6th Annual Cold Chain Distribution for Pharmaceuticals

Gaining Greater Control of Your Global Cold Chainand Ensuring International Regulatory Compliance

The World's Largest Global Forum for ColdChain Specialists - Sold Out in the US, UK,Belgium, Brazil, Singapore and Germany

September 22-25, 2008Philadelphia Convention Center • Philadelphia, PA

Register Today: Call 1-800-882-8684 • www.coldchainpharma.com

for PharmaceuticalsDistributionCold Chain Cold Chain

Register by 7/11/08

and SAVE $400

Gain InternationalInsights from:

Rafik H. Bishara, PhDTechnical Advisor and ChairPharmaceutical Cold Chain Interest Group(PCCIG) USA Branch, PDA

Ian HollowayManager, Defective Medicines ReportCentreMHRA

Gwyn MurdochManager, Distribution Quality ComplianceEli Lilly

Harold RodeChief, Pandemic Influenza Division,Biologics and Genetic TherapiesDirectorateHealth Canada

Dr Mary FosterUSP Packaging and Storage ExpertCommittee MemberUS Pharmacopeia (USP)

Nathan HabeckePedigree Initiative Program ManagerBaxter Healthcare

Brad ElrodManager, Global Logistics & SecurityPfizer

Geoffrey GlauserDirector Cold Chain Technology, BiotechTechnology & Engineering - Drug Product,Wyeth Pharmaceuticals

Allen NapetianDrug Product Finishing Associate Director,Genentech

BRAND NEW!Only at Cold Chain Distribution 2008 Will You Benefit from:

• Discussions on ePedigree Compliance & the impact of theimminent state and FDA deadlines

• Views & guidance from 6 International Regulatory Agenciesincluding: MHRA, Health Canada, USP, GS1, PCCIG and U.S. Customs

• A choice of 11 workshops relevant to your evolving Cold Chain

• A look at managing an international Cold Chain & expanding intoemerging markets

• 1 intensive Master Class on “Re-Engineering the Cold Chain” bySanofi Pasteur

• 4 newly focused tracks on Cold Clinical Supplies, ePedigree &Packaging, Qualifying Your Cold Chain, and Supply Chain and the‘Last Miles’

Sponsors:

TM

6th Annual Global Forum

PS: Donlt miss your opportunity to get

up-to-speed with TODAY lS critical

issues during the interactive pre /

mid conference workshops. Choose from

11 new workshops!

PLUS –Maximize your time out

of the office by

attending the post-

conference full-day

Master Class

‘Re-Engineering Your

Cold Chain

Management’, led by

Sanofi-Pasteur. (See

page 12 for the agenda.)

Regulatory Expectations Plenary Sessions . . . . . . . . . . . . .5

ePedigree and Packaging Track . . . . . . . . . . .5-6

Cold Clinical SupplyOperations Track . . . . . . . . . . .5-6

Networking Roundtable Discussions . . . . . . . . . . . . . . . . .6

International Cold Chain Plenary Sessions . . . . . . . . . . . . .7

Qualifying Your Cold Chain Track . . . . . . . . . .7-8

Supply Chain Management & ‘Last Miles’ Track . . . . . . . .7-8

Pre / Mid Conference Workshop Programs . . . . . . . . . . . . . . .9-11

Sanofi-Pasteur Master Class Agenda . . . . . . . .12

About Sponsors and Exhibitors . . . . . . . . . .13-14

Pricing and Registration Information . . . . . . . . . . . . . . .15

Cold Chain Distribution for PharmaceuticalsCold Chain Distribution for Pharmaceuticals TM

Table of Contents:

2 Register Today: Call 1-800-882-8684 • www.coldchainpharma.com


Dear Colleague,

It’s been a pleasure speaking with many of you during the planning of this year’s Cold Chain Distributionfor Pharmaceutical conference program. The positive feedback to the annual industry gathering inPhiladelphia has been encouraging and a fantastic foundation for the 2008 event!

The 6th Annual Global Forum is the largest, most comprehensive temperature control forum forbiopharmaceutical professionals, with 300+ peers in Supply Chain, Distribution, QA, Regulatory,Transportation, Packaging and Security attending this event each year.

All new, for you – Cold Chain Distribution for Pharmaceuticals 2008!

To bring fresh and innovative content to the 2008 program, we’ve been consulting with you and yourindustry peers to understand the critical issues facing the industry right now and for the future.

New 2008 sessions include:

• Planning International Supply Chains & Overcoming Custom Challenges – With a Close Look at India andOther Emerging Markets

• Improving Supply Chain Visibility by Implementing Mass Serialization & Updating Your ePedigreeCompliance

• Understanding What it Takes to Control Products During the "Last Miles"• Standardizing Packaging Validation & Using Green Packaging • Meeting International Regulations for the Cold Chain• Overcoming the Specific Challenges to Cold Clinical Supplies for International Trials • Implementing Process Improvement Opportunities to Minimize Temperature Deviations and Streamline

End-to-End Operations

Plus don’t miss this annual opportunity to discuss regulatory expectations and industry best practices withkey international leaders and industry partners speaking at Cold Chain Distribution 2008, including:

• Health Canada… are you conducting the right validation studies for -20°F?• Medicines Healthcare Regulatory Agency (MHRA)… getting cold clinical supplies right• U.S. Customs and Border Control… avoiding custom delays during international trade • United States Pharmacopeia (USP)… implementing the final <1079> Chapter• GS1… taking direction for industry best practice mass serialization and ePedigree• PCCIG…industry best practices for today’s cold chain• …plus numerous industry case studies

Don’t miss the chance to attend the year’s premier cold chain event. It’s the ideal networkingopportunity to meet with regulators, academia, top industry leaders and partners of cold chain solutions.

The speakers, sponsors and Pharma IQ team look forward to seeing you in September in Philadelphia forthe Cold Chain Distribution for Pharmaceuticals 2008 conference.

