The World's Larg                               Don't Miss Day Three on...
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

                                                              Temperature Mapping and Pro...
DAY                                  Specialist Discussion Forums
can you edit this workshop so
                                                     11.15 - 2.15           (Registration 11...
DAY Main Conference Sessions
                      TWO                   Tuesday, September 21, 2010

7.15   Registration...
•   Composting, Biodegradability and Recycling
           •   Cost and Performance Attributes
           Michael Hays, Vic...
DAY   Main Conference Sessions
                        THREE                       Wednesday, September 22, 2010

2.05   Supply Partner Perspective: Stability Data and Label                                  Qualification of an Insulated...
DAY                        Main Conference Sessions
                      FOUR                       Thursday, September 2...
About Our Sponsors
                        ThermoSafe Brands, a Strategic Business Unit of Tegrant                        ...
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
Cold Chain Pharma2
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Cold Chain Pharma2

  1. 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
  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 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 Sponsors:
  3. 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 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. 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 Sponsors:
  5. 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. 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 Sponsors:
  7. 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. 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 To lead this roundtable, contact 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 To lead this roundtable, contact 5.35 Summary of Roundtable Discussions 6.25 Closing Remarks Day One from Chairperson 6.30 Networking Drinks in Exhibition Hall 8 Sponsors:
  9. 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. 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 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 Sponsors:
  11. 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. 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: 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: 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, and you also receive hard-copy documentation of the temperature inside the vehicle, the world’s most popular air cargo internet portal. or container throughout transport. This assists our pharmaceutical customers Website: 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: 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: 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: 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: 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: 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: Website: 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. Website: 12 Sponsors: