The World’s Largest Global Forum for Cold
Chain Specialists – Sold out in the US, Canada,
Belgium, UK, Brazil, Singapore and Germany
Solid Partnerships, Transport Processes and Risk September 21 – 24, 2009
Mitigation for Cost-Effective Temperature Pennsylvania Convention Center
Controlled Shipment of Products and Supplies Philadelphia, PA
Top 5 Reasons to Attend: Attend the industry’s favorite
• Re-evaluate your transportation & logistics strategy to cold chain event and learn from
ensure cost-effectiveness and streamlined processes
35+ top professionals, including:
• Ensure compliance of international & domestic
regulations of temperature-sensitive products and Keynote: Edward J. Kelley, General
supplies through risk assessment & stability case studies Manager for Air Cargo, U.S. Dept. of
• Establish qualified lanes, packaging and processes to Homeland Security – “TSA Screening
internationally ship your new high-value vaccines, blood Cargo Program”
products and biological materials
Rafik H. Bishara, PhD, Technical Advisor and
• Implement effective last mile logistics processes to Chair PCCIG USA Branch, PDA
ensure product integrity to the patient and to remote
Ian Holloway, Manager, Defective Medicines
destinations Report Centre, MHRA
• Network with 350+ professionals from manufacturing, Sarah Skuce, Compliance Specialist, Health
logistics, packaging, QA, regulatory agencies, wholesale Canada
and logistics and freight partners Bob Seevers, Principal Regulatory Scientist,
Regulatory Affairs, CMC, Eli Lilly and
Company
ALL NEW, for you: Cold Chain Distribution 2009 Anthony Moran, Director of Procurement,
Siemens
New industry sector and cold chain stakeholder perspectives from: Joanna Ward, Senior Director, Manufacturing
and Supply Chain Management, Seattle
Genetics Research Biotech R&D McKesson Wholesalers
Genetics
Animal Health Insurance Underwriter Novartis Clint Pollard, Manager, Transportation, Merial
Medical Devices US Military American Red Cross Animal Health
Geoff Glauser, Director of Global Packaging
Plus - Hear how Cathay Pacific, Air France/KLM, American and Delta meet new IATA Technology, Wyeth
guidelines and TSA Screening Security requirements Rose Bicksler, Senior Manager, Global Quality
Assurance and Validation, Johnson & Johnson
Vincent Porzio, Clinical Supplies Manager,
Don’t miss the new Clinical Register by July 10th and Schering-Plough
Claude Jolicoeur, Director of Regulatory Affairs
Logistics Focus Day SAVE up to $2,595 and Corporate GMP Officer, McKesson Canada
Corp.
Sponsors:
www.coldchainpharma.com

September 21 – 24, 2009
Pennsylvania Convention Center
Philadelphia, PA
Solid Partnerships, Transport Processes and Risk Mitigation for Cost-Effective Temperature
Controlled Shipment of Products and Supplies
Table of Contents:
Dear Colleague,
Pre-Conference Specialist
The ‘cold chain’ we used to know Discussion Forums . . . . . . . . . . . . . . 5-6
is history. Today, biopharmas, med
and other organizations face new ical device Transportation &
challenges controlling, monitoring
mitigating risk involved in transpor and Logistics Plenary Sessions . . . . . . . . . . 7
ting & distributing temperature-sen
products. Regulators require tem sitive
perature control of many tempera Biological Materials &
cost pressures are forcing compan ture ranges,
ies to re-evaluate their transportatio Clinical Supplies Track . . . . . . . . . . . . . 8
strategy, revised modes of transpor n
t require new risk profiles, and mor
biological drugs are entering internat e Last Mile Cold Chain Logistics Track. . 8
ional trials and the market.
Regulatory Compliance
At the 7th Annual Cold Chain Dist Plenary Sessions . . . . . . . . . . . . . . . . . 9
ribution for Pharmaceuticals, you
learn from expert speakers and indu will
stry colleagues through case-studies QA Distribution &
discussions and plenary sessions how , panel
to update your temperature control Risk Management Track . . . . . . . . . . . 9
logistics and QA to meet today’s chal
lenges. In addition, you’ll compare
quality initiatives, transportation strat new Cold Chain Packaging
egies and qualified packaging whic & Materials Track . . . . . . . . . . . . . . . . 9
more control, increased compliance h offer
and efficiency for international distr
of cold chain products, IMPs and ibution Clinical Logistics Focus Day . . . . . . . . 11
bulk material.
As always, peer-to-peer networki About Our Sponsors . . . . . . . . . . 12-13
ng is at its best at Pharma IQ’s
event as: annual Venue & Accommodations . . . . . . . . 14
•
The largest cold chain show, bringing Pricing & Registration Information. . . 15
together 350+ temperature control
supply, logistics, packaging, IT and
QA professionals
•
A ‘one stop shop’ exhibition for part
icipants to consult with 40+ new
existing cold chain partners in tran or
sport, packaging, freight forwardi A special thank you to our
information systems ng and
2009 Executive Advisory
Time out of the office is sometimes
peers – if you’re going to attend one
hard to come by, however just ask
your Board:
Cold Chain conference this year –
industry’s choice for the best educatio the Rafik H. Bishara, PhD, Technical Advisor and
nal value and networking opportu
Pharma IQ’s Cold Chain event in Phila nity is Chair PCCIG USA Branch, PDA
delphia.
Geoff Glauser, Director of Global Packaging
The speakers, sponsors and Pharma Technology, Wyeth
IQ team look forward to seeing you
September in Philadelphia for the in
7th Annual Cold Chain Distribution Kevin O'Donnell, Chief Technical Officer,
Pharmaceuticals 2009 conference. for
Thermosafe & Author
www.coolerheadsblog.com
Sincerely,
Karl Kussow, Manager, Quality and Validation,
FedEx Custom Critical
Gwyn Murdoch, Quality Manager,
Materials/Packaging Quality Systems, Eli Lilly
Jim Bacon, Director, Global Demand Planning
and Customer Service, Talecris
PS: Don’t miss
Courtney Becker-James th Bobby Boehm, Associate Director, Cold Chain,
Conference Director Clinical Logistics e new Bristol Myers Squibb
Day! See page Focus
Pharma IQ, a division of IQPC Rich Ellinger, Director of Global Marketing and
www.coldchainpharma.com Business Development, Tegrant Corporation
courtney.becker@iqpc.co.uk 11 for
details. Nick Basta, Editor in Chief, Pharmaceutical
Commerce
2 www.coldchainpharma.com

What’s New for
Clinical Logistics Focus Day
Smaller validated packaging, countless clinical sites, patient cold chain
compliance, site practitioner issues… the list continues for the unique
challenges faced by Clinical Supply professionals. Join us for a focused day
on how to cost-effectively and compliantly ship clinical materials and
comparators for international clinical trials.
“Implementing Automated Temperature Monitoring to Improve Clinical
Distribution Processes” - Schering-Plough
“Best Practices to Improve Patient and Clinical Site Cold Chain
Compliance” - Bernstein CMC Regulatory Consulting
“Case Study: Managing a Massive Large Scale Vaccine Clinical Trial”
- Wyeth
Transportation and Logistics Plenary
Keynote: Edward J. Kelley, U.S. Dept. of Homeland Security
“Qualifying for the TSA Cargo Screening Program”
Interview with Airlines
Hear how leading carries including Cathay Pacific, Air France/KLM, American
and Delta are updating their processes to meet updated IATA Chapter 17
*Don’t miss the ‘hot topic’ workshop*
“Quality and Efficiency for Cost & Temperature Controlled
Transportation”
Last Mile Logistics
“Role of the Wholesaler in the Distribution Of Temperature-Controlled
Products” - McKesson
“Distribution of Cold Chain Products to the Public and Emergency
Planning” - Public Health District Leader, Alexandria, Virginia
Biological Materials & Clinical Supplies
“Quality Control for the Storage and Transportation of Blood and
Biologics” - American Red Cross
“Global Logistics for the Clinical Distribution of Cytotoxic
Antibody-Drug Conjugates” - Seattle Genetics
“Cold Chain Planning and Shipping of Bulk Protein Internationally
at -60°C” - Novartis
3

