7th Cold Chain Distribution for Pharmaceuticals


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Only at the 7th Cold Chain Distribution for Pharmaceuticals, will you have the opportunity to network with the largest group of cold chain professionals, regulators and logistics providers. Key discussions include evaluating transportation strategy from top to bottom, developing KPIs & SOPs when qualifying 3PL providers, considering international shipment and import/export procedures and updates from regulatory agencies on new & proposed guidelines. Plus – don’t miss hearing from industry colleagues on Managing International Cold Clinical Supplies, during the NEW Post-Conference Focus Day.

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7th Cold Chain Distribution for Pharmaceuticals

  1. 1. The World’s Largest Global Forum for Cold Chain Specialists – Sold out in the US, Canada, Belgium, UK, Brazil, Singapore and Germany Solid Partnerships, Transport Processes and Risk September 21 – 24, 2009 Mitigation for Cost-Effective Temperature Pennsylvania Convention Center Controlled Shipment of Products and Supplies Philadelphia, PA Top 5 Reasons to Attend: Attend the industry’s favorite • Re-evaluate your transportation & logistics strategy to cold chain event and learn from ensure cost-effectiveness and streamlined processes 35+ top professionals, including: • Ensure compliance of international & domestic regulations of temperature-sensitive products and Keynote: Edward J. Kelley, General supplies through risk assessment & stability case studies Manager for Air Cargo, U.S. Dept. of • Establish qualified lanes, packaging and processes to Homeland Security – “TSA Screening internationally ship your new high-value vaccines, blood Cargo Program” products and biological materials Rafik H. Bishara, PhD, Technical Advisor and • Implement effective last mile logistics processes to Chair PCCIG USA Branch, PDA ensure product integrity to the patient and to remote Ian Holloway, Manager, Defective Medicines destinations Report Centre, MHRA • Network with 350+ professionals from manufacturing, Sarah Skuce, Compliance Specialist, Health logistics, packaging, QA, regulatory agencies, wholesale Canada and logistics and freight partners Bob Seevers, Principal Regulatory Scientist, Regulatory Affairs, CMC, Eli Lilly and Company ALL NEW, for you: Cold Chain Distribution 2009 Anthony Moran, Director of Procurement, Siemens New industry sector and cold chain stakeholder perspectives from: Joanna Ward, Senior Director, Manufacturing and Supply Chain Management, Seattle Genetics Research Biotech R&D McKesson Wholesalers Genetics Animal Health Insurance Underwriter Novartis Clint Pollard, Manager, Transportation, Merial Medical Devices US Military American Red Cross Animal Health Geoff Glauser, Director of Global Packaging Plus - Hear how Cathay Pacific, Air France/KLM, American and Delta meet new IATA Technology, Wyeth guidelines and TSA Screening Security requirements Rose Bicksler, Senior Manager, Global Quality Assurance and Validation, Johnson & Johnson Vincent Porzio, Clinical Supplies Manager, Don’t miss the new Clinical Register by July 10th and Schering-Plough Claude Jolicoeur, Director of Regulatory Affairs Logistics Focus Day SAVE up to $2,595 and Corporate GMP Officer, McKesson Canada Corp. Sponsors: www.coldchainpharma.com
  2. 2. September 21 – 24, 2009 Pennsylvania Convention Center Philadelphia, PA Solid Partnerships, Transport Processes and Risk Mitigation for Cost-Effective Temperature Controlled Shipment of Products and Supplies Table of Contents: Dear Colleague, Pre-Conference Specialist The ‘cold chain’ we used to know Discussion Forums . . . . . . . . . . . . . . 5-6 is history. Today, biopharmas, med and other organizations face new ical device Transportation & challenges controlling, monitoring mitigating risk involved in transpor and Logistics Plenary Sessions . . . . . . . . . . 7 ting & distributing temperature-sen products. Regulators require tem sitive perature control of many tempera Biological Materials & cost pressures are forcing compan ture ranges, ies to re-evaluate their transportatio Clinical Supplies Track . . . . . . . . . . . . . 8 strategy, revised modes of transpor n t require new risk profiles, and mor biological drugs are entering internat e Last Mile Cold Chain Logistics Track. . 8 ional trials and the market. Regulatory Compliance At the 7th Annual Cold Chain Dist Plenary Sessions . . . . . . . . . . . . . . . . . 9 ribution for Pharmaceuticals, you learn from expert speakers and indu will stry colleagues through case-studies QA Distribution & discussions and plenary sessions how , panel to update your temperature control Risk Management Track . . . . . . . . . . . 9 logistics and QA to meet today’s chal lenges. In addition, you’ll compare quality initiatives, transportation strat new Cold Chain Packaging egies and qualified packaging whic & Materials Track . . . . . . . . . . . . . . . . 9 more control, increased compliance h offer and efficiency for international distr of cold chain products, IMPs and ibution Clinical Logistics Focus Day . . . . . . . . 11 bulk material. As always, peer-to-peer networki About Our Sponsors . . . . . . . . . . 12-13 ng is at its best at Pharma IQ’s event as: annual Venue & Accommodations . . . . . . . . 14 • The largest cold chain show, bringing Pricing & Registration Information. . . 15 together 350+ temperature control supply, logistics, packaging, IT and QA professionals • A ‘one stop shop’ exhibition for part icipants to consult with 40+ new existing cold chain partners in tran or sport, packaging, freight forwardi A special thank you to our information systems ng and 2009 Executive Advisory Time out of the office is sometimes peers – if you’re going to attend one hard to come by, however just ask your Board: Cold Chain conference this year – industry’s choice for the best educatio the Rafik H. Bishara, PhD, Technical Advisor and nal value and networking opportu Pharma IQ’s Cold Chain event in Phila nity is Chair PCCIG USA Branch, PDA delphia. Geoff Glauser, Director of Global Packaging The speakers, sponsors and Pharma Technology, Wyeth IQ team look forward to seeing you September in Philadelphia for the in 7th Annual Cold Chain Distribution Kevin O'Donnell, Chief Technical Officer, Pharmaceuticals 2009 conference. for Thermosafe & Author www.coolerheadsblog.com Sincerely, Karl Kussow, Manager, Quality and Validation, FedEx Custom Critical Gwyn Murdoch, Quality Manager, Materials/Packaging Quality Systems, Eli Lilly Jim Bacon, Director, Global Demand Planning and Customer Service, Talecris PS: Don’t miss Courtney Becker-James th Bobby Boehm, Associate Director, Cold Chain, Conference Director Clinical Logistics e new Bristol Myers Squibb Day! See page Focus Pharma IQ, a division of IQPC Rich Ellinger, Director of Global Marketing and www.coldchainpharma.com Business Development, Tegrant Corporation courtney.becker@iqpc.co.uk 11 for details. Nick Basta, Editor in Chief, Pharmaceutical Commerce 2 www.coldchainpharma.com
  3. 3. What’s New for Clinical Logistics Focus Day Smaller validated packaging, countless clinical sites, patient cold chain compliance, site practitioner issues… the list continues for the unique challenges faced by Clinical Supply professionals. Join us for a focused day on how to cost-effectively and compliantly ship clinical materials and comparators for international clinical trials. “Implementing Automated Temperature Monitoring to Improve Clinical Distribution Processes” - Schering-Plough “Best Practices to Improve Patient and Clinical Site Cold Chain Compliance” - Bernstein CMC Regulatory Consulting “Case Study: Managing a Massive Large Scale Vaccine Clinical Trial” - Wyeth Transportation and Logistics Plenary Keynote: Edward J. Kelley, U.S. Dept. of Homeland Security “Qualifying for the TSA Cargo Screening Program” Interview with Airlines Hear how leading carries including Cathay Pacific, Air France/KLM, American and Delta are updating their processes to meet updated IATA Chapter 17 *Don’t miss the ‘hot topic’ workshop* “Quality and Efficiency for Cost & Temperature Controlled Transportation” Last Mile Logistics “Role of the Wholesaler in the Distribution Of Temperature-Controlled Products” - McKesson “Distribution of Cold Chain Products to the Public and Emergency Planning” - Public Health District Leader, Alexandria, Virginia Biological Materials & Clinical Supplies “Quality Control for the Storage and Transportation of Blood and Biologics” - American Red Cross “Global Logistics for the Clinical Distribution of Cytotoxic Antibody-Drug Conjugates” - Seattle Genetics “Cold Chain Planning and Shipping of Bulk Protein Internationally at -60°C” - Novartis 3
  4. 4. More than 150 different companies attended Cold Chain Distribution 2008 including: Abbott Laboratories Global Pharmaceutical Supply Group AcuTemp Thermal Systems Hamilton Park Capital Alexion Pharmaceuticals Inc Health Canada Almac Group An eye opener on several Immunogen Inc Altus Pharmaceuticals Impeva Labs American Thermal Instruments Inc. topics. I enjoyed both Integra Lifesciences Corporation Amgen Inc Janseen-Cilag Amylin Pharmaceuticals Inc days and would JeanCoutu Pharmacy Anesiva Inc. Johnon & Johnson Sales & Logistics Co. APP Pharmaceuticals recommend such an event Johnson Matthey Pharma Materials AstraZeneca Pharmaceuticals JOM Pharmaceutical Services Inc ATL Pharma Security Label Systems to other colleagues. Also, Kirin Pharma USA Inc Auxilium Pharmaceuticals Inc Kryotrans Bausch & Lomb networking was great! Kuehne Nagel Inc Bax Global Lanter Distribution Baxter Healthcare Lantheus Medical Imaging Bayer Corp. – Program Manager of Quality Life Packaging Technology Bayer HealthCare Assurance Compliance, Abbott Lifoam Industries, LLC BioMarin Pharmaceutical MannKind Corporation BioMérieux Inc Laboratories MAYA Simulation Technologies, Ltd. Blue Vector Medarex, Inc BlueBird Express Medco Health Services Boston Scientific Medicis Pharmaceutical Corp Bressler Group MedImmune Inc Bristol Myers Squibb Medtronic Spinal & Biologics Brookwood Pharmaceuticals Mellenium Burris Logistics Cangene Corporation The subject matter was Mentor Biologics Merck and Company Cardinal Health Catalent Pharma Solutions excellent and covered all Merial Limited Minnesota Thermal Science Cathay Pacific Airways CBMS Chemical Biological Medical Systems aspects of what to do and Myoderm Medical NanoCool Celgene Corp Centocor what is on the horizon for Novartis Pharmaceuticals NovaRx Centocor R&D Cephalon Inc companies in the next Onqor Packaging Science Resources CEVA Freight Management - RDU Chick Packaging Group few years. IQPC staff PackagingPrice Inc Pakoil Climate Controlled Containers Inc Panther Expedited Services Cold Chain Technologies really put together an Perrigo Covidien Pfizer CSafe LLC action-packed conference Polyair CSL Behring Pop Technology Cubist Pharmaceuticals and managed well. Priority Solutions Dawson Logistics Quality Solutions Defense Supply Center-Philadelphia – Director, Pharmaceutical Rand-Whitney Container DeltaTRAK Sanofi Pasteur Ltd. Dentsply International Packaging Services, Schering- Schering-Plough Corporation DHS U.S. Immigration & Customs Sensitech Enforcement Plough Corporation Sentry Logistic Solutions DoubleDay Holdings Shire Pharmaceuticals EDUQUEST SNC Lavalin Pharma Elan Pharmaceuticals, Inc. Takeda Pharmaceutical Eli Lilly and Company Talecris Biotherapeutics, Inc. Elpro Services TCP Reliable Emergent BioDefense Operations Lansing Tegrant Thermosafe Brands Envirotainer Very good speakers and TempTime Corporation Ernest Packaging Solutions Teva Pharmaceuticals USA , Inc. Falvey Cargo Underwriters subject matter and was Thermal Packaging Solutions FedEx Tucker Company Fisher Bio Services filled with information uniPHARM Wholesale Drugs Fisher Clinical Services University of Florida Flexpoint rather than basic UPS Frontier Paper US Pharmacopeia FUJIREBIO INC GBSC LLC - J&J concepts. USPack Courier Service UTI Gene News Genetech – Logistics Project Manager, ViroPharma Wal-Mart Specialty Pharmacy Genvec Genzyme Corporation Bilcare, Inc. Willerup Consulting, LLC World Courier Gilbert’s LLP Wyeth Pharmaceuticals Gilead Sciences Xdicator Corporate GlaxoSmithKline ZLB Plasma 4 www.coldchainpharma.com Sponsors:
  5. 5. Pre-Conference Specialist Discussion Forums Monday, September 21, 2009 8:00 am – 11:00 am Registration at 7:45 (Coffee will be served) A Cold Chain Program Management: Utilizing Temperature Information for Continuous Process Improvements Performing a cold chain audit is the first step in identifying potential risks in a • Statistically evaluating supply chain processes with the goal of improving supply temperature-sensitive supply chain. Second, banking cold chain data and chain performance and overall efficiency statistically evaluating supply chain performance over time enables the • Food industry examples driven by customer retention and product quality development of continuous process improvement programs. Third, knowledge of What you will learn: the global regulatory and industry standard guidance for the storage, handling • Apply a risk-based approach grounded in industry guidance and driven by and distribution of temperature sensitive medicinal products is critical to process validation for insuring overall cold chain compliance protecting patient safety. Choose from Workshop A or B • Drive efficiency and reduce costs while meeting regulatory requirements How you will benefit: • Document and mitigate risks through the development of improved This workshop will address the above three key elements together in an • Standard Operating Procedures (SOPs) – while driving improved efficiencies and interactive and thoughtful discussion linked to specific case studies, including lowering overall costs examination of: • Temperature-sensitive risk assessment Your Workshop Leaders: • Developing a cold chain program the identifies process trends and utilizes Henry Ames, Director of Strategic Marketing, Sensitech shipping reports to feed into continuous improvement efforts Mark Maurice, Project Manager, Sensitech • Meeting Quality defined storage requirements 8:00 am – 11:00 am Registration at 7:45 (Coffee will be served) B Leveraging New Refrigerant Technologies: Use of Engineered Phase Change Materials in Cold Chain Packaging Design What you will learn: • How traditional water based refrigerants are best utilized and what are their • Alternatives to traditional gel pack refrigerants available in the industry true limitations • How to identify and evaluate the trade-offs in material costs v. the total costs of • How engineered phase materials can contribute to your company sustainability the packaging and distribution initiatives • Performance variables to consider in the selection of a PCM • Re-usability v. Single use? What types of applications are engineered PCM’s best deployed? How you will benefit: Through case studies interaction with packaging and logistics peers, you will go Your Workshop Leader: through examples to understand: Anthony Alleva, Technical Services Manager, TCP Reliable/Cryopak 11:15 am – 2:15 pm Registration at 11:00 (Lunch will be served) C Sea Transportation of Temperature Controlled Pharmaceutical Products How you will benefit: What you will learn: Through discussions and case scenarios of sea transport, you will discuss with your • Current reefers on the market that afford cost-effective, low risk options for industry colleagues and those experienced with sea transport, how to: transporting pharmaceutical products • Attain buy in from senior management and colleagues in quality management • Compare efficiency vs. cost of sea transport to other modes • Define common ground and ways to work effectively with sea carriers • Risks of sea transport: Examining risks with longer routes, port authorities and • Developing SOPs with ocean carriers various other handlers • Implement proactive contingency plans • Understand what sea carriers offer competitive services for transport of temperature controlled pharmaceuticals Workshop leader to be announced. Please check www.coldchainpharma.com for updates. Choose from Workshop C or D 11:15 am – 2:15 pm Registration at 11:00 (Lunch will be served) D Which Shipping Solution is Greener? What You Measure Might Surprise You! Using Science and Data-Driven Decisions When Choosing Among How you will benefit: Green Cold Chain Shipping and Logistics Options Through case examples and interactive exercises, you will discuss with the CCT Appropriately, companies are placing more and more emphasis on utilizing and MIT team how to: “green”, “sustainable”, “reusable” and/or “recyclable” shipping and logistics • Evaluate green and sustainable packaging and logistics options solutions for their cold chain packaging and distribution needs. The difficulty arises • Consider the value proposition for environmentally-friendly choices in putting hard measurements around the level of “green-ness” or sustainability, • Better understand the practicalities of using green packaging attributes whose very definitions are subject to wide interpretation. In conjunction • Develop a measurement model to fit your needs with a team from the Massachusetts Institute of Technology (MIT), Cold Chain Your Workshop Leaders: Technologies (CCT) has developed a data-driven and dynamic model to help Anthony “TJ” Rizzo, Strategic Account Engineer, Cold Chain Technologies evaluate product delivery options in terms of both logistics costs and environmental impact, using derived, hard values. Bob Bohne, VP & General Manager, Cold Chain Technologies What you will learn: Jeremy Stewart, Leaders for Global Operations Fellow, Massachusetts • Life Cycle Analysis Institute of Technology • State-of-the-art approaches to sustainability Angelo Capuzzi, Leaders for Global Operations Fellow, Massachusetts • Measurement methods and values for measuring environmental impact Institute of Technology • Case Study: Evaluating various high-volume refrigerant delivery method options • Approaches for developing your own model 5
  6. 6. 2:30 pm – 5:30 pm Registration at 2:15 E Quality and Efficiency for Cost & Temperature Controlled Transportation The workshop will facilitate a discussion of considerations for choosing a How you will benefit: transportation method, including international regulations, shipping environments, Through case studies of real-life examples and interactive exercises, you will and the strengths and weaknesses of available temperature control options for air understand how transport systems can be designed to significantly reduce or and ground transport. eliminate common problems in domestic US and international air transport. You will The group will discuss solution options and criteria for designing best practice gain an appreciation for the relative costs and benefits of achieving your transportation systems and procedures that appropriately blend the needs of your transportation objectives within the framework of your GDP requirements and product, your business, and available services. We will also explore the effectiveness discuss how to minimize those costs while maintaining safe transport requirements. of various choices by considering case studies for both ground and air transport. • Improve your ability to implement high quality, secure, and cost-effective transportation What you will learn: Choose from Workshop E or F • Enhance your ability to apply industry and governmental guidance on Good Gain insight into carrier quality systems for both standard transportation and Distribution Practices in your transportation plans temperature control including: • Increase your understanding of how to effectively work with your carrier to • Strategies for implementing best practices for achieving high quality and safety in maximize the quality, consistency, and economy of your shipping lane both air and ground transport • Effective procedures to address transport risk issues Your Workshop Leader: • Decision making factors for evaluating cost-effective transportation strategies for Karl Kussow, Manager, Quality, FedEx Custom Critical cold chain 2:30 pm – 5:30 pm Registration at 2:15 F Examining the Impact of Packaging and Shipping on Supply Chain Integrity for Vaccines and Challenging Destinations The Department of Defense has unique challenges which require more stringent sometimes remote unit such as mobile hospitals, field paramedics and combat temperature controls, delivery time pressures and sometimes difficult to reach zones destinations. This workshop is a unique opportunity to learn from the US • How to establish processes for emergencies and working within defined timelines Department of Defense’s Cold Chain Manager how to ensure effective, safe and • Working with specialty carriers for bio materials compliant shipping of vaccines and biomaterials. How you will benefit: What you will learn: • Balance cost pressure with time and temperature requirements to find suitable • The role of appropriate packaging and transportation handling in the supply chain packaging to maintain Cold Chain Integrity • Understand different packaging requirements for temperature controlled • How to choose packaging solutions and vendors to ensure quality substances • Passive, small parcel, refrigerated packaging protocols • Understand specific challenges in the US Military Supply Chain as a military • Passive, “disposable,” bulk shipper with validated pack-outs for all 3 personnel yourself or as a key supply partner temperature range requirements • Alternatives to passive packaging Your Workshop Leader: • Logistical challenges in shipping supplies to international destination and Ms. Dana L. Dallas, Vaccine/Cold Chain Program Manager, Defense Supply Center Philadelphia 5:45 pm – 8:45 pm Registration at 5:30 (Dinner will be served) G Bringing Your Logistic Operations to Meet Today’s Airline Cargo and Transportation Security Challenges Maximizing supply-chain value may depend on how well you are navigating new How you will benefit: complexities regarding airline security, international importation, customs and cold- Through case examples and one-on-one discussion, you will interact with leading chain options in global pharmaceutical transport. This workshop will feature insights aviation and security experts from American Airlines, the Transportation Security on these issues with aviation and security experts, in an interactive format. Administration and the Pharmaceutical Industry. • Gain a better understanding of the global regulatory environment What you will learn: • Evaluate current options available for meeting TSA screening mandates • Options for meeting the U.S. governments 100% screening mandate • Collaborate with the experts to develop new approaches • Case Study: Innovative approaches that are currently being taken in the • Understanding how to balance supply chain issues to deliver more value in Cold- Pharmaceutical Industry Chain shipment transport • New IATA regulations surrounding international transport Choose from Workshop G or H • Navigating importation and customs issues Your Workshop Leader: • Keys to maximizing success in cold-chain transport Dave Brooks, President, American Airlines Cargo 5:45 pm – 8:45 pm Registration at 5:30 (Dinner will be served) H Assembling the Puzzle: A New Paradigm in Clinical Supplies Distribution Challenges that are unique to the distribution of clinical supplies place high • Use of Containers demands on a Company’s technology line-up. The ability to deliver sustainable • Taking a closed loop approach to the use of containers results is contingent upon creating achievable goals, selecting proper tools, and How you will benefit: leveraging cross-functional supply chain capabilities. By understanding the • Gain an understanding of operating challenges related to Clinical Trials distribution pathway, you are able to take action that mitigates risks during supply • How Stability Data can be appropriated chain handoffs, thereby achieving higher levels of compliance. • See how data loggers suit your approach This workshop provides the details of success experienced in Schering-Plough’s • Realize the advantages during container selection global supply chain. • Better understand instances for closed-loop-distribution What you will learn: Your Workshop Leaders: • Considerations for Shipping Tools in Clinical Applications Kevin Grimm, Engineer, Schering-Plough • Understanding and Leveraging Stability Data Vincent Porzio, Engineering & Technical Services Manager, Schering-Plough • Use of Data Loggers Amlan Dutta, Engineering & Technical Services Director, Schering-Plough 6 www.coldchainpharma.com Sponsors:
  7. 7. Main Conference Day One Tuesday, September 22, 2009 7:00 Registration and Coffee • How has global economics affected the airline industry? • What changes in the airline industry do you see that may affect cargo 8:00 Pharma IQ Welcome capacity? Panelists: 8:05 Opening Remarks from Conference Chairperson Jack Lo Rafik H. Bishara, PhD Cargo Product and Marketing Manager Technical Advisor and Chair PCCIG USA Branch Cathay Pacific Cargo PDA Stephane Lemaire Director Pharmaceutical Logistics Transportation and Logistics Air France KLM Cargo 8:15 Introductory Remarks from Plenary Chairperson Don Harrison Project Manager, Product Development Kevin O'Donnell United Airlines Cargo Director & Chief Technical Advisor, Tegrant Corp., ThermoSafe Brands & Chair A Representative IATA Time & Temperature Task Force Air Canada Cargo 8:25 KEYNOTE: Meeting US Security Standards and Qualifying 10:45 Morning Networking Break for the TSA Screening Program to Avoid Custom Delays • Program background, motivations and looming deadlines 11:30 Standardizing Qualification and Auditing of Transportation • How to prove Chain of Custody: Documentation, application ad and Warehousing Partners authentication • Defining quality parameters and expectations of our transportation partners • Case stories of biopharma company compliance • Streamlining transportation agreements across partners • Freight forwarders qualification requirements • Central Eastern Europe Case Study: Certifying new warehouse and transport suppliers Edward J. Kelley • Feedback on the best practice guidance document from the PCCIG General Manager for Air Cargo, Transportation Security Steering Committee on Standardizing Qualification of 3PLs Administration Department of Homeland Security Arminda O. Montero Distribution QA Program Manager, Global Pharmaceutical Operations 9:05 Panel Discussion: Panel Navigating the New TSA Abbott Requirements –Why a Layered Risk-Based Approach to Air Cargo Security Provides the Best Model for Safely 12:10 Case Study: Using Advanced Predictive Thermal Modeling Shipping Pharmaceuticals to Determine the Acceptable Product Payload • Why does a layered risk-based approach make sense? Characteristics for a Shipping Lane with a Defined Ambient • What innovative steps are being taken to adapt to the 100 percent Temperature Profile screening environment? Pharmaceutical manufacturers ship a wide variety of thermally sensitive • How will supply-chain value be impacted for Pharmaceutical shipments? products to various locations around the world. As such, it becomes impractical for these companies to perform operational qualification (OQ) Panelists: studies for all combinations of product that could possibly be shipped inside David R. Brooks an existing shipper design. This presentation will discuss how advanced President thermal modeling software is applied to define the acceptable product load American Airlines Cargo characteristics in such a way that they can be applied to multiple products, Edward J. Kelley and how to define those characteristics analytically. • Bracketing payload characteristics: thermal mass (product density), product General Manager for Air Cargo, Transportation Security Administration type (liquid, lyophilized), volume (syringe, vial) and quantity of product • Using analytical modeling to derive and bound acceptable product load Department of Homeland Security characteristics for an existing shipper in a given shipping lane with a Brad Elrod defined ambient temperature profile Senior Manager, Global Logistics Security • Verifying and validating the thermal models through physical testing once Pfizer the worst-case configurations representing the load limits are selected • Predicting how an existing shipping solution will perform and how the drug 9:55 ‘Interview with an Airline’ Panel Discussion: Meeting IATA product will be affected when subjected to new, potentially more severe, Chapter 17 Revised Regulations and Biopharma ambient temperatures Requirements for Temperature Sensitive Products • Understanding how the analytical model can provide insight into the critical Reducing transportation costs while shipping temperature sensitive effects of convection, conduction and refrigerant phase change inside the pharmaceuticals in a timely fashion is a balancing act for cold chain shipper professionals. Rapid air transport is a desirable and sometime necessary mode, but biopharma companies still wonder ‘can the airline effectively Jeffrey Simpson handle my shipments?’ or ‘how do I know air carriers are taking all the Director of Engineering and Technical Services necessary precautions to ensure temperature controls?’ This session will Cold Chain Technologies ‘interview’ airlines handling temperature controlled biopharma products Geoffrey Glauser including discussion on: Director of Global Packaging Technology • What evidence can be provided to biopharma customers to document any Wyeth Pharmaceuticals temperature deviations at the airport? • What does a Quality Management System mean to you and how has your 12:50 Optimizing Logistics Modeling: Maximizing On Time airline implemented it? Delivery Performance • What strides have you made to comply with the new Time and Cold chain products have unique characteristics challenging the traditional Temperature Label usage requirements? supply chain. The primary purpose of an optimized logistics model is to • What other programs or process have airlines implemented to reduce deliver the therapy to the patient when it is expected, while protecting the environmental risks to time and temperature-sensitive healthcare integrity of the product. This discussion will concentrate on the supply chain products? 7
  8. 8. from origination to delivery to the patient and the various reasons why and exceptions by delineating between internal and external causes of deliveries are not made, the financial impact, and a solution to detect, service delays troubleshoot, intercept and provide delivery. Discussion points will include • Establish optimized distribution modeling for maximum on time delivery opportunities to optimize your mode of transportation, reducing performance transportation and packaging spend, and meeting customer’s delivery • Define process which can be employed to control seemingly expectations. Additionally, processes to evaluate root cause analysis of uncontrollable service delays such as weather and consignees not being these delivery exceptions and corrective action implementation to minimize available future / repeat occurrences will be outlined. This discussion aims to: • Present industry best in class processes to analyze current distribution Josh A. Hobick Senior Vice President patterns and determine opportunities for service improvement and cost Dawson Logistics avoidance. (Improve on time service to your patience and reduce reships) • Demonstrate analytical applications to realize root cause of service gaps 1:30 Networking Luncheon Concurrent Sessions begin: Choose Track A or B Track A: Biologic Materials & Clinical Supplies Track B: Last Mile Cold Chain Logistics 2:40 Addressing Cold Chain Logistical Challenges within the Distribution of Cold Chain Products to the Public and Military Blood Program Emergency Planning • Evaluation and determination of need • Challenges to ensure temperature control in the public health arena • Assessing the environment • Preparing for mass immunizations • Proper methods of data gathering and analysis • Defining optimal levels of stock piles and ‘ready to dispense’ logistics • Defining requirements for specific products • Working with the CDC and government agencies for pandemic • Evaluating solutions and available options emergency scenarios • Developing a plan for implementation and success Dr. Lisa Kaplowitz • Lessons learned in this type of process. Public Health District Leader, Alexandria, Virginia,Former US Military speaker pending final approvals Deputy Commissioner for Emergency Preparedness and Response State of Virginia 3:25 Global Logistics for the Clinical Distribution of Cytotoxic Role of the Wholesaler in the Distribution of Antibody-Drug Conjugates Temperature-Controlled Products • Introduce the unique characteristics and requirements for ADC molecules • Updating processes and practices to monitor required temperatures • How to establish and qualify multiple legs of the cold chain from US of biopharma products to EU and back to US • Visibility and temperature control after leaving warehouse depot • Challenges with maintaining and monitoring temperature: • Preparing to meet Health Canada regulatory expectations for 0069 • Establishing qualified storage sites in Europe for distribution guidelines • Import/export logistics; customs, compliance and VAT considerations • Addressing how McKesson is meeting industry standards and • Packaging and safety measures for highly toxic, potent materials technical guidance Joanna Ward Claude Jolicoeur Senior Director, Manufacturing and Supply Chain Management Director of Regulatory Affairs and Corporate GMP Officer Seattle Genetics McKesson Canada Corp. 4:05 Afternoon Networking Break 4:35 Cold Chain Planning and Shipping of Bulk Protein Setting up International Transport and Logistics to New Internationally at -60°C Markets • Developing supply chain options for highly volatile demand forecast • Designing new transportation routes and temperature profiles • Establishing large volume shipping containers for biotech material • Evaluating modes of transport for certain lanes stored at -60C • Preparing for 0% allowable excursions in some countries such as • Assessing and developing new pallet shippers to hold maximum Mexico or Brazil material, maintaining temperature and minimizing cost • Evaluating packaging technology and logistic partners for global routes • Understanding customs controls in emerging countries with unusual Christina Pavlik regulations Manufacturing Planning Manager Novartis Anthony Moran Director of Procurement Siemens 5:20 Quality Control for the Storage and Transportation of Panel Discussion: Achieving Greater Visibility into Cold Blood and Biologics Chain Control and Compliance Post-Manufacture • Developing shipping protocols for the blood supply chain • Assessing requirements including validation master plan, routes, • Conducting qualification processes according to GDP requirements timelines to ensure an effective cold chain • Temperature maintenance for international transport of blood to • Qualifying shipping systems and assessing suitability Australia and Europe • Adopting a bracketing approach to cold chain validation studies • Qualification of boxes for longer shipping times • Discussing Industry Standards guidelines and their application to • IATA Chapter 17 new developments for shipment of biologics, controlling your downstream cold chain including training for active systems All Track B speakers and participants are invited to join the discussion Boriana Cavicchia Manager, Systems Quality, BioMedical Services American Red Cross 6:00 Closing Remarks 6:10 Networking Cocktail Reception in Exhibition Hall Join your colleagues from across disciplines to exchange ideas and network in an informal environment. Take this time to learn from the industry’s top technology and logistics providers to update and advance your cold chain management. 8 www.coldchainpharma.com Sponsors:
  9. 9. Main Conference Day Two Wednesday, September 23, 2009 7:45 Registration and Coffee practices in protecting materials from exposure to temperatures outside recommended storage conditions and evaluating the impact of such Regulatory Compliance exposures when they do occur. Bob Seevers 8:30 Opening Remarks from Chairperson Principal Regulatory Scientist, Regulatory Affairs, CMC Rafik H. Bishara, PhD Eli Lilly and Company Technical Advisor and Chair PCCIG USA Branch PDA 11:40 Biopharma Temperature Control Industry Best Practice Initiatives 8:35 European Regulatory Guidelines: Controlled or Ambient The leadership of the Pharmaceutical Cold Chain Interest Group (PCCIG) Temperatures, Stability Data and Compliance continues post publication of PDA Technical Report No. 39. This • Expectations and documenting for ambient or CRT products presentation will review progress being made for the Industry Best Practices • Regulatory expectation for qualification or validation in multiple project areas including: • Last Mile for the distribution of pharmaceutical products to the end-user • Stability studies versus shipping studies -are stability studies enough to • Good Distribution Practices (GDPs) for the pharmaceutical supply chain set the limits for your cold chain? • Mean Kinetic Temperature (MKT) Ian Holloway • Active system temperature profiling Manager, Defective Medicines Report Centre • Global regulatory requirements MHRA • Harmonized labeling for cold chain • Distribution Validation Master Plan (VMP) 9:10 Health Canada's Guidelines on Monitoring Temperature • Supply Chain Partner Management best practices Control of Drug Products in the End to End Cold Chain • From the first to the last mile • Proposed revisions to Health Canada's GUI-0069 • Wholesaling, storage and shipping Rafik H. Bishara, PhD • Regulatory expectations for temperature control of drug products Technical Advisor and Chair PCCIG USA Branch • Common questions and misconceptions regarding temperature control PDA of drug products 12:15 Ask the Regulator and Industry Panel Discussion Sarah Skuce • Lessons learned in justifying pharma company actions and validation plans Compliance Specialist to regulators – what exactly demonstrates control? Health Canada • New regulations on storage, handling and distribution of drug samples & mail-order drugs 9:45 Understanding and Applying the USP <1079> Revised • Extrapolating future regulatory requirements in-line with cold chain trends Guidelines • Outlining the new 1079 Chapters for implementation (Anonymous questions may be submitted to the panel before hand by • Understanding 1079’s definition of validation (for packaging) and sending to courtney.becker@iqpc.co.uk) comparing to other industry standard guidelines Moderator: • Specific protocols for receiving, shipping and storing temperature Rafik H. Bishara, PhD controlled pharmaceuticals Technical Advisor and Chair PCCIG USA Branch • Using examples and grids to demonstrate how to use the guidance to PDA make decisions for your cold chain management Panelists: Dr. Mary Foster Ian Holloway USP Packaging and Storage Expert Committee Member Manager, Defective Medicines Report Centre US Pharmacopeia (USP) MHRA 10:20 Morning Networking Break Sarah Skuce Compliance Specialist 11:05 Regulatory Points to Consider for Cold Chain Distribution Health Canada With the increasing trend toward using more third party resources to Dr. Mary Foster manufacture and distribute drug products, the identification and control of USP Packaging and Storage Expert Committee Member risks encountered in the distribution environment have evolved into a US Pharmacopeia (USP) major element in the process of storing and shipping pharmaceuticals. The WHO, PDA Technical Report 39, and FDA have all identified that the Bob Seevers holding of drugs includes distribution and is seen as a cGMP regulated Principal Regulatory Scientist, Regulatory Affairs, CMC process. This presentation will use the principles presented by global Eli Lilly and Company regulators to provide recommendations and note current industry best 1:00 Networking Luncheon Concurrent Sessions begin: Choose Track A or B Track A: QA Distribution & Risk Management Track B: Cold Chain Packaging and Materials 2:00 Developing a Risk Model and Tool for the Evaluation of Understanding Green Packaging Solutions for Your Shipping Practices Business and Cold Chain • Tightening the risk management process by adding more control in • Cost vs. environmental impact vs. ‘reward’ the front end to ensure maintenance of product quality throughout • Logistics practicalities of recycling of temperature controlled packout the distribution supply chain components: Expanded polystyrene’, gel packs, bubble wrap, • The risk grid defines acceptable risk by utilizing several key factors that cardboard, etc. compose the shipping process • Assessing options for non-dry ice solutions for frozen packout • Based on the outcome of the risk classification performed, the requirements shipping requirements for each product type and/or product family can • Biodegradable packaging considerations & suppliers be determined 9
  10. 10. Gwyn Murdoch Ms. Betsy Steiner Quality Manager, Materials/Packaging Quality Systems Executive Director Eli Lilly Alliance of Foam Packaging Recyclers 2:40 Risk-Based Evaluation of Cold Chain Issues for Operational Qualification of an Active Heating and Effective Supply Chain Distribution Management Cooling Air Cargo Container, a considered approach: Effective risk management of cold chain issues with the distribution • What parameters should be considered during the design network of a supply chain requires consideration of several challenging qualification? elements including regulatory, logistics, financial and operational • How does one handle the concepts of repeatability and consistency? considerations. Balancing these often contradictory constraints and • Should active container qualifications be compared to passive implementing an optimal logistics solution is an iterative challenge that container qualifications? requires on-going evaluation and adjustment. The session will include • What technical considerations should be covered in the laboratory several “case studies” and practical examples of the types of risk qualification, field qualification? mitigation steps to avoid losses from spoilage, contamination, and Geoffrey Glauser other temperature-driven issues. • Transportation vendor vetting, collaboration and review Director of Global Packaging Technology • Negotiation to incorporate SOP’s directly into a logistics contract Wyeth Pharmaceuticals • Critical challenges in the selection and management of transportation vendors and the implementation of control elements • Threat/exposure identification of cold chain transit risk elements • Effective contingency planning for specialized cold chain processes Eric Newman Vice President, Loss Prevention Falvey Cargo Underwriting 3:15 Afternoon Networking Break 3:45 Temperature Controlled Transportation and QA Case Case Study: Qualifying an Active Heating/Cooling Study System Logistics and Quality personnel engage in daily and periodic activities to • Using a Failure Mode Evaluation to evaluate potential risks of the ensure the maintenance of a robust cold chain management system. new system These activities support initial vendor qualification, packaging • Qualification testing performed in the lab component validation, packout design and qualification, and other • Working with freight forwarders to develop SOPs for handling components of the Quality System that impact cold chain management. processes at airport This session of will focus on how evolving industry practice and • Conducting trial runs and collecting temperature data available guidance in cold chain management, increased scrutiny of • Assessing the cost – benefit of the new system drug safety and corporate focus on waste reduction necessitate the • Current status efficient management of relationships, risk, and processes to ensure Rose Bicksler appropriate stewardship and control of drugs in the supply chain. • Managing partner relationships to ensure compliance and effective Senior Manager, Global Quality Assurance and Validation Global Pharmaceutical Supply Group processes Johnson & Johnson - Working with 3PLs to ensure back up systems and plans are in place for our warehouses - Contingency planning with carriers - Ensuring risk mitigation procedures are in place • Re-evaluating cold packaging to extend shipping stability time and balance with the most cost-effective transportation modes Clint Pollard Manager, Transportation Merial Animal Health Zachery Thompson Manager, Quality Systems, Global Quality Merial Animal Health 4:25 Panel Discussion: Defining Stability Profiles and Panel Discussion: Defining the Future of Temperature Extrapolating Correct and Sufficient Stability Data to Controlled Packaging for Biopharmaceuticals Cover Temperature/Time Excursions • Balancing increasingly higher value medicines with cost-reduction • How low can you go: How flexible can stability profiles be to remain pressures compliant? • Comparing EPS , PUR and VIP packaging • Understanding varying country regulatory ‘allowable excursions’ • Rapid Evaporation Technology – 5 or 10 years away? • Defining what to put in regulatory file • Myths and realities of returnable /recycling programs • Communication to regulators • Other emerging technologies? • Assembling regulatory package Ms. Betsy Steiner • Using a general acceptable approach in practice to handling Executive Director deviations and excursions Alliance of Foam Packaging Recyclers Ian Holloway Geoffrey Glauser Manager, Defective Medicines Report Centre Director, Cold Chain Technology MHRA Wyeth Bob Seevers Rose Bicksler Principal Regulatory Scientist, Regulatory Affairs, CMC Senior Manager, Global Quality Assurance and Validation, Eli Lilly and Company Global Pharmaceutical Supply Group Henry Ames Johnson & Johnson Director of Strategic Marketing Sensitech 5:00 Closing Remarks 10 www.coldchainpharma.com Sponsors:
  11. 11. Clinical Logistics Focus Day Thursday, September 24, 2009 8:15 Registration and Coffee 1:50 Boosting Clinical Trial Efficiency by Outsourcing Clinical Logistics to Global Partners 8:50 Opening Remarks by Chairperson In late 2006, Wyeth Research and DHL Deutsche Post signed a strategic agreement with the intent to have DHL serve as the 9:00 Planning and Management of Pfizer’s International primary preferred carrier in the shipment of test articles, ancillaries Clinical Supply Distribution and other supporting materials. In the session, the discussion will • Preparing for key country regulatory approvals focus upon key attributes of the relationship, as well as highlighting • Managing export/import challenges and risks for efficient customs some current and future technological and operational clearance enhancements that continues to flourish in this dynamic relationship. • Outsourcing considerations for our clinical logistics The outcome has been very successful for both companies, with • Setting up effective partnerships and alliance structures emphasis on planning between key stakeholders, versus • Monitoring cold chain products and biologicals conventional transaction-related freight. • Decision factors in outsourcing clinical logistics Catherine Hall • Steps for building a global alliance with preferred partners Supply Chain Coordinator • Defining SOPs and KPIs Pfizer Global Research and Development • Implementing effective service and quality agreements • Extending global reach and finding additional cost-cutting 9:40 Case Study: Managing a Massive Large Scale Vaccine opportunities and services by moving from 3PL partnerships to 4PL Clinical Trial • Advanced temperature control packaging choices for our clinical • Delivering positive results by using risk management, contingency supplies and mitigation planning for offsetting challenges of international • Establishing 'chain of custody' of our clinical supplies internally and transportation routes and potential delays. with our global partner • Value of effective partnerships and leveraging core expertise to • Implementing innovative methods to track temperature and further mutual objectives location, providing data points for overall supply chain database • Changing distribution models as recruitment rates fluctuate and resources shift. How risk drives innovation to deliver. outstanding Bruce T. Guenter performance with challenging temperature profiles and shipping Director, Global Materials Logistics conditions Wyeth Research • Using Project management as a tool to solve the challenging aspects of a large study 2:30 Afternoon Networking Break C. Ray Goff, Jr. 3:00 Best Practices to Improve Patient and Clinical Site Cold PMP, CPM, PMM, Director of Vaccine R&D Chain Compliance Wyeth • Qualifying if clinical supply chain partners have sufficient refrigeration or systems 10:20 Morning Networking Break • How to maximize ability of patient to maintain necessary temperatures of their medications 10:50 My Temperature Sensitive Product Deviated for 2 • Labeling of investigational supplies best practices and examples hours: Making Quick Decisions on How to Handle that ensure patient compliance Temperature Excursions for Clinical Materials • Project management aspects that help improve cold chain • Developing a proactive stability database compliance downstream • Building procedures that qualify if materials are still viable • Avoid recalling products, repeated processes and lengthy QA David Bernstein investigation processes Vice President, Pharmaceutical Sciences and Regulatory Compliance • Examples of deviations and proactive responses Bernstein CMC Regulatory Consulting David Bernstein 3:35 Considerations for Shipping Comparators to Vice President, Proactive Damage Control International Markets Bernstein CMC Regulatory Consulting • Working with vendors to understand new markets for clinical sites • Cold chain concerns and temperature monitoring for comparators 11:25 Panel Discussion: Preparing for International Clinical • Temperature control packaging: Cost, IVRS systems and cooling Cold Chain Regulatory Requirements methods • Meeting EU Clinical Directive requirements • Shipping to international sites and dealing with depot • Challenges shipping into Latin America: Key partners and management overcoming import/export roadblocks Douglas Hawley 12:10 Networking Luncheon IM Operations Sr. Specialist, Global Logistics Celgene Corp. 1:10 Implementing Automated Temperature Monitoring to Improve Clinical Distribution Processes 4:10 Clinical Material Packaging, Labeling and Distribution: • Eliminate manual data entry and review of data from every From Factory to Clinic shipment utilizing the ELPRO data logger • Choosing appropriate packaging for bulk supplies and small vials • Programming the data logger for other shipments • Making data available worldwide to communicate temperature • Using IVRS to ensure minimal loss of supplies by having two-way deviations integration between shipper and IVRS • Reducing guesswork wit early phase materials with little data • Implementing cold chain strategies that ensure minimal distribution to clinical trials Vincent Porzio Clinical Supplies Manager Michele Alm Schering-Plough Supply Chain Manager Fibrogen 4:45 Closing Remarks 11