climates.

Cool Chain & Clinical TrialsTransportation of time and temperature sensitive products

The key factors in Cool Chain management of clinical trials are

efficiency (speed), value of information and easy to use systems –

making the gathering and analysis of data easy and reliable.

The Cool Chain ExplainedA Cool Chain (or Cold Chain) is a supply chain along which a

product’s temperature is maintained from the point of manufacture

until its end use.

Cool Chain is a core element in the transportation of temperature

controlled pharmaceutical products. Most Cool Chain products need

to be stored between +2°C and +8°C for stability and in accordance

with regulatory body requirements. These temperatures are usually

the ‘magic numbers’ in the industry. Cool Chain is an expanding

part of the industry and will continue to be so given increasing

compliance requirements. This coupled with larger numbers of new

drugs in clinical trials and R&D requiring chilled temperature control

in storage means a potentially prosperous future for temperature

controlled logistics.

Temperature controlled supply chains are not always ‘cool’. Some

products have to be kept frozen – this is often achieved by packing it

with dry ice. Other products must be kept warm – often this means a

room temperature band of something like +15°C to +25°C.

Harriet King

Marketing Executive, Biocair International.

Graduated with a BA(Hons) in Marketing,

Advertising and PR; Harriet brings a fresh look

to Pharmaceutical Marketing by combining

traditional marketing techniques with New Media

practices. During her education she worked with

a number of PR & Events agencies and spent a

year with car giants BMW MINI, before making her

debut in Pharmaceutical Marketing with Biocair.

Email: [email protected]

//BIOGRAPHY


So, that’s the ‘Cool Chain’ – a chain of transportation ensuring that

the product travels at a desired temperature to preserve its qualities.

Why is Cool Chain so important in Clinical Trials? To explain this, it is important to understand what a Clinical Trial is,

its different stages and how much of the world one Clinical Trial can

cover:

Clinical Trials are most commonly performed to analyse new

drugs, medical devices, biologics, psychological therapies or other

interventions. They are a requirement before the relevant national

authority approves marketing of the drug or device. There are several

different types of Clinical Trial:

• Prevention Trials – testing new approaches that doctors

believe to lower the risk of developing a disease

• Screening Trials – testing the best ways to find a

condition/disease in it early stages

• Diagnostic Trials - testing better procedures for existing

diseases or conditions

• Treatment Trials - testing new medicines or new

approaches to surgery/therapy

• Quality of Life - ways to improve comfort and Quality of

Life for patients (e.g. incontinence drugs)

• Compassionate Use Trials - treatment option for

patients suffering from a disease for which no satisfactory,

authorised alternative therapy exists

There are four phases to a Clinical Trial involving new drugs, and

each phase of the drug development process is managed as a

separate Clinical Trial. These phases are usually known as:

•PhaseIStudies

•PhaseIITrials

•PhaseIIITrials

•PhaseIVTrials

Phase I StudiesThis is the first stage of testing in humans. Normally, a small (20-

100) group of healthy volunteers will be selected. Phase I Studies

most often include healthy volunteers, however, there are some

circumstances when real patients are used. Cases where patients

who have terminal cancer or HIV and lack other treatment options

(Compassionate Use Trials).

Phase II TrialsIn these, the potential drug is tested in around 20 to 300 volunteer

patients suffering from whatever condition the drug is to potentially

treat. They are designed to show whether the drug is safe in the

specific patient population and to look for signs that it might be

effective.

Phase III TrialsIf Phase II trials are successful, then the potential drug will undergo

Phase III trials, which are widespread multicentre trials on at least 300

to 3000 patients in clinics to test the efficiency of the product. They

are usually randomised and double blind (this is where neither the

patients or the researcher know who’s being given the active drug).

Once Phase III trials are completed, the drug is filed with the relevant

country authority for review. In the UK, this is the Medicines and

Healthcare products Regulatory Agency (MHRA); in the US, it is the

Food and Drug Administration (FDA); in Australia it is the Therapeutic

Goods Administration (TGA) and in Japan, the Ministry of Health

and Welfare. Some Phase III trials will continue while the regulatory

submission is pending at the appropriate regulatory agency. This

allows patients to continue to receive possibly lifesaving drugs until

the drug can be obtained by purchase. Because of their size and

comparatively long duration, Phase III trials are the most expensive,

time-consuming and difficult trials to design and run, especially in

therapies for chronic medical conditions.


Phase IV TrialsAfter the drug is launched, further Phase IV studies are

carried out to monitor possible adverse reactions or

other responses when large numbers of patients begin

using the drug.

During the ‘drug pipeline’ or ‘drug discovery process’

drugs may also go through a ‘pre-clinical studies phase’.

This stage of the drug development pipeline is a study

to test a drug, procedure or other medicinal treatment.

They involve in vitro and in vivo experiments using

wide-ranging doses of the study drug to obtain

It is understood that drugs that are intended to be used on humans, must be tested on humans to ensure they are safe for use. It is due to this fact that quite often the samples taken are blood or tissue samples, and need to be sent to the research laboratories quickly, efficiently and undamaged.

preliminary efficacy, toxicity and pharmacokinetic information. The aim is to collect data in support of safety.

Preclinical studies are required before clinical trials start.

So, as you can see when coordinating shipments from a Clinical Trial the need for Cool Chain assistance is

heightened.

It is understood that drugs that are intended to be used on humans, must be tested on humans to ensure

they are safe for use. It is due to this fact that quite often the samples taken are blood or tissue samples, and

need to be sent to the research laboratories quickly, efficiently and undamaged. It is well known that the

different stages of Clinical Trials can take place in many different global locations. This makes the ‘need for

speed’ and temperature control even more vital.

For example, the drug could be created in a University in Poland, administered to the patient in a hospital or

clinic in Africa and the sample be sent to a Research Laboratory in India or China. This is a very long chain of

transportation where the drugs and samples will experience a variety of different climates. Appropriate Cool

Chain packaging measures must be in place to ensure the shipment arrives at optimum viability.

Emerging CountriesWe have all read the articles and seen the trend emerging – where countries such as India, China, Russia and

more recently many African countries are becoming hotspots for conducting Clinical Trials. Just last month in

this publication there was much conversation about Australia and the Caribbean being the ‘Ones to Watch’ in

Clinical Studies.

The popularity of these countries only amplifies how ‘international’ a Clinical Trial can be. And it’s this

‘internationality’ that is really beginning to test the Cool Chain. Samples need to be sent quickly, efficiently

and carefully to ensure they arrive at their destinations in a usable state, i.e. in perfect condition.