More than 150 different companies attended Cold Chain Distribution 2008 including:
Abbott Laboratories Global Pharmaceutical Supply Group
AcuTemp Thermal Systems Hamilton Park Capital
Alexion Pharmaceuticals Inc Health Canada
Almac Group An eye opener on several Immunogen Inc
Altus Pharmaceuticals Impeva Labs
American Thermal Instruments Inc. topics. I enjoyed both Integra Lifesciences Corporation
Amgen Inc Janseen-Cilag
Amylin Pharmaceuticals Inc days and would JeanCoutu Pharmacy
Anesiva Inc. Johnon & Johnson Sales & Logistics Co.
APP Pharmaceuticals recommend such an event Johnson Matthey Pharma Materials
AstraZeneca Pharmaceuticals JOM Pharmaceutical Services Inc
ATL Pharma Security Label Systems to other colleagues. Also, Kirin Pharma USA Inc
Auxilium Pharmaceuticals Inc Kryotrans
Bausch & Lomb networking was great! Kuehne Nagel Inc
Bax Global Lanter Distribution
Baxter Healthcare Lantheus Medical Imaging
Bayer Corp.
– Program Manager of Quality Life Packaging Technology
Bayer HealthCare Assurance Compliance, Abbott Lifoam Industries, LLC
BioMarin Pharmaceutical MannKind Corporation
BioMérieux Inc Laboratories MAYA Simulation Technologies, Ltd.
Blue Vector Medarex, Inc
BlueBird Express Medco Health Services
Boston Scientific Medicis Pharmaceutical Corp
Bressler Group MedImmune Inc
Bristol Myers Squibb Medtronic Spinal & Biologics
Brookwood Pharmaceuticals Mellenium
Burris Logistics
Cangene Corporation
The subject matter was Mentor Biologics
Merck and Company
Cardinal Health
Catalent Pharma Solutions
excellent and covered all Merial Limited
Minnesota Thermal Science
Cathay Pacific Airways
CBMS Chemical Biological Medical Systems
aspects of what to do and Myoderm Medical
NanoCool
Celgene Corp
Centocor
what is on the horizon for Novartis Pharmaceuticals
NovaRx
Centocor R&D
Cephalon Inc
companies in the next Onqor
Packaging Science Resources
CEVA Freight Management - RDU
Chick Packaging Group
few years. IQPC staff PackagingPrice Inc
Pakoil
Climate Controlled Containers Inc Panther Expedited Services
Cold Chain Technologies
really put together an Perrigo
Covidien Pfizer
CSafe LLC action-packed conference Polyair
CSL Behring Pop Technology
Cubist Pharmaceuticals and managed well. Priority Solutions
Dawson Logistics Quality Solutions
Defense Supply Center-Philadelphia – Director, Pharmaceutical Rand-Whitney Container
DeltaTRAK Sanofi Pasteur Ltd.
Dentsply International Packaging Services, Schering- Schering-Plough Corporation
DHS U.S. Immigration & Customs Sensitech
Enforcement Plough Corporation Sentry Logistic Solutions
DoubleDay Holdings Shire Pharmaceuticals
EDUQUEST SNC Lavalin Pharma
Elan Pharmaceuticals, Inc. Takeda Pharmaceutical
Eli Lilly and Company Talecris Biotherapeutics, Inc.
Elpro Services TCP Reliable
Emergent BioDefense Operations Lansing Tegrant Thermosafe Brands
Envirotainer Very good speakers and TempTime Corporation
Ernest Packaging Solutions Teva Pharmaceuticals USA , Inc.
Falvey Cargo Underwriters subject matter and was Thermal Packaging Solutions
FedEx Tucker Company
Fisher Bio Services filled with information uniPHARM Wholesale Drugs
Fisher Clinical Services University of Florida
Flexpoint rather than basic UPS
Frontier Paper US Pharmacopeia
FUJIREBIO INC
GBSC LLC - J&J
concepts. USPack Courier Service
UTI
Gene News
Genetech
– Logistics Project Manager, ViroPharma
Wal-Mart Specialty Pharmacy
Genvec
Genzyme Corporation
Bilcare, Inc. Willerup Consulting, LLC
World Courier
Gilbert’s LLP Wyeth Pharmaceuticals
Gilead Sciences Xdicator Corporate
GlaxoSmithKline ZLB Plasma
4 www.coldchainpharma.com Sponsors:

Pre-Conference Specialist Discussion Forums
Monday, September 21, 2009
8:00 am – 11:00 am Registration at 7:45 (Coffee will be served)
A Cold Chain Program Management: Utilizing Temperature Information for Continuous
Process Improvements
Performing a cold chain audit is the first step in identifying potential risks in a • Statistically evaluating supply chain processes with the goal of improving supply
temperature-sensitive supply chain. Second, banking cold chain data and chain performance and overall efficiency
statistically evaluating supply chain performance over time enables the • Food industry examples driven by customer retention and product quality
development of continuous process improvement programs. Third, knowledge of
What you will learn:
the global regulatory and industry standard guidance for the storage, handling • Apply a risk-based approach grounded in industry guidance and driven by
and distribution of temperature sensitive medicinal products is critical to
process validation for insuring overall cold chain compliance
protecting patient safety.
Choose from Workshop A or B
• Drive efficiency and reduce costs while meeting regulatory requirements
How you will benefit: • Document and mitigate risks through the development of improved
This workshop will address the above three key elements together in an • Standard Operating Procedures (SOPs) – while driving improved efficiencies and
interactive and thoughtful discussion linked to specific case studies, including lowering overall costs
examination of:
• Temperature-sensitive risk assessment Your Workshop Leaders:
• Developing a cold chain program the identifies process trends and utilizes Henry Ames, Director of Strategic Marketing, Sensitech
shipping reports to feed into continuous improvement efforts Mark Maurice, Project Manager, Sensitech
• Meeting Quality defined storage requirements
8:00 am – 11:00 am Registration at 7:45 (Coffee will be served)
B Leveraging New Refrigerant Technologies: Use of Engineered Phase Change Materials
in Cold Chain Packaging Design
What you will learn: • How traditional water based refrigerants are best utilized and what are their
• Alternatives to traditional gel pack refrigerants available in the industry true limitations
• How to identify and evaluate the trade-offs in material costs v. the total costs of • How engineered phase materials can contribute to your company sustainability
the packaging and distribution initiatives
• Performance variables to consider in the selection of a PCM • Re-usability v. Single use? What types of applications are engineered PCM’s best
deployed?
How you will benefit:
Through case studies interaction with packaging and logistics peers, you will go Your Workshop Leader:
through examples to understand: Anthony Alleva, Technical Services Manager, TCP Reliable/Cryopak
11:15 am – 2:15 pm Registration at 11:00 (Lunch will be served)
C Sea Transportation of Temperature Controlled Pharmaceutical Products
How you will benefit:
What you will learn: Through discussions and case scenarios of sea transport, you will discuss with your
• Current reefers on the market that afford cost-effective, low risk options for
industry colleagues and those experienced with sea transport, how to:
transporting pharmaceutical products • Attain buy in from senior management and colleagues in quality management
• Compare efficiency vs. cost of sea transport to other modes • Define common ground and ways to work effectively with sea carriers
• Risks of sea transport: Examining risks with longer routes, port authorities and • Developing SOPs with ocean carriers
various other handlers • Implement proactive contingency plans
• Understand what sea carriers offer competitive services for transport of
temperature controlled pharmaceuticals Workshop leader to be announced. Please check www.coldchainpharma.com for
updates.
Choose from Workshop C or D
11:15 am – 2:15 pm Registration at 11:00 (Lunch will be served)
D Which Shipping Solution is Greener? What You Measure Might Surprise You!
Using Science and Data-Driven Decisions When Choosing Among How you will benefit:
Green Cold Chain Shipping and Logistics Options Through case examples and interactive exercises, you will discuss with the CCT
Appropriately, companies are placing more and more emphasis on utilizing and MIT team how to:
“green”, “sustainable”, “reusable” and/or “recyclable” shipping and logistics • Evaluate green and sustainable packaging and logistics options
solutions for their cold chain packaging and distribution needs. The difficulty arises • Consider the value proposition for environmentally-friendly choices
in putting hard measurements around the level of “green-ness” or sustainability, • Better understand the practicalities of using green packaging
attributes whose very definitions are subject to wide interpretation. In conjunction • Develop a measurement model to fit your needs
with a team from the Massachusetts Institute of Technology (MIT), Cold Chain
Your Workshop Leaders:
Technologies (CCT) has developed a data-driven and dynamic model to help
Anthony “TJ” Rizzo, Strategic Account Engineer, Cold Chain Technologies
evaluate product delivery options in terms of both logistics costs and
environmental impact, using derived, hard values. Bob Bohne, VP & General Manager, Cold Chain Technologies
What you will learn: Jeremy Stewart, Leaders for Global Operations Fellow, Massachusetts
• Life Cycle Analysis Institute of Technology
• State-of-the-art approaches to sustainability Angelo Capuzzi, Leaders for Global Operations Fellow, Massachusetts
• Measurement methods and values for measuring environmental impact Institute of Technology
• Case Study: Evaluating various high-volume refrigerant delivery method options
• Approaches for developing your own model
5