Sincerely,

Courtney Becker-JamesConference DirectorPharma IQ, a division of IQPCwww.coldchainpharma.com [email protected]

Choose from Workshop I or J or K

Seniority

■ 42% Manager ■ 26% Director ■ 10% President ■ 9% Specialist ■ 6% Vice President■ 6% Team Leader/Supervisor ■ 1% CEO

Function

■ 21% Global/Regional Supply Chain ■ 18% QA and Validation ■ 14 % Logistics/Distribution/Transport ■ 12% Clinical Trial Supply ■ 10% Packaging Engineer ■ 8% Regulatory Affairs and Compliance ■ 7% Marketing and Sales ■ 6% Materials Management ■ 2% Cold Chain Management ■ 1% Supply Sourcing ■ 1% Customer Service

Industry

■ 64% Biopharmaceutical Manufacturer

■ 13% Technology Providers ■ 10% Medical Device and

Diagnostic ■ 9% Transport Providers ■ 5% Government Officials ■ 1% Nutraceuticals

Who will attend:

Choose from Workshop A or B

Choose from Workshop C or D

Choose from Workshop E or F

Choose from Workshop G or H

A8:00 am – 11:00 am Breakfast will be servedQuality by Design – What it Means to the Cold ChainNeritan Mustafa, Life Sciences Program Manager, Sensitech

B 8:00 am – 11:00 am Breakfast will be servedMaster Course for Today’s Packaging EngineersGeorge Flora, President, Minnesota Thermal Science

E 2:30 pm – 5:30 pmCritical Designing, Evaluating and TestingTemperature Sensitive Product PackagingAnthony Alleva, Project Engineer & Mike Paterno, ProjectManager, TCP Reliable

F 2:30 pm – 5:30 pmBest Practices in Temperature-ControlledTransportationKarl Kussow, Manager Quality and Validation, FedEx CustomCritical

G 5:45 pm – 8:45 pm Dinner will be servedHow to Meet GMP and GDP Regulations UsingTemperature Monitoring SolutionsMartina Brennan, National Sales Manager, ColdTRAKCharles Craig, Validation and Technical Engineer, DeltaTRAK

H 5:45 pm – 8:45 pm Dinner will be servedTemperature Mapping, Supply Chain Planning andSpeciality Logistics for International Clinical TrialsTony Mistretta, Distribution Manager, ALMAC GROUP

I 6:45 pm – 9:00 pm Dinner will be servedReusable Packaging in the Cold ChainDr. John Pring, CEO, Control Quality SystemsChris Pollard, CEO, KryoTrans International Ltd.

K 6:45 pm – 9:00 pm Dinner will be servedSecurity Challenges and Tools for the Cold ChainPhil Viggiani, V.P. Sales & Marketing, IDGLOBAL Corp.

J 6:45 pm – 9:00 pm Dinner will be servedIndustry Best Practice Trailer Thermal MappingAccording to Technical Report 39Kathy Denholm, Director, Life Sciences & PharmaceuticalIndustry, Panther Expedited Services, Inc.

C 11:15 am – 2:15 pm Lunch will be servedOutsourcing Your Cold Chain Project Management:Opportunities & Strategies for SuccessRobert (Bob) Bohne, VP, General Manager, Cold Chain TechnologiesJeff Simpson, Director of Engineering & Technical Services, ColdChain TechnologiesAnthony Rizzo, Project Manager, Cold Chain TechnologiesJim Nilsen, Project Manager, Cold Chain Technologies

D 11:15 am – 2:15 pm Lunch will be servedRevelations in Heat TransferRob Abramovitch, General Manager, Insulation, PolyairBrian Martin, VP, Consumer Markets North America, PolyairRudy Ponce, Sr. Director of Marketing, Polyair

3

Pre-Conference Workshops • Monday, September 22, 2008

Mid-Conference Workshops • Tuesday, September 23, 2008

Acambis

Accredo Health - Medco

Agensys Inc.

Air Canada Cargo

Alexion Pharmaceuticals

Almac Group

Althea

AmerisourceBergen Corp.

Amylin Pharmaceuticals Inc

Anchorage Economic DevelopmentCorporation

Andlauder Transportation Services

Anesiva Inc

Arteragen

ATS Andlauer Transportation Services

Auxilium Pharmaceuticals Incorporated

Baxter Healthcare

Baxter Pharmaceutical Solutions

Bilcare Inc

BioCair, Inc.

Biogen Idec

BioMerieux Inc

Boston Scientific

Bristol Meyers Squibb

Burris Logistics

Calea Ltd.

Cardinal Health

Cavalier Logistics

Celgene

Centeror

Charles River Laboratories Inc.

Cold Chain Technologies

Covidien Health Care

CSL Behring

Dallas Semiconductor Corp

Dayton

Defense Supply Center Philadelphia

Dendreon Corp

Dentsply Pharmaceutical

Discovery Labs.

Eli Lilly

Elpro Services

Envirotainer

Ernest Paper Products

Escort Data Loggers Inc

Expeditors - Healthcare Industry Group

Express Scripts

FedEx Custom Critical

Fisher Bio Services

Fisher Clinical Service Inc

Frontier Paper

Gen Probe

Genetech

Genzyme Corporation

Great Point Partners

Green Capital Consulting LLC

Health Canada Drug Distribution Center

Hospira Healthcare Corp

Immunogen Inc

Iris Diagnostics Inc.

J&J Centocor

Johnson and Johnson Sales and LogisticsCo. LLC

Kodiak Thermal Technologies

KryoTrans International

Kuehne & Nagel, Inc.

Laminar Medica

LifeConEx LLC

Madgetech Inc

MannKind Corporation

McKesson Canada

Medco Health Services

Medtronic Spinal & Biologics

Merck & Co. Inc.

Merial

MGI Pharama

MicroDAQ.com,Ltd

Midnite Express

Minnesota Thermal Science

Mirsalcom Transport & Delivery Services LLC

Motorola Inc.

Nadro

Nanocool

Neose Technologies

Novartis Animal Health Us Inc

Packaging Products Corp

Paddock Laboratories Inc.

PANTHER Expedited Services

PDL BioPharma

Pfizer Inc.

PharmaCare Specialty Pharmacy

Pharmaceutical Partners of Canada

Plastilite Corp

Polyair

Rand Whitney Container

RatioPharm

Remel Inc

Rite Aid

Roche Diagnostics Operations Inc

Roche Molecular Systems

Sanofi Pasteur

Schering Plough Corporation

Schwarz Biosciences

Sealed Air Corp.

Sensitech

Sepracor

Shire Human Genetic Therapies

Talecris Biotherapeutics Inc.

TCP Reliable Inc

Tegrant Thermosafe Brands

Temp Time Corp

Tempcell

Tunnell Consulting

UPS Customer Solutions

US Pharmacopeia

Valsource Inc.

Walgreens- Medmark Inc

Watson Pharmaceuticals

World Courier

Wyeth Biotech

Wyeth Pharmaceuticals

Wyeth Research

Xanodyne Pharmaceuticals Inc

ZLB Plasma

121 different companies attended Cold Chain Distribution 2007


Very good speakers

and subject matter

and was filled with

information rather

than basic concepts.

- Logistics Project

Manager, Bilcare Inc.

Very informative!

- Stability Project

Analyst, Merck & Co

Information was

very valuable

– Director, Global

Logistics, Bilcare Inc.

Excellent info and

great presentations

– Packaging Engineer,

Remel

7:00 Breakfast & Registration

7:45 Pharma IQ Welcome

7:50 Opening Remarks from the ChairpersonRafik H. Bishara, PhD, Technical Advisor and ChairPharmaceutical Cold Chain Interest Group (PCCIG) USA Branch,PDA

8:00 MHRA Regulatory Feedback - Ensuring YourProducts Comply With European TemperatureControl Regulations From Clinical Materials toMarketed Products• Comparing MHRA regulations with other European National

Agencies – Are U.S. companies on the right track to complyacross Europe?

• Gaining a European regulatory view on how industries cangain more control of temperature-sensitive products furtherdownstream in the cold chain

• Clinical materials – What are the Regulators concerns andexpectations?

• Describing what information and how much should beincluded in quality reports and risk assessments

Ian Holloway, Manager, Defective Medicines Report Centre,MHRA

9:00 Meeting Canadian Regulatory and InspectionRequirements for Temperature SensitiveProducts• Understanding the feedback from recent audits on how to

show evidence of compliance: Are you conducting the rightvalidation studies for -20°F?

• Describing stability studies and data that work• Recognizing how manufacturers can assist the Canadian

Provinces when there is a cold chain breachHarold Rode, Chief, Pandemic Influenza Division, Biologics andGenetic Therapies Directorate, Health Canada

9:45 Morning Networking & Refreshment Break

10:30 The Final Updated Revisions to GeneralChapter 1079: Practical Guidance to UpdatingYour Cold Chain Management• Explaining recommended control strategies – from warehouse

through end-user• Describing specific protocols for receiving, shipping and

storing – when, how and how much• Following the tables in the updated guidance to make the

right choices in your cold chain management • Understanding the updated SOPs and how to implement

them Dr Mary Foster, USP Packaging and Storage Expert CommitteeMember, US Pharmacopeia (USP)

11:15 Panel Discussion: Understanding Current andFuture Regulatory Expectations for the ColdChain• Reviewing global regulatory concerns • Understanding the impact of outsourcing manufacturing on

the cold chain • Controlling and working with Controlled Room Temperatures

Ian Holloway, Manager, Defective Medicines Report Centre,MHRA

Harold Rode, Chief, Pandemic Influenza Division, Biologics andGenetic Therapies Directorate, Health Canada

Dr Mary Foster, USP Packaging and Storage Expert CommitteeMember, US Pharmacopeia (USP)

Rafik H. Bishara, PhD, Technical Advisor and ChairPharmaceutical Cold Chain Interest Group (PCCIG) USA Branch,PDA

12:15 Lunch and Networking for Speakers &Delegates

1:15 Gearing up for International Harmonization ofSerialization and RFID Data and Practices inHealthcare• Understanding GS1 recommendations for serialization• Working toward harmonization of RFID and Bar Code data• Providing sensor (temperature) data through the EPCIS standard• Gaining an up-to-date understanding of how industry standards

for serialization are working toward compliance of US ePedigreelaws and deadlines

Bob Celeste, Director, Healthcare, GS1 US / EPCglobal NorthAmerica

Main Conference Day OneMain Conference Day One

Track A – ePedigree & Packaging

Concurrent Tracks

Tuesday, September 23, 2008

5

Track B – Cold Chain Supply Operations

1:15 Case Study – Managing Temperature SensitiveClinical Supplies for International Clinical Trials • Evaluating the risks of shipping longer distances to specific

countries• Calculating probability for product loss and overage to

determine optimal quantities of shipments• Implementing strategies for each eventuality – custom delays in

certain countries, various regional temperature profiles andfactoring timelines for raw materials

• Defining methods for improved monitoring and temperaturemapping of longer distance shipments for clinical trials

• Improving project management aspects of international coldclinical operations

C. Ray Goff, Jr., Director, Vaccine R&D, Wyeth Research

3:30 Afternoon Refreshments

A) ePedigree in the Cold Chain: Exchanging Strategies with Other Companies to Decide Next Steps

B) Process Improvements in Transportation: Using Your Knowledge, Science and Standards to StreamlineYour Transportation ProcessRoundtable Leader: Jim Bacon, Director, Global DemandPlanning & Customer Operations, Talecris Biotherapeutics

C) FDA Audits: What Are the Transportation Requirements We Have to be Ready For?

D) Developing and Maintaining a Strategy for ControlledRoom Temperature (CRT) Requirements

E) Measures to Ensure Temperature and Product Compliance?Roundtable Leaders: Keith Holland, Distribution Services Manager,Schering Plough& Kathy Denholm, Director, Life Sciences & PharmaceuticalIndustry, Panther Expedited Services

F) What About our Own Sales Reps? How Can we be Sure TheyAre Handling our Valuable Products Correctly?

G) Developing Scientifically Sound and Standardized Cold ChainPackaging Models – How to Build Qualified Containers Roundtable Leader: Geoffrey Glauser, Director, Cold ChainTechnology, Wyeth Pharmaceuticals

H) Green Packaging and Logistics – Investigating Reusable andRecyclable Solutions to Gain Competitive Advantage and Cut Costs

4:00 Networking Roundtable DiscussionsAfter a full day of presentations, it’s time for all participants to take an active role and get answers to specific questions.Attendees will get a comprehensive review of the surrounding issues, technical capabilities and differing end-user views.

Discussion facilitators will present a short case study as a benchmark for a 60-minute discussion and question session.Delegates choose from one of the following parallel sessions:


Day One continued...

2:00 The Building Blocks of ePedigree Compliance:Baxter Healthcare Case Study • Gearing up for ePedigree compliance amidst legal uncertainties • Key challenges for a pharmaceutical manufacturer –

implementing mass serialization • Handling serialized products in the distribution chain • Data management, sharing and synchronization • Business process improvement challenges, opportunities &

solutionsNathan Habeck, ePedigree Initiative Program Manager, Baxter Healthcare

2:45 Standardization of Package QualificationThe qualification of insulated packages should be linked to acompany-wide master qualification plan that aligns objectivesand scope of a qualification effort and provides guidance on thequalification philosophy and approach to projects. Althoughindividual packout specifics are not contained in a master plan,Design Qualification, Operational Qualification and PerformanceQualification should be addressed such that operationalparameters are clearly delineated and incorporated into theindividual package protocols. This session will explore these keyissues further:• Aligning qualifications across design, operations and

performance measures according to the company’s master plan• Defining the technical qualifications of your packaging and

establishing a numerical value for each• Setting expectations of using this data as templates to answer

questions and solve issues for continuous processimprovements

Geoffrey Glauser, Director Cold Chain Technology, BiotechTechnology & Engineering - Drug Product,Wyeth Pharmaceuticals

2:00 Transitioning from Clinical Studies toLaunching Commercial Products: Putting theValidation Pieces Together • Undergoing new shipping validation studies with new routes

and greater quantities • Implementing new process validation studies – Adapting

stability data and validation information to demonstrate aregulatory qualified process

• Validating new packaging components – Evaluating re-usableoptions and costs

• Forming partnerships with appropriate logistic partners: SOPs,training and monitoring to ensure product integrity

• Putting the pieces together considering financial aspects andtraining new staff

Please check www.coldchainpharma.com for speakerupdates and opportunities.

