Understand Key Requirements and Standards from Major Regulatory and Government Agencies • Overcome International Shipping Challenges for Temperature Sensitive Products • Obtain technologies and techniques to maintain cold chain to ensure product efficacy • Key insights of material transfer and permit • Mitigate Operational Risks and Assuring Cargo Security • Explore RF Enabled Temperature Monitoring

1. 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:
Register Today! Call Sam Eid at 416-597 4719 or e-mail: sam.eid@iqpc.com

2. 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! Call Sam Eid at 416-597 4719 or e-mail: sam.eid@iqpc.com
2

3. 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
Register Today! Call Sam Eid at 416-597 4719 or e-mail: sam.eid@iqpc.com
3

4. 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.
4 Website: www.sensitech.com

5. 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
S
Sam Eid at 416-597 4719 or e-mail:
• Looking at the cargo cabinet temperature
environment and the impact sam.eid@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
Sam Eid at 416-597 4719 or e-mail: sam.eid@iqpc.com.
moving temperature-controlled biologics
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 Sam Eid 416-5974719
or e-mail: sam.eid@iqpc.com.
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
Register Today! Call Sam Eid at 416-597 4719 or e-mail: sam.eid@iqpc.com arrangement of this brochure constitute a trademark of IQPC.
5
Unauthorized reproduction will be actionable under the Lanham Act and
common law principles.

6. 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_______________________________
3 EASY WAYS TO REGISTER:
E-mail__________________________________________________________________
❑ Please keep me informed via email about this and other related events. 1 E-mail: sam.eid@iqpc.com
❑ Check enclosed for $_________ (Payable to IQPC) 2 Call: 1-416-597 4719
❑ Charge my __Amex __Visa __Mastercard __Diners Club Fax: 1-416-598 7934
3
Card #____________________________________Exp. Date___/___
Details for making payment via EFT or wire transfer can be found on
preceding page.
❑ 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