The world's most Global Forum's 10th Anniversary Cold Chain 2012 Agenda.pdfIn today’s complex supply chain, constantly evolving regulations, technology developments and cost pressures

presents

Hyatt Regency McCormickPlace, Chicago, ILSeptember 24 - 28, 2012

www.ColdChainPharma.com

What’s New For 2012International Focus Day: Central& Latin America

Collaboration & HarmonizationFocus

Interactive In-Transit Cargo Theft “Table-Top” Exercise

Re-Usable, “Green”, Eco-Friendly& Cost Effective Packaging

Technology Innovation Theater

Breakfast Briefings

United Airlines Site Tour - ChicagoO’Hare International Airport

Global Logistics Case Studies

Topic Focus for 2012Global Compliance: Regulator,Industry and SupportingAgencies Perspectives

Global Supply Chain & Logistics

Stability Management & SupplyChain Data

Cold Chain Packaging – ADeeper Dive for Engineers

Quality Distribution & RiskManagement

Supply Chain Security & Tracking

Clinical Supply

Air Freight

Secure, Cost-Effective Logistics and Quality Proceduresfor your BioPharma Supply Chain

Gold Sponsors:

Silver Sponsors:

Sponsors:

The world's mostcomprehensive & largestnetworking forum fortemperature control! Covering all temperature ranges & life science products:

-20°C -80°C 2-8°C 10-30°C 15-25°C

Choose from 60+ Sessions,Case Studies, Panel Discussions& Networking Round Tables

Keynote Speakers:• United States Pharmacopeia • SINDUSFARMA• MHRA• ANMAT• Johnson & Johnson

Industry Perspectives: • Eli Lilly• Bayer Healthcare• Abbott• Baxter Healthcare• Takeda PharmaceuticalsAmerica, Inc.

• Genentech• Sanofi-Aventis, Mexico• Alexion• Gemedco• Cubist Pharmaceuticals• Human Genome Sciences, Inc.• Grifols, Inc.• PPD• Pfizer - Peru • Forrest Laboratory• Abbott Laboratories• GS1 Healthcare US • IATA• ISTA• TSA• CDC• U.S. Department of Health & Human Services (HHS)

• U.S Department of Justice – Drug EnforcementAdministration (DEA)

• TAPA Americas• Institute For TransfusionMedicine

• Farma Mondo SA• Merck• Novartis• Medco Health Solutions• Cardinal Health Canada• Catalent• Charles River• Lifecell Corp.• GSK – Colombia

Supply Chain Integrity

Global Forum's 10th AnniversaryGlobal Forum's 10th Anniversary

2

September 24 - 28, 2012Hyatt Regency McCormickPlace, Chicago, IL

Dear Life Science Professional,

We are exited to bring you the 10th Anniversary special of the annualCold Chain & Temperature Management Global Forum. Tocelebrate, we are moving to Chicago, you spoke and we listened!

In today’s complex supply chain, constantly evolving regulations,technology developments and cost pressures require the most up to dateinformation, a reality for Supply Chain Healthcare professionals. Join usto learn about the leading solutions, strategies and regulations intemperature controlled distribution from around the world.

The 2012 Global Forum will reflect key challenges in the market andbring you peer-to-peer experiences, networking and hard-hitting newinformation on overcoming the most pressing issues facing temperaturecontrol logistics and QA professionals today.

Make sure to take advantage of all the networking opportunities;review our schedule of events on page 4 for more details!

Don’t miss the world’s most comprehensive and largest networkingforum for temperature control attracting hundreds of supply chainstakeholders including manufacturing professionals, supply chain &logistics partners and regulators & associations from around the globe.

The speakers, sponsors, Advisory Boards and I look forward to welcomeyou to the 10th Anniversary of IQPC`s annual Cold Chain & TemperatureManagement Global Forum this September in Chicago.

Kind regards,

Claudia RubinoSr. Program Director, IQPCwww.coldchainpharma.com

Industry Advisory Board:

Rafik H. Bishara, PhDTechnical Advisor

Mary FosterChair, Packaging and Storage ExpertCommittee, United States Pharmacopeia

Maryann GribbinDirector Quality Assurance, GlobalPharmaceutical Supply Group, Johnson &Johnson

Geoffrey GlauserBiomedical Advanced Research andDevelopment Authority (BARDA), U.S.Department of Health & Human Services(HHS), USA

Bob HeinrichTransportation Advisor, Novartis

Martha KlissManager, US Distribution andImport/Export, UCB Inc.

Arminda O. MonteroDistribution QA Program Manager,Strategic Quality InitiativesGlobalPharmaceutical Operations, Abbott,Mexico

Kevin O'DonnellSenior Partner, Exelsius US & Chair, IATATime & Temperature Task Force

Partner Advisory Board:

Henry AmesStrategic Marketing Director, Sensitech

Nikki CubanVP of Sales and Marketing, On AssetIntelligence

Richard EllingerPresident, Temperature Assurance Group

Larry GordonPresident, Cold Chain Technologies

Andrew MillsCEO, Intelsius

Karl KussowQuality and Validation Manager, FedEx

Kevin LawlerVice President, Sales, Minnesota ThermalScience

Paul HarberPrincipal, Modality Solutions LLC

Gary HutchinsonPresident, Modality Solutions LLC

Berkley StaffordHead of Healthcare Sales - The Americas,Envirotainer, Inc.

Special Thanks to ourAdvisory Boards fortheir Support andGuidance

See what’snew this year

on pages 4-5!

presents Global Forum's 10th AnniversaryGlobal Forum's 10th Anniversary

Why the move to Chicago?

Broadening HorizonsThe US Midwest is home to an extensive community ofbiopharma and life science manufacturers. Meet newcolleagues, share common stories.

Meet you Halfway?Chicago is closer for West Coast biopharma colleaguesto attend the annual September Global Forum. Let’sget networking!

Survey Says!IQPC surveyed participants from previous Cold ChainGlobal Forum asking if the event should move (78%said yes) and to which location. Chicago was the #1 answer.

A Supply Chain EpicenterChicago is dubbed the “transportation hub of theworld”. One million tons of air cargo moved throughO’Hare International Airport in 2011. Freight forwardersand corporations benefit from the extensive distributioninfrastructure, central geography and expresswaynetwork.

A Unique OpportunityUnited Airlines have opened a new state-of-the-art250,000-square-foot facility at O’Hare InternationalAirport. IQPC Cold Chain Global Forum participantshave been invited experience exactly how temperaturecontrol life science products are handled on the groundand in the air. The site tour is complimentary toqualified participants. To see if you qualify please [email protected]

PhillyWe still love ya! - If your travel budget doesn’t stretchto Chicago, Call us. We’ll help you get there. Travelrebates are available for Northeast and Mid-Atlanticbiopharma manufacturers (limited to first 20 registrants)

United Airlines Site TourChicago O’Hare International Airport

Chicago is the hometown of United, theworld’s leading airline. Earlier this year, UnitedCargo began operating out of its new state-of-the-art 250,000-square-foot facility at O’Hare

Airport in Chicago. This is the first facility built specifically for the combined cargooperations of the merged United. The new facility features large freezer, cooler and“controlled room temperature” areas to support the fastest-growing segment of aircargo’s business: shipments requiring temperature-controlled transport. United Airlines is opening their doors to the new facility to IQPC Cold Chain GlobalForum participants to see first-hand the air freight handling and processing that happensat the airport. This is your opportunity to see exactly who handles your products andwhat types of controls are in place to ensure temperature compliance. The tour iscomplimentary to qualified end-user participants and limited to 30 participants. Pleasecontact [email protected] to enquire about availability.

Did you know?As a major supply chain hub, freight forwarders, brokers, and corporations enjoy thesuperior advantages of Chicago's distribution infrastructure, central geography, largeeconomy, and expressway network. Considering O’Hare’s status as an air freight hub,the amount of goods moved via surface transport and the region’s proximity to the U.S.population (nearly one-third of the total U.S. population lives within a 500-mile radiusof Chicago), Chicago can accurately claim to be “the transportation hub of the world.”

Chicago O'Hare International Airport is a global leader in the movement of freight,mail, and goods. The airport consistently ranks in the top 10 in North America andthe top 25 in the world in terms of its annual air cargo volume. More than onemillion tons of air cargo moved through O’Hare in 2011.

O'Hare air cargo is among the nation's and the region's most valuable imports andexports, representing billions of dollars in annual trade, from medicines andmachinery to fine clothing and electronics.

3www.ColdChainPharma.com • 1-800-882-8684 • [email protected]

Welcome to Chicago

Tour Date: Tuesday September 25th Time: 9 AM - 2 PM


What’s New for 2012Temperature Control Logistics and Quality Distribution in Central and Latin America

In today’s global supply chain market, Central & South America is a key market for both manufacturersand suppliers in this space. The geographical area represents unique challenges including meetingregulatory requirements, designing quality strategy for cold chain supply, domestic distribution, optimaltransportation model, risk management and supply chain security. Share best practices with industryleaders and practitioners including:• Pharm. Elina ISE, National Program for the Control of Drugs and Medical Devices Market, National

Administration of Drugs, Food and Medical Devices (ANMAT)• Jair Calixto, Good Practices and Pharmaceutical Audits Manager, SINDUSFARMA• Carlos Castro, Transportation / Cold Chain Project Manager, Bayer Healthcare• Francisco Mello, Country Manager Brazil, Farma Mondo SA – Switzerland• Humberto Laserna, Quality Coordinator, Pfizer – Peru• Diego Rincon, Director, Logistics/Technical, General Medica de Colombia S.A/ Gemedco S.A• Rosalinda Mondragon, IP Manager, Sanofi-Aventis – Mexico• Mr. Carlos Gastelum Avila, Manager Warehouse 23 at Customs of Airport Benito Juarez (Mexico)

Mexico, AAACESA• Staci Hargraves, Senior Director, Global Clinical Supplies, PPD

Technology Innovation Theater

Innovative technology manufacturers and designers will be present and demonstrate theirtechnology in 15 minutes segments at the Technology Innovation Theatre in the Exhibition Hall. Thepresentations will take place during the morning and afternoon networking break. Please see theschedule of events on page 5 for more details.

The IQPC production team is working with the Industry Advisory Board to devise a short list of innovativetechnology manufacturers who will be pre-qualified and invited to present their technology. Participantswill vote for the 'Most Innovative Cold Chain Technology 2012' and the Award will be presentedDay Two of the conference. If you have a suggestion for an innovation to be considered, please visitwww.coldchainpharma.com to download submission form and send to [email protected].

Re-Usable, “Green”, Eco-Friendly & Cost Effective Packaging

The Global Forum will be featuring re-usable & green packaging case studies and panel discussions. Thesessions will tackle key challenges and provide real life solutions including lowering costs, reducingthe carbon footprint associated with materials used, recovery and recycling of materials andimplementation re-usable packaging systems Join us and discover the latest innovation and developmentseffecting cold chain packaging:

• Real Life Implementation Re-Usable Packaging Systems Case Study

• A study in Economics – Consumable Cold Chain Shippers Versus Re-Usable Systems

• Industry/Provider Panel Discussion: Improving Green Packaging Solutions

• Case Study: Achieving 40% Cost Reduction and Carbon footprint: Comparing Passive Versus ActiveShipping for Air Cargo

Breakfast Briefings

Beat the crowds! Join one of our early morning breakfast briefings. Take advantage of this intimatesetting to discuss key topics. Thursday September 27, 7:15am – 8:00am

Briefing A: AgroChemical Cold Chain & Food SafetyBriefing Leader: Jean-Pierre Emond, Ph.D., Director of Cold Chain Research, Georgia Tech ResearchInstitute

Briefing B: CDC Perspective: Challenges in the Providers OfficeBriefing Leader: Patricia Beckenhaupt, RN, MS, MPH, Public Health Analyst, CDC/NCIRD/ISD/VSAB

Briefing C: Challenges Exporting & Importing Controlled Pharmaceuticals from IndiaBriefing Leader: Maheshwar Chilukuri, Faculty – Engineering, Anglo Eastern Maritime Academy


What’s New for 2012Collaboration & Harmonization

Partnerships are not just a buzzword in temp control pharma - it’s the future! With increased globalpharmaceutical operations, including significant growth in emerging markets, the need for more intenseconversations between partners is becoming ever more crucial. This year's event focus will highlight howcompanies are working hand in hand with their 3PL and forwarding partners to overcome barriers in newmarkets, reduce logistics cost and comply with regulatory requirements. Don’t miss out on the conversations:

• 2 part Survey & Panel Discussion: Exploring Partner Provider Collaboration for a One-Stop SourceSolution, Partner Provider Collaboration. Featuring results from our industry survey and lead by JimBacon, Senior Director, Global Demand Planning & Customer Operations, Grifols, Inc.

• Panel discussion: Reactions & Perspectives from Manufacturers and Key Solution Providers on PartnerProvider Collaboration

• Global Supply Chain Harmonization: Strategies to Improve Collaboration with your Freight Forwarder.Carlos Castro, Transportation / Cold Chain Project Manager, Bayer HealthcareMichele Johnson, Supply Chain Consultant, Cubist Pharmaceuticals

• Wholesaler/Manufacturer Partnerships: Improving Communication to Benefit the Customer.Jeffrey Mesaros, Regulatory Affairs Supply Chain, Medco Health SolutionsChris J. Anderson, Director of Quality Systems, Corporate Pharmaceutical Distribution, Cardinal HealthHumberto Laserna, Quality Coordinator, Pfizer – Peru

• Operating a Fully Outsourced Supply Chain Model in a Highly Regulated Environment.Michele Johnson, Supply Chain Consultant, Cubist PharmaceuticalsSue Rogers, Sr. Director - Distribution, Trade & Customer Operations, AlexionLarry Sweeney, Chief Operating Officer, DDN

New Edition of the Transportation & Logistics Management - 2 day Training Course

Today, temperature control is part and parcel of a life science supply chain. A thorough understanding ofall 'its moving parts' as well as every day challenges and responsibilities are essential to contribute valueto its smooth and compliant operations.