2:45 Discussion Session: Exchanging Best Practicesfor Temperature Sensitive Multi-NationalClinical Supply OperationsClinical Supplies are a whole other animal compared to commercialproducts. In this session we will discuss key differences and theunique challenges of smaller, more variable clinical shipmentsincluding:• So many different products, shipping requirements and

shipping lanes: How are companies dealing with suchvariables?

• How is packaging best qualified for longer transit routes?• Evaluating stability studies used for clinical supplies• Managing excursions for clinical distributions • Where is the information held and how is the data used for

global trials? • Controlled Room Temperature solutions and strategies

Panelists:Tony Mistretta, Distribution Manager, ALMAC GROUP


5:00 Summary of Roundtable Discussions: Taking Key Lessons from Each Discussion All participants will re-convene in the main conference room to hear five minute summaries from discussion leaders to learn the most interestingfindings of each discussion.

5:40 Closing Remarks from Chairperson and End of Day One

5.45 Cocktail Reception and Networking OpportunityJoin 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.

Main Conference Day TwoMain Conference Day TwoWednesday, September 24, 2008

7:45 Breakfast & Registration

8:15 Opening Remarks from the Chairperson

8:30 Keynote Session: Ensuring Valuable MedicinesAre Transported Effectively and Safely – Howto Avoid Custom Delays in an InternationalTrade Market• Understanding what documentation is necessary and when• Dangerous goods classifications and requirements• Should industry be using specialized carriers for human and

blood samples for quicker customs clearance?• Counterfeit drug concerns – how we can work together to

protect consumers• C-TPAT – A great opportunity to ensure expedited customs

clearance • Common misconceptions to be aware of and advice to

industry Representative, Port of Philadelphia, US Customs andBorder Protection

9:15 Working and Complying with the New TSACertified Cargo Screening Program to AvoidCostly and Risky DelaysBy February 2009, 50% of your air cargo on passenger aircraftswill have to be screened at piece level through the new TSAscreening program. By August 2010, it will be 100%. Todecrease cargo delays and ensure expedited supply chain flow,manufacturers may choose to become certified to do their ownscreening, rather than have untrained people break down thepackaging of high value products at a remote site. This sessionwill provide feedback about collaboration in the TSA pilot tobecome certified to screen your own products. Key topics willinclude:• Explaining what this voluntary, but regulated program means

to the pharmaceutical manufacturer and how the burden is tothe industry

• Understanding the levels of personnel, procedural, physical, ITand facility security – how to ensure your people andprocesses are compliant

• Proving Chain of Custody – Documentation, Application andAuthentication

• Comparing TSA to C-TPAT – an update on how to complywith custom importation

Brad Elrod, Manager, Global Logistics & Security, Pfizer

10:00 Shipping In / Out of India: Examining theUnique Regulations, Customs and LocalTransport Partners• Examining storage conditions for temperature sensitive

samples • Conducting excursion studies including exposure to light,

length of storage, variable weather• Explaining what documentation, licenses or other

requirements are necessary for expeditious customs clearancein and out of India

• Sharing experience with U.S. customs clearance• Lessons learned in dealing with variable temperatures in route

from India to the U.S. and other regions Dr Ramendra N. Pandey, Senior Director, Head ofChemPharm Analytical Development, Analytical &Pharmaceutical Development Center, Janssen-Cilag, India

10:45 Morning Networking & Refreshment Break

11:15 Ocean Reefer Case Study: Establishing NewOcean Lanes, Cost-Effective, Full Visibility andReliable Transport• Exploring the business drivers for ocean carriers of temperature

sensitive products and bulk material including cost andreliability

• Examining the results of the first test campaign of current andnew ocean reefers

• Identifying suitable transport lanes using different types of oceanreefer

• Evaluating new tracking and monitoring technologies • Discussing the drivers and steps for converting air and ground

shipments to ocean reeferProfessor Jean-Pierre Emond, Co-Director, Institute of Foodand Agricultural Sciences, University of Florida

12:00 Panel Discussion: Best Practice InternationalDistribution and Logistics of Cold and CRTProducts Biopharmaceutical companies are increasingly outsourcingmanufacturing, distribution and speciality logistics operations.Many complex challenges exist in ensuring a safe supply oftemperature sensitive medicines to the patient and regulatorycompliance in global markets. In this panel discussion, we willexchange best practices in gaining more visibility, decreasingrisk and working with distribution partners.• Understanding custom clearance issues in global markets to

avoid transit delays• Importation safety into the U.S. – What processes, laws and

solutions are we putting in place to monitor drugs cominginto the U.S.?

• Developing a trusted global network of distribution partners• Evaluating cold chain packaging for longer transit routes –

what technology stands the test of time?• Implementing continuous process improvement programs or

CAPA initiatives for temperature control supply chains

Panelists: Dr Ramendra N. Pandey, Senior Director, Head ofChemPharm Analytical Development, Analytical &Pharmaceutical Development Center, Janssen-Cilag, India

Brad Elrod, Manager, Global Logistics & Security, Pfizer

Todd DeVore, Director Product Development and Packaging,AcuTemp

Representative, Port of Philadelphia, US Customs and Border Protection

12:45 Lunch and Networking for Speakers &Delegates

7

Outstanding!– Director of Logistics, Chemical Biological Medical Systems Joint Project Management Office, Department of Defense


Day Two continued...

Concurrent Tracks

1:45 Keynote Session: A Model for Predicting Qualityand Integrity of Cold Chain Products DuringTransport - Identifying the Weak Link in Distribution • Leveraging shipping reports and transportation evaluations to

provide more information on time and temperature during shipping• Using your knowledge and experience from your own cold

chain to benefit the most from the gathered data • Improving relationships with providers to create a disciplined cold chain

and a common base for understanding of cold chain requirements • Ensuring both businesses provide transparency for quick

response and targeted resolution when excursions occur • Sharing current evidence supporting the creation of a

repeatable process for confidence in desired outcomeJim Bacon, Director, Global Demand Planning & CustomerOperations, Talecris Biotherapeutics

2:30 Case Study: Re-Defining Cold ChainManagement Philosophy & ReducingTemperature Deviations• Building a team & establishing a philosophy• Understanding the end-to-end process, defining the process

requirements, evaluating the existing controls, & implementingthe new process

• Leveraging immediate benefits while planning for long-termimprovements

• Deviation reduction and managementAllen Napetian, Drug Product Finishing Associate Director,Genentech

3:45 A Novel Risk Management Approach to Shippingand Distributing Temperature-Sensitive Products• Outlining the complexities of domestic and international shipping

and distribution processes - including airports, docks, and a varietyof methods of transport

• Applying risk management principles to these complex processesand establishing internal standards that support the risk-basedapproach

