tlp insight

TLPINSIGHTIssue 2 - 2013

The Logistics Portal magazine

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

keeping coollooking into the various areas of multi-physics within temperature controlled packaging

TLP Insight: a journal for the life science logistics industry

BUILDING SUCCESSFULSUPPLY CHAIN IN CLINICALTRIAL SUPPLIES

COUNTING THE COST

11

14

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SWISSWORLDCARGO.COM

SWISS °Celsius PassiveFor your temperature sensitivesupply chain

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MANAGING DIRECTORLee Atkinson

MANAGING EDITORBridget Langston

COMSULTANT EDITORTony Wright

SENIOR DESIGNERJoey Graham

EDITORIAL ASSISTANTSNicholas RidgmanJamie Ward

CIRCULATION MANAGERTony Williams

SALESRakesh Makwana, Lee Atkinson

ADMINISTRATIONKatie Galelli

WEBSITE DESIGNKnut Henriksen

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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

Pharmaceutical Logistics in South America: Opportunities and ChallengesAn authoritative and interesting insight into the challenges facing pharmaceutical logistics in the rapidly expanding market of South America. Based on research carried out by ColdChainIQ.com, Shawn Siegel gives us the Top 8 Cold Chain Issues.

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The Pharmaceutical Industry in SwitzerlandMarkus Scheuber, Product Manager SWISS °Celsius and SWISS X-Presso at Swiss WorldCargo and Annette Kreuziger, Director – Head of Marketing and Product Management at Swiss WorldCargo tell us about the active and passive solutions provided by Swiss WordCargo and which illustrate why they are an experienced partner when it comes to temperature sensitive supply chains.

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Concerned about ensuring drug efficacy throughout the whole of your cold

chain? CSafe tell us about the pitfalls that can and do occur during the ‘last mile’

and the solutions they offer to make sure that the cold chain retains integrity to

its very end point.

Read the full article on page 28 »

//WHEN LIVES AND LIVELIHOODS RELY ON LAST MILE

Use of RFID in Air CargoIATA keeps us up-to-date with the latest review by the IATA Cargo RFID Working Group (CRFIDWG) and let’s us know where the group will focus its interest next.

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Contents continue on page 4 »SWISSWORLDCARGO.COM

SWISS °Celsius PassiveFor your temperature sensitivesupply chain

130320_SWC_Celsius_Passive_Anzeige_210x297.indd 1 15.04.13 13:34

TLPINSIGHT www.the-logistics-portal.com4.

THE LOGISTICS PORTAL MAGAZINEWWW.THE-LOGISTICS-PORTAL.COM Issue 02 - 2013TLP

//CONTENTS

//BUILDING SUCCESSFUL SUPPLY CHAIN SOLUTIONS IN CLINICAL TRIAL SUPPLIES

Ian Morgan, General Manager of Sharp Clinical Services (UK) Ltd has over 30 years of experience in the pharmaceutical and medical device industries in quality and operations. Here he shares his knowledge and understanding of building successful supply chains, reviewing the importance of good project and programme management in bringing about that success.

Aerospace derived technology helps create more insightful temperature-controlled packaging solutionsRichard Wood, Design Manager at DS Smith Plastics Cool Logistics, has been involved in hundreds of bespoke, customer-defined projects. Here he offers us a solution to the lengthy, initial development period using groundbreaking simulation technology. And the benefits of its use are not just restricted to time saving.

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Risk Mitigation: The invisible component of cold chain managementSmart cold chain management addresses the underlying structure and stability of their monitoring programs by looking beyond the visible components to risk mitigation. In this White Paper, Sensitech looks at the kind of questions we need to ask ourselves in relation to this, in our quest for quality management in the cold chain.

34

Read the full article on page 38 »

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//TLP INSIGHT FOREWORD

www.the-logistics-portal.com

There can be no greater evidence of the need for an effective temperature controlled supply chain than to have experienced some

of the unusual weather patterns across Northern Europe over the last few weeks (and months). Metres of snow in places not

accustomed to anything more than a sprinkling, extended freezing conditions and then within a day or so, being transformed in

20 degrees Celsius and more. Getting your packaging and supply chain to cope with all of this can be a real challenge.

So it’s timely that this edition of TLP includes a number of articles that look at those challenges. Starting right at the Design

Qualification (DQ) stage, Richard Wood introduces us to the world of multi-physics, a process that uses 3-D modeling and simulation

to speed up the overall qualification process. Whilst this is not aimed at replacing any of the important elements of qualification, it may

provide an opportunity to condense the initial development period, perhaps by months. As we all know, time is money and cost savings

are the Holy Grail of a high-quality temperature controlled supply chain so this may be an interesting step for all of us to look more

deeply at.

Talking of quality, it’s that overall theme that Ian Morgan reviews in his article when he discusses the vital issue of collaborative planning

with both internal and external (supplier) teams, in his feature concerned with the clinical trials process. Ian correctly argues that

good project and programme management can significantly enhance the success of a clinical supply chain and I would add that those

principles apply equally to any part of the pharmaceutical or biopharmaceutical logistics process. Look at the focus being placed by

regulators such as the European Union, in their latest ‘Guidelines on Good Distribution Practice of Medicinal products for Human Use’

(2013/C 698/01) and it’s easy to spot the increased emphasis being placed on written agreements, performance management and

supply chain responsibility.

Finally, that often-used phrase ‘Last Mile’, with all it conjures up in terms of risk to the products that manufacturers have spent many

millions developing, is highlighted by new product developments from CSafe Global. As their article points out, using the power of a

medical sales representative calling on doctors and physicians can have a significant impact upon the success of a product’s launch. But

as recent evidence has shown, the control and management of temperature-sensitive vaccines and other drug products is not always

how we would want it to be at the final point of delivery. Aside from the basic GCP process inside the clinic or pharmacy, the vital aspect

of how sales representatives transport these products, moving from site to site and in and out of the uncontrolled environment of a car

boot or trunk, is often overlooked and can have a devastating effect upon patient safety. Thankfully there are advanced solutions at

hand.

What these three articles highlight is that we must never miss the opportunity to constantly improve the efficiency of our temperature

controlled supply chain. We must use advances in technology wisely and couple these with innovative packaging and transportation

solutions and combine these with good planning, teamwork and effective management.

TLP Insight would like to extend a big, warm welcome to Tony Wright, Founder and Owner of

EXELSIUS, a Specialist Healthcare Cold Chain Management Consultancy.

Tony has a thirty-five year history in the distribution; temperature controlled and air cargo

logistics sectors. During this time he has been Global Sales and Development Director of British

Airways World Cargo and the Senior Vice President of Envirotainer, amongst many other key

roles and activities.

We very much look forward to working with Tony and are sure that his experience and expertise

will help us all to focus our thoughts and ideas, to shape TLP Insight into the best publication in

the industry.

Lee AtkinsonManaging Director - Intensive Media Ltd

Tony WrightCEO Exelsius Cold Chain Management

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USE OF RFIDIN AIR CARGO

Applications of Radio Frequency Identification (RFID) technology

are once again at the top of the cargo agenda. The main drivers

are believed to be the following:

• RFID has become a relatively mature technology and the price of

RFID tags have been decreasing

• The growing air cargo market generates higher competitive

pressures, which require new cost-benefit-sharing models and

efficient logistics procedures to survive in such an environment.

RFID technology contributes considerably to addressing these

upcoming challenges. Various RFID applications in air cargo

operations have been developed, such as:

• automatic identification of ULDs

• time/temperature/humidity monitoring

• piece level tracking

• unauthorized door opening and vibration monitoring for security

control.

Today only some local solutions and smaller pilot projects for testing

purposes have been conducted by member airlines, however, there

is no industry-wide standard or procedures to ensure interline

compatibility.

The IATA Cargo RFID Working Group (CRFIDWG) was established

to provide recommendations on common industry standards and

best practices for the applications of RFID technology in air cargo

operations. The working group has recently completed the review of

the recommended practice on the ‘application of RFID for automatic

identification of ULDs’. The potential benefits of such an application

were identified as follows:

1. reduce human errors and ensure reliability/accuracy in data

capturing

2. eliminate paper handling and processing costs

3. achieve higher speed throughput at read/write locations

4. enable efficient tracking and locating the ULDs within the local

RFID system

5. facilitate the association of shipment information with the ULD

ID Code.

During the course of the review and along the progress of the

working group, some challenges and concerns were also identified:

• lack of strong expertise in RFID technology deployment

• insufficient/outdated industry standards to ensure compatibility

and interoperability

• lack of coordination across various RFID applications** and other

available wireless technologies to ensure optimal deployment

• unclear regulatory approval requirements for active RFID devices

on board an aircraft

• various RFID tag data formats available but unclear which one

would be appropriate.

** Besides the above-mentioned RFID applications in cargo

operations, a typical airline might consider the applications of RFID

technology in baggage handling, aircraft part tracking and tracing, in-

flight catering trolley management, ground support equipment (GSE)

identification, etc.

The Working Group will soon be working on its next task, which is

‘time and temperature monitoring devices’. Meanwhile, knowing

that there are various wireless technologies (RFID is only one of the

wireless technologies) being applied in today’s air cargo operations,

e.g. GPS and GPRS in temperature monitoring, the IATA Secretariat

is reviewing the Terms of Reference of the Working Group in order

to make it more relevant to the industry needs.

It is believed that IATA should play a more leading role in establishing

the industry standards and procedures for the application of RFID

and other wireless technologies throughout the air cargo supply

chain, to maximize efficiency as well as ensure compatibility and

interoperability.

Look out for the next issue of TLP Insight for a follow-up interview on RFID and the CRFIDWG cargo

USE OF RFIDIN AIR CARGO

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THE LOGISTICS PORTAL MAGAZINEwww.the-logistics-portal.com Issue 02 - 2013TLP

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

THE LOGISTICS PORTAL MAGAZINEIssue 02 - 2013 www.the-logistics-portal.com TLP

The worldwide pharmaceutical logistics market is booming, and in none of the global regions is this growth more notable than two of the most rapidly expanding markets - South America and Asia.

In a recent article exploring the trend, Air Cargo World cited

estimates from Transport Intelligence suggesting that the

pharmaceutical logistics industry expanded by more than 12 percent

from 2010 to 2011, reaching a value of approximately $61.7 billion

(£40.7 billion) internationally.

Figures for 2012 are expected to show an even bigger increase,

partly thanks to growing demand for these services in South America

and Asia.

According to the Transport Intelligence figures, the South American

pharmaceutical logistics market expanded by more than 20 percent

between 2010 and 2011, reaching a value of $9.4 billion.

In Brazil alone, the sector was worth $5.1 billion after experiencing

growth of almost 14 percent in the same period.

Worldwide, South America and Brazil respectively accounted for 15

percent and 8.3 percent of the total pharmaceutical logistics industry

in 2011.

Pharmaceutical Logistics in South America: Opportunities and Challenges


THE LOGISTICS PORTAL MAGAZINEwww.the-logistics-portal.com Issue 02 - 2013TLP

This expansion brings its own unique challenges, such as the need

to extend the supply chain and deal with the complications related

to infrastructure in developing nations and regulations enforced by

different governments.

One of the biggest issues for the industry to consider is the need to

maintain a temperature controlled supply chain, which requires the

involvement of dedicated solutions providers such as CSafe.

Mark Mohr, director of customer support and partner management

for CSafe, said his company is experiencing growing demand for its

services in South America.

“Although there is more inbound and not a lot of outbound traffic out

of South America, clinical trials present a unique opportunity and [it]

is a prime market,” he said.

Cold Chain Challenges

Cold Chain IQ published a report noting that Latin America has

become a “major hotbed” of pharmaceutical and supply chain

growth but also faces its fair share of challenges, among which is the

provision of temperature controlled logistics.

The human factor is seen as particularly important, with 60 percent

of respondents to a recent Cold Chain IQ survey citing training as the

biggest barrier to improving the temperature controlled supply chain

in Central America.

Another potential obstacle to the growth of pharmaceutical logistics

in this part of the world is infrastructure.

Factors such as small, narrow aircraft runways preventing long-haul

carriers from accessing particular locations mean countries like

Nicaragua and Colombia have a low ranking on the World Bank’s

Logistics Performance Index.

The Cold Chain IQ report also highlighted concerns such as the

potential for political instability in emerging regions, as has been seen

in the Middle East and North Africa, and questions over security.

Other considerations that pharmaceutical logistics providers have

to take into account in South America include unreliable power

sources outside urban centres and a diversity of climate zones and

geographical settings encompassing everything from rainforests to

mountain ranges.

Human error, as opposed to technological shortcomings, remains the cause of the majority of failures in this particular part of the industry.

Along with other emerging markets, Latin America has been a major hotbed of pharmaceutical and supply chain growth. But the region provides its share of challenges.

1: A Well-Trained Workforce

In a recent survey from ColdChainIQ.com, 60% of respondents said that “training” was the biggest barrier to improving temperature control

supply chain in Central America.

The majority of cold chain failures still come from human error as opposed to technological error.

Top 8 Cold Chain issuesin Latin AmericaBy Shawn Siegel for ColdChainIQ.com


THE LOGISTICS PORTAL MAGAZINEIssue 02 - 2013 www.the-logistics-portal.com TLP

#2: Infrastructure

This is a problem that is not peculiar to cold chain, but supply chain logistics generally.

Countries such as Nicaragua and Colombia rank particularly low on the World Bank’s Logistics Performance Index.

Smaller and narrower runways mean that traditional long-haul carriers might not

be able to access certain locales. On the positive side, this is an opportunity for local

carriers to take advantage of.

#3: Instability

Currently, the political situation in the region is relatively stable. However, as

recent events in the Middle East and North

Africa region show, this can change quite

quickly. Instability adds an extra level of risk

management control that must be in place.

#4: Local Government Culture

According to the Eco Chamber of Commerce,

more and more countries in the region are

demanding documentation of individual

shipments as a requirement of entry.

However, different localities require different

documentation.

#5: Regulations

Cold Chain logistics are becoming increasingly regulated around the globe, not only in

South America, but also in North America, Europe and elsewhere.

#6: Power Supply

Particularly outside of urban centres, inconsistent and unreliable power sources can be

an added wrinkle not encountered in countries like the US.

#7: Geography & Climate

As the global market seeps into distant corners, complexity obviously increases. Longer distances must be covered (which means higher fuel

costs), multiple hubs or distribution centres must be employed, and multiple climates must be encountered.

Compared to Europe for example, Latin America features extreme climate zones, including the 7,000-mile long Andes mountain range and the

Rain Forests of Brazil.

#8: Security

Reputation aside, the reality is that countries in South America have homicide rates that far exceed most developed nations. While the US rate

of 5 homicides per 100,000 people is quite high for developed world standards, the rate in Brazil is well over 20 per 100,000 and countries

such as Honduras and Venezuela are more than twice that of Brazil, according to the United Nations Office on

Drugs and Crime.

While murder rates are not the main concern of cold chain transportation, the lack of security on

highways is a serious threat.

Cold Chain issues

A One Page Guide to the Top 20 Busiest Ports in the World

With oil prices consistently above $100 a barrel in 2012, logistics providers have beenlooking at more energy-efficient and cost-effective ways of shipping temperature-sensitive products around the world. As a result, most ocean freight markets areshowing growth in shipping volumes and there has been an increase in the availabilityof reefer plug-in points at ports. Want to know which port has the biggest throughput inthe world? This infographic identifies the Top 20 busiest container ports ofthe world measured in TEU (Twenty-Foot Equivalent Unit).

WWW.COLDCHAINIQ.COM

CONNeCT TO A COLD CHAINIQ sOCIAL NeTWOrk

RANK PORT, COUNTRY VOLUME 2011 (MILLION-TEUS) 1 Shanghai, China 31.74

2 Singapore, Singapore 29.94

3 Hong Kong, China 24.38

4 Shenzhen, China 22.57

5 Busan, South Korea 16.17

6 Ningbo-Zhoushan, China 14.72

7 Guangzhou Harbor, China 14.26

8 Qingdao, China 13.02

9 Jebel Ali, Dubai, United 13.01 Arab Emirates

10 Rotterdam, Netherlands 11.88

11 Tianjin, China 11.59

12 Kaohsiung, Taiwan, China 9.64

13 Port Kelang, Malaysia 9.60

14 Hamburg, Germany 9.04

15 Antwerp, Belgium 8.66

16 Los Angeles, U.S.A. 7.94

17 Keihin Ports, Japan* 7.64

18 Tanjung Pelepas, Malaysia 7.50

19 Xiamen, China 6.47

20 Dalian, China 6.40

18 Tanjung Pelepas 7.50

13 Port Kelang 9.60

2 Singapore 29.94

6 Ningbo-Zhoushan 14.72

7 Guangzhou Harbor 14.26

19 Xiamen 6.47

20 Dalian 6.40

8 Qingdao 13.02

11 Tianjin 11.59

9 Jebel Ali, Dubai, 13.01

3 Hong Kong 24.38

12 Kaohsiung, Taiwan 9.64

1 Shanghai 31.74

16 Los Angeles 7.94

14 Hamburg 9.0410 Rotterdam 11.88

15 Antwerp 8.66

4 Shenzhen 22.57

17 Keihin Ports, Japan 7.64

5 Busan 16.17

Cold Chain IQ cannot take responsibility for the accuracy of this information. Source: World Shipping Council, Top 50 World Container Ports PATH, World Health Organization: Ocean shipment of vaccines



The pharmaceutical industry in Switzerland

Markus Scheuber & Annette Kreuziger

Many sectors of the airfreight industry are

suffering. The weaknesses in Europe’s

economy have led to a decline in the volume

of high value consumer goods being transported.

The pharmaceutical logistics industry is a sector that

may not have proved itself to be completely immune

to external influences, but is at least considerably

resistant to them. How can airlines make the best use

of their potential to exploit the opportunities in this

field, and what are the risks and side effects that they

have to bear today and in the coming years?

Switzerland has a very long tradition as a

pharmaceuticals production centre. The headquarters

of many of the large international pharmaceuticals

corporations are mainly located in Basel, as well

as in Geneva and Zurich. In 2011 the volume

of Switzerland’s airfreight transportation of

pharmaceutical products was fourth in Europe, behind

only the three much larger national economies of

Germany, France and the United Kingdom.

Transportation is the biggest challenge in the entire

supply chain for pharmaceutical products. Managing

these cold chains means maintaining a product’s

temperature from manufacturer to the end user of the

chain. Temperature control is therefore a key feature

when transporting time and temperature sensitive

products. For the service providers in the so-called cold

chain it is extremely important to ensure the required

temperature in order to preserve the quality of the

pharmaceutical product. The slightest temperature

deviation might cause a broken cold chain, reducing

the efficiency of the pharmaceutical product or even

destroying it. Required temperature range could mean

room temperature in the band of +15°C to +25°C,

refrigerated temperature range in the band of +2°C to

+8°C or even frozen at a temperature level of around

-20°C..

Based on the urgency of these pharmaceutical

shipments and the value of these products, most of

the temperature sensitive shipments are transported

by air. The challenges for the airlines are high and very

complex: extreme deviations of ambient temperature in

the respective countries worldwide and different kinds

of airport infrastructure in those countries.

To manage these challenges it is important that the

airline understands the needs of the pharmaceutical

and healthcare industry. Awareness and training of

correct handling of healthcare consignments is as

imperative as state-of-the-art equipment and defined

processes accompanied by a detailed documentation.

Swiss WorldCargo: Pioneer in the industry

Being located in Switzerland and having understood

the requirements of the pharmaceutical and healthcare

industry when it comes to airfreight, Swiss WorldCargo

stepped up to the plate in 2006 and introduced SWISS

°Celsius Active, a tailor-made, high-quality solution

for shipments that require seamless transportation

in active temperature controlled containers. The

motivation to introduce such a product had been the

predicted steady market growth, the high affinity

for airfreight, the high-quality requirement and the

in the Fast Lanein the Fast Lane

Bus sin con niscias sitatec atatur, con et quia Ximo doluptae sed que nimi, autenda eostore


THE LOGISTICS PORTAL MAGAZINEIssue 02 - 2013 WWW.THE-LOGISTICS-PORTAL.COM TLP

in the Fast Lanein the Fast Lane

Bus sin con niscias sitatec atatur, con et quia Ximo doluptae sed que nimi, autenda eostore

In 2011 the volume of Switzerland’s airfreight transportation of pharmaceutical products was fourth in Europe



demand for value added services. As a partner for these active,

temperature controlled containers Swiss WorldCargo decided on

Envirotainer.

Since then, the collaboration between Envirotainer and Swiss

WorldCargo has developed further. Swiss WorldCargo has been

accredited as Qualified Envirotainer Provider (QEP). This QEP

programme has been developed by Envirotainer to “acknowledge

transport service providers that they are capable of properly

managing shipments using the Envirotainer container”. Achieving

the Qualified Envirotainer Provider (QEP) status at a station

demonstrates Swiss WorldCargo’s commitment to continuously

provide high-quality services and high reliability towards its

customers when handling the cool containers.

Over the years technology and quality of these cool containers has

advanced further. Today’s premium containers no longer rely on dry

ice, they provide an active temperature control system based on

compressor technology that allows them not only cooling but also

electric heating.

Acknowledging these upcoming technologies, Swiss WorldCargo

has kept its pioneering spirit and passion, responding to shippers’

requirements and offering the right equipment with an advanced

technology in their service portfolio.

Additionally, new providers have joined the market - CSafe being

amongst them. With the integration of RKN AcuTemp from CSafe in

their portfolio, Swiss WorldCargo is among the first airlines to use

RAPe2 containers within their services for healthcare shipments. The

integration of new ULDs in their cool container portfolio, provide

Swiss WorldCargo’s customers with the option to be flexible in their

choice for an appropriate container solution.

Along with an extended cool container portfolio, Swiss WorldCargo

offers standardised operational procedures that have been

successfully in place for several years and have always been adapted

to changing customer needs. Swiss WorldCargo also offers the

flexibility and know-how to provide tailor-made solutions for

customer requirements that go beyond the standard process.

A new high-quality solution: Swiss °Celsius Passive

But not only has the technology for active temperature controlled

containers evolved during this time. The so-called “Passive Solutions”



have entered the market. Pharmaceutical

and healthcare companies around the globe

are investing more and more resources in

sophisticated passive packaging solutions

for their time and temperature sensitive

consignments.

However, besides the packaging, a successful

supply chain for such temperature

sensitive goods also relies on high-quality

standardised processes and speed and

adequate storage wherever possible. In

order to respond to the growing volumes

of this transportation solution, Swiss

WorldCargo launched SWISS °Celsius

Passive. To provide high quality and

reliability to its customers, processes

worldwide have been improved, global

standards introduced and stations audited

with regards to their handling and storage

capability for healthcare products based on

IATA Chapter 17 regulations and far beyond.

Wherever possible, three temperature

ranges can be offered at various Swiss

WorldCargo stations worldwide when it

comes to storage of temperature sensitive

shipments: Controlled Room Temperature

(CRT) +15°C to +25°C, Refrigerated Temperature (COL) +2°C to +8

°C and Deep Frozen (FRO) at -20°C.

With further enhancements to the Zurich hub, Swiss WorldCargo

can revert to a sophisticated temperature controlled ULD stacker for

shipments that need a “controlled room temperature”. The stacker

also features a separate cool tunnel with ample space for ULD

shipments that need to be kept between +2°C and +8°C. An exclusive

area for loose “controlled room temperature” shipments as well as

“refrigerated temperature” and “deep frozen” is additionally offered.

Short distances between warehouse and aircraft position limit the

exposure to outside conditions to a minimum.

Summary

Swiss WorldCargo is an experienced partner when it comes to

temperature sensitive healthcare shipments. In the end it is the

customer who decides whether to use an active temperature

controlled container or to opt for a passive packaging solution; Swiss

WorldCargo can accommodate both. In addition to SWISS °Celsius

Active, for shipments transported in active temperature controlled

containers, Swiss WorldCargo completes their offer with SWISS

°Celsius Passive for temperature sensitive shipments transported in

special passive packaging.

Enhanced standardised processes along with the proverbial Swiss

Quality and a high flexibility to respond to customer requirements

individually, makes Swiss WorldCargo the right partner in

temperature sensitive supply chains.

Authors

Markus Scheuber, Product Manager SWISS °Celsius and SWISS

X-Presso at Swiss WorldCargo, the cargo division of Swiss

International Air Lines. Having joined Swiss WorldCargo in 2011,

in his function as a product manager he led the project team that

developed SWISS °Celsius Passive.

Email: [email protected]

Annette Kreuziger, Director – Head of Marketing and Product

Management at Swiss WorldCargo, the cargo division of Swiss

International Air Lines. With over fifteen years of experience

in the airfreight and logistics industry, in her function as

Head of Marketing and Product Management she is open to

new industry trends and supports product development and

enhancement accordingly.


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making huge strides in assisting with the development

process of temperature-controlled packaging systems, in order to

provide forward-thinking and cost-efficient solutions to meet the

complex needs of the global healthcare industry. Richard Wood from

DS Smith Plastics Cool Logistics advises how the technology used in

developing jet engines and Formula One cars has now crossed over

to cold chain packaging.


THE LOGISTICS PORTAL MAGAZINEWWW.THE-LOGISTICS-PORTAL.COM Issue 02 - 2013TLPReal World Simulations

Simulation and virtual prototyping is becoming an important and

indispensable stage in the development of robust, cost-effective

temperature-controlled packaging, especially when project timeline

pressures are a major factor. Technology such as Computational

Fluid Dynamics (CFD) was originally used to simulate airflow over

aircraft bodies in the late 1960’s. However, since then the method

of simulating 3D flows and Heat Transfer has been coupled with the

ability to replicate phase change; this software is often referred to

as Multi-Physics (MP). This innovative technology is used in many

industries worldwide and is often

known as the digital development

of a product. This means that

the initial development phase is

performed virtually on a computer,

before any prototype or initial

testing is carried out.

Used primarily in the automotive

and aerospace industries,

Multi-Physics is now becoming

more popular and accessible

for many niche industry sectors, including temperature-controlled

packaging suppliers. In essence, it is the same software that F1

teams use to simulate the airflow of the body of their cars to improve

aerodynamics. NASA uses Multi-Physics to simulate the thermal

stress that will be placed on a satellite orbiting Mars, utilising the

software to predict how much radiated heat the craft will be exposed

to and thus design heat shields to sufficiently protect the fragile

inner components. Even weather forecasters use it to predict climate

conditions and how the effects of Global Warming will change our

weather patterns in the mid to long term. In fact, Multi-Physics is

now being used extensively in almost all complex design and test

development projects across the world.

Breaking the tradition

The use of Multi-Physics and Computational Fluid Dynamic software

in the packaging industry is relatively new, and has really only

been available for the past few years, whereas in industries such

as aerospace and automotive, it has been a standard development

tool for at least 10 years. Due to the widespread use and the new

accessibility of this technology, the packaging

industry is now able to consider its use for

developing complex temperature-controlled

solutions for its pharmaceutical clients.

Quite simply, the simulation capabilities

enable packaging suppliers to significantly

increase the efficiency of a design process

and allow for a more expansive and innovative

exploration of design solutions to meet

customer requirements. In fact, a test using

Multi-Physics technology will take approximately one tenth of the

time it would take to run a physical test in a laboratory.

Instead of buying two new test chambers, manufacturers are now

able to consider investing in a simulation workstation and reap the

benefits of having more in-depth insights into the products they are

developing. This powerful tool means that packaging suppliers can

quickly produce ‘virtual’ prototypes and qualify their performance in

a fraction of the time that traditional methods take.

Thermal variations throughout the entire shipping system.

Exploded view of the shipping system showing the different components within it.

NASA uses Multi-Physics to simulate the thermal stress that will be placed on a satellite orbiting Mars

Cool Logistics

For more information call

+44 (0) 1525 243770

Intelligent PackagingThe Ultimate In Temperature Control

Cool Logistics – specialises in the design, test and qualification of temperature controlled packaging solutions and is dedicated to meeting the complex needs of the global Healthcare Industry.

Drugs Patient samplesMedical devices VaccinesClinical trial IMP Diagnostics

Blood related products

To discuss your temperature controlled packaging needs call +44 (0) 1525 243770

Cool Logistics Celsius House,

Stanbridge Road, Leighton Buzzard. LU7 4QQ www.cool-logistics.com Cool Logistics is part of DS Smith Plastics

10175 CL New A4 Advert V3.indd 1 29/01/2013 12:06



However, in order to fully understand the term ‘Multi-Physics’,

let’s first take a look at it in context. Ultimately, Multi-Physics is a

descriptor of computer simulation for physical phenomena. It was

one of the first applications of digital computers, and continues to be

a contributing factor in the progress of scientific computing today.

The software programme is used to simulate how a temperature-

controlled packaging system will perform when it is exposed to a

certain external ambient stress heat load. It works by creating a

3D CAD model of the temperature-controlled packaging that is

to be tested, which includes the various insulating materials, the

temperature stabilising components and the product in the shipper,

with temperature variables being associated with each part.

Traditionally, when developing and testing a new temperature-

controlled packaging system for a client, packaging suppliers would

undertake a number of iterative Design Qualification Tests, taking

into account the transit duration time and variable temperatures it

would expect to see during transport, in order to configure a shipping

solution in the laboratory: a process, which undertaken in real time,

could take months.

Depending on the complexity of the project and the number of

variables to take into consideration, such as testing with minimum

and maximum product loads and multiple ambient profiles, there are

a number of Design Qualification Tests each solution needs to pass

before producing a system that will fulfil the client’s requirements.

Furthermore, each time any change in the configuration is made,

such as moving a coolant component from one position to another,

or adding one or taking one away, each Design Qualification Test has

to be repeated in the laboratory against every different variable, in

order to know whether or not the shipper will perform as required.

For example, in real time, if a laboratory test takes five days to

perform, packaging suppliers will initially have to wait five days

before they know whether or not their first configuration of a system

will work. By using Multi-Physics, a virtual Design Qualification Test

is performed and although the results are not relied on to be one

hundred per cent accurate, they give an extremely strong indication

as to whether a packaging configuration will be good enough to move

it to the laboratory for the physical Design Qualification Test. So, in

essence, rather than undertaking a three-month development phase

Airflow direction and velocity within the shipping system.

“Ultimately, Multi-Physics is a descriptor of computer simulation for physical phenomena”



in the laboratory, three weeks can be taken using the Multi-Physics

software. Consequently, rather than providing a replacement for

physical testing, Multi-Physics facilitates an initial condensing of the

development period, which enables suppliers to fulfil their customers’

requirements that much sooner.

Forward-thinking Innovation

Another insight that the Multi-Physics software also allows for, is

a more in-depth understanding of other aspects of design, such as

airflow within the system, as well as predict how a shipping system

could be affected if it is subjected to ambient profiles different to

those to which it was originally qualified. This can offer peace of

mind to customers who wish to use a particular system on a new,

unqualified shipping lane.

Multi-Physics enables temperature-controlled packaging suppliers

to see how energy (heat) is transferring through a shipping system.

During a physical test, thermocouples are attached to the product

load inside the shipping system to record the temperatures at those

discreet locations. However, unfortunately, they are unable to show

how energy is being passed through the shipping system or where the

hot and cold spots are outside of that payload space, which may have

an effect on how it performs overall.

But by using Multi-Physics, the whole shipping system can be

analysed, including the insulation, coolant components and product

load area. Hot and cold spots can be identified and the flow of energy

(heat) in and out of the shipper from external surfaces can be seen,

identifying exactly how the external ambient environment is affecting

it. Furthermore, it can also give a complete picture of the solid/liquid

phase of the coolant components in the shipping system, rather than

(in a physical test) just seeing that the components have melted when

a box has been opened after the test has finished. The software also

simulates the phase change of the coolant components, showing the

detail of a frozen (solid) component melting during the simulation

into its liquid phase. This makes it possible to view the transition

accurately to pinpoint the end of the phase change period, which is

critical when designing cost-effective shipping systems.

Ultimately, this means that over-engineering shipping systems

to be on the safe side could actually become a thing of the past.

Multi-Physics provides a better understanding of how to design the

shipping system with exactly the right amount of energy absorbing

phase change material to ensure internal payload temperatures are

maintained within the correct range for the desired transit duration.

This means that the old design method ‘safety buffer’ can be removed,

whilst still being confident that the shipping system is fit for purpose.

Setting a new standard

Time is of the essence and temperature-controlled packaging

suppliers are striving to do all they can to reduce lead times

associated with the supply of high quality temperature-controlled

systems in order to meet the time and temperature sensitive

demands of pharmaceutical companies. In fact, the software can run

a simulation for a 120-hour transport route, in approximately twelve

hours and there’s no set up time involved. This is where Multi-Physics

really comes into its own, because the more complex the shipping

system, the more efficiencies can be gained by using the software.

In essence, information on how a product may perform can be

obtained a lot quicker, so the development time is shortened.

This means that products can be launched to market in a shorter

time frame and from an efficiency point of view, products can be

engineered to see if they perform as well as they need to in the

marketplace with as few materials required as possible, so there is an

environmental saving as well.

During the Design Qualification phase, fewer materials are used

in the final product design, so there is less waste being put into the

environment. Furthermore, a virtual computer simulation reduces the

amount of physical laboratory testing in the development stage, so

rather than having to receive costly prototype materials and run the

environmental chambers, which use a lot of energy, that stage is taken

out and replaced with a virtual development stage.

