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8th Cold Chain Distribution for Pharmaceuticals Global Forum
1. est
orld's Larg
Don’t Miss the Evening Seminar
The W Global Forum for
‘AIR CARGO 201’ & Day Four on
presents International Distribution and
Temperature Control Specialists Shipping to New Markets,
including Latin America, China
and Africa
Keynote Speakers:
Food and Drug Administration
(FDA)
US Department of Homeland
Security
Distributing Safe Medicines Internationally CEO, Talecris Biotherapeutics
in Collaboration with Temperature Control CEO, East China Pharmaceuticals
Partners and Stakeholders September 20-23, 2010
Pennsylvania Convention Industry and Healthcare
Center, Philadelphia, PA Speakers:
Medtronic
Abbott
Genentech
Pfizer
Savient Pharmaceuticals
Johnson & Johnson
Pfizer-Peru
East China Pharmaceuticals
Bristol Myers Squibb
Cardinal Health
McKesson Canada
Genzyme
Merck & Company
PATH
US Department of Veterans Affairs
New Discussions at the Industry’s Most Medco Health Solutions
Recognized Cold Chain Forum: Abbott Brasil
Eli Lilly
✔ Comply with international regulations and adhere to
industry best practices by deciphering guidance Plus Industry
documents and making them work for your company Association Speakers:
✔ Devise cost-effective strategies with your packaging IATA ISPE
and transport partners to control Ambient, Refrigerated, ISTA PDA
Cold and Controlled Room Temperatures
✔ Streamline your global cold chain by harmonizing An outstanding compilation
quality systems, transport providers and processes of speakers and topics –
allowing our industry to stay
✔ Deliver safe drugs to patients and protect against product
on the cutting edge of
loss by building security processes into your cold chain
technology and regulations!
✔ Ensure high-value medicines reach patients efficaciously by proactively Manager, Global Distribution,
working with and educating pharmacies and wholesalers bioMérieux
Premiere Sponsors:
www.coldchainpharma.com
2. Dear Colleague,
Recently, the international consulting firm Oliver Wyman, conducted a survey with more than 30 CEOs of top global air cargo
players which indicated "Temperature-controlled and pharmaceutical shipping are widely expected to lead the recovery in terms
of growth rates" and "The most immediate CEO investment priorities include... cold chain capabilities.”
These findings give a clear picture as to the growing importance of cold chain management for pharmaceuticals. The number of
cold chain shipments by air, road and sea continue to increase due to greater temperature ranges to adhere to (15-30°) and
novel biotech drugs coming onto the market.
As a professional responsible for temperature control products, the 8th Annual Cold Chain Distribution for Pharmaceuticals
Global Forum is the perfect place to get up to speed with the latest technology, processes and regulations that are necessary to
operate a cost-effective and compliant temperature control supply chain.
The Global Forum is the largest and most comprehensive event of its kind. By attending, you will have the choice to attend 34
conference presentations, 5 panel discussions, 6 specialist discussion forums, 10 roundtable discussions and 1 evening seminar
'AIR CARGO 201'.
Plus, network with 450+ temperature controlled supply chain stakeholders from:
• Pharmaceutical, Biotech and Medical Device Manufacturers • Freight Forwarders
• Transportation Providers including Airlines, Truckers and Ocean Shippers • Packaging Partners
• Government Healthcare Agencies and Shippers • Wholesalers
• Pharmacies
We'd like to thank the 2010 Cold Chain Executive Advisory Board who helped to bring new, innovative content to you:
• Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA Branch, PDA
• Brad Elrod, Director, Global Conveyance Security & Logistics Compliance, Pfizer
• Claude Jolicoeur, Director of Specialty Pharmaceutical Distribution Services, McKesson Canada
• Arminda Orozco Montero, Distribution QA Program Manager, Strategic Quality Initiatives, Global Pharmaceutical
Operations, Abbott
• Chris J. Anderson, Director, Quality & Regulatory Affairs, Pharmaceutical & Medical Distribution, Cardinal Health
• Maryann Gribbin, Director Quality Assurance, Global Pharmaceutical Supply Group, Johnson & Johnson
• Karin Baer, Vice President, Global Compliance, Teva
• Geoffrey Glauser, Director, Global Packaging Technology, Pfizer
• Kevin O'Donnell, Director & Chief Technical Advisor, Tegrant Corporation, ThermoSafe Brands
• Larry Sweeney, Senior Director, Distribution and Logistics, Genzyme
The Advisory Board, speakers, sponsors and Pharma IQ team look forward to seeing you in September in Philadelphia for the
8th Annual Global Forum.
Sincerely, Table of Contents:
Day One: Specialist Discussion Forums ............................5-6
Day Two: Main Conference................................................7-8
Day Three: Main Conference ...........................................9-10
Day Four: Main Conference ................................................11
Courtney Becker-James About our Sponsors .......................................................12-14
Event Director
Registration Information.....................................................15
Pharma IQ, a division of IQPC
Venue & Accommodations..................................................15
2 www.coldchainpharma.com Sponsors:
3. What's New for
International Distribution and Shipping to New Markets -
Conference Day Three
Companies are making strategic decisions to use lower cost centers for
manufacturing, clinical trials and new distribution markets. These new markets
post great challenges for the logistics professional having to navigate less traveled
lanes, interpret obscure regulations and collaborate with new logistics partners.
Learn how pharma companies, logistic partners and non-profit agencies are
effectively delivering cold chain medicines to new markets by:
• Distributing through mountains and jungles with limited airport facilities and
cold chambers in local towns
• Training immunization organizations and staff on cold chain
• Finding local reliable cold chain partners and developing a trusted network of
cold chain partners
• Aligning approaches between shipper, freight forwarder and 3PLs
• Using robust packaging solutions suitable for remote destinations
• Overcoming weather conditions such as “El Nino”
Plus, don't miss the FDA Keynote Presentation on
Importation Safety for a Global Supply Chain!
Healthcare Cold Chain Distribution Track
Great lengths and investments have been made to ensure your high-value medicines
are temperature controlled. But how much visibility and control do you have over the
last legs of your cold chain? Join pharmacists, wholesalers and shippers to discuss
how to ensure medicines reach patients safely and efficaciously by:
• Improving metrics and processes for evaluating product excursions for health care
professionals and patients
• Developing industry guidance Technical Report 46 to work toward greater
education of healthcare professionals
• Developing Quality Agreements with wholesale partners
Currently, a mass population survey for pharmacists is being devised to gain
detailed insight to how cold chain products are being handled. Stay tuned to
www.coldchainpharma.com for the posting of survey results!
