TLP INSIGHT

TLPINSIGHT

The Logistics Portal magazine

Issue 1 - 2013

ASSESSING THE OPTIONS

LOOKING AT ACTIVE VERSUS PASSIVE IN THE DISTRIBUTION SUPPLY CHAIN

Popular Ukraine A BACKGROUND ON CLINICAL LOGISTICS IN THE UKRAINE

IATA

STANDARDS

Transportation of Time and Temperature Sensitive Products

TLP Insight: a journal for the life science logistics industry AIR CARGO - RFID - TEMPERATURE CONTROLLED - CLINICAL - BIO PHARMA - LOGISTICS

I am Peace of Mind

Mambio Ravezzi Sales Manager Cargo Italy Of course, Swiss WorldCargo is a hallmark for quality, precision and a dedicated global team.

But all you really need to know is this: the moment you hand over your cargo to us, you can stop worrying. This is the true meaning of: We care for your cargo.

SWISSWORLDCARGO.COM

//MAIN CONTENT

TLPINSIGHT MANAGING DIRECTOR Lee Atkinson

//MAXIMIZING CONFIDENCE IN TEMPERATURE-CONTROLLED PHARMACEUTICAL SHIPPING American Airlines looks into the strict requirements that air cargo handlers are placed under. They also tell us how they have implemented a high-visibility, multi-layered tracking program for ExpediteTC, which guarantees all temperaturesensitive shipments.

Read the full article on page 18 »

8 IATA Standards: Transportation of Time and Temperature Sensitive Products

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

chain logistics for the pharma industry to Japan 14 Cool and Asia

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

22 Integration of dangerous goods management solutions into existing software environments

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

Contents continue on page 4 »

MANAGING EDITOR Bridget Langston SENIOR DESIGNER Joey Graham EDITORIAL ASSISTANTS Nicholas Ridgman Jamie Ward CIRCULATION MANAGER Tony Williams SALES Rakesh Makwana, Lee Atkinson ADMINISTRATION Katie Galelli WEBSITE DESIGN Knut Henriksen PRINTED BY CBF Cheltenham Business Forms Ltd www.cbfnet.co.uk CONTACT US Sales: info@intensivemedia.co.uk Subscription: subscription@intensivemedia.co.uk TLP INSIGHT Is published 4 times a year February, May, July, October by Intensive Media Ltd Send address changes to: 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

TLPINSIGHT 3.

//CONTENTS 28 Cool Chain and Clinical Trials

Biocair explains the ever-increasing importance of the Cool Chain in Clinical Trials, where different phases often take place on different continents and samples need to be in the right place at the right time and in the right condition.

32 Clinical Logistics in Ukraine

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

38

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

41

RFID and Cold Chain Management

51

China Continues to Attract Biopharma

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

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

//MANAGING YOUR RISK IN THE SAFE TRANSPORTATION OF LIFE-SAVING PHARMACEUTICALS. ACTIVE VERSUS PASSIVE IN THE DISTRIBUTION SUPPLY CHAIN Kavita Somaroo at DS Smith Plastics Cool Logistics looks at the decision on whether to use an active system or passive packaging to transport temperature-sensitive products.

Read the full article on page 45 »

4.

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www.the-logistics-portal.com TLPINSIGHT © 2012 Softbox Systems Ltd all rights reserved

5.

//TLP INSIGHT FORWARD The first of its kind

W

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

2012 has been a tough year in a long line of tough years for everyone in the Life Science Logistics industry, but here at TLP Insight we have remained optimistic from the outset that with a lot of hard work and a desire to bring the very best to market

we could buck the trend.

TLP Insight has grown out of our online presence, The Logistics Portal, a Pharmaceutical Logistics B2B directory, which provides an informed and comprehensive information hub for the Life Science Logistics industry. Our publication is our response to the needs of the industry for a book to compliment the online portal and we are very pleased to have been able to bring it to fruition.

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

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

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

The aim of this is to encourage the flow of information between all the different parties involved in Life Science Logistics, promote discussion on all topics and nurture a cross-fertilisation of ideas. And in so doing, promote understanding of the different problems and challenges faced by different elements that can ultimately impact on the industry as a whole.

In this issue we cover IATA Standards: Transportation of Time and Temperature Sensitive Products. IATA’s Andrea Gruber, Manager Cargo Business, Process and Standards and Dave Brennan, Assistant Director Cargo Safety and Standards provide our main feature which gives an in depth insight into the framework within which our industry needs to work and the ways in which IATA are rising to the challenges presented in the transportation of time and temperature sensitive products.

Issues around documenting the authenticity of pharmaceuticals are a very hot topic, with many people working in the industry trying to anticipate changing or new directives from governments. Peter Norton a Supply Chain Consultant from Intelleflex Corporation argues the need for inference in his article The Need for Inference: Impacts on Anti-Counterfeiting, Serialisation and Product Tracking.

Alex Guillen the CEO of Escort Cold Chain Solutions SA (ECCS) gives us thought-provoking perspectives on the current state of play of RFID and Cold Chain Management and why he believes that long-awaited progress will be made in this area of our industry.

Over the course of the coming year, in what looks to be a full and busy schedule for TLP Insight, we will be focused on covering a variety of topics: from Green Packaging and the various packaging regulations, reusable packaging and labelling associated with it to discussing global regulatory issues within air cargo, within emerging markets and within clinical trial logistics as well as touching further on anticounterfeiting.

I would like to thank the contributors and our staff for all their efforts and hope you enjoy the publication. I hope too that you will stay with us as we move from strength to strength.

All the best for 2013

Lee Atkinson Managing Director and Founder of Intensive Media Ltd

6.

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7.

IATA STANDARDS

Transportation of Time and Temperature Sensitive Products

Air cargo delivering the modern world

IATA delivers standards and solutions to ensure a safe and

The global economy relies on air transport to deliver high

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

quality products at competitive prices to consumers worldwide.

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

International trade is now estimated at over USD 15 trillion and

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

about 35% of that value is transported by air.

where they are needed.

With the healthcare market becoming a key engine of the global

The market for healthcare products continues to grow and shows

economy, pharmaceutical and biomedical industries are facing new

strong resilience to global economic downturns. An increasingly

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

ageing population requires access to new products and spending

in the consumer supply chain ensuring continual access to quality

on national healthcare programs is an important part of many

and choice but it cannot work on its own.

government social policies. The emergence and expansion of Brazil, Russia, India, China and South Africa as major consumer markets will shift demand and lead to more balanced trade flows in the air cargo industry. This is already seen in China and to an extent in India.

The growing middle classes in emerging economies are discerning high end consumers who will continue to sustain air freight growth in the years to come. Understanding customer needs, anticipating them and adding value in delivery is key to achieving an effective supply chain. In particular the healthcare industry is concerned with ensuring the integrity of sensitive products is maintained when transported by air. IATA in collaboration with supply chain stakeholders and partners has undertaken collaborative actions to address these concerns.

Speed to market is essential and the healthcare industry is increasingly dependent upon air cargo. It is vital to address the challenge of keeping products at the correct temperature range to ensure the quality of the product is not affected in transit.

Temperature control in transport is therefore an important

8.

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

component of the industry and is continuously rising in line with

global trade association and represents some 240 airlines comprising

international trade. The most important issue for the industry and

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

its logistic providers is to clarify mutual expectations to minimize

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

risks and challenges for airfreight within the cool chain. Temperature

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

deviations and temperature excursions throughout the journey

forwarders, governments, Customs and shippers).

require the establishment of a complete logistical process to

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//BIOGRAPHY Andrea Gruber Manager Cargo Business Process & Standards International Air Transport Association maintain the shipment integrity. Quality, reliability and

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

performance are crucial, and to achieve this dialogue, joint

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

strategy and standardization throughout the complete supply chain is needed. The shipper is ultimately responsible for ensuring the product (and any necessary packaging) is preconditioned to the required temperature, and will remain within a temperature range for a certain period of time, using the appropriate refrigeration method adapted to the shipping circumstances. However the accountability is shared by all of the stakeholders within the healthcare

standards and processes for the air cargo supply chain.

Mrs. Gruber is responsible for the IATA regulations related to the transport of Live Animals, Perishables and Healthcare Cargo. She is secretary to the IATA Live Animals and Perishables Board and the Time and Temperature Task Force.

Prior to working with IATA, Mrs. Gruber worked at the International Road Transport Union (IRU) as head of a division implementing, at the Customs and business level, tools to assist the application of risk management.

Mrs. Gruber studied in Geneva at the University and at the Graduate Institute of International Studies (I.U.H.E.I.) and holds a Master of Sciences in International Relations.

supply chain. Meeting the challenges can only be achieved by cooperation between all stakeholders involved in the supply chain, who recognize the need for guidelines.

Background To address the challenges in transporting healthcare products, IATA established a dedicated working group: the IATA Time and Temperature Task Force (TTTF) under the supervision of the IATA Live Animals and Perishables Board, a governance body comprised of 12 Airline members,

David Brennan Assistant Director Cargo Safety & Standards International Air Transport Association David joined IATA in May 2002 as the Manager, Dangerous Goods Technical Services. In April 2004 David was appointed Assistant Director Cargo Safety & Standards.

endorsing healthcare standards for the air cargo industry

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

recommended by the Time and Temperature Task Force

responsible for the IATA standards publications and products that address dangerous

members. The work undertaken by this healthcare industry

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

subject matter expert Task Force composed of airlines, ground handling agents, freight forwarders, shippers,

also the Panel member nominated by IATA to the International Civil Aviation Organization (ICAO) Dangerous Goods Panel.

international and national organizations, airports, and

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

equipment manufacturers led to the inclusion of a specific

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

chapter in the existing IATA Perishable Cargo Regulations

of 26 years holding a number of supervisory and management positions

(PCR). Today the air cargo industry is using the IATA PCR as the essential reference guide for all parties involved in the packaging and handling and distribution by air of time and temperature sensitive healthcare products. Chapter 17 “Air Transport Logistics for Time and Temperature Sensitive Healthcare Products� in the PCR specifically addresses the

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TLPINSIGHT

9.

temperature control management issues identified by the industry

regulations and the appearance of the label.

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

The PCR Chapter 17 requirement mandates the lower half of the

Time and Temperature Sensitive label, developed together with the

label to indicate the external transportation temperature range of

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

the shipment. The responsibility to apply and complete the label for time and temperature sensitive healthcare cargo shipments booked

Mandatory Shipping Label

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

The Time and Temperature Sensitive label came about as a result

service agreement). Though transportation begins with the shipper,

of standardizing the nearly endless parade of labels applied by

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

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

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

to the healthcare industry, that must be affixed to shipments

which triggers the appropriate handling and operational processes

transported as time and temperature sensitive cargo. Regarded

associated to healthcare transport. The label only supports the

as a recommendation, the air cargo industry recognizes this label

booking, thus the transportation temperature range specified on the

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

label must match the transportation temperature range stated on

Time and Temperature Sensitive label became mandatory for

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

To strengthen the overall supply chain a 24-hour contact telephone number of a person knowledgeable about the shipment will have to be provided at the time of booking on the Air Waybill as well as in the SLA or SOP, to allow contacting the appropriate person in the event of a significant delay or disruption to the shipment that may impact on the viability of the contents of the shipment. More

+15ºC to +25ºC

information can be accessed on the IATA website using the following link: http://www.iata.org/whatwedo/cargo/pharma/Pages/index.aspx

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

Monitoring devices

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

In addition to the label and new healthcare requirements, IATA is working on a number of other projects to help tackle difficulties

the transportation of healthcare cargo shipments transported as temperature sensitive cargo. The decision to implement this step resulted from a collective recommendation supported by the Time and Temperature Task Force and Working Group members and endorsed by the IATA Live Animals and Perishables Board.

IATA’s aim is to ensure the integrity of the time and temperature sensitive healthcare cargo shipments and that the air cargo supply chain is prepared to handle the demands of these healthcare shipments. The application of this new requirement will enhance the transport and handling of specific healthcare commodities with the aim to ensure the highest quality through effective cold chain distribution. Therefore, it is imperative that airlines, ground handling agents and other stakeholders in the supply chain – including freight forwarders, terminal operators, ULD manufacturers, packaging and tracking and tracing companies – are familiar both with the

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in pharmaceutical transportation. IATA by means of an industry working group, the Cargo RFID Working Group (RFIDWG), will be focusing on temperature monitoring devices and their use, as currently there are no clearly defined standards that exist that permit the use of electrically active devices in cargo shipments.

The healthcare industry is increasingly using monitoring systems, which may be placed in individual packages, to track temperature or other parameters through the whole distribution chain. These track and trace devices, such as electronic temperature data loggers, are used on or in passive packages but different types of active containers with advanced monitoring and tracing devices are also arriving on the market. These active devices such as Global Positioning System (GPS) systems raise security concerns and also issues with the potential interference with aircraft navigation and electrical systems.

Stay Compliant Effective immediately, use the 54th Edition of the DGR Manual or your shipments may be at risk.

If you’re not using the 54th Edition of the DGR Manual your dangerous good shipment may not be compliant. Don’t risk having your shipment returned or being fined thousands of dollars because of faulty documentation, packing or labeling.

Get the 54th edition of the DGR Manual today and be current with the latest regulations for completing the Shipper’s Declaration. Remember, if you use previous editions, you are knowingly putting yourself and your company at serious risk.

iata.org/dgr www.the-logistics-portal.com

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11.

In addition, it is critical to understand that most temperature

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

monitoring devices contain lithium batteries (commonly lithium

maintained. For the stakeholders involved in Time and Temperature

metal batteries), which are dangerous goods. Lithium batteries

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

represent a significant safety concern. Incorrectly manufactured and/

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

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

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

batteries must be transported in accordance with the provisions

is essential that each member of the supply chain understands what

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

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

Technical Instructions). Guidance material on the transport of lithium

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

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

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

In addition active devices must comply with the appropriate air worthiness standards regarding electromagnetic interference of aircraft systems. The responsibility to comply with these requirements is with the shippers of such devices. To determine the requirements shippers are advised to make contact in advance with the applicable airline to determine the suitability of including such active devices in shipments.

and temperature sensitive cargo handling to ensure compliance with the Perishable Cargo Regulation Chapter 17.

IATA is working with the industry and for the industry, and therefore such initiatives are carried out in cooperation with the appropriate cold chain stakeholders in the healthcare industry. This is only the start: there will be continuous development of the standards to reinforce IATA’s vision for a safe, secure and profitable air transport

Training Supply chain excellence is achieved as a result of applying fundamental principles that answer customer’s needs. Training therefore becomes paramount. Training of staff handling sensitive

12. TLPINSIGHT

the IATA Training and Development Institute leads training in time

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industry that sustainably connects and enriches our world.

[RELIABILITY] 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/

A SEAMLESS COOL CHAIN

over 200 hours.

Using special coolants so that there is no need for

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

Cool Chain Logistics

attached to monitor the temperature.

COOL CHAIN LOGISTICS FOR THE PHARMA INDUSTRY TO JAPAN AND ASIA

maintain strict temperature control and the popular Envirotainer t2

An introduction to air cargo systems There is a growing demand for transport by air from Europe of temperature sensitive cargo to Japan and various countries in Asia.

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

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

model can be set at a wide range of temperatures.

Thermal blankets are used to avoid extremes of temperatures and sudden fluctuations of temperatures.

Ice Battery System

transport products to the European air freight market in order to send temperature sensitive cargo securely and timely to Japan and other Asian destinations by aircraft without risking the quality of the pharmaceuticals.

The main commodities transported tend to be in addition to pharmaceuticals: life science samples, bio samples, chemicals, medicals, life saving drugs, clinical trials supplies, diagnostics.

Customer Requirements Certain commodities such as pharma require temperature control and monitoring throughout the transport process. Common temperature ranges requested are -20deg C deep-frozen and 2~8 deg C or avoidance of fluctuations and extreme temperatures whether high or low.

coolant plates placed inside the IBS

Pharma shippers are often looking for written evidence of items

Temperature can be set

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

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

handling, temperature graph of storage room, written information

internal loading space of the box is 41x36x31cms.

to prove standards or explanation of procedures to handle pharma.

A typical handling procedure would look like this:-

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

1.

and which provide for individually tailored standard operation procedures (SOPs), which can be agreed with the shippers.

Equipment There are various types of cool equipment which can be used inside the cargo holds of aircraft such as thermal blankets, use of Envirotainer e1 and t2, Ice Battery System (IBS) which are used by airlines and forwarders. Airline staff are trained to handle these products and follow carefully made SOPs agreed in advance with the shippers. The choice of equipment depends upon the degree performance needed to maintain the quality of the cargo.

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

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2.

3.

4.

5.

6.

7.

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

Agent picks the box up at Departure Airport.

Agent or shipper sets cargo in the box.

Agent delivers the box to the airline after Customs clearance.

The box is handled by the airline based on the SOP. Agent picks up the box after Customs clearance and delivers it to consignee.

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

An example from LHR (London Heathrow) needed -20deg C. The Unit was prepared and handed over to the designated forwarder in Cheshire close to Manchester, the cargo loaded inside the IBS and returned to LHR. As the unit can be kept cool for over 200 hours or kept frozen for 100 hours this allows for sufficient time that covers duration of delivery to the airport and the flight to Tokyo, the final

Long Lasting

Over 200 Hours destination in Japan and time for collection from the airport and

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

delivery to the consignee in Japan.

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

Envirotainer e1 E1 container performance is stable for precise set temperatures

Handling

over many hours and airline staff have training to handle shipments

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

requiring stable temperatures. Internal temperatures can be set

standard operation procedures (SOP).

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

•

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

•

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

•

Staff who are well-trained handle pharmaceutical products.

request checks can be made of the temperature inside and outside the units and detailed checks recorded on a check sheet. This unit does not require dry ice.

Envirotainer t2 This popular cool container is often to be seen on flights from European gateways with the latest units from the manufacturer Envirotainer.

Temperature can be set from -20 to +20 deg C and is powered by batteries and dry ice.

SOP The SOP set up by an airline in agreement with the shipper and cargo forwarder and will include the following type of items to meet the needs of the shipper and consignee:-

Training programme

Thermal Blanket Used widely, the Thermal Blanket is able to minimise temperature fluctuations with no extremes of heat or cold. The build up of the blankets and cargo is done under airline staff supervision making certain of secure handling. With shipping temperatures of between 1 and 30 deg C direct sunlight is avoided and extreme cold too.

Blankets are available in 2 sizes, LD3

Trained staff in both origin, transit and destination airports.

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

■Priority service Honour the flight schedule, ensure space onboard is available

■Contact list Communicate delays or problems to the forwarder

■ Check sheet Update any temperature log sheets

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15.

■ Storage area

Conclusion

Store the product in conditions that are within a defined temperature range

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

■ Equipment

various categories of service and equipment which are available according to the preciseness of temperature control and monitoring of the air transport process required and airlines are able to provide that service to pharma shippers and their forwarders by use of

Handle active cooling containers in accordance with the supplier’s instruction

■ Duration Maintain recommended cargo hold temperature setting

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

Customer feedback and satisfaction An increasing number of pharma shippers are requiring temperature control and monitoring for their transport. Airlines are able to meet those requirements even including at transit points in Asia when the final destination is beyond the airline hub.

Especially appreciated by the customers is the personal check by airline staff and monitoring with the check sheet to ensure all parts of the chain are being carefully followed. In cases where any issues or problems are noted then it provides an opportunity for the process to be re-examined and strengthened in light of that feedback and agreement between the parties involved to be made.

16. TLPINSIGHT

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

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carefully agreed SOPs covering handling, checks and providing special cool equipment.

This can encompass the whole air cargo chain from the shippers’ premises, acceptance at the origin airport up to the destination airport by the airline and then delivery to the consignee.

Contacts: JAL Cargo Cool Chain Logistics c/o Adrian Rayner Tel +0044(0)1784 422 283 adrian.rayner@jal.com

DID YOU KNOW? Our Cold Chain Solutions Speak Multiple Languages

So when your temperature-sensitive cargo needs priority boarding in any of the countries we serve, you can rest assured our efficient, state-of-the-art procedures and select interline partners allow us to deliver uninterrupted, temperature-controlled services, even in hard-to-reach locations. Our network alliances build greater partnerships with our customers because strong links are essential in a global cold chain. Come see why no matter where your freight is headed, we speak your language.

To learn more about our global cold chain solutions for temperature-sensitive cargo, please visit www.aacargo.com.

AACargo.com AmericanAirlines Cargo and ExpediteTC are marks of American Airlines Inc.

18. TLPINSIGHT

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//MAXIMIZING CONFIDENCE IN TEMPERATURE-CONTROLLED PHARMACEUTICAL SHIPPING Pharmaceuticals Require Strict Temperature Controls Pharmaceutical products are considered one of the fastest growing and most valuable cargo commodity categories handled by air

pharmaceuticals were carefully developed using the following information: •

from major airlines and freight forwarders

carriers. It is estimated that biotech and pharmaceutical products represent the highest value per air-lifted pound of any cargo shipped

•

distribution process travel by air, the significance of maximizing

from key pharmaceutical companies •

references and incompatibility/segregation information •

containers, tracking systems and highly-trained personnel. Processes

Airlines contact information, dedicated websites, and specific rules regarding perishable cargo

Pharmaceutical industry confidence in air cargo can be further gained by using state-of-the-art equipment packaging and

Comprehensive classification of perishable commodities, including temperature/humidity requirements, packaging

shipper confidence in every aspect of the quality and reliability of the shipping process is of utmost importance.

International and local regulations for goods shipped and stored under optimal conditions in on and off airport locations

by the airlines. And taking into account that many temperaturesensitive pharmaceutical products will at some point during the

Scientific data from research institutions, and field experience

•

Pharmaceutical product information based on World Health Organization (WHO) guidelines.

that provide detailed documentation or proof that these sensitive products have been well maintained throughout the shipping process allow pharmaceutical companies the control they need to manage their products effectively.

Protecting these valuable assets with proven, precise handling and strict temperature-control can literally save companies millions of dollars in lost inventory. This is also ultimately essential for protecting patients and end-users of the pharmaceutical products.

Therefore, it is imperative for pharmaceutical companies, freight forwarders and air carriers alike to understand and overcome the challenges of cost effectively delivering high-value, temperaturesensitive pharmaceuticals across widely varying climates to their customers worldwide.

Additionally, pharmaceutical and biotech materials are closely governed by specific federal requirements that must be observed, including growing requirements for more advanced equipment, permits, and training in order to move medical material and pharmaceuticals.

With the growth of pharmaceutical manufacturing internationally, it is increasingly common for a drug to start as an active pharmaceutical ingredient (API) and go to a finished product in multiple steps across multiple countries. As a result, the requirements have increased for packaging, storing, transporting and distributing pharmaceutical ingredients and finished products.

The shipping process must be as reliable and sophisticated as the manufacturing process for these products.

Requirements-Driven Approach The International Air Transport Association (IATA), which promotes

Proven Reliability in Handling of Pharmaceutical Shipments

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

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

developed additional regulatory requirements for the handling of

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

temperature-sensitive pharmaceutical products. Effective July 1,

was developed to deliver a highly reliable, temperature-controlled

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

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

Perishable Cargo Regulations, specifically addressing air transport

its worldwide launch, ExpediteTC offers customers specialized

logistics for temperature-sensitive healthcare products, changing

handling, monitoring and tracking of sensitive pharmaceutical

its previous passive guidelines to a more strict requirements-driven

shipments. Americans ExpediteTC service is available at more than

approach.

100 cities throughout its worldwide cargo network.

The IATA regulations for the air transport of temperature-sensitive

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19.

Multi-Layered, High-Visibility System

before, American Airlines Cargo has implemented standardized processes and procedures that support customers with their

American Airlines Cargo has implemented a high-visibility, multilayered tracking program for ExpediteTC , which guarantees all temperature-sensitive shipments are closely monitored. ExpediteTC is a program that delivers the specialized air cargo expertise needed by the pharmaceutical industry with all system layers supported by a team of highly trained professionals that have the commitment to deliver ongoing superior service.

American has also developed innovative internal systems that ensure efficient and reliable handling of temperature-controlled ExpediteTC shipments. These systems enable cargo teams to thoroughly monitor temperature compliance.

With this system, American is able to provide high-visibility monitoring and unique tracking of the high-value shipment. Because the pharmaceutical industry is facing more regulation than ever

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regulatory requirements of tracking shipments to ensure that they have been transported under the correct conditions.

Meeting or exceeding their needs, shipments are closely tracked and supervised by knowledgeable service teams. Customer-prescribed Standard Operating Procedures are put in place, which involve high-visibility watch and proactive tracking from end to end. The teams closely monitor the temperature and provide for maintenance services such as re-icing and battery replacement when needed.

Careful handling also includes blue special tags that make these crucial shipments easily recognizable to personnel loading the aircraft.

//MAXIMIZING CONFIDENCE IN TEMPERATURE-CONTROLLED PHARMACEUTICAL SHIPPING Certified Training of Personnel Worldwide Enhances Service Reliability and Accessibility The strength of American’s QEP accreditation is bolstered by the extensive hands-on training of more than 2,400 cargo team members globally. Customers are assured that QEP Certified personnel have a thorough understanding of all aspects of Envirotainer control, operation, maintenance and troubleshooting.

This includes the complete operation of the control panel all the way to the handling and changing of dry ice, cooling fans and container batteries. Achieving QEP status in multiple key locations and cities worldwide demonstrates American’s commitment to providing the highest standard of service and shipment reliability to its temperature-sensitive cargo customers.

Summary American Airlines has made significant capital investments in our cargo facilities to accommodate temperature-senstive shipments in the various cities we serve. Every station is equipped with an environment area for temperature-senstive cargo and several of our key locations (including New York, Chicago, Miami, Dallas and San Juan) will be outfitted with dedicated CRT rooms, specifically designed to accommodate passive packaging. CRT rooms will be added in additional locations worldwide in the near future.

American has implemented a multi-layered, high-visibility system that combines state-of-the-art Envirotainer containers with accredited, highly-trained cargo personnel in major cities worldwide. All are designed to provide shipper confidence in the end-to-end shipping process for pharmaceutical products. A testament to the success of this multi-layered, high-visibility approach is that customers who started with the air carrier’s pilot program have continued to use American Airlines Cargo for their temperature-controlled shipments.

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

THE STRENGTH OF AMERICAN’S QEP ACCREDITATION IS BOLSTERED BY THE EXTENSIVE HANDS-ON TRAINING OF MORE THAN 2,400 CARGO TEAM MEMBERS GLOBALLY. CUSTOMERS ARE ASSURED THAT QEP CERTIFIED PERSONNEL HAVE A THOROUGH UNDERSTANDING OF ALL ASPECTS OF ENVIROTAINER CONTROL, OPERATION, MAINTENANCE AND TROUBLESHOOTING.

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21.

INTEGRATION OF DANGEROUS GOODS MANAGEMENT SOLUTIONS INTO EXISTING SOFTWARE ENVIRONMENTS Biography of Heman Teering Managing Director DGM Software Development Group Before coming to DGM in 1997, he was a logistics expert in the Dutch army. He worked for 5 years as a logistics coordinator for Explosives and Fuel distribution and 5 years as expert on international movement of equipment, ordnance and personnel.

Adding dangerous goods logistics solutions to

existing

back

office

systems

like

warehouse management systems (WMS), customer relation management (CRM) or

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

enterprise resource planning (ERP) solutions

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

can create a lot of additional value to these

the international DGM network.

systems, but can also cause a lot of problems

Since 2003 he has been Managing Director of DGM Software Development Group, an IT company specialized in databases, tools and solutions for all modes of transport, production, storage, handling and waste of Dangerous Goods.

P

– both financial and operational – if the options are not clear and integration is not managed well.

From experience, we have learned that there

and

have all article-related documentation – like

are basically three options to implement

goods

a material data safety sheet (MSDS)– up to

these solutions, and in this article description

are subject to many regularly changing,

date and on hand, and make sure that you

– as well as positive and negative aspects of

national and international rules and

have your workplace instructions, product

each option – will be given.

regulations. Most of these rules and

labelling and safety measures in place.

roduction,

handling,

transporting

of

storage

dangerous

regulations have a direct impact on

The separate solution

logistic processes, related documentation

On top of that, you have to be aware of

and reporting requirements.

differences between the various regulations

In this setup there is basically no connection

as, for instance, goods can be dangerous

between the back office system and

As these rules and regulations can differ

according to the Globally Harmonized

the dangerous goods solution. The user

between countries, and in some cases

System of Classification and Labeling of

processes the orders as usual in the back

even between states or communities, the

Chemicals (GHS), but not dangerous for

office system and then switches to the

challenges for the industry are numerous.

transport under one of the regulations for

dangerous goods solution. This solution

On the one hand you would like a minimum

the Transport of Dangerous goods. Likewise,

can be a software package offered by

impact on your processes, and on the other

you can have goods which are dangerous for

several suppliers either locally installed on

hand you want to be in compliance with

one transport modality but not for another.

computers, on the company’s intranet, or

the applicable rules and regulations. This

For the purposes of this article, the focus

accessed via the internet. Also, the good old

means you must be able to prepare all the

will be on the logistics and related transport

‘copy and paste’ solution is still used on many

required reports and transport documents,

documentation.

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Safety first in Dangerous Goods Management

Dangerous Goods Management is all about

automated where possible to save you time

safety and minimizing risk. In air transpor tation,

and to reduce error rate to a minimum.

staying compliant with all of the many rules and regulations is not an easy task. However,

DGOffice.net was developed as an on-line

supported by DGOffice.net with its specific

application, meaning you can access it anytime

modules for air transportation, it becomes a

from anywhere in the world. Alternatively,

clean cut operation. From Packing Instructions

run it as you see fit: within your own network

to Shipper’s Declaration and ‘NOtification TO

or on a stand-alone computer.

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

DGM SDG A/S, Kokholm 3b, DK 6000 Kolding, +45 75 575 790, info@dgm-sdg.com, www.dgoffice.net

014016_DGOffice_adv_203x280.indd 2

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23.

11-12-12 16:56

occasions whereby a Word or Excel template

related information is processed in the

between the article number in the order

is completed with information typed in from

separate remote dangerous goods logistics

system and the ID used for the dangerous

the regulations.

solution.

goods data. This so-called article classification

The interface connecting the two systems is

can be done in two ways. The first option

The order data is entered in the solution and

running in the background and is triggered

is to maintain all information in the order

documents are generated accordingly.

by user-initiated actions on the back office

processing system, meaning a complete set

Depending on the solution, there are options

system. This can be anything from a new

of dangerous goods information (including

for checking several issues like segregation

order to a simple change in the status of a

the key) needs to reside in the system. The

requirements, mixed packing provisions,

shipment. The user does not have to take

dangerous goods key needs to be assigned

verification

additional actions, other than collecting the

to the article based on the characteristics

processed documents from the printer, the

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

email system or any specified file location.

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

of

required

information,

emergency response information etc.

Also depending on the solution, prepared documents are stored within the solution and/or exported in printed and digital format.

Options may be available to export the

packaging and required quantity need to be A remote server solution should be capable of offering the following solutions:

document data for re-use in the back office

• automatic generation of dangerous goods

system, or creation of statistical information

declarations for shipments in any mode of

to fulfil reporting requirements which may

transport

be required by some rules or regulations.

• printing the declarations on any printer defined

The benefit of a separate solution is the speed of implementation: for instance, a solution that can be accessed via the internet can be set up in a very short time without the need of IT staff to interfere as long as access to the

The second option is that the article classification is handled entirely by the dangerous goods logistics solution, whereby the article numbers from the back office

in the user’s network

system are loaded in the solution and the

• preparation of the declarations in PDF or XML

article classification is completed using the

format (e-freight ready)

solution itself.

• adding (version-controlled) documents like MSDS or handling instructions to declarations based on customer requirements.

• instant or batch order processing.

internet is possible. The costs are also known in advance

defined.

Connecting and processing data Once the order is ready and shipment papers need to be made, the back office

In general, a typical order processing system

system needs to generate a message to

works with articles. These articles have a

the dangerous goods logistics system. This

The negative side of a separate solution is

unique identifier, such as the article number.

message needs to be drawn up in the specific

the double work in data entry, the different

All other objects specified for a single article

format for the chosen solution. If there is no

locations where data is stored, and the issue

are linked to the article number on database

message generator tool available in your

of connecting, for example, shipment data

level. For example the trade name, pricing,

back office system, this requires additional

from the back office system to the dangerous

location, stock, and so on. When a customer

programming.

goods solution and vice versa.

orders a quantity of a specific article, the user

A separate solution could well work in situations where a small number of dangerous goods shipments a week are processed, or in situations where IT support

will only have to enter the article number and the order quantity. Everything else is automatically added from the connected database.

The message contains the shipper and consignee information, the method of transport required, as well as the article information and/or the dangerous goods key.

Depending on the way article classification

is not at hand or too expensive to realise one

The dangerous goods logistics system has

is handled, additional information might be

of the other solutions. It could also serve as a

a similar setup, but for dangerous goods

needed.

basis to realise the connected solution in due

only. The database is built around unique

time.

identifiers. Selecting a specific ID will make all

In the message, the type of output and

related data available.

where it should be delivered is specified.

The connected solution

For example, the declarations can be sent

This setup connects a dangerous goods

Article classification

logistics solution to the back office systems.

Key in a connected solution is the connection

to a local or a remote printer. Messages can be processed instantly or stored for batch processing.

The actual shipments are prepared as usual in the back office system, but the required

documentation

and/or dangerous goods-

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Generating results The

dangerous

goods

integrated into the back office system.

Some providers of back office systems offer modules or extensions that contain (parts of ) the dangerous goods logistics solution, but in most cases the user will have to add data and /or functionality to realise the desired solution.

The most important issue in this setup is the availability and consistency of the dangerous goods-related data which is needed for the whole system to run on. This requires a thorough planning and inventory of the minimum needs, the operational requirements, and perhaps additional wishes that need to be incorporated in the final solution.

Based on that inventory, the dataset needs to be designed and structures need to be logistics system will generate the required

automatic creation of documentation and/or

developed. In this phase the designer should

information or documentation as specified

information pages.

be aware that the rules and regulations are

in the message. If the articles are maintained

Another plus is the time that is saved with

dynamic and can change on any particular

in the solution, it will take all relevant

the maintenance of the dangerous goods

moment resulting in additional data or the

information from there.

data as this is handled by the supplier of

need for a structure change in the databases.

the system, and the automatic production

Also in this phase a decision will need to be

An interesting option is to utilise document

of documentation based on the input from

made as to who will be responsible for the

management modules if they are available.

the back office system so no need for double

data. Will it be own staff filling the structures

Here,

work.

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

MSDSs, handling information or workplace

In general, the experience is that a connected

routines will be required to make sure the

instructions, can be connected to your articles

solution can be realised in a short timeframe.

data integrity stays intact.

and printed along with the declarations when

The total time required depends on the

The negative side of this setup is budgeting.

required. When version control is available,

wishes and the availability of IT support to

As already indicated, regulations and rules

you can also make sure your customer will

the back office system.

change and do not take into consideration

automatically receive the latest version of

Negative points can be the need of IT support

that you are in the middle of designing a

these documents.

and/or developers, as the connections need

solution. So during the development, changes

to be made with the back office system.

can be implemented which cause delays and

Another option is the use of web services

Also the choice of where the actual article

increases in costs. Also, changing wishes and

that might be available in the dangerous

classification takes place has effect on the

requests for additional functionality during

goods logistics system, which can be used

work to be done in the back office system.

the design and development process could

to retrieve information or checks back into

Costs can also be unpredictable. However,

drag a project on and on. Hence planning and

the back office system and as such create

the costs for the dangerous goods logistics

firm time frames are essential.

the option to do a storage segregation check

solution are mostly transparent. The changes

The big benefit is that the final solution can be

at the moment of receiving goods in the

required in the back office system can cause

as perfect as possible for your situation and

warehouse, present packing and labeling

some serious increase in costs if it is not clear

can generate tremendous additional value.

information to the packers etc.

what the needs and wishes are before the

additional

documentation

like

work starts.

Herman Teering

The major advantage of a connected solution

The same is even more important when

Managing Director

is the addition of dangerous goods-specific

talking about the third option.

DGM Software Development Group A/S

information and documentation to the back office system without the need to keep all

www.dgm-sdg.com

The integrated solution

data in the system. Also, the user of the back office system will not notice a difference

This is more or less the ultimate solution

besides the changes that might be made

whereby all data and processes, as described

in the back office system and of course the

in the separate and connected solutions, are

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25.

Cool Chain & Clinical Trials Transportation of time and temperature sensitive products

The key factors in Cool Chain management of clinical trials are

//BIOGRAPHY

efficiency (speed), value of information and easy to use systems – making the gathering and analysis of data easy and reliable.

Harriet King

The Cool Chain Explained

Marketing Executive, Biocair International.

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

Graduated with a BA(Hons) in Marketing,

product’s temperature is maintained from the point of manufacture

Advertising and PR; Harriet brings a fresh look

until its end use.

to Pharmaceutical Marketing by combining traditional marketing techniques with New Media practices. During her education she worked with a number of PR & Events agencies and spent a year with car giants BMW MINI, before making her debut in Pharmaceutical Marketing with Biocair.

Email: hjk@biocair.com

Cool Chain is a core element in the transportation of temperature controlled pharmaceutical products. Most Cool Chain products need to be stored between +2°C and +8°C for stability and in accordance with regulatory body requirements. These temperatures are usually the ‘magic numbers’ in the industry. Cool Chain is an expanding part of the industry and will continue to be so given increasing compliance requirements. This coupled with larger numbers of new drugs in clinical trials and R&D requiring chilled temperature control

I quite often see articles written on Cool Chain and articles written on Clinical Trials, but there aren’t many that integrate the two together. This piece will discuss the current problems that exist in running a clinical trial in an emerging country such as Russia, Brazil or India – and the Cool Chain issues that will inevitably be encountered in these climates.

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in storage means a potentially prosperous future for temperature controlled logistics.

Temperature controlled supply chains are not always ‘cool’. Some products have to be kept frozen – this is often achieved by packing it with dry ice. Other products must be kept warm – often this means a room temperature band of something like +15°C to +25°C.

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

In these, the potential drug is tested in around 20 to 300 volunteer

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

patients suffering from whatever condition the drug is to potentially treat. They are designed to show whether the drug is safe in the

Why is Cool Chain so important in Clinical Trials?

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

To explain this, it is important to understand what a Clinical Trial is,

effective.

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

Phase III Trials

cover: Clinical Trials are most commonly performed to analyse new drugs, medical devices, biologics, psychological therapies or other interventions. They are a requirement before the relevant national authority approves marketing of the drug or device. There are several

If Phase II trials are successful, then the potential drug will undergo Phase III trials, which are widespread multicentre trials on at least 300 to 3000 patients in clinics to test the efficiency of the product. They are usually randomised and double blind (this is where neither the

different types of Clinical Trial:

• Prevention Trials – testing new approaches that doctors believe to lower the risk of developing a disease

• Screening Trials – testing the best ways to find a condition/disease in it early stages

• Diagnostic Trials - testing better procedures for existing diseases or conditions

• Treatment Trials - testing new medicines or new approaches to surgery/therapy

• Quality of Life - ways to improve comfort and Quality of Life for patients (e.g. incontinence drugs)

• Compassionate Use Trials - treatment option for patients suffering from a disease for which no satisfactory, authorised alternative therapy exists There are four phases to a Clinical Trial involving new drugs, and

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

each phase of the drug development process is managed as a

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

separate Clinical Trial. These phases are usually known as:

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

• Phase I Studies

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

• Phase II Trials

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

• Phase III Trials • Phase IV Trials

Phase I Studies

Goods Administration (TGA) and in Japan, the Ministry of Health and Welfare. Some Phase III trials will continue while the regulatory submission is pending at the appropriate regulatory agency. This allows patients to continue to receive possibly lifesaving drugs until

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

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

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

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

most often include healthy volunteers, however, there are some

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

circumstances when real patients are used. Cases where patients

therapies for chronic medical conditions.

who have terminal cancer or HIV and lack other treatment options (Compassionate Use Trials).

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27.

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

Phase IV Trials After the drug is launched, further Phase IV studies are carried out to monitor possible adverse reactions or other responses when large numbers of patients begin using the drug.

During the ‘drug pipeline’ or ‘drug discovery process’ drugs may also go through a ‘pre-clinical studies phase’.

This stage of the drug development pipeline is a study to test a drug, procedure or other medicinal treatment.

They involve in vitro and in vivo experiments using wide-ranging doses of the study drug to obtain

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

Preclinical studies are required before clinical trials start.

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

It is understood that drugs that are intended to be used on humans, must be tested on humans to ensure they are safe for use. It is due to this fact that quite often the samples taken are blood or tissue samples, and need to be sent to the research laboratories quickly, efficiently and undamaged. It is well known that the different stages of Clinical Trials can take place in many different global locations. This makes the ‘need for speed’ and temperature control even more vital.

For example, the drug could be created in a University in Poland, administered to the patient in a hospital or clinic in Africa and the sample be sent to a Research Laboratory in India or China. This is a very long chain of transportation where the drugs and samples will experience a variety of different climates. Appropriate Cool Chain packaging measures must be in place to ensure the shipment arrives at optimum viability.

Emerging Countries We have all read the articles and seen the trend emerging – where countries such as India, China, Russia and more recently many African countries are becoming hotspots for conducting Clinical Trials. Just last month in this publication there was much conversation about Australia and the Caribbean being the ‘Ones to Watch’ in Clinical Studies.

The popularity of these countries only amplifies how ‘international’ a Clinical Trial can be. And it’s this ‘internationality’ that is really beginning to test the Cool Chain. Samples need to be sent quickly, efficiently and carefully to ensure they arrive at their destinations in a usable state, i.e. in perfect condition.

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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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29.

Clinical logistics in Ukraine As Ukraine becomes ever more popular as a venue for international clinical trials, industry players need advice on how to operate in this exciting – but still quite specific and challenging – market, particularly in the field of logistics of clinical trial materials. This article gives practical background on the matter.

Ukrainian clinical research market Ukraine has been rapidly emerging as a clinical trial provider since 1996, when the first industry-sponsored trial came to the country. As of November 2012, 917 investigational new drug (IND) trials conducted in Ukraine are registered on www.clinicaltrials.gov 1. The trend has been positive over recent years as well. Thus, the number of regulatory approvals granted for IND trials in Ukraine increased from 142 in 2009 to 201 in 2011 (see Fig 1).

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

Source: Ministry of Health of Ukraine

The local market of clinical trials is growing in monetary value as well. The Polish market research company PMR estimates the market at around $208 million in 2011 (a 19% year-on-year increase), with a predicted growth rate of 10–20% over the next three years.

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The unique combination of the following factors contributes to

5

Study performance

making Ukraine the perfect location for clinical drug development:

•

1

•

Good geographical location and demography • • •

2

There is a Caucasian population of 45 million.

It is located in the strategically important region of Eastern Europe.

Five cities have a population above 1 million.

Matured clinical research infrastructure • •

• •

3

All top international CROs and Sponsors conduct their studies here.

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

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

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

Well-developed public healthcare system •

•

•

4

• •

•

•

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

Low mobility of population contributes to retaining study subjects.

Data is of a high quality.

Investigators are motivated and qualified, and see their involvement in clinical trials as an important opportunity to be on the front line of innovations and get integrated into the global medical science community.

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

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

This considerably improves quality of clinical oversight.

Criteria for the perfect local depot When planning study logistics in Ukraine one should bear in mind some particularities that make selection of the right local logistics vendor crucial for successful study performance.

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

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

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

Regulatory policy •

•

•

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

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

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

Firstly, Ukraine has its customs area isolated from both the EU and the Eurasian Economic Community, which gets the customs territories of Russia, Belarus and Kazakhstan united. That is why one cannot ship study materials to investigative sites from the EU or Moscow directly.

A locally based depot is needed. This has resulted in the development of a fully matured local clinical logistics market. Up to a dozen local speciality companies currently operate in the field. Some big CROs have their own IMP storage facilities and customs brokers.

placebo-controlled studies.

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31.

Secondly, clinical trial logistics involves added complexity in

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

comparison to the supply of marketed pharmaceutical products, and

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

there are specific selection criteria for local logistics vendors:

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

Project-based approach

delays.

Clinical logistics is project-based by its nature. That requires

IMP handling

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

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

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

Continual environment control, accurate documenting and tracking

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

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

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

dispatch) are essential. Usage of validated warehouse management

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

systems provides a client with precise accountability, tracking and

study.

reporting.

Validation of storage premises, used software and shipment methods is a must.

The needs of re-labelling/re-packaging arise often in the course of a clinical project. The logistics vendor must be capable of performing these operations in concordance with GMP practices.

The process of returning an IMP to a sponsor abroad is long, expensive and complicated, and, consequently, is rarely practised.

Investigative sites are not capable of IMPs. In most cases IMPs in Ukraine are destroyed at special destruction sites. The destruction process requires adherence to many regulations and may involve a number

Regulatory compliance and expertise Clinical logistics activities should be compliant with good manufacturing practice / good distribution practice requirements as well as complementary with good clinical practice standards.

Local regulations prohibit storage of investigational medical products (IMPs) with licensed pharmaceuticals. That is why IMP should be stored at dedicated IMP storage facilities only; the Ukrainian legislation does not require having such facilities licensed.

A local depot should be skilled in regulatory submissions since import/export licenses need to be obtained at competent authorities.

Customs clearance may be a tough task in Ukraine. Import regulations are frequently changed. Customs authorities have rather formal approach. So sometimes it is quite difficult to meet their requirements and expectations. That may lead to delays, re-evaluation of customs values and other annoying issues.

Import/export regulatory paths differ for the marketed products and

of activities like IMP return from sites, selection and in some cases regulatory approval of adequate destruction methods, video/photo fixation, issuance of destruction certificates and so on. A logistics vendor should select a licensed destruction provider and oversee the process efficiently.

Cold Chain Local depots should have capabilities of storage clinical materials in various conditions:

• • • •

2–8 °C - 20°C -70°C -180°C

It should be kept in mind that storage of cell therapies and transplants require a license in Ukraine. Only validated refrigerators, freezers, shipment methods and temperature monitoring systems should be used. Particular attention should be paid to back-up solutions in the event of refrigerators failure or electricity outage.

IMPs as an investigational product have no market licence and are not for sale. So customs brokers experienced specifically in clinical trial

Non-investigational medical products (NIMPs) and

materials are needed.

ancillary supplies

Study materials often require urgent delivery. Sponsors do not

Apart from IMP’s, there is frequent need for ancillary supplies (labkits,

32. TLPINSIGHT

www.the-logistics-portal.com

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

continual and extensive education. The quality of training programmes

rescue therapy, comparators). These products are commercially available

should be assessed by review of internal educational programmes and

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

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

importation. Logistics providers should hold the drug retailer license to

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

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

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

NIMPs may require re-labelling adaption following local regulations or

process is always painful and inevitably affects study performance.

sponsor requirements. That is why the depot must have a written relabelling procedure compliant with GMP.

Conclusion Ukraine is an important but still challenging and idiosyncratic market. The

Quality management

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

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

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

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

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

budget. Quality should be managed by a dedicated Quality Assurance

experience with import/export operations, IMP handling procedures,

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

capabilities of local sourcing of comparators, internal quality assurance

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

systems, human resources availability and management.

operational procedures – SOPs) covering every single business process

The regulations and public institutions are not as advanced and stable

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

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

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

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

level of the logistics provider’s qualification.

will make study progress smooth and will allow you to benefit from all the advantages of conducting studies in Ukraine.

Besides the logistical processes, the SOPs should also cover other areas like quality assurance, personnel management, vendor selection, information

References

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

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

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

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

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

to-exceed-700m-in-2014

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

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

and independent audits, as well as by tracking, analysis and eliminating of root causes of all non-conformances and customer complaints.

Authors Sergii Pomerantsev, Head of Logistics Department at Centre of Clinical

Human resources

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

A local depot should employ highly qualified personnel who are able to

50 clinical projects in Ukraine.

follow thoroughly sometimes rather complicated operational procedures

Email: ccr@ccr.com.ua

and the numerous changeable requirements of various sponsors.

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

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

www.the-logistics-portal.com

TLPINSIGHT

33.

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

RFID & COLD CHAIN MANAGEMENT buzz in the market that

did not always have control of the chain

technology will allow

all the way to the patient. Control escaped

temperature-sensitive

with change of ownership, and due to

product manufacturers

the number of players in the supply chain

Alex Guillen is currently CEO of Escort Cold Chain Solutions

to finally have seamless

- distributors, cargo companies, freight

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

monitoring from

forwarders, pharmacies and physicians - full

Commercial Operations-Public markets for Novartis Vaccines.

production to patient,

control was difficult. The manufacturer could

In the last few years ECCS has evolved from the exclusive

to be able to monitor

make recommendations, audit and qualify

distributor of Escort data loggers for the cold chain market

all the way to, what we

partners, issue severe warnings, etc. to make

to an independent solution provider of Radio Frequency

call in the industry, “the

sure the cold chain was strictly controlled,

Identification RFID and real-time monitoring solutions. Today

last mile”. However,

but full control was, and still is, what could

ECCS has its own range of temperature monitors and time

biotech and pharma

be described as hard to reach.

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

companies with

communication technologies such as tablets, smartphones and

temperature-sensitive

transferring and managing data in the cloud.

products all seemed

Email: aguillen@escortcoldchain.com

to agree that while

www.escortcoldchain.com

technology was going to take cold chain

W

management beyond

e would think new technologies

the enormous amount of manual work

in cold chain management

needed to program, re-program, download,

would have made great progress in

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

terms of automation in the last few

save and retrieve data loggers, they would

years, particularly with the evolution

still not be able to have full retrievable data

of temperature sensors using RFID

all the way to the patient.

communication, but somehow this has

The interest, of course, by biotech and

not been the case, at least in two of the

pharma companies to evaluate new

industries that should benefit the most

technologies was obvious, and many

from it: biotech and pharma. Let us

pharma companies became active in

analyse what has happened, why it has

investigating new ways to improve their

happened and why we should believe that

method of handling the cold chain, but

things will fortunately change.

despite the great efforts there was one

In the last three years we have heard a lot of

problem: The manufacturer, in most cases,

Throughout the supply chain, all the players certainly did and do their best to reinforce “their” chain, and never compromise the efficacy or quality of product, but due to the amount of players, a solution to make one controlled chain instead of several independent ones, seemed always to offer the best way ahead for the future. After all, several players could always hold to one chain, and by having one chain the manufacturer could configure it and analyse it while other parties could control it and react to it - even the pharmacist or the physician - all with the same understanding: if the cold chain was broken the product would not reach the patient. Nevertheless, despite all the good intentions and strong efforts, cold chain management is still where it was 10 years ago with few, very few exceptions.

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TLPINSIGHT

35.

Tradition and More Tradition

at this; Elpro was perhaps a pioneer with

of these kind of devices are the following:

We see that today even in the USA or

its innovation. A year ago it launched a

data download does not need manual

Europe, and particularly in the UK, strip-

quick view solution for quickly obtaining

intervention; reading through the box

chart recorders are still widely used to

information fast on paper, namely the

is possible so intermediate checkpoints

monitor temperature during transportation

LIBERO. Berlinger is always developing new

can be implemented without the risk of

for pharmaceuticals. Strip-chart recorders

electronic indicators to improve monitoring,

breaking the cold chain; by mixing the

are mechanical loggers that print the

particularly in the last mile, and ECCS (Escort

identification capability of standard RFID

temperature history directly onto a strip

Cold Chain Solutions SA) developed a USB

with temperature data logging it is possible

of paper. They are cheap and they do not

logger that can be read by an Android

to implement an integrated track and trace

require additional equipment or software.

tablet and the data sent to a cloud. All this

and cold chain management solution.

Most users know its limitations but also their

is happening now quite quickly, but these

RFID data loggers are becoming cheaper

practicality; there is no need for software to

developments still require some form of

and cheaper with new developments and

have an idea of the temperature conditions,

manual intervention, and seamless control

the growth of the market, so that in a few

and the driver can simply sign a piece of

without manual or human intervention is

months they should be well suited for box-

paper upon receipt, confirming that he has

what RFID can do. This is the technology that

level monitoring. Still, the cost limits the

seen that the temperature was maintained

not only can provide seamless monitoring

usage at item level for most products but, in

as it should be.

all the way to the last mile, but can also

these cases, a complete solution for the cold

reduce operational costs.

chain that also covers the last mile can be

Technology has had a hard time over the last

implemented with a mix of technology (e.g.

few decades to replace paper, and cold chain

RFID for Cold Chain Management

RFID logger at box level plus an RFID passive

control - not only for pharma, but also for the

While electronic data loggers are similar

label with an integrated TTI at item level or

food industry - was no exception. In fact, the

to the strip-chart recorders, the difference

2D barcodes with item level information

sales in volume for this type of equipment

is that they store the information inside a

being stored on the RFID tag using inference

are numbered in millions, despite its large,

memory that can be downloaded later by

to authenticate the product).

bulky plastic case and high cost of transport.

connecting the device to a PC. They have to

Today there are very few players offering

Nevertheless, alternatives to paper-like ways

be extracted from the isolated box, breaking

RFID solutions for the cold chain, but

to read data are coming, and the answer is of

the cold chain and consequently not

surprisingly the industry that most rapidly

course smartphones and tablets, and for this

allowing intermediate checkpoints along

adopted RFID technology for cold chain

temperature-monitor manufacturers have

the supply chain.

monitoring was fresh produce; growers

already started to put new products on the RFID data loggers on the other hand are

market.

essentially electronic data loggers, with the difference that the data can be downloaded The Swiss seem to be pretty innovative

36. TLPINSIGHT

using a wireless link. The main advantages

www.the-logistics-portal.com

and exporters of fruits and vegetables.

Fruit and vegetable exporters realised that RFID would give them actual data, whereas previously they only used temperature monitors in case there was dispute over

the responsibility of breaking the cold

question is, are these systems good enough

blocked them from taking a step forward

chain. Because of this, they, particularly in

for pharma? Just think that while the classic

to adopting RFID technology for their

South America and South Africa as major

range of control for biotech products like

cold chain management? Probably it is a

export markets, just went for it. Exporters

vaccines is 2-8°C, asparagus and cherries

combination of three factors. Firstly, the

could finally reach their wish: “Monitoring

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

qualification of new products and validation

food from farm to fork” and not only in

excellent accuracy and resolution are

of new processes take a long time and

terms of temperature, but also the much-

fundamental in the conservation of food,

are highly costly in the pharma industry,

needed traceability to give assurance to

just as important as in biotech and pharma.

certainly more than in the food industry.

the consumer that what they had on their

And what about the difference in value, and

Therefore the traditional pharma company

plate really came from where they thought

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

changes something in its operations or

it had come. The most recent case of

find out the cost of shipment of cherries and

process only if is not working any more or if

confusion, with terrible health and economic

the health consequences of broken cold

there is a specific project with a clear reason

consequences, was when Spain was forced

chain in the food industry and you will start

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

to stop its exports of vegetables into the

realising that in fact the food - particularly

the frequency of monitoring). This is good

rest of Europe because E. coli was suspected

perishables - supply chain also has very

until some companies realise that the cost

to have come from their cucumbers. Later

tough regulations, just like pharma and

of waiting sometimes is higher than the cost

it was found that the contamination did

biotech do. I heard a few years ago in one

of innovating. Secondly, this same resistance

not come from Spanish cucumbers, but the

cold chain conference a representative of a

to change did not encourage temperature

economic damage to Spanish growers and

large biotech company saying that perhaps

monitor manufacturers to invest in solutions

exporters was done.

they should also look at what the food

for the pharma or biotech industries. In

industry is doing on cold chain management

other words: why invest in innovation for an

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

industry that will hardly change its current

but it is doubtful many companies took this

solutions anyway? This can be seen by

initiative and there are reasons.

the fact that the number one supplier in

An RFID system manufactured by the company Stepac in Israel was the first to enter this market, as their systems works in such a way that as soon as pallets reach their destination the shipper can see online the condition of their shipment, temperature, humidity and CO2. The switch from electronic data loggers to RFID was followed by a large number of exporters and growers who were happy to pay a bit more for a technology that gave them so much information. Stepac has focused development on the food industry with success, but has also opened a path to change with no return to more traditional systems.

As a reader from the pharma industry, you may think that this is new. It is not. The switch started happening over two years ago and today it is almost complete for some countries, while most pharma companies are still in the RFI (request for information) phase. The “D” is still missing. Now the next

temperature monitoring today, Sensitech, RFID Technology for Pharma

is still the major supplier for the industry,

If the technology is there and most pharma

despite the industry seeing that some of the

and biotech companies know it, what has

new players were being more innovative.

Thirdly, in the pharma industry, no data to prove that a process is safe means that it will not be adopted; so since there was no data that biotech products could be affected by radio frequencies then there was no way to prove the contrary, and therefore biotech companies did not wish to take a chance to be the first ones to do so.

Some biotech companies have been trying to find data and with positive results. A study published in the July/August 2012 edition of the Parenteral Drug Association’s PDA Journal documents research that showed that in vitro test results for more than 100 biopharmaceutical products from eight

www.the-logistics-portal.com

TLPINSIGHT

37.