• Utilizing the product’s stability data to support alternative shippingconditions defined by temperature ranges, for a defined durationof time, without adverse effect on its quality

• Demonstrating the results of this novel approach of shipping atconditions outside the specified storage conditions - A cost-efficient, quality-driven, risk-based method for the distribution oftemperature sensitive products

Gwyn Murdoch, Manager, Quality, US Distribution, Eli Lilly andCompany

4:30 Panel Discussion: Updating Your Risk ManagementActivities to Cover New Products, Routes andRegulatory Requirements including CRT• Updating Risk Management activities to include longer routes,

new routes and new climates in increasingly international coldchains

• Working toward temperature mapping and updatingtemperature profiles for each and every route

• Discussing the value of temperature mapping transport partnervehicles

• Updating Risk Assessments to include compliance with CRTrequirements

All Track A speakers and participants are invited to jointhis discussion

3:15 Afternoon Refreshment & Networking Break

Track A – Qualifying Your Cold Chain Track B – Supply Chain Management & ‘Last Miles’

1:45 Keynote Session: Gaining Control of the ‘LastMile’: How Can the Industry Implement Stepsto Ensure Product Integrity Downstream• Addressing lack of infrastructure in remote areas and some

current initiatives to work around this• Gaining regulatory input on how to improve temperature

control further down the supply chain• Cold Chain monitoring and temperature excursion approaches • Appropriate data collection and analysis measures • Taking lessons from other industries to improve the healthcare

supply chain• Overcoming technical cold chain challenges in transporting to

remote areasRafik H. Bishara, PhD, Technical Advisor

2:30 Implementing Downstream Compliance Programsto Ensure Clinical Supply Integrity in the ‘Last Miles’• Understanding the unique complexities of clinical supplies in

the last miles and some common misunderstandings• Gaining more control of clinical supplies and patient

compliance downstream by building clear communication andnew procedures with key stakeholders - wholesalers, CRO,pharmacists and physicians

• Updating study parameters and investor roles to the changingdynamics of clinical trials today

• Creating new pack outs to ensure product integritydownstream that is easy to use for nurses and patients


3:45 Specialty Pharmacy Perspective: CorrectlyHandling of Temperature SensitivePharmaceutical Products in the ‘Last Miles’ tothe Patient• Implementing initiatives to ensure product integrity during the

trip from store to home• Initiative to ensure product integrity for high value

pharmaceuticals within USP "room temperature" parameters• Explaining the controls in place with Wal-Mart’s Mail Order

distribution site in Texas • Engaging more with manufacturers on how to control

temperaturesJames L. Soucey, Director of Clinical Services, Wal-MartSpecialty Pharmacy

4:30 Panel Discussion: Detailing a Clearer Picture ofWhat it will Take to Gain Better Control ofTemperature Sensitive Medicines in the ‘LastMiles’• Defining the risks of shipping longer distances to remote areas • Evaluating new strategies and technologies for pharmaceutical

manufacturers to implement to gain greater controldownstream

• Discussing industry collaborations, standards and best practices All Track B speakers and participants are invited to jointhis discussion

5:15 Closing Remarks from Chairperson and End of Conference

Pre-Conference WorkshopsPre-Conference WorkshopsMonday, September 22, 2008

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A8:00 am – 11:00 am Registration 7:45 Breakfast will be served

Quality by Design – What it Means to the Cold ChainThe new paradigm adopted by FDA and the industry is Quality by Design(QbD) which “means that product and process performance characteristics arescientifically designed to meet specific objectives…”. QbD provides theconditions for reaching a much preferred state where the industry, regulatorybodies and society have a mutual goal where the life sciences market producesquality products for consumers.

What you will learnThe author of the presentation titled “QbD for GCCMP” reviews theframework of QbD for GCCMP including examination of these key issues:• Supply Chain Process Flow Diagram• Implementing relevant regulations

• The philosophy of the Validation, Qualification and Statistical Process Control(SPC) Application

• Achieving QbD in Good Cold Chain Management Practices (GCCMP)

How will you benefitParticipants will examine the steps necessary to QbD according to currentregulations and industry standards. The workshop leader will make the casethat quality should be built into the system in order to attain Good Global ColdChain Management practices as well as operational and compliance excellence.

Your Workshop Leaders:Neritan Mustafa, Life Sciences Program Manager, SensitechMark Maurice, Senior Project Manager, Sensitech Inc.

B8:00 am – 11:00 am Registration 7:45 Breakfast will be served

Master Course for Today’s Packaging EngineersWith increasing global supply chains and uncertain weather conditions,packaging engineers are facing complex challenges in updating packagingdesign, testing and validation for longer transit routes.

What you will learn• What information is necessary and how to acquire it for a good

requirements capture • Quick Overview of Insulation & Heat Transfer Key Points - R-value and

thermal conductivity• Thermal Packaging Testing & Live Shipment Testing

• Protocol design & Test equipment selection• Laboratory & equipment certification

• Proper steps for Designing a New Shipper and Building a Business ROI• Proper phases for new shipper design• Typical methods for tooling for each phase

• How are phase change materials incorporated into a passive thermalcontainer design?

• Designing Environmentally Friendly Shippers • Discuss materials and designs that can be utilized to reduce environmental

impact of shipping temperature sensitive payload• How green designs add to your overall ROI• How green designs ensure that your payload and personnel remain safe

• Latest New Technologies in Thermal Shippers - Identifying and discuss newtechnologies and how they are improving thermal shippers

How you will benefit This intensive workshop will provide today’s packaging engineers with themost up-to-date knowledge and information to update their pack outs andpackaging practices.

Your Workshop Leader: George Flora, President, Minnesota Thermal Science

C11:15 am – 2:15 pm Registration 11:00 Lunch will be served

Outsourcing Your Cold Chain Project Management: Opportunities & Strategies for SuccessWhile operating budgets and resources are contracting, understanding theimportance of proper planning and management of cold chain requirements isincreasing, along with regulatory involvement and oversight. In order to meet thesegrowing and wide-ranging requirements in a thorough, robust and timely manner,each component must be handled in a highly coordinated fashion with strongproject management methodologies regardless of whether the work is beingperformed internally or with third-party providers.

What you will learnThe links, interactions and steps along the entire cold chain from needs assessmentthrough finished goods distribution. Additionally, we will review how third-party coldchain solution providers can help you manage and execute your project needs.Roundtable discussions and case studies will cover:• Project Specifications: packaging, storage, handling and movement• Temperature Profile Development and Temperature Criteria Development• Controlled Room Temperature Solution Strategies• Package Design: process, design trade-offs, component attributes, advanced

modeling techniques• Multi-use Packaging: Planning for a matrix of product variety• Documentation Requirements• Packaging Issues: Storage, Re-Use, Disposal, Refrigerant Conditioning and Handling

• Monitoring Strategies: Where and when they are needed, how to developan effective program and air vs. product temperature

• Thermal Mapping: packaging, trailers, warehouses and shipping lanes• Shipping Options: Plan for excursions• Keeping in sync with industry guidelines and regulatory directions (USP

1079, TR 39, etc.)