Defining Industry Cold Chain Best Practice
• The New ISPE Cold Chain Good Practice Guide
• The New ISTA 7E Temperature Profiles and Manual 20
• Additions to existing PDA TR #39 and the USP <1079>
Are you trying to make the best use of the several industry best practice
documents? Join industry colleagues to decipher new guidelines and compare
them to existing guidelines to understand synergies and what document is used
for certain applications and issues.
3
4. What's New for
...continued
Temperature Mapping and Profiling for Cold, CRT and
Ambient Products
Today, with several product temperature ranges, companies are designing
transportation and thermal mapping studies to collect sufficient stability data for
product categories. Solid temperature profiles are determined for these product
categories to ensure streamlined packaging and lane qualification.
Join discussions on best practice temperature profiling, reviewing company case
studies and the new ISTA temperature profiles. Find out how other organizations
are working with packaging and transportation partners to find cost-effective
solutions for Ambient and CRT products.
Hear from:
• Bristol Myers Squib • Johnson & Johnson
• Savient Pharmaceuticals • Merck
• Thermosafe • ISTA
• Eli Lilly • EnviroCooler
• TempTrip
Transportation & Security Plenary
With pharmaceutical cargo theft and tampering on a rampant increase,
high-value cold chain products are a target and require greater security measures!
Don't miss presentations about:
• TSA Certified Cargo Screening Program: Post August 2010 Deadline
• Building security capabilities into your temperature controlled supply chain
• Establishing security processes that ensure cold chain products are delivered
safely to patients
• Contingency planning for air travel and international cold chain distribution
• Bridging the gap with air transport: Meeting industry critical standards and
devising effective contingency plans
Evening Networking Seminar: AIR CARGO 201
As a follow up session to last year's 'Interview with an Airline' Panel Discussion, this
Evening Seminar is planned to take a deeper examination of how carriers, ground
handlers and shippers all have a role in ensuring cold chain effectiveness of air freight.
Questions and Discussion Points:
• How can the industry standardize training and auditing of airport facilities?
• How are carriers ensuring agents and ground handlers are adhering to Chapter 17
guidelines?
• How can airport infrastructure obstacles be overcome? Discussing examples in
India, Doha, Chicago, Dublin, London and Japan
4 www.coldchainpharma.com Sponsors:
5. DAY Specialist Discussion Forums
ONE Monday, September 20, 2010
Choose from Workshop A or B 8.00am - 11.00am (Registration 7.30, coffee will be served)
A Utilizing Continuous Process Improvement to
Demonstrate a Risk-Based Approach for Your
B Cost Effective Transportation Strategies for
2-30°C Pharmaceutical Products
Temperature-Sensitive Supply Chain
This workshop will look at how a manufacturer and their lead cold chain
This workshop, will review the benefits offered through integration of solutions provider were able to significantly reduce transportation costs
traditional enterprise applications (enterprise resource planning ERP, and risks to the manufacturer’s product through close collaboration with
warehouse management systems WMS, and transportation management the air carrier and freight forwarder. The principles applied in this case
systems TMS) and cold chain management systems. The session leaders study can be applied to any temperature-controlled transportation
will explore managing a temperature-sensitive supply chain through the requirement.
application of a risk-based approach. What you will learn:
• How can the temperature of a product be controlled in flight?
Banking cold chain data and statistically evaluating supply chain
• How do you identify and address potential gaps in the transport
performance over time enables the development of continuous process
improvement however traditional solutions have lacked the ability to process
• What role do your providers play in addressing any gaps
integrate logistics data housed in other applications.
• An example of an integrated program that addresses the gaps
Integration of logistics data with time and temperature enables efficient
analysis of temperature variability by supply chain segment (ground How you will benefit:
origin, warehouse/cross dock, air, ground destination, warehouse, etc...) Through discussions and case scenarios of air transport, you will discuss
with your industry colleagues and those experienced with air transport,
This workshop will explore these key elements together in an interactive
how to:
and thoughtful discussion linked to specific case studies. • Design a collaborative cold chain process that works in the real world
What you will learn: of air transportation
• Opportunities provided by integrating a cold chain management system • Anticipate the challenges that threaten your cold chain
with other relevant software applications including (ERP, WMS, and • Reduce costs while minimizing risk to the product
TMS)
• Benefits provided through automated supply chain segmentation
Your workshop leader:
John Liebe, Head of Sales for North America, LifeConEx LLC.
analysis of time and temperature data – (integration of logistics data
and time and temperature data)
• Opportunities to drive efficiency and reduce costs while meeting
regulatory requirements
• The benefits of ongoing monitoring programs and how they support
continuous process improvement
• Demonstrate and document compliance with regulatory requirements
and standards-based guidance
• Document and mitigate risks through improved Standard Operating
Procedures (SOPs)
How you will benefit:
Through case examples and interactive exercises, you will learn how to
leverage cold chain data to make informed decisions regarding your cold
chain distribution. You will examine:
• Temperature-sensitive risk assessment
• Reduction of quarantine incidents and streamlined approval process
• Statistical evaluation of supply chain processes
• Case study analysis
Your workshop leaders:
Mark Maurice, Senior Project Manager – Industrial Engineer, Sensitech
Nicole Nepomuceno, Program Manager – Industrial Engineer, Sensitech
Henry Ames, Director Strategic Marketing, Sensitech
"IQPC delivers a cohesive delegation of life science and pharmaceutical cold
chain professionals that you will not find in any other event. We have found the industry
pulse and opinion can be found at the Global Forum.”
- Cliff Wyllie, VP Bio-Pharma Healthcare Services, Cavalier Logistics
5
6. Choose from Workshop C or D 11.15 - 2.15 (Registration 11.00, Lunch will be served)
C Advanced Predictive Simulation Software
Technology – Virtual Cold Chain
D Environmentally-Friendly Approaches for the
Distribution of Temperature-Sensitive Drugs
Management
This workshop will present a wide-ranging overview of environmentally-
The workshop will facilitate an overview of Advanced Predictive Simulation friendly packaging designs and distribution methods available for
Software as applied to cold chain transportation shippers. The group will discuss temperature-sensitive pharmaceutical distribution. Evaluation
the “As Is” process of iterative physical testing for the design and validation of methodologies and economic aspects will be discussed.
cold chain shippers. We will also discuss solution options or possible “To Be” What you will learn
process improvements by utilizing simulation software early in the design or • Recycling & Reuse Programs
selection phase of cold chain shipper configurations. • Material Considerations and Innovations
• Current Available Products & Their Applications
Through a case study, presented by Ben Romero, Senior Packaging Engineer at
• Distribution Models
Genentech, you will learn firsthand how Genentech is deploying and utilizing
• Carbon Footprint & Life Cycle Analysis
predictive simulation software to evaluate shipper performance.
• Waste Management
What you will learn:
• Gain insight into how simulation software can assist in the design and
How you will benefit
• Enhance Your Knowledge of Material Options and Their Environmental
validation of Cold Chain Shippers
• 3D Modeling techniques
Implications
• Learn Ways to Measure Environmental Impact
• Modeling methods use for Phase Change material selection
• Understand How to Analyze Total Program Costs
• Simulate transient thermal profiles
• Become Better Equipped to Make Smart, Environmentally-Focused
• Decision making factors for evaluating cost-effective transportation systems
Product Decisions
How you will benefit:
You will gain an appreciation for the relative costs and benefits of achieving your **Workshop open to qualified end-user participants only
transportation objectives within the framework of your GDP requirements and Your workshop leaders:
discuss how to minimize those costs while maintaining safe transport Anthony (TJ) Rizzo, Strategic Account Engineer, Cold Chain
requirements by utilizing Advanced Predictive Simulation Technology. Technologies, Inc.
• Enhance your ability to select or design cold chain shippers that meet your
Bob Bohne, V.P., General Manager, Cold Chain Technologies, Inc.
requirements before testing
• Obtain the knowledge on how to optimize your cold chain shippers to reduce
cost and maximize performance
• Increase your understanding of how to effectively work with simulation
technology to implement process improvements in your current environment.
• How to mitigate risk associated with transporting temperature sensitive goods
Your workshop leaders:
Iftekhar Ahmed, Senior Specialist, Cold Chain Management, MAYA
Simulation Technologies Ltd.
Ben Romero, Senior Packaging Specialist, Genentech
Choose from Workshop E or F 2.30 - 5.30 (Registration 2.15)
E Performing an Efficient Cold Chain
Compliance and Process Gap Analysis
F Exploring Best Practices when Implementing
Active ULDs and Logistics Processes in a
New Trade Lane
The pharmaceutical cold chain concept implies all necessary means to
maintain therapeutic products in the specified manufacturer’s temperature Growing your business means reaching more customers in markets that have
limits during all the logistic and distribution process (manufacture, storage, been historically challenging due to infrastructure, service limitations, and
transportation, final use). The cold chain compliance and process gap potential risks. In this workshop, you will be presented with proven
analysis is the very first step to allow you to critically evaluate the techniques and best practices that have facilitated increased efficiencies to the
compliance of your operations, logistics and packaging with regard to the transportation plan and packaging system for temperature sensitive products.
regulatory context and to the security of your products.
What will be covered:
What you will learn: • What are the steps involved in developing a new trade lane and how
• The regulatory aspects related to the cold chain
does they help mitigate risk?
• Responsibilities in the supply chain
• Do you have an internal “qualification process” for your Transportation
• Requirements for the storage and handling of drug products
Providers?
• Packaging, transportation and distribution of drug products
• What are the advantages of opening up dialogue with all stakeholders
• Performing a gap analysis to know what needs to be done in order to
in the cold chain?
fully comply with regulations and optimize your processes • Do you have Contingency Planning at each touch point?
• Ways and means to develop an executable action plan
• How can we use Post Shipment Analysis so that they provide us with
predictable patterns?
How you will benefit: • What are we doing with the temperature monitor data? Can it be
• Understand how to execute a cold chain regulatory gap analysis
used to improve the process?
• Discover what should be covered when looking at cold chain compliance
• Gap analysis: The first step to develop a cold chain compliance program How you will benefit:
• Uncover the requirements for the storage and distribution of drug • Gain firsthand knowledge about current procedures used to establish a
products new trade lane for distribution of your temperature sensitive product
• Sharing the responsibilities for a good cold chain compliance • Compare and contrast your method of developing a new temperature
sensitive trade lane
Your workshop leaders: • Experience case studies about how a collaborative data management,
Jean Bédard, Chief Executive Officer, Alternatives Technologie analysis, and reporting activity can add value to your program objectives
Pharma
Anthony Alleva, Technical Services Manager, Cryopak/TCP Your workshop leader:
Berkley Stafford, Global Key Account Manager, Envirotainer
6 www.coldchainpharma.com Sponsors:
7. DAY Main Conference Sessions
TWO Tuesday, September 21, 2010
7.00 Registration and Coffee of the 10 Edition of the Perishable Cargo Regulations (effective July, 1,
2010)
8.00 Pharma IQ Welcome Remarks • Steps for implementing a successful Chapter 17 compliant program
• What to expect for 2011-2012 edition.
8.15 Opening Remarks from Chairperson Kevin O'Donnell, Director & Chief Technical Officer, Tegrant Corporation,
Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA Branch, Thermosafe Brands
PDA
10.40 Morning Networking Break
8.20 Opening Keynote: Cold Chain - A Business Critical Function
Mary Kuhn, Executive Vice President, Operations, Talecris 11.25 Introducing the New ISPE Cold Chain Good Practice Guide
Biotherapeutics, Inc. The Good Practice Guide is intended to provide practical guidance to
assist companies in establishing good practice and achieving compliance
International Regulations & Industry Standards for the transfer, packing, storing, distributing, receiving and unpacking of
product requiring controlled cold conditions to maintain its safety, efficacy
9.00 Observations and Guidance for Conducting Regulatory and quality.
Compliant Cold Chain Operations Geoffrey Glauser, Director, Global Packaging Technology, Pfizer
• Feedback from recent audits of pharmaceutical manufacturers and noting
trends 11.40 Panel Discussion: Cooperation and Synergies of USP <1079>,
• Risk mitigation initiatives from a regulatory perspective
PDA TR 39, ISTA Manual 20, ISPE Good Cold Chain Guidelines
• Beyond temperature monitoring: Future regulatory concerns on humidity
and WHO Regulatory Oversight Guidance
and other parameters • Overview from each group: Objective of guidance, how unique to the
• Stability data for transportation: Regulatory expectations and shipment
other documents and industry uptake
outside labeled storage conditions • Understanding what type of company uses which document for specific
• Commenting on the new PDA Stability "In Use' Conditions guidelines
projects
Ian Holloway, Manager, Defective Medicines Report Centre, MHRA • Clarifying redundant aspects of cold chain qualification requirements across
documents and how each individual document serves a purpose
9.40 The Final Updated USP <1079>: Validating and Documenting • Examining the process of temperature mapping and temperature profile
Each Step of Your Cold Chain development within each pertaining guideline
• Quality Management System (QMS) • Discussing potential efforts to harmonize across guidance documents
• Storage Management System (SMS)
• Transportation Management System (TMS) Panelists:
• Environmental Management System (EMS) Dr. Mary Foster, Chair, Packaging and Storage Expert Committee, US
• Industry feedback Pharmacopeia (USP)
Dr. Mary Foster, Chair, Packaging and Storage Expert Committee, US Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA Branch, PDA
Pharmacopeia (USP)
Paul Harber, Associate Engineering Consultant, Eli Lilly
10.20 Complying with IATA Chapter 17 Revised Regulations for Geoffrey Glauser, Director, Global Packaging Technology, Pfizer
Temperature Sensitive Healthcare Products
• What’s changed? A review of the major revisions to Chapter 17 12.30 Networking Lunch
Concurrent sessions begin: Choose Track A or B
Track A: Green and Innovative Packaging Track B: Healthcare Cold Chain Distribution
1.45 Redesigning Long-Haul Shippers to Reduce Costs and Management of Stability Data for the Last Mile: A Case
Environmental Footprint Presentation and Review of Technical Report 46 "Last Mile"
• Validation of 2-30° pack-outs for international distribution •Working with quality professionals to provide sufficient information
• Switching from refrigerated gel packs to ambient brick gels to our customers and patients
• 'Go Green' initiative: Recyclable and returnable pack-outs, including • Improving the metrics and process for evaluating product excursions
reduction in foam used for health care professionals and patients
• Collecting and analyzing temperature data for five+ years to develop • Tech Report 46: Distribution from Point of Dispensing to End Use in
accurate profiles to test and qualify packaging Mail Service Pharmacy
• Realizing significant costs savings Bella Cohen, PharmD., Global Medical Information, Global
• Next steps: Other products and additional temperature ranges Pharmaceutical Regulatory & Medical Sciences, Abbott
Robin Turner, Director, Global Packaging Development, Medtronic
2.20 From Corn to Biodegradable Packaging: Developing Expanded Practical Issues Faced by Front-Line Staff in The Last, But
PLA (EPLA) for Moldable Cold Chain Shippers Important Leg of the Cold Chain
As pharmaceutical manufacturers increase their focus on environmental •Stability practice disparity between companies and pharmacies
responsibility, much of the activity has centered on recycling and reusability. As •Practical and economic issues with refrigeration of medications in
an attractive alternative, EPLA represents a potential game-changing material the pharmacy and patient care areas
innovation which would alter the way we analyze return logistics and recycling • How stability issues contribute to medication safety challenges
needs and disposal. In addition to EPLA, expanded polystyrene resins are now Mary E. Burkhardt, MS, RPh., Medication Safety Consultant,
available with 50—75% of post-consumer, recycled content. Medication Safety Solutions
• Developing the EPLA Manufacturing Process
• Recycled Polystyrene Raw Material Resins
• Composting, Biodegradability and Recycling
• Cost and Performance Attributes
Michael Hays, Vice President, Foam Fabricators, Inc.
Bob Bohne, V.P., General Manager, Cold Chain Technologies, Inc.
Stephen Good, Project Manager, Packaging Engineering & Development,
Abbott (Final confirmation pending)
7
8. 2.55 Upgrading of Traditional Cold Chain Shipping Systems Strengthening The Wholesaler and Pharmaceutical
Using Custom Phase Change Materials Manufacturer Relationship
• New, high performance cold chain shipping systems have become available • Discussing the value of sharing stability and shipping data
utilizing both vacuum panel insulation and custom phase change materials • Developing Quality Agreements with wholesale partners
• These new systems have greatly improved performance, but incur • Consider sharing the financial burden
higher material costs, and may require reusability. Even if the ‘total • Working together to ensure supply chain and patient safety
cost’ is competitive, this represents a challenge because of the potential Chris J. Anderson, Director, Quality & Regulatory Affairs,
scope of the change & how it affects current operations & mind set Pharmaceutical & Medical Distribution, Cardinal Health
• An interim approach, bridging traditional shipping systems, and new
technologies will be presented to illustrate how the two can be combined
in order to gradually shift an organization to these new technologies
Ben Romero, Senior Engineer, Pharma and Packaging Development,
Genentech
3.30 Solving Unique Cold Chain Challenges Through Available Panel Discussion: Proactive and Collaborative Efforts to
Technology and Innovative Reusable Container Designs Ensure Cold Chain Adherence Downstream and Solid
While Gaining a Return on Your Investment Supply Partnership
• Description of thermal shipper and reusability aspects • Understanding the current ‘state of play’: Measures and QA
• Operational Qualification Testing: General approach, transit testing, procedures currently in place at wholesaler and at pharmacies
thermal performance testing • Educating pharmacies on the cold chain requirements and solutions
• Live shipment test results available
• Conclusions from testing results & collaboration between Pfizer and • Addressing some of the costs involved and how to overcome
MTS budgetary issues
• Qualities and initiatives of the collaboration that ensured beneficial • Monitoring prescription drugs – but what about diagnostic devices,
operational and financial outcomes OTC and drugs bought on the internet?
Bill Mayer, Director of Engineering, Minnesota Moderator:
Thermal Science Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA
Branch, PDA
Michael Kreuze, Principal Engineer, Pfizer, Inc.
Panelists:
Mary E. Burkhardt, MS, RPh., Medication Safety Consultant,
Institute for Safe Medicines Practices (ISMP) & Medication
Safety Solutions
Bella Cohen, PharmD., Global Medical Information, Global
Pharmaceutical Regulatory & Medical Sciences, Abbott
Chris J. Anderson, Director, Quality & Regulatory Affairs,
Pharmaceutical & Medical Distribution, Cardinal Health
Chris Chandler Pharm D., Quality Assurance, Consolidated Mail
Outpatient Pharmacy, US Department of Veterans Affairs
4.05 Afternoon Networking Break
4.50 Roundtable Discussions
After a full day of presentations, it’s time for all participants to take an active role and get answers to specific questions. These informal discussions
will provide an opportunity to exchange ideas related specifically to job functions and interests. Facilitators will present a short case study as an
introduction to the 60 minute discussion and question session.