This course will give you the tools and understanding of Good Transportation Practices by air, roadand ocean for temperature sensitive healthcare products. Learn the importance of SOP’s and QualityAgreements, trends in distribution and take part in practical demonstrations of packaging solutions andtemperature monitoring. September 24th & 25th, 2012

Led by two well-known air logistics leaders:• Tony Wright, CEO, Exelsius Cold Chain Management • Kevin O’Donnell, Senior Partner, Exelsius Cold Chain Management

Supply Chain Security & Tracking

Growing security concerns and challenges affecting the Supply Chain particularly when operatingglobally has begun to raising eyebrows. This focused track will discuss improving healthcare SupplyChain visibility, track & trace status updates and outlook, RFID technology and steps towards eliminatingcounterfeit products.

• GS1 Standards: Improving Visibility, Safety, and Efficiency in the Healthcare Supply ChainJohn Roberts, Director, GS1 Healthcare US

• Panel Discussion: Supply Chain Track & Trace – How Close Are We? Status Update for 2015Demetra Ashley, Diversion Program Manager, Office of Diversion Control, U.S Department ofJustice – Drug Enforcement Administration (DEA)

• RFID: A promising Solution for the Elimination of Counterfeits?Scott R. Rasmussen, CSCP, CQA, GPO Distribution QA Manager, Abbott Laboratories

The program will also feature an interactive 2 part session:

• Part 1: Standards Overview & Developing a Quality In-Transit Supply Chain Security Program

• Part 2: Interactive: In-Transit Cargo Theft “Table-Top” Exercise


Wednesday, September 26th

10:00AM - 3:00PM United Airlines Site TourChicago O’Hare International Airport United Airlines is opening their doors to the new facility to IQPC Cold Chain Global Forum participants to see first-hand the air freight handling andprocessing that happens at the airport. This is your opportunity to see exactly who handles your products and what types of controls are in place to ensuretemperature compliance. The tour is complimentary to qualified end-user participants and limited to 30 participants. Please enquire with IQPC to registerand for availability or email [email protected]

7:00PM - 9:00PM Welcome Reception at the Hyatt hotelJoin industry colleagues for an informal networking evening to `break the ice` over drinks, meeting new people and seeing familiar faces.

Thursday, September 27th

Tuesday, September 25th

Exhibition Hall & NetworkingSchedule of EventsReview the schedule of events to take advantage of all the networkingopportunities and maximize your time out of the office. There is alwayssomething to do at the Global Forum.

ALL DAY Career Opportunities CenterDon't miss stopping in the Career Opportunities Center to check out the latest career advancement opportunities and job postings, located in theprivate Speakers Corner lounge.

9:30AM - 10:30AM Morning Networking BreakJoin your peers to browse the 2012 Solution Hall where you’ll be able to find all the latest packaging/container, transportation, logistics, temperaturemonitoring, security, and data management solutions. The ideal place to meet existing and new partners.

10:00AM - 10:15AM Innovation Technology Theater Presentations& Take the time to learn about the latest and most innovative technologies available to the industry. These presentations will feature innovative10:15AM - 10:30PM technologies approved by the Global Forum`s advisory board. To nominate an Innovative Technology for presentation, please contact

[email protected]. The Global Forum Innovative Technology Award will be given Thursday at 3:00pm.

3:30PM - 4:30PM Afternoon Networking BreakJoin your peers to browse the 2012 Solution Hall, the ideal place to meet existing and new partners.

4:00PM - 4:15PM Innovation Technology Theater Presentations& Take the time to learn about the latest and most innovative technologies available to the industry. These presentations will feature4:15PM - 4:30PM innovative technologies approved by the Global Forum`s advisory board. To nominate an Innovative Technology for presentation, please

contact [email protected]. The Global Forum Innovative Technology Award will be given Thursday at 3:00pm.

5:45PM - 7:30PM 10th Anniversary Networking Drinks Reception in Exhibition HallJoin us in celebrating the Global Forum’s 10 year Anniversary! It’s been a long day filled with information, time to relax and enjoy great conversationsover drinks.

ALL DAY Career Opportunities CenterDon't miss stopping in the Career Opportunities Center to check out the latest career advancement opportunities and job postings, located in the privateSpeakers Corner lounge.

9:30AM - 10:30AM Speaker's CornerTake advantage of this unique opportunity for a one-on-one to sit down with: Ian Holloway, Head of the Defective Medicines Report Centre, MHRA

9:55AM - 10:55AM Bingo Game and PrizesPick up your Bingo card at the registration booth now; without it you will not be eligible to enter for the outstanding list of prizes. 2011 prizes included anApple iPad; 40inch plasma TV; $500 cash! The card must be completed by 2:35 Networking Break to guarantee entry to prize drawing

9:55AM - 10:55AM Morning Networking BreakBrowse the 2012 Solution Hall, the ideal place to meet existing and new partners.

10:25AM - 10:40AM Innovation Technology Theater Presentations& Take the time to learn about the latest and most innovative technologies available to the industry. These presentations will feature10:40AM - 10:55AM innovative technologies approved by the Global Forum`s advisory board. To nominate an Innovative Technology for presentation, please

contact [email protected]. The Global Forum Innovative Technology Award will be given Thursday at 3:00pm.

2:20PM - 3:05PM Speaker's CornerTake advantage of this unique opportunity for a one-on-one to sit down with: Pharm. Elina ISE, National Program for the Control of Drugs and MedicalDevices Market, National Administration of Drugs, Food and Medical Devices (ANMAT)

2:35PM - 3:35PM Afternoon Networking BreakJoin your peers to browse the 2012 Solution Hall, the ideal place to meet existing and new partners.

3:05PM Innovation Technology Theater Award & PrizesJoin us for in congratulating the Technology Innovation Theater winner. The winner will be selected based on your votes. Please make sure to attend theinnovation theater’s presentations to be eligible for prize.

Pre-Conference Training DaysTwo Day Training: Monday September 24th – Tuesday September 25th, 2012

Good Distribution Practices by Air, Road & Ocean for Temperature Sensitive Healthcare Products:Through interactive learning, case studies and group student participation, this unique training course will provide you with the tools upon which to increase your understandingof end-to-end temperature assurance and the importance of individual practices within the supply chain. Learns the importance of SOP’s and Quality Agreements, trends indistribution and take part in practical demonstrations of packaging solutions and temperature monitoring. The course ends with a fun but serious assessment and certification ofyour learning by taking part in the Cold Chain Game©.

Monday, September 24th

Session 1 10:00-12:15 (11:00 Break) Session 2 1:00-2:30 (1:45 Break) Session 3 3:00-5:00 (4:00 Break)

Welcome & IntroductionThe International World of HealthcareLogistics. Impact of Cold Chain Logisticsgrowth

Case Study 1: Real Drugs for Real People • From research to consumer products

• How? The product development cycle.• Roles and responsibilities in Healthcarecompanies – what’s important to whom ingood distribution?

• The international regulatory environment -what you need to follow and why

Group Exercise 1: Responsibility in thesupply chain: Let’s map it out together!

Good Temperature Management• The 6’P’s’ of Good Temperature Management• Validation and qualification explained• Understanding stability data impact

Introduction to Basic Thermal Dynamics

Protect your drug!What you need to know about active andpassive packaging systems• Choosing the right solution• Universal & seasonal configurations

Group Exercise #2: Practical Packagingdemonstrations: Preparing a ‘Passive’Shipment

Meeting Cold Chain Transportation Requirements• Air Cargo

• Security• Regulations including IATA Chapter 17• Labeling – what & how?

• Ocean & Road Transportation• Ocean Transportation• Road Transportation

Facilities• Temperature mapping • Control

Case Study #2: Real Drugs for Real People • Temperature Monitoring Device – Get set foryour overnight exercise!

Tuesday September 25th

Session 4 9:30-12:00 (11:00 Break) Session 5 1:00-2:30 (1:45 Break) Session 6 2:45-3:20

Review of Yesterday• Temperature monitoring: what we learnedfrom our overnight exercise

Quality management in healthcareLogistics • Quality Systems –purpose & method• Audit preparation & Risk Assessment

Training – what & how

Let’s unpack our ‘shipment’ from yesterday

SOP’s and Quality (Service) Agreements• The role of Quality Agreements • Critical Control Points & KPI’s

Group Exercise #3: An unorthodox look atusing an SOP

CAPA and its role in GDP

Group Exercise #4: CAPA Case Study • What went wrong.? Where, why, • How could we have done better?• Steps for preventive action

Recap• Course Review and Assessment‘The Cold Chain Game©’

Personal Certification

Course Benefits: Gain a detailed understanding of:• The world of healthcare logisticsand globalization pressures

• The various and varies roles withthe logistics supply chain

• The regulatory environment forGood Distribution Practices

• Good temperature management• Passive and Active transportationsolution

• Best practices in Air, Land, andOcean distribution

• Service Level Agreement andSPO’s

• Improving supplier performance• Audit requirements• CAPA• Quality management in logistics

Good Distribution Practices by Air, Road & Ocean for TemperatureSensitive Healthcare ProductsThrough interactive learning, case studies and group student participation,this unique training course will provide you with the tools upon which toincrease your understanding of end-to-end temperature assurance and theimportance of individual practices within the supply chain. Learns theimportance of SOP’s and Quality Agreements, trends in distribution and takepart in practical demonstrations of packaging solutions and temperaturemonitoring. The course ends with a fun but serious assessment andcertification of your learning by taking part in the Cold Chain Game©.


Course Designers and Facilitators:

Tony Wright, CEO of Exelsius Cold Chain Management has many years’ experience of the distribution and temperature-controlled air cargo sector, having worked as a SeniorExecutive with British Airways World Cargo and subsequently as Senior Vice President at Swedish cold-chain container company, Envirotainer. His experiences in these sectors lead Tony toform Exelsius in 2007as an international cool chain management consultancy. Since then the company has progressively developed into a foremost provider of independent leadership,consulting, research and education services to manufacturers, airlines, forwarders and other companies in the life science logistics sector. With its unique cross-sector knowledge of theindustry, Exelsius has been consulted on a diverse range of projects around the world and Tony has been a driving force behind the development of the IATA Chapter 17 Regulations for

Time and Temperature-Sensitive Healthcare Products, having co-authored the publication and chair of the working group that created the Time & Temperature-Sensitive air cargo label. Tony is amember of the Parenteral Drug Association (PDA) and serves on its European Cold Chain Interest Group as well as being an elected member of the IATA ‘Time and Temperature Task Force’.

Kevin O’Donnell is Senior Partner at Exelsius Cold Chain Management. Kevin previously held the position of Director and Technical Advisor to Industry for Tegrant Corporation,ThermoSafe Brands, the world-leading packaging provider for time-and temperature-sensitive healthcare products. Prior to his time at ThermoSafe, Kevin was a Principle PackagingEngineer at Abbott Laboratories Global Pharmaceutical Division. His 26-year career at Abbott included more than 20 years of temperature assurance packaging experience. He retired fromAbbott in 2005. As an engineer, author and educator, Kevin’s 32-years of experience has centered on continuously improving transport packaging, logistics and distribution within thepharmaceutical industry. He is recognized internationally as a key opinion leader and devotes much of his time promoting and implementing good cold-chain distribution practices. His

activities includes: Chair, International Air Transport Association (IATA) Time & Temperature Task Force (2008-2012); Expert Committee Member for Packaging, Storage and Distribution, United StatesPharmacopeia Convention: (2010-2015 cycle); Temporary Advisor and Mentor, World Health Organization; and member of the ISTA Thermal Council

GDPs and Stability Testing – Characterization Studies Ensure Drug Product Formulation SuccessD

3.00 - 6.00

(Reg

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Most Common Mistakes Observed in Cold Chain Pharmaceutical Mail Order PackagingA


Pre-Conference Workshops &Specialist DiscussionsTuesday, September 25th, 2012

This workshop will present different scenarios of cold chain pharmaceutical shipmentsthat did not maintain the required temperature range. The top most common problemswill be presented, allowing teams to work together to determine the cause oftemperature failure and methods to resolve them.

Participants will also:• Understand thermal behavior inside of a cold chain package • Understand the dynamic of temperature distribution inside a shipping package

• Learn about the impacts of shipping environments• Learn about the human factor in a packing line operation

Workshop Leaders:Jean-Pierre Emond, Ph.D., Director of Cold Chain Research, Georgia TechResearch Institute

Melissa Germain, M.Sc., Assistant Director of Cold Chain Research, Georgia TechResearch Institute

Real Solutions to Current Challenges in Cold Chain DistributionC

KPIs and their Association with Dashboards to Help Understand the Logistics Around Product Performance B

Welcome Reception: Join industry colleagues for an informal networking evening to'break the ice' meeting new people and continuing discussions with established contacts.

8.30 - 11.30 (R

egis

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ion

8.00

)11.45 - 2.45 (R

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11.1

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How to Develop an Insulated Shipping Container & Understanding Design ConstraintsEThe development of an Insulated Shipping Container (ISC) is a time consuming processthat requires detailed design specifications to properly design an ISC. The designspecifications will shape the final ISC design making it imperative that these specificationsare well understood and representative of the distribution process. This workshop willaddress the most important design criteria, highlight potential implications, and providethe framework to understand how design criteria will shape your final ISC design.

What will be covered:• ISC design process overview• Identifying your design specifications• Understanding the implications• Team Exercise: ISC design for multiple scenarios

How you will benefit:• Develop the toolset for identifying ISC design specifications• Understand the implications of your ISC design specifications• Develop highly optimized ISC’s• Reduce ISC development time with the correct information the first time around• Reduce your total cost of ownership by reducing deviations and optimizing theratio between packaging and shipping costs

Ben Vanderplas, Global Product Manager for ISC Labs, ThermoSafe Brands

Iftekhar Ahmed, Senior Design Engineer, ThermoSafe Brands

Actual case studies detail successful approaches and effective solutions to the latestissues in temperature-controlled distribution. Participants will gain insight on howother industry players are addressing these issues including:• Using expanded stability for room temperature products to save packaging cost,complexity and freight

• Development of a Bio-degradable shipping system

• Emerging market bulk shipping solution• Optimizing an extended duration shipping solution with PCM• Innovative Physician Sample Shipper• Implementing Temperature Indicators to Improve Patient Experience

Workshop Leader:Anthony (TJ) Rizzo, Director of Sales, Cold Chain Technologies

• Good Distribution Practices (GDP) Pillars and stability testing for distribution• The role of environmental hazards other than temperature on liquid formulations ofbiologics

• Labeled storage conditions vs. temperature excursions during transport• Integrating your Cold Chain Management Systems

• Real world vs. simulation testing – Pros and Cons

Workshop Leaders:Gary Hutchinson, President, Modality-Solutions LLC

Paul Harber, Principal, Modality-Solutions LLC

Timely logistic data related to the distribution of temperature-sensitive medicinalproducts is an important element of any company’s quality initiatives. Throughout thesupply chain, there are many unforeseen and uncontrollable factors that can causeproducts to be exposed to temperatures outside of their acceptable range for storageand distribution. These variations, if not managed carefully, may result in expensiveand time-consuming quarantine processes, a loss of product quality, or irreversibledamage to the product.

Implementing a comprehensive monitoring tool like Cold Stream Cold Chain Manager,a web-based application, linked to Key Performance Indicators (KPIs) and using adashboard, enables managers to review the current state of the supply chain andassess various risks. These reports allow for the implementation of fast and effectivepreventative measures thus minimizing risks in the supply chain.

The workshop will focus on two objectives: • Outlining the methods used to set up appropriate data collection processesenabling the development of meaningful KPIs

• Industry best practices and the pitfalls of data collection and report generationwill be explored

• Lastly, the workshop will demonstrate how certain KPIs can be used to supportcontinuous process improvement.

Workshop Leaders:John Bratz, Manager Life Science Professional Service, Sensitech, Inc.

David Magargee, Lead Project Manager, Industrial Engineer, Sensitech, Inc.

(6:00 PM& Hyatt)


Conference Day One Wednesday, September 26th, 2012

7:00 Registration and Breakfast

7:50 Welcome Remarks Cold Chain IQ, a division of IQPC

7:55 Welcome Remarks by United Airlines

8:00 Temperature Control Distribution Around the World:A Report from IQPC's Global Cold Chain Event Series& Advisors • Feedback from IQPC Dubai: Unique aspects of distribution in theMiddle East and South Africa

• Feedback from IQPC Basel: Pan-European distribution highlights • Feedback from Cold Chain IQ - the international online portal

Rafik H. Bishara, PhD, Technical Advisor & Leader PCCIG, PDA

8:20 UK MHRA Regulatory Perspective on Distribution ofTemperature Controlled Medicines• MHRA Regulatory Provisions for Quality Controlled Distribution ofLife Science Products

• EU Guidelines on Good Distribution of Medicinal Products forHuman Use 94/C 63/03

• Revision Annex 16 of the GMP Guide and the Cold Chain• Best practice recommendations for preparation towardsimplementation of the falsified medicines directive

Ian Holloway, head of the Defective Medicines Report Centre, MHRA

8:55 USP Update & Importance of Chapter 1083• Perspectives for USP General Chapter <1083> and its improvement• Ensuring the integrity of key areas of the supply chain• Good Importation Practices• Combating Counterfeit Drugs, and Diversion and Theft• Addressing major challenges facing pharmaceutical companies in this area

Mary Foster. Chair Expert Committee, Packaging, Storage andDistribution of Drug Products at United States Pharmacopeia

9:30 Morning Networking BreakJoin your peers to browse the 2012 Solution Hall where you’ll be ableto find all the latest packaging/container, transportation, logistics,temperature monitoring, security, and data management solutions.The ideal place to meet existing and new partners.

10:30 Global Compliance A 2 Part Panel Discussion: Join us forthis 2 part Panel Discussion offering regulatory, industry andassociation perspectives on how to meet regulatory requirements bothnationally and internationally.

Moderator:Rafik H. Bishara, PhD, Technical Advisor & Leader PCCIG, PDA

PART 1 - Panel Discussion: Regulatory Perspective:Taking a Coordinated Approach to Understandingand Meeting Global Regulatory Requirements • Mapping - how much is enough? • Examples of acceptable stability data, including in ‘last miles’ • Shipping to label claim in new markets where control and visibility ismore challenging

• Addressing the different monitoring approaches (Ambient or CRT)and monitoring technologies

• Providing the right level of data and information to ensureregulatory satisfaction in case of shipping outside of label

• Ensuring the stability data supports the distribution and or excursion • New guidelines: Brazil, Turkey, China and Russia, ETC • What are the new USP standards that have to be met?• Panelists concerns regarding the supply chain integrity and security?

Part 1 Panelists:Ian Holloway, Head of the Defective Medicines Report Centre, MHRAMary Foster, Chair Expert Committee, Packaging, Storage andDistribution of Drug Products, United States PharmacopeiaFarm. Elina Ise, Coordinadora de Cadena de Distribución, ANMATJair Calixto, Good Practices and Pharmaceutical Audits Manager,SINDUSFARMA

PART 2 - Panel Discussion: Industry and SupportingAgencies Perspective: Taking a CoordinatedApproach to Understanding and Meeting GlobalRegulatory Requirements• Mapping - how much is enough? • Examples of acceptable stability data, including in ‘last miles’ • Shipping to label claim in new markets where control and visibilityis more challenging

• Addressing the different monitoring approaches (Ambient or CRT)and monitoring technologies

• Providing the right level of data and information to ensureregulatory satisfaction and understanding

• Ensuring the stability data supports the distribution and or excursion • New guidelines: Brazil, Turkey, China and Russia • How realistic is harmonization?• How is the end user (patient) protected from counterfeiting,diversion and tampering?

• How does the DEA support the holistic supply chain?• What is the rate of implementing IATA’s Chapter 17 and therecommended label?

Part 2 Panelists:Andrea Gruber, Manager Business Process & Standards, IDFS Cargo,International Air Transport Association (IATA) Demetra Ashley, Diversion Program Manager, Office of DiversionControl, U.S Department of Justice – Drug EnforcementAdministration (DEA)Francisco Mello, Country Manager Brasil, Farma Mondo SA -SwitzerlandChris Fore, Compliance Manager, Envirotainer, Inc.Invited: Bob Seevers, Principal Regulatory Scientist, Eli Lilly & Co.

11:40 Networking Round Table DiscussionsThis is your chance to bring your challenges, issues and share commonideas/mistakes with your peers. Learn from interactive conversationsover common challenges and take them head on! Join one of thenetworking round table discussions lead by industry thought leaders:

1. Addressing Regulatory Challenges on Shipping TemperatureSensitive Medicines to BrazilRound Table Leader: Jair Calixto, Good Practices and PharmaceuticalAudits Manager, SINDUSFARMA

2.Latin America: Risk Management of Cold Chain TransportationCold chain risk in international and national distribution in SouthAmerica. Round Table Leader: Humberto Laserna, QualityCoordinator, Pfizer – Peru

3. Using Customs Tariffs during Export, Transit and ImportRound Table Leader: Robert Heinrich, Sr. Traffic AdministrationAdvisor, Novartis Pharmaceuticals Corporation

4. Vaccine’s “True Last Mile”: Providers Office Storage &Handling PracticesRound Table Leader: Patricia Beckenhaupt, RN, MS, MPH, PublicHealth Analyst, CDC/NCIRD/ISD/VSAB

5. New Technology for Price-Competitive Insulation MaterialsRound Table Leader: Dr. Douglas Smith, Chief Technology Officer,NanoCool LLC

6. Examining Logistics Challenges and Packaging Options toShip Extreme Cold Bulk Internationally

7. Information Technology and Communication in the Supply Chain

8. Defining a Temperature Excursion Global Company Policy

9. FDA Validated Warehouses

10. Practical Experience in China and Russia for ExpeditingPharmaceutical Clearance

11. Developing a Global Shipping Qualification Master PlanIncluding “Last-Mile” Distribution

12:25 Networking Luncheon

OPENING CHAIRPERSO

N'S

REM

ARKS

TRACK A: Cold ChainPackaging – A Deeper Dive forEngineersTrack Chairs: Michael English, Sr. Project Engineer –Packaging Technology,Merck & Co Inc.Tom Pringle, Industry Consultant andEducator, Temperature-Controlled TransportPackaging, Pringle Consulting, LLC

TRACK B: Global Supply Chain& Logistics

Track Chair:Jim Bacon, Senior Director, GlobalDemand Planning & CustomerOperations, Grifols, Inc.

TRACK C: StabilityManagement & Supply ChainData

Track Chair: Bob Seevers, Principal RegulatoryScientist, Eli Lilly & Co.

1:30 Quick Win Networking An opportunity to exchange business cardswith colleagues focusing on packaging

1:35 Refrigerated Product Case Study:Phase Change Materials andThermal Modeling – AdvancingPassive Shipper Design• Overview on Phase Change Materials (PCM)• PCM technical advantages for systemperformance and overall cost reduction

• Thermal modeling benefits in conjunctionwith PCM design

• Leveraging thermal modeling forcontinuous improvement post qualificationand launch

Benjamin Romero, Senior Engineer,Genentech, member of the Roche Group

James Chasteen, Product DevelopmentManager, Cold Chain Technologies

2:15 Case Study: Real LifeImplementation Re-UsablePackaging Systems• Discussing advantages and disadvantages ofre-usable packaging systems

• Case study examples of re-usable packagingin action, including potential pitfalls andcost-saving considerations

• Points to consider in implementing “green”change and re-usable packaging, includingunforeseen risk, costs and matchingprocesses with expectations

• Working with third party solution providersto investigate cost saving measures and“green” technologies

• Staying up to speed with current best-practices in cold chain operations, includingenvironmental impact

Scott Lansdale, Package Engineering,LifeCell

Linda Carducci,Senior Manager, PackageEngineering, Lifecell

Quick Win NetworkingAn opportunity to exchange business cardswith colleagues focusing logistics

Exploring Partner ProviderCollaboration for a One-StopSource Solution Imagine if a number of providers collectivelycreated a cold chain offering. Think of it as aCold Chain Exchange where you are offered achoice of solutions or options based on yourown criteria that provides the best fit for yourbusiness need, risk tolerance, and budget.• A carrier or freight forwarder bringstogether a number of solution providers

• Using existing accepted standards createsan offering that provides / addresses;Qualified Active Cooling, Validated PassiveCooling, Temperature monitoring, End toend process and hand-offs

• Establish set of solutions for ready use• The customer is able to access these providersthrough the carrier / freight forwarder to;Determine best solution and establish Process

Jim Bacon, Senior Director, GlobalDemand Planning & CustomerOperations, Grifols, Inc.

Partner Provider CollaborationSurvey & Panel Discussion:

Part 1: Survey Says…Revealing Manufacturers Perspective onPartner Provider Collaboration A survey will be conducted prior to the GlobalForum collecting information and insightsfrom the manufacturers perspective on SupplyChain collaboration, their needs and biggestchallenges. The results will be revealed in part1 and discussed by industry leaders in part 2.The survey will be available starting June 1ston the global forum’s website. Log on andcontribute to the discussion!

Part 2: Panel DiscussionTackling Compiled Survey Answers:Reactions & Perspectives fromManufacturers and Key SolutionProviders on Partner ProviderCollaborationPanel discussion addressing compiled surveyresults from part 1.• Thoughts on manufacturers survey answers• Current and future initiatives

Quick Win Networking An opportunity to exchange business cardswith colleagues focusing on Data

Time and Temperature Profiles‘Think Tank’ Discussion This session will use several short companycase studies to discuss different scientificapproaches to developing temperatureprofiles and what statistics are being used.The Think Tank discussion will include 2 ‘mini’case studies in addition to ISTA`s perspective:• Case Study 1• Case Study 2• ISTA Thermal Council Perspective

Mike Broughton, Director GlobalLogistics, Eli Lilly & Co.

Maryann Gribbin, Director of QualityAssurance, Johnson & Johnson

Edward Church, President, ISTA

Case Study: Discussing TestingStrategies to Widen ShippingRanges • Understanding what data regulators arelooking for and will accept

• Shipping cycle studies: Various approachesand expectations of regulators

• Understand the supply chain temperaturethat drives the ambient profile

• Addressing Stability data for distribution during validation

Arminda O. Montero, GlobalDistribution QA Program Manager,Abbott Laboratories

Conference Day One ...continued



TRACK A: Cold Chain Packaging –A Deeper Dive for Engineers

TRACK B: Global Supply Chain &Logistics

TRACK C: Stability Management& Supply Chain Data

2:55 From Pallet Shipper to LogisticsTool: Total Cost Analysis of BulkShippers• Examining the increased requirements bypharmaceutical companies for cold chainpackaging beyond temperature protectionand cost of packaging

• Examining how bulk shippers are evolvinginto logistics tools and the multiple layers ofcost:

• Labor cost at origin and destination• Freight cost inbound / outbound / return• Quality costs from estimated loss intransport from assembly errors

• Loss from theft• Packaging cost that now involves re-use ofboth carton and refrigerants

• Assessing sustainability as a total systemequation, not just recyclability

• A case study with pharmaceutical customerthat quantifies total cost and measuresperformance

Chris Day, Vice President US, Sofrigram

3:30 Afternoon Networking BreakJoin your peers to browse the 2012 Solution Hall where you’ll be able to find all the latest packaging/container, transportation, logistics, temperaturemonitoring, security and data management solutions. The ideal place to meet existing and new partners.

• What are major barriers to providercollaboration?

• How can these barriers be overcome?• Do you see a benefit in a one-stop sourcefor solution?

• Are there concerns about investment vs.return?

• Are there existing examples of collaboration?• What are the pros and cons from movingforward with this?

• Can this offering be competitive? • Performance & KPI management for coldchain partners

Moderator:Jim Bacon, Senior Director, GlobalDemand Planning & CustomerOperations, Grifols, Inc.

Panelists:Dana Dallas, Vaccine/cold ChainProgram Manager, Defense LogisticsAgency Troop Support

Berkley Stafford, Head of Healthcare Sales-The Americas,Envirotainer, Inc.

Alan J. Davis, Supply ChainTemperature Control Leader, Johnson& Johnson

Case Study: Shipping ControlRoom Temperature Productswithin TemperatureRequirements • Understanding the regulatory requirements • Meeting internal company expectations • Utilizing product stability data • Regulatory submission data • Temperature profiles – all 4 seasons • Exploring packaging options for yourcontrol room temperature products

• Managing total cost• Product label

Mike Broughton, Director GlobalLogistics, Eli Lilly

Bryan Cardis, Associate Consultant –Packaging Engineering, Eli Lilly

4:30 A Study in Economics –Consumable Cold Chain ShippersVersus Re-Usable Systems• History of reusable containers• Assessment of reusable pallet containers• Small package cold chain shipping solutions• Pros and cons of reusable systems versussingle use shipping systems

• Use a calculator to evaluate the economicsof the single use versus reusable systems

• Building the business case in yourorganization

• Environmentally friendly at a reduced cost

John Howe, Chief Technology Officer,Intelligent Thermal Solutions

Global Cold Chain Supply andTemperature ManagementStrategies for Emerging Markets• Regulatory & operational considerations forcold chain logistics in emerging markets

• Seasonal concerns in the collection andlogistics of time and temperature materials

• New technologies enabling extendedglobal reach

• Case studies in cold chain logistics andpackaging innovations to emergingmarkets

Dan Bell, Director of CommercialOperations / Director RegulatoryCompliance, Marken, Ltd

Pharma Distribution Insightthrough Extended Data MiningData Capture• Secure and reliable data collection throughsimplicity of operation, lean processes andintegration with ERP Systems

• Utilizing global corporate SOP’s andcentrally controlled standard temperatureprofiles based on stability data

Data Processing• User defined standard reports showingtemperature performance with respect totransportation methods, destinations,seasons etc.

• Risk assessment of shipments by analyzingtemperature data not only from anexcursion perspective, but also from a riskperspective

• Identification of bottle necks andevaluation of freight forwarder and carrierperformance by automatic integration ofmilestones

Niclas Ohlson, Chief ExecutiveOfficer, Temperature SensitiveSolutions (TSS)


TRACK A: Cold Chain Packaging –A Deeper Dive for Engineers

TRACK B: Global Supply Chain &Logistics

TRACK C: Stability Management& Supply Chain Data

5:10 Panel Discussion: Industry/Provider Panel Discussion:Improving Green PackagingSolutions • Robust and durable• Custom issues for recyclable boxes• Testing long-term performance or the life ofa re-usable system

• Cost effectively track and recover valuedshipping containers for reuse and/or recycle

• Disposal of units• Options for EPS materials after use

Michael English, Sr. Project Engineer –Packaging Technology,Merck &Co Inc.

Linda Carducci, Senior Manager, PackageEngineering, Lifecell

Tom Pringle, Industry Consultant andEducator, Temperature-Controlled TransportPackaging, Pringle Consulting, LLC

Emilio Frattaruolo, CPP, Product Engineer –BioPharma, Pelican Products, Inc.

Case Study: Developing a SecureCold Chain for a Small toMedium Size Biopharm Company• Using a documented understanding of aproduct stability profile to align theorganization around packaging andshipping requirements

• Developing a broad understanding of riskin your supply lane

• How to choose, develop, and manage thecarrier base

• Moving beyond shipping validation to totallane risk mitigation

• Lessons learned the hard way

Al Forthman, Logistics Manager,Human Genome Sciences, Inc.

Panel Discussion: IntegratingInformation, Supply ChainFunctions and Teams to EnsureEfficient Cross-CountryInformation and Product Flow • What to do with and how to handlecollected data from cold chain logisticsmonitoring tools

• Ensuring awareness across the board throughincreased transparency, data flow betweenemployees, and improved communication

• Integrating best practices and updating standardprocedures to align with industry expectations

• Implementing proper domestic as well asinternational process flow for supply chain

• Aligning and Integrating Supply ChainFunctions and Teams to Ensure EfficientCross-Country Information and Product Flow

• Integrating supply chain data to ensureoptimal shipping lanes, container used,transportation mode… and quality

• Protecting products by having visibility andinformation to intervene shipments andtake corrective actions

Panelists:Roy White, Distribution Manager,Catalent Pharma Solutions

Jamie McNulty, Sr. Manager, SupplyChain, Takeda Pharmaceuticals America, Inc.

David O’Toole, Director, GlobalLogistics & Distribution, Charles River



5:45 End of Conference Day 1

5.45

10th Anniversary Networking Drinks Reception in Exhibition HallJoin your peers to browse the 2012 Solution Hall where you’ll be able to find all the latestpackaging/container, transportation, logistics, temperature monitoring and data management solutions.The ideal place to meet existing and new partners!

7.45 Chicago ConciergeJoin colleagues on the complimentary shuttle bus to take you to a dining ‘hot spot’ in downtown Chicago.The shuttles will return to the Hyatt McCormick

Global Forum's 10th AnniversaryGlobal Forum's 10th Anniversary- 7.15

CONFERENCE DAY TWO Thursday, September 27th, 2012

Breakfast Briefings 7:15 – 8:00 (Optional sessions taking place during breakfast)

A) AgroChemical Cold Chain & Food Safety

B) CDC Perspective: Challenges in the Providers

Office

C) Challenges Exporting &Importing Controlled

Pharmaceuticals from India

Taking lessons from the new FDA Food Safety‘cold chain’ guidance

Jean-Pierre Emond, Ph.D., Director of Cold ChainResearch, Georgia Tech Research Institute

The true “Last Mile”

Patricia Beckenhaupt, RN, MS, MPH, PublicHealth Analyst CDC/NCIRD/ISD/VSAB

Maheshwar Chilukuri, Faculty – Engineering,Anglo Eastern Maritime Academy


7:30 Coffee and Networking and Networking inExhibition Hall

8:20 Opening Remarks by Chairman

8:25 CRT Air Freight: International Challenges toAvoid Delays and Temperature Excursions –Active vs. Passive• Regulatory requirements and increased compliance for CRTproducts

• Demand planning, capacity, and compliance strategies• Addressing speed of delivery, security, visibility and minimalexposure to environmental risks such as temperature extremes

Alan J. Davis, Supply Chain Temperature Control Leader,Johnson & Johnson

Randy Desir, Manager of International Sourcing & SupplierPerformance, Johnson & Johnson

9:00 TSA’s Lessons Learned from the Field & Effortsto Ensure 100% Screening of Air Cargo onPassenger Aircraft• Discussion of congressional law that directed the 100%screening mandate

• TSA’s 2 fold approach to implementing 100% screening ofinternational inbound cargo. Coordination with CBP and otherglobal organizations

• Discussion of Yemen incident that drove escalation of ACASproject. Establishment of DHS working committees andstrategy that enhance coordination with internationalstakeholders

• Advance Air Cargo Screening (ACAS): Detailed discussion ofATS expansion and associated pilot programs. Overview ofACAS procedures

• National Cargo Security Program (NCSP)

Douglas J. Foster, Acting International Branch Chief with U SDepartment of Homeland Security, Transportation SecurityAdministration

Gary E. Lupinacci, Assistant Branch Chief, Certified CargoScreening Program with U S Department of Homeland Security,Transportation Security Administration

9:35 Morning Networking BreakJoin your peers to browse the 2012 Solution Hall where you’ll beable to find all the latest packaging/container, transportation,logistics, temperature monitoring, security and data managementsolutions. The ideal place to meet existing and new partners.

10:35 Panel Discussion: Global Supply ChainHarmonization: Strategies to ImproveCollaboration with your Freight ForwarderWith increased global pharmaceutical operations, includingsignificant growth in emerging markets, the need for more intenseconversations between partners is becoming ever more crucial.The industry is also becoming increasingly competitive as patentsexpire and competition from generic companies increase, makingtime-to-market a crucial success factor. As the pharmaceuticalindustry seeks to outsource non-core activities it creates a greatopportunity for innovative solution providers to go beyond basicfreight management.• Cost-cutting activities i.e. comprehensive review of the fullsupply chain costs

• Cross-divisional activities and increasingly centralized decisionmaking

• Interaction between pharmaceutical companies, freightforwarders and carriers

• Taking `The last mile` into account• Knowledge sharing to optimize processes• Importance of minimizing on/off loading places and transportmode changes of is one of best ways to create time-effectiveand secure solutions

Carlos Castro, Transportation / Cold Chain Project Manager,Bayer Healthcare

Michele Johnson, Supply Chain Consultant, CubistPharmaceuticals

Alan J. Davis, Supply Chain Temperature Control Leader,Johnson & Johnson

David O’Toole, Director, Global, Logistics & Distribution, CharlesRiver

11:20 Case Study: Designing a Pallet Shipper forInternational Shipments of RheumatoidArthritis from US to Latin America• 2-8 C, 96 hours seasonal packout• Testing against a very robust profile that covers cold US andwarm Latin American temperatures

• Collaborating with shipper to use water based pallet shipper• Optimizing design by reducing weight and total cost andimprove temperature performance and compliance

• Objectives achieved: Using Phase Change Materials to deliverhigh degree of compliance and reduced weight of the box,while maintaining and improving payload size

Ken Maltas, VP Engineering, ThermoSafe Brands

Guest speaker from Abbott

11:55 Networking Luncheon

2:20 Afternoon Networking BreakJoin your peers to browse the 2012 Solution Hall where you’ll be able to find all the latest packaging/container, transportation, logistics, temperaturemonitoring, security and data management solutions. The ideal place to meet existing and new partners. Drawing of the Bingo Prizes. Make sure tosubmit your completed Bingo game sheet by 2pm!


Conference Day Two ...continued

TRACK A: Air Freight

Track Chair: Rafik H. Bishara, PhD,Technical Advisor & Leader PCCIG, PDA

TRACK B: Quality Distribution& Risk ManagementTrack Chair: Robert HeinrichSr. Traffic Administration AdvisorNovartis Pharmaceuticals Corporation

TRACK C: Supply ChainSecurity & Tracking

1:00 Quick Win Networking An opportunity to exchange business cardswith colleagues focusing on air freight

1:05 Managing AirfreightTransportation forPharmaceuticals & HealthcareProducts in a ControlledEnvironmentThis presentation addresses the keyexpectations and challenges faced by thelogistics industry for the managing ofairfreight transportation for pharmaceuticals &healthcare products. Based on theseexpectations and challenges an assessment ismade of how these requirements are currentlydelivered and where the most significant risksremain. The presentation will conclude byoutlining a solution that addresses theseindustry needs to minimize key risks.• The weakest links in the airfreight pharma &healthcare logistics process

• How a dedicated global pharma andhealthcare competence can minimize risk

• Assessment of passive and active packagingalternatives in order to optimize carriercapabilities

• How innovative monitoring and visibilitysolutions, involving RFID technology allowsfor the proactive response to in transitissues and events

Steven P. Atcheson, Senior Vice President –Global Strategic Customer Development,Pharma & Healthcare, Kuehne + Nagel, Inc.

1:45 Case Study: Achieving 40% CostReduction and Carbon footprint:Comparing Passive Versus ActiveShipping for Air Cargo• Reducing the costs associated with coldchain shipping (weight, preparation time,direct costs) Active vs. passive

• Reducing the Carbon footprint associatedwith materials used, recovery and recyclingof materials

• Reducing the Carbon footprint during allphases of shipping when using passivesystems vs active systems

Liza Kalfon, Vice President, Emball'Iso Inc.

Client speaker TBD

Quick Win NetworkingAn opportunity to exchange business cardswith colleagues focusing on quality & riskmanagement

Detailed Insight to Supply Chainand Cold Chain Risk Management• Can you over apply the risk concept? Orover engineer? Or over spend!

• A tactical level approach to your transportchoices: can you do point to point bytruck? Then look at other options?Breaking up shipments?

• Examine each touch points in transportand their risk

• Robustness of active vs. passive containers;Preliminary check lists and test shipmentsare used to mitigate risk

• Looking at other industries – how to assessfinancial risk for moves you are planning to take

Geoffrey Glauser, BiomedicalAdvanced Research and DevelopmentAuthority (BARDA), U.S. Departmentof Health & Human Services (HHS)

Case Study: Developing &Implementing a RiskManagement Program toAddress Deviations• Step by step development of the program• Handling documentation of deviationswhen they happen

• Incorporating key metrics and categorizingoccurrences

• Remediation in preventing the occurrences • Analyzing the organization’s globalnumbers and determining how they wouldhave effected the business

• FDA direction and concerns

Roxanne M. Tata , Vice President andChief Quality Officer, Institute ForTransfusion Medicine

Quick Win Networking An opportunity to exchange business cardswith colleagues focusing on Supply Chainsecurity & tracking

GS1 Standards: ImprovingVisibility, Safety, and Efficiency inthe Healthcare Supply Chain Inside view from GS1, the leading globalorganization dedicated to the design andimplementation of global standards andsolutions to improve the efficiency andvisibility of the supply and demand chainsglobally and across sectors. • Update on current pharmaceutical labelingactivities

• Direction of pedigree and track and traceefforts and how they pertain to cold chainproducts

John Roberts, Director, GS1Healthcare US

Panel Discussion: Supply ChainTrack & Trace – How Close AreWe? Status Update for 2015• Clarifying GS1 US and GS1 Globalstandards: Making your value chain morevisible, secure and sustainable

• How to best plan and manage globalinventory and be compliant globally?

• A cost-effective solution• Developing and implementing qualityStandard Operating Procedures

• Identifying tracking techniques andstrategies: Understanding how theyimpact a complex globalized supply chains

• Setting the stage for expanded use ofserialization: California's 2015 pedigreemandate and the European Union’s (EU)ratified Falsified Medicine Directive

• Pharmaceutical Traceability EnhancementCode (RxTEC) Act: The “stepping-stone”to Full Traceability in the U.S.

Panelists:John Roberts, Director, GS1 Healthcare US

Amanda Marchialette, Project Manager,Supply Chain - Global Standards, BaxterHealthcare

Demetra Ashley, Diversion ProgramManager, Office of Diversion Control,U.S Department of Justice – DrugEnforcement Administration (DEA)

1:45

TRACK A: Clinical Supply TRACK B: Quality Distribution &Risk Management

TRACK C: Supply Chain Security& Tracking

3:05 Clinical Trial Materials – ReleaseProcess & Monitoring StabilityStudies for Rest of the World Market • Successfully driving & Managing CTM (Clinical Trial Materials) by utilizing astrategic release plan

• Avoid Launch Delays• Proactive approach – Four pillars : Planning/Organizing/ Coordination/Leading & Controlling

• Packaging process between R & D andCommercial

• Monitoring Stability studies – CTM &Registration batches

• Best Practice to support Global Market

Dinesh Jaiswal, Associate Director, ForrestLaboratory

3:45 Case Study: Developing QualitySupply Chain Operations in Africa • Investigating logistical operations,budgeting and cold chain forecasting inAfrican markets as compared to the US

• Specific regional challenges with supplychain in African countries, includingtransportation and supply obstacles

• Moral and ethical issues with operatingclinical trials in emerging markets

• Feasibility and inherit risk associated withcold chain in emerging markets

• South Africa and lessons learned• Available infrastructure

Staci Hargraves, Senior Director, GlobalClinical Supplies, PPD

4:25 Challenges with Maintaining“The Chain of Condition” inGlobal Shipping for ClinicalSupplies and How to Prosper in2012• Depot setups within different countries andtheir capabilities

• Working with vendors and solutionproviders in the field to develop bestpractices in chain of condition for clinicalsupplies

• Monitoring drug products and keepingtrack of potency and viability of fragilebiologics

• Establishing a stable forecasting andplanning strategy that is in compliance withGDP

• Understanding monitoring considerationsand proactively preparing for short comingsand disasters

Roy White, Distribution Manager, CatalentPharma Solutions

Case Study: How Breaking Glassin the Lab Prevents Broken Glassin the Field• Explore economic drivers to product qualityrisk in the supply chain

• Introduction to simple lab test to evaluateproduct protection

• Learn to estimate the degree of protectionneeded to avoid breakage through the lastmile

• Review best practices in carton design forvial protection

Christopher Renz, PackagingDevelopment Manager, Genentech

Panel Discussion: Operating aFully Outsourced Supply ChainModel in a Highly RegulatedEnvironmentAdapting to changing regulations andtechnology• New cold chain technology• Changing regulations in distribution andsupply chain

• International challenges• Packaging• Time sensitive deliveries

Michele Johnson, Supply ChainConsultant, Cubist Pharmaceuticals

Sue Rogers, Sr. Director - Distribution,Trade & Customer Operations, Alexion

Larry Sweeney, Chief OperatingOfficer, DDN

Panel Discussion: Wholesaler/Manufacturer Partnerships:Improving Communication toBenefit the Customer • Establishing quality agreements betweenparties

• Standardization of quality agreements• Improving packaging to help ensureproduct integrity

• Customer communication and benefits

Jeffrey Mesaros, Regulatory AffairsSupply Chain, Medco HealthSolutions

Chris J. Anderson, Director of QualitySystems, Corporate PharmaceuticalDistribution, Cardinal Health

Humberto Laserna, QualityCoordinator, Pfizer - Peru

RFID: A promising Solution forthe Elimination of Counterfeits?• Analyzing the market drivers, barriers,future outlook and challenges for RFIDadoption in the pharmaceutical industry

• EU anti-counterfeit legislation, proposed USSerialization and Track & Trace legislation

• Low adoption rates due to budget restrictions • Concerns with read accuracy • Proliferation of tag reading hardware orlack there of

• Barcodes as an adjunct data carrier to RFID tags• Use to provide supply chain efficiencies

Scott R. Rasmussen, CSCP, CQA, GPODistribution QA Manager, AbbottLaboratories

Interactive 2 Part Security Session:Part 1: Standards Overview &Developing a Quality In-TransitSupply Chain Security Program• Standards of care & protection (TAPA)• Examining new regulation and the roadtaken to develop these best practices

• Ensuring in-transit supply chain securityinvolves adapting new processes and aconstant analysis of evolving technologies.

• Revisiting standards of supply chain security management systems, developing andimplementing an effective security structure

• Cargo Disruption Trends and Solutions tohelp avoid potential risks

• Analyzing supply chain security initiatives(Pharmaceutical Cargo Security Coalition)

Alan F. Spear, Chair, TAPA Americas

Jamie McNulty, Sr. Manager, SupplyChain, Takeda PharmaceuticalsAmerica, Inc.

Part 2: Interactive: In-TransitCargo Theft “Table-Top” ExerciseWith the growing risk associated with increasedglobal shipments, in-transit security can becompromised at any point throughout thesupply chain. Few companies know what to dowhen the “worst-case” scenario strikes. Beingprepared and taking a proactive approach cansave your organization millions of dollars. Pleasejoin our group of industry experts as theypresent and role play a large-scale cargo theftincident in front of our audience. • The “table-top” exercise will take youthrough a logical and effective step by stepprocess immediately following a cargo loss.

• The exercise is performed in a “theatre-in-the-round” format, where everyone in theaudience will be encouraged to participateand learn from the experience.

• Representatives from key players involved inlarge-scale cargo theft

5:00 End of Conference Day 2


Conference Day Two ...continued

Focus DayFriday, September 28, 2012

Temperature Control Logistics and QualityDistribution in Central and Latin America


8:15 Coffee and Networking and Networking inExhibition Hall

8:50 Opening Remarks by Chairman

9.00 National Administration of Drugs, Food & MedicalTechnology (ANMAT) Perspective: Supply ChainControl in Argentina as Strategy to AssureLegitimacy, Quality, Efficacy and Safety of Medicines• The National Program for the Control of Drugs and MedicalDevices Market: Argentina’s approach against falsified andother illegitimate products

• Enforcement of Good Distribution Practices in Argentina inorder to prevent unlawful products supply: regulatoryframework, relevant features and preventive measures

• Addressing medicines traceability in Argentina: NationalTraceability System, traceability per unit, technologies andmodels, regulatory framework and phased implementation

• Current situation, prospects and challenges

Pharm. Elina ISE, National Program for the Control of Drugs andMedical Devices Market, National Administration of Drugs,Food and Medical Devices (ANMAT)

9:40 Brazil Regulatory Updates & Challenges onShipping Temperature Sensitive Medicines• ANVISA specific guidelines for temperature sensitive medicines• Challenges for pharmaceutical industry• Traceability system for medicines• Secure supply chain• Opportunities for logistic supply chain in Brazil

Jair Calixto, Good Practices and Pharmaceutical Audits Manager,SINDUSFARMA

10:20 Morning Networking Break

10:50 Case Study: Practical Examples from a SwissCompany: An International PharmaceuticalWholesaler Operating in Brazil• How to export medicines to Brazil? -> Rules and practical examples.• When can I buy from Brazil? -> How to export from anemergent market like Brazil.

• Temperature Control Challenges -> Working on the fifth largestcountry in the world (-4ºc to 40ºc)

• Traceability System -> Does it work?• The Brazilian Supply Chain -> The real case. The Big problem?

Francisco Mello, Country Manager Brasil, Farma Mondo SA -Switzerland

11:25 Case Study: Risk Management of Cold ChainTransportation in Latin America• Cold chain risk in international and national distribution inSouth America

• Training plan strategy for all stakeholders• A detailed overview of facilities and qualification• Restrictions in cold chain materials• Regulatory Inspection in cold chain system

Humberto Laserna, Quality Coordinator, Pfizer - Peru

12:00 Networking Lunch

1:00 Case Study: Selecting the Optimal TransportationModel for Temperature Control ProductShipments to Columbia• Challenges in dealing with inadequate infrastructure• Regulations not aligned with leading countries• Last Mile: ensuring product integrity through to the end consumer

• Security challenges in Columbia

Diego Rincon, Director, Logistics/Technical, General Medica deColombia S.A/ Gemedco S.A

1:35 Case Study: Designing a Quality Strategy forCold Chain Supply in Latin & Central America• Exposing the cold chain risk in international and nationaldistribution in Latin America

• Developing training and planning strategies for all stakeholders• Good Manufacturing Practices (GMPs) and Good DistributionPractices (GDPs)

• Cold chain strategy against temperature excursions andcompliance

• A detailed overview of facilities and qualification

Rosalinda Mondragon, IP Manager, Sanofi-Aventis Mexico

2:10 Panel Discussion: Collaborating with Affiliatesand ‘Sister Companies’ to Share Cold ChainExpertise and Choose the Right Solutions forDomestic Distribution Latin & Central America• Planning for delays• Dissemination of cold chain information to emerging marketcolleagues

• Addressing the challenges in finding reliable routings• Reducing risk related to natural disaster and war zones• Ensuring a quality Supply Chain security program• Collaborating with internal supply chain partners to ensure athorough understanding of risk and a fluid execution ofsecurity programs


Rosalinda Mondragon, IP Manager, Sanofi-Aventis Mexico

Jamie McNulty, Sr. Manager, Supply Chain, TakedaPharmaceuticals America, Inc.

2:50 Afternoon Networking Break

3:20 Colombian Regulatory Perspective onTransportation and Distribution of TemperatureControlled Medicines.• Regulation of Transportation and Distribution of TemperatureControlled Medicines: Key points and regulatory requirementsin Colombia.

• Regulatory comparison between Colombia Vs leading countries• Regulatory Challenges specific to Colombia

Laura Galvis, Senior Regulatory Advisor, GlaxoSmithKline -Colombia

3:55 Panel Discussion: Facilitating Entry into Mexicoand Brazil• Secure Ground Transportation• Country infrastructures• Partnering strategies to improve overall supply chain qualityand lower costs

• Ensuring GMP and GDP compliance

Mr. Carlos Gastelum Avila, Manager Warehouse 23 at Customsof Airport Benito Juarez Mexico, AAACESA


Staci Hargraves, Senior Director, Global Clinical Supplies, PPD

Jair Calixto, Gerente Boas Práticas e Auditorias Farmacêuticas,SINDUSFARMA

4:35 End of Conference

Sponsors

17

Gold Sponsors

American Airlines CargoWebsite: www.AACargo.comAmerican Airlines CargoSM, a division of American Airlines, Inc., provides one of the largest cargo networks in the world, withcargo terminals and interline connections available across the globe. American’s global network serves over 250 cities in 40countries worldwide; including major cities in the United States, Europe, Canada, Mexico, the Caribbean, Latin America and Asia.American Airlines Cargo provides Cold-Chain transport utilizing its temperature controlled ExpediteTCSM product. ExpediteTCSMprovides priority boarding, priority handling, fastest flight connections, high-visibility shipment tracking, automatic statusnotifications, and a 100% guarantee to be flown-as-booked.

Cold Chain Technologies (CCT)Website: www.coldchaintech.comCold Chain Technologies (CCT) is a leading global provider of insulated thermal packaging solutions that protect the integrity oftemperature sensitive products. We offer a wide range of cost-effective packaging options for JIT delivery, including standard andcustom KoolTemp containers, Koolit refrigerants and temperature indicators and loggers. Our team of experts draws uponunrivaled experience throughout the cold chain, from design and testing to thermal modeling and total project management.With multiple sites across the U.S. and partnership in Europe, we provide local support of global shipping needs, ensuring productsafety through the industry's largest selection of smart solutions.

EnvirotainerWebsite: www.envirotainer.comPioneer and market leader Envirotainer offers flexible leasing (rental) of advanced transport solutions for worldwide air cargoshipments of temperature-sensitive products. Customers within the healthcare, life sciences and high-tech industries benefit fromthe combination of advanced container technology, extensive cold chain management services and a global network of servicepartners, airlines and forwarders – providing a unique one-way leasing service. Envirotainer secures the safety and integrity ofproduct cold chains by providing an active temperature-control system, training all parties along the cold chain and supportingcustomers in transport validations and risk management. With sales representation in 17 countries, the company has its R&D,Manufacturing and Quality Assurance departments at the headquarter premises in Lagga Marma near Stockholm, Sweden.

Intelligent Thermal Solutions Intelligent Thermal Solutions is a south Texas company headquartered in Kingsville, TX previously known as Active CC Boxes LLC.ITS manufactures reusable cold chain shipping containers with extended hold times meeting the unique safety needs ofpharmaceutical and biologics companies. EcoTherm™ containers overcome the cumbersome limitations of corrugated boxes linedwith polystyrene or urethane insulation and filled with dry ice or frozen gel packs. The technology in EcoTherm™ containers wasrecognized in 2002 with the Dupont Gold Award for packaging design innovation for cold chain, and the 2002 R&D 100 Awardsrecognizing the 100 most technologically-significant products of 2002.

MarkenWebsite: www.marken.comMarken is one of the leading suppliers of cold-chain logistics for clinical supplies worldwide. Temperature-control during thehandling, storage and distribution of cold-chain products is a critical element of the clinical trial process. Our expertise is of criticalimportance to ensuring the safe arrival of high value shipments to sites. We provide:• Global distribution of temperature controlled trial medication, vaccines & CTM • Temperature control monitoring for ambient, 2-8C and frozen products to maintain integrity of supplies • Advice on packaging materials and provision of containers for global transportation • Refrigerated trucking services • Customs brokerage accelerating clearance

Minnesota Thermal Science, LLCWebsite: www.goldenhourtechnology.comMinnesota Thermal Science, LLC develops unique storage and shipping systems that address the challenges of maintaining constant andpredictable temperatures when transporting temperature sensitive medical materials. Founded in 2004 following an industry wide searchby the Walter Reed Army Institute of Research for a more effective combat environment container, MTS has continued to apply itstechnology to handle other important medical materials including all types of biomaterials and pharmaceuticals that require controlledtemperatures Its patent pending Golden Hour® Technology, winner of a "U.S. Army Greatest Inventions" award, is credited with savingsoldier's lives on the battlefield and with revolutionizing the methods used for distributing temperature sensitive medical supplies.

SofrigamWebsite: www.en.sofrigam.comSofrigam’s expertise, packaging which warranty the cold chain security. Sofrigam designs and qualifies isothermal and refrigeratedpackaging enabling the transport of heat sensitive products (fresh or frozen) in non-refrigerated vehicles. The materials used associatedwith the expertise of our engineers and our Laboratory, mean our products are suitable for sectors that are VERY demanding with regardto quality and safety, such as the pharmaceutical, chemical, biotechnology and even agri-food industries. We offer our clients a range ofstandard or made-to-measure products and services enabling them to establish secure, economical and ecological cold chain logistics.

ThermoSafe BrandsWebsite: www.thermosafe.comThermoSafe Brands, a Strategic Business Unit of Tegrant Corporation, is the leading provider of temperature assurance solutions.Tegrant Corporation is a premier manufacturer of a variety of highly engineered packaging solutions and energy efficientcomponents with over 35 manufacturing and testing facilities across North America and approximately 2,100 employees.ThermoSafe Brands complete portfolio of transport assurance and temperature assurance shipping products for the safe andefficient transportation of bio-substances, blood and other sensitive specimens across the entire temperature continuum. Ourportfolio includes an extensive array of expanded polystyrene and polyurethane insulated shipping containers, refrigerants in awide range of temperatures and configurations, pre-qualified shipping systems for off-the-shelf ease of use and peace of mind. Inaddition, ThermoSafe Brands’ ISC Labs brings our customers experience and innovation in package design and certifiedindependent testing services to meet all regulatory requirements and concerns.

Sponsors ...continued

Silver Sponsors

Modality SolutionsWebsite: www.modality-solutions.com/Integrate Your Cold Chain Management Systems.Modality Solutions’ subject-matter experts provide insight into cold chain thermal package engineering, transport validation, andcontrolled-environment logistics solutions in highly-regulated industries. We are specialists in the Biopharmaceutical and Health,Nutrition, and Wellness industries.Our unique Advantage Transport Simulation Laboratory provides valuable data on the impact of environmental hazards to critical-to-quality attributes of biologic drug formulations. We decrease product development cycle times by helping our clientsunderstand and protect against the impact of temperature, humidity, shock, vibration, and pressure changes.We help enhance the reputation of our clients by ensuring regulatory compliance, product quality, and patient safety duringshipment of clinical trials to patients and commercial distribution around the globe

OnAsset Intelligence Inc.Website: www.onasset.comOnAsset Intelligence Inc. is a leading provider of wireless devices and software solutions focused on helping customers wirelesslylocate, track, connect, and manage fixed and mobile assets in real-time. The company’s machine-to-machine (M2M) products andservices include SENTRY™ wireless hardware with its flagship product line FlightSafe™ for tracking high-value air cargo includingpharmaceuticals, electronics, and even large equipment, and ContainerSafe™ for intermodal container security, its web-basedOnAsset Platform™, and global wireless connectivity services. The company is headquartered in Irving, Texas.

Sponsors:

AcuTemp Thermal SystemsWebsite: www.acutemp.comAcuTemp Thermal Systems designs and manufactures cold chain temperature management solutions to maintain valuable andoften life-saving payloads at the right temperature during storage or transport. AcuTemp combines thermal expertise andengineering know-how to produce highly efficient passive and powered delivery solutions, from small boxes and carriers to largepallet-sized shipping containers. The company’s newest product, the AcuTemp AX2100L thermal pallet shipper, provides reliablecompressor-based heating and cooling functionality with state-of-the-art data logging capabilities to ensure accurate temperaturemonitoring. When it’s critical, use AcuTemp: The Right Temperature. From the Experts.

Air Canada Website: www.aircanadacargo.comAir Canada is Canada’s largest full-service airline and the largest provider of scheduled passenger services in the Canadian market,the Canada – U.S. transborder market and in the international market to and from Canada. The airline’s cargo division Air CanadaCargo, provides direct cargo service to over 150 destinations on five continents as well as extended global coverage throughinterline partnerships and Road Feeder & Trucking connections between key business centres.Their team of industry-leading experts offers customers a unique set of business solutions tailored to meet the shippingcommunity’s needs efficiently and cost-effectively. Customers may choose from a range of Shipping Solutions from pets, toprecious art and life-saving vaccines. Shipping options, Priority 1 or Standard, are determined by several factors including the typeof shipment and handling requirements.In 2010, Air Canada became the first air cargo carrier to offer a comprehensive mobile shipment tracking solution. The Air CanadaCargo application (App) is integrated into the current Air Canada mobile application giving customers instant access to real-timeinformation about their shipments at their fingertips.To learn more, please visit www.aircanadacargo.com.

American Thermal InstrumentsWebsite: www.americanthermal.comFounded in 1981, American Thermal Instruments, Inc. provides temperature monitoring solutions for the pharmaceutical andbiopharmaceutical market. Products include liquid crystal thermometers, irreversible temperature indicators, color changingproducts, microencapsulation services, and Log-ic® electronic content monitoring. Log-ic® gives you the most complete and costeffective coverage for temperature monitoring. The durable, compact RFID tags eliminate the risks of fragile electronic sensors andoffer an efficient solution at the unit, case, pallet or truck level. The Log-ic® system is revolutionizing the Cold Chain industry.ATI's advanced technology and customized solutions allow businesses to monitor, investigate and minimize temperatureexcursions at any point in the supply chain, easily and cost-effectively. When temperature matters, ATI reduces risk with rapid,accurate and comprehensive decision support tools. Our facility is ISO 9001 certified, FDA registered, and operates under cGMP.

BerlingerWebsite: www.berlinger.comInnovation has propelled the Berlinger Company through the past 150 years. Our customer base challenges us to build intelligentdecision making tools for the entire cold chain process. Now a temperature sensitive product can be monitored through the entiredistribution cycle, including the last mile. Berlinger products are approved by the WHO, UNICEF, and PATH. They are used formonitoring product temperatures in storage and transportation. We welcome your next temperature monitoring challenge.



British Airways World CargoWebsite: www.baworldcargo.com/constantclimateConstant climate introductionIf you need to transport vaccines, biotech products or any other temperature-sensitive pharmaceutical material, Constant Climateprovides all the care and precision you could ask for to make sure it stays in perfect condition every step of the way. ConstantClimate offers you 2 products for you to choose from:• Constant Climate Active • Using sophisticated Envirotainers, Constant Climate Active keeps your product temperature stable. It supports temperaturebetween -20°C and +20°C.

• Constant Climate Passive• Designed for the transportation of pre-packaged shipments to maintain desired product temperatures. Our procedures protectthe integrity and quality of your pharmaceutical products.

• For all your temperature sensitive pharmaceuticals, British Airways World Cargo always has a solution.

Catalent Pharma Solutions14 Schoolhouse RoadSomerset, NJ 08873 | Tel: 1-866-720-3148 | Email: [email protected] drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success.With over 75 years of experience, we have the deepest expertise, the broadest offerings, and the most innovative technologies tohelp you get more molecules to market faster, enhance product performance and provide superior, reliable manufacturing andpackaging results.Catalent. More products. Better treatments. Reliably supplied.™

Cavalier LogisticsWebsite: www.cavlog.comCavalier Logistics is dedicated to providing “Turn-Key Cold Chain Solutions” for business in the Life and Analytical Sciences,Pharmaceutical Manufacturing, Diagnostic Kit Manufacturing, Vaccine and Healthcare Providers. In addition, we provide servicegovernment agencies that are responsible for the stockpiling and rapid deployment of pharmaceutical products for disaster andpandemic relief. We offer a unique service to healthcare providers because we can provide one-stop 3PL logistical services fromthe point of manufacture, in Cavalier validated refrigerated equipment. We also have validated 5°-C, -10°-C to -40°- C, -80°-Cand -156°-C storage at our Washington D.C. Headquarters. Our Washington Headquarters is licensed by the United States DrugEnforcement Agency and the Commonwealth of Virginia Board of Pharmacy to house and distribute schedule 2-6 pharmaceuticalproducts. We provide seamless third party logistical services for high value vaccines, clinical trial samples, specimens, reagents anda multitude of products that require expert handling.

CryopakWebsite: www.cryopak.comCryopak (a TCP Reliable Company), specializes in the field of temperature controlled packaging and services including packagedesign, qualification, testing manufacturing insulated shippers, refrigerants, phase change materials and temperature monitors. Allservices are provided in strict conformance with ISO 9001:2000, ISTA and ASTM test methodology, and FDA good manufacturingpractices. TCP maintains facilities in Quebec, British Columbia, New Jersey and France.

CryoportWebsite: www.cryoport.comThe Cryoport Express® provides the highest frozen clinical specimen integrity available, lowers frozen shipping costs, incentivizesclinical sites and client labs to enroll more patients, provides significant competitive advantages to clinical trial sponsors, CROs anddiagnostic labs, improves the integrity of clinical specimen collection, and will contribute to every company’s green andsustainability initiatives. The Cryoport Express offers 10+ days holding time at -150°C in an advanced, light-weight liquid nitrogenvapor (LN2-vapor) Dry Shipper that comes pre-filled with liquid nitrogen, is pre-packaged and specially designed for globalshipping, is NON-hazardous, produces virtually no waste products and is reused and recycled by Cryoport, Inc. Cryoport alsoarranges and manages all of the logistics of the shipment, including the preparation of all of the paperwork necessary for thetransit of the shipper and tracking and monitoring the shipment throughout its journey.

DDNWebsite: www.ddnnet.comA subsidiary of the 151-year-old Dohmen Company, DDN is headquartered in Menomonee Falls, Wis., with distribution facilitieslocated in Memphis, Tenn. and Ontario, Calif. DDN has become the largest privately held provider of outsourced channelmanagement and business services to the life science industry by streamlining processes, reducing costs and improving efficienciesfor emerging, mid-tier and market leading life science companies. By providing superior business processes and operations, DDNfrees manufacturers’ resources for R&D, acquisition and other core initiatives. DDN now offers data analytics services and recentlylaunched DDN Medical Affairs, providing specialized regulatory knowledge in preparing adverse event reports, labelingmanagement, product complaints and medical and technical product inquiries. For more information please call 888-374-8873.

DGP IntelsiusWebsite: www.intelsius.comIncorporated in 1998, DGP Intelsius specializes in the design, manufacture and supply of temperature-controlled packaging andregulatory-compliant sample transport solutions. With a strong focus on developing environmentally sustainable products andprocedures, we offer clients an eco-friendly way to ensure the integrity of their products. DGP Intelsius has a growing globalpresence, with manufacturing facilities, distribution hubs and local offices situated throughout the world, including NorthAmerica, Europe and Asia.

DHL Same DayThe special services subsidiary of DHL Express, Global Same Day has more than 30 years of experience in the white glove next flightout, hand carry, charter and dedicated drive delivery to support the life science industry. Its global network provides superior serviceand local knowledge 24/7/365. Including benefits such as market leading GPS tracking (Smart Sentry), temperature monitoring,customized packaging and up to the minute shipment information via SMS texting, email or phone. DHL Same Day is dedicated toproviding everything necessary to satisfy the requirements of sensitive and/or time critical life science shipping requirements.Web: www.dhlsameday.com; www.howfastisfast.com | Contact: [email protected] | Phone: 800-DHL-ASAP 19


Emball'Iso Website: www.emballiso.comFounded in 1990 by chemical engineer Pierre Casoli, Emball’iso designs, manufactures, tests and qualifies temperature controlledpackaging, working in partnership with major pharmaceutical groups for the protection of their thermo sensitive products intransit.• an international presence to support you in your projects with its factories and teams in Europe, Asia and North America • a team of 200 employees in the 6 production sites: France, Germany, China, Singapor and United States • a R&D facility which studies and develops solutions for the future • commitment to continuous improvement, efficiency and quality resulting in accreditation to Iso 9001V2000 in 2006 and ISO14001 in May 2011

• growing business turnover with 40% of production now exported Emball’iso continues to demonstrate its commitment to its development: the company invested more than 4.5 million Euros in thebuilding of new premises to satisfy the growth of its major clients, to enhance production efficiency and to meet safety standards.Emball’Iso also incorporated in North America with a business development office at the Science Center in Philadelphia and iscurrently opening a local production facility in Lebanon, PA.

Elpro Services, Inc.Website: www.elpro.comElpro Services, Inc. is a leading manufacturer of high quality temperature, humidity, and CO2 dataloggers, providing recording andmonitoring solutions while observing regulatory compliances (GMP/GLP/FDA 21CFR11). LAN/W-LAN solutions are fully scalable tomeet your central monitoring requirements and future growth. Our New Libero PDF-logger® (No Software Required) providessimple cold chain monitoring of temperature sensitive pharmaceuticals. This ground-breaking concept of producing the report in aPDF file eliminates the need to install, qualify and validate any specific software at destination. Available in 100 and 400 daymodels, our Libero PDFlogger ® also supports compliance with FDA standard 21 CFR 11.

EnviroCoolerWebsite: www.envirocooler.comEnviroCooler® LLC is the innovation leader in the manufacture, design and implementation of validated global solutions for thesafe and compliant transportation of Temperature-Sensitive-Products (TSPs). EnviroCooler®s patented product portfolio is dividedinto 4 distinct categories: Parcel Loads; Pallet Loads; Tank Loads; and Bottle & Bag loads. Each category is supported byEnviroCooler®’s patented design technology platforms and is available for both long-lane (PUR) and short-lane (EPS) options,assuring cost-effective transportation for your products. EnviroCooler LLC Global Supply Locations: California (US); Kentucky (US);Puerto Rico (US); Ireland (EU); Australia (AP). Soon to come online: Singapore (Asia); Central Europe (EU); South America (SA).

EnvirotainerWebsite: www.envirotainer.comPioneer and market leader Envirotainer offers flexible leasing (rental) of advanced transport solutions for worldwide air cargoshipments of temperature-sensitive products. Customers within the healthcare, life sciences and high-tech industries benefit fromthe combination of advanced container technology, extensive cold chain management services and a global network of servicepartners, airlines and forwarders – providing a unique one-way leasing service. Envirotainer secures the safety and integrityof product cold chains by providing an active temperature-control system, training all parties along the cold chain and supportingcustomers in transport validations and risk management. With sales representation in 17 countries, the company has its R&D,Manufacturing and Quality Assurance departments at the headquarter premises in Lagga Marma near Stockholm, Sweden.

InmarkWebsite: www.inmarkinc.comInmark has been offering innovative packaging solutions for over 30 years and we are a Global Supplier of temperature control,dangerous goods and clinical trial packaging. World class design testing and validation facilities along with 20 years of in-depthindustry experience in cold chain technology thru our alliance with Softbox Systems have created innovative award winningdesigns for thermal packaging now used globally. Our dangerous goods regulatory development includes a delegate at UN Sub-Committee of Experts on the Transport of Dangerous Goods in Geneva. The clinical trials packaging systems we developed andimplemented for the central laboratories in North America, Europe and Asia are now the industry standard.

IntelleflexWebsite: www.intelleflex.comIntelleflex is the leader in Extended Capability RFID solutions, products, and technologies. Its XC3 Platform, comprising highperformance multi-protocol chips, tags and readers, enables solutions for cold chain management, asset tracking, vehicle/yardmanagement, manufacturing WIP control, supply chain automation, parts maintenance, access control, and other applications. Itfeatures range, reliability, memory capacity, and security far beyond standard passive RFID, and at a fraction of the cost of activeRFID solutions. For more information, please visit www.intelleflex.com

Klinge CorporationWebsite: www.klingecorp.comReliable refrigeration and freezing equipment for your pharmaceutical cold chainCompanies around the world have transported dangerous chemicals—in addition to pharmaceuticals—in our RedundantRefrigerated Containers. They offer the ultimate peace of mind with two complete and independent refrigeration units. OurRedundant Refrigerated Containers are available with an integral generator set that powers the two refrigeration units if loss ofexternal power supply occurs or during transport on a truck/trailer.Klinge Corporation is the leading provider of specialized transport refrigeration and power generation equipment. Founded as aspin-off of York International’s Transport Refrigeration Equipment department, Klinge has been producing refrigeration equipmentat its manufacturing facilities and headquarters in York, Pennsylvania, USA for 27 years.In addition to Redundant Refrigerated Containers, Klinge Corporation offers Blast Freezers (freezes cargo to -76°F), StorageFreezers (maintains cargo temperatures within 32°F to -76°F), Explosion-Proof Refrigerated Containers, Refrigerated TankContainers, Quick Thaw Units, Clip-On and Under-Chassis Generator Sets, and Collapsible Food Storage Bins.



Kuehne+NagelWebsite: www.kn-portal.com/Kuehne + Nagel is a global leader in providing integrated logistics services for the pharmaceutical and healthcare industry.Healthcare companies can expect flexible, cost-efficient solutions for sea, air, road and rail transportation, warehousing,distribution and reverse logistics. Our services ensure maintenance of temperature tolerances for products that require bothambient and cold chain services. Complete customs brokerage services include expert trade compliance advice from Kuehne +Nagel-managed offices throughout the world. Clients can depend on Kuehne + Nagel, one of the world's leading airfreightforwarders, to provide the highest services. As the first globally Cargo 2000 Phase 2-certified logistics provider, Kuehne + Nagelensures that every airfreight shipment is electronically planned and proactively monitored from door to door, providing clients withindustry-leading delivery reliability. KN Login, Kuehne + Nagel’s Web-based visibility, monitoring and reporting application, keepsclients and their customers apprised of order, shipment, inventory and delivery statuses.

LoJack®Website: www.LoJackSCI.com LoJack® Supply Chain Integrity provides integrated solutions for supply chain protection that includes shared supply chainintelligence and analytics, covert cargo tracking, monitoring, and recovery services. The LoJack® SCI solutions feature proactivealert based security and increased visibility across all modes of transportation with clear chain of custody management utilizingactive sensing of the cargo’s environment while in-transit.

LifeScience LogisticsLifeScience Logistics is a third party logistics provider in the pharmaceutical, biologic and med device industries. We arecommitted to offering the highest quality, flexibility, and compliance in supply chain solutions. From major pharmaceuticals tosmall startups, from traditional to direct channels, we offer a full range of standard and customized services including order-to-cash, contract management, warehousing & distribution, transportation management, and real-time business intelligencereporting. Our cGMP compliant facilities allow our clients to distribute frozen, refrigerated and controlled ambient products whileoutsourcing as much or as little of the process as they desire.

MD Logistics Website: www.mdlogistics.com. MD Logistics is a third party logistics (3PL) company specializing in customized supply chain solutions. Our vertical markets includeLife Sciences and Pharmaceuticals, Retail and Consumer Goods, and Transportation Services. In addition to cold chain logisticsand foreign trade zone warehousing, our services range from packaging and fulfillment, to global freight forwarding and freightmanagement. Located in Indiana and Nevada, our facilities include state of the art Pharmaceutical and Retail warehouse space.We provide the highest quality, most flexible supply chain solutions for our customers. Responding decisively and promptly to theircomplex challenges and working with them through their process.

Ocasa Logistics SolutionsWebsite: www.ocasa.comWith more than 25 years of experience, developing Critical Logistics Solutions, OCASA relays on a worldwide network of affiliatesand branches strategically located around the globe (North America, Latin America, Europe, Africa and South East Asia), makingOCASA an integrated logistics Company with a global scope. OCASA owes its rapid growth to a Tailor-Made solutions approachand uncompromising service. We have formed strategic partnerships with thousands of satisfied customers around the world. OurBio Pharma business unit offers solutions for the Bio-Pharmaceutical community including export, import, distribution, fulfillmentand temperature controlled warehousing for: Diagnostic Specimens, Medication / Vaccines, Experimental Drugs, ControlledSubstances, Dangerous Goods, and Medical Supplies

Panther Expedited Services Website: www.pantherexpedite.comPanther Expedited Services, Inc. is the largest independent provider of premium logistics services. With on-demand, single sourcesolutions, we offer dedicated door-to-door service to and from any location in the world. Our technology, network strength, andworld class customer service have resulted in millions of dollars in cost-savings, industry leading on-time service levels, andnumerous industry awards. On the ground, in the air, and across the ocean, Panther provides a full range of global solutions.Panther delivers On Time, On Target, No Exceptions.

SensitechWebsite: www.sensitech.comSensitech - The leading provider of cold chain visibility solutions that enable our customers to track and monitor assets across thesupply chain, protecting the quality, efficacy, and integrity of their temperature-sensitive products. Our product portfolio includescomprehensive analytic services, enterprise software systems and validated data acquisition devices. We address our customers’most complex perishable cold chain problems and deliver powerful insights that drive measurable process improvement. Sensitechsupports cold chain monitoring programs in 18 of the top 20 multi-national pharmaceutical companies and 9 of the top 10biopharmaceutical companies. Sensitech is a business unit of Carrier Corp.

ShockWatchWebsite: www.shockwatch.comFor over thirty years ShockWatch has been providing supply chain monitoring solutions targeted at reducing damage-related costs.By offering a full range of cold chain solutions from single use indicators to full featured recorders, customers can select the correctsolution to meet their monitoring needs - whether it is from the manufacturer to the distributor or in the last mile. ShockWatchmonitors provide accurate, irreversible evidence of unacceptable temperature, impact, vibration or tilt events safeguarding yourproducts’ efficacy and allowing you to make smarter decisions. Need a partner in damage prevention? We’re on it.


Supply Chain Integrity


SafTPakWebsite: www.saftpak.comNow available in North America exclusively from Saf-T-Pak™, the Laminar Medica product line has long been the premierprovider of insulated shipping systems to the Pharma and Biotech industries in Europe. Spotlighting the innovative newChilltherm™ family of shippers, the Laminar products provide true global cold chain solutions for your most demandingchallenges. Additionally, Saf-T-Pak features their own Saf-T-Temp™ line of proprietary phase change materials and is a globalprovider of regulatory training and shipping systems for the safe transport of infectious and exempt patient specimens. Nowmore than ever…We’ve Got You Covered™.

Savsu Technologies Website: www.savsu.comSavsu Technologies designs and builds reusable containers for the shipping and storage of temperature sensitive materialsutilizing proprietary patent pending technology, which was developed for use by NASA. Savsu has recently introduced a line ofNANO Q containers, which deliver extremely long safe storage performance while using wet ice. Featuring anti-freezetechnology the NANO Q line of containers can provide safe storage performance as long as 10 days while keeping contentsbetween 2-8C. NANO Q containers also provide electronic security and data logging capability for the most critical shipments.’

SensitechWebsite: www.sensitech.comSensitech - The leading provider of cold chain visibility solutions that enable our customers to track and monitor assets acrossthe supply chain, protecting the quality, efficacy, and integrity of their temperature-sensitive products. Our product portfolioincludes comprehensive analytic services, enterprise software systems and validated data acquisition devices. We address ourcustomers’ most complex perishable cold chain problems and deliver powerful insights that drive measurable processimprovement. Sensitech supports cold chain monitoring programs in 18 of the top 20 multi-national pharmaceuticalcompanies and 9 of the top 10 biopharmaceutical companies. Sensitech is a business unit of Carrier Corp.

Softbox SystemsWebsite: www.softboxsystems.comSoftbox Systems designs and manufactures passive insulated shipping containers that enable pharmaceutical companies tosecure their cold chains and ensure the safety and efficacy for the distribution of their temperature sensitive products. Ouraward winning patented systems are manufactured and available regionally in Europe, USA, India and Asia Pacific. To find outhow we have helped some of the worlds leading pharmaceutical companies improve efficiency, reduce cost and lower CO2emissions for their cold chain shipments please visit us at our conference booth to meet one of our specialists.

Southwest Airlines®Website: swacargo.comSouthwest Airlines® Cargo provides expedited air cargo services for Customers who need fast, friendly, and reliable service.With service to over 90 destinations, you can depend on our Shipmates to deliver on time while extending the same friendlyservice with a smile. Visit swacargo.com to learn about our service levels: Next Flight Guaranteed (NFG), RUSH Priority Freight,and FREIGHT service. We are proud to maintain some of the shortest cutoff and recovery times in our industry. With thecombination of our outstanding Employees and commitment to Customer Service, it's no wonder we have been recognizedfor our award-winning service!

Temptime CorporationWebsite: www.temptimecorp.comTemptime’s TransTracker is a monitoring device containing scientifically proven time-temperature indicator technology.TransTracker products identify exposure to freezing, high heat and cumulative heat exposure during shipping and short-termstorage. TransTracker is easy to read, accurate and can deliver cost savings of over 50%. Temptime is the world leader in time-temperature indicator technology. Temptime operates under a quality system certified to ISO 9001:2000 and ISO 13485standards and is compliant with medical device Good Manufacturing Practices. For more information contact Chris Caulfieldat 973-984-6012.

Texas FoamWebsite: www.texasfoam.comTexas Foam knows Cold Chain Packaging, and is an industry leader in quality and innovation. Since 1991, we havemanufactured products that meet or exceed our customer requirements for quality and value. New, state of the artmanufacturing equipment was acquired in 2008 and 2009, resulting in enhanced production capability. Our expertise enablesus to offer customers an assortment of Foam materials and package designs. We also work closely with corrugated designersto incorporate foam and corrugate into the most beneficial package for our customers. For 2010 a new line of XDS ExtendedDuration Shippers has been introduced. Two years in design and testing these products are recycle easily, reduce package costsby up to 80% versus PUR shippers, are super tough, durable, and provide for equal or better performance than PURcontainers. Texas Foam offers a wide selection of foam products, and the best customer service in the industry. We arepackaging experts who work to effectively solve your insulation, packaging, and molded component needs. In addition to ourstock items, we offer custom molding, custom fabrication, and fulfillment.

TSSWebsite: www.tss.se/public.action?view&content.id=5Few companies can demonstrate TSS's track record, know-how and proven technology required to operate global cold chaininformation solutions. We have and will continue to invest heavily in the future success of our customers by providingcustomer driven solutions. TSS’s Cold Chain Information System does not only provide you with extremely reliable dataloggers and simplicity of use, but also the outstanding system management capabilities required for global operations.



United CargoWebsite: www.unitedcargo.com/United and Continental are combining to create the world’s leading cargo airline. The new United will operate a fleet of 1,255aircraft, including 150 widebodies, over 10 hubs – including hubs in the four largest cities in the United States. Together wewill serve over 370 destinations in 59 countries with 5,800 daily flights. With enhanced service to Asia, Europe, Latin America,Africa and the Middle East, United Cargo has the capacity to move your freight virtually anywhere on the globe. The newUnited Cargo also offers a portfolio of special services to meet the needs of cargo customers worldwide while building on ourcommitment to award-winning customer service with industry-leading on-time performance.

UPSWebsite: healthcare.ups.comUPS has deep expertise in the healthcare industry and provides a broad range of services and solutions to manage the entirehealthcare supply chain. From small- to mid-sized businesses to large, global pharmaceutical and medical devicemanufacturers, UPS helps healthcare companies speed products to market; facilitate new product introductions; meet time-critical customer needs; ensure regulatory compliance; reduce inventory management costs; streamline ordering and billingprocesses; and maximize supply chain visibility.

UTi PharmaWebsite: www.UTiPharma.comUTi Pharma is a division of UTi Worldwide and leading Pharmaceutical supply chain solution provider. UTi Pharma clientsinclude manufacturers, wholesalers, retailers, pharmacies and direct patients. UTi Worldwide Inc. is an international, non-asset-based supply chain services and solutions company providing air and ocean freight forwarding, contract logistics,customs brokerage, distribution, inbound logistics, truckload brokerage and other supply chain management services. Thecompany serves a large and diverse base of global and local companies, including clients operating in industries with uniquesupply chain requirements such as the pharmaceutical, retail, apparel, chemical, automotive and technology industries. Thecompany seeks to use its global network, proprietary information technology systems, relationships with transportationproviders, and expertise in outsourced logistics services to deliver competitive advantage to each of its clients' supply chains.

va-Q-tec AGWebsite: www.va-Q-tec.comva-Q-tec AG develops and produces VacuumInsulationPanels (VIPs) and PhaseChangeMaterials (PCM) for high performancethermal packaging products and other applications. In most cases these packaging solutions comprise both, VIPs and PCM.This leads to the most reliable and temperature stable passive system solutions used to transport valuable and temperaturesensitive products for up to 6 days and even longer. The va-Q-tec solutions range from one-way shippers to air freightcontainers. va-Q-tec offers small quantities from the standard portfolio to large quantity custom tailored series production. Theapplications range from pharma and biotec products to food and fine arts. The va-Q-tec headquarters in Würzburg / Germany(ca. 100 km from Frankfurt) with its more than 4 000 m2 high tech production area offers excellent facilities for testing andofficial validation run by our experts in thermal physics. va-Q-tec has won several national and international awards for theadvanced technology of saving and storing energy efficiently.

World Courier of Canada Ltd.Website: www.worldcourier.comWorld Courier has set the benchmark for worldwide time & temperature sensitive transportation. We remain the onlyspecialist courier company with its own global company network .Each office ISO 9001 certified with the same operatingstandards dedicated to treating every shipment on an individual, priority basis. World Courier is utilized in approximately 80%of the world’s clinical trials requiring the use of a specialty courier. With experience in managing the logistics of over 7,500clinical trials worldwide, we are the acknowledged experts in handling temperature-sensitive specimen and drug shipments.

SPi GlobalWebsite: www.spi-global.comRepresenting world-class Solutions, People, and innovations, SPi Global creates synergy with its customers to help them succeed intheir business by delivering value-driven customer relationship management solutions that work. As the world’s largest Philippine-owned global BPO organization, and winner of the 2011 International ICT Awards BPO Companyof the Year, we have established a winning 31 year track record of improving operating efficiency, lowering costs, andstrengthening the competitive position of more than 500 clients in North America, Europe, Australia and Asia. With over 15,000employees driving customer care, sales and marketing initiatives in telecommunications, financial services, healthcare, publishing,entertainment & media, and travel & hospitality industries, we are the experts in fulfilling your outsourcing needs. To learn moreabout how SPi Global can improve your business processes and results, contact us at [email protected] or call (888) 906-2369.

Cold Chain Technologies (CCT)Website: www.coldchaintech.comCold Chain Technologies (CCT) is a leading global provider of insulated thermal packaging solutions that protect the integrity oftemperature sensitive products. We offer a wide range of cost-effective packaging options for JIT delivery, including standard andcustom KoolTemp containers, Koolit refrigerants and temperature indicators and loggers. Our team of experts draws uponunrivaled experience throughout the cold chain, from design and testing to thermal modeling and total project management. Withmultiple sites across the U.S. and partnership in Europe, we provide local support of global shipping needs, ensuring product safetythrough the industry's largest selection of smart solutions VaisalaWebsite: www.vaisala.comVaisala Environmental Monitoring and Measurement solutions serve customers in over 150 countries, helping them understand andmanage their controlled environments. Vaisala Cold Chain solutions reduce the risk of ruined or adulterated vaccines, pharmaceuticals,biologics, and other perishable products during distribution. A uniquely small and sensitive device, the single-use CCL100 Cold Chaindata loggers are plugged into the USB port of a computer to generate a report of time and temperature history, graphs, and summarydata. Along with ensuring product safety, Vaisala cold chain solutions reduce the risk of deviations from GxP quality guidelines.



Registration Information

*IQPC reserves the right to determine who identifies as an end user orvendor upon registration for an event. Those who are determined avendor will be denied access to end user pricing.

Please note multiple discounts cannot be combined.

A $99 processing charge will be assessed to all registrations notaccompanied by credit card payment at the time of registration.

MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC

* CT residents or people employed in the state of CT must add 6.35%sales tax.

Team Discounts: For information on team discounts, please contactIQPC Customer Service at 1-800-882-8684. Only one discount may be applied per registrant.

Special Discounts Available: A limited number of discounts areavailable for the non-profit sector, government organizations andacademia. For more information, please contact customer service at 1-800-882-8684.

Details for making payment via EFT or wire transfer:JPMorgan Chase - Penton Learning Systems LLC dbaIQPC: 937332641ABA/Routing #: 021000021Reference: Please include the name of the attendee(s) and the eventnumber: 10366.006

Payment Policy: Payment is due in full at the time of registration andincludes lunches and refreshment. Your registration will not beconfirmed until payment is received and may be subject tocancellation.

For IQPC’s Cancellation, Postponement and Substitution Policy, pleasevisit www.iqpc.com/cancellation

Special Dietary Needs: If you have a dietary restriction, pleasecontact Customer Service at1-800-882-8684 to discuss your specificneeds.

©2012 IQPC. All Rights Reserved. The format, design, content andarrangement of this brochure constitute a trademark of IQPC.Unauthorized reproduction will be actionable under the Lanham Actand common law principles.

Your old ideas about convention hotels will instantly disappear when you stay at Hyatt RegencyMcCormick Place. Here, chic yet inviting décor welcomes you from the moment you enter ournewly renovated Chicago Hyatt hotel, turning our expansive space into a welcoming retreat.Take in the incredible views of downtown from contemporary guestrooms, savor a variety ofdelicious cuisines in our popular restaurants, or relax in our indoor pool and fitness center.

Connected to North America's largest conference center, we offer the most comprehensiveevent venues of all hotels in Chicago, Illinois – making us ideal for everything from groupmeetings to reunions and weddings. With amenities designed to pamper every guest, naturallighting throughout and friendly staff, our versatile Chicago Illinois hotel remains the preferredchoice for visitors year after year.

Group Rate - $239 plus 16.39% per nightPlease identify you are part of the IQPC – Cold Chain group to ensure the special rate. Notethat you are eligible for this rate three day prior and three days post the event based onavailability.

Reservations Telephone – (800) 233-1234 or (312) 567-1234

Please make your reservation before September 1, 2012 in order to ensure you are eligible forthe group rate.

Hyatt Regency McCormick Place2233 S Martin Luther King DriveChicago, IL 60616T: 312-567-1234W: www.mccormickplace.hyatt.com

VENUE INFORMATION

SilverBronze Gold

End User June 15 July 20 Aug. 24 Standard2012 2012 2012

Bronze $999 $1499 $1799 $1999

Vendor June 15 July 20 Aug. 24 Standard2012 2012 2012

Bronze $2699 $2799 $2899 $2999


Silver $1599 $1999 $2399 $2599


Silver $2999 $3199 $3499 $3799


Gold $2800 $3400 $3700 $3999

June 15 2012 July 20 2012 Aug. 24 2012 Standard

2-Day Training $1699 $1799 $1899 $1899

Focus Day Only $799

Workshop $549 each


Gold $4699 $4799 $4899 $4999

• 2 Day MainConference

• 2 DAY TRAINING • LatAm Focus Day • Welcome SpeakerSponsors DrinksReception

• Unlimited time inthe Exhibition Hall

• Buffet Breakfast • Lunch • Drinks Reception

• Cold Chain IQMembership and accessto 100's of Articles,Podcasts and Webinars

• Post EventPresentations Access

• Selection of 2 Site-tours • Access to the ColdChain IQ Memberlounge

** Limited Packages to 25(capacity of training)


• Unlimited time in theExhibition Hall

• Buffet Breakfast • Lunch • Networking DrinksReception

• Cold Chain IQMembership andaccess to 100's ofArticles, Podcasts andWebinars



• LatAm Focus Day • Selection of up to 3Workshops (pendingregistrationqualification)

• Unlimited time in theExhibition Hall

• Buffet Breakfast• Lunch • Drinks Reception • Cold Chain IQMembership andaccess to 100's ofArticles, Podcasts andWebinars


ALA CARTE

United Site Tour is Complimentary (free of charge ) to qualified participants. Capacity is limited. Please contact IQPC.

September 24 - 28, 2012Hyatt Regency McCormickPlace, Chicago, IL

Choose from 60+Sessions, Case Studies,Panel Discussions &Networking Round TablesUnited States Pharmacopeia SINDUSFARMAMHRAANMAT (Invited)AbbottEli LillyBayer HealthcareJohnson & JohnsonGenentechSanofi-Aventis, MexicoAlexionGemedcoCubist PharmaceuticalsHuman Genome Sciences, Inc.Grifols, Inc.PPDPfizer - Peru Forrest LaboratoryAbbott LaboratoriesGS1 Healthcare US IATAand Many More!

www.ColdChainPharma.com

Secure, Cost-Effective Logistics and Quality Proceduresfor your BioPharma Supply Chain

Sponsors

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Web: www.ColdChainPharma.com

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10366.006/SM

presents Global Forum's 10th AnniversaryGlobal Forum's 10th Anniversary

Providing an international resource center forthe temperature control life science professional,Cold Chain IQ delivers insightful, unbiased

information about today's 'hot topics' around the world. Learn moreabout Cold Chain IQ at www.coldchainiq.com.

The world's most Global Forum's 10th Anniversary Cold Chain 2012 Agenda.pdfIn today’s complex supply chain, constantly evolving regulations, technology developments and cost pressures

Documents