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Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
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Cold Chain Pharma2

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  • 1. est The World's Larg Don't Miss Day Three on International Distribution Global Forum for Temperature Control Specialists and Shipping to New Markets including Latin America, China and Africa & the Evening Seminar 'AIR CARGO 201' Keynote Speakers: US Department of Homeland Security US Department of Commerce Distributing Safe Medicines Internationally International Trade in Collaboration with Temperature Control Administration Partners and Stakeholders September 20-23, 2010 CEO, Talecris Biotherapeutics Pennsylvania Convention Center, Philadelphia, PA Industry and Healthcare Speakers: Medtronic Abbott Genentech Pfizer Savient Pharmaceuticals Johnson & Johnson Pfizer-Peru East China Pharmaceuticals Bristol Myers Squibb Cardinal Health McKesson Canada Institute for Safe Medicines Practices PATH New Discussions at the Industry’s Most US Department of Veterans Affairs Recognized Cold Chain Forum: Medco Health Solutions ✔ Comply with international regulations and adhere to Plus Industry industry best practices by deciphering guidance Association Speakers: documents and making them work for your company IATA ISPE ✔ Devise cost-effective strategies with your packaging ISTA PDA and transport partners to control Ambient, Refrigerated, 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 Sponsors: Coldpack Maxim IP Texas Foam unable to open file, please resupply 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 Content: Day One: Specialist Discussion Forums ............................5-6 Day Two: Main Conference Day 1.....................................7-8 Day Three: Main Conference Day 2 ................................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 Cold chains today are inevitably international. Plus, companies are making strategic decisions to use lower cost centers for manufacturing, clinical trials and distribution markets. These new markets pose great challenges with less traveled lanes, sometimes obscure regulations and new logistic partners. Hear case studies from: • US Department of Commerce International Trade Administration • Pfizer Peru • East China Pharmaceuticals • American Airlines, PATH • Johnson & Johnson • Envirotainer Healthcare Cold Chain Distribution Track Great lengths and investments have been taken 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 • ...Added 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, comparing company case studies to the new ISTA profiles and working with packaging providers to find more cost-effective solutions. 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 Patient • 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 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 8.00am - 11.00am (Registration 7.45, coffee will be served) A Utilizing Continuous Process Improvement to Demonstrate a Risk-Based Approach for Your Temperature-Sensitive Supply Chain This workshop, will review the benefits offered through integration of • Opportunities to drive efficiency and reduce costs while meeting traditional enterprise applications (enterprise resource planning ERP, regulatory requirements warehouse management systems WMS, and transportation • The benefits of ongoing monitoring programs and how they support management systems TMS) and cold chain management systems. The continuous process improvement Choose from Choose from Workshop A or B session leaders will explore managing a temperature-sensitive supply • Demonstrate and document compliance with regulatory requirements chain through the application of a risk-based approach. and standards-based guidance • Document and mitigate risks through improved Standard Operating Banking cold chain data and statistically evaluating supply chain Procedures (SOPs) performance over time enables the development of continuous process improvement however traditional solutions have lacked the ability to How you will benefit: integrate logistics data housed in other applications. Through case examples and interactive exercises, you will learn how to leverage cold chain data to make informed decisions regarding your Integration of logistics data with time and temperature enables efficient cold chain distribution. You will examine: analysis of temperature variability by supply chain segment (ground • Temperature-sensitive risk assessment origin, warehouse/cross dock, air, ground destination, warehouse, etc...) • Reduction of quarantine incidents and streamlined approval process This workshop will explore these key elements together in an interactive • Statistical evaluation of supply chain processes and thoughtful discussion linked to specific case studies. • Case study analysis What you will learn: Your workshop leaders: • Opportunities provided by integrating a cold chain management Mark Maurice, Senior Project Manager – Industrial Engineer, Sensitech system with other relevant software applications including (ERP, WMS, Nicole Nepomuceno, Program Manager – Industrial Engineer, Sensitech and TMS) • Benefits provided through automated supply chain segmentation Henry Ames, Director Strategic Marketing, Sensitech analysis of time and temperature data – (integration of logistics data and time and temperature data) 8.00am - 11.00am (Registration 7.45, coffee will be served) B Cost Effective Transportation Strategies for 2-30°C Pharmaceutical Products This workshop will look at how a manufacturer and their lead cold How you will benefit: chain solutions provider were able to significantly reduce transportation Through discussions and case scenarios of air transport, you will discuss costs and risks to the manufacturer’s product through close with your industry colleagues and those experienced with air transport, collaboration with the air carrier and freight forwarder. The principles how to: applied in this case study can be applied to any temperature-controlled • Design a collaborative cold chain process that works in the real world transportation requirement. of air transportation • Anticipate the challenges that threaten your cold chain What you will learn: • Reduce costs while minimizing risk to the product • How can the temperature of a product be controlled in flight? • How do you identify and address potential gaps in the transport Your workshop leader: process John Liebe, Head of Sales for North America, LifeConEx LLC. • What role do your providers play in addressing any gaps • An example of an integrated program that addresses the gaps x x x x x x x x x x x x x x x x x x xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx x x x x x x x x x xx x x x x x x x x x x x x x x x x x x x x x x x x x xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx x x x x x x x x x xx x x x x x x x x x x x x x x x x x x x x x x x x x xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx x x x x x x x x x xx x x x x x x x x x x x x x x x x x x x x x x x x x xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx x x x x x x x x x xx x x x x x x x x x x x x x x x x x x x x x x x x x xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx x x x x x x x x x xx x x x x x x x xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx – Xxxx, xxxxxxxxxx, xxxxxxx Coldpack Maxim IP Texas Foam Escort Data 5
  • 6. can you edit this workshop so 11.15 - 2.15 (Registration 11.00, Lunch will be served) we can fit more of workshop F C Advanced Predictive Simulation Software Technology – Virtual Cold Chain Management The workshop will facilitate an overview of Advanced Predictive • Decision making factors for evaluating cost-effective transportation Simulation Software as applied to cold chain transportation shippers. systems The group will discuss the “As Is” process of iterative physical testing How you will benefit: Choose from Choose from Workshop C or D for the design and validation of cold chain shippers. We will also You will gain an appreciation for the relative costs and benefits of discuss solution options or possible “To Be” process improvements by achieving your transportation objectives within the framework of your utilizing simulation software early in the design or selection phase of GDP requirements and discuss how to minimize those costs while cold chain shipper configurations. maintaining safe transport requirements by utilizing Advanced Predictive Simulation Technology. The workshop leader, Iftekhar Ahmed, will explore the effectiveness of • Improve your ability to implement high quality and cost-effective simulation technology by reviewing examples for both active and transportation shippers passive shipper units. • Enhance your ability to select or design cold chain shippers that meet Through a case study, presented by Ben Romero, Senior Packaging your requirements before testing • Obtain the knowledge on how to optimize your cold chain shippers Engineer at Genentech, you will learn firsthand how Genentech is deploying and utilizing predictive simulation software to evaluate to reduce cost and maximize performance • Increase your understanding of how to effectively work with shipper performance. Mr. Romero’s case study will also include the characterization of a shipper component, as well as the correlation simulation technology to implement process improvements in your between physical test data and simulation results. current environment. • How to mitigate risk associated with transporting temperature What you will learn: sensitive goods Gain insight into how simulation software can assist in the design and validation of Cold Chain Shippers Your workshop leaders: • 3D Modeling techniques Iftekhar Ahmed, Senior Specialist, Cold Chain Management, MAYA • Modeling methods use for Phase Change material selection Simulation Technologies Ltd. • Simulate transient thermal profiles Ben Romero, Senior Packaging Specialist, Genentech 11.15 - 2.15 (Registration 11.00, Lunch will be served) D Environmentally-Friendly Approaches for the Distribution of Temperature-Sensitive Drugs This workshop will present a wide-ranging overview of environmentally- How you will benefit friendly packaging designs and distribution methods available for • Enhance Your Knowledge of Material Options and Their temperature-sensitive pharmaceutical distribution. Evaluation Environmental Implications methodologies and economic aspects will be discussed. • Learn Ways to Measure Environmental Impact • Understand How to Analyze Total Program Costs What you will learn • Become Better Equipped to Make Smart, Environmentally-Focused • Recycling & Reuse Programs Product Decisions • Material Considerations and Innovations • Current Available Products & Their Applications **Workshop open to qualified end-user participants only • Distribution Models • Carbon Footprint & Life Cycle Analysis Your workshop leaders: • Waste Management Anthony (TJ) Rizzo, Strategic Account Engineer, Cold Chain Technologies, Inc. Bob Bohne, V.P., General Manager, Cold Chain Technologies, Inc. 2.30 - 5.30 (Registration 2.15) E Performing an Efficient Cold Chain Compliance and Process Gap Analysis Choose from Choose from Workshop E or F The pharmaceutical cold chain concept implies all necessary means to • Ways and means to develop an executable action plan maintain therapeutic products in the specified manufacturer’s temperature limits during all the logistic and distribution process (manufacture, storage, How you will benefit: transportation, final use). The cold chain compliance and process gap • Understand how to execute a cold chain regulatory gap analysis analysis is the very first step to allow you to critically evaluate the • Discover what should be covered when looking at cold chain compliance compliance of your operations, logistics and packaging with regard to the • Gap analysis: The first step to develop a cold chain compliance program regulatory context and to the security of your products. • Uncover the requirements for the storage and distribution of drug products What you will learn: • Sharing the responsibilities for a good cold chain compliance • The regulatory aspects related to the cold chain • Responsibilities in the supply chain Your workshop leaders: • Requirements for the storage and handling of drug products Jean Bédard, Chief Executive Officer, Alternatives Technologie • Packaging, transportation and distribution of drug products Pharma • Performing a gap analysis to know what needs to be done in order to Anthony Alleva, Technical Services Manager, Cryopak/TCP fully comply with regulations and optimize your processes 2.30 - 5.30 (Registration 2.15) F Envirotainer Workshop xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 6 www.coldchainpharma.com Sponsors:
  • 7. DAY Main Conference Sessions TWO Tuesday, September 21, 2010 7.15 Registration and Coffee •Steps for implementing a successful Chapter 17 compliant program •What to expect for 2011-2012 edition. 8.00 Pharma IQ Welcome Remarks Kevin O'Donnell, Director & Chief Technical Officer, Tegrant Corporation, Thermosafe Brands 8.15 Opening Remarks Chairperson: Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA 10.40 Morning Networking Break Branch, PDA 11.25 Introducing the New ISPE Cold Chain Good Practice Guide 8.20 Opening Keynote: Cold Chain - A Business Critical Function The Good Practice Guide is intended to provide practical Mary Kuhn, Executive Vice President, Operations, Talecris guidance to assist companies in establishing good practice and Biotherapeutics, Inc. achieving compliance for the transfer, packing, storing, distributing, receiving and unpacking of product requiring controlled cold International Regulations & Industry Standards conditions to maintain its safety, efficacy and quality. Geoffrey Glauser, Director, Global Packaging Technology, Pfizer 9.00 Observations and Guidance for Conducting Regulatory Compliant Cold Chain Operations 11.40 Panel Discussion: Cooperation and Synergies of USP • Feedback from recent audits of pharmaceutical manufacturers and <1079>, PDA TR 39, ISTA Manual 20, ISPE Good Cold noting trends Chain Guidelines and WHO Regulatory Oversight • Risk mitigation initiatives from a regulatory perspective Guidance • Beyond temperature monitoring: Future regulatory concerns on • Overview from each group: Objective of guidance, how unique to humidity and other parameters the other documents and industry uptake • Stability data for transportation: Regulatory expectations and • Understanding what type of company uses which document for shipment outside labeled storage conditions specific projects • Commenting on the new PDA Stability "In Use' Conditions guidelines • Clarifying redundant aspects of cold chain qualification Ian Holloway, Manager, Defective Medicines Report Centre, MHRA requirements across documents and how each individual document serves a purpose 9.40 The Final Updated USP <1079>: Validating and • Examining the process of temperature mapping and temperature Documenting Each Step of Your Cold Chain profile 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, • Industry feedback US Pharmacopeia (USP) Dr. Mary Foster, Chair, Packaging and Storage Expert Committee, Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA US Pharmacopeia (USP) Branch, PDA 10.20 Complying with IATA Chapter 17 Revised Regulations Paul Harber, Associate Engineering Consultant, Eli Lilly for Temperature Sensitive Healthcare Products Geoffrey Glauser, Director, Global Packaging Technology, Pfizer • What’s changed? A review of the major revisions to Chapter 17 of the 10 Edition of the Perishable Cargo Regulations (effective 12.30 Networking Lunch July, 1, 2010) 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 • Developing industry guidance Technical Report 46 to work toward accurate profiles to test and qualify packaging greater education of healthcare professionals • Realizing significant costs savings • Tech Report 46: Distribution from Point of Dispensing to End Use in • Next steps: Other products and additional temperature ranges Mail Service Pharmacy Robin Turner, Director, Global Packaging Development, Medtronic Bella Cohen, PharmD., Global Medical Information, Global Pharmaceutical Regulatory & Medical Sciences, Abbott 2.20 From Corn to Biodegradable Packaging: Developing Practical Issues Faced by Front-Line Staff in The Last, But Expanded PLA (EPLA) for Moldable Cold Chain Shippers Important Leg of the Cold Chain As pharmaceutical manufacturers increase their focus on • Stability practice disparity between companies and pharmacies environmental responsibility, much of the activity has centered on • Practical and economic issues with refrigeration of medications in recycling and reusability. As an attractive alternative, EPLA represents a the pharmacy and patient care areas potential game-changing material innovation which would alter the • How stability issues contribute to medication safety challenges way we analyze return logistics and recycling needs and disposal. In Mary E. Burkhardt, MS, RPh., Medication Safety Consultant, addition to EPLA, expanded polystyrene resins are now available with Medication Safety Solutions 50—75% of post-consumer, recycled content. • What is Expanded Polyactic Acid? • Developing the EPLA Manufacturing Process • Recycled Polystyrene Raw Material Resins • Case Study: Comparing Standard EPS vs. EPLA vs. Recycled EPS in a Temperature Sensitive Drug Shipment 7
  • 8. • 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 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) Small or Mid-size Pharma Cold Chain Management: F) Ocean Carrier and Reefer SOPs Implementing Systems and Complying with Regulations To lead this roundtable, contact courtney.becker@iqpc.co.uk To lead this roundtable, contact courtney.becker@iqpc.co.uk G) Understanding the Processes and Systems Needed to B) Applying the ISTA 7E Temperature Profiles & Manual 20 Certification Accumulate Temperature Excursion Data Throughout the Roundtable Leader: Jim Cox, PhD., Certified Thermal Transport Supply Chain Auditor, ISTA Roundtable Leader: Jim Bacon, Senior Director, Global Demand C) Investigating and Validating Cost-Effective Solutions for CRT Planning and Customer Operations, Talecris Biotherapeutics or Ambient Products H) Measuring the Impact of Humidity on Product Stability Roundtable Leader: Larry Sweeney, Senior Director, Distribution Roundtable Leader: Rafik H. Bishara, PhD, Technical Advisor and and Logistics, Genzyme Chair PCCIG USA Branch, PDA D) Devising Quality Agreements with Your Wholesalers I) Mail Order Pharmacy Cold Chain Delivery Challenges Roundtable Leaders: Claude Jolicoeur, Director of Regulatory Roundtable Leader: Tina Beshears, Medication Strategy, Director, Affairs and Corporate GMP Officer, McKesson Canada & Pharma Professional Practice, Medco Health Solutions partner being confirmed J) Shipping Cold Clinical Supplies Internationally: Today's E) Packaging Design Considerations for Today's Cold Chain Logistics Considerations Challenges To lead this roundtable, contact courtney.becker@iqpc.co.uk To lead this roundtable, contact courtney.becker@iqpc.co.uk 5.35 Summary of Roundtable Discussions 6.25 Closing Remarks Day One from Chairperson 6.30 Networking Drinks in Exhibition Hall 8 www.coldchainpharma.com Sponsors:
  • 9. DAY Main Conference Sessions THREE Wednesday, September 22, 2010 7.30 Morning Coffee 10.55 Bridging the Gap With Air Transport: Meeting Industry Critical Standards and Devising Effective 8.00 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 8.10 TSA Certified Cargo Screening Program: Post August tougher regulatory standards. Upgrading management capabilities to 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 Member, Pharmaceutical Cargo Security Coalition airline capabilities • Live examples of when contingency plans were employed and 9.30 Security & Control in the Pharmaceutical Temperature why preparation was critical Control Supply Chain • Global trends effecting security, complexity, and temperature Kyle Betterton, Vice President, United Cargo control within the pharma supply chain Don Harrison, Operations Excellence, United Cargo • How to continue to maintain quality within the transportation process in spite of increasing difficulties 11.35 Optimization of a Passive Pallet Shipping System for • Understanding the different transportation models and what the International Vaccine Transport appropriate expectations are of each partner in the process • Identify, analyze, and prioritize demands from multi-national task • Technological advancements assisting the security aspects during forces transportation in the pharma supply chain • Design and development overview of the next generation pallet • The effective layering of security options depending upon the shipper needs of the cargo and the interests of the parties involved • Product attributes that help overcome challenges in international Karl Kussow, Manager of Quality, FedEx Custom Critical vaccine transport • Thermal performance review 10.10 Morning Networking Break 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 • Discussing the current gap in international guidance and the Manual 20 Thermal Laboratory Certification development of a consensus around industry best practices • ISTA 7E Temperature Profile Standard Project: Results, Analysis and • Collecting the appropriate stability data to support wider shipping Profile Development ranges • ISTA Manual 20: Package Thermal Qualification Standards & Case • The possibilities and risks of shipping outside label claim Study • The benefits to downstream partners and cold chain compliance • ISTA Laboratory & Package Certification: How can you have your Arminda O. Montero, Distribution QA Program Manager, Global shipping solutions tested and certified under the new international Pharmaceutical Operations, Abbott standards Moderator: 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 Coldpack Maxim IP Texas Foam Escort Data 9
  • 10. 2.05 Supply Partner Perspective: Stability Data and Label Qualification of an Insulated Container from Israel to Information the Mid-West U.S. • The case for expanded temperature ranges in last-mile transportation • Development activities • Typical life cycle of a mail order pharmacy shipment • Summer and winter real time qualifications • Labeling guidance for expanded stability data use by partners and patients • Product temperature vs. internal ambient temperature • "Outside" temperature mapping Chris Chandler, Quality Assurance, Consolidated Mail Outpatient • Lessons learned and next steps Pharmacy, US Department of Veterans Affairs Suzan R. Lanz, Associate Director, Project Management, Savient Tina Beshears, Medication Strategy, Director, Professional Practice, Pharmaceuticals, Inc. Medco Health Solutions 2.40 Developing a Sound Risk Management Mechanism for Thermal Mapping the World Cold 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 6.00 - 8.30 (Registration and Networking Drinks 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 working ISO standards into your Quality Management System? Discussion was a popular session and yielded great insight into how airlines • How can industry standardize training and auditing of facilities? handled temperature controlled pharmaceuticals. Finally airlines 'had a • How are you adjusting your airline procedures to adhere to TSA voice' and pharmaceutical manufacturers got a clear picture as to what Screening requirements? cold chain best practices airlines adhered to. Discussion Points: With the IATA Chapter 17 July 2010 deadline and the TSA 100% • Handling airport infrastructure obstacles in different parts of the world: Screening August 2010 deadline, this Evening Seminar will be a great Discussing examples in India, Doha, Chicago, Dublin, London and Japan opportunity to gage the progress of airlines and supply chain stakeholders • New 'pharma centers' for distribution at India's airports implementing greater control and visibility into shipping temperature • Ensuring a collaborative and responsible approach between the sensitive air freight. Have these regulations made an impact on operating a shipper, freight forwarder agent and airline robust cold chain in the air? (and on the tarmac!) • Filling gap between capacity and growth demand: What are airlines doing to match capacity with demand? The Evening Seminar will provide an opportunity for air carriers, shippers, • What can industry to do get greater cooperation across supply chain freight forwarders and 3PLs to discuss remaining gaps in shipping to help improve the supply chain process? temperature sensitive air freight. Submit questions to discussion leaders to courtney.becker@iqpc.co.uk Interview with an Airline - Part II: before the seminar. • What differentiates your product and process from other temperature controlled air cargo operations? Seminar Moderators: • What are your experiences to date working with industry or companies Kevin O'Donnell, Director & Chief Technical Officer, Thermosafe & to develop that process? Chair, IATA Time & Temperature Task Force • What have you learned to create a sustainable process to support Tony Wright, Managing Director, Exelsius - Cold Chain Management shipment of temperature controlled pharmaceuticals? Consultancy • How are you ensuring your agents and ground handlers are adhering to Chapter 17 guidelines? Panelists confirmed: • Can agents realistically adhere to Chapter 17 and maintain 15-25°? Don Harrison, Operations Excellence, United Cargo • How do you define your service levels and agreements with agents? If Representative, American Cargo issues arise, how are they resolved and how are risks mitigated? Larry Sweeney, Senior Director, Distribution and Logistics, Genzyme Brandon Fried, Executive Director, Air Forwarders Association 10 www.coldchainpharma.com Sponsors:
  • 11. DAY Main Conference Sessions FOUR Thursday, September 23, 2010 7.15 Registration and Coffee Shipping to New Markets 8.00 Opening Remarks from Chairperson 1.00 Distributing Vaccines to Remote Populations in Peru • Use of Thermal Bags as a safer way for packing Jim Bacon, Senior Director, Global Demand Planning and Customer • Refrigerated truck for campaign of vaccination to places remote in Operations, Talecris Biotherapeutics Peruvian Andes • Maintaining the cold chain in places without electricity, available International Transport and Logistics roads and extreme weather 8.10 Keynote Session: Navigating New and Emerging Humberto Laserna Zubiaga, Quality Coordinator, Pfizer-Peru Pharmaceutical Markets xxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxx 1.40 South American Andean Region Case Study: xxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxx Distribution of Vaccines Challenges and Opportunities xxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxx • Describing key challenges shipping in the Andean Region Confirmed: Representative, US Department of Commerce including Venezuela, Colombia, Peru, Ecuador and Bolivia International Trade Administration • Customs processes, facilities and imports regulations (Case of Private Market, Government purchase to PAHO) 8.50 Latin American Case Study: The Importance of • Weather conditions: Examining what happened when "El Developing a Collaborative Model for Successful Niño"(*) appeared and how we managed cold chain products International Air Transit of Temperature-Controlled • Distribution from Pacific coast through mountains and jungle: Products Airports facilities, Cold Chambers capacity by town • Streamlining front-end planning and communications among • Security risks assessment: Cost considerations and review of key issues supply-chain partners for successful outcomes Ursula Vértiz, Engineer, Independent Consultant (Formerly, • Maintaining product integrity end-to-end through challenging Technical Operations and Product Supply Manager, Wyeth Peru) regulatory environments • Effective management of customs and regulatory hurdles for cost 2.20 Afternoon Networking Break containment • Managing uncertainty through effective contingency planning 2.50 Introducing New Vaccines to Remote Markets Case Speaker being confirmed, American Airlines Cargo Study: Distributing the First Fully-Liquid Pentavalent Vaccine 9.30 Morning Networking Break • Collaborating with The Global Alliance for Vaccines and Immunization (GAVI) to get needed vaccines to Asia and Africa 10.00 Harmonizing Processes and Quality Systems for the and the Pan American Health Organization (PAHO) to distribute Global Supply Chain vaccines to Latin America • Qualifying transportation partners and standardizing the • Training immunization organizations and staff on cold chain and qualification process safe immunization practice • Temperature excursion management • Providing correct and sufficient documentation Maryann Gribbin, Director Quality Assurance, Global • Options for public – private cooperation Pharmaceutical Supply Group, Johnson & Johnson • Encountering distribution challenges • Lessons learned and suggested actions for improvements in the 10.40 Freight Forwarder/ 3PL Perspective: Implementing IATA future Chapter 17, SOPs and Quality Agreements Sanja Saftic PhD., Forecasting Manager, Strategic Vaccines Supply, • Understanding Chapter 17 guidance and proposed changes Accelerated Vaccine Introduction, PATH • Assessing an organization’s Quality Management System • Developing a formal training program for the real world 3.30 Pharmaceutical Cold Chain Management in China: The • Quality Agreements- The importance of defining expectations Latest Progress • Case study- transport service provider implements Chapter 17 • Examining current regulatory standards in China for cold chain Chris Fore, Manager Industry Compliance and Regulatory Affairs, distribution Envirotainer • Current and emerging issues regarding product safety environment in China: Assessing different pharmaceutical 11.20 Panel Discussion: Aligning Approaches between products using cold chain Pharma, Freight Forwarders and 3PLs • Managing pitfalls and strategies for cold chain distribution in China: • Contract negotiations: Optimizing costs for temperature control • Best Practices to be adopted when looking for a reliable Cold shipping chain partner in China • Setting up service agreements and service levels • Devising cold chain Standard Operating Procedures (SOPs) with • Accessing real time data to achieve total product visibility Chinese cold chain partners • Keeping partners accountable day to day • Technology updates for China: Utilizing RFID (and other latest • New Markets: Consulting your supply chain partners and innovations) for traceability, temperature logging and safety conducting independent new market research Xing Fu Feng, CEO, East China Pharmaceuticals (Huadong Moderator: Ningbo Pharmaceuticals Co Ltd) Jim Bacon, Senior Director, Global Demand Planning and Customer Amit Ghosh, International Business Development Manager, East Operations, Talecris Biotherapeutics China Pharmaceuticals (Huadong Ningbo Pharmaceuticals Co Ltd) Panelists: Chris Fore, Manager Industry Compliance and Regulatory Affairs, 4.15 Prize Drawing for Close of Conference (must be Envirotainer present to win) Maryann Gribbin, Director Quality Assurance, Global Pharmaceutical Supply Group, Johnson & Johnson 4.20 Closing Remarks and End of Day 12.00 Networking Lunch 11
  • 12. About Our Sponsors ThermoSafe Brands, a Strategic Business Unit of Tegrant A subsidiary of the 151-year-old Dohmen Company, DDN is Corporation, is the leading provider of temperature headquartered in Menomonee Falls, Wis., with distribution assurance solutions. Tegrant Corporation is a premier facilities located in Memphis, Tenn. and Ontario, Calif. DDN has become the manufacturer of a variety of highly engineered packaging solutions and energy largest privately held provider of outsourced channel management and business efficient components with over 35 manufacturing and testing facilities across services to the life science industry by streamlining processes, reducing costs and North America and approximately 2,100 employees. ThermoSafe Brands complete improving efficiencies for emerging, mid-tier and market leading life science portfolio of transport assurance and temperature assurance shipping products for companies. By providing superior business processes and operations, DDN frees the safe and efficient transportation of bio-substances, blood and other sensitive manufacturers’ resources for R&D, acquisition and other core initiatives. DDN now specimens across the entire temperature continuum. Our portfolio includes an offers data analytics services and recently launched DDN Medical Affairs, providing extensive array of expanded polystyrene and polyurethane insulated shipping specialized regulatory knowledge in preparing adverse event reports, labeling containers, refrigerants in a wide range of temperatures and configurations, pre- management, product complaints and medical and technical product inquiries. For qualified shipping systems for off-the-shelf ease of use and peace of mind. In more information please call 888-374-8873. Website: www.ddnnet.com addition, ThermoSafe Brands’ ISC Labs brings our customers experience and innovation in package design and certified independent testing services to meet United Cargo uses nearly 3,300* flights a day to transport all regulatory requirements and concerns. Website: www.thermosafe.com cargo to over 230 U.S. and international destinations. With key global air rights in the Asia-Pacific region, Europe and FedEx Custom Critical offers a complete array of surface Latin America, United Cargo has the schedule and capacity to reach virtually and air solutions to safely and securely ship temperature- every major business market in the world. Over 400 additional worldwide sensitive products. You can choose from exclusive-use destinations are available through United Cargo’s network of reliable interline vehicles with temperaturecontrolled cargo boxes to airfreight solutions utilizing partners. Two convenient on-line options are available for booking and temperature-controlled air containers. With our Temp-Assure Validated services, managing shipments: our industry-leading website, unitedcargo.com and you also receive hard-copy documentation of the temperature inside the vehicle cargoportalservices.com, the world’s most popular air cargo internet portal. or container throughout transport. This assists our pharmaceutical customers Website: www.unitedcargo.com with their compliance needs through a documented audit trail of their products’ temperature throughout the shipping process. FedEx Custom Critical services are Pioneer and market leader Envirotainer offers flexible available 24/7/365 with surface solutions throughout the U.S. and Canada and leasing (rental) of advanced transport solutions for air solutions across the globe. Website: www.customcritical.fedex.com worldwide air cargo shipments of temperature-sensitive products. Customers within the healthcare, life sciences and high-tech industries benefit from the Minnesota Thermal Science, LLC develops unique storage combination of advanced container technology, extensive cold chain and shipping systems that address the challenges of management services and a global network of service partners, airlines and maintaining constant and predictable temperatures when forwarders – providing a unique one-way leasing service. Envirotainer secures transporting temperature sensitive medical materials. Founded in 2004 following the safety and integrity of product cold chains by providing an active an industry wide search by the Walter Reed Army Institute of Research for a temperature-control system, training all parties along the cold chain and more effective combat environment container, MTS has continued to apply its supporting customers in transport validations and risk management. With sales technology to handle other important medical materials including all types of representation in 17 countries, the company has its R&D, Manufacturing and biomaterials and pharmaceuticals that require controlled temperatures Its patent Quality Assurance departments at the headquarter premises in Lagga Marma pending Golden Hour® Technology, winner of a "U.S. Army Greatest near Stockholm, Sweden. Website: www.envirotainer.com Inventions" award, is credited with saving soldier's lives on the battlefield and with revolutionizing the methods used for distributing temperature sensitive Elpro Services, Inc. is a leading manufacturer of high quality medical supplies. Website: www.goldenhourtechnology.com temperature, humidity, and CO2 dataloggers, providing recording and monitoring solutions while observing regulatory compliances American Airlines CargoSM, a division of American (GMP/GLP/FDA 21CFR11). LAN/W-LAN solutions are fully scalable to meet your Airlines, Inc., provides one of the largest cargo central monitoring requirements and future growth. Our New Libero PDF- networks in the world, with cargo terminals and interline connections available logger® (No Software Required) provides simple cold chain monitoring of across the globe. American’s global network serves over 250 cities in 40 temperature sensitive pharmaceuticals. This ground-breaking concept of countries worldwide; including major cities in the United States, Europe, producing the report in a PDF file eliminates the need to install, qualify and Canada, Mexico, the Caribbean, Latin America and Asia. American Airlines validate any specific software at destination. Available in 100 and 400 day Cargo provides Cold-Chain transport utilizing its temperature controlled models, our Libero PDFlogger ® also supports compliance with FDA standard 21 ExpediteTCSM product. ExpediteTCSM provides priority boarding, priority CFR 11. Website: www.elpro.com handling, fastest flight connections, high-visibility shipment tracking, automatic status notifications, and a 100% guarantee to be flown-as-booked. MAYA Simulation Technologies Ltd. is a developer of Website: www.AACargo.com thermal and flow simulation software tools. MAYA's simulation solutions provide comprehensive and accurate insight into the thermal behavior SCA Cool Logistics specializes in the design, test, of a wide range of cold chain transport systems reducing the need for prototype manufacture and qualification of insulated shipping systems. testing. MAYA offers a complete software simulation solution for the thermal Our off-the-shelf and bespoke packaging solutions are design and optimization of cold chain transport systems. MAYA's thermal designed to safely transport temperature sensitive products for pharmaceuticals, simulation solution can model all aspects of heat transfer including conduction, biotechnology, clinical trials and diagnostics throughout the world. Forming part convection and radiation. The thermal and flow solvers are fully capable of of the SCA Packaging Group, SCA Cool Logistics has manufacturing capabilities modeling steady state as well as transient thermal/flow conditions. Additionally in the UK, Czech Republic, Singapore and South Africa and with access to 128 we incorporate advanced tools such as phase change materials, SCA sites worldwide we provide a local supply service to a global market. condensation/humidity calculations, dust/smoke distribution tracking etc. Website: www.sca-cool-logistics.com Website: www.mayahtt.com Cold Chain Technologies is a leading source for Lufthansa Cargo ranks among the world’s leading cargo engineering-based thermal packaging solutions. For almost carriers. In the 2008 financial year, the airline transported 40 years, we’ve continued to excel in providing efficient, cost around 1.7 million tonnes of freight and mail and clocked up 8.3 billion revenue effective thermal packaging products and services to a wide range of customers tonne-kilometres. The Company currently employs about 4,600 people, – from local start-ups to Fortune 100s. Pharmaceutical, biotech, healthcare, worldwide. Lufthansa Cargo focuses on the airport-to-airport business. The medical device, and food service companies count on us to solve their cold cargo carrier serves some 300 destinations in 90 countries with its own fleet of chain challenges. Distributed from multiple locations throughout the U.S. and freighters, the belly capacities of Lufthansa’s passenger aircraft and an extensive internationally, our product line includes KoolTempTM insulated containers, road services network. The bulk of the cargo business is routed through Koolit® refrigerants, and KoolWatchTM temperature indicators. Cold Chain Frankfurt Airport. Lufthansa Cargo is a wholly-owned Lufthansa subsidiary. In Laboratories, our affiliated company, is a premier source for expert design and the 2008 financial year, it posted revenues totalling 2.9 billion euros. Website: qualification testing of thermal packaging solutions. www.lufthansa-cargo.com Website: www.coldchaintech.com 12 www.coldchainpharma.com Sponsors:
  • 13. Delta Cargo offers several shipping solutions for temperature Founded in 1981, American Thermal Instruments, Inc. sensitive pharmaceuticals ranging from fine chemicals, bio- has been exceeding customer expectations as an technology and base materials to medical and blood samples, international organization specializing in temperature bulk drugs and all other products used for the production of pharmaceuticals. monitoring solutions. ATI temperature monitoring solutions include liquid crystal Pharma 1 is designed for products that require transport in an active thermometers, irreversible temperature indicators, color changing products, Log- temperature-controlled container. Pharma 2 and Pharma 3 are Delta Cargo’s ic® electronic content monitoring, and microencapsulation services. Our facility shipping solutions for products requiring transport in passive temperature- is ISO 9001 certified, FDA registered, and operates under cGMP. ATI controlled containers. Delta Air Lines is the world’s largest airline. From its hubs manufactures non toxic, non-breakable, reusable, disposable and easy-to-read in Atlanta, Cincinnati, Detroit, Memphis, Minneapolis-St. Paul, New York-JFK, thermometers for diverse markets and applications. ATI acts as a distribution Salt Lake City, Amsterdam and Tokyo-Narita, Delta offers service to 368 arm for the Log-ic® Temperature Tracking System. The Log-ic® system is destinations in 66 countries. Website: www.deltacargo.com revolutionizing the Cold Chain, giving customers the capability to track and trace temperature history of shipments. Website: www.americanthermal.com Entropy Solutions is the industry’s innovation leader in thermal technology. With the introduction of the GREENBOX Thermal Cool Containers LLC has designed the PharmaPort Management system, Entropy has once again revolutionized how 360, a cold-chain cargo container that can be used for thermally sensitive products are shipped and maintained. Our 100% the transport of pharmaceuticals and other materials organic, sustainable, passive thermal solution can maintain precise target that temperature control during transport. The PharmaPort 360 Temperature temperatures for unprecedented periods of time. Through a unique combination Controlled Shipper Device is designed for air or ground transport of temperature of technology and design, GREENBOX™ delivers the industries most effective sensitive pharmaceutical products at 5 C. The shipper device is designed to and cost efficient shipping method on the market today. Website: maintain the 5 C storage temperature in transport mode for 72 hrs when the www.greenboxsystems.com ambient temperature is 30 C. The device is also designed to maintain 5 C during ambient temperature excursions to -40 C and +60 C. Marken is one of the leading suppliers of cold-chain logistics for clinical supplies worldwide. Temperature-control during the Softbox Systems design and manufacture passive insulated shipping handling, storage and distribution of cold-chain products is a critical element of containers that enable pharmaceutical companies to secure their cold the clinical trial process. Our expertise is of critical importance to ensuring the chains and ensure the safety and efficacy for the distribution of their safe arrival of high value shipments to sites. We provide: temperature sensitive products. Our award winning patented systems • Global distribution of temperature controlled trial medication, vaccines & CTM are manufactured and available regionally in Europe, USA, India and Asia Pacific. • Temperature control monitoring for ambient, 2-8C and frozen products to To find out how we have helped some of the worlds leading pharmaceutical maintain integrity of supplies companies improve efficiency, reduce cost and lower CO2 emissions for their • Advice on packaging materials and provision of containers for global cold chain shipments please visit us at our conference booth to meet one of our transportation specialists. Website: www.softboxsystems.com • Refrigerated trucking services • Customs brokerage accelerating clearance va-Q-tec AG develops and produces Website: www.marken.com VacuumInsulationPanels (VIPs) and PhaseChangeMaterials (PCM) for high performance With more than 25 years of experience, developing Critical thermal packaging products and other applications. In most cases these Logistics Solutions, OCASA relays on a worldwide network of packaging solutions comprise both, VIPs and PCM. This leads to the most affiliates and branches strategically located around the globe (North America, reliable and temperature stable passive system solutions used to transport Latin America, Europe, Africa and South East Asia), making OCASA an valuable and temperature sensitive products for up to 6 days and even longer. integrated logistics Company with a global scope. OCASA owes its rapid growth The va-Q-tec solutions range from one-way shippers to air freight containers. to a Tailor-Made solutions approach and uncompromising service. We have va-Q-tec offers small quantities from the standard portfolio to large quantity formed strategic partnerships with thousands of satisfied customers around the custom tailored series production. The applications range from pharma and world. Our Bio Pharma business unit offers solutions for the Bio-Pharmaceutical biotec products to food and fine arts. The va-Q-tec headquarters in Würzburg / community including export, import, distribution, fulfillment and temperature Germany (ca. 100 km from Frankfurt) with its more than 4 000 m2 high tech controlled warehousing for: Diagnostic Specimens, Medication / Vaccines, production area offers excellent facilities for testing and official validation run by Experimental Drugs, Controlled Substances, Dangerous Goods, and Medical our experts in thermal physics. va-Q-tec has won several national and Supplies Website: www.ocasa.com international awards for the advanced technology of saving and storing energy efficiently. Website: www.va-Q-tec.com Sensitech - The leading provider of cold chain visibility solutions that enable our customers to track and monitor assets across World Courier has set the benchmark for worldwide the supply chain, protecting the quality, efficacy, and integrity of time & temperature sensitive transportation. We their temperature-sensitive products. Our product portfolio remain the only specialist courier company with its includes comprehensive analytic services, enterprise software systems and own global company network .Each office ISO 9001 certified with the same validated data acquisition devices. We address our customers’ most complex operating standards dedicated to treating every shipment on an individual, perishable cold chain problems and deliver powerful insights that drive priority basis. World Courier is utilized in approximately 80% of the world’s measurable process improvement. Sensitech supports cold chain monitoring clinical trials requiring the use of a specialty courier. With experience in programs in 18 of the top 20 multi-national pharmaceutical companies and 9 of managing the logistics of over 7,500 clinical trials worldwide, we are the the top 10 biopharmaceutical companies. Sensitech is a business unit of Carrier acknowledged experts in handling temperature-sensitive specimen and drug Corp. Website: www.sensitech.com shipments. 24 x 7 x 365. Website: www.worldcourier.com Sofrigam’s expertise, packaging which warranty the cold AcuTemp Thermal Systems designs and chain security. Sofrigam designs and qualifies isothermal and manufactures cold chain temperature management refrigerated packaging enabling the transport of heat sensitive solutions to maintain valuable and often life-saving products (fresh or frozen) in non-refrigerated vehicles. The materials used payloads at the right temperature during storage or transport. AcuTemp associated with the expertise of our engineers and our Laboratory, mean our combines thermal expertise and engineering know-how to produce highly products are suitable for sectors that are VERY demanding with regard to efficient passive and powered delivery solutions, from small boxes and carriers quality and safety, such as the pharmaceutical, chemical, biotechnology and to large pallet-sized shipping containers. The company’s newest product, the even agri-food industries. We offer our clients a range of standard or made-to- AcuTemp AX2100L thermal pallet shipper, provides reliable compressor-based measure products and services enabling them to establish secure, economical heating and cooling functionality with state-of-the-art data logging capabilities and ecological cold chain logistics. Website: en.sofrigam.com to ensure accurate temperature monitoring. When it’s critical, use AcuTemp: The Right Temperature. From the Experts. Website: www.acutemp.com Temptime’s TransTracker is a monitoring device containing scientifically proven time-temperature indicator technology. Asia Pallet Pooling LLC (APP) offers companies the ability to TransTracker products identify exposure to freezing, high monitor temperature controlled environments on a microclimate heat and cumulative heat exposure during shipping and short-term storage. level through the use of RFID enabled plastic pallets. In partnership TransTracker is easy to read, accurate and can deliver cost savings of over 50%. with GS1 Hong Kong, APP offers a cold chain logistics portal called Temptime is the world leader in time-temperature indicator technology. ezTRACK which works in conjunction with our pallets to monitor temperature, Temptime operates under a quality system certified to ISO 9001:2000 and ISO time, and location data for end to end visibility of international shipments. Thru 13485 standards and is compliant with medical device Good Manufacturing the use of our services, companies across a variety of industries have achieved Practices. For more information contact Chris Caulfield at 973-984-6012. increased economic benefits and supply chain efficiency. By providing essential Website: www.temptimecorp.com information, APP assists our customers in making decisions based on accurate and timely data of their shipments. Website: www.asiapalletpooling.com Coldpack Maxim IP Texas Foam Escort Data 13
  • 14. EnviroCooler® LLC is the innovation leader in the Cryopak (a TCP Reliable Company), specializes in the manufacture, design and implementation of validated field of temperature controlled packaging and services global solutions for the safe and compliant including package design, qualification, testing transportation of Temperature-Sensitive-Products (TSPs). EnviroCooler®s manufacturing insulated shippers, refrigerants, phase change materials and patented product portfolio is divided into 4 distinct categories: Parcel Loads; temperature monitors. All services are provided in strict conformance with ISO Pallet Loads; Tank Loads; and Bottle & Bag loads. Each category is supported by 9001:2000, ISTA and ASTM test methodology, and FDA good manufacturing EnviroCooler®’s patented design technology platforms and is available for both practices. TCP maintains facilities in Quebec, British Columbia, New Jersey and long-lane (PUR) and short-lane (EPS) options, assuring cost-effective France. Website: www.cryopak.com transportation for your products. EnviroCooler LLC Global Supply Locations: California (US); Kentucky (US); Puerto Rico (US); Ireland (EU); Australia (AP). unable to open file, Texas Foam knows Cold Chain Packaging, and is an industry Soon to come online: Singapore (Asia); Central Europe (EU); South America (SA). please resupply leader in quality and innovation. Since 1991, we have Website: www.envirocooler.com manufactured products that meet or exceed our customer requirements for quality and value. New, state of the art manufacturing Inmark has been offering innovative packaging solutions for over equipment was acquired in 2008 and 2009, resulting in enhanced production 30 years and we are a Global Supplier of temperature control, capability. Our expertise enables us to offer customers an assortment of Foam dangerous goods and clinical trial packaging. World class design materials and package designs. We also work closely with corrugated designers testing and validation facilities along with 20 years of in-depth industry to incorporate foam and corrugate into the most beneficial package for our experience in cold chain technology thru our alliance with Softbox Systems have customers. For 2010 a new line of XDS Extended Duration Shippers has been created innovative award winning designs for thermal packaging now used introduced. Two years in design and testing these products are recycle easily, globally. Our dangerous goods regulatory development includes a delegate at reduce package costs by up to 80% versus PUR shippers, are super tough, UN Sub-Committee of Experts on the Transport of Dangerous Goods in Geneva. durable, and provide for equal or better performance than PUR containers. The clinical trials packaging systems we developed and implemented for the Texas Foam offers a wide selection of foam products, and the best customer central laboratories in North America, Europe and Asia are now the industry service in the industry. We are packaging experts who work to effectively solve standard. Website: www.inmarkinc.com your insulation, packaging, and molded component needs. In addition to our stock items, we offer custom molding, custom fabrication, and fulfillment. LifeConEx is a joint venture between DHL Global Forwarding, Website: www.texasfoam.com the world's largest air and ocean freight forwarder, part of Deutsche Post World Net, and Lufthansa Cargo, the leading Escort Data Loggers, Inc is a global organization domestically airfreight cargo company on the international market. LifeConEx is the only headquartered in Buchanan, Virginia and internationally industry-specific provider of integrated end-to-end temperature controlled headquartered in Auckland, New Zealand. We have been an transportation solutions for the life sciences industry ensuring that highly sensitive international innovator of precision, digital monitoring equipment and software products are delivered at the right place, at the right time, and in the right for more than twenty years. Our product line meets the diverse needs of various condition. A global provider of end-to-end qualified transportation services industries including perishable food, life science, pharmaceutical and industrial worldwide, designed to protect the integrity and quality of the products posting manufacturing. We provide solutions for in-transit, in-storage and in-production fewer delays, less cycle time, less temperature deviations, less damage, and far monitoring of temperature and humidity, as well as Escort Web Track software fewer claims than typically experienced by shippers. LifeConEx offers regulatory for data storage, tracking and analysis. Website: www.escortdls.com compliant process mapping, customized quality agreements, comprehensive 24/7 process and quality control, and technical consulting. Strategically LifeConEx looks Cavalier Logistics is dedicated to providing “Turn-Key to integrate new practices and more efficient ways of managing temperature- Cold Chain Solutions” for business in the Life and sensitive products, by providing overall value in regard to time and productivity. Analytical Sciences, Pharmaceutical Manufacturing, LifeConEx boosts various temperature controlled supply chains with greater Diagnostic Kit Manufacturing, Vaccine and Healthcare Providers. In addition, we control, reduction of risk, and elevation of ROI. Website: www.lifeconex.com provide service government agencies that are responsible for the stockpiling and rapid deployment of pharmaceutical products for disaster and pandemic relief. MD Logistics: The MD family of companies provide compliant We offer a unique service to healthcare providers because we can provide one- storage for finished and WIP products, packaging, inventory stop 3PL logistical services from the point of manufacture, in Cavalier validated management, third party logistics, transportation, and global refrigerated equipment. We also have validated 5°-C, -10°-C to -40°- C, -80°-C freight forwarding focusing on cold chain activities for the health and life and -156°-C storage at our Washington D.C. Headquarters. Our Washington science industry. We offer turnkey as well as custom supply chain solutions from Headquarters is licensed by the United States Drug Enforcement Agency and the manufacturing to distribution. Website: www.mdlogisitics.com Commonwealth of Virginia Board of Pharmacy to house and distribute schedule 2-6 pharmaceutical products. We provide seamless third party logistical services OnAsset Intelligence Inc. is a leading provider of for high value vaccines, clinical trial samples, specimens, reagents and a wireless devices and software solutions focused on helping multitude of products that require expert handling. Website: www.cavlog.com customers wirelessly locate, track, connect, and manage fixed and mobile assets in real-time. The company’s machine-to-machine (M2M) products and services With annual revenues of approximately $1.6 billion, BDP include SENTRY™ wireless hardware with its flagship product line FlightSafe™ International is one of the leading privately held freight for tracking high-value air cargo including pharmaceuticals, electronics, and logistics/transportation management firms based in the U.S. It even large equipment, and ContainerSafe™ for intermodal container security, its operates freight logistics centers in more than 20 cities throughout North web-based OnAsset Platform™, and global wireless connectivity services. The America and a network of subsidiaries, joint ventures and strategic partnerships company is headquartered in Irving, Texas. Website: www.onasset.com in over 120 countries. The company serves more than 4,000 customers worldwide. BDP provides a range of services, including ocean, air and ground Skelton has provided refrigerated services for 28 years to transportation; lead logistics process analysis, design and management; export Pharmaceutical/Biological companies. We partner with freight forwarding; import customs brokerage and regulatory compliance; customers to ensure we maintain product integrity through project and energy logistics; warehousing/consolidation/distribution; and out the cold chain link. Our Critical Care Division validated trailers are devoted Internet shipping transaction/ tracking management systems. Website: for products that require 2°C to 8°C with double reefers units to ensure the www.bdpinternational.com safety of the products. Our investment in assets, people and training have provided our customers with a Tried, Tested and Proven solution that meets and exceeds Health Canada 0069 regulations. Website: www.skeltontruck.com Media Partners 14 www.coldchainpharma.com Sponsors:
  • 15. Registration Information Register by Register by Register by Standard Pricing June 18, 2010 July 30, 2010 August 27, 2010 Pricing 2-day main conference (Tuesday & Wednesday) $1,199 (save $1,000) $1,599 (save $600) $1,799 (save $400) $2,199 3-day main conference (Tuesday - Thursday) $1,599 (save $1,000) $1,999 (save $600) $2,199 (save $400) $2,599 All-Access Pass (Monday - Thursday) $2,199 (save $2,995) $2,399 (save $2,795) $2,799 (save $2,395) $3,199 (save $1,995) Workshop(s) Only (Monday) $549 each $549 each $549 each $549 each Workshop Day (Monday) $999 $999 $999 $999 *All access pass includes conference + all workshops. Special Discounts Available: A limited number of discounts are available for the non-profit sector, government organizations and Please note multiple discounts cannot be combined. academia. For more information, please contact customer service at 1-800-882-8684. A $99 processing charge will be assessed to all registrations not Details for making payment via EFT or wire transfer: accompanied by credit card payment at the time of registration. JPMorgan Chase - Penton Learning Systems LLC dba IQPC: 957-097239 MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC ABA/Routing #: 021000021 * CT residents or people employed in the state of CT must add 6% Reference: Please include the name of the attendee(s) and the event number: 10366.004 sales tax. Payment Policy: Payment is due in full at the time of registration and includes lunches and refreshment. Your registration will not be Team Discounts: For information on team discounts, please confirmed until payment is received and may be subject to cancellation. contact IQPC Customer Service at 1-800-882-8684. Only one For IQPC’s Cancellation, Postponement and Substitution Policy, please visit www.iqpc.com/cancellation discount may be applied per registrant. Special Dietary Needs: If you have a dietary restriction, please contact Customer Service at 1-800-882-8684 to discuss your specific needs. ©2010 IQPC. All Rights Reserved. The format, design, content and arrangement of this brochure constitute a trademark of IQPC. Unauthorized reproduction will be actionable under the Lanham Act and common law principles. Sponsorship and Exhibition Venue: Opportunities Pennsylvania Convention Center 12th & Arch Street (West Entrance) Sponsorships and exhibits are excellent Philadelphia, PA, 19107 opportunities for your company to showcase its Telephone: (215) 418-4700 or 800-428-9000 products and services to high-level, targeted decision-makers attending the 8th Annual Cold The Pennsylvania Convention Center (PACC) is conveniently Chain Distribution for Pharmaceuticals Global located in the heart of downtown Philadelphia. For more Forum. IQPC and Pharma IQ help companies information about the Pennsylvania Convention Center, please like yours achieve important sales, marketing visit www.paconvention.com. and branding objectives by setting aside a limited number of event sponsorships and x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x exhibit spaces – all of which are tailored to x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x assist your organization in creating a platform x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x to maximize its exposure at the event. x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x For more information on sponsoring or x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x exhibiting at the Cold Chain Distribution for x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x Pharmaceuticals Global Forum, please contact x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x Mario Matulich at 212-885-2719 or x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x sponsorship@iqpc.com. About the Organizer: Visit www.coldchainpharma.com for exclusive, complimentary content! • Speaker Q&As • News articles Pharma IQ, the pharmaceutical division of • Podcasts • Presentations from IQPC, provides a forum to address the • Webinars past events critical issues facing the pharmaceutical industry today. Pharma IQ utilizes workshop, conference and training course formats to facilitate a learning environment for Network with our Cold Chain communities! pharmaceutical professionals working in all Follow us on areas of drug development: from Discovery to Post-marketing. at http://twitter.com/PharmaIQ Visit www.iqpc.com to see what other exciting and information-packed conferences Join the Group: and webinars are being offered by the International Quality & Productivity Center. Cold Chain Distribution for Pharmaceuticals 15
  • 16. International Quality & Productivity Center REGISTRATION CARD 535 5th Avenue, 8th Floor YES! New York, NY 10017 Please register me for ❑ 2-day main conference (Tuesday & Wednesday) ❑ 3-day main conference (Tuesday - Thursday) ❑ All-Access Pass (Monday - Thursday) ❑ Workshop(s) Only (Monday) Choose Your Workshop(s) ❑ Workshop Day (Monday) ❑A or ❑B | ❑C or ❑D | ❑E or ❑F See Page 15 for pricing details. Your customer registration code is: When registering, please provide the code above. Name__________________________________ Job Title ________________________ Organization____________________________________________________________ Approving Manager______________________________________________________ Address________________________________________________________________ City__________________________________State______________Zip____________ Phone________________________________Fax_______________________________ E-mail__________________________________________________________________ 5 EASY WAYS TO REGISTER: ❑ Please keep me informed via email about this and other related events. 1 Web: www.coldchainpharma.com ❑ Check enclosed for $_________ (Payable to IQPC) 2 Call: 1-800-882-8684 ❑ Charge my __Amex __Visa __Mastercard __Diners Club 3 Email: info@iqpc.com Card #__________________________________Exp. Date___/___ CVM Code ______ 4 Fax: 1-646-378-6025 Details for making payment via EFT or wire transfer can be found on 5 Mail: IQPC preceding page. 535 5th Avenue, 8th Floor, ❑ I cannot attend, but please keep me informed of all future events. 10366.004/D/AL New York, NY 10017 est orld's Larg New Discussions at the The W Global Forum for Industry’s Most Recognized Cold Chain Forum: Temperature Control Specialists ✔ Comply with international regulations and adhere to industry best practices by deciphering guidance documents and making them work for your company ✔ Devise cost-effective strategies with your packaging and transport partners to control Ambient, Refrigerated, Cold and Controlled Room Temperatures ✔ Streamline your global cold chain by harmonizing quality systems, transport providers and processes Distributing Safe Medicines Internationally in Collaboration ✔ Deliver safe drugs to patients and protect against product with Temperature Control Partners and Stakeholders loss by building security processes into your cold chain ✔ Ensure high-value medicines reach September 20-23, 2010 patients efficaciously by proactively working with and educating Pennsylvania Convention Center, Philadelphia, PA pharmacies and wholesalers Sponsors: Coldpack Maxim IP Texas Foam unable to open file, please resupply www.coldchainpharma.com

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