2:30 pm – 5:30 pm Registration at 2:15
E Quality and Efficiency for Cost & Temperature Controlled Transportation
The workshop will facilitate a discussion of considerations for choosing a How you will benefit:
transportation method, including international regulations, shipping environments, Through case studies of real-life examples and interactive exercises, you will
and the strengths and weaknesses of available temperature control options for air understand how transport systems can be designed to significantly reduce or
and ground transport. eliminate common problems in domestic US and international air transport. You will
The group will discuss solution options and criteria for designing best practice gain an appreciation for the relative costs and benefits of achieving your
transportation systems and procedures that appropriately blend the needs of your transportation objectives within the framework of your GDP requirements and
product, your business, and available services. We will also explore the effectiveness discuss how to minimize those costs while maintaining safe transport requirements.
of various choices by considering case studies for both ground and air transport. • Improve your ability to implement high quality, secure, and cost-effective
transportation
What you will learn:
Choose from Workshop E or F
• Enhance your ability to apply industry and governmental guidance on Good
Gain insight into carrier quality systems for both standard transportation and
Distribution Practices in your transportation plans
temperature control including: • Increase your understanding of how to effectively work with your carrier to
• Strategies for implementing best practices for achieving high quality and safety in
maximize the quality, consistency, and economy of your shipping lane
both air and ground transport
• Effective procedures to address transport risk issues Your Workshop Leader:
• Decision making factors for evaluating cost-effective transportation strategies for Karl Kussow, Manager, Quality, FedEx Custom Critical
cold chain
2:30 pm – 5:30 pm Registration at 2:15
F Examining the Impact of Packaging and Shipping on Supply Chain Integrity for
Vaccines and Challenging Destinations
The Department of Defense has unique challenges which require more stringent sometimes remote unit such as mobile hospitals, field paramedics and combat
temperature controls, delivery time pressures and sometimes difficult to reach zones
destinations. This workshop is a unique opportunity to learn from the US • How to establish processes for emergencies and working within defined timelines
Department of Defense’s Cold Chain Manager how to ensure effective, safe and • Working with specialty carriers for bio materials
compliant shipping of vaccines and biomaterials.
How you will benefit:
What you will learn: • Balance cost pressure with time and temperature requirements to find suitable
• The role of appropriate packaging and transportation handling in the supply chain packaging
to maintain Cold Chain Integrity • Understand different packaging requirements for temperature controlled
• How to choose packaging solutions and vendors to ensure quality substances
• Passive, small parcel, refrigerated packaging protocols • Understand specific challenges in the US Military Supply Chain as a military
• Passive, “disposable,” bulk shipper with validated pack-outs for all 3 personnel yourself or as a key supply partner
temperature range requirements
• Alternatives to passive packaging Your Workshop Leader:
• Logistical challenges in shipping supplies to international destination and Ms. Dana L. Dallas, Vaccine/Cold Chain Program Manager, Defense Supply
Center Philadelphia
5:45 pm – 8:45 pm Registration at 5:30 (Dinner will be served)
G Bringing Your Logistic Operations to Meet Today’s Airline Cargo and
Transportation Security Challenges
Maximizing supply-chain value may depend on how well you are navigating new How you will benefit:
complexities regarding airline security, international importation, customs and cold- Through case examples and one-on-one discussion, you will interact with leading
chain options in global pharmaceutical transport. This workshop will feature insights aviation and security experts from American Airlines, the Transportation Security
on these issues with aviation and security experts, in an interactive format. Administration and the Pharmaceutical Industry.
• Gain a better understanding of the global regulatory environment
What you will learn: • Evaluate current options available for meeting TSA screening mandates
• Options for meeting the U.S. governments 100% screening mandate • Collaborate with the experts to develop new approaches
• Case Study: Innovative approaches that are currently being taken in the • Understanding how to balance supply chain issues to deliver more value in Cold-
Pharmaceutical Industry
Chain shipment transport
• New IATA regulations surrounding international transport
Choose from Workshop G or H
• Navigating importation and customs issues
Your Workshop Leader:
• Keys to maximizing success in cold-chain transport
Dave Brooks, President, American Airlines Cargo
5:45 pm – 8:45 pm Registration at 5:30 (Dinner will be served)
H Assembling the Puzzle: A New Paradigm in Clinical Supplies Distribution
Challenges that are unique to the distribution of clinical supplies place high • Use of Containers
demands on a Company’s technology line-up. The ability to deliver sustainable • Taking a closed loop approach to the use of containers
results is contingent upon creating achievable goals, selecting proper tools, and
How you will benefit:
leveraging cross-functional supply chain capabilities. By understanding the • Gain an understanding of operating challenges related to Clinical Trials
distribution pathway, you are able to take action that mitigates risks during supply • How Stability Data can be appropriated
chain handoffs, thereby achieving higher levels of compliance. • See how data loggers suit your approach
This workshop provides the details of success experienced in Schering-Plough’s • Realize the advantages during container selection
global supply chain. • Better understand instances for closed-loop-distribution
What you will learn:
Your Workshop Leaders:
• Considerations for Shipping Tools in Clinical Applications
Kevin Grimm, Engineer, Schering-Plough
• Understanding and Leveraging Stability Data
Vincent Porzio, Engineering & Technical Services Manager, Schering-Plough
• Use of Data Loggers
Amlan Dutta, Engineering & Technical Services Director, Schering-Plough
6 www.coldchainpharma.com Sponsors:

Main Conference Day One
Tuesday, September 22, 2009
7:00 Registration and Coffee • How has global economics affected the airline industry?
• What changes in the airline industry do you see that may affect cargo
8:00 Pharma IQ Welcome capacity?
Panelists:
8:05 Opening Remarks from Conference Chairperson Jack Lo
Rafik H. Bishara, PhD Cargo Product and Marketing Manager
Technical Advisor and Chair PCCIG USA Branch Cathay Pacific Cargo
PDA Stephane Lemaire
Director Pharmaceutical Logistics
Transportation and Logistics Air France KLM Cargo
8:15 Introductory Remarks from Plenary Chairperson Don Harrison
Project Manager, Product Development
Kevin O'Donnell United Airlines Cargo
Director & Chief Technical Advisor, Tegrant Corp., ThermoSafe Brands &
Chair A Representative
IATA Time & Temperature Task Force Air Canada Cargo
8:25 KEYNOTE: Meeting US Security Standards and Qualifying 10:45 Morning Networking Break
for the TSA Screening Program to Avoid Custom Delays
• Program background, motivations and looming deadlines 11:30 Standardizing Qualification and Auditing of Transportation
• How to prove Chain of Custody: Documentation, application ad and Warehousing Partners
authentication • Defining quality parameters and expectations of our transportation partners
• Case stories of biopharma company compliance • Streamlining transportation agreements across partners
• Freight forwarders qualification requirements • Central Eastern Europe Case Study: Certifying new warehouse and
transport suppliers
Edward J. Kelley • Feedback on the best practice guidance document from the PCCIG
General Manager for Air Cargo, Transportation Security Steering Committee on Standardizing Qualification of 3PLs
Administration
Department of Homeland Security Arminda O. Montero
Distribution QA Program Manager, Global Pharmaceutical Operations
9:05 Panel Discussion: Panel Navigating the New TSA Abbott
Requirements –Why a Layered Risk-Based Approach to Air
Cargo Security Provides the Best Model for Safely 12:10 Case Study: Using Advanced Predictive Thermal Modeling
Shipping Pharmaceuticals to Determine the Acceptable Product Payload
• Why does a layered risk-based approach make sense? Characteristics for a Shipping Lane with a Defined Ambient
• What innovative steps are being taken to adapt to the 100 percent Temperature Profile
screening environment? Pharmaceutical manufacturers ship a wide variety of thermally sensitive
• How will supply-chain value be impacted for Pharmaceutical shipments? products to various locations around the world. As such, it becomes
impractical for these companies to perform operational qualification (OQ)
Panelists: studies for all combinations of product that could possibly be shipped inside
David R. Brooks an existing shipper design. This presentation will discuss how advanced
President thermal modeling software is applied to define the acceptable product load
American Airlines Cargo characteristics in such a way that they can be applied to multiple products,
Edward J. Kelley and how to define those characteristics analytically.
• Bracketing payload characteristics: thermal mass (product density), product
General Manager for Air Cargo, Transportation Security
Administration type (liquid, lyophilized), volume (syringe, vial) and quantity of product
• Using analytical modeling to derive and bound acceptable product load
Department of Homeland Security
characteristics for an existing shipper in a given shipping lane with a
Brad Elrod defined ambient temperature profile
Senior Manager, Global Logistics Security • Verifying and validating the thermal models through physical testing once
Pfizer the worst-case configurations representing the load limits are selected
• Predicting how an existing shipping solution will perform and how the drug
9:55 ‘Interview with an Airline’ Panel Discussion: Meeting IATA product will be affected when subjected to new, potentially more severe,
Chapter 17 Revised Regulations and Biopharma ambient temperatures
Requirements for Temperature Sensitive Products • Understanding how the analytical model can provide insight into the critical
Reducing transportation costs while shipping temperature sensitive effects of convection, conduction and refrigerant phase change inside the
pharmaceuticals in a timely fashion is a balancing act for cold chain shipper
professionals. Rapid air transport is a desirable and sometime necessary
mode, but biopharma companies still wonder ‘can the airline effectively Jeffrey Simpson
handle my shipments?’ or ‘how do I know air carriers are taking all the Director of Engineering and Technical Services
necessary precautions to ensure temperature controls?’ This session will Cold Chain Technologies
‘interview’ airlines handling temperature controlled biopharma products Geoffrey Glauser
including discussion on: Director of Global Packaging Technology
• What evidence can be provided to biopharma customers to document any
Wyeth Pharmaceuticals
temperature deviations at the airport?
• What does a Quality Management System mean to you and how has your
12:50 Optimizing Logistics Modeling: Maximizing On Time
airline implemented it? Delivery Performance
• What strides have you made to comply with the new Time and
Cold chain products have unique characteristics challenging the traditional
Temperature Label usage requirements? supply chain. The primary purpose of an optimized logistics model is to
• What other programs or process have airlines implemented to reduce
deliver the therapy to the patient when it is expected, while protecting the
environmental risks to time and temperature-sensitive healthcare integrity of the product. This discussion will concentrate on the supply chain
products?
7

from origination to delivery to the patient and the various reasons why and exceptions by delineating between internal and external causes of
deliveries are not made, the financial impact, and a solution to detect, service delays
troubleshoot, intercept and provide delivery. Discussion points will include • Establish optimized distribution modeling for maximum on time delivery
opportunities to optimize your mode of transportation, reducing performance
transportation and packaging spend, and meeting customer’s delivery • Define process which can be employed to control seemingly
expectations. Additionally, processes to evaluate root cause analysis of uncontrollable service delays such as weather and consignees not being
these delivery exceptions and corrective action implementation to minimize available
future / repeat occurrences will be outlined. This discussion aims to:
• Present industry best in class processes to analyze current distribution Josh A. Hobick
Senior Vice President
patterns and determine opportunities for service improvement and cost
Dawson Logistics
avoidance. (Improve on time service to your patience and reduce reships)
• Demonstrate analytical applications to realize root cause of service gaps
1:30 Networking Luncheon
Concurrent Sessions begin: Choose Track A or B
Track A: Biologic Materials & Clinical Supplies Track B: Last Mile Cold Chain Logistics
2:40 Addressing Cold Chain Logistical Challenges within the Distribution of Cold Chain Products to the Public and
Military Blood Program Emergency Planning
• Evaluation and determination of need • Challenges to ensure temperature control in the public health arena
• Assessing the environment • Preparing for mass immunizations
• Proper methods of data gathering and analysis • Defining optimal levels of stock piles and ‘ready to dispense’ logistics
• Defining requirements for specific products • Working with the CDC and government agencies for pandemic
• Evaluating solutions and available options emergency scenarios
• Developing a plan for implementation and success
Dr. Lisa Kaplowitz
• Lessons learned in this type of process.
Public Health District Leader, Alexandria, Virginia,Former
US Military speaker pending final approvals Deputy Commissioner for Emergency Preparedness and Response
State of Virginia
3:25 Global Logistics for the Clinical Distribution of Cytotoxic Role of the Wholesaler in the Distribution of
Antibody-Drug Conjugates Temperature-Controlled Products
• Introduce the unique characteristics and requirements for ADC molecules • Updating processes and practices to monitor required temperatures
• How to establish and qualify multiple legs of the cold chain from US of biopharma products
to EU and back to US • Visibility and temperature control after leaving warehouse depot
• Challenges with maintaining and monitoring temperature: • Preparing to meet Health Canada regulatory expectations for 0069
• Establishing qualified storage sites in Europe for distribution guidelines
• Import/export logistics; customs, compliance and VAT considerations • Addressing how McKesson is meeting industry standards and
• Packaging and safety measures for highly toxic, potent materials technical guidance
Joanna Ward Claude Jolicoeur
Senior Director, Manufacturing and Supply Chain Management Director of Regulatory Affairs and Corporate GMP Officer
Seattle Genetics McKesson Canada Corp.
4:05 Afternoon Networking Break
4:35 Cold Chain Planning and Shipping of Bulk Protein Setting up International Transport and Logistics to New
Internationally at -60°C Markets
• Developing supply chain options for highly volatile demand forecast • Designing new transportation routes and temperature profiles
• Establishing large volume shipping containers for biotech material • Evaluating modes of transport for certain lanes
stored at -60C • Preparing for 0% allowable excursions in some countries such as
• Assessing and developing new pallet shippers to hold maximum Mexico or Brazil
material, maintaining temperature and minimizing cost • Evaluating packaging technology and logistic partners for global routes
• Understanding customs controls in emerging countries with unusual
Christina Pavlik regulations
Manufacturing Planning Manager
Novartis Anthony Moran
Director of Procurement
Siemens
5:20 Quality Control for the Storage and Transportation of Panel Discussion: Achieving Greater Visibility into Cold
Blood and Biologics Chain Control and Compliance Post-Manufacture
• Developing shipping protocols for the blood supply chain • Assessing requirements including validation master plan, routes,
• Conducting qualification processes according to GDP requirements timelines to ensure an effective cold chain
• Temperature maintenance for international transport of blood to • Qualifying shipping systems and assessing suitability
Australia and Europe • Adopting a bracketing approach to cold chain validation studies
• Qualification of boxes for longer shipping times • Discussing Industry Standards guidelines and their application to
• IATA Chapter 17 new developments for shipment of biologics, controlling your downstream cold chain
including training for active systems
All Track B speakers and participants are invited to join the discussion
Boriana Cavicchia
Manager, Systems Quality, BioMedical Services
American Red Cross
6:00 Closing Remarks
6:10 Networking Cocktail Reception in Exhibition Hall
Join your colleagues from across disciplines to exchange ideas
and network in an informal environment. Take this time to
learn from the industry’s top technology and logistics providers
to update and advance your cold chain management.
8 www.coldchainpharma.com Sponsors:

Main Conference Day Two
Wednesday, September 23, 2009
7:45 Registration and Coffee practices in protecting materials from exposure to temperatures outside
recommended storage conditions and evaluating the impact of such
Regulatory Compliance exposures when they do occur.
Bob Seevers
8:30 Opening Remarks from Chairperson Principal Regulatory Scientist, Regulatory Affairs, CMC
Rafik H. Bishara, PhD Eli Lilly and Company
Technical Advisor and Chair PCCIG USA Branch
PDA 11:40 Biopharma Temperature Control Industry Best Practice
Initiatives
8:35 European Regulatory Guidelines: Controlled or Ambient The leadership of the Pharmaceutical Cold Chain Interest Group (PCCIG)
Temperatures, Stability Data and Compliance continues post publication of PDA Technical Report No. 39. This
• Expectations and documenting for ambient or CRT products presentation will review progress being made for the Industry Best Practices
• Regulatory expectation for qualification or validation in multiple project areas including:
• Last Mile for the distribution of pharmaceutical products to the end-user
• Stability studies versus shipping studies -are stability studies enough to
• Good Distribution Practices (GDPs) for the pharmaceutical supply chain
set the limits for your cold chain?
• Mean Kinetic Temperature (MKT)
Ian Holloway • Active system temperature profiling
Manager, Defective Medicines Report Centre • Global regulatory requirements
MHRA • Harmonized labeling for cold chain
• Distribution Validation Master Plan (VMP)
9:10 Health Canada's Guidelines on Monitoring Temperature • Supply Chain Partner Management best practices
Control of Drug Products in the End to End Cold Chain • From the first to the last mile
• Proposed revisions to Health Canada's GUI-0069
• Wholesaling, storage and shipping Rafik H. Bishara, PhD
• Regulatory expectations for temperature control of drug products Technical Advisor and Chair PCCIG USA Branch
• Common questions and misconceptions regarding temperature control PDA
of drug products
12:15 Ask the Regulator and Industry Panel Discussion
Sarah Skuce • Lessons learned in justifying pharma company actions and validation plans
Compliance Specialist to regulators – what exactly demonstrates control?
Health Canada • New regulations on storage, handling and distribution of drug samples &
mail-order drugs
9:45 Understanding and Applying the USP <1079> Revised • Extrapolating future regulatory requirements in-line with cold chain trends
Guidelines
• Outlining the new 1079 Chapters for implementation (Anonymous questions may be submitted to the panel before hand by
• Understanding 1079’s definition of validation (for packaging) and sending to courtney.becker@iqpc.co.uk)
comparing to other industry standard guidelines Moderator:
• Specific protocols for receiving, shipping and storing temperature Rafik H. Bishara, PhD
controlled pharmaceuticals Technical Advisor and Chair PCCIG USA Branch
• Using examples and grids to demonstrate how to use the guidance to PDA
make decisions for your cold chain management
Panelists:
Dr. Mary Foster Ian Holloway
USP Packaging and Storage Expert Committee Member Manager, Defective Medicines Report Centre
US Pharmacopeia (USP) MHRA
10:20 Morning Networking Break Sarah Skuce
Compliance Specialist
11:05 Regulatory Points to Consider for Cold Chain Distribution Health Canada
With the increasing trend toward using more third party resources to
Dr. Mary Foster
manufacture and distribute drug products, the identification and control of
USP Packaging and Storage Expert Committee Member
risks encountered in the distribution environment have evolved into a
US Pharmacopeia (USP)
major element in the process of storing and shipping pharmaceuticals. The
WHO, PDA Technical Report 39, and FDA have all identified that the Bob Seevers
holding of drugs includes distribution and is seen as a cGMP regulated Principal Regulatory Scientist, Regulatory Affairs, CMC
process. This presentation will use the principles presented by global Eli Lilly and Company
regulators to provide recommendations and note current industry best
1:00 Networking Luncheon
Concurrent Sessions begin: Choose Track A or B
Track A: QA Distribution & Risk Management Track B: Cold Chain Packaging and Materials
2:00 Developing a Risk Model and Tool for the Evaluation of Understanding Green Packaging Solutions for Your
Shipping Practices Business and Cold Chain
• Tightening the risk management process by adding more control in • Cost vs. environmental impact vs. ‘reward’
the front end to ensure maintenance of product quality throughout • Logistics practicalities of recycling of temperature controlled packout
the distribution supply chain components: Expanded polystyrene’, gel packs, bubble wrap,
• The risk grid defines acceptable risk by utilizing several key factors that cardboard, etc.
compose the shipping process • Assessing options for non-dry ice solutions for frozen packout
• Based on the outcome of the risk classification performed, the requirements
shipping requirements for each product type and/or product family can • Biodegradable packaging considerations & suppliers
be determined
9

Gwyn Murdoch Ms. Betsy Steiner
Quality Manager, Materials/Packaging Quality Systems Executive Director
Eli Lilly Alliance of Foam Packaging Recyclers
2:40 Risk-Based Evaluation of Cold Chain Issues for Operational Qualification of an Active Heating and
Effective Supply Chain Distribution Management Cooling Air Cargo Container, a considered approach:
Effective risk management of cold chain issues with the distribution • What parameters should be considered during the design
network of a supply chain requires consideration of several challenging qualification?
elements including regulatory, logistics, financial and operational • How does one handle the concepts of repeatability and consistency?
considerations. Balancing these often contradictory constraints and • Should active container qualifications be compared to passive
implementing an optimal logistics solution is an iterative challenge that container qualifications?
requires on-going evaluation and adjustment. The session will include • What technical considerations should be covered in the laboratory
several “case studies” and practical examples of the types of risk qualification, field qualification?
mitigation steps to avoid losses from spoilage, contamination, and
Geoffrey Glauser
other temperature-driven issues.
• Transportation vendor vetting, collaboration and review
Director of Global Packaging Technology
• Negotiation to incorporate SOP’s directly into a logistics contract
Wyeth Pharmaceuticals
• Critical challenges in the selection and management of
transportation vendors and the implementation of control elements
• Threat/exposure identification of cold chain transit risk elements
• Effective contingency planning for specialized cold chain processes
Eric Newman
Vice President, Loss Prevention
Falvey Cargo Underwriting
3:15 Afternoon Networking Break
3:45 Temperature Controlled Transportation and QA Case Case Study: Qualifying an Active Heating/Cooling
Study System
Logistics and Quality personnel engage in daily and periodic activities to • Using a Failure Mode Evaluation to evaluate potential risks of the
ensure the maintenance of a robust cold chain management system. new system
These activities support initial vendor qualification, packaging • Qualification testing performed in the lab
component validation, packout design and qualification, and other • Working with freight forwarders to develop SOPs for handling
components of the Quality System that impact cold chain management. processes at airport
This session of will focus on how evolving industry practice and • Conducting trial runs and collecting temperature data
available guidance in cold chain management, increased scrutiny of • Assessing the cost – benefit of the new system
drug safety and corporate focus on waste reduction necessitate the • Current status
efficient management of relationships, risk, and processes to ensure
Rose Bicksler
appropriate stewardship and control of drugs in the supply chain.
• Managing partner relationships to ensure compliance and effective
Senior Manager, Global Quality Assurance and Validation
Global Pharmaceutical Supply Group
processes
Johnson & Johnson
- Working with 3PLs to ensure back up systems and plans are in
place for our warehouses
- Contingency planning with carriers
- Ensuring risk mitigation procedures are in place
• Re-evaluating cold packaging to extend shipping stability time and
balance with the most cost-effective transportation modes
Clint Pollard
Manager, Transportation
Merial Animal Health
Zachery Thompson
Manager, Quality Systems, Global Quality
Merial Animal Health
4:25 Panel Discussion: Defining Stability Profiles and Panel Discussion: Defining the Future of Temperature
Extrapolating Correct and Sufficient Stability Data to Controlled Packaging for Biopharmaceuticals
Cover Temperature/Time Excursions • Balancing increasingly higher value medicines with cost-reduction
• How low can you go: How flexible can stability profiles be to remain pressures
compliant? • Comparing EPS , PUR and VIP packaging
•
Understanding varying country regulatory ‘allowable excursions’ • Rapid Evaporation Technology – 5 or 10 years away?
•
Defining what to put in regulatory file • Myths and realities of returnable /recycling programs
•
Communication to regulators • Other emerging technologies?
•
Assembling regulatory package
Ms. Betsy Steiner
•
Using a general acceptable approach in practice to handling
Executive Director
deviations and excursions
Alliance of Foam Packaging Recyclers
Ian Holloway
Geoffrey Glauser
Manager, Defective Medicines Report Centre
Director, Cold Chain Technology
MHRA
Wyeth
Bob Seevers
Rose Bicksler
Principal Regulatory Scientist, Regulatory Affairs, CMC
Senior Manager, Global Quality Assurance and Validation,
Eli Lilly and Company
Global Pharmaceutical Supply Group
Henry Ames Johnson & Johnson
Director of Strategic Marketing
Sensitech
5:00 Closing Remarks
10 www.coldchainpharma.com Sponsors:

Clinical Logistics Focus Day
Thursday, September 24, 2009
8:15 Registration and Coffee 1:50 Boosting Clinical Trial Efficiency by Outsourcing
Clinical Logistics to Global Partners
8:50 Opening Remarks by Chairperson In late 2006, Wyeth Research and DHL Deutsche Post signed a
strategic agreement with the intent to have DHL serve as the
9:00 Planning and Management of Pfizer’s International primary preferred carrier in the shipment of test articles, ancillaries
Clinical Supply Distribution and other supporting materials. In the session, the discussion will
• Preparing for key country regulatory approvals focus upon key attributes of the relationship, as well as highlighting
• Managing export/import challenges and risks for efficient customs some current and future technological and operational
clearance enhancements that continues to flourish in this dynamic relationship.
• Outsourcing considerations for our clinical logistics The outcome has been very successful for both companies, with
• Setting up effective partnerships and alliance structures emphasis on planning between key stakeholders, versus
• Monitoring cold chain products and biologicals conventional transaction-related freight.
• Decision factors in outsourcing clinical logistics
Catherine Hall • Steps for building a global alliance with preferred partners
Supply Chain Coordinator • Defining SOPs and KPIs
Pfizer Global Research and Development • Implementing effective service and quality agreements
• Extending global reach and finding additional cost-cutting
9:40 Case Study: Managing a Massive Large Scale Vaccine opportunities and services by moving from 3PL partnerships to 4PL
Clinical Trial • Advanced temperature control packaging choices for our clinical
•
Delivering positive results by using risk management, contingency supplies
and mitigation planning for offsetting challenges of international • Establishing 'chain of custody' of our clinical supplies internally and
transportation routes and potential delays. with our global partner
• Value of effective partnerships and leveraging core expertise to • Implementing innovative methods to track temperature and
further mutual objectives location, providing data points for overall supply chain database
• Changing distribution models as recruitment rates fluctuate and
resources shift. How risk drives innovation to deliver. outstanding Bruce T. Guenter
performance with challenging temperature profiles and shipping Director, Global Materials Logistics
conditions Wyeth Research
• Using Project management as a tool to solve the challenging
aspects of a large study 2:30 Afternoon Networking Break
C. Ray Goff, Jr. 3:00 Best Practices to Improve Patient and Clinical Site Cold
PMP, CPM, PMM, Director of Vaccine R&D
Chain Compliance
Wyeth • Qualifying if clinical supply chain partners have sufficient
refrigeration or systems
10:20 Morning Networking Break • How to maximize ability of patient to maintain necessary
temperatures of their medications
10:50 My Temperature Sensitive Product Deviated for 2 • Labeling of investigational supplies best practices and examples
hours: Making Quick Decisions on How to Handle that ensure patient compliance
Temperature Excursions for Clinical Materials • Project management aspects that help improve cold chain
• Developing a proactive stability database compliance downstream
• Building procedures that qualify if materials are still viable
• Avoid recalling products, repeated processes and lengthy QA David Bernstein
investigation processes Vice President, Pharmaceutical Sciences and Regulatory Compliance
• Examples of deviations and proactive responses Bernstein CMC Regulatory Consulting
David Bernstein 3:35 Considerations for Shipping Comparators to
Vice President, Proactive Damage Control
International Markets
Bernstein CMC Regulatory Consulting • Working with vendors to understand new markets for clinical sites
• Cold chain concerns and temperature monitoring for comparators
11:25 Panel Discussion: Preparing for International Clinical • Temperature control packaging: Cost, IVRS systems and cooling
Cold Chain Regulatory Requirements methods
• Meeting EU Clinical Directive requirements • Shipping to international sites and dealing with depot
• Challenges shipping into Latin America: Key partners and management
overcoming import/export roadblocks
Douglas Hawley
12:10 Networking Luncheon IM Operations Sr. Specialist, Global Logistics
Celgene Corp.
1:10 Implementing Automated Temperature Monitoring to
Improve Clinical Distribution Processes 4:10 Clinical Material Packaging, Labeling and Distribution:
• Eliminate manual data entry and review of data from every From Factory to Clinic
shipment utilizing the ELPRO data logger • Choosing appropriate packaging for bulk supplies and small vials
• Programming the data logger for other shipments
• Making data available worldwide to communicate temperature • Using IVRS to ensure minimal loss of supplies by having two-way
deviations integration between shipper and IVRS
• Reducing guesswork wit early phase materials with little data • Implementing cold chain strategies that ensure minimal
distribution to clinical trials
Vincent Porzio
Clinical Supplies Manager Michele Alm
Schering-Plough Supply Chain Manager
Fibrogen
4:45 Closing Remarks
11

About Our Sponsors
Cold Chain Technologies is a leading source for system, training all parties along the cold chain and supporting customers
engineering-based thermal packaging solutions. For in transport validations and risk management.
almost 40 years, we’ve continued to excel in providing Website: www.envirotainer.com
efficient, cost effective thermal packaging products
and services to a wide range of customers – from local start-ups to Fortune FedEx Custom Critical offers a complete array of
100s. Pharmaceutical, biotech, healthcare, medical device, and food service surface and air solutions to safely and securely ship
companies count on us to solve their cold chain challenges. Distributed temperature-sensitive products. You can choose from
from multiple locations throughout the U.S. and internationally, our product exclusive-use vehicles with temperaturecontrolled cargo boxes to airfreight
line includes KoolTempTM insulated containers, Koolit® refrigerants, and solutions utilizing temperature-controlled air containers. With our Temp-
KoolWatchTM temperature indicators. Cold Chain Laboratories, our Assure Validated services, you also receive hard-copy documentation of the
affiliated company, is a premier source for expert design and qualification temperature inside the vehicle or container throughout transport. This
testing of thermal packaging solutions. assists our pharmaceutical customers with their compliance needs through
Website: www.coldchaintech.com a documented audit trail of their products’ temperature throughout the
shipping process. FedEx Custom Critical services are available 24/7/365 with
American Airlines CargoSM, a division of surface solutions throughout the U.S. and Canada and air solutions across
American Airlines, Inc., provides one of the the globe. Website: www.customcritical.fedex.com
largest cargo networks in the world, with cargo
terminals and interline connections available across the globe. American’s ThermoSafe Brands, a Strategic Business Unit of
global network serves over 250 cities in 40 countries worldwide; including Tegrant Corporation, is the leading provider of
major cities in the United States, Europe, Canada, Mexico, the Caribbean, temperature assurance solutions. Tegrant
Latin America and Asia. American Airlines Cargo provides Cold-Chain Corporation is a premier manufacturer of a variety
transport utilizing its temperature controlled ExpediteTCSM product. of highly engineered packaging solutions and energy efficient components
ExpediteTC SM provides priority boarding, priority handling, fastest flight with over 35 manufacturing and testing facilities across North America and
connections, high-visibility shipment tracking, automatic status notifications, approximately 2,100 employees. ThermoSafe Brands complete portfolio of
and a 100% guarantee to be flown-as-booked. For more information visit transport assurance and temperature assurance shipping products for the
www.AACargo.com. Website: www.AACargo.com safe and efficient transportation of bio-substances, blood and other
sensitive specimens across the entire temperature continuum. Our portfolio
Minnesota Thermal Science, LLC develops unique includes an extensive array of expanded polystyrene and polyurethane
storage and shipping systems that address the insulated shipping containers, refrigerants in a wide range of temperatures
challenges of maintaining constant and predictable and configurations, pre-qualified shipping systems for off-the-shelf ease of
temperatures when transporting temperature sensitive use and peace of mind. In addition, ThermoSafe Brands’ ISC Labs brings
medical materials. Founded in 2004 following an industry wide search by our customers experience and innovation in package design and certified
the Walter Reed Army Institute of Research for a more effective combat independent testing services to meet all regulatory requirements and
environment container, MTS has continued to apply its technology to concerns. For more information visit www.thermosafe.com or call us at
handle other important medical materials including all types of biomaterials 866-484-4392. Website: www.thermosafe.com
and pharmaceuticals that require controlled temperatures Its patent
pending Golden Hour® Technology, winner of a \"U.S. Army Greatest Delta Cargo offers several shipping solutions for
Inventions\" award, is credited with saving soldier's lives on the battlefield temperature sensitive pharmaceuticals ranging
and with revolutionizing the methods used for distributing temperature from fine chemicals, bio-technology and base
sensitive medical supplies. Website: www.goldenhourtechnology.com materials to medical and blood samples, bulk drugs and all other products
used for the production of pharmaceuticals. Pharma 1 is designed for
Dawson Logistics is a leading provider of customized products that require transport in an active temperature-controlled
supply chain solutions specializing in the container. Pharma 2 and Pharma 3 are Delta Cargo’s shipping solutions for
pharmaceutical industry and industrial manufacturing products requiring transport in passive temperature-controlled containers.
sector. The company has developed industry leading, Delta Air Lines is the world’s largest airline. From its hubs in Atlanta,
innovative customized pharmaceutical solutions. These specific programs Cincinnati, Detroit, Memphis, Minneapolis-St. Paul, New York-JFK, Salt Lake
have revolutionized on time service standards and have streamlined the City, Amsterdam and Tokyo-Narita, Delta offers service to 368 destinations
Specialty Pharmacy cold chain logistics model by minimizing spoilage, in 66 countries. Website: www.deltacargo.com
dramatically reducing re-ships and improving overall on time delivery to
their patients. In addition, the company enables organizations of all sizes to Entropy Solutions is the industry’s innovation leader in thermal
realize efficiencies in their specific industry by offering total supply chain technology. With the introduction of the GREENBOX Thermal
management, including network optimization, turnkey fulfillment, Management system, Entropy has once again revolutionized
warehousing, reverse logistics, and asset management. In 2007 and 2008, how thermally sensitive products are shipped and maintained.
Dawson Logistics was named one of the fastest growing privately held Our 100% organic, sustainable, passive thermal solution can
companies in the America by Inc. Magazine. The company will also be maintain precise target temperatures for unprecedented periods of time.
featured in an upcoming episode of “Eye on America” as part of a series Through a unique combination of technology and design, GREENBOX™
on Global Supply Chain Solutions which will air nationally. Dawson delivers the industries most effective and cost efficient shipping method on
Logistics' company mantra of exceeding our customer's expectations, every the market today. Website: www.greenboxsystems.com
time on every touch has set the foundation for their success in streamlining
complex pharmaceutical supply chain challenges. Sensitech - The leading provider of cold chain visibility
Website: www.dawsonlogistics.com solutions that enable our customers to track and
monitor assets across the supply chain, protecting the
Pioneer and market leader Envirotainer offers quality, efficacy, and integrity of their temperature-
flexible leasing (rental) of advanced transport sensitive products. Our product portfolio includes comprehensive analytic
solutions for worldwide air cargo shipments of services, enterprise software systems and validated data acquisition devices.
temperature-sensitive products. Customers within the healthcare, life We address our customers’ most complex perishable cold chain problems
sciences, food and high-tech industries benefit from the combination of and deliver powerful insights that drive measurable process improvement.
advanced container technology, extensive cold chain management services Sensitech supports cold chain monitoring programs in 18 of the top 20
and a global network of service partners, airlines and forwarders - providing multi-national pharmaceutical companies and 9 of the top 10
a unique one-way leasing service. Envirotainer secures the safety and biopharmaceutical companies. Sensitech is a business unit of Carrier Corp.
integrity of product cold chains by providing an active temperature-control Website: www.sensitech.com
12 www.coldchainpharma.com Sponsors:

Temptime’s TransTracker is a monitoring device TCP Reliable specializes in the field of temperature
containing scientifically proven time-temperature controlled packaging and services including package
indicator technology. TransTracker products identify design, qualification, testing manufacturing insulated
exposure to freezing, high heat and cumulative heat shippers, refrigerants, phase change materials and
exposure during shipping and short-term storage. TransTracker is easy to temperature monitors. All services are provided in strict conformance with
read, accurate and can deliver cost savings of over 50%. Temptime is the ISO 9001:2000, ISTA and ASTM test methodology, and FDA good
world leader in time-temperature indicator technology. Temptime operates manufacturing practices. TCP maintains facilities in New Jersey, British
under a quality system certified to ISO 9001:2000 and ISO 13485 standards Columbia, and Quebec. Website: www.tcpreliable.com
and is compliant with medical device Good Manufacturing Practices. For
more information contact Chris Caulfield at 973-984-6012. Cavalier Logistics is dedicated to providing “Turn-Key
Website: www.temptimecorp.com Cold Chain Solutions” for business in the Life and
Analytical Sciences, Pharmaceutical Manufacturing,
Founded in 1981, American Thermal Instruments, Diagnostic Kit Manufacturing, Vaccine and Healthcare Providers. In addition,
Inc. has been exceeding customer expectations as an we provide service government agencies that are responsible for the
international organization specializing in temperature stockpiling and rapid deployment of pharmaceutical products for disaster and
monitoring solutions. ATI temperature monitoring pandemic relief. We offer a unique service to healthcare providers because we
solutions include liquid crystal thermometers, irreversible temperature can provide one-stop 3PL logistical services from the point of manufacture, in
indicators, color changing products, Log-ic® electronic content monitoring, Cavalier validated refrigerated equipment. We also have validated 5°-C, -10°-C
and microencapsulation services. Our facility is ISO 9001 certified, FDA to -40°- C, -80°-C and -156°-C storage at our Washington D.C. Headquarters.
registered, and operates under cGMP. ATI manufactures non toxic, non- Our Washington Headquarters is licensed by the United States Drug
breakable, reusable, disposable and easy-to-read thermometers for diverse Enforcement Agency and the Commonwealth of Virginia Board of Pharmacy
markets and applications. ATI acts as a distribution arm for the Log-ic® to house and distribute schedule 2-6 pharmaceutical products. We provide
Temperature Tracking System. The Log-ic® system is revolutionizing the seamless third party logistical services for high value vaccines, clinical trial
Cold Chain, giving customers the capability to track and trace temperature samples, specimens, reagents and a multitude of products that require expert
history of shipments. Website: www.americanthermal.com handling. Website: www.cavlog.com
Inmark has been offering innovative packaging International Foam Packaging, LLC.
solutions for over 30 years and we are a Global (the \"Company\"), a Virginia
Supplier of temperature control, dangerous goods corporation, is a privately owned
and clinical trial packaging. World class design corporation with both its corporate office and manufacturing facility
testing and validation facilities along with 20 years of in-depth industry located in Richmond, Virginia. The Company manufactures a shipping
experience in cold chain technology thru our alliance with Softbox Systems package that is unique in the small package industry. The Xpander Pak®
have created innovative award winning designs for thermal packaging now product, with its patented construction and foam cushioning, provides
used globally. Our dangerous goods regulatory development includes a much greater protection against the shock and vibration encountered in
delegate at UN Sub-Committee of Experts on the Transport of Dangerous shipping than ordinary shipping materials including bubble or padded
Goods in Geneva. The clinical trials packaging systems we developed and envelopes. Xpander Pak® products protect fragile contents with thick,
implemented for the central laboratories in North America, Europe and Asia flexible polyurethane foam; yet, they are light in weight and reduce
are now the industry standard. Website: www.inmarkinc.com shipping costs significantly. In 2000, the Company transitioned from its
manufacturing operations into a newly renovated warehouse. Recognizing
Elpro Services, Inc. is a leading manufacturer of the importance of maintaining the highest quality production standards, the
high quality temperature, humidity, and CO2 Company took over the manufacturing of its entire product line, which is
dataloggers, providing recording and monitoring now handled from a 40,000- square-foot facility in Richmond, Virginia.
solutions while observing regulatory compliances Consequently, all functions from new product development, to
(GMP/GLP/FDA 21CFR11). LAN/W-LAN solutions are fully scalable to meet manufacturing and shipping, to sales and marketing-are handled directly by
your central monitoring requirements and future growth. Our New Libero Company personnel, resulting in better quality, quicker response to
PDF-logger® (No Software Required) provides simple cold chain monitoring customer needs, and innovative solutions for just about any packaging
of temperature sensitive pharmaceuticals. This ground-breaking concept of need. Website: www.intfoam.com
producing the report in a PDF file eliminates the need to install, qualify and
validate any specific software at destination. Available in 100 and 400 day DGP is a global manufacturer of UN
models, our Libero PDFlogger ® also supports compliance with FDA compliant and cold chain packaging solutions
standard 21 CFR 11. Website: www.elpro.com for Infectious Substances Category A,
Biological Substances Category B and Pharmaceutical products. DGP is also
AcuTemp Thermal Systems designs and a leading manufacturer and distributor of clinical trial Site Visit Kits (SVK’s)
manufactures cold chain temperature management and blood and tissue collection kits to the pharmaceutical clinical trials
solutions to maintain valuable and often life-saving market. DGP offers a wide range of specimen and temperature controlled
payloads at the right temperature during storage or packaging systems. Our standard product range has been developed
transport. AcuTemp combines thermal expertise and engineering know-how specifically from customer feedback and market demands and is supplied to
to produce highly efficient passive and powered delivery solutions, from the Pharmaceutical; Biotech; Clinical Trial; Medical & Veterinary Research
small boxes and carriers to large pallet-sized shipping containers. The sectors. DGP is replacing existing EPS solutions with DGP GREENFOAM to
company’s newest product, the AcuTemp AX2100L thermal pallet shipper, enable the natural biodegrading of packaging waste, and reduce the total
provides reliable compressor-based heating and cooling functionality with emissions and carbon footprint arising from production, transport and
state-of-the-art data logging capabilities to ensure accurate temperature disposal of these packaging foams. Website: www.dgpgroup.com
monitoring. When it’s critical, use AcuTemp: The Right Temperature. From
the Experts. Website: www.acutemp.com
MAYA Simulation Technologies Ltd. is a developer
Sponsorship and Exhibition Opportunities:
of thermal and flow simulation software tools. MAYA's Sponsorships and exhibits are excellent opportunities for your company to
simulation solutions provide comprehensive and showcase its products and services to high-level, targeted decision-makers
accurate insight into the thermal behavior of a wide attending the 7th Cold Chain Distribution for Pharmaceuticals. IQPC and
range of cold chain transport systems reducing the need for prototype Pharma IQ help companies like yours achieve important sales, marketing
testing. MAYA offers a complete software simulation solution for the and branding objectives by setting aside a limited number of event
thermal design and optimization of cold chain transport systems. MAYA's sponsorships and exhibit spaces – all of which are tailored to assist your
thermal simulation solution can model all aspects of heat transfer including organization in creating a platform to maximize its exposure at the event.
conduction, convection and radiation. The thermal and flow solvers are fully
capable of modeling steady state as well as transient thermal/flow For more information on sponsoring or exhibiting at the 7th Cold Chain
conditions. Additionally we incorporate advanced tools such as phase Distribution for Pharmaceuticals, please contact Mario Matulich at (212)
change materials, condensation/humidity calculations, dust/smoke 885-2719 or sponsorship@iqpc.com.
distribution tracking etc. Website: www.mayahtt.com
13