A) Balancing Effective Cold Chain Strategies Across the Supply F) New Standards Based RFID Technology Offers Increased Cold
Chain Chain Visibility and E-pedigree: Assessing the Technology,
Roundtable Leader: Mark Wiesman, President, DDN Applications and Company Experiences
B) Applying the ISTA 7E Temperature Profiles & Manual 20 Certification Roundtable Leaders: Thomas C. Reese, Sr. Director, Business
Roundtable Leader: Jim Cox, PhD., Certified Thermal Transport Development, Intelleflex Corporation and
Auditor, ISTA Stan Tseng, President, Asia Pallet Pooling
C) Investigating and Validating Cost-Effective Solutions for CRT G) Understanding the Processes and Systems Needed to Accumulate
or Ambient Products Temperature Excursion Data Throughout the Supply Chain
Roundtable Leader: Larry Sweeney, Senior Director, Distribution Roundtable Leader: Jim Bacon, Senior Director, Global Demand
and Logistics, Genzyme Planning and Customer Operations, Talecris Biotherapeutics
D) Devising Quality Agreements with Your Wholesalers H) Measuring the Impact of Humidity on Product Stability
Roundtable Leaders: Claude Jolicoeur, Director of Regulatory Roundtable Leader: Rafik H. Bishara, PhD, Technical Advisor and
Affairs and Corporate GMP Officer, McKesson Canada & Pharma Chair PCCIG USA Branch, PDA
partner being confirmed I) Mail Order Pharmacy Cold Chain Delivery Challenges
E) Packaging Design Considerations for Today's Cold Chain Roundtable Leader: Tina Beshears, Medication Strategy, Director,
Challenges Professional Practice, Medco Health Solutions
Roundtable Leader: Richard C. Ellinger, Principal, Temperature J) Shipping Cold Clinical Supplies Internationally: Today's
Assurance Group Logistics Considerations
To lead this roundtable, contact courtney.becker@iqpc.co.uk
5.35 Summary of Roundtable Discussions
6.25 Closing Remarks from Chairperson
6.30 Networking Reception in Exhibit Hall
8 www.coldchainpharma.com Sponsors:
9. DAY Main Conference Sessions
THREE Wednesday, September 22, 2010
7.15 Registration and Coffee 10.55 Bridging the Gap With Air Transport: Meeting
Industry Critical Standards and Devising Effective
8.10 Opening Remarks from Chairperson Contingency Plans
General air cargo processes are insufficient to support the stringent
Transportation and Security requirements of pharmaceutical cold chain logistics, particularly the
newer “biologics” and even the traditional compounds now facing
8.00 Keynote Address: TSA Certified Cargo Screening tougher regulatory standards. Upgrading management capabilities to
Program: Post August 2010 Deadline meet these standards requires education in pharmaceutical handling,
• Industry progress training in cold chain processes and advance planning for each
• Cost considerations for implementing shipment, all completed, documented, and tested before the first
Gary E. Lupinacci, Assistant Branch Chief, Certified Cargo shipment is handled. When all runs as planned, these SOPs for air
Screening Program, TSA/TSNM, Department of Homeland cargo provide a secure and robust system that may be included in the
Security overall cold chain. Unfortunately, all aircraft are subject to uncertainties
due to weather, unplanned maintenance, or other factors that can
8.50 Supply Chain Security & Risk Mitigation Practical force plans to change. The risk associated with exterior events can be
Measures mitigated with thorough advance planning, documentation and
• Current trends and best practices to reduce risks in the supply communication. Planning and understanding of shipper requirements
chain, warehouse facilities and in-transit cargo leads to success. In this presentation we will discuss:
• Working as an industry to indentify and mitigate risks
• How specialized handling processes and contingencies ensure safe
• Use of technology to capture real time information that ensures
and rapid transit of pharma products
products do not incur temperature or supply chain deviations • The role of shipper, freight agent, and airline in preparing air
• Experience and feedback from local authorities on how to
cargo standard operating procedures
conduct best practice communications about high value medicines • Gaining control of the air cargo portion of cold chain through
in distribution simple, robust processes
Carlos Velez, Worldwide Security Director, Johnson & Johnson • The importance of transparency into shipper requirements and
airline capabilities
9.30 Security & Control in the Pharmaceutical Temperature • Live examples of when contingency plans were employed and
Control Supply Chain why preparation was critical
• Global trends effecting security, complexity, and temperature
control within the pharma supply chain Kyle Betterton, Vice President, United Cargo
• How to continue to maintain quality within the transportation
Don Harrison, Operations Excellence, United Cargo
process in spite of increasing difficulties
• Understanding the different transportation models and what the
11.35 Optimization of a Passive Pallet Shipping System for
appropriate expectations are of each partner in the process International Vaccine Transport
• Technological advancements assisting the security aspects during
• Identify, analyze, and prioritize demands from multi-national task
transportation in the pharma supply chain forces
• The effective layering of security options depending upon the
• Design and development overview of the next generation pallet
needs of the cargo and the interests of the parties involved shipper
Karl Kussow, Manager of Quality, FedEx Custom Critical • Product attributes that help overcome challenges in international
vaccine transport
10.10 Morning Networking Break • Thermal performance review
Michael English, Senior Packaging Engineer, Merck & Company
Auston Matta, Senior Project Engineer, ThermoSafe Brands
12.15 Networking Lunch
Concurrent sessions begin: Choose Track A or B
Track A: Product Stability and QA Track B: Packaging and Lane Qualification
1.30 Stability Testing Data to Support Distribution and 'In New International Safe Transit Authority (ISTA)
Use' Conditions: A Report from the PDA Working Group Standards & Certification: 7E Thermal Profiles & ISTA
• ISTA 7E Temperature Profile Standard Project: Results, analysis and Manual 20 Thermal Laboratory Certification
profile development • ISTA 7E Temperature Profile Standard Project: Results, Analysis and
• ISTA Manual 20: Package Thermal Qualification Standards & case Profile Development
study • ISTA Manual 20: Package Thermal Qualification Standards & Case
• ISTA Laboratory & Package Certification: How can you have your Study
shipping solutions tested and certified under the new international • ISTA Laboratory & Package Certification: How can you have your
standards shipping solutions tested and certified under the new international
standards
Arminda O. Montero, Distribution QA Program Manager, Global Moderator:
Pharmaceutical Operations, Abbott Ed Church, Executive Director, ISTA
Panelists:
Paul Harber, Associate Engineering Consultant, Eli Lilly
Rod Derifield, President, EnviroCooler LLC
Jim Cox, PhD., Scientific Advisor, TempTrip and ISTA Auditor
9
10. 2.05 Supply Partner Perspective: Stability Data and Label Information Qualification of an Insulated Container from Israel to
• The case for expanded temperature ranges in last-mile transportation the Mid-West U.S.
• Typical life cycle of a mail order pharmacy shipment • Development activities
• Labeling guidance for expanded stability data use by partners and patients • Summer and winter real time qualifications
• Product temperature vs. internal ambient temperature
Chris Chandler, Quality Assurance, Consolidated Mail Outpatient • "Outside" temperature mapping
Pharmacy, US Department of Veterans Affairs • Lessons learned and next steps
Tina Beshears, Medication Strategy, Director, Professional Practice, Suzan R. Lanz, Associate Director, Project Management, Savient
Medco Health Solutions Pharmaceuticals, Inc.
2.40 Developing a Sound Risk Management Mechanism for Cold Thermal Mapping the World
Chain Transportation • Collecting data from 26 countries to develop winter and summer
• Working with the PCCIG to develop guidelines for detecting and profiles for each region
analyzing potential risks throughout the cold chain • Approach and results to the temperature studies
• Risks in developing temperature profiles • Benefits to temperature data
• Risk assessment when developing shipping protocols
Bobby Boehm, Associate Director, Cold Chain, Bristol Myers Squibb
• Ambient temperature product risk mitigation efforts
• Learning about risk mitigating mechanisms for a secure transportation chain
Boriana Cavicchia, Manager, System Quality Biomedical Services,
American Red Cross
3.15 Afternoon Networking Break
Temperature Mapping and Profiling for Cold, CRT and Ambient Products
3.45 Temperature Mapping North American Supply Chains
• Designing a study for transportation from multiple Distribution Centers within the US
• Examples of seasonal temperatures & mapping results
• Sourcing multiple solutions for temperature compliance of CRT or Ambient products
• Monitoring of solution's performance to our defined standards
Alan J. Davis, Supply Chain Temperature Control Leader, Johnson & Johnson
4.20 Panel Discussion: Controlled Room Temperature Products: Working with Partners to Meet Regulatory Requirements
Cost-Effectively
• Working with packaging providers to find more cost-effective solution
• How do carriers handle CRT Products: Do transportation providers have a helpful solution?
• What are the temperature ranges if we don’t have the stability data?
Panelists:
Alan J. Davis, Supply Chain Temperature Control Leader, Johnson & Johnson
Bobby Boehm, Associate Director, Cold Chain, Bristol Myers Squibb
Boriana Cavicchia, Manager, System Quality Biomedical Services, American Red Cross
5.00 Closing Remarks from Chairperson
G 6.00 - 8.30 (Registration 5.30, Dinner will be served)
Evening Networking Seminar: AIR CARGO 201
At last year's Cold Chain conference, the 'Interview with an Airline' Panel • How are you adjusting your airline procedures to adhere to TSA
Discussion was a popular session and yielded great insight into how airlines Screening requirements?
handled temperature controlled pharmaceuticals. Finally airlines 'had a
Discussion Points:
voice' and pharmaceutical manufacturers got a clear picture as to what • Handling airport infrastructure obstacles in different parts of the world:
cold chain best practices airlines adhered to.
Discussing examples in India, Doha, Chicago, Dublin, London and Japan
With the IATA Chapter 17 July 2010 deadline and the TSA 100% • New 'pharma centers' for distribution at India's airports
Screening August 2010 deadline, this Evening Seminar will be a great • Ensuring a collaborative and responsible approach between the
opportunity to gage the progress of airlines and supply chain stakeholders shipper, freight forwarder agent and airline
implementing greater control and visibility into shipping temperature • Filling gap between capacity and growth demand: What are airlines
sensitive air freight. Have these regulations made an impact on operating a doing to match capacity with demand?
robust cold chain in the air? (and on the tarmac!) • What can industry to do get greater cooperation across supply chain to
help improve the supply chain process?
The Evening Seminar will provide an opportunity for air carriers, shippers,
freight forwarders and 3PLs to discuss remaining gaps in shipping Submit questions to discussion leaders to courtney.becker@iqpc.co.uk
temperature sensitive air freight. before the seminar.
Interview with an Airline - Part II: Seminar Moderators:
• What differentiates your product and process from other temperature Kevin O'Donnell, Director & Chief Technical Officer, Thermosafe &
controlled air cargo operations? Chair, IATA Time & Temperature Task Force
• What are your experiences to date working with industry or companies Tony Wright, Managing Director, Exelsius - Cold Chain Management
to develop that process? Consultancy
• What have you learned to create a sustainable process to support
Panelists:
shipment of temperature controlled pharmaceuticals?
• How are you ensuring your agents and ground handlers are adhering to
Don Harrison, Operations Excellence, United Cargo
Roger Samways, Director, Global Accounts and Sales Strategy,
Chapter 17 guidelines?
• Can agents realistically adhere to Chapter 17 and maintain 15-25°?
American Airlines Cargo
• How do you define your service levels and agreements with agents? If
Larry Sweeney, Senior Director, Distribution and Logistics, Genzyme
Brandon Fried, Executive Director, Air Forwarders Association
issues arise, how are they resolved and how are risks mitigated?
• How are you working ISO standards into your Quality Management System?
Jim Tyrrell, Deputy Director, Aviation, Property Management and
• How can industry standardize training and auditing of facilities?
Business Development, Philadelphia International Airport
10 www.coldchainpharma.com Sponsors:
11. DAY Main Conference Sessions
FOUR Thursday, September 23, 2010
7.30 Registration and Coffee Shipping to New Markets
8.00 Opening Remarks from Chairperson 12.55 Brazil Case Study: Regulations and Quality Operations of
Jim Bacon, Senior Director, Global Demand Planning and Customer Shipping Temperature Control Pharmaceuticals
Operations, Talecris Biotherapeutics • Outlining specific requirements by ANVISA for handling, storing and
distribution cold chain medicines in Brazil
• Product and temperature control by hospitals and distributor customers
International Transport and Logistics • Importation of pharmaceutical products into Brazil: Overcoming custom
8.05 Keynote Session: Pharmaceutical Import Safety from a challenges
• Experiences at airport with personnel and accessing cold chain
Global Supply Chain Perspective
shipments
• Today's medicines supply chain: Increasing global trade, complex • Working with affiliates to ensure effective international transportation
products and transnational food and drug supply chains
• Working in critical partnership with both industry and state and local
and validation of products
Elaine Araujo Menezes, Quality Operations Coordinator, Abbott Brasil
health authorities domestically and internationally
• Good importer practices and experiences with industry to date
1.35 Distributing Vaccines to Remote Populations in Peru
Lori Rose, Consumer Safety Officer, Food & Drug Administration • Use of Thermal Bags as a safer way for packing
(FDA) • Refrigerated truck for campaign of vaccination to places remote in
Peruvian Andes
8.45 Latin American Case Study: The Importance of Developing a • Maintaining the cold chain in places without electricity, available roads
Collaborative Model for Successful International Air Transit and extreme weather
of Temperature-Controlled Products Humberto Laserna Zubiaga, Quality Coordinator, Pfizer-Peru
• Streamlining front-end planning and communications among supply-
chain partners for successful outcomes 2.10 South American Andean Region Case Study: Distribution
• Maintaining product integrity end-to-end through challenging regulatory of Vaccines Challenges and Opportunities
environments • Describing key challenges shipping in the Andean Region including
• Effective management of customs and regulatory hurdles for cost Venezuela, Colombia, Peru, Ecuador and Bolivia
containment • Customs processes, facilities and imports regulations (Case of Private
• Managing uncertainty through effective contingency planning Market, Government purchase to PAHO)
Dave Brooks, President, American Airlines Cargo • Weather conditions: Examining what happened when "El Niño"
appeared and how we managed cold chain products
• Distribution from Pacific coast through mountains and jungle: Airports
9.25 Harmonizing Processes and Quality Systems for the Global
Supply Chain facilities, Cold Chambers capacity by town
• Security risks assessment: Cost considerations and review of key issues
• Qualifying transportation partners and standardizing the qualification
process Ursula Vértiz, Engineer, Independent Consultant (Formerly, Technical
• Temperature excursion management Operations and Product Supply Manager, Wyeth Peru)
Maryann Gribbin, Manager Industry Compliance and Regulatory Affairs, 2.50 Afternoon Networking Break
Johnson & Johnson
3.20 Introducing New Vaccines to Remote Markets Case Study:
10.05 Morning Networking Break Distributing the First Fully-Liquid Pentavalent Vaccine
• Collaborating with The Global Alliance for Vaccines and Immunization
10.35 Contingency Management: Mitigating Risk During (GAVI) to get needed vaccines to Asia and Africa and the Pan
International Shipment of Temperature Sensitive Products American Health Organization (PAHO) to distribute vaccines to Latin
• Understanding the Quality Risk Management principles as defined in ICH America
Q10 • Training immunization organizations and staff on cold chain and safe
• Identifying and measuring the impact of events on the supply chain immunization practice
• Developing and implementing effective contingency plans • Providing correct and sufficient documentation
• Case study: Learning from a shipper’s perspective, including a risk based • Options for public – private cooperation
• Encountering distribution challenges
analysis or FMEA procedure
• Lessons learned and suggested actions for improvements in the future
Chris Fore, Manager Industry Compliance and Regulatory Affairs,
Envirotainer Sanja Saftic PhD., Forecasting Manager, Strategic Vaccines Supply,
Accelerated Vaccine Introduction, PATH
11.15 Panel Discussion: Aligning Approaches between Pharma,
Freight Forwarders and 3PLs 4.00 Closing Keynote Address: Pharmaceutical Cold Chain
• Contract negotiations: Optimizing costs for temperature control shipping Management in China: The Latest Progress
• Setting up service agreements and service levels
• Examining current regulatory standards in China for cold chain
• Accessing real time data to achieve total product visibility distribution
• Current and emerging issues regarding product safety environment in
• Keeping partners accountable day to day
• New Markets: Consulting your supply chain partners and conducting China: Assessing different pharmaceutical products using cold chain
• Managing pitfalls and strategies for cold chain distribution in China:
independent new market research • Best Practices to be adopted when looking for a reliable Cold chain
Moderator: partner in China
Jim Bacon, Senior Director, Global Demand Planning and Customer • Devising cold chain Standard Operating Procedures (SOPs) with Chinese
Operations, Talecris Biotherapeutics cold chain partners
• Technology updates for China: Utilizing RFID (and other latest
Panelists:
Chris Fore, Manager Industry Compliance and Regulatory Affairs, innovations) for traceability, temperature logging and safety
Envirotainer Xing Fu Feng, CEO, East China Pharmaceuticals (Huadong Ningbo
Maryann Gribbin, Director Quality Assurance, Global Pharmaceutical Pharmaceuticals Co Ltd)
Supply Group, Johnson & Johnson Amit Ghosh, International Business Development Manager, East China
Pharmaceuticals (Huadong Ningbo Pharmaceuticals Co Ltd)
11.55 Networking Lunch
4.40 Closing Remarks and Close of Conference
11
12. About Our Sponsors
ThermoSafe Brands, a Strategic Business Unit of Tegrant knowledge in preparing adverse event reports, labeling management, product
Corporation, is the leading provider of temperature assurance complaints and medical and technical product inquiries. For more information please call
solutions. Tegrant Corporation is a premier manufacturer of a 888-374-8873. Website: www.ddnnet.com
variety of highly engineered packaging solutions and energy efficient components with
over 35 manufacturing and testing facilities across North America and approximately United Cargo uses nearly 3,300* flights a day to transport cargo
2,100 employees. ThermoSafe Brands complete portfolio of transport assurance and to over 230 U.S. and international destinations. With key global
temperature assurance shipping products for the safe and efficient transportation of bio- air rights in the Asia-Pacific region, Europe and Latin America,
substances, blood and other sensitive specimens across the entire temperature United Cargo has the schedule and capacity to reach virtually every major business
continuum. Our portfolio includes an extensive array of expanded polystyrene and market in the world. Over 400 additional worldwide destinations are available
polyurethane insulated shipping containers, refrigerants in a wide range of temperatures through United Cargo’s network of reliable interline partners. Two convenient on-line
and configurations, pre-qualified shipping systems for off-the-shelf ease of use and options are available for booking and managing shipments: our industry-leading
peace of mind. In addition, ThermoSafe Brands’ ISC Labs brings our customers website, unitedcargo.com and cargoportalservices.com, the world’s most popular air
experience and innovation in package design and certified independent testing services cargo internet portal. Website: www.unitedcargo.com
to meet all regulatory requirements and concerns. Website: www.thermosafe.com
Pioneer and market leader Envirotainer offers flexible leasing
FedEx Custom Critical offers a complete array of surface and (rental) of advanced transport solutions for worldwide air cargo
air solutions to safely and securely ship temperature-sensitive shipments of temperature-sensitive products. Customers within the healthcare, life
products. You can choose from exclusive-use vehicles with sciences and high-tech industries benefit from the combination of advanced container
temperaturecontrolled cargo boxes to airfreight solutions utilizing temperature- technology, extensive cold chain management services and a global network of service
controlled air containers. With our Temp-Assure Validated services, you also receive partners, airlines and forwarders – providing a unique one-way leasing service.
hard-copy documentation of the temperature inside the vehicle or container Envirotainer secures the safety and integrity of product cold chains by providing an
throughout transport. This assists our pharmaceutical customers with their compliance active temperature-control system, training all parties along the cold chain and
needs through a documented audit trail of their products’ temperature throughout supporting customers in transport validations and risk management. With sales
the shipping process. FedEx Custom Critical services are available 24/7/365 with representation in 17 countries, the company has its R&D, Manufacturing and Quality
surface solutions throughout the U.S. and Canada and air solutions across the globe. Assurance departments at the headquarter premises in Lagga Marma near Stockholm,
Website: www.customcritical.fedex.com Sweden. Website: www.envirotainer.com
Minnesota Thermal Science, LLC develops unique storage and Elpro Services, Inc. is a leading manufacturer of high quality
shipping systems that address the challenges of maintaining temperature, humidity, and CO2 dataloggers, providing recording
constant and predictable temperatures when transporting and monitoring solutions while observing regulatory compliances
temperature sensitive medical materials. Founded in 2004 following an industry wide (GMP/GLP/FDA 21CFR11). LAN/W-LAN solutions are fully scalable to meet your central
search by the Walter Reed Army Institute of Research for a more effective combat monitoring requirements and future growth. Our New Libero PDF-logger® (No
environment container, MTS has continued to apply its technology to handle other Software Required) provides simple cold chain monitoring of temperature sensitive
important medical materials including all types of biomaterials and pharmaceuticals pharmaceuticals. This ground-breaking concept of producing the report in a PDF file
that require controlled temperatures Its patent pending Golden Hour® Technology, eliminates the need to install, qualify and validate any specific software at destination.
winner of a "U.S. Army Greatest Inventions" award, is credited with saving soldier's Available in 100 and 400 day models, our Libero PDFlogger ® also supports
lives on the battlefield and with revolutionizing the methods used for distributing compliance with FDA standard 21 CFR 11. Website: www.elpro.com
temperature sensitive medical supplies. Website: www.goldenhourtechnology.com
MAYA Simulation Technologies Ltd. is a developer of thermal and
American Airlines CargoSM, a division of American flow simulation software tools. MAYA's simulation solutions provide
Airlines, Inc., provides one of the largest cargo networks comprehensive and accurate insight into the thermal behavior of a
in the world, with cargo terminals and interline connections available across the wide range of cold chain transport systems reducing the need for prototype testing.
globe. American’s global network serves over 250 cities in 40 countries worldwide; MAYA offers a complete software simulation solution for the thermal design and
including major cities in the United States, Europe, Canada, Mexico, the Caribbean, optimization of cold chain transport systems. MAYA's thermal simulation solution can
Latin America and Asia. American Airlines Cargo provides Cold-Chain transport model all aspects of heat transfer including conduction, convection and radiation. The
utilizing its temperature controlled ExpediteTCSM product. ExpediteTCSM provides thermal and flow solvers are fully capable of modeling steady state as well as
priority boarding, priority handling, fastest flight connections, high-visibility shipment transient thermal/flow conditions. Additionally we incorporate advanced tools such as
tracking, automatic status notifications, and a 100% guarantee to be flown-as- phase change materials, condensation/humidity calculations, dust/smoke distribution
booked. Website: www.AACargo.com tracking etc. Website: www.mayahtt.com
SCA Cool Logistics specializes in the design, test, manufacture Lufthansa Cargo ranks among the world’s leading cargo
and qualification of insulated shipping systems. Our off-the-shelf carriers. In the 2008 financial year, the airline transported
and bespoke packaging solutions are designed to safely transport around 1.7 million tonnes of freight and mail and clocked up
temperature sensitive products for pharmaceuticals, biotechnology, clinical trials and 8.3 billion revenue tonne-kilometres. The Company currently employs about 4,600
diagnostics throughout the world. Forming part of the SCA Packaging Group, SCA people, worldwide. Lufthansa Cargo focuses on the airport-to-airport business. The
Cool Logistics has manufacturing capabilities in the UK, Czech Republic, Singapore cargo carrier serves some 300 destinations in 90 countries with its own fleet of
and South Africa and with access to 128 SCA sites worldwide we provide a local freighters, the belly capacities of Lufthansa’s passenger aircraft and an extensive road
supply service to a global market. Website: www.sca-cool-logistics.com services network. The bulk of the cargo business is routed through Frankfurt Airport.
Lufthansa Cargo is a wholly-owned Lufthansa subsidiary. In the 2008 financial year, it
Cold Chain Technologies is a leading source for engineering- posted revenues totalling 2.9 billion euros. Website: www.lufthansa-cargo.com
based thermal packaging solutions. For almost 40 years, we’ve
continued to excel in providing efficient, cost effective thermal Delta Cargo offers several shipping solutions for temperature
packaging products and services to a wide range of customers – from local start-ups sensitive pharmaceuticals ranging from fine chemicals, bio-technology
to Fortune 100s. Pharmaceutical, biotech, healthcare, medical device, and food service and base materials to medical and blood samples, bulk drugs and all
companies count on us to solve their cold chain challenges. Distributed from multiple other products used for the production of pharmaceuticals. Pharma 1 is designed for
locations throughout the U.S. and internationally, our product line includes products that require transport in an active temperature-controlled container. Pharma 2
KoolTempTM insulated containers, Koolit® refrigerants, and KoolWatchTM and Pharma 3 are Delta Cargo’s shipping solutions for products requiring transport in
temperature indicators. Cold Chain Laboratories, our affiliated company, is a premier passive temperature-controlled containers. Delta Air Lines is the world’s largest airline.
source for expert design and qualification testing of thermal packaging solutions. From its hubs in Atlanta, Cincinnati, Detroit, Memphis, Minneapolis-St. Paul, New York-
Website: www.coldchaintech.com JFK, Salt Lake City, Amsterdam and Tokyo-Narita, Delta offers service to 368
destinations in 66 countries. Website: www.deltacargo.com
A subsidiary of the 151-year-old Dohmen Company, DDN is
headquartered in Menomonee Falls, Wis., with distribution facilities Entropy Solutions is the industry’s innovation leader in thermal technology.
located in Memphis, Tenn. and Ontario, Calif. DDN has become the With the introduction of the GREENBOX Thermal Management system,
largest privately held provider of outsourced channel management and business services Entropy has once again revolutionized how thermally sensitive products are
to the life science industry by streamlining processes, reducing costs and improving shipped and maintained. Our 100% organic, sustainable, passive thermal
efficiencies for emerging, mid-tier and market leading life science companies. By solution can maintain precise target temperatures for unprecedented periods of time.
providing superior business processes and operations, DDN frees manufacturers’ Through a unique combination of technology and design, GREENBOX™ delivers the
resources for R&D, acquisition and other core initiatives. DDN now offers data analytics industries most effective and cost efficient shipping method on the market today.
services and recently launched DDN Medical Affairs, providing specialized regulatory Website: www.greenboxsystems.com
12 www.coldchainpharma.com Sponsors: