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Dear Colleague,

    Recently, the international consulting firm Oliver Wyman, conducted a survey with more than 30 CEOs o...
What's New for
                                                           International Distribution and Shipping to New M...
What's New for
    ...continued

                                                              Temperature Mapping and Pro...
DAY                    Specialist Discussion Forums
                  ONE                    Monday, September 20, 2010


...
Choose from Workshop C or D                           11.15 - 2.15 (Registration 11.00, Lunch will be served)



     C   ...
DAY Main Conference Sessions
                       TWO                       Tuesday, September 21, 2010


7.00    Regist...
2.55   Upgrading of Traditional Cold Chain Shipping Systems                             Strengthening The Wholesaler and P...
DAY   Main Conference Sessions
                      THREE                       Wednesday, September 22, 2010


7.15   Re...
2.05   Supply Partner Perspective: Stability Data and Label Information                      Qualification of an Insulated...
DAY                           Main Conference Sessions
                        FOUR                          Thursday, Sep...
About Our Sponsors
                         ThermoSafe Brands, a Strategic Business Unit of Tegrant              knowledge...
8th Cold Chain Distribution for Pharmaceuticals Global Forum
8th Cold Chain Distribution for Pharmaceuticals Global Forum
8th Cold Chain Distribution for Pharmaceuticals Global Forum
8th Cold Chain Distribution for Pharmaceuticals Global Forum
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Transcript of "8th Cold Chain Distribution for Pharmaceuticals Global Forum"

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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:

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