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4th Transportation & Transfer of Biologics and Biological Agents Summit
 

4th Transportation & Transfer of Biologics and Biological Agents Summit

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The 4th Transportation and Transfer of Biologics and Biological Agents will bring together the key specialists leading improvement efforts in global logistics, quality assurance, shipping, packaging, ...

The 4th Transportation and Transfer of Biologics and Biological Agents will bring together the key specialists leading improvement efforts in global logistics, quality assurance, shipping, packaging, transportation, and supply chain security. You will hear best practices for good distribution methods and learn strategies to create compliant, secure, and efficient procedures related to the movement of biologics and biological agents on a global scale.

May 11-13, 2009 - San Francisco, CA

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    4th Transportation & Transfer of Biologics and Biological Agents Summit 4th Transportation & Transfer of Biologics and Biological Agents Summit Document Transcript

    • Register by 3/27/09 and save up to $1000 4th Transportation & Transfer TM Understand Regulations and Manage of Biologics and Risks Proactively to Elevate Supply Chain Integrity and Material Efficacy Biological Agents May 11 – 13, 2009 • San Francisco, CA Hear Insightful Case Meet and Hear from Regulatory Agencies Including: Studies From Leading Department of Transportation (DOT) Department of Homeland Security (DHS) Practitioners: International Air Transport Association Centers for Disease Control and (IATA) Prevention (CDC) Novartis World Courier Crucial Take-Aways: ALMAC Cold Chain Technologies Understand Key Requirements and Standards from Major Regulatory and • Genentech Government Agencies Wyeth Pharmaceuticals Overcome International Shipping Challenges for Temperature Sensitive • American Red Cross Products Defense Logistics Agency Obtain technologies and techniques to maintain cold chain to ensure • Thermo Fisher Scientific product efficacy Minnesota Thermal Science, LLC Key insights of material transfer and permit • Abbott Laboratories Mitigate Operational Risks and Assuring Cargo Security Michigan State University • Envirotainer, Inc. Explore RF Enabled Temperature Monitoring • Human Genome Sciences Sponsors: Media Partners: www.iqpc.com/us/transport • 1-800-882-8684
    • 4th Who Will Attend Transportation & Transfer TM This conference is designed for multi- disciplinary professionals from transportation, quality and regulatory departments including: of Biologics and Biological Agents Logistics & Transportation Vice President / Director / Manager / Engineer / Analyst of Logistics • Transportation • Packaging • Global transportation • Supply chain management • Warehouse and storage • Material management • Clinical supplies • Dear Colleagues, Quality Assurance Vice President / Director / Manager / The expansion of global clinical trial Engineer / Analyst of s, manufacturing and distribution , along with the rapid growth of the Quality management biotech and biopharma industry, is • demanding agile global supply cha in management and advanced Quality control/quality assurance • technologies for the transport of ever increasing quantity of Material quality and integrity • temperature-sensitive materials. Com Sample management plicated transport routes with • different temperature environmen t, global and regional regulatory Specimen management • discrepancies and emerging cargo security concerns are posing new Clinical supplies • challenges throughout the transpo rtation and supply chain management. Regulatory & Compliance Vice President / Director / Manager / PharmaIQ continues to listen to the Engineer / Analyst of market to keep up with the industry pulse and proudly presents Regulatory affairs • the 4th Transportation and Transfer of Biologics and Biological Agents Global regulatory • Conference to bring along both regulatory speakers and leading prac Compliance • titioners to exam various factors in the supply chain to avoid costly dela Clinical supplies • ys and product damage. Join us in San Francisco this May Co-Located with the 9th to learn from and network with you r peers from the biopharma, pharma Contract Manufacturing , logistics, packaging and transportation industries. We look forward to meeting you there! Conference Highlights Analyzing the CMO Market: Tools for • Choosing a Preferred CMO Maximizing your Understanding the Impact of an Economic • Downturn on Overseas Outsourcing learning by attending Cathy Gu Execution of Multiple Outsourcing Projects • Conference Director, Pharma IQ Influencing the Ability to Sustain Validation • interactive pre-conference and Process Compliance – Post CMO IQPC Collaboration workshops! Cathy.gu@iqpc.com Understanding the Essential Elements for • Successful Technology Transfer Addressing Product Quality Issues • Register Today! www.iqpc.com/us/CM www.iqpc.com/us/transport 2
    • Main Conference Day One Tuesday, May 12, 2009 Regulations & Compliance Supply Chain Optimization & Consolidation Registration and Coffee Panel Discussion: Successful Selection and 8:00 1:00 Implementation of Temperature Controlled Pallet Welcome Remarks from Chairperson Containers 8:45 Bulk and pallet sized temperature sensitive shipments are increasingly Meeting the Requirements from Department of 9:00 playing a larger role in the distribution of API, biologics, vaccines and Transportation other pharma articles. Whether deciding to use active or passive pallet Effectively packaging, labeling and documenting hazardous shippers to control temperature, experienced users know they need to • materials according to 49 CFR Part 72 be prepared to use a shipping system that has met thermal and physical • Explaining international shipping standards qualifications, provide JIT and simplified packout, meet distribution • Discussing the enforcement efforts to ensure compliance logistical requirements, and reduce costs and risks by mitigating the field • Getting up to date with dry ice shipping regulation specifications support required to properly get product distributed around the globe. Patricio F. Romero, Transportation Specialist, Hazardous Listen to three companies who are tops in the fields: pharmaceutical Materials Safety Assistance Team -Western Region, Pipeline manufacturing, clinical services and cold chain logistics discuss their and Hazardous Materials Safety Administration, U.S. decision making process as they determine critical factors to temperature Department of Transportation controlled pallet system success. Special Acknowledgement: Eileen Edmonson, Pipeline and • Discussing the challenges of temperature controlled pallet Hazardous Materials Safety Administration, U.S. Department of shipping qualification, packout and field support Transportation • Understanding what are the key factors for the selection of appropriate shipping system and container IATA Dangerous Goods Regulations Updates 9:30 • Streamlining the decision making process and minimizing Providing background information on IATA and understand the risks • basis of the Dangerous Goods Regulations Scott McCurdy, Clinical Distribution Supervisor, ALMAC Group • Discussing the importance of proper packaging for ensuring Karen Oliver, Director Global Accounts, World Courier, Inc safe transport of biological substances With Panelist from Novartis • Exploring the latest requirements for safely transporting lithium International Focus: Import/Export Shipping batteries and the impact on cold chain temperature monitoring 1:45 Challenges process Isabel Molina, Manager, Cargo Standards, International Air A lot of the challenges of supply chain optimization lie in the Transport Association (IATA) import/export procedures and most of the time it's not the U.S customs but more obstacles from other customs. How to know Understanding the Requirements and 10:00 better about the customs operations outside of the U.S is key to Operations from the US Customs to Ensure avoid the delay. In this session, global customs regulations and Cargo Security and Supply Chain Integrity requirements will be explored and discussed and best practices Identifying the sources of customs delays and developing will be shared. • strategies to overcome them Xiaomi Tong, Senior Director of Regulatory Affairs, • Working with governments to minimize faculty interpretations Emergent Biosolutions of import and export documentation Afternoon Networking Break • Discussing anti-counterfeiting issues and challenges 2:30 SS/A Craig S. Thurber, Dept of Homeland Security, ICE Case Study: Developing and Streamlining National Intellectual Property Rights Center, U.S 3:00 Packaging, Validation and Transportation Department of Homeland Security Strategies to Build Reliable Global Biologic Supply Morning Networking Break Chain 10:30 In this panel case study, key members from Genentech Pack to Understanding CDC’s Oversight Involving 11:00 Ship Reliability Key Focus Area project will share critical factors in Transfers of Agents various aspects of the transportation process from packaging, Explaining the requirements of 42 CFR 71.54 - importation shipping and regulation compliance to achieve operation • Explaining the transfer requirements of Select Agent excellence and ultimate reliability in global biologic supply chain. • Regulations - 42 CFR 73 • Packaging • Challenges involving transfer of agents • Quality Assurance Lori Bane, Compliance Officer, CDC Division of Select • Global Transportation Agents and Toxins Lisa Mazzoni, Associate Director of Logistics, Genentech Irina Kasatkina, Associate Director, Quality Assurance, Getting Up to Date with TSA Regulations to 11:30 Genentech Get through the Checking Points and Avoid Potential Delays Case Study: Best Practices of Setting up 3:45 Protocols & Procedures for Blood Transportation Examining the primary security threats from TSA Air Cargo • • Discussing TSA’s multi-layered approach to air cargo security Understanding the global blood regulations – domestic and • • Explaining the main screening milestones international • TSA screening program update with industry participation • Studying the major guidelines to ensure compliance Invited Speaker: Ed Kelly, Air Cargo General Manager, TSA • Overcoming the temperature control challenges • Developing and executing protocols for the entire supply chain Networking Luncheon with Government 12:00 to ensure safety and efficiency Speakers Boriana Cavicchia, Manager, Systems Quality, Biomedical Services, American Red Cross End of Day One 4:30 www.iqpc.com/us/transport 3
    • Main Conference Day Two Wednesday, May 13, 2009 Supply Chain Security & Temperature Control Morning Networking and Coffee Learning RF hardware and supporting infrastructure 8:00 • Exploring implementation issues and challenges • Remarks from Chairperson • Specifying Time Out of Refrigeration (TOR) and Mexico goal details 8:45 • Developing general pilot protocol Mitigating Operational Risks and Assuring Cargo • Sharing RF-Pilot Results 9:00 Security Scott Rasmussen, GPO Distribution QA, Abbott Laboratories Minimizing the potential for damage during transport through • Lunch 12:30 comprehensive security processes and procedures • Understanding the development process necessary to ensure an Case Study: Creating the Cold Chain for a New 1:30 effective security strategy Commercial Company • Developing effective tracing and tracking strategies to protect Factoring in regulatory environment for cold chain development shipments and eliminate vulnerabilities • Considering multiple factors during the selection of shipping solutions: • Examining and leveraging various technologies • temperature profiles, duration, security etc. Invited speaker: Charlie Bennett, Director, Global Logistics • Leveraging active and passive temperature control in different Operations and Sourcing, Wyeth Pharmaceuticals situations Case Study: Examining the Impact of Packaging and • Assuring compliance through validation simulation programs 9:45 Transportation on Supply Chain Cold Chain Integrity Al Forthman, Logistics Manager, Human Genome Sciences Discussing the role of appropriate packaging and transportation • Addressing the Ambient Temperature Transportation 2:15 handling in the supply chain to maintain Cold Chain Integrity and Storage Understanding different packaging requirements for temperature • Understanding what is ambient temperature and what’s the impact of controlled substances • ambient temperature on your biologics product • Choosing your packaging solutions and vendors to ensure quality • Addressing the challenges of ambient temperature control • Analyzing specific challenges in the US Military Supply Chain • Developing best practices on ambient temperature transportation and Dana Dallas, Cold Chain Vaccine Manager and Packaging Analyst, storage Defense Logistics Agency Please visit website for speaker updates: Morning Networking Break www.iqpc.com/us/transport 10:30 Afternoon Networking Break Protecting Temperature Sensitive Products 3:00 11:00 throughout the Cold Chain to Minimize Product Loss Managing Shipping Challenges in a University and Business Impact 3:30 Setting: A Michigan State University Case Study Understanding your cold chain challenges • Generally speaking, shipping biological materials in a university setting • Considering multiple factors during the selection of shipping solutions: requires the cooperation of several departments or processes. temperature profiles, duration, security etc. Communicating these processes to thousands of researchers and • Leveraging active and passive temperature control in different associates becomes the most formidable challenge facing shipping and situations regulatory personnel. The following case study involves the shipping • Comparing LN2 vs. generator transport processes that occur at Michigan State University (MSU) and will include: • Case study on dry shipper work flow • Description of the processes required to ship 6.2 dangerous goods, • Optimizing cold chain with advanced technologies patient specimens and GMO’s at MSU • Forecasting cold chain transportation industry direction • Methods of communication used to present processes to the Bruce C. Simpson, Senior Director, Commercial Operations, Fisher University’s research community BioServices, Thermo Fisher Scientific • Shipping successes and failures (including corrective actions) Karl Schlenker, Vice President, Minnesota Thermal Science, LLC Dr. Jamie Sue Willard-Smith, Biological Safety Officer, Select Pilot Case Study: RF Enabled Temperature Agent Responsible Official, Michigan State University, EHS/ORCBS 11:45 Monitoring End of Conference 4:15 Studying RF and RF-enabled temperature monitoring devices • Understanding why do the pilot and what were the goals • About Our Sponsors Minnesota Thermal Science, LLC develops unique storage and shipping systems that Cold Chain Technologies is a leading source for engineering-based thermal address the challenges of maintaining constant and predictable temperatures when packaging solutions. For almost 40 years, we’ve continued to excel in providing transporting temperature sensitive medical materials. Founded in 2004 following an efficient, cost effective thermal packaging products and services to a wide range of industry wide search by the Walter Reed Army Institute of Research for a more effective combat customers – from local start-ups to Fortune 100s. Pharmaceutical, biotech, healthcare, medical device, environment container, MTS has continued to apply its technology to handle other important medical and food service companies count on us to solve their cold chain challenges. Distributed from multiple materials including all types of biomaterials and pharmaceuticals that require controlled temperatures Its locations throughout the U.S. and internationally, our product line includes KoolTempTM insulated patent pending Golden Hour® Technology, winner of a quot;U.S. Army Greatest Inventionsquot; award, is containers, Koolit® refrigerants, and KoolWatchTM temperature indicators. Cold Chain Laboratories, credited with saving soldier's lives on the battlefield and with revolutionizing the methods used for our affiliated company, is a premier source for expert design and qualification testing of thermal distributing temperature sensitive medical supplies. Website: www.goldenhourtechnology.com packaging solutions. Website: www.coldchaintech.com Pioneer and market leader Envirotainer offers flexible leasing (rental) of LifeConEx is a joint venture between DHL Global Forwarding and Lufthansa Cargo advanced transport solutions for worldwide air cargo shipments of founded in 2005. LifeConEx is the only industry specific global provider of end-to- temperature-sensitive products. Customers within the healthcare, life sciences, food and high-tech end temperature controlled transportation solutions for Life Sciences Industry. We industries benefit from the combination of advanced container technology, extensive cold chain systematically integrate and rigorously measure all supply chain partners to ensure management services and a global network of service partners, airlines and forwarders - providing a the proper storage, handling and distribution of temperature-sensitive medicinal products, delivering unique one-way leasing service. Envirotainer secures the safety and integrity of product cold chains by fewer delays, shorter cycle time, fewer temperature deviations, less damage, and far fewer claims than providing an active temperature-control system, training all parties along the cold chain and supporting typically experienced by shippers. customers in transport validations and risk management. Website: www.envirotainer.com World Courier has set the benchmark for worldwide time & temperature Sensitech - The leading provider of cold chain visibility solutions that enable our sensitive transportation. We remain the only specialist courier company with customers to track and monitor assets across the supply chain, protecting the its own global company network. Each office ISO 9001 certified with the quality, efficacy, and integrity of their temperature-sensitive products. Our product same operating standards dedicated to treating every shipment on an individual, priority basis. World portfolio includes comprehensive analytic services, enterprise software systems and Courier is utilized in approximately 80% of the world’s clinical trials requiring the use of a specialty validated data acquisition devices. We address our customers’ most complex perishable cold chain courier. With experience in managing the logistics of over 7,500 clinical trials worldwide, we are the problems and deliver powerful insights that drive measurable process improvement. Sensitech supports acknowledged experts in handling temperature-sensitive specimen and drug shipments. Website: cold chain monitoring programs in 18 of the top 20 multi-national pharmaceutical companies and 9 of www.worldcourier.com the top 10 biopharmaceutical companies. Sensitech is a business unit of Carrier Corp. www.iqpc.com/us/transport 4 Website: www.sensitech.com
    • Pre-Conference Workshops Sponsorship and Exhibition Opportunities Monday, May 11, 2009 Sponsorships and exhibits are excellent A opportunities for your company to showcase its 8:00 am – 11:00 am Registration 7:45am (Breakfast included) products and services to high-level, targeted Risk Based Approach to Look at Temperature Sensitive Transportation decision-makers attending the Transportation & Challenges Transfer of Biologics and Biological Agents. The temperature control is the key to maintain How will you benefit: IQPC and Pharma IQ help companies like yours the cold chain and keep the product efficacy. In • Understanding and avoiding the pitfalls during achieve important sales, marketing and this workshop, we are taking a risk based your cold chain transport branding objectives by setting aside a limited approach to examine the challenges in • Mitigating risks by taking full control of the number of event sponsorships and exhibit temperature recording and control throughout process spaces – all of which are customer-tailored to the transport and transfer. • Learning the best practices to build up efficient assist your organization in creating a platform to and risk free cold chain maximize its exposure at the event. What will be covered: • Examining the main risks in the temperature Your workshop Leader: For more information on sponsoring or excursion Henry Ames, Director, Strategic Marketing - exhibiting at the Transportation & Transfer of • Understanding the challenges from ambient Life Sciences, Sensitech Biologics and Biological Agents, please contact temperature Mario Matulich at (866) 232-8660 or • Looking at the cargo cabinet temperature environment and the impact sponsorship@iqpc.com. • Effective and proper packaging for better control • Searching new methods for temperature End User Pricing monitoring and control Register By Register Register Standard By 3/13/09 By 3/27/09 By 4/17/09 Price (save $500) (save $400) (save $400) Conference Only $1,299 $1,399 $1,599 $1,799 (save $1,200) (save $1,000) (save $700) (save $250) B 11:15am – 2:15pm Registration 11:00am (Lunch included) All Access Pass $2,246 $2,446 $2,746 $3,196 Addressing the Costs of “Non-Quality” in Life Sciences Logistics for Workshops Only $549 each $549 each $549 each $549 each Temperature Sensitive Products Content Package $699 $699 $699 $699 The explosion and globalization of biotech and How will you benefit biopharma industries have triggered a significant • Building up efficient supply chain to mitigate Vendor Pricing growth of international shipment of biological risk, ensuring product safety and patient safety Register Register Standard materials. New challenges are arising accordingly. • Developing comprehensive end-to-end solutions By 3/27/09 By 4/17/09 Price In this session, these challenges and the potential to protect your materials and your patients (save $800) (save $400) costs presented by these challenges will be • Quantify the benefits to your organization of Conference Only $1,999 $2,399 $2,799 examined and participants will share practical robust, quality-focused solutions (save $1,000) (save $700) (save $250) suggestions on providing end-to-end solutions All Access Pass $3,446 $3,746 $4,196 and protection during your cold chain transport. Your workshop Leader: Workshops Only $549 each $549 each $549 each John Liebe, Director of Sales, North What will be covered? America, LifeConEx, LLC Content Package $699 $699 $699 • Examining the security concerns and scrutiny from global regulatory authorities Please note that multiple discounts cannot be combined. • Looking into larger biosafety issues Team Discounts For information on team discounts, please contact • Analyzing the direct and indirect costs in IQPC Customer Service at moving temperature-controlled biologics 1-800-882-8684. Only one discount may be applied per registrant. globally Special Discounts Available: A limited number of discounts are available for the non-profit sector, government organizations and academia. For more information, please contact customer service at 1- 800-882-8684. Discounts valid for qualified executives involved with remote device C 2:30pm – 5:30pm Registration 2:15pm monitoring and service only. Discounts are taken off the full conference Meeting Transport Service Provider Obligations for Managing price only and do not apply to workshop only registrations. No two discounts can be combined. IQPC reserves the right to qualify your Temperature Sensitive Shipments registration before applying your discount. Other includes: Solution Providers, Consultants, or any third party This workshop reviews the latest changes to How will you benefit: vendors that partner with or provide services to organizations. IQPC industry guidance and the implication for • Understanding the key regulations and maintains the right to enforce pricing based on company type. transport service providers. Meeting the industry’s standards for transport service providers A $99 processing charge will be assessed to all registrations not accompanied by credit card payment at the time of registration. requirements for an effective quality management • Utilizing various quality management tools for system is discussed in detail with a case study of process control MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC * CT residents or people employed in the state of CT must add 6% sales tax. an approach taken by a platform provider to • Learning how to improve service provider Details for making payment via EFT or wire transfer: ensure effective management of the solution. capabilities from hands-on case studies JPMorgan Chase Penton Learning Systems LLC dba IQPC: 957-097239 What will be covered: Your Workshop Leader: ABA/Routing #: 021000021 • Review of current industry guidance (PDA Christopher Fore, Technical Support Reference: Please include the name of the attendee(s) and the event number: 12928.002 Technical Report # 39/IATA Perishable Cargo Manager, Envirotainer, Inc. Payment Policy: Payment is due in full at the time of registration and Manual) includes lunches, refreshment and detailed conference materials. Your • Gauging service provider capabilities – registration will not be confirmed until payment is received and may be QMS/process control subject to cancellation. • Developing a Quality Management System For IQPC’s Cancellation, Postponement and Substitution Policy, • Creating one vendors model – Envrotainer QEP please visit www.iqpc.com/cancellation • Case study – TBD Venue: Please see the website for the most up-to-date information on the event venue. Special Dietary Needs: If you have a dietary restriction, please contact Customer Service at 1-800-882-8684 to discuss your specific needs. ©2009 IQPC. All Rights Reserved. The format, design, content and www.iqpc.com/us/transport arrangement of this brochure constitute a trademark of IQPC. 5 Unauthorized reproduction will be actionable under the Lanham Act and common law principles.
    • International Quality & Productivity Center REGISTRATION CARD 535 5th Avenue, 8th Floor New York, NY 10017 YES! Please register me for 4th Transportation & Transfer TM of Biologics and Biological Agents ❑ Conference Only ❑ Conference + 1 Workshop ❑ Conference + 3 Workshops ❑ Workshop Only ❑ Conference + 2 Workshops See Page 5 for pricing details. Your customer registration code is: When registering, please provide the code above. Name__________________________________ Job Title ________________________ Organization____________________________________________________________ Approving Manager______________________________________________________ Address_______________________________________________________________ City__________________________________State______________Zip___________ Phone________________________________Fax_______________________________ 5 EASY WAYS TO REGISTER: E-mail__________________________________________________________________ ❑ Please keep me informed via email about this and other related events. Web: www.iqpc.com/us/transport 1 ❑ Check enclosed for $_________ (Payable to IQPC) 2 Call: 1-800-882-8684 or 1-646-378-6026 ❑ Charge my __Amex __Visa __Mastercard __Diners Club Email: info@iqpc.com 3 Card #____________________________________Exp. Date___/___ Fax: 1-646-378-6025 4 5 Details for making payment via EFT or wire transfer can be found on Mail: IQPC preceding page. 535 5th Avenue, 8th Floor, New York, NY 10017 ❑ I cannot attend, but please keep me informed of all future events. 12928.002/D/AS Register by 3/27/09 and save up to $1000 4th Transportation & Transfer TM Understand Regulations and Manage of Biologics and Risks Proactively to Elevate Supply Chain Integrity and Material Efficacy Biological Agents May 11 – 13, 2009 • San Francisco, CA