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TLPINSIGHT

The Logistics Portal magazine

Issue 2 - 2013

keeping cool

looking into the various areas of multi-physics within temperature controlled packaging COUNTING THE COST

BUILDING SUCCESSFUL SUPPLY CHAIN IN CLINICAL TRIAL SUPPLIES TLP Insight: a journal for the life science logistics industry AIR CARGO - RFID - TEMPERATURE CONTROL - CLINICAL - BIO PHARMA - LOGISTICS


SWISS 째Celsius Passive For your temperature sensitive supply chain

SWISSWORLDCARGO.COM


//MAIN CONTENT

TLPINSIGHT MANAGING DIRECTOR Lee Atkinson

//WHEN LIVES AND LIVELIHOODS RELY ON LAST MILE 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 »

MANAGING EDITOR Bridget Langston COMSULTANT EDITOR Tony Wright SENIOR DESIGNER Joey Graham EDITORIAL ASSISTANTS Nicholas Ridgman Jamie Ward CIRCULATION MANAGER Tony Williams SALES Rakesh Makwana, Lee Atkinson ADMINISTRATION Katie Galelli

8 Use of RFID in Air Cargo

IATA 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.

11 Pharmaceutical Logistics in South America:

WEBSITE DESIGN Knut Henriksen PRINTED BY CBF Cheltenham Business Forms Ltd www.cbfnet.co.uk CONTACT US Sales: info@intensivemedia.co.uk

Opportunities and Challenges

Subscription: subscription@intensivemedia.co.uk

An 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.

TLP INSIGHT Is published 4 times a year February, May, July, October by Intensive Media Ltd Send address changes to:

14 The Pharmaceutical Industry in Switzerland Markus 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.

145 - 157 St Johns Street London EC1V 4PW United 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

Contents continue on page 4 »


TLP

THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 02 - 2013

//CONTENTS

19 Aerospace derived technology helps create more insightful temperaturecontrolled packaging solutions

Richard 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.

34 Risk Mitigation: The invisible component of cold chain management Smart 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.

//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. Read the full article on page 38 Âť

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//TLP INSIGHT FOREWORD

T

here 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.

Tony Wright CEO Exelsius Cold Chain 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 Atkinson Managing Director - Intensive Media Ltd

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Customized temperatures, reaching four corners of the world. We provide the most suitable transit conditions for all perishable cargo to maintain their freshness. Entrust our expertise with your need for ultimate care. For detailed information please contact: specialcargo@thy.com

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USE OF RFID IN AIR CARGO A

pplications of Radio Frequency Identification (RFID) technology are once again at the top of the cargo agenda. The main drivers

5. facilitate the association of shipment information with the ULD ID Code.

are believed to be the following: • RFID has become a relatively mature technology and the price of RFID tags have been decreasing

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

• 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.

• insufficient/outdated industry standards to ensure compatibility and interoperability • lack of coordination across various RFID applications** and other

RFID technology contributes considerably to addressing these

available wireless technologies to ensure optimal deployment

upcoming challenges. Various RFID applications in air cargo

• unclear regulatory approval requirements for active RFID devices

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.

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, inflight catering trolley management, ground support equipment (GSE)

Today only some local solutions and smaller pilot projects for testing

identification, etc.

purposes have been conducted by member airlines, however, there

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

is no industry-wide standard or procedures to ensure interline

‘time and temperature monitoring devices’. Meanwhile, knowing

compatibility.

that there are various wireless technologies (RFID is only one of the wireless technologies) being applied in today’s air cargo operations,

The IATA Cargo RFID Working Group (CRFIDWG) was established

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

to provide recommendations on common industry standards and

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

best practices for the applications of RFID technology in air cargo

to make it more relevant to the industry needs.

operations. The working group has recently completed the review of the recommended practice on the ‘application of RFID for automatic

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

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

the industry standards and procedures for the application of RFID

were identified as follows:

and other wireless technologies throughout the air cargo supply

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

chain, to maximize efficiency as well as ensure compatibility and interoperability.

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

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


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TLP[ R E L I A B I L I T Y ]

THE LOGISTICS PORTAL MAGAZINE

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Provide the best solution for the transportation of pharmaceuticals.

COOL CHAIN LOGISTICS

-SOLUTIONS PHARMA Constant Temperature Control

Dedicated Logistics Team

Contact: Cool Chain Logistics Team c/o Adrian Rayner Tel: +44-(0)1784 - 422- 637 adrian.rayner@jal.com www.jal.co.jp/en/jalcargo/


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Pharmaceutical Logistics in South America:

Opportunities and Challenges 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.

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 a recent article exploring the trend, Air Cargo World cited

in 2011.

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 (ÂŁ40.7 billion) internationally.

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THE LOGISTICS PORTAL MAGAZINE www.the-logistics-portal.com Issue 02 - 2013

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.

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

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. Another potential obstacle to the growth of pharmaceutical logistics Mark Mohr, director of customer support and partner management

in this part of the world is infrastructure.

for CSafe, said his company is experiencing growing demand for its services in South America.

Factors such as small, narrow aircraft runways preventing long-haul carriers from accessing particular locations mean countries like

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

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

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

Logistics Performance Index.

is a prime market,” he said. The Cold Chain IQ report also highlighted concerns such as the

Cold Chain Challenges

potential for political instability in emerging regions, as has been seen in the Middle East and North Africa, and questions over security.

Cold Chain IQ published a report noting that Latin America has become a “major hotbed” of pharmaceutical and supply chain

Other considerations that pharmaceutical logistics providers have

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

to take into account in South America include unreliable power

provision of temperature controlled logistics.

sources outside urban centres and a diversity of climate zones and geographical settings encompassing everything from rainforests to

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

mountain ranges.

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.

Cold Chain issues

Top 8 in Latin America By Shawn Siegel for ColdChainIQ.com

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.

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#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.

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TLPINSIGHT 13.


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

PORT, COUNTRY (MILLION-TEUS)

VOLUME 2011

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 Arab Emirates

13.01

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

16 Los Angeles

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

7.94

With oil looking sensitive showing of reefer the worl the worl

10 Rotterdam

11

15 Antwerp

8.6


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

1.88

20 Dalian

6.40

13.02

8 Qingdao

5 Busan 14 Hamburg

9.04

11 Tianjin

19 Xiamen 9 Jebel Ali, Dubai,

11.59 17 Keihin Ports, Japan 7.64

6 Ningbo-Zhoushan

66

16.17

14.72 31.74

12 Kaohsiung, Taiwan

9.64

4 Shenzhen

22.57

3 Hong Kong

24.38

6.47

13.01

7 Guangzhou Harbor

1 Shanghai

14.26

13 Port Kelang

9.60

18 Tanjung Pelepas

7.50

2 Singapore

29.94

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The pharmaceutical industry in Switzerland Markus Scheuber & Annette Kreuziger

M

any sectors of the airfreight industry are

destroying it. Required temperature range could mean

suffering. The weaknesses in Europe’s

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

economy have led to a decline in the volume

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

of high value consumer goods being transported.

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

The pharmaceutical logistics industry is a sector that

-20°C..

may not have proved itself to be completely immune to external influences, but is at least considerably

Based on the urgency of these pharmaceutical

resistant to them. How can airlines make the best use

shipments and the value of these products, most of

of their potential to exploit the opportunities in this

the temperature sensitive shipments are transported

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

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

have to bear today and in the coming years?

complex: extreme deviations of ambient temperature in

in th

the respective countries worldwide and different kinds Switzerland has a very long tradition as a

of airport infrastructure in those countries.

pharmaceuticals production centre. The headquarters of many of the large international pharmaceuticals

To manage these challenges it is important that the

corporations are mainly located in Basel, as well

airline understands the needs of the pharmaceutical

as in Geneva and Zurich. In 2011 the volume

and healthcare industry. Awareness and training of

of Switzerland’s airfreight transportation of

correct handling of healthcare consignments is as

pharmaceutical products was fourth in Europe, behind

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

only the three much larger national economies of

processes accompanied by a detailed documentation.

Germany, France and the United Kingdom.

Swiss WorldCargo: Pioneer in the industry

Transportation is the biggest challenge in the entire supply chain for pharmaceutical products. Managing these cold chains means maintaining a product’s

Being located in Switzerland and having understood

temperature from manufacturer to the end user of the

the requirements of the pharmaceutical and healthcare

chain. Temperature control is therefore a key feature

industry when it comes to airfreight, Swiss WorldCargo

when transporting time and temperature sensitive

stepped up to the plate in 2006 and introduced SWISS

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

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

chain it is extremely important to ensure the required

for shipments that require seamless transportation

temperature in order to preserve the quality of the

in active temperature controlled containers. The

pharmaceutical product. The slightest temperature

motivation to introduce such a product had been the

deviation might cause a broken cold chain, reducing

predicted steady market growth, the high affinity

the efficiency of the pharmaceutical product or even

for airfreight, the high-quality requirement and the

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

he Fast Lane

sin con niscias ec atatur, con et Ximo doluptae que nimi, nda eostore

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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 02 - 2013

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

requirements and offering the right equipment with an advanced

temperature controlled containers Swiss WorldCargo decided on

technology in their service portfolio.

Envirotainer. Additionally, new providers have joined the market - CSafe being Since then, the collaboration between Envirotainer and Swiss

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

WorldCargo has developed further. Swiss WorldCargo has been

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

accredited as Qualified Envirotainer Provider (QEP). This QEP

RAPe2 containers within their services for healthcare shipments. The

programme has been developed by Envirotainer to “acknowledge

integration of new ULDs in their cool container portfolio, provide

transport service providers that they are capable of properly

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

managing shipments using the Envirotainer container”. Achieving

choice for an appropriate container solution.

the Qualified Envirotainer Provider (QEP) status at a station demonstrates Swiss WorldCargo’s commitment to continuously

Along with an extended cool container portfolio, Swiss WorldCargo

provide high-quality services and high reliability towards its

offers standardised operational procedures that have been

customers when handling the cool containers.

successfully in place for several years and have always been adapted to changing customer needs. Swiss WorldCargo also offers the

Over the years technology and quality of these cool containers has

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

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

customer requirements that go beyond the standard process.

ice, they provide an active temperature control system based on

A new high-quality solution: Swiss °Celsius Passive

compressor technology that allows them not only cooling but also electric heating. Acknowledging these upcoming technologies, Swiss WorldCargo

But not only has the technology for active temperature controlled

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

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

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TLP

have entered the market. Pharmaceutical

Enhanced standardised processes along with the proverbial Swiss

and healthcare companies around the globe

Quality and a high flexibility to respond to customer requirements

are investing more and more resources in

individually, makes Swiss WorldCargo the right partner in

sophisticated passive packaging solutions

temperature sensitive supply chains.

for their time and temperature sensitive consignments.

Authors

However, besides the packaging, a successful

Markus Scheuber, Product Manager SWISS °Celsius and SWISS

supply chain for such temperature

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

sensitive goods also relies on high-quality

International Air Lines. Having joined Swiss WorldCargo in 2011,

standardised processes and speed and

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

adequate storage wherever possible. In

developed SWISS °Celsius Passive.

order to respond to the growing volumes

Email: markus.scheuber@swiss.com

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

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. Email: annette.kreuziger@swiss.com

°Celsius Passive for temperature sensitive shipments transported in special passive packaging.

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TLPINSIGHT 19.


Biotec Trusted Globally To Deliver

High Quality Clinical Supplies Services Biotec has established itself as a truly international trusted partner delivering clinical supplies services.

Our services include:

Biotec have built a global reputation as a company with the commitment to quality and technical excellence, the accredited expertise and the in-depth experience needed to take your clinical trials from Phase I to Phase IV and onto commercial supply.

Biotec Services International Ltd Biotec House, Central Park, Western Avenue, Bridgend Industrial Estate, Bridgend, CF31 3RT, UK


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Aerospace

DERIVED technology Helps create more insightful t e m p e r at u r e - c o n t r o l l e d packaging solutions

G

roundbreaking

simulation

technologies,

previously

unavailable to the healthcare packaging industry, are 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.

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TLPINSIGHT 21.


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Real World Simulations

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

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

Thermal variations throughout the entire shipping system.

pressures are a major factor. Technology such as Computational Fluid Dynamics (CFD) was originally used to simulate airflow over

The use of Multi-Physics and Computational Fluid Dynamic software

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

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

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

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

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

as aerospace and automotive, it has been a standard development

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

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

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,

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

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

Multi-Physics is now becoming

exploration of design solutions to meet

more popular and accessible

customer requirements. In fact, a test using

for many niche industry sectors, including temperature-controlled

Multi-Physics technology will take approximately one tenth of the

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

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

teams use to simulate the airflow of the body of their cars to improve aerodynamics. NASA uses Multi-Physics to simulate the thermal

Instead of buying two new test chambers, manufacturers are now

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

able to consider investing in a simulation workstation and reap the

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

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

to and thus design heat shields to sufficiently protect the fragile

developing. This powerful tool means that packaging suppliers can

inner components. Even weather forecasters use it to predict climate

quickly produce ‘virtual’ prototypes and qualify their performance in

conditions and how the effects of Global Warming will change our

a fraction of the time that traditional methods take.

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Cool Logistics

Intelligent Packaging The Ultimate In Temperature Control

Drugs Patient samples Medical devices Vaccines Clinical trial IMP Diagnostics

Bloodrelatedproducts

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. For more information call

+44 (0) 1525 243770

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


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Airflow direction and velocity within the shipping system.

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

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

Depending on the complexity of the project and the number of

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

variables to take into consideration, such as testing with minimum

descriptor of computer simulation for physical phenomena. It was

and maximum product loads and multiple ambient profiles, there are

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

a number of Design Qualification Tests each solution needs to pass

a contributing factor in the progress of scientific computing today.

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

The software programme is used to simulate how a temperature-

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

controlled packaging system will perform when it is exposed to a

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

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

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

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

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

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

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

temperature stabilising components and the product in the shipper, with temperature variables being associated with each part.

For example, in real time, if a laboratory test takes five days to perform, packaging suppliers will initially have to wait five days

Traditionally, when developing and testing a new temperature-

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

controlled packaging system for a client, packaging suppliers would

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

undertake a number of iterative Design Qualification Tests, taking

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

into account the transit duration time and variable temperatures it

hundred per cent accurate, they give an extremely strong indication

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

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

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

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

could take months.

essence, rather than undertaking a three-month development phase

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

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

software. Consequently, rather than providing a replacement for

associated with the supply of high quality temperature-controlled

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

systems in order to meet the time and temperature sensitive

development period, which enables suppliers to fulfil their customers’

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

requirements that much sooner.

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

Forward-thinking Innovation

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.

Another insight that the Multi-Physics software also allows for, is a more in-depth understanding of other aspects of design, such as

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

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

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

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

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

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

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

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

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

unqualified shipping lane.

marketplace with as few materials required as possible, so there is an environmental saving as well.

Multi-Physics enables temperature-controlled packaging suppliers to see how energy (heat) is transferring through a shipping system.

During the Design Qualification phase, fewer materials are used

During a physical test, thermocouples are attached to the product

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

load inside the shipping system to record the temperatures at those

environment. Furthermore, a virtual computer simulation reduces the

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

amount of physical laboratory testing in the development stage, so

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

rather than having to receive costly prototype materials and run the

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

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

an effect on how it performs overall.

out and replaced with a virtual development stage.

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

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

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.

As well as shortening the development time of a shipping system, the software can also simulate different styles of product that a

Ultimately, this means that over-engineering shipping systems

customer might be shipping inside one temperature-controlled

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

packaging system. For example, a specific temperature-controlled

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

solution has been developed in the laboratory and signed off with

shipping system with exactly the right amount of energy absorbing

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

phase change material to ensure internal payload temperatures are

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

maintained within the correct range for the desired transit duration.

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

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

performance of the shipper, and how well would that configuration

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

protect different styles of product being transported? The answers to

Setting a new standard

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

Time is of the essence and temperature-controlled packaging

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

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A graphical representation of the thermal simulation provides a simple method to appraise the performance of the shipping system. 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: Richard.wood@dssmith.eu

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

SMi presents its 7th Annual Conference on

Clinical Trial Logistics 22ND - 23RD MAY 2013 | COPTHORNE TARA HOTEL | LONDON, UK EUROPE'S LEADING CLINICAL TRIAL LOGISTICS EVENT

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: PLUS AN INTERACTIVE PRE-CONFERENCE WORKSHOP

Transport Logistic Strategies 13.30 - 17.30 Tuesday 21st May 2013 Copthorne Tara Hotel, London, UK Workshop Leader: Sue Lee, Regional Quality Manager, World Courier

• 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

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How to book

Visit www.smi-online.co.uk/goto/2013logistics11.asp Alternatively call Fateja Begum on +44 (0)20 7827 6184 Or email her on fbegum@smi-online.co.uk


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PROMOTIONAL FEATURE | GOOEY GLOBAL

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E

Speaking on the occasion, Bessem Bikhazi, Managing Director, Gooey UK Ltd; said, "We are re-launching Gooey Data with a clear objective of facilitating database services at one place”. With the philosophy of “Buy, Append or let us arrange data for you”, the new division will be the one stop solution for all data related services that aviation-related companies usually require for their direct networking and other objectives. “Gooey, which is a pioneer company in Air Transport Information management globally has to become a huge success since its inception back in 2010 and is way ahead of its time in its alliances with companies that supports this venture. With our new-style contact databases, we hope to serve the industry in the same dedicated way with an exuded excellence and customized efforts to simplify things for marketers”, adds the director of Data, John Devos.

ntrepreneur Bessem Bikhaziis a man with an ambition to make the everyday life of the aviation businessman that little less stressful.

His well knowledgeable group of industry experts have spent the past few years developing the most powerful communication tool that allows businesses to reach key decision makers with procurement responsibilities faster than ever before.

BRANDS: Airline XL, Airport XL, Cargo XL, Handler XL, Supplier XL and Freight XL is an extension of services by Gooey which provides a host of Direct Key Contacts of CEOs, VPs and 20 other Department heads from 192 global locations. A subscription based model (fixed fee) wherein the data and information services can be availed as per chosen package offered by Gooey including free and frequent updates. Gooey has an extensive reach practically in all aviation verticals encapsulating over 55,000 business details followed by names, job title, email addresses and direct-dial of those key contacts. Points in this portal allows you to Search by company name, by country, by category, IATA and ICAO, job function... etc.

To Request a Brochure, contactCharlotte Willis: info@gooey.uk.com

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“WE ARE PUSHING AT AN OPEN DOOR WITH THIS ONE AND WE’LL BE GLOBAL VERY SOON.” m Bikhazi, MD: “we are pushing at an open door with this one”

Gooey was founded in 2010 with a unique concept of Aviation Information and Database marketing and has not looked back since. Gooey has lead its way to providing unmatched services in the global market roping in strong partnership and subscribers everywhere. Services of Gooey includes gaining direct access to key contacts on a platform similar to a Spreadsheet but smarter! With numerous clients from airlines, airports, airport authorities, handling agents, industry suppliers, organisations and association and conference/tradeshow organisers. Industry players are very much in favour of this venture, remarks Bessem. “ we are pushing at an open door with this one and we’ll be global very soon.”

‘’Our mission is to help aviation professionals help themselves by simplifying processes while reducing costs and improving


Head of Business Development

Executive VP/ Deputy CEO Chairman/ CEO

Quality & Risk Assessment

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Head of I.T Head of Technical

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Head of Sales/ Communication

COO CFO

Head of Inflight

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direct networkinG: Gain access to world airlines, airports & handlers direct key contacts! Gooey has spent the last few years developing the most powerful communication tool that allows aviation professionals to reach key decision makers faster than ever before.

claim your free trial: info@gooey.uk.com www.gooey.uk.com | www.gooey-global.com


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When

lives & liveliho rely on last mile Authored by CSafe Global


hoods

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Pharmaceutical companies spend an estimated ÂŁ5 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.

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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 02 - 2013

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

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

marketing budget to the new products when they launch

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

them, pharmas often overlook adequately planning the

informed and have everything they need to be successful.

salesperson’s transportation of samples where a simple solution can make all the difference.

The increasing regulation in the USA and Europe is not, however, making any of this easier. 2011 research shows that drugmaker

Current market intelligence estimates that physicians only see 1 in

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

7 salespeople who ask for an appointment and drug companies say

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

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

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

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

and transport of sales reps’ products have been tightened.

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

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

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

storage and delivery arrangements for these medicinal products must be validated to ensure the medicinal product will be

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

transported expeditiously under controlled Good Distribution

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

Practice (GDP) conditions and in accordance with labelled storage

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

requirements at all times.”

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?

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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%


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

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

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

introduced following the global success of the PX1 liter.

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

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

as expected (because it was incorrectly handled while transported)

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

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

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

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

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

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

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

compromised and the valuable sales opportunity gone.

phase change materials

There is a prevalent misunderstanding throughout the healthcare

Pharmaceutical companies are under relentless pressure to reduce

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

costs while ensuring that their products are handled properly

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

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

Program (VFC) provides immunizations to children whose families

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

are unable to afford them and approximately 80 million vaccines have been distributed to over 40 million children from low-income

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

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

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

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

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

participating in the program did not store their vaccines at suitable

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

temperatures and that their improper storage represented a major

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

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

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

quarters of the immunization providers were storing vaccines at

drive to get a quick uptake from healthcare professionals.

a temperature either higher or lower than specifications. More broadly, it was found that not one of the providers properly managed

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

the vaccines according to all of the VFC program requirements,

of actively controlled mobile refrigeration units for life sciences,

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

healthcare, military and international disaster relief agencies.

and between individual clinics and their satellite sites. For more information Many other examples could be cited on the same theme. The

CSafe Global

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

Tel: 937-312-0114

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

Fax: 937-312-1277

trained to understand the need for temperature control in drug

Email: Sales@CSafeGlobal.com

transportation and storage and the consequence of NOT doing so,

Web: www.CSafeGlobal.com

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

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


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

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R i s K M i t i G At i o n

The Invisible Component of Cold Chain Management Overview The 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.

Defining Risk Mitigation Risk mitigation of cold chain management is defined 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 efficacy of a cold chain program is substantially strengthened, as is the confidence 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.

A part of UTC Climate, Controls & Security


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A Company Commitment Quality 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 1 IT 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 Questions 1 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

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Element 2 Supply 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 AsK 1 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 3 Disaster 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 AsK 1 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?

Risk Mitigation The Invisible Component of Cold Chain Management

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Stability and Thought Leadership Founded in 1990, Sensitech is a global leader in cold chain monitoring. First certified under ISO in 1999, Sensitech has an unbroken history of recertification in its primary facilities, and currently is certified to ISO 9001:2008 standards. All of Sensitech’s outsourced manufacturing sites are certified to ISO 9001:2008 and ISO 13485 standards for Founded in 1990, Sensitech is a global leader in cold chain monitoring. First certified under ISO in 1999, Sensitech medical device manufacturing. has an unbroken history of recertification in its primary facilities, and currently is certified to ISO 9001:2008 standards. The rst companyoutsourced to offer global, single-use,sites electronic monitoring has provided almost All offiSensitech’s manufacturing are certifi ed to ISOprograms, 9001:2008Sensitech and ISO 13485 standards for a quarter of innovation and thought leadership in driving Good Cold Chain Management Practices (GCCMP) medicalcentury device manufacturing. for the pharmaceutical, food, and industrial chemical industries. The first company to offer global, single-use, electronic monitoring programs, Sensitech has provided almost a This includes active membership the Parenteral DruginAssociation (PDA), in a number of subgroups, quarter century of innovation andinthought leadership driving Good Coldparticipation Chain Management Practices (GCCMP) and contributions to Technical Reports. Sensitech hasindustries. also participated as a member of the technical steering for the pharmaceutical, food, and industrial chemical committee of the PDA’s Pharmaceutical Cold Chain Interest Group (PCCIG), the International Safe Transit This includes(ISTA) activeThermal membership in the Drug Association (PDA), participation in Chain a number of subgroups, Association Council, the Parenteral Association Francaise du Froid (AFF) French Cold Council, and is on and contributions to Technical Reports. Sensitech has also participated as a member of the technical steering the International Air Transport Association’s (IATA) Time and Temperature Task Force (TTTF) a subgroup of its Live committee the PDA’s Pharmaceutical Cold Chain Interest Group (PCCIG), the International Safe Transit to U.S. Animal and of Perishable Board (LAPB). Additionally, Sensitech has contributed documentation of best practices Association (ISTA)(USP) Thermal Council,and the Storage Association Francaise du Froid (AFF) FrenchofCold Council, and<1079> is on Pharmacopeia’s Packaging Expert Committee for the re-write USPChain General Chapter the International Air Transport Association’s (IATA) Time and Temperature Task Force (TTTF) a subgroup of its Live Good Storage and Distribution Practices for Drug Products. Animal and Perishable Board (LAPB). Additionally, Sensitech has contributed documentation of best practices to U.S. Sensitech’s efforts overPackaging the past decade have Expert helped Committee to clarify standards for lithium battery compliance, and Pharmacopeia’s (USP) and Storage for the re-write of USP General Chapter <1079> for electromagnetic interferencePractices (EMI) compliance and documentation. In support of this effort, Sensitech was Good Storage and Distribution for Drug Products. awarded the Cool Chain Europe 2010 Best Quality, Qualification or Risk Management Project by Pharma IQ. Sensitech’s efforts over the past decade have helped to clarify standards for lithium battery compliance, and Beyond regulations,interference Sensitech continues to provide thedocumentation. cold chain industry with electronic dataloggers, for electromagnetic (EMI) compliance and In support of this effort, Sensitechsoftware, was and globalthe cold chain programs serveQualifi over 12,000 customers around the world.by Pharma IQ. awarded Cool Chain Europe that 2010presently Best Quality, cation or Risk Management Project

Stability and Thought Leadership

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 Inc. Sensitech is proud of its commitment to a disciplined Quality Management System, rigorous Security and

Redundancy comprehensive Supply Chain Risk Management, powerful Disaster Recovery Planning Putting it practices, All Together and thought-leadership throughout the global cold chain monitoring industry. Taken together, these practices Sensitech is proud with of itsacommitment a disciplined System, Security and of provide customers level of Risk to Mitigation that isQuality uniqueManagement in the industry, and anrigorous essential component Redundancy practices, comprehensive Supply Chain Risk Management, powerful Disaster Recovery Planning every Sensitech customer offering. 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.

A part of UTC Climate, Controls & Security

2/13 1000

© 2013 Sensitech Inc. All rights reserved.

Amsterdam Boston Hong Kong Melbourne Mumbai Santiago A part of UTC Climate, Controls & Security 2/13 1000 Sensitech EMEA • Lireweg 42-52 • P.O. Box 59 • 2150 AB Nieuw-Vennep • The Netherlands • Tel: +31 (0)252 211 108 • Fax: +31 (0)252 231 032 © 2013 Sensitech Inc. All rights reserved. www.sensitech.com • info@sensitech.eu 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)252 231 032 www.the-logistics-portal.com www.sensitech.com • info@sensitech.eu

TLPINSIGHT 39.


SPOTLIGHT 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.

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Building successful supply chain solutions in clinical trial supplies Pharmaceutical companies spend an estimated ÂŁ5 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. Article continues on page 43 Âť

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© 2012 Softbox Systems Ltd all rights reserved


THE LOGISTICS PORTAL MAGAZINE Issue 02 - 2013 WWW.THE-LOGISTICS-PORTAL.COM

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Supply chain team reporting structure Supply 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

W

options for building flexibility into a clinical material supply chain will hile some of this may paint a gloomy picture, the fact is

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

that all companies developing and marketing drugs need

of alternative labelling approach options, pack designs and packag-

to show a healthy R&D expenditure to assure themselves

ing locations should be available for consideration. Building global

and their investors, that they have pipelines that will potentially

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

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

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

clinical drug development industry continues to grow at a healthy

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

rate across the board with many elements, including clinical supplies

ments to other studies in the programme.

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

When the supply chain for one protocol resides within a programme of studies, the option to pool as many stages of manufacturing,

Common objectives of teams working in drug development judge the

packaging and assembly of the clinical supplies across protocols

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

becomes more and more compelling. If the correct packaging,

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

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

processes and generated as trial data. The objective of building

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

successful clinical trial material supply chains should be clearly

packaged stock, label designs and even complete multi-protocol

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 comparator 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 requirements • Supply chain Good Manufacturing Practice (GMP) certification in

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

support of CTA application

are not realised until forecasting across protocols is shared with the supplies group to allow appropriate inventory levels to be continually

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TLPINSIGHT 43.


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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 02 - 2013

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

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

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

distribution and studies using adaptive trial designs are increasing.

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

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

a downside if the patient recruitment rate is slower than predicted

assemble truly efficient global packaging supply chains capable of

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

supporting regional just in time packaging, labelling, release and

following importation into the country. This import/export restriction

distribution to clinical sites is the harmonisation of processes and

within one country is extremely challenging. In order to evaluate

service delivery.

the optimal supply chain, with the greatest flexibility, the groups supporting the supplies work need to perform a similar spectrum of

There will be a greater need to integrate more regional packaging

service capabilities across a global footprint of facilities. Thus having

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

the ability to manufacture, package and label clinical supplies for

supplies group to work on fully integrated software programmes

both regional and global study supplies removes constraints in the

to offer parity of approach when performing the just in time

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

activities. Clinical supplies groups today use proprietary enterprise/

plan, reporting tools, a communication plan and infrastructure to

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

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

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

perspective to the rest of the trial team.

both. Whatever the combination, there will be a greater need for integration in global control and reporting systems. This ensures

Global approaches to primary and secondary packaging can assist

that the clinical trial materials are packaged, labelled and released

with both optimising and adding flexibility into supply chains.

correctly according to the randomisation schedule and regulatory

Currently the clinical supplies industry is focused on automation

requirements for the material, regardless of the location.

and the adoption of standardisation of approach to the equipment and components being used. This also means the third party

Harmonised informatics platforms also allow for a consistent

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

approach to unique pack identification in the global inventory system,

pack standardisation is that more complex packaging solutions are

by barcodes, RFID or proprietary tagging technologies. These all

overlooked and patient compliance levels compromised. In the future

enhance accuracy in the clinical supplies inventory, distribution

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

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

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

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

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

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

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

storage conditions, pending shipment status, shipment history and

number of compounds in the clinic requiring cold chain storage and

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

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THE LOGISTICS PORTAL MAGAZINE Issue 02 - 2013 WWW.THE-LOGISTICS-PORTAL.COM

TLP

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 nonconformances/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. returns to the informatics platform allows â&#x20AC;&#x153;cradle to graveâ&#x20AC;? reporting capability for the clinical supplies. The ability to integrate these

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

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

highlight the differing needs for scale and approach to clinical

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

supplies. The smaller development groups and the large pharma

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

model have different demands for their ideal clinical packaging supply

essential to the ability to scale up the clinical supplies distribution

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

process.

cultural mindset to work on supply chains that are nimble, responsive and innovative, which rapidly accommodates Phase I clinical trials

The IVR/IWR interface removes human data entry on shipment

packaging, whilst also having the global presence, processes and

request and status and thus potential errors. The electronic interface

capacity for managing multiple Phase III trial packaging needs.

also allows temperature traces to be associated to the specific shipments and kits, as USB-enabled temperature monitoring devices

Building successful supply chain solutions in clinical trial supplies

for both cold and increasingly controlled ambient supplies can be

needs careful planning. When considering clinical supplies activities

used. A further benefit in Europe to utilising closely interfacing

the proposed supply chain must be focused on achieving a flexible

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

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

to expiry date-free labelling. This has been slow to gather momentum but in the future, should the adoption of electronic patient diaries

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

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

Ian has over 30 years experience within pharmaceutical and medical device

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

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

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

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

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

ject Management roles at Fisher Clinical Services and Operations at Aptuit

Medicinal Products (IMP) kit labels in patientsâ&#x20AC;&#x2122; hands will allow better

(formerly Quintiles Transnational) supporting Large Pharma and Biotech

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

companies globally.

with compliance and pharmacovigilance monitoring. The industry standard approach to measuring and managing the performance of a

Email: ian.morgan@sharpclinical.com

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.

www.the-logistics-portal.com

TLPINSIGHT 45.


EVA INTERNATIONAL MEDIA LTD AVIATION PUBLISHERS & EVENTS SPECIALISTS

PHARMACEUTICALS IN THE COOL CHAIN CONFERENCE Join the Cool Chain Members on the

25 September 2013 at Tivoli Lisboa, Lisbon The theme of the conference is The Pharma Cool Logistics Supply Chain. Come and listen to eminent speakers from the worldâ&#x20AC;&#x2122;s airlines, airports, seaports, freight forwarders and pharmaceutical companies who will provide in-depth insights into this specialised and important sector and share valuable lessons in healthcare logistics and how they can also be applied to the perishables market.

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

To Register for this event please visit: http://evaint.com/our-events/cool-chain-pharmaceuticals-in-the-cool-chain Or email Bhavi Patel: bhavi@evaint.com To find out more on becoming a sponsor of this event email Parveen Raja: parveen@evaint.com or call: + 44 (0) 20 8 668 9118 MEDIA SPONSORS


CONFERENCE AGENDA 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?

08.00 REGISTRATION AND WELCOMING COFFEE 09.00 OPENING REMARKS FROM THE CHAIRMAN Sebastiaan Scholte, Chairman of the Cool Chain Association and CEO of Jan de Rijk Logistics.

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

09.15 MARKET OVERVIEW Trends 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.

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

10.00 THE WEAKEST LINK What 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?

15.00 DELEGATE ROUND TABLE DISCUSSION FINDINGS 16.00 BREAK FOR REFRESHMENTS 16.30 MOVING FORWARD Panelists review the discussions and topics of the day and offer some further thoughts and reďŹ&#x201A;ections.

10.45 BREAK FOR REFRESHMENTS AND VIEWING OF EXHIBITION

17.15 CLOSING WORDS FROM THE CHAIRMAN 17.30 END OF CONFERENCE

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

19.00 COCKTAIL RECEPTION

CONFIRMED SPEAKERS

BART POUWELS

MARCEL FUJIKE

STEVE HILL

STEVEN POLMANS

NINA HEINZ

Director Business Development Cargo, Amsterdam Airport Schiphol

Senior Vice President, Products & Services Air Logistics,

Principal Industry Consultant, CHAMP Cargosystems

Head of Cargo at Brussels Airport

Head of Quality, LifeConEx

YOURI BUSAAN

EDWIN W. KALISCHNIG

STEVE TARBUCK

CHRISTOPHER DEHIO

MARKUS SCHEUBER

Treasurer, Cool Chain Association

Secretary General, Cool Chain Association & CEO, Xtreme Technologies BV

Business Development Manager, Copenhagen Airports A/S (CPH)

Senior Manager Global Key Accounts Temperature Controlled Airfreight, Lufthansa Cargo AG

Product Manager, Swiss WorldCargo

Kuehne + Nagel

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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 02 - 2013

//INDEX OF ADVERTISERS IFC

Swiss World Cargo

5

UPS

7

Turkish Cargo

9

IATA

10

JAL Cargo

18

Biotec Services International

21

Cool Logistics

25

SMI

27

Gooey

31

TLP Insight

33

Laminar Medica

34-37

Sensitech

40

Softbox

44-45

EVA International

IBC

Air Canada

OBC

American

FOR ADVERTISING INFORMATION CONTACT: Sales: Info@intensivemedia.co.uk Subscription: subscription@intensivemedia.co.uk

//EVENTS Cool Chain Strategies Summit 07-05-2013 Mumbai,India This conference, hosted by the KMedia, takes place on May 7, 2013, in Mumbai, India BioLogistics 03-06-2013 San Francisco,United States This conference, hosted by the IQPC, takes place from June 3 to 5, 2013 2013 PDA/FDA Pharmaceutical Supply Chain Workshop 06-03-2013 Bethesda,United States This conference, hosted by the PDA, takes place from June 3 to 5, 2013, Temperature Maintenance of Biopharmaceuticals 06-05-2013 Boston,United States This conference, hosted by the Arena International, takes place from June 5 to 6, 2013, in Boston, Massachussets

48. TLPINSIGHT

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TLP INSIGHT  

TLP INSIGHT issue 2 The only publication completely dedicated to the Life Science Logistics Industry.

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