RFID & COLD CHAIN MANAGEMENT major drug companies demonstrated no

the reader’s firmware). Basically the major

evolve, but so will the solutions available

non-thermal effect by radio frequency

advantage of Intelleflex is its long range

out there integrating RFID with the latest

radiation . This has triggered enthusiasm

facilitating the installation. Both systems

communication technologies.

that something might be about to change.

can suit specific needs and both deserve

Other biotech companies have been

the credit of innovation to be compliant

searching for information with frequent

to the pharma industry. The question is,

RFI on RFID temperature monitoring. And

now that there has been commitment from

this is good news for the industry, as the

these and other valuable manufacturers to

technology itself has never been more ready.

innovate and adapt RFID technology to be

Two companies that have pushed the

suitable for pharma, will pharma and biotech

technology to be suitable for pharma are

companies also take the step to appreciate

Intelleflex and CAEN. Both of their systems

and adopt this innovation? Time will

have their advantages, and I just would like

answer this, but time is not what innovative

to set out the major difference so that the

companies have in excess. It will be up to the

reader can understand what to look for.

pharma company to reach out and benefit

Intelleflex uses standard UHF frequency and

innovation or remain on more traditional

their products are based on both the ISO/IEC

systems despite its limitations and higher

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

operational costs.

Battery Assisted Passive (BAP) and EPCglobal

RFID may also not be the best solution

C1G2 standards, while CAEN RFID developed

for all applications; perhaps in the end it

a technology using standard UHF frequency

will be a combination of RFID and more

based solely on EPCglobal C1G2 standard.

traditional temperature monitors as well

To simplify the matter, the major advantage

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

of Intelleflex is its capacity to read the tags

to integrate data from conventional data

from up to 100 meters in “Class 3” mode

loggers, RFID tags and all the information

and thereby through packaging, though at

that is crucial to the management of the cold

shorter distances. Intelleflex readers can

chain and shipping of products, so that the

also read tags in standard C1G2 mode but

huge amount of data that is collected starts

at much shorter distances. The CAEN RFID

to make sense for the users. For this, pharma

reader has a shorter range because it uses

companies must also be willing to come

standard frequency and could read anything

out to manufacturers and simply ask them

in an environment, but has the advantage

what they want: monitoring, managing data,

that any UHF reader (including standard

shipments, inspecting, tracing, proactive

PDAs) could read their tags (a standard

action or reducing cost. I am sure that either

UHF reader, while it may find/locate the

from today’s players, or from the new ones

tags, they will not be able to read the

to come, the solution is there - as long as

temperature data logs without modifying

they are told what they need. Needs will

38. TLPINSIGHT

The Future of RFID RFID is an established technology, but innovation of types and performance of sensors beyond temperature: humidity, shock, light, CO2 and others using RFID as a form of communication has numerous applications beyond pharma and beyond cold chain. Authentication is the most important: there has been standardisation in protocol such as EPC Global 1 GEN 2 and ISO/IEC 18000-6:2010 as well as the use of UHF as standard frequency in most countries. This has been the first step in allowing RFID technology to help instruments to be compatible with each other and therefore reduce investment capital when sensors are integrated in the company process systems. Developments on different frequencies for more proprietary systems facilitating installation and maintenance will also continue, making it easy for companies to try what RFID has to offer. But the most exciting thing of all will be to see for the first time technology making a difference to the one who will really benefit from it: the patient. Technology today can monitor seamlessly from production to the patient, and he should have the right sometimes to see that cold chain graph or that green light LED that assures him that what he is ingesting has the same efficacy it had when it left production.

Are pharma companies willing to evaluate this scenario? Utopia? I am sure we will soon be there.

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TLPINSIGHT

39.

Face of the Future

ground. They will need to convert their recommendation into a

Global requirements for documenting the authenticity of

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

pharmaceuticals are going to change and change dramatically.

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

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

global markets as a result of supply chain security inefficiencies.

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

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

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

products, or managing the conversion of a manufacturing line to

facto standard that pharmaceutical companies and 3PLs are building

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

towards. Many of the people that work in the pharmaceutical

in doing this without a slowdown in output comes with many

supply chain and logistics field have been anxiously waiting for

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

larger governmental agencies (such as the US Food and Drug

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

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

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

directive that mandates the actual requirements relating to tracking

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

drug shipments and anti-counterfeiting measures. Will governments

for their medications.

mandate a 2D barcode at the unit level? Will there be a pedigree definition? How would inference, the method of identifying the

Planning Ahead

contents of a shipping container to confirm its contents without

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

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

when serialisation and tracking the authenticity of products through

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

the supply chain becomes a reality?

beyond 2013 and what may happen before California requirements start to become law in 2015.

GS1 compliant 2D barcodes are globally recognisable and are, by far, the easiest way to get started on the production line. Many

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

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

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

Electronic Product Code Information System (EPCIS) database

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

that can be synchronised for data integration between system

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

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

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

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

40. TLPINSIGHT

www.the-logistics-portal.com

can track the individual products from manufacturing to local

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

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

the individual item serial numbers contained within the carton

down the supply chain.

it is attached to. Using inference, the time consuming and costly effort of opening each carton to scan individual item codes and

By implementing this approach, the manufacturer is now assured

serial numbers would be essentially eliminated, reducing cost and

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

significantly reducing the risk of the compromising of any cold chain

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

product shipments.

numbers against the serial numbers of the received product and the shipment database, or EPCIS.

With serialisation and e-Pedigree, manufacturers, distributors and couriers will need to focus not only on ensuring quality and efficacy

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

the need for the acceptance of inference.

potentially in the case of Cold Chain shipments.

The Benefits of Inference

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

Inference was regularly discussed in the days leading up to the

pallet labels will more than suffice for basic drug shipments,

original California serialisation plans. This is because inference

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

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

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

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

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

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

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TLPINSIGHT

41.

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

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

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

effective alternative to the standard printed barcode approach. The

entire contents of the container could become compromised.

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

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

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

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

cold chain products that need to be consistently monitored on their

In the area of temperature monitoring, the commonly used USB

journey.

data loggers or chemical recorders will provide a record of the temperatures and any deviations during the shipping process. The

Peter Norton is a supply chain consultant with Intelleflex Corporation.

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

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

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

chain and logistics industry. Email Peter at pnorton@intelleflex.com.

print device and, in the case of the USB tags, this compromises the contents when the carton is opened.

For drug manufacturers developing their strategies for managing the shipment of cold chain products requiring serialisation and/or security tracking, or those who are trying to reduce costs, there is another RFID solution that should be considered. Battery Assisted Passive RFID tags, compared to standard temperature recording data loggers or passive tags, are capable of performing many of the functions that previously required more than one device to handle.

Because they can offer sizeable memory, 2 years of battery life and can be read through a pharmaceutical shipping carton, they can be used in transit to show temperature and serial number content. Data can also be entered along the route to record changes in the chain of custody.

When these enhanced features are combined with inference, these newer RFID tags allow any serialised shipment to be read and recorded as part of the chain of custody logging. And, in the case of cold chain products, the current and shipping temperature logs can also be read at the same time – all without even opening the box!

Global manufacturers starting down the serialisation path and

42. TLPINSIGHT

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Š 2012 by Intelleflex Corporation – Used with permission

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TLPINSIGHT

43.

T

he growth in demand for biologics and preventative

distributed.

medicines will only lead to further increase the amount

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

of temperature-sensitive products moving though the global

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

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

Shipping across international borders adds complexities above those

temperature-sensitive and the requirements for high-value,

of domestic transport due to fragmented supply chains, extreme

life saving healthcare products such as blood plasma, insulin,

ambient temperatures and the infrastructure of those countries

vaccines and other biological pharmaceuticals are at an all-time

through which the product must pass.

high.

Airfreight is the most expensive mode of transportation and as such, This means that there is also a rise in the need for safe and effective

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

global transportation of these products and as such, industry experts

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

predict that the world cold chain market for healthcare products will

often transported via multiple flights that include stopovers: this

grow by 10 per cent year on year.

increases the route’s complexity, duration and touch points where things can go wrong.

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

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

pharmaceutical industry in the safe transportation of temperature-

procedures and customs that affect international shipments and

controlled pharmaceutical products is to keep the temperature

can result in delays. The infrastructure differs greatly from more

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

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

per cent of temperature-sensitive healthcare products have to be

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

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

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

chain can compromise drug or sample integrity, breach security,

goods and has a thorough understanding of their requirements,

delay shipments and ultimately result in financial loss or liability.

while a country such as India has a poor modern transport infrastructure which could result in additional overland transport of

Packaging systems, transport companies, freight forwarders and

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

airlines all need to take the necessary measurements to ensure

but delays are possible due to custom regulations. Regulatory

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

requirements are only increasing, particularly in emerging

easy task, especially when multiple handlers are active within the

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

cold chain or different products with different temperatures are

implications.

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Assessing the options

Small units may use single-use chemical reactions or pressure

Being able to ensure that a shipment will remain within a

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

temperature range for an extended period of time largely comes

units resemble large freezers, fridges or cold rooms and include

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

heating or cooling elements that power air through heat exchangers

method.

and circulate it around the product space.

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

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

the ambient temperatures experienced are important in deciding

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

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

is needed, dry ice or conventional refrigeration are the typical

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

methods, using electrically driven or fuel-powered compressors.

containers, to 40 foot vehicles, which have their own powered refrigeration units.

Because active systems are reliant on external power sources there are higher cost implications and restrictions on handling

For high-value products that have strict temperature requirements,

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

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

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

environment and temperature during transport are active solutions

intervention during transit to either physically replace or recharge

or passive temperature-controlled packaging. But which option

the batteries or re-ice after 72 hours.

provides the best and most cost-effective solution? The decision can be reached through assessing the different transport and product

Units are fitted with control and data logging systems to monitor

requirements: reviewing the market, quantity, timing, destination

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

and of course cost.

ambient temperature, as well as door openings and alarms for temperature deviations and system failures.

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

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

a refrigerator, generally the containers maintain a thermostatically

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

controlled environment based on two technologies: compressor

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

cooling and electric heating or dry ice refrigeration using a

and additional costs might be incurred to deliver the system to

compressor.

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

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TLPINSIGHT

45.

of thermal protection for its mapped-out journey. The combination of this blend of componentry acts to keep the temperature of the payload area within a certain temperature range for a specific time system often requires limited preparation and can be packed simply following a standard operating procedure (SOP). However, active systems are generally only cost-effective in large volumes, as partial loads incur similar costs to full loads. This is because the system still requires the same level of handling and the product transported does not significantly alter the system volume and weight.

Passive packaging

up to 120 hours. The use of different component configurations enables the system to cope with a wide range of ambient temperatures.

The passive packing system requires components to be prepared before being packed around the product. This preparation requires the phase change materials to be preconditioned and maintained at specified temperatures 24 to 48 hours before packing, until the systems are ready to be assembled.

Whilst ‘less intelligent’ than an active system, passive, by nature means that once the system has been ‘packed up’ it is then not interfered with at any point during its journey.

Passive temperature-controlled packaging works by combining components usually manufactured from a variety of commonly found insulation materials such as polystyrene, polyurethane or vacuum insulated panels to provide good insulation without significantly increasing temperature.

Packages can range from single vials to multiple pallets and once assembled for shipping, they can be sealed and dispatched without the need for power supply or the requirement for additional attention from highly trained personnel, who have needed to be educated in temperature-sensitive product transportation handling.

The only changes to the state of the package are due to physical processes caused by the flow of heat through the components, i.e. the melting of ice. With this greater flexibility comes the increased

Systems are packed with temperature stabilisers such as ice, gel, cool packs or other phase-change materials to provide a fixed amount

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option of transporting a passive shipment via more carriers and routes.

process where an in-depth understanding of typical and extreme temperatures a package may encounter is achieved. Compared to active systems, passive packaging has considerably lower capital costs and is available for a range of budgets and performance capabilities. They can provide frozen protection below -20°C by using either the dry ice sublimation phase change at -78°C, or the melting phase change of tailored materials to keep temperatures above - 40°C. There are also passive systems that can maintain +2°C to +25°C and +15°C to +25°C, using both water and specialised phase change materials. However, their main

“

Compared to active systems, passive packaging has considerably lower capital costs and is available for a range of budgets and performance capabilities.

They can provide frozen protection below -20°C

“

Prior to shipment, each passive package goes through a qualification

use is for the maintenance of refrigerated products between +2°C and

By contrast, passive packaging’s basic construction means that it can be shipped without considerable handling restrictions, which in turn offers greater flexibility in terms of having more potential carriers and routes available. However, because of its ‘simplicity’ there is a +8°C, while active systems can be tailored to an exact temperature

general misconception that passive packaging does not perform as

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

well as an active solution.

International transportation

Conclusion

When using an active system a logistics service provider and airline

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

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

whereas passive packaging resists external temperatures for as long

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

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

helping to combat extremes of temperature exposure on the route.

This demands monitoring of the temperatures upon acceptance, in

The decision on whether to use an active system or passive

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

packaging to transport temperature-sensitive products is largely

replacing batteries, as required.

determined by the products’ requirements, the owners approach and attitude to risk, as well as the destination and budget. One

Air transport can involve the product sat on airport tarmac prior

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

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

shipping requirements can be found if you have a comprehensive

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

understanding of the options available.

solutions are fitted with control and data logging systems to monitor and verify events such as start and stop operations as well as cargo and ambient temperatures. These register outside temperatures in order to maintain the required conditions inside the container.

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47.

Passive packaging Can it be packed on-site?

√ Coolant conditioning may be required

Active Systems √ May require specific handling equipment

Can the size be customized to requirements?

√ Can be custom sized to maximize packaging efficiency

X Designs are based on cargo unit load

Can it heat and cool?

X Can maintain temperatures and cool

√ Units with heating only are limited

Are they available globally?

√ Available locally via multiple carriers and routes

√ Dependent on local availability and

√ Yes can be kept on the shelf

√ Dependent on shipping origin and

Are they available immediately?

devices (ULD) sizes

route

destination Does it need management during transportation?

√ Once sealed it needs no further intervention

X Requires management during transit

Can it be used for one-way shipping?

√ Designed to be const-effective for single use

X Multi-use only and must be returned to

Is product space maximised?

√ Size versatile and can ship a single vial

X Only cost-effective in large volumes

Can it handle extreme ambient temperatures?

√ Multiple coolant configurations can be

√ Heating and cooling units available to

adapted for different extremes

handle extreme temperatures

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

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

√ Can be sent via air to any global destination

X Can only go via certified handlers and

Are there any special freight handling requirements?

Can it be used to distribute products anywhere?

a hub at users cost

gerous goods’ and can attract a premium freight charge

not to every country

About the author Kavita Somaroo, Marketing Manager, DS Smith Plastics Cool Logistics Kavita has over eight years experience in the packaging sector, beginning her career in the DG packaging industry and moving to cosmetics, before finding her niche in pharma/cold chain, when she joined DS Smith Plastics Cool Logistics in 2009.

During her time at DS Smith Cool Logistics, Kavita has experienced success through being able to adapt quickly and effectively to the changing market conditions and enjoys working with many of the leading Pharma, Biotech and Clinical Research sector companies to provide solutions that enable the movement of high value products.

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

Contact: kavita.somaroo@dssmith.eu

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“The Life Science and healthcare industry in China holds its own despite the global economic crisis. We are optimistic that this sector will continue to offer promising growth.”

I

ndustry experts predict the biggest growth in

However hurdles for those working in the temperature controlled

temperature controlled pharmaceutical shipments

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

will come from emerging markets. Much of this

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

expected growth is attributed to China’s growing

Logistics Europe in February 2012 think China will not only present

importance in the global pharmaceutical industry.

the greatest business opportunities for cold chain distribution in the BRIC countries, but also the greatest challenges.

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

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

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

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

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

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

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

14%.

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

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

in the West.

industry, however “this growth requires a supporting infrastructure

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

which allows pharmaceutical companies to transport drugs and

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

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

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

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

will continue to offer promising growth.”

risk management strategy to protect the supply chain and skilled

China has proved to be attractive for investors with an influx of companies and global logistics providers in the past few years.

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

professionals with local knowledge of the market is also important to maintain business relationships and deal with issues that might arise in real-time.

Shanghai, together with its four express hubs in the Asia-Pacific Shanghai, Hong Kong, Bangkok and Singapore. DHL plans to use the $175 million Shanghai-based hub to better tap into China’s growing demand for logistics services.

“Opening the new hub today shows how we are confident in the development in China...and this reinforces our commitment to the logistics business,” said CEO Frank Appel.

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TLPINSIGHT

49.

PROMOTIONAL FEATURE | GOOEY GLOBAL

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.

“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”

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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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

✉

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24

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Our databases, in their user-friendly format, give you access to over 55,000 key decision makers from 22 various departments in virtually 192 countries worldwide.

✓

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The first ever communication tool that provides the most up-todate direct key contacts enables airports and airport authorities, airlines, handling agents, GSSAs, freight forwarders, industry suppliers of products/ services and MRO to network with each other.

Is it not time you made the gooey connection?

Request a free demo: info@gooey.uk.com gooey advert 175X230mm.indd 1

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TLPINSIGHT 29/11/2012 51.

0

//INDEX OF ADVERTISERS 17-21. AA CARGO OBC. AA CARGO IBC. AIR CANADA CARGO IFC. SWISS WORLD CARGO 5. SOFTBOX SYSTEMS 7. TURKISH CARGO 11. IATA 13.

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

//EVENTS 11th Annual Cold Chain & Temperature Management Summit - Canada Hyatt Regency, Toronto, Canada - February 25-28, 2013

Pharmaceutical DistrIbution - Central and Eastern Europe 2013 Budapest, Hungary - March 1-1, 2013

Cold Chain Central and Latin America Intercontinental Miramar, Panama City, NAA - March 18-20, 2013

Cool Chain Russia & CIS Summit 2013 Moscow, Russia - March 19-21, 2013

2nd Annual Cold Chain India 2013 Venue to be confirmed, Mumbai, NAA - May 16-17, 2013

Clinical Trial Logistics London, United Kingdom - May 22-23 May 2013

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In this industry the highest level of care is absolute.

What happens when pharmaceutical experts meet shipping experts? You get twice the amount of care.

With uncompromised handling and effective Cool Chain management, our specially trained attendants treat your life-saving pharmaceutical goods with as much care and dedication as you do when developing them. Our AC Absolute° and AC Pharmacair solutions ensure that your shipments will always be in good hands.

More direct destinations and more scheduled departures to and from Canada means we go even further for you than before.

Continuous temperature control • Seamless coordination • The strongest link in your supply chain logistics Think of us as business class for your commodities.

AC Expedair | AC Live | AC Secure | AC DGR | AC General Cargo | AC Compassion | AC Cool Chain | AC Post

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53.

DID YOU KNOW? Our Cold Chain Solutions Speak Multiple Languages

So when your temperature-sensitive cargo needs priority boarding in any of the countries we serve, you can rest assured our efficient, state-of-the-art procedures and select interline partners allow us to deliver uninterrupted, temperature-controlled services, even in hard-to-reach locations. Our network alliances build greater partnerships with our customers because strong links are essential in a global cold chain. Come see why no matter where your freight is headed, we speak your language.

To learn more about our global cold chain solutions for temperature-sensitive cargo, please visit www.aacargo.com.

AACargo.com AmericanAirlines Cargo and ExpediteTC are marks of American Airlines Inc.