As well as shortening the development time of a shipping system,

the software can also simulate different styles of product that a

customer might be shipping inside one temperature-controlled

packaging system. For example, a specific temperature-controlled

solution has been developed in the laboratory and signed off with

one product type, such as freeze dried powder. But how will the same

shipper handle the transportation of another product, such as a liquid

product inside a vial? How would changing the product affect the

performance of the shipper, and how well would that configuration

protect different styles of product being transported? The answers to

these questions can be simulated by using the characteristics of each

product type, tested against the previously qualified solution in the

laboratory. Thereby demonstrating a comparability of result without

the need to re-run those real-time laboratory tests.

By using Multi-Physics, the whole shipping system can be analysed, including the insulation, coolant components and product load area.



Furthermore, if the developed shipping system needs to be used on a different route and experience different temperatures to which it has

been qualified against in the laboratory, the software can simulate how the shipper will respond to those different ambient profiles. So if a

shipper that was used to distribute products to Europe now needs to be transported to China or South America, the software can give an

indication on how well it will perform on different routes using different ambient profiles to test against. Thereby demonstrating efficiencies by

not having to redevelop a whole new set of shipping systems. Instead, it can simply appraise how well the shipping system performed before,

against a new set of challenges.

Conclusion

In our ever growing and fast-paced global healthcare market anything that can reduce time in order to help get life-saving pharmaceuticals to

market quicker, without increasing the cost may sound too good to be true. It may appear that offering a tool such as this is more costly to a

customer wishing to source a temperature-controlled packaging system. However, it is in fact likely that the development cost of solution will

be lower, as the lengthy and costly development phase will be significantly less than traditional initial laboratory testing.

Ultimately, the availability of Multi-Physics technology to this sector now enables temperature-controlled packaging suppliers to provide their

data quicker, more accurately and with additional insights.

Richard Wood

Richard has worked in various design and manufacturing engineering functions during his career. He currently holds the position of Design Manager at DS Smith

Plastics Cool Logistics, where he has worked since 2005. During this time, Richard has been involved in literally hundreds of bespoke, customer-defined projects.

Richard has also helped to ensure that manufacturing practices are standardised across the Cool Logistics partners network. Richard’s current role within DS

Smith Plastics Cool Logistics is focused on standardising development, qualification and manufacturing practices to help support the company’s global customer

base.

Contact: [email protected]

A graphical representation of the thermal simulation provides a simple method to appraise the performance of the shipping system.

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

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SMi presents its 7th Annual Conference on

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PLUS AN INTERACTIVE PRE-CONFERENCE WORKSHOP

Transport Logistic Strategies13.30 - 17.30

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

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lives & livelihoods When

rely on last mile Authored by CSafe Global

lives & livelihoods rely on last mile

Authored by CSafe Global



Pharmaceutical companies spend an estimated

£5 billion to get a drug to market as it can take

decades of research, development, testing and

clinical trials followed by further time to obtain

regulatory approvals. They also invest heavily in

logistics for temperature sensitive pharmaceuticals

to ensure that the drug efficacy is protected

throughout the cold chain distribution during the

trials/testing period and subsequently when it is

approved and being distributed for sale.



Yet, happy to make this investment and then dedicate a large

marketing budget to the new products when they launch

them, pharmas often overlook adequately planning the

salesperson’s transportation of samples where a simple solution can

make all the difference.

Current market intelligence estimates that physicians only see 1 in

7 salespeople who ask for an appointment and drug companies say

that 30% of meetings result in an intent to prescribe. However, even

when an appointment is made, industry sources also report that 40%

are cancelled last minute and the rep is told: “Just leave the sample

and the literature at reception and we’ll look at it later.”

While the pharma sales forces in the USA and Europe are shrinking,

they are expanding at a rapid rate in Japan (up 20% between 2007

and 2011), in Eastern Europe and Russia, they have remained stable,

and increasing by up to 50% in emerging markets such as China

and Brazil. However, these figures do not paint the whole picture as

it is becoming more and more normal for pharmas in the USA and

Europe to hire freelance sales for specific jobs.

The dilemma for the pharmas is that, although sales forces are

expensive to maintain (hence why they are cut back in times of

austerity), when they are successful they can make all the difference

to a drug’s uptake from its launch. Which pharma cannot afford to

recoup new product development?

It is, therefore, more important than ever before that sales reps,

who are also the “face of a pharma’s business”, be trained, equipped,

informed and have everything they need to be successful.

The increasing regulation in the USA and Europe is not, however,

making any of this easier. 2011 research shows that drugmaker

spending on samples left in physicians’ offices has fallen by 25%

since 2007 and the number of retailer visits that include samples has

dropped 35%¹. This is largely because rules governing the storage

and transport of sales reps’ products have been tightened.

For example, in the UK, the MHRA ruling states clearly: “…the

storage and delivery arrangements for these medicinal products

must be validated to ensure the medicinal product will be

transported expeditiously under controlled Good Distribution

Practice (GDP) conditions and in accordance with labelled storage

requirements at all times.”

Research shows that drugmaker spending on samples left in physicians’ offices has fallen by 25% since 2007 and the number of retailer visits that include samples has dropped 35%



The reason for the ruling is clear – the temperature in a reps’ car

trunk may see extreme temperatures such as -30 or 65°C.

Should a physician provide a sample to a patient that does not work

as expected (because it was incorrectly handled while transported)

the patients’ health could be at risk, the doctor will assume that the

drug is no good and unlikely to make any further orders, the sales

rep’s visit has been a waste of time, patients’ health might have been

compromised and the valuable sales opportunity gone.

There is a prevalent misunderstanding throughout the healthcare

sector of the need to keep drugs at a constant and stable

temperature. For example, in the US, the Vaccines for Children

Program (VFC) provides immunizations to children whose families

are unable to afford them and approximately 80 million vaccines

have been distributed to over 40 million children from low-income

homes at a cost of approximately $3.6 billion. However, ABC News

found that many of the approximately 44,000 offices and clinics

participating in the program did not store their vaccines at suitable

temperatures and that their improper storage represented a major

breakdown in the program’s management process. Over three-

quarters of the immunization providers were storing vaccines at

a temperature either higher or lower than specifications. More

broadly, it was found that not one of the providers properly managed

the vaccines according to all of the VFC program requirements,

falling short with both on-site storage and the delivery of vaccines to

and between individual clinics and their satellite sites.

Many other examples could be cited on the same theme. The

most important parts of the chain that are missing are training,

understanding and good quality cool chain solutions. If the staff is

trained to understand the need for temperature control in drug

transportation and storage and the consequence of NOT doing so,

then they will be more likely to ensure that rules are adhered to

and check with suppliers or forwarders that the shipment has been

handled properly during transit.

One such solution to solve the issues described above is the

AcuTemp brand Courier and coolant belts which are able to maintain

the required temperatures for long durations in very extreme

ambient temperatures. Manufactured in the United States, the

Courier was also designed to be extremely easy to use and re-use

enabling a sales team to implement them without arduous training.

One should invest in cool chain solutions that work, are easy to use

and are robust enough to stand up to the exigencies of being out on

the road.

CSafe Global’s AcuTemp brand has provided over ten thousand

active systems since its founding over 25 years ago. CSafe is now

proud to introduce a series of AcuTemp brand Courier hand-held

mobile carriers in popular payload sizes, durations and temperature

profiles. The new sizes – 3L, 6L and 12L PX Couriers - were

introduced following the global success of the PX1 liter.

There are more than 10,000 Courier PX1Ls utilized globally and

this new launch comes at a time when the global market for last mile

solutions is searching for reliable, re-usable, cost-effective and easy

to use solutions. One of the distinctive features of the Courier PXs

PCM belt (patent pending) is that it requires no bench time for the

phase change materials

Pharmaceutical companies are under relentless pressure to reduce

costs while ensuring that their products are handled properly

throughout the cold chain. 1% of global shipments are lost every year

and 25% of all lost pharma shipments are due to temperature failure.

Pharmas are facing tough times as so many of their drugs are coming

off patent, but there is currently 7% growth in the new drugs pipeline

globally, the majority already in 2nd phase development and 50%

of these are biopharmaceutical products. All of this means that an

informed and reliable sales force, rock solid cold chain and last mile

solutions are going to be essential part of the sales and marketing

drive to get a quick uptake from healthcare professionals.

Authored by CSafe Global, one of the world’s largest producer

of actively controlled mobile refrigeration units for life sciences,

healthcare, military and international disaster relief agencies.

For more information

CSafe Global

Tel: 937-312-0114

Fax: 937-312-1277


Web: www.CSafeGlobal.com

¹Source Cegedim Strategic Data U.S. Promotion Database.

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NEW BULK CARGO SYSTEMS USING OUR UNIQUEPATENTED ‘LOCK AND LOAD’ ASSEMBLY MECHANISM

A part of UTC Climate, Controls & Security

The Invisible Component of Cold Chain Management

RisK Mit iGAt ion

OverviewThe practice of cold chain management continues to evolve rapidly. New developments in hardware, software and global connectivity provide an unprecedented window into cold chain performance.This has led to dramatic improvements in handling, storage and distribution, and the promise of greater cooperation among supply chain partners.

This has also convinced cold chain managers that their monitoring program must be greater than the sum of its parts. Robust, responsive and accurate dataloggers are essential, as is powerful software and reliable, secure web hosting. However, smart cold chain management looks beyond the visible components of monitoring programs to address their underlying structure and stability. One of these critical but less visible components is risk mitigation.

Defi ning Risk MitigationRisk mitigation of cold chain management is defi ned by three key, auditable elements:• IT security and redundancy• Supply chain risk management• Disaster recovery planning

If these three components are properly structured, the long-term viability and effi cacy of a cold chain program is substantially strengthened, as is the confi dence of the cold chain management team.

In addition, knowledgeable managers also look to the stability, industry knowledge and thought leadership of their solution provider as another way to assess the strength and competitiveness of their program.



Risk Mitigation The Invisible Component of Cold Chain Management

A Company CommitmentQuality Management System (QMS)

Sensitech’s QMS represents a companywide commitment to Quality that enhances every activity the company undertakes. As a supplier of “critical components,” the company tests its hardware and software products against rigorous standards, including the National Institute of Standards and Technology (NIST), ISO 9001:2008, and applicable elements of common Good Manufacturing Practices (cGMP). Sensitech adheres to validation protocols and enforces quality control at every level. The underlying QMS is grounded in a well-documented and audited program of continuous process improvement and incorporates standards in Relentless Root Cause Analysis (RRCA) and Corrective Action / Preventative Action (CAPA). Finally, Sensitech’s manufacturing principals are grounded in six sigma and lean manufacturing programs.

Element 1IT Security and Redundancy

Sensitech is a subsidiary of Carrier Transicold, which is part of UTC Climate, Controls & Security, a $17 billion unit of United Technologies Corporation. The internal IT resources available to Sensitech, and the standards for redundancy and security it must meet under UTC quality guidelines, embody world-class practices.

Designed with redundant architecture, Sensitech’s ColdStream® solution is used by customers to collect data, monitor shipments, and provide notification and alarms. The ColdStream smart client installed on customers’ desktops works in online or offline modes, reducing impact on the real-time acceptance of product and ensuring data integrity in the event of intermittent internet connectivity at a remote receiving site. Network infrastructure and servers are fully redundant to insure minimal impact to customers in the event of a server or network issue.

Customer-specific ColdStream databases are hosted on dedicated application servers, in a hardened data center, located in an offsite, independent facility that provides power sources, redundant points of connectivity to the Internet, and security mechanisms against fire, physical threats and natural disasters. All ColdStream databases are monitored and supported 24x7 with a fully replicated mirrored site in a separate geographic region of the United States. Data is synchronized between the two sites, regularly audited, and compliant with Statement on Standards for Attestation Engagements (SSAE) 16.

The ColdStream application and data hosting components are built to satisfy the requirements of FDA 21 CFR Part 11, including audit trail and traceability for all electronic records, multi-layered permissioning, and backward compatibility for previously acquired data files.

Customer data is backed-up according to information technology best practices. Before the data is stored in an offsite data vault, the back-up process includes encryption and compression; these formats remain throughout the length of storage. Backed-up data is tested and verified to be recoverable annually.

Sensitech’s ColdStream environment and Quality Management System (QMS) have successfully passed all customer audits, now numbering more than 100 over the past decade, to the satisfaction of our cGMP customer base. Sensitech securely hosts cold chain and logistics data for over 200 companies around the globe.

Key Questions1 Is data integrity ensured?2 Is data warehousing adequate and compliant with 21 CFR Part 11?3 Can these cold chain protocols be audited?



Risk Mitigation The Invisible Component of Cold Chain Management

Element 2Supply Chain Risk Management

Many of Sensitech’s customers consider temperature dataloggers and their related systems to be “critical components” of a Quality Management System. Therefore, a disruption in the supply of monitors can lead directly to disruption of the shipment of a customer’s product.

Sensitech has three primary means of mitigating this risk:• Adequate safety stock• Dual-sourcing strategy for critical components• Multiple manufacturing sites

Sensitech employs high standards to meet its goal of adequate safety stock, factoring in the variability of demand at the component, work-in-process, and finished goods levels. The use of a pull-based replenishment system supports global flexibility and drives a high-velocity supply chain. Sensitech maintains at least three month’s finished goods inventory in various global locations, at manufacturing sites and in-transit. Safety stocks are verified through scheduled reporting and site visits.

The company’s dual-sourcing strategy incorporates alternate component qualifications, as well as testing and validation of goods produced with these alternate components. Sensitech’s quality procedures ensure continuous testing from the component specification to the finished goods level with quarterly reported statistics. Additionally, unit-level calibration is linked to the unique serial number at the device level and documented in certificates of validation provided with each order.

Finally, Sensitech’s products can be manufactured in Asia, Eastern Europe and the United States. Each manufacturing facility has the assets and infrastructure to meet all Sensitech volume requirements. Sensitech’s primary manufacturers also have remotely located sister companies that support the manufacturer’s disaster recovery program and provide added assurance to Sensitech.

Questions to AsK1 Does my cold chain provider keep adequate safety stock?2 Does my provider have a credible plan for the dual-sourcing of critical components?3 Does my provider have the reach and supply chain muscle to carry out its plans?4 Do I feel comfortable that the risk of product disruption is minimized?

Element 3Disaster Recovery Planning

Under the guidance of United Technologies Corporation, Sensitech adheres to a Business Continuity and Disaster Recovery protocol designed to either maintain or resume mission-critical functions in the event of a disaster. The Sensitech plan specifies annual readiness evaluations, and the ability to deploy multiple monitor programming sites and fulfillment operations around the globe. Sensitech’s practices mandate the monitoring of adequate safety stock, coverage by appropriate levels of general liability insurance to protect Sensitech assets and infrastructure, and immediate notification to customers in the event disaster recovery is invoked.

At all times Sensitech has access to the corporate resources of Carrier, UTC Climate, Controls & Security, and UTC.

Questions to AsK1 Does my cold chain provider have a Business Continuity / Disaster Recovery Plan?2 Is it adequate to meet the needs of my cold chain in the event of a disaster?3 Are notification practices adequate?4 Are my cold chain provider’s insurance levels adequate to protect its assets and infrastructure?




© 2013 Sensitech Inc. All rights reserved.

Amsterdam Boston Hong Kong Melbourne Mumbai Santiago

Sensitech EMEA • Lireweg 42-52 • P.O. Box 59 • 2150 AB Nieuw-Vennep • The Netherlands • Tel: +31 (0)252 211 108 • Fax: +31 (0)252 231 032www.sensitech.com • [email protected]

2/13 1000

Stability and Thought LeadershipFounded in 1990, Sensitech is a global leader in cold chain monitoring. First certifi ed under ISO in 1999, Sensitech has an unbroken history of recertifi cation in its primary facilities, and currently is certifi ed to ISO 9001:2008 standards. All of Sensitech’s outsourced manufacturing sites are certifi ed to ISO 9001:2008 and ISO 13485 standards for medical device manufacturing.

The fi rst company to offer global, single-use, electronic monitoring programs, Sensitech has provided almost a quarter century of innovation and thought leadership in driving Good Cold Chain Management Practices (GCCMP) for the pharmaceutical, food, and industrial chemical industries.

This includes active membership in the Parenteral Drug Association (PDA), participation in a number of subgroups, and contributions to Technical Reports. Sensitech has also participated as a member of the technical steering committee of the PDA’s Pharmaceutical Cold Chain Interest Group (PCCIG), the International Safe Transit Association (ISTA) Thermal Council, the Association Francaise du Froid (AFF) French Cold Chain Council, and is on the International Air Transport Association’s (IATA) Time and Temperature Task Force (TTTF) a subgroup of its Live Animal and Perishable Board (LAPB). Additionally, Sensitech has contributed documentation of best practices to U.S. Pharmacopeia’s (USP) Packaging and Storage Expert Committee for the re-write of USP General Chapter <1079> Good Storage and Distribution Practices for Drug Products.

Sensitech’s efforts over the past decade have helped to clarify standards for lithium battery compliance, and for electromagnetic interference (EMI) compliance and documentation. In support of this effort, Sensitech was awarded the Cool Chain Europe 2010 Best Quality, Qualifi cation or Risk Management Project by Pharma IQ.

Beyond regulations, Sensitech continues to provide the cold chain industry with electronic dataloggers, software, and global cold chain programs that presently serve over 12,000 customers around the world.

Sensitech Inc.Putting it All Together

Sensitech is proud of its commitment to a disciplined Quality Management System, rigorous Security and Redundancy practices, comprehensive Supply Chain Risk Management, powerful Disaster Recovery Planning and thought-leadership throughout the global cold chain monitoring industry. Taken together, these practices provide customers with a level of Risk Mitigation that is unique in the industry, and an essential component of every Sensitech customer offering.


© 2013 Sensitech Inc. All rights reserved.

Amsterdam Boston Hong Kong Melbourne Mumbai Santiago

Sensitech EMEA • Lireweg 42-52 • P.O. Box 59 • 2150 AB Nieuw-Vennep • The Netherlands • Tel: +31 (0)252 211 108 • Fax: +31 (0)252 231 032www.sensitech.com • [email protected]

2/13 1000

Stability and Thought LeadershipFounded in 1990, Sensitech is a global leader in cold chain monitoring. First certifi ed under ISO in 1999, Sensitech has an unbroken history of recertifi cation in its primary facilities, and currently is certifi ed to ISO 9001:2008 standards. All of Sensitech’s outsourced manufacturing sites are certifi ed to ISO 9001:2008 and ISO 13485 standards for medical device manufacturing.

The fi rst company to offer global, single-use, electronic monitoring programs, Sensitech has provided almost a quarter century of innovation and thought leadership in driving Good Cold Chain Management Practices (GCCMP) for the pharmaceutical, food, and industrial chemical industries.

This includes active membership in the Parenteral Drug Association (PDA), participation in a number of subgroups, and contributions to Technical Reports. Sensitech has also participated as a member of the technical steering committee of the PDA’s Pharmaceutical Cold Chain Interest Group (PCCIG), the International Safe Transit Association (ISTA) Thermal Council, the Association Francaise du Froid (AFF) French Cold Chain Council, and is on the International Air Transport Association’s (IATA) Time and Temperature Task Force (TTTF) a subgroup of its Live Animal and Perishable Board (LAPB). Additionally, Sensitech has contributed documentation of best practices to U.S. Pharmacopeia’s (USP) Packaging and Storage Expert Committee for the re-write of USP General Chapter <1079> Good Storage and Distribution Practices for Drug Products.

Sensitech’s efforts over the past decade have helped to clarify standards for lithium battery compliance, and for electromagnetic interference (EMI) compliance and documentation. In support of this effort, Sensitech was awarded the Cool Chain Europe 2010 Best Quality, Qualifi cation or Risk Management Project by Pharma IQ.

Beyond regulations, Sensitech continues to provide the cold chain industry with electronic dataloggers, software, and global cold chain programs that presently serve over 12,000 customers around the world.

Sensitech Inc.Putting it All Together

Sensitech is proud of its commitment to a disciplined Quality Management System, rigorous Security and Redundancy practices, comprehensive Supply Chain Risk Management, powerful Disaster Recovery Planning and thought-leadership throughout the global cold chain monitoring industry. Taken together, these practices provide customers with a level of Risk Mitigation that is unique in the industry, and an essential component of every Sensitech customer offering.


SPOTLIGHTBuilding successful supply

chain solutions in clinical trial supplies needs careful planning.

When considering clinical supplies activities the proposed supply chain

must be focused on achieving a flexible model to allow for unforeseen changes to the

study or programme.


Pharmaceutical companies spend an estimated £5 billion to get a drug to market as it can

take decades of research, development, testing and clinical trials followed by further time

to obtain regulatory approvals. They also invest heavily in logistics for temperature sensitive

pharmaceuticals to ensure that the drug efficacy is protected throughout the cold chain

distribution during the trials/testing period and subsequently when it is approved and being

distributed for sale.

Building successful supply chain solutions in clinical trial supplies

Article continues on page 43 »

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While some of this may paint a gloomy picture, the fact is

that all companies developing and marketing drugs need

to show a healthy R&D expenditure to assure themselves

and their investors, that they have pipelines that will potentially

replace current revenues of drugs as they move off patent. The

clinical drug development industry continues to grow at a healthy

rate across the board with many elements, including clinical supplies

packaging, seen as non-core activity, using outsourced supply chain

solutions.

Common objectives of teams working in drug development judge the

execution of a clinical trial as successful when the project is finished

on time and on budget and has a high level of quality built into the

processes and generated as trial data. The objective of building

successful clinical trial material supply chains should be clearly

defined before initiating any project to meet these three pillars of

project success whilst overcoming the challenges in clinical trials

outlined below. Whether a sponsor has an insourcing or outsourcing

model for clinical supplies activities, it is essential that the assembly

and management of trial material supply chains meet these

objectives.

Elements to consider are:

• Active Pharmaceutical Ingredient (API), drug product and compara-

tor manufacture location

• Packaging specifications to protect the product

• Packaging requirements to enhance patient compliance

• Labelling requirements to meet all local regulatory requirements

• Country language text or final label formatted text included in the

Clinical Trial Application (CTA)

• European Qualified Person (QP) and other regional regulatory

release requirements

• Warehousing and distribution strategies to meet regulatory re-

quirements

• Supply chain Good Manufacturing Practice (GMP) certification in

support of CTA application

Supply chain team reporting structureSupply chain team interaction with trial reporting tools. Once the

clinical trial protocol is drafted, countries or regions for the study are

selected. Bulk drug manufacture location is known and key clinical/

sponsor team locations are identified. Many elements for building the

most appropriate clinical material supply chain are in place. Often the

locations of API and Chemistry and Manufacturing Control (CMC)

manufacture during development have limited flexibility. So the main

options for building flexibility into a clinical material supply chain will

be where the clinical supplies packaging takes place. Ideally, a number

of alternative labelling approach options, pack designs and packag-

ing locations should be available for consideration. Building global

supply chains that will be successful can be difficult if the number of

alternative options is limited. If the study forms part of a programme

it is paramount to consider synergies of the individual study require-

ments to other studies in the programme.

When the supply chain for one protocol resides within a programme

of studies, the option to pool as many stages of manufacturing,

packaging and assembly of the clinical supplies across protocols

becomes more and more compelling. If the correct packaging,

labelling and kit designs are used, the benefits in cost and flexibility

of stock by sharing blinded bulk drug, comparator and placebo,

packaged stock, label designs and even complete multi-protocol

labelled kits across protocols can be great. However, the real benefits

are not realised until forecasting across protocols is shared with the

supplies group to allow appropriate inventory levels to be continually



maintained by the global project management team.

Key questions that arise for both specific studies and a

programme of protocols are:

• What is the country/site initiation plan?

• Is there going to be a need for a centralised/global or

regional approach to labelling and packaging due to specific

regional/ local comparator requirements?

• Is there an economy of scale in centralised packaging for a

study or pooling across studies for specific parts, or all of the

packaging supply chain?

• Is it preferable to perform the labelling and packaging close

to where the bulk drug is already and distribute kits globally

in bulk, or ship the bulk drug to a packaging location closer to

where the majority of patients are projected to be recruited?

In many instances today the packaging segment of the supply

chain still takes place at a location close to the sponsor’s

key decision-makers. The convenience of their location over

cost and with a potential delay in shipping is chosen, rather

than sending the bulk to a clinical supplies facility closer to

the location where the majority of patients will be recruited.

Packaging supplies close to the patients also means that

once the packed kits are released they are immediately available to

ship over a shorter transit time to clinical sites. However, there is

a downside if the patient recruitment rate is slower than predicted

in the country; the clinical supplies will then have to be exported

following importation into the country. This import/export restriction

within one country is extremely challenging. In order to evaluate

the optimal supply chain, with the greatest flexibility, the groups

supporting the supplies work need to perform a similar spectrum of

service capabilities across a global footprint of facilities. Thus having

the ability to manufacture, package and label clinical supplies for

both regional and global study supplies removes constraints in the

supply chain. The clinical supplies group will also need a global project

plan, reporting tools, a communication plan and infrastructure to

report the status of the study or programme from a clinical supplies

perspective to the rest of the trial team.

Global approaches to primary and secondary packaging can assist

with both optimising and adding flexibility into supply chains.

Currently the clinical supplies industry is focused on automation

and the adoption of standardisation of approach to the equipment

and components being used. This also means the third party

suppliers used between facilities need to be global. The risk with

pack standardisation is that more complex packaging solutions are

overlooked and patient compliance levels compromised. In the future

it has been speculated that there will be pressure for just in time

packaging/labelling and release. As drug cost grows, the amount of

drug available is lower, and there is increased pressure to reduce the

amount of unused drug currently being packed. Added to this, the

number of compounds in the clinic requiring cold chain storage and

distribution and studies using adaptive trial designs are increasing.

With these studies and their inherent challenges, the only way to

assemble truly efficient global packaging supply chains capable of

supporting regional just in time packaging, labelling, release and

distribution to clinical sites is the harmonisation of processes and

service delivery.

There will be a greater need to integrate more regional packaging

facilities into the supply chain. It will be essential for the clinical

supplies group to work on fully integrated software programmes

to offer parity of approach when performing the just in time

activities. Clinical supplies groups today use proprietary enterprise/

manufacturing resource planning (ERP, MRP), label design and

print systems or in-house developed software or a mixture of

both. Whatever the combination, there will be a greater need for

integration in global control and reporting systems. This ensures

that the clinical trial materials are packaged, labelled and released

correctly according to the randomisation schedule and regulatory

requirements for the material, regardless of the location.

Harmonised informatics platforms also allow for a consistent

approach to unique pack identification in the global inventory system,

by barcodes, RFID or proprietary tagging technologies. These all

enhance accuracy in the clinical supplies inventory, distribution

set-up and execution of the clinical supplies pick and pack shipment

process. These systems also allow wider team access, via secure

portals, to blinded and un-blinded inventory reports, warehouse

storage conditions, pending shipment status, shipment history and

in-transit track and trace. Adding the functionality of clinical supplies

The risk with pack standardisation is that more complex packaging solutions are overlooked and patient compliance levels compromised.



returns to the informatics platform allows “cradle to grave” reporting

capability for the clinical supplies. The ability to integrate these

systems with interactive voice/web response (IVR/IWR) platforms,

via a File Transfer Protocol (FTP) site or similar electronic file-sharing

interface, has become commonplace. This interface is now seen as

essential to the ability to scale up the clinical supplies distribution

process.

The IVR/IWR interface removes human data entry on shipment

request and status and thus potential errors. The electronic interface

also allows temperature traces to be associated to the specific

shipments and kits, as USB-enabled temperature monitoring devices

for both cold and increasingly controlled ambient supplies can be

used. A further benefit in Europe to utilising closely interfacing

clinical supplies with the IVR/IWR platform is the potential to move

to expiry date-free labelling. This has been slow to gather momentum

but in the future, should the adoption of electronic patient diaries

take predominance, it is another area that the supplies can interface

in the supply chain. The use of smart-phones and personal digital

assistant(PDAs) and the integration of supplies into electronic-patient

reported outcomes (e-PRO), that can read dispensed Investigational

Medicinal Products (IMP) kit labels in patients’ hands will allow better

control of expiry date-free IMP and offer the potential to assist

with compliance and pharmacovigilance monitoring. The industry

standard approach to measuring and managing the performance of a

supply chain solution is the adoption of metrics and key performance

indicators (KPIs). Increasingly service level agreements are placed on

the clinical supplies groups by the clinical teams/sponsors.

Supplies groups must be mindful that these service level agreements

are also built into the critical vendors they use such as couriers

and depots. The simplest way to cover this is by measuring and

managing these service providers in the supply chain to the same

KPIs. On-time release of kits, on-time delivery of IMP to site and

minimising temperature excursions in transit are really all that matter,

but right first time documentation and other quality-related non-

conformances/complaints/corrective and preventative action (CAPA)

close outs are the indicators of quality and efficiency of a clinical

supplies supply chain. These KPIs allow clinical and supplies teams

along with the sponsor, to measure and manage elements of the

supply chain that affect the study objectives (on time, on budget, and

with a high level of quality built into the processes).

Good project and programme management can significantly enhance

the success of a clinical supplies supply chain. Agreeing up-front and

being willing to adapt as required, global project plans, a project or

programme reporting structure, a communication plan and defining

expectations of team members in the supply chain are essential to

clearly defining roles and responsibilities. Periodical status updates

from across the supply chain back to the project management team

ensure that everything is in control or establish if certain elements of

the supply chain need more support to overcome a challenge.

The M&A models, discussed in the first part of this review, further

highlight the differing needs for scale and approach to clinical

supplies. The smaller development groups and the large pharma

model have different demands for their ideal clinical packaging supply

chains. The holy grail of clinical supplies services is to develop a

cultural mindset to work on supply chains that are nimble, responsive

and innovative, which rapidly accommodates Phase I clinical trials

packaging, whilst also having the global presence, processes and

capacity for managing multiple Phase III trial packaging needs.

Building successful supply chain solutions in clinical trial supplies

needs careful planning. When considering clinical supplies activities

the proposed supply chain must be focused on achieving a flexible

model to allow for unforeseen changes to the study or programme.

Ian Morgan, General Manager, Sharp Clinical Services (UK) Ltd.

Ian has over 30 years experience within pharmaceutical and medical device

industries in quality and operations. The last 15 years has been specifically

involved in Clinical Trial Supplies. Prior to joining Sharp he worked in Pro-

ject Management roles at Fisher Clinical Services and Operations at Aptuit

(formerly Quintiles Transnational) supporting Large Pharma and Biotech

companies globally.


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BARTPOUWELS

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MARCEL FUJIKE

Senior Vice President, Products & Services

Air Logistics,Kuehne + Nagel

STEVE HILL

Principal Industry Consultant,

CHAMP Cargosystems

STEVEN POLMANS

Head of Cargo at Brussels Airport

NINA HEINZ

Head of Quality, LifeConEx

YOURI BUSAAN

Treasurer, Cool Chain Association

EDWIN W. KALISCHNIG

Secretary General, Cool Chain Association

& CEO, Xtreme Technologies BV

STEVE TARBUCK

Business Development Manager, Copenhagen

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MARKUS SCHEUBER

Product Manager, Swiss WorldCargo

25 September 2013 at Tivoli Lisboa, Lisbon

08.00 REGISTRATION AND WELCOMING COFFEE

09.00 OPENING REMARKS FROM THE CHAIRMANSebastiaan Scholte, Chairman of the Cool Chain Association and CEO of Jan de Rijk Logistics.

09.15 MARKET OVERVIEWTrends and highlights from the last 12 months in pharmaceutical and healthcare logistics. Including changes in demand and supply patterns; trends in logistics purchasing behaviour; inter-modality and modal shift; new legislative or regulatory challenges.

10.00 THE WEAKEST LINKWhat are the weak links in the pharmaceutical/healthcare air logistics chain? How can these be addressed? How can the necessary changes in behaviour, processes or infrastructure be driven and funded, including any necessary training? Is there a role for a quality standard/benchmark for airports or cargo handlers covering cool-chain handling, training and facilities?

10.45 BREAK FOR REFRESHMENTS AND VIEWING OF EXHIBITION

11.15 MANAGING EMERGING MARKETSWhat are the current main challenges for pharmaceutical and healthcare organisations in supplying products

to and from less developed but rising markets? How are companies overcoming the challenges of imperfect supply-chain infrastructure and what improvements could be made?

12.00 VISIBLY BETTERHow can we create more visibility in the chain? How can technology contribute to this?

12.45 BREAK FOR LUNCH AND VIEWING OF EXHIBITION

14.15 DELEGATE ROUND TABLE DISCUSSION How to respond to modal shift and what tangible actions we could take to improve the weak links and respond to modal shift

15.00 DELEGATE ROUND TABLE DISCUSSION FINDINGS

16.00 BREAK FOR REFRESHMENTS

16.30 MOVING FORWARDPanelists review the discussions and topics of the day and offer some further thoughts and refl ections.

17.15 CLOSING WORDS FROM THE CHAIRMAN

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19.00 COCKTAIL RECEPTION

CONFERENCE AGENDA

To be chaired by Sebastiaan Scholte, CEO of Jan Der Rijk B.V. and Chairman of CCA

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31

33

34-37

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44-45

IBC

OBC

Swiss World Cargo

UPS

Turkish Cargo

IATA

JAL Cargo

Biotec Services International

Cool Logistics

SMI

Gooey

TLP Insight

Laminar Medica

Sensitech

Softbox

EVA International

Air Canada

American

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