Sponsored by

Lead Sponsor Supported by

KEY SPEAKERS:• Sandra Hoffman, Project Manager, Boehringer-Ingelheim• Tobias Frey, Global Clinical Label Management Associate, Roche • Mike Isles, Executive Director, EAASM• Tamara Spuergin, Senior Clinical Distribution Manager, Novartis• Vimal Unewal, Planning Manager, Ferring• Biljana Coneska, Chief of the Department for Solid Tumors, University

Clinic Macedonia• Harvey Rubin, Director, Institute for Strategic Threat Analysis and

Response, University of Pennsylvania • Vladimir Anisimov, Senior Strategic Biostatistics Director, Quintiles• Sharai Chitando, Lead Research Nurse, Guy’s & St Thomas’ NHS

Foundation Trust• Tom Cochrane, Head of Security, Napp Pharmaceuticals

KEY REASONS TO ATTEND:• Explore the latest regulatory challenges currently being faced and

consider strategies to comply with GDP and GCP regulations• Learn from industry case studies on logistic developments and

warehouse management• Develop your understanding of risk analysis and demand forecasting• Understand the latest in security issues and vendor relationship

management• Hear first-hand accounts of conducting clinical trials in emerging

markets and running global multi-centre trials• Discuss latest logistical and temperature sensitive distribution issues

with key industry professionals

SMi presents its 7th Annual Conference on

Clinical Trial Logistics

PLUS AN INTERACTIVE PRE-CONFERENCE WORKSHOP

Transport Logistic Strategies13.30 - 17.30

Tuesday 21st May 2013Copthorne Tara Hotel, London, UK

Workshop Leader:Sue Lee, Regional Quality Manager,

World Courier

How to book

Visit www.smi-online.co.uk/goto/2013logistics11.aspAlternatively call Fateja Begum on +44 (0)20 7827 6184

Or email her on [email protected]

22ND - 23RD MAY 2013 | COPTHORNE TARA HOTEL | LONDON, UK

EUROPE'S LEADING CLINICAL TRIAL LOGISTICS EVENT

• Book by 28th March to save £100• Registration includes a FREE end of Day One Evening Dinner and a FREE Pre-Conference Workshop

advert_2 24/01/2013 18:42 Page 1


Sponsored by

Lead Sponsor Supported by

KEY SPEAKERS:• Sandra Hoffman, Project Manager, Boehringer-Ingelheim• Tobias Frey, Global Clinical Label Management Associate, Roche • Mike Isles, Executive Director, EAASM• Tamara Spuergin, Senior Clinical Distribution Manager, Novartis• Vimal Unewal, Planning Manager, Ferring• Biljana Coneska, Chief of the Department for Solid Tumors, University

Clinic Macedonia• Harvey Rubin, Director, Institute for Strategic Threat Analysis and

Response, University of Pennsylvania • Vladimir Anisimov, Senior Strategic Biostatistics Director, Quintiles• Sharai Chitando, Lead Research Nurse, Guy’s & St Thomas’ NHS

Foundation Trust• Tom Cochrane, Head of Security, Napp Pharmaceuticals

KEY REASONS TO ATTEND:• Explore the latest regulatory challenges currently being faced and

consider strategies to comply with GDP and GCP regulations• Learn from industry case studies on logistic developments and

warehouse management• Develop your understanding of risk analysis and demand forecasting• Understand the latest in security issues and vendor relationship

management• Hear first-hand accounts of conducting clinical trials in emerging

markets and running global multi-centre trials• Discuss latest logistical and temperature sensitive distribution issues

with key industry professionals

SMi presents its 7th Annual Conference on

Clinical Trial Logistics

PLUS AN INTERACTIVE PRE-CONFERENCE WORKSHOP

Transport Logistic Strategies13.30 - 17.30

Tuesday 21st May 2013Copthorne Tara Hotel, London, UK

Workshop Leader:Sue Lee, Regional Quality Manager,

World Courier

How to book

Visit www.smi-online.co.uk/goto/2013logistics11.aspAlternatively call Fateja Begum on +44 (0)20 7827 6184

Or email her on [email protected]

22ND - 23RD MAY 2013 | COPTHORNE TARA HOTEL | LONDON, UK

EUROPE'S LEADING CLINICAL TRIAL LOGISTICS EVENT

• Book by 28th March to save £100• Registration includes a FREE end of Day One Evening Dinner and a FREE Pre-Conference Workshop

advert_2 24/01/2013 18:42 Page 1


As Ukraine becomes ever more popular as a venue for international clinical trials, industry players need advice on how to operate in this

exciting – but still quite specific and challenging – market, particularly in the field of logistics of clinical trial materials. This article gives practical

background on the matter.

Ukrainian clinical research market Ukraine has been rapidly emerging as a clinical trial provider since 1996, when the first industry-sponsored trial came to the country. As of

November 2012, 917 investigational new drug (IND) trials conducted in Ukraine are registered on www.clinicaltrials.gov 1. The trend has been

positive over recent years as well. Thus, the number of regulatory approvals granted for IND trials in Ukraine increased from 142 in 2009 to 201

in 2011 (see Fig 1).

The local market of clinical trials is growing in monetary value as well. The Polish market research company PMR estimates the market at

around $208 million in 2011 (a 19% year-on-year increase), with a predicted growth rate of 10–20% over the next three years.

Figure 1: Number of clinical trial regulatory approvals granted in Ukraine in 2008–2011. Source: Ministry of Health of Ukraine

Clinical logistics in Ukraine


The unique combination of the following factors contributes to

making Ukraine the perfect location for clinical drug development:

2 Matured clinical research infrastructure

1 Good geographical location and demography

3 Well-developed public healthcare system

4 Regulatory policy

5 Study performance

• There is a Caucasian population of 45 million.• It is located in the strategically important region of Eastern

Europe.• Five cities have a population above 1 million.

• All top international CROs and Sponsors conduct their studies here.

• Global transport companies (TNT, DHL, World Courier) possess good infrastructure in Ukraine ensuring fast delivery of clinical study materials from all over the world and throughout the country.

• A number of local depots involved exclusively in clinical trial logistics provide efficient logistical support.

• A few private laboratories have customized their services to meet most of the industry needs and may be used as study central labs.

• The main national healthcare provider is a well-established network of public sector healthcare settings, based on the territorial principle with vertical patient referrals (Soviet heritage!). Such organisation of the healthcare system ensures concentration of patients with certain pathologies in large specialised regional centres, facilitating easy subject recruitment (including orphan indications).

• The area has the highest number of physicians per 10,000 of population in the Commonwealth of Independent States and Central and Eastern Europe regions (49.3 in 2011)3.

• The medical education system includes 15 medical universities, and a number of specialised scientific and postgraduate educational institutions.

• National legislation is being intensively adapted to the EU requirements, pursuing the strategic country’s objective to join the European Union.

• Regulatory policy is generally favourable to the development of the clinical trial industry, as the government seems to consider clinical trials as an effective tool, both to bring in investment to the public healthcare educate scientific personnel, and to prevent ‘brain drain’.

• Initial study review by health authorities takes around two months, which is in line with the EU timelines. The absolute majority of clinical trials are approved including paediatric and

placebo-controlled studies.

• Lots of treatment-naive patients who are willing to have access to innovative therapies ensure high recruitment rates.

• Low mobility of population contributes to retaining study subjects.

• Data is of a high quality.• Investigators are motivated and qualified, and see their

involvement in clinical trials as an important opportunity to be on the front line of innovations and get integrated into the global medical science community.

• Cost efficiency arises from shorter study timelines (fast recruitment, reasonable startup period), cheaper infrastructure and investigator fees compared to the Eastern European countries, EU members and Russia.

• Local CROs have opportunity to hire the brightest people in the local labour market: most local CRAs are certified physicians.

This considerably improves quality of clinical oversight.

Criteria for the perfect local depotWhen planning study logistics in Ukraine one should bear in mind

some particularities that make selection of the right local logistics

vendor crucial for successful study performance.

Firstly, Ukraine has its customs area isolated from both the EU and the

Eurasian Economic Community, which gets the customs territories of

Russia, Belarus and Kazakhstan united. That is why one cannot ship

study materials to investigative sites from the EU or Moscow directly.

A locally based depot is needed. This has resulted in the development

of a fully matured local clinical logistics market. Up to a dozen local

speciality companies currently operate in the field. Some big CROs

have their own IMP storage facilities and customs brokers.


Secondly, clinical trial logistics involves added complexity in

comparison to the supply of marketed pharmaceutical products, and

there are specific selection criteria for local logistics vendors:

Project-based approachClinical logistics is project-based by its nature. That requires

involvement of clinical logistics managers (CLMs) at the early stage

in order to forecast logistical needs and risks, calculate budget, set up

timelines and so on, in the course of clinical supply plan development.

An experienced CLM with knowledge of the local market is of crucial

importance for the effective and cost-efficient supply chain in the

study.

Regulatory compliance and expertiseClinical logistics activities should be compliant with good

manufacturing practice / good distribution practice requirements as

well as complementary with good clinical practice standards.

Local regulations prohibit storage of investigational medical products

(IMPs) with licensed pharmaceuticals. That is why IMP should be stored

at dedicated IMP storage facilities only; the Ukrainian legislation does

not require having such facilities licensed.

A local depot should be skilled in regulatory submissions since

import/export licenses need to be obtained at competent authorities.

Customs clearance may be a tough task in Ukraine. Import regulations

are frequently changed. Customs authorities have rather formal

approach. So sometimes it is quite difficult to meet their requirements

and expectations. That may lead to delays, re-evaluation of customs

values and other annoying issues.

Import/export regulatory paths differ for the marketed products and

IMPs as an investigational product have no market licence and are not

for sale. So customs brokers experienced specifically in clinical trial

materials are needed.

Study materials often require urgent delivery. Sponsors do not

tolerate delays at customs. This is why the perfect logistics vendor

should have customs brokers in the staff as well as partner external

customs brokers as a back-up solution for preventing any potential

delays.

IMP handlingAll the IPM-handling related procedures need to be described in detail.

Continual environment control, accurate documenting and tracking

of all warehouse operations (receipt, intra-depot transfers and

dispatch) are essential. Usage of validated warehouse management

systems provides a client with precise accountability, tracking and

reporting.

Validation of storage premises, used

software and shipment methods is a must.

The needs of re-labelling/re-packaging

arise often in the course of a clinical

project. The logistics vendor must be

capable of performing these operations in

concordance with GMP practices.

The process of returning an IMP to a sponsor

abroad is long, expensive and complicated,

and, consequently, is rarely practised.

Investigative sites are not capable of IMPs.

In most cases IMPs in Ukraine are destroyed

at special destruction sites. The destruction

process requires adherence to many

regulations and may involve a number

of activities like IMP return from sites, selection and in some cases

regulatory approval of adequate destruction methods, video/photo

fixation, issuance of destruction certificates and so on. A logistics

vendor should select a licensed destruction provider and oversee the

process efficiently.

Cold ChainLocal depots should have capabilities of storage clinical materials in

various conditions:

• 2–8 °C• - 20°C• -70°C• -180°C

It should be kept in mind that storage of cell therapies and transplants

require a license in Ukraine. Only validated refrigerators, freezers,

shipment methods and temperature monitoring systems should be

used. Particular attention should be paid to back-up solutions in the

event of refrigerators failure or electricity outage.

Non-investigational medical products (NIMPs) and ancillary suppliesApart from IMP’s, there is frequent need for ancillary supplies (labkits,


administration lines, equipments etc) and NIMPs (eg, co-medication,

rescue therapy, comparators). These products are commercially available

and the task of the logistics provider is to procure them locally or facilitate

importation. Logistics providers should hold the drug retailer license to

be able to procure pharmaceuticals. Before distribution to clinical sites,

NIMPs may require re-labelling adaption following local regulations or

sponsor requirements. That is why the depot must have a written re-

labelling procedure compliant with GMP.

Quality managementQuality in clinical trials counts for a lot. ‘Minor’ quality issues may

compromise the integrity of the whole trial with a multimillion-pound

budget. Quality should be managed by a dedicated Quality Assurance

Manager who is independent of the operations. The best practice is

to have back-up quality assurance. The written procedures (standard

operational procedures – SOPs) covering every single business process

are the basic thing to ensure quality. SOPs should outline the way the

things are done, ensure uniformity of processes and directly reflect the

level of the logistics provider’s qualification.

Besides the logistical processes, the SOPs should also cover other areas like

quality assurance, personnel management, vendor selection, information

handling, security, emergency plans etc, as these things may also have

critical impact on performance and risks. As the matter of fact, a clinical

logistics company should ideally have the set of SOPs in concordance with

ISO standards. Quality has also to be assured by regular self-inspections

and independent audits, as well as by tracking, analysis and eliminating of

root causes of all non-conformances and customer complaints.

Human resourcesA local depot should employ highly qualified personnel who are able to

follow thoroughly sometimes rather complicated operational procedures

and the numerous changeable requirements of various sponsors.

A logistics vendor should demonstrate a commitment to its staff’s

continual and extensive education. The quality of training programmes

should be assessed by review of internal educational programmes and

training materials used. Self-reading is the least efficient way of training,

so instructor-led training and workshops should prevail in a good training

programme. It is not a good sign if staff turnover is high – a handover

process is always painful and inevitably affects study performance.

ConclusionUkraine is an important but still challenging and idiosyncratic market. The

logistics of clinical study materials in Ukraine needs involvement of a local

depot. It should be thoroughly selected according to the criteria based on

approach to management of a study supply chain, regulatory expertise,

experience with import/export operations, IMP handling procedures,

capabilities of local sourcing of comparators, internal quality assurance

systems, human resources availability and management.

The regulations and public institutions are not as advanced and stable

as in Western Europe and the USA. This is why experience and skills of a

local vendor become absolutely crucial. In other words, a good vendor

will make study progress smooth and will allow you to benefit from all the

advantages of conducting studies in Ukraine. References

1. http://www.clinicaltrials.gov/

2.http://www.pmrpublications.com/press-releases/303/clinical-market-in-cis-

to-exceed-700m-in-2014

3. State Statistics Committee of Ukraine; http://www.ukrstat.gov.ua/

AuthorsSergii Pomerantsev, Head of Logistics Department at Centre of Clinical

Research (CCR); experience in managing clinical supply chains for more than

50 clinical projects in Ukraine.


Sergii Myronenko, Quality Assurance Manager at Centre of Clinical Research.

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We would think new technologies

in cold chain management

would have made great progress in

terms of automation in the last few

years, particularly with the evolution

of temperature sensors using RFID

communication, but somehow this has

not been the case, at least in two of the

industries that should benefit the most

from it: biotech and pharma. Let us

analyse what has happened, why it has

happened and why we should believe that

things will fortunately change.

In the last three years we have heard a lot of

buzz in the market that

technology will allow

temperature-sensitive

product manufacturers

to finally have seamless

monitoring from

production to patient,

to be able to monitor

all the way to, what we

call in the industry, “the

last mile”. However,

biotech and pharma

companies with

temperature-sensitive

products all seemed

to agree that while

technology was going

to take cold chain

management beyond

the enormous amount of manual work

needed to program, re-program, download,

ship, change, reset, restart, re-download,

save and retrieve data loggers, they would

still not be able to have full retrievable data

all the way to the patient.

The interest, of course, by biotech and

pharma companies to evaluate new

technologies was obvious, and many

pharma companies became active in

investigating new ways to improve their

method of handling the cold chain, but

despite the great efforts there was one

problem: The manufacturer, in most cases,

did not always have control of the chain

all the way to the patient. Control escaped

with change of ownership, and due to

the number of players in the supply chain

- distributors, cargo companies, freight

forwarders, pharmacies and physicians - full

control was difficult. The manufacturer could

make recommendations, audit and qualify

partners, issue severe warnings, etc. to make

sure the cold chain was strictly controlled,

but full control was, and still is, what could

be described as hard to reach.

Throughout the supply chain, all the players

certainly did and do their best to reinforce

“their” chain, and never compromise the

efficacy or quality of product, but due to

the amount of players, a solution to make

one controlled chain instead of several

independent ones, seemed always to offer

the best way ahead for the future. After

all, several players could always hold to

one chain, and by having one chain the

manufacturer could configure it and analyse

it while other parties could control it and

react to it - even the pharmacist or the

physician - all with the same understanding:

if the cold chain was broken the product

would not reach the patient. Nevertheless,

despite all the good intentions and strong

efforts, cold chain management is still

where it was 10 years ago with few, very few

exceptions.

RFID & COLD CHAIN MANAGEMENT

Alex Guillen is currently CEO of Escort Cold Chain Solutions

SA (ECCS) with HO in Switzerland, and formerly Director of

Commercial Operations-Public markets for Novartis Vaccines.

In the last few years ECCS has evolved from the exclusive

distributor of Escort data loggers for the cold chain market

to an independent solution provider of Radio Frequency

Identification RFID and real-time monitoring solutions. Today

ECCS has its own range of temperature monitors and time

temperature indicators (TTI), making particular use of the latest

communication technologies such as tablets, smartphones and

transferring and managing data in the cloud.


www.escortcoldchain.com


Tradition and More Tradition

We see that today even in the USA or

Europe, and particularly in the UK, strip-

chart recorders are still widely used to

monitor temperature during transportation

for pharmaceuticals. Strip-chart recorders

are mechanical loggers that print the

temperature history directly onto a strip

of paper. They are cheap and they do not

require additional equipment or software.

Most users know its limitations but also their

practicality; there is no need for software to

have an idea of the temperature conditions,

and the driver can simply sign a piece of

paper upon receipt, confirming that he has

seen that the temperature was maintained

as it should be.

Technology has had a hard time over the last

few decades to replace paper, and cold chain

control - not only for pharma, but also for the

food industry - was no exception. In fact, the

sales in volume for this type of equipment

are numbered in millions, despite its large,

bulky plastic case and high cost of transport.

Nevertheless, alternatives to paper-like ways

to read data are coming, and the answer is of

course smartphones and tablets, and for this

temperature-monitor manufacturers have

already started to put new products on the

market.

The Swiss seem to be pretty innovative

at this; Elpro was perhaps a pioneer with

its innovation. A year ago it launched a

quick view solution for quickly obtaining

information fast on paper, namely the

LIBERO. Berlinger is always developing new

electronic indicators to improve monitoring,

particularly in the last mile, and ECCS (Escort

Cold Chain Solutions SA) developed a USB

logger that can be read by an Android

tablet and the data sent to a cloud. All this

is happening now quite quickly, but these

developments still require some form of

manual intervention, and seamless control

without manual or human intervention is

what RFID can do. This is the technology that

not only can provide seamless monitoring

all the way to the last mile, but can also

reduce operational costs.

RFID for Cold Chain Management

While electronic data loggers are similar

to the strip-chart recorders, the difference

is that they store the information inside a

memory that can be downloaded later by

connecting the device to a PC. They have to

be extracted from the isolated box, breaking

the cold chain and consequently not

allowing intermediate checkpoints along

the supply chain.

RFID data loggers on the other hand are

essentially electronic data loggers, with the

difference that the data can be downloaded

using a wireless link. The main advantages

of these kind of devices are the following:

data download does not need manual

intervention; reading through the box

is possible so intermediate checkpoints

can be implemented without the risk of

breaking the cold chain; by mixing the

identification capability of standard RFID

with temperature data logging it is possible

to implement an integrated track and trace

and cold chain management solution.

RFID data loggers are becoming cheaper

and cheaper with new developments and

the growth of the market, so that in a few

months they should be well suited for box-

level monitoring. Still, the cost limits the

usage at item level for most products but, in

these cases, a complete solution for the cold

chain that also covers the last mile can be

implemented with a mix of technology (e.g.

RFID logger at box level plus an RFID passive

label with an integrated TTI at item level or

2D barcodes with item level information

being stored on the RFID tag using inference

to authenticate the product).

Today there are very few players offering

RFID solutions for the cold chain, but

surprisingly the industry that most rapidly

adopted RFID technology for cold chain

monitoring was fresh produce; growers

and exporters of fruits and vegetables.

Fruit and vegetable exporters realised that

RFID would give them actual data, whereas

previously they only used temperature

monitors in case there was dispute over


the responsibility of breaking the cold

chain. Because of this, they, particularly in

South America and South Africa as major

export markets, just went for it. Exporters

could finally reach their wish: “Monitoring

food from farm to fork” and not only in

terms of temperature, but also the much-

needed traceability to give assurance to

the consumer that what they had on their

plate really came from where they thought

it had come. The most recent case of

confusion, with terrible health and economic

consequences, was when Spain was forced

to stop its exports of vegetables into the

rest of Europe because E. coli was suspected

to have come from their cucumbers. Later

it was found that the contamination did

not come from Spanish cucumbers, but the

economic damage to Spanish growers and

exporters was done.

An RFID system manufactured by the

company Stepac in Israel was the first to

enter this market, as their systems works

in such a way that as soon as pallets reach

their destination the shipper can see

online the condition of their shipment,

temperature, humidity and CO2. The switch

from electronic data loggers to RFID was

followed by a large number of exporters

and growers who were happy to pay a bit

more for a technology that gave them so

much information. Stepac has focused

development on the food industry with

success, but has also opened a path to

change with no return to more traditional

systems.

As a reader from the pharma industry, you

may think that this is new. It is not. The

switch started happening over two years

ago and today it is almost complete for some

countries, while most pharma companies

are still in the RFI (request for information)

phase. The “D” is still missing. Now the next

question is, are these systems good enough

for pharma? Just think that while the classic

range of control for biotech products like

vaccines is 2-8°C, asparagus and cherries

must be kept from 1.1°C to 2.2°C. Therefore,

excellent accuracy and resolution are

fundamental in the conservation of food,

just as important as in biotech and pharma.

And what about the difference in value, and

the “it is not the same thing” argument? Just

find out the cost of shipment of cherries and

the health consequences of broken cold

chain in the food industry and you will start

realising that in fact the food - particularly

perishables - supply chain also has very

tough regulations, just like pharma and

biotech do. I heard a few years ago in one

cold chain conference a representative of a

large biotech company saying that perhaps

they should also look at what the food

industry is doing on cold chain management

to learn from them. She was right to say so,

but it is doubtful many companies took this

initiative and there are reasons.

RFID Technology for Pharma

If the technology is there and most pharma

and biotech companies know it, what has

blocked them from taking a step forward

to adopting RFID technology for their

cold chain management? Probably it is a

combination of three factors. Firstly, the

qualification of new products and validation

of new processes take a long time and

are highly costly in the pharma industry,

certainly more than in the food industry.

Therefore the traditional pharma company

changes something in its operations or

process only if is not working any more or if

there is a specific project with a clear reason

to change (e.g. to reduce cost or improve

the frequency of monitoring). This is good

until some companies realise that the cost

of waiting sometimes is higher than the cost

of innovating. Secondly, this same resistance

to change did not encourage temperature

monitor manufacturers to invest in solutions

for the pharma or biotech industries. In

other words: why invest in innovation for an

industry that will hardly change its current

solutions anyway? This can be seen by

the fact that the number one supplier in

temperature monitoring today, Sensitech,

is still the major supplier for the industry,

despite the industry seeing that some of the

new players were being more innovative.

Thirdly, in the pharma industry, no data to

prove that a process is safe means that it will

not be adopted; so since there was no data

that biotech products could be affected by

radio frequencies then there was no way to

prove the contrary, and therefore biotech

companies did not wish to take a chance to

be the first ones to do so.

Some biotech companies have been trying

to find data and with positive results. A study

published in the July/August 2012 edition

of the Parenteral Drug Association’s PDA

Journal documents research that showed

that in vitro test results for more than 100

biopharmaceutical products from eight


major drug companies demonstrated no

non-thermal effect by radio frequency

radiation . This has triggered enthusiasm

that something might be about to change.

Other biotech companies have been

searching for information with frequent

RFI on RFID temperature monitoring. And

this is good news for the industry, as the

technology itself has never been more ready.

Two companies that have pushed the

technology to be suitable for pharma are

Intelleflex and CAEN. Both of their systems

have their advantages, and I just would like

to set out the major difference so that the

reader can understand what to look for.

Intelleflex uses standard UHF frequency and

their products are based on both the ISO/IEC

18000-6:2010 (sometimes called “Class 3”) for

Battery Assisted Passive (BAP) and EPCglobal

C1G2 standards, while CAEN RFID developed

a technology using standard UHF frequency

based solely on EPCglobal C1G2 standard.

To simplify the matter, the major advantage

of Intelleflex is its capacity to read the tags

from up to 100 meters in “Class 3” mode

and thereby through packaging, though at

shorter distances. Intelleflex readers can

also read tags in standard C1G2 mode but

at much shorter distances. The CAEN RFID

reader has a shorter range because it uses

standard frequency and could read anything

in an environment, but has the advantage

that any UHF reader (including standard

PDAs) could read their tags (a standard

UHF reader, while it may find/locate the

tags, they will not be able to read the

temperature data logs without modifying

the reader’s firmware). Basically the major

advantage of Intelleflex is its long range

facilitating the installation. Both systems

can suit specific needs and both deserve

the credit of innovation to be compliant

to the pharma industry. The question is,

now that there has been commitment from

these and other valuable manufacturers to

innovate and adapt RFID technology to be

suitable for pharma, will pharma and biotech

companies also take the step to appreciate

and adopt this innovation? Time will

answer this, but time is not what innovative

companies have in excess. It will be up to the

pharma company to reach out and benefit

innovation or remain on more traditional

systems despite its limitations and higher

operational costs.

RFID may also not be the best solution

for all applications; perhaps in the end it

will be a combination of RFID and more

traditional temperature monitors as well

as 2D barcodes. The key will be to be able

to integrate data from conventional data

loggers, RFID tags and all the information

that is crucial to the management of the cold

chain and shipping of products, so that the

huge amount of data that is collected starts

to make sense for the users. For this, pharma

companies must also be willing to come

out to manufacturers and simply ask them

what they want: monitoring, managing data,

shipments, inspecting, tracing, proactive

action or reducing cost. I am sure that either

from today’s players, or from the new ones

to come, the solution is there - as long as

they are told what they need. Needs will

evolve, but so will the solutions available

out there integrating RFID with the latest

communication technologies.

The Future of RFIDRFID is an established technology, but

innovation of types and performance of

sensors beyond temperature: humidity,

shock, light, CO2 and others using RFID as

a form of communication has numerous

applications beyond pharma and beyond

cold chain. Authentication is the most

important: there has been standardisation

in protocol such as EPC Global 1 GEN

2 and ISO/IEC 18000-6:2010 as well as

the use of UHF as standard frequency in

most countries. This has been the first

step in allowing RFID technology to help

instruments to be compatible with each

other and therefore reduce investment

capital when sensors are integrated in the

company process systems. Developments on

different frequencies for more proprietary

systems facilitating installation and

maintenance will also continue, making it

easy for companies to try what RFID has

to offer. But the most exciting thing of all

will be to see for the first time technology

making a difference to the one who will

really benefit from it: the patient. Technology

today can monitor seamlessly from

production to the patient, and he should

have the right sometimes to see that cold

chain graph or that green light LED that

assures him that what he is ingesting has the

same efficacy it had when it left production.

Are pharma companies willing to evaluate

this scenario? Utopia? I am sure we will soon

be there.

RFID & COLD CHAIN MANAGEMENT


Face of the FutureGlobal requirements for documenting the authenticity of

pharmaceuticals are going to change and change dramatically.

The State of California’s e-Pedigree law, now set to go into effect

in January of 2015, will impact on every company that sells

pharmaceuticals in the state and is, for the moment at least, the de

facto standard that pharmaceutical companies and 3PLs are building

towards. Many of the people that work in the pharmaceutical

supply chain and logistics field have been anxiously waiting for

larger governmental agencies (such as the US Food and Drug

Administration (FDA) in the United States) to define a regulation or

directive that mandates the actual requirements relating to tracking

drug shipments and anti-counterfeiting measures. Will governments

mandate a 2D barcode at the unit level? Will there be a pedigree

definition? How would inference, the method of identifying the

contents of a shipping container to confirm its contents without

actually opening the container, play into this? The list of questions

goes on. So let’s assume that we have a crystal ball and can see

beyond 2013 and what may happen before California requirements

start to become law in 2015.

Many in the industry feel that, over the next few years, there will

be a flood of companies who will be seeking guidance, some form

of help, or a delay in implementing the law because they will not

be ready − or even have a strategy in place − to jump-start their

programmes. Governments will likely need to put a stake in the

ground. They will need to convert their recommendation into a

regulation to prevent yet another delay in what is a much needed

initiative. This is due to the annual rise in illegal drugs that are hitting

global markets as a result of supply chain security inefficiencies.

Any of us that have gone through the serialising of a range of

products, or managing the conversion of a manufacturing line to

print barcodes on moving bottle caps, know that the sheer effort

in doing this without a slowdown in output comes with many

challenges. However, we should not turn away from the fact that for

every day, month and year that there is a delay in implementing a

standardised e-Pedigree solution, more and more patients will be

put at risk due to the quality and security of the distribution source

for their medications.

Planning Ahead Given the alternatives, what’s the best way to prepare for the day

when serialisation and tracking the authenticity of products through

the supply chain becomes a reality?

GS1 compliant 2D barcodes are globally recognisable and are, by

far, the easiest way to get started on the production line. Many

companies have systems that can read and store this data in an

Electronic Product Code Information System (EPCIS) database

that can be synchronised for data integration between system

manufacturers. The data from the EPCIS can even be used to

formulate an e-Pedigree and, when linked in with an ERP system,


can track the individual products from manufacturing to local

warehouses to actual shipment, and to the first point of custody

down the supply chain.

By implementing this approach, the manufacturer is now assured

(in principle) that the first leg of the supply chain is secure. You can

provide a security sanity check by comparing the e-Pedigree serial

numbers against the serial numbers of the received product and the

shipment database, or EPCIS.

However, when we look a little deeper into the overall process,

once the product reaches the first chain of custody change at the

warehouse, each one of the individual saleable units would need to

be scanned with a 2D barcode reader to confirm the serial number

(and possibly the product code). This creates an added cost burden

to the wholesaler, as the wholesaler would need to unpack each

shipping carton to do the scanning which, in the case of cold chain

products, could compromise the entire shipment. This is why there is

the need for the acceptance of inference.

The Benefits of InferenceInference was regularly discussed in the days leading up to the

original California serialisation plans. This is because inference

relates to being able to read only the code device on the outer

shipment package (be it a standard data matrix GS1 2D standard

barcode, standard strip or flat-level GS1 1D container code, or

an RFID tag). This in turn, will provide a breakdown of each of

the individual item serial numbers contained within the carton

it is attached to. Using inference, the time consuming and costly

effort of opening each carton to scan individual item codes and

serial numbers would be essentially eliminated, reducing cost and

significantly reducing the risk of the compromising of any cold chain

product shipments.

With serialisation and e-Pedigree, manufacturers, distributors and

couriers will need to focus not only on ensuring quality and efficacy

at the item level. but also to ensure security at the total shipment

level. Because of this, they’ll need a solution for their supply chain

that can track both product IDs and also monitor the status of the

products as they travel through the supply chain to the end user.

The best approach to labeling the individual units, as stated earlier,

could well be standard GS1 2D barcodes. But for case and pallet level

tagging, 2D or 1D codes as defined by the Health Care Distribution

Management Association (HDMA) will more than fit the bill, except

potentially in the case of Cold Chain shipments.

Even though these standard 2D and 1D shipping container and

pallet labels will more than suffice for basic drug shipments,

and allow for inference, they will only be a “one function, one

use” solution. In the real world, the need for the recording of the

exchange of custody to generate an e-Pedigree will become a reality.


Therefore, in the case of Cold Chain shipments, if the carton needs to

be opened to get a reading of the individual product barcodes, the

entire contents of the container could become compromised.

Standard RFID tags in some cases are now being used on shipping

containers and pallets but are generally single-use passive tags.

In the area of temperature monitoring, the commonly used USB

data loggers or chemical recorders will provide a record of the

temperatures and any deviations during the shipping process. The

drawback is that they are typically single use and need to be read

outside of the carton via connections to a computer or a special

print device and, in the case of the USB tags, this compromises the

contents when the carton is opened.

For drug manufacturers developing their strategies for managing

the shipment of cold chain products requiring serialisation and/or

security tracking, or those who are trying to reduce costs, there is

another RFID solution that should be considered. Battery Assisted

Passive RFID tags, compared to standard temperature recording

data loggers or passive tags, are capable of performing many of the

functions that previously required more than one device to handle.

Because they can offer sizeable memory, 2 years of battery life and

can be read through a pharmaceutical shipping carton, they can be

used in transit to show temperature and serial number content. Data

can also be entered along the route to record changes in the chain of

custody.

When these enhanced features are combined with inference, these

newer RFID tags allow any serialised shipment to be read and

recorded as part of the chain of custody logging. And, in the case of

cold chain products, the current and shipping temperature logs can

also be read at the same time – all without even opening the box!

Global manufacturers starting down the serialisation path and

developing their e-Pedigree strategy now have a viable and cost

effective alternative to the standard printed barcode approach. The

ability to cost-effectively capture data in-transit, without opening the

container, make Battery Assisted Passive RFID tags an ideal option for

cold chain products that need to be consistently monitored on their

journey.

Peter Norton is a supply chain consultant with Intelleflex Corporation.

He has over ten years of experience working in the pharmaceutical cold

chain and logistics industry. Email Peter at [email protected].

© 2012 by Intelleflex Corporation – Used with permission


The growth in demand for biologics and preventative

medicines will only lead to further increase the amount

of temperature-sensitive products moving though the global

supply chains. Today, 25 per cent of all healthcare products are

temperature-sensitive and the requirements for high-value,

life saving healthcare products such as blood plasma, insulin,

vaccines and other biological pharmaceuticals are at an all-time

high.

This means that there is also a rise in the need for safe and effective

global transportation of these products and as such, industry experts

predict that the world cold chain market for healthcare products will

grow by 10 per cent year on year.

The challenge for the pharmaceutical industryProbably one of the most prominent challenges faced by the

pharmaceutical industry in the safe transportation of temperature-

controlled pharmaceutical products is to keep the temperature

of the product within its required band during transit. Indeed, 20

per cent of temperature-sensitive healthcare products have to be

destroyed as a result of a broken cold chain. Any weak link in the

chain can compromise drug or sample integrity, breach security,

delay shipments and ultimately result in financial loss or liability.

Packaging systems, transport companies, freight forwarders and

airlines all need to take the necessary measurements to ensure

that the product’s temperature stays within its range. This is not an

easy task, especially when multiple handlers are active within the

cold chain or different products with different temperatures are

distributed.

Due to the urgency of shipments and the value of the products, most

high-value temperature-sensitive products are transported by air.

Shipping across international borders adds complexities above those

of domestic transport due to fragmented supply chains, extreme

ambient temperatures and the infrastructure of those countries

through which the product must pass.

Airfreight is the most expensive mode of transportation and as such,

in order for airlines to make money from its cargo, the lanes that are

available for shipping are often limited. To combat this, products are

often transported via multiple flights that include stopovers: this

increases the route’s complexity, duration and touch points where

things can go wrong.

Furthermore, each country has its own regulations, codes, policies,

procedures and customs that affect international shipments and

can result in delays. The infrastructure differs greatly from more

mature markets to those of emerging markets, which of course are

the growth drivers of the future. For example, Frankfurt is Europe’s

busiest cargo hub. It is used to handling temperature-sensitive

goods and has a thorough understanding of their requirements,

while a country such as India has a poor modern transport

infrastructure which could result in additional overland transport of

up to 72 hours. In contrast, China has a great transport infrastructure,

but delays are possible due to custom regulations. Regulatory

requirements are only increasing, particularly in emerging

markets and then of course there is the pressure of associated cost

implications.


Assessing the optionsBeing able to ensure that a shipment will remain within a

temperature range for an extended period of time largely comes

down to the type of container that is used and the refrigeration

method.

Factors such as duration of transit, the size of the shipment and

the ambient temperatures experienced are important in deciding

what type of system is needed for each route. Options can range

from small insulated boxes that require dry ice or gel packs, rolling

containers, to 40 foot vehicles, which have their own powered

refrigeration units.

For high-value products that have strict temperature requirements,

such as +2°C to +8°C, the two main ways of maintaining the correct

environment and temperature during transport are active solutions

or passive temperature-controlled packaging. But which option

provides the best and most cost-effective solution? The decision can

be reached through assessing the different transport and product

requirements: reviewing the market, quantity, timing, destination

and of course cost.

Active systemsIn a nutshell, active systems are exactly as they say, ‘active’. Similar to

a refrigerator, generally the containers maintain a thermostatically

controlled environment based on two technologies: compressor

cooling and electric heating or dry ice refrigeration using a

compressor.

Small units may use single-use chemical reactions or pressure

differences to provide set periods of heating or cooling, while larger

units resemble large freezers, fridges or cold rooms and include

heating or cooling elements that power air through heat exchangers

and circulate it around the product space.

If a product requires heating it is usually done electronically, utilising

heavy battery packs or via an external power supply. If cooling

is needed, dry ice or conventional refrigeration are the typical

methods, using electrically driven or fuel-powered compressors.

Because active systems are reliant on external power sources

there are higher cost implications and restrictions on handling

and shipping. To offset the cost, active systems are often leased

to customers. They also require attention in the form of human

intervention during transit to either physically replace or recharge

the batteries or re-ice after 72 hours.

Units are fitted with control and data logging systems to monitor

and verify events such as start and stop operations, cargo and

ambient temperature, as well as door openings and alarms for

temperature deviations and system failures.

Due to their high cost, active containers are generally leased on a

short-term basis to customers, and there is only a certain amount

in global circulation. They are positioned at various global ‘stations’

and additional costs might be incurred to deliver the system to

the required point of origin. Once at its departure point, an active


system often requires limited preparation and can be packed simply

following a standard operating procedure (SOP). However, active

systems are generally only cost-effective in large volumes, as partial

loads incur similar costs to full loads. This is because the system still

requires the same level of handling and the product transported

does not significantly alter the system volume and weight.

Passive packagingWhilst ‘less intelligent’ than an active system, passive, by nature

means that once the system has been ‘packed up’ it is then not

interfered with at any point during its journey.

Passive temperature-controlled packaging works by combining

components usually manufactured from a variety of commonly

found insulation materials such as polystyrene, polyurethane

or vacuum insulated panels to provide good insulation without

significantly increasing temperature.

Systems are packed with temperature stabilisers such as ice, gel, cool

packs or other phase-change materials to provide a fixed amount

of thermal protection for its mapped-out journey. The combination

of this blend of componentry acts to keep the temperature of the

payload area within a certain temperature range for a specific time

up to 120 hours. The use of different component configurations

enables the system to cope with a wide range of ambient

temperatures.

The passive packing system requires components to be prepared

before being packed around the product. This preparation requires

the phase change materials to be preconditioned and maintained

at specified temperatures 24 to 48 hours before packing, until the

systems are ready to be assembled.

Packages can range from single vials to multiple pallets and once

assembled for shipping, they can be sealed and dispatched without

the need for power supply or the requirement for additional

attention from highly trained personnel, who have needed to be

educated in temperature-sensitive product transportation handling.

The only changes to the state of the package are due to physical

processes caused by the flow of heat through the components, i.e.

the melting of ice. With this greater flexibility comes the increased

option of transporting a passive shipment via more carriers and

routes.


Prior to shipment, each passive package goes through a qualification

process where an in-depth understanding of typical and extreme

temperatures a package may encounter is achieved. Compared to

active systems, passive packaging has considerably lower capital

costs and is available for a range of budgets and performance

capabilities. They can provide frozen protection below -20°C by

using either the dry ice sublimation phase change at -78°C, or the

melting phase change of tailored materials to keep temperatures

above - 40°C. There are also passive systems

that can maintain +2°C to +25°C and

+15°C to +25°C, using both water

and specialised phase change

materials. However, their main

use is for the maintenance

of refrigerated products

between +2°C and

+8°C, while active systems can be tailored to an exact temperature

range required, be it greater than -20°C to +20°C.

International transportation When using an active system a logistics service provider and airline

carrier are required to have a hands-on monitoring role during

transit. Indeed, each cog in the supply chain is responsible for

helping to combat extremes of temperature exposure on the route.

This demands monitoring of the temperatures upon acceptance, in

transit, upon collection and during dwell time, as well as re-icing or

replacing batteries, as required.

Air transport can involve the product sat on airport tarmac prior

to loading and this is where some of the most common risks occur

due to exposure to the ambient temperatures on the day. Active

solutions are fitted with control and data logging systems to monitor

and verify events such as start and stop operations as well as cargo

and ambient temperatures. These register outside temperatures in

order to maintain the required conditions inside the container.

Compared to active systems, passive packaging has considerably lower capital costs and is available for a range of budgets and performance capabilities. They can provide frozen protection below -20°C

By contrast, passive packaging’s basic construction means that it can

be shipped without considerable handling restrictions, which in turn

offers greater flexibility in terms of having more potential carriers

and routes available. However, because of its ‘simplicity’ there is a

general misconception that passive packaging does not perform as

well as an active solution.

ConclusionUltimately, active systems can react to changes in the environment,

whereas passive packaging resists external temperatures for as long

as there is energy available from the coolant within the shipper.

The decision on whether to use an active system or passive

packaging to transport temperature-sensitive products is largely

determined by the products’ requirements, the owners approach

and attitude to risk, as well as the destination and budget. One

solution doesn’t necessarily fit all, but the best system for each

shipping requirements can be found if you have a comprehensive

understanding of the options available.

“

“


About the authorKavita Somaroo, Marketing Manager, DS Smith Plastics Cool Logistics

Kavita has over eight years experience in the packaging sector, beginning her career in the DG packaging industry and moving to cosmetics,

before finding her niche in pharma/cold chain, when she joined DS Smith Plastics Cool Logistics in 2009.

During her time at DS Smith Cool Logistics, Kavita has experienced success through being able to adapt quickly and effectively to the changing

market conditions and enjoys working with many of the leading Pharma, Biotech and Clinical Research sector companies to provide solutions that

enable the movement of high value products.

Kavita holds a Bachelor of Arts (BA) in French and Hispanic Studies and a Master of Arts (MA) in Marketing.

Contact: [email protected]

Passive packaging Active Systems

Can it be packed on-site? √ Coolant conditioning may be required √ May require specific handling equip-

ment

Can the size be customized to requirements? √ Can be custom sized to maximize pack-aging efficiency

X Designs are based on cargo unit load

devices (ULD) sizes

Can it heat and cool? X Can maintain temperatures and cool √ Units with heating only are limited

Are they available globally? √ Available locally via multiple carriers and routes

√ Dependent on local availability and

route

Are they available immediately? √ Yes can be kept on the shelf √ Dependent on shipping origin and

destination

Does it need management during transportation?

√ Once sealed it needs no further interven-tion

X Requires management during transit

Can it be used for one-way shipping? √ Designed to be const-effective for single use

X Multi-use only and must be returned to

a hub at users cost

Is product space maximised? √ Size versatile and can ship a single vial X Only cost-effective in large volumes

Can it handle extreme ambient temperatures? √ Multiple coolant configurations can be

adapted for different extremes

√ Heating and cooling units available to

handle extreme temperatures

Are there any special freight handling requirements?

√ Classified and handled as temperature-sensitive and stored in a controlled warehouse ready for loading rather than left airside

√ Units using dry-ice are classified as ‘dan-

gerous goods’ and can attract a premium

freight charge

Can it be used to distribute products any-where?

√ Can be sent via air to any global destination

X Can only go via certified handlers and

not to every country


Industry experts predict the biggest growth in temperature controlled pharmaceutical shipments

will come from emerging markets. Much of this expected growth is attributed to China’s growing importance in the global pharmaceutical industry.

As more companies are attracted to the market, by next year China is

expected to be the third largest pharmaceutical market in the world,

with an estimated growth rate of 20% per year through 2010-2015.

According to Alen Yan, General Manager for World Courier, the costs

of drug development can be just 10 per cent of the price it would be

in the West.

Steve Huang, Managing Director, DHL Global Forwarding China, said:

“The Life Science and healthcare industry in China holds its own

despite the global economic crisis. We are optimistic that this sector

will continue to offer promising growth.”

China has proved to be attractive for investors with an influx of

companies and global logistics providers in the past few years.

Just a few months ago DHL opened its biggest Asian hub in

Shanghai, together with its four express hubs in the Asia-Pacific -

Shanghai, Hong Kong, Bangkok and Singapore. DHL plans to use the

$175 million Shanghai-based hub to better tap into China’s growing

demand for logistics services.

“Opening the new hub today shows how we are confident in the

development in China...and this reinforces our commitment to the

logistics business,” said CEO Frank Appel.

However hurdles for those working in the temperature controlled

supply chain still exist, and over one third of professionals 35%

who took part in a live polling session at IQPC’s 11th Cool Chain

Logistics Europe in February 2012 think China will not only present

the greatest business opportunities for cold chain distribution in the

BRIC countries, but also the greatest challenges.

A significant number of the survey respondents – over 41% - selected

China as the BRIC economy which had the most opportunity for their

business, followed by Brazil and Russia both with 17% and India with

14%.

A presence in China is a must for most players in the pharmaceutical

industry, however “this growth requires a supporting infrastructure

which allows pharmaceutical companies to transport drugs and

related equipment in a safe, timely and cost-effective manner” said

Cold Chain IQ in Cold Chain Management in China. An effective

risk management strategy to protect the supply chain and skilled

professionals with local knowledge of the market is also important to

maintain business relationships and deal with issues that might arise

in real-time.

“The Life Science and healthcare industry in China holds its own despite the

global economic crisis. We are optimistic that this sector will continue to offer

promising growth.”


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