Media Partners
Venue & Accommodations:
Venue Accommodations
Pennsylvania Convention Center Loews Philadelphia Hotel
12th & Arch Street 1200 Market Street
(West Entrance) Philadelphia, PA 19107
Philadelphia, PA, 19107 Telephone: (215) 627-1200
Telephone: (215) 418-4700
or 800-428-9000
IQPC has a reduced rate room block for participants of Cold Chain
The Pennsylvania Convention Center (PACC) is conveniently 2009 at the Loews Philadelphia Hotel, which is located across the
located in the heart of downtown Philadelphia. For more street from the Pennsylvania Convention Center. The group rate is
information about the Pennsylvania Convention Center, please available for 3 days pre and post conference, based on availability. For
visit www.paconvention.com. room reservations, please contact the hotel directly at (215) 627-1200
by August 31st. Be sure to mention that you are attending IQPC’s
Cold Chain Distribution 2009 for the group rate when making your
reservation.
The first skyscraper ever built in the City of Brotherly Love is home to
Loews Philadelphia Hotel. Contemporary décor and gracious
hospitality make Loews one of Philadelphia’s most inviting luxury
hotels. Enjoy supremely comfortable rooms and personalized service,
as well as delicious cuisine from the hip Sole Food restaurant.
IQPC provides us with our most focused cold chain event with a large senior group of executives, leading edge
technical and business content and a core message that attracts professionals domestically and from abroad.
The ROI has been exceptional and has dramatically shortened our sales cycle so we make this event our priority
each year.
– Stephen Maietta, Director of Sales, The Americas, Envirotainer
The IQPC, Cold Chain Conference in Philadelphia, continues to be an enjoyable and productive experience. I
always receive great support from the friendly and efficient staff. This IQPC conference creates a relaxed
working atmosphere that facilitates productive business discussion and information sharing that improves my
ability to develop quality operations and grow our business
– Karl Kussow, Manager, Quality and Validation, FedEx Custom Critical
The IQPC Cold Chain Global Forum is second to none. With companies looking closer at where they spend their
investment dollars, this event remains at the top of our conference list. The value the event delivers to our
organization in regards to industry trends, market needs, exposure to key decision makers, and sales is
invaluable. Even in a declining market we continue to support this event at all levels and are already making
plans for the 2010 event!
– Larry Gordon, CEO, Cold Chain Technologies
14 www.coldchainpharma.com Sponsors:

Registration Information
Qualified Pharmaceutical, Biotech, Medical Device organizations:
Register by Register by Register by Standard
7/10/2009 7/24/2009 8/21/2009 Pricing
(save $700) (save $400) (save $200)
Main Conference Only $1,299 $1,599 $1,799 $1,999
All-Access Pass
2-day main conference, choice of 4 (save $2,595) (save $2,295) (save $2,095) (save $1,895)
Pre-Conference Specialist Forums and the $2,399 $2,699 $2,899 $3,099
Post-Conference Focus Day
Post-Conference Focus Day $799 $799 $799 $799
Pre-Conference Specialist Forum(s) $549 each $549 each $549 each $549 each
All Others
Register by Register by Standard
7/24/2009 8/21/2009 Pricing
(save $1,000) (save $500)
Main Conference Only $1,999 $2,499 $2,999
All-Access Pass (save $2,195) (save $1,695) (save $1,195)
2-day main conference, choice of 4 Pre-Conference Specialist Forums $3,799 $4,299 $4,799
and the Post-Conference Focus Day
Post-Conference Focus Day $799 $799 $799
Pre-Conference Specialist Forum(s) $549 each $549 each $549 each
Please visit www.coldchainpharma.com for an explanation of Qualified Pharmaceutical, Biotech and Medical Device Organizations and All Others.
Please note multiple discounts cannot be combined. Details for making payment via EFT or wire transfer:
A $99 processing charge will be assessed to all registrations not JPMorgan Chase - Penton Learning Systems LLC dba IQPC: 957-097239
accompanied by credit card payment at the time of registration. ABA/Routing #: 021000021
Reference: Please include the name of the attendee(s) and the event number: 10366.003
MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC
* CT residents or people employed in the state of CT must add Payment Policy: Payment is due in full at the time of registration and includes lunches,
6% sales tax. refreshment and detailed conference materials. Your registration will not be confirmed
until payment is received and may be subject to cancellation.
TEAM DISCOUNTS
For information on team discounts, please contact IQPC For IQPC’s Cancellation, Postponement and Substitution Policy, please visit
Customer Service at 1-800-882-8684. Only one discount may be www.iqpc.com/cancellation
applied per registrant. Special Dietary Needs: If you have a dietary restriction, please contact Customer Service
Special Discounts Available: A limited number of discounts are at 1-800-882-8684 to discuss your specific needs.
available for the non-profit sector, government organizations ©2009 IQPC. All Rights Reserved. The format, design, content and arrangement of this
and academia. For more information, please contact customer brochure constitute a trademark of IQPC. Unauthorized reproduction will be actionable
service at 1-800-882-8684. under the Lanham Act and common law principles.
About the Organizer:
Pharma IQ, the pharmaceutical division of IQPC, provides a forum to address the critical issues facing the pharmaceutical
industry today. Pharma IQ utilizes workshop, conference and training course formats to facilitate a learning environment for
pharmaceutical professionals working in all areas of drug development: from Discovery to Post-marketing.
Visit www.iqpc.com to see what other exciting and information-packed conferences and webinars are being offered by the International Quality &
Productivity Center.
“Very informative and very good!”
- Senior Logistics Supervisor, Wyeth
15

International Quality & Productivity Center
REGISTRATION CARD 535 5th Avenue, 8th Floor
New York, NY 10017
YES! Please register me for
❑ Main Conference Only ❑ Pre-Conference Specialist Forum(s)
❑ All-Access Pass ❑ Post-Conference Focus Day
❑A or ❑B ❑C or ❑D ❑E or ❑F ❑G or ❑H
See Page 15 for pricing details.
Your customer registration code is:
When registering, please provide the code above.
Name__________________________________ Job Title ________________________
Organization____________________________________________________________
Approving Manager______________________________________________________
Address_______________________________________________________________
City__________________________________State______________Zip___________
Phone________________________________Fax_______________________________
E-mail__________________________________________________________________ 5 EASY WAYS TO REGISTER:
❑ Please keep me informed via email about this and other related events. 1 Web: www.coldchainpharma.com
❑ Check enclosed for $_________ (Payable to IQPC) 2 Call: 1-800-882-8684 or 1-646-378-6026
❑ Charge my __Amex __Visa __Mastercard __Diners Club 3 Email: info@iqpc.com
Card #________________________________Exp. Date____/____CVM code: ______ 4 Fax: 1-646-378-6025
Details for making payment via EFT or wire transfer can be found on 5 Mail: IQPC
preceding page. 535 5th Avenue, 8th Floor,
❑ I cannot attend, but please keep me informed of all future events. New York, NY 10017
10366.003/D/AL
The World’s Largest Global Forum for Cold Chain
Specialists – Sold out in the US, Canada, Belgium,
UK, Brazil, Singapore and Germany
Solid Partnerships, Transport Processes and Risk
Mitigation for Cost-Effective Temperature Register by
Controlled Shipment of Products and Supplies July 10th and SAVE
up to $2,595
September 21 – 24, 2009
Pennsylvania Convention Center, Philadelphia, PA
Sponsors:
www.coldchainpharma.com