How you will benefitBy attending this workshop you will gain a better understanding of:• How the many parts of cold chain logistics and distribution interact • The importance of managing all the aspects in a highly coordinated fashion• How to more effectively manage the process• How to successfully outsource cold chain project management

Your Workshop Leaders:Robert (Bob) Bohne, VP, General Manager, Cold Chain TechnologiesJeff Simpson, Director of Engineering & Technical Services, Cold ChainTechnologiesAnthony Rizzo, Project Manager, Cold Chain TechnologiesJim Nilsen, Project Manager, Cold Chain Technologies

D11:15 am – 2:15 pm Registration 11:00 Lunch will be served Revelations in Heat Transfer

Packaging issues are multifaceted. Efficiency, cost and sustainability are at thecore of the problems faced in the packaging of temperature sensitivepharmaceuticals.

What will you learn"One can always tell how tall a building is going to be by how deep of a holeis dug." -Albert Einstein.

It is with this quote in mind that you will examine heat transfers and learn: • Why is it so difficult to get an extra day out of a packaging solution in one part of

the country versus another? Or one part of the year versus another? • What does the amount of product matter when shipping? • How does elevation affect heat transfer?• When deciding upon different insulating materials, what are some of the

variables that need to be examined? • How do I adjust my SOP's to take into consideration all of the variables that

may come into play? • Why is it important to complete detailed temperature mapping? • How can I ship longer distances to remote areas?

How you will benefitThis workshop will demonstrate answers to each of the questions above. Theheat transfer principles discussed will be based on science and math that willhelp in answering questions of efficacy. They will aide you in the designprocess and help eliminate the misconceptions that are costing thepharmaceutical industry time, energy and money.

Your Workshop Leaders: Rob Abramovitch, General Manager, Insulation, PolyairBrian Martin, VP, Consumer Markets North America, PolyairRudy Ponce, Sr. Director of Marketing, Polyair

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Critical Designing, Evaluating and Testing Temperature Sensitive Product PackagingThis comprehensive workshop is tailored for people responsible for cold chainshipping of pharmaceuticals. It will include detailed steps required for successin selecting and designing temperature controlled shipping solutions.Participants will gain a precise understanding of the most thorough andeffective approach to critical details related to packaging including design,testing and qualification.

What you will learn• Defining the project scope• Understanding design options and tradeoffs• Methods to establish temperature profiles• Elements of a temperature sensitive package design• Examples of shipping solutions

How you will benefit• Walk away better prepared to define scope, schedule and cost of cold chain

project• Attain knowledge of design choices of refrigerants, insulation and their

interaction• Gain an understanding of the elements and advantages of well defined test

protocol• Obtain a clear concept of the package testing and qualification process

Your Workshop Leaders:Anthony Alleva, Project Engineer & Mike Paterno, Project Manager, TCPReliable

F2:30 pm – 5:30 pm Registration 2:15

Best Practices in Temperature-Controlled TransportationThis presentation will cover best practices that support the pharmaceuticalindustry’s regulatory compliance requirements relative to the transportation oftemperature-control product. This includes case studies of truck validation andair transportation environments and a discussion of relative strengths andweaknesses of various approaches at common temperature ranges: 2-8° C,deep frozen and controlled room temperature.

What you will learnWith a dual focus on quality both in transportation and in temperature control,you will gain insight to the carriers' quality systems including: • Documentation audit trail• Real-time monitoring• SOPs, including contingency planning• Training

How you will benefit Through case examples and interactive exercise, you will understand howconcepts of validation can be applied to enhance the consistency and qualityof service in the transportation arena, including: • Transportation Validation Master Plan• Truck/aircraft thermal mapping• Exclusive-use truck validation case study (IQ/OQ/PQ), including a discussion

of common errors in truck qualification approaches • Temperature-controlled international air shipment case study • Practical recommendations for implementing new regulatory and industry

guidelines: <USP 1079> and TR-39 • Discussing pre-forma transportation quality agreements and considerations

to address in the design of a transportation plan

Your Workshop Leader:Karl Kussow, Manager Quality and Validation, FedEx Custom Critical

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How to Meet GMP and GDP Regulations Using Temperature Monitoring SolutionsThis workshop will share case studies and best practices related to cold chainmanagement during clinical trials, warehousing, shipment and distribution.

What you will learnAttendees will be invited to participate in interactive exercises covering: • Proper methods for choosing and validating a Temperature Monitoring

Solution• The challenge of monitoring "The Last Mile" to the consumer • Selecting the right solution from available environmental monitoring

technologies

How you will benefit This session will include round table discussions about the current GMP andGDP regulations surrounding Temperature Monitoring. DeltaTRAK will sharewith you important educational information about cold chain management oftemperature sensitive (bio) pharmaceuticals.

Your Workshop Leaders: Martina Brennan, National Sales Manager, ColdTRAKCharles Craig, Validation and Technical Engineer, DeltaTRAK

H5:45 pm – 8:45 pm Registration 5:30 Dinner will be served

Temperature Mapping, Supply Chain Planning and Specialty Logistics for InternationalClinical Trials

The dynamics of clinical trials have changed drastically with increasing multi-national trials, at home clinical administration and changing patientpopulations. This workshop will look at how you can update your cold clinicalsupply operations to meet these increasing challenges.

What will you learn:• How to meet the demands of global clinical trial supply planning • Implementing flexible procedures and sufficient contingency plans• Updating your practices to control temperature sensitive supplies to the

patient with increasingly geriatric patient populations • Overcoming challenges in using less traveled shipping lanes

How will you benefit:In breakout discussion groups, you will explore:• How to manage risk while minimizing costs• Updating your temperature mapping for international clinical trials • Implementing best practices for temperature controlled clinical supply

operations • Dealing with incomplete stability data and information• Delivering clinical supplies to remote areas and clinical sites

Your Workshop Leader:Tony Mistretta, Distribution Manager, ALMAC GROUP


Mid-Conference WorkshopsMid-Conference WorkshopsTuesday, September 23, 2008

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Reusable Packaging in the Cold Chain

Environmental ‘consciousness’ now exists in many industries, including thetransportation and packaging industries. However, significant key businessdrivers exist in moving to green packaging. This workshop will examine whatyour company needs to implement to achieve cost savings, meet regulatoryrequirements and consumer satisfaction.

What you will learn:This workshop will explore all aspect of reusable packaging. If your company isconsidering green packaging for cold chain in the future, you will benefitattending this workshop to understand the key challenges, including:• Repositioning your packaging strategy• Funding of green packaging• Understanding perceived cost issues • Changing traditional methodologies • Estimating the initial investment • Evaluating and working with new suppliers • Meeting health regulatory requirements

How you will benefit:This workshop will explore the advantages of using reusable packaging forcold chain, including: • Using robust container, built to stand up to international transportation over

many years • Implementing high-quality phase-change materials • Working with superior loggers that:• Display internal and external temps • Log events • Comply completely with CFR11 Part II audit trail • Benefiting from cost savings • Exploring security elements • Understanding the passive technology • Reducing environmental impact and addressing CSR issues

Your Workshop Leaders:Dr. John Pring, CEO, Control Quality SystemsChris Pollard, CEO, KryoTrans International Ltd.

J Industry Best Practice Trailer Thermal Mapping According to Technical Report 39

How you will benefit:The debate is ongoing – to trailer map or not to trailer map? This workshopdiscussion with your peers will help you make your own conclusions abouttrailer mapping. Attend to get all of the variations of trailer mapping into bestpractices.

What you will learn:• Overview of thermal mapping

- Processes- Systems- QA & Regulatory Compliance

• Understand other key factors contributing to temperature control includingtrailer maintenance

How you will benefit• Gain an in depth understanding of the PCCIG’s technical report 39 guidance

and how that can be utilized for your trailer mapping strategy • Learn how to how to close the gap between manufacturer’s and solution

provider capabilities, communication and due diligence processes

Your Workshop Leader:Kathy Denholm, Director, Life Sciences & Pharmaceutical Industry,Panther Expedited Services, Inc.

6:45 pm – 9:00 pm Registration 6:30 Dinner will be served

K Security Challenges and Tools for the Cold Chain6:45 pm – 9:00 pm Registration 6:30 Dinner will be served

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Excellent!– Distribution Coordinator, Pfizer Inc

Very informative and very good– Sr. Logistic Supervisor, Wyeth

With increasing security concerns in the pharmaceutical supply chain, thisworkshop will explore they key tools to help ensure your temperature sensitiveproducts reach the end-user safely and that product security isn’tcompromised.

What you will learn You will learn how a combination of forensic detection technology, track andtrace technology and overt and covert applications are necessary to ensure thesupply of vaccines and medicines to distant clinics in hot climates served bypoorly developed transport networks. Disruption of “ANY” cold chain mayproduce considerable consequences.

How you will benefit• Forensic Identification for absolute proof of product packaging

authentication• Track and Trace “mass serialization” technology to track each unit, group

batch and container through critical validation (supply chain) points

• Building a qualified state of your distribution process by conductingComponent Qualification on the packaging

• On site, in situ, distribution, with full “web authentication” via client, brandowner, investigators and customs enforcement and border personnel

• E-Pedigree “pharma” documentation and constant covert/overt markingtechnology that matches the product by forensic “physical” identification

• Multi-party communication standards and protocols to transfer or create acentral repository or hub to track information across the supply chain

• Access to critical data and building sufficient data set that clearlydemonstrates the process is in compliance and in a state of control

• Cyber certification fluidity• Legal-Liability issues - Investigations enforcement

Your Workshop Leaders:Phil Viggiani, V.P. Sales & Marketing, IDGLOBAL Corp. David Faulconer, Section Chief, Department of Homeland Security & ICE (Customs and Immigration Enforcement)Jeffery Lord, Pharmaceutical Labeling Engineer, ATL Pharma Security Label SystemsNathaniel Lipkus, Pharmaceutical Research Specialist, Gilbert's LLP

Post-Conference Master Class TrainingPost-Conference Master Class Training Thursday, September 25, 2008

Re-engineering Cold Chain Management for Today’s Challenges

This interactive training day is a valuable opportunity to learn from theexperience of Sanofi Pasteur how they have updated their cold chainmanagement practices to be more robust and inline with increasingdemands of international supply chains. They’ve invested heavily in thismodernization and though for this training day. Now you have theopportunity to learn from their experience, and their mistakes.

A range of presentations, small break out group discussions and casestudies will be used to demonstrate how to:

• Avoid excursions by learning how to update your temperaturemapping and profiles for each and every route and their climates

• Change your mindset on how to effectively managing your cold chainby learning some common misunderstandings and how to fix them

• Update your Cold Chain Management from QA driven to cost-effectivelogistics with proven temperature profiles and routes

Trainer: Sherman Chung, Director of Materials Management, Sanofi Pasteur

Training Agenda

8:00 Registration and Coffee

Session 1: Seven Deadly Myths - The Right and Wrong ofCold Chain Management • Some very critical “Myths” inappropriate traditional

approaches and concepts that seriously affect theperformance Cold Chain Transportation

• The Wrong and Right approaches

Session 2: The Transporters – with an ExtensiveExamination of Airline Carrier Capabilities andCompliance Abilities • Your own Logistics Personnel • Freight Forwarder – Value-added or Road Block process?• Carriers

• Airlines – comparing, contrasting and evaluating our options • On the road• Courier

Session 3: The Distribution Itinerary • Why itinerary is critical to cold chain performance?• Itinerary Design Criteria • The Transportation Mode• The Carriers• Routing

12:00 Lunch

Session 4: The Temperature Monitoring and Tracking • Why monitor and track temperature during the transportation • Types of monitoring available in the market• Types of monitoring that should be used in different shipment

modes• How to operate different types of monitors• How to monitor• How to interpret the temperature during the shipment• Cold Chain deviation and product lost

Session 5: The Re-engineering of Cold Chain Management • Logistics role in Cold Chain management• Cold Chain performance is not guaranteed• Challenges we are facing -• Partnership – why and how?• Training and Education needed for your internal staff and

external partnerships

4:45 End of Training Day


www.PharmCast.com is the world leading website designed specifically forpharmaceutical, clinical and biotechnology professionals. www.PharmCast.com brings up-

to-date information on pharmaceutical patents, FDA, news, jobs and Buyer's Guide to our visitors. It wascreated and is maintained by pharmaceutical and biotechnology professionals. Visit www.PharmCast.com anddiscover for yourself why it is so popular among professionals.

A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. TheMarketplace features the Request for Quote Outsourcing Services Showcase & MatchingMarketplace; the Portal features our biopharmaceutical and venture capital directories and

databases. Publications include the BioMedical Outsourcing Report. Supporting CanBiotech is the consultingdivision enabling outsourcing of drug discovery and development. Website: www.canbiotech.com

Published by Analysts in Media, Future Pharmaceuticals plays a strong role inconnecting top pharmaceutical organizations with the industry’s powerhouse vendors and

key leaders. While each issue provides decision-makers with tactical strategies and ground-breaking solutions;Future Pharmaceuticals serves as a vital building block for overcoming the industry’s most trying obstacles.

Piribo is a UK-based independent online store supplying business information on thepharmaceutical and biotechnology industries. The website now carries nearly 10,000 English

language titles including, market reports, studies and books and is the UK's largest online biopharmainformation store. www.piribo.com

Packaging decision-makers in the pharmaceutical, biologics, medical device, andnutraceutical markets heartily endorse Healthcare Packaging, from the publishers of

Packaging World. Each edition features best practices, products and advice from experts, as reported byEditor Jim Butschli. Published six times yearly in print and monthly as an e-newsletter, subscribe atwww.healthcare-packaging.com.

Since 1999, PharmiWeb.com has been bringing the latest news and developments inthe pharmaceutical industry to a global audience, now reaching close to a quarter of a

million professionals. Sponsored by many of the world’s leading pharmaceutical corporations,PharmiWeb.com is widely regarded as the leading pharma portal, with an extensive and innovative range offeatures:

• Accurate and wide ranging news – online and real time • Incisive and informative features • Press releases, product announcements, and industry perspectives • Thousands of the best jobs from all the leading players – updated every day • Direct posting options of careers, news and features and PharmiwWeb.com JobSearch™ ASP-based careers

search functionality – all available for pharmaceutical, biotech and related organisations • The optimum online channel for engaging with the industry • Become part of the PharmiWeb.com community – contact us to find out how To find out more about PharmiwWeb.com, and the other offerings from PharmiWeb solutions, please visitwww.pharmiwebsolutions.com

PharmaVOICE magazine, reaching more than 17,500 U.S.-based life-sciences executives,is the forum that allows business leaders to engage in a candid dialogue on thechallenges and trends impacting the industry. PharmaVOICE, and its supporting VIEW

publications, provide readers with insightful and thought-provoking commentary in a multiple-perspectiveformat through forums, topics, and articles covering a range of issues from molecule through market.PharmaVOICE subscribers are also kept abreast of the latest trends and information through additional mediaresources, including WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-Alerts. Additionally, PharmaVOICEMarketplace.com provides a comprehensive directory of products, services,and solutions for the life-sciences industry. To Raise Your VOICE, contact [email protected].

Freightnet.com is the internet’s largest Freight, Logistics & Cargo Directory and Resourcewhich was launched in 1995. Today it has over 25,000+ registered members and thewebsite attracts more than 1.2 million visitors every year. The portfolio includes FreightPress,

FreightDebt, FreightThermal, FreightReports and FreightCareers. Freightnet has a defined strategy to makeglobal business easier, safer and concise. It is backed by a team of dedicated professionals with scores ofexperience and understanding of the fast moving business of global trade. www.freightnet.com

Media Partners:

About the Sponsors and Exhibitors

Badge Sponsor:Cold Chain Technologies is a leading source for engineering-basedthermal packaging solutions. For almost 40 years, we’ve continued toexcel in providing efficient, cost effective thermal packaging productsand services to a wide range of customers – from local start-ups to

Fortune 100s. Pharmaceutical, biotech, healthcare, medical device, and food servicecompanies count on us to solve their cold chain challenges. Distributed from multiplelocations throughout the U.S. and internationally, our product line includes KoolTempTM

insulated containers, Koolit® refrigerants, and KoolWatchTM temperature indicators. ColdChain Laboratories, our affiliated company, is a premier source for expert design andqualification testing of thermal packaging solutions. www.coldchaintech.com

Lanyard Sponsor:Pioneer and market leader Envirotainer offers flexible leasing(rental) of advanced transport solutions for worldwide air cargoshipments of temperature-sensitive products. Customers within

the healthcare, life sciences, food and high-tech industries benefit from the combinationof advanced container technology, extensive cold chain management services and aglobal network of service partners, airlines and forwarders - providing a unique one-wayleasing service. Envirotainer secures the safety and integrity of product cold chains byproviding an active temperature-control system, training all parties along the cold chainand supporting customers in transport validations and risk management.www.envirotainer.com

Panel Sponsor:AcuTemp Thermal Systems designs and manufactures coldchain temperature management solutions to maintain valuableand often life-saving payloads at the right temperature during

storage or transport. AcuTemp combines thermal expertise and engineering know-howto produce highly efficient passive and powered delivery solutions, from small boxes andcarriers to large pallet-sized shipping containers. The company’s newest product, theAcuTemp AX2100L thermal pallet shipper, provides reliable compressor-based heatingand cooling functionality with state-of-the-art data logging capabilities to ensureaccurate temperature monitoring. When it’s critical, use AcuTemp: The RightTemperature. From the Experts. www.acutemp.com

Almac Clinical Services provides a global solution formanufacturing, packaging, labelling, distribution, analysis and

return of clinical trial supplies. Services include; Comparator sourcing, Over-encapsulation & blinding, Packaging, Label printing, Randomised Labelling of clinicalsupplies, Global Distribution and Depot network, Unrivalled refrigerated storagecapacity, QP release into EU and analytical services, Web-based patient ,Randomization (WebEZ™), Integrated IVRS (with Almac Clinical Technologies) andClinical supplies management.

Sponsors:Elpro Services, Inc. is a leading manufacturer of high qualitytemperature, humidity, and CO2 dataloggers, providing recordingand monitoring solutions while observing regulatory compliances(GMP/GLP/FDA 21CFR11). LAN/W-LAN solutions are fully scalable

to meet your central monitoring requirements and future growth. Our New Libero PDF-logger® (No Software Required) provides simple cold chainmonitoring of temperature sensitive pharmaceuticals. This ground-breaking concept ofproducing the report in a PDF file eliminates the need to install, qualify and validate anyspecific software at destination. Available in 100 and 400 day models, our Libero PDF-logger® also supports compliance with FDA standard 21 CFR 11.

Since 1989, DeltaTRAK, Inc. has been developing andmanufacturing high quality portable test instruments such as chartrecorders and data loggers that monitor / record temperature andhumidity. We've subsequently developed affordable and dependable

digital probe and infrared thermometers to provide better end-to-end cold chainmanagement solutions. In addition, we have added state-of-the-art data download /management / analysis software to our data logger product line. Our products andservices are depended on by businesses big and small around world.Only DeltaTRAK offers the ColdTrak® Program, which includes cold chain managementsolutions for validation, quality assurance and safety of food, pharmaceuticals, chemicalsand other perishable or temperature-sensitive commodities during processing, shipment,handling, and storage. Follow-up support and value-added services are an integral partof the ColdTrak program.

Cavalier Logistics is dedicated to providing “Turn-Key ColdChain Solutions” for business in the Life and AnalyticalSciences, Pharmaceutical Manufacturing, Diagnostic Kit

Manufacturing, Vaccine and Healthcare Providers. In addition, we provide servicegovernment agencies that are responsible for the stockpiling and rapid deployment ofpharmaceutical products for disaster and pandemic relief. We offer a unique service tohealthcare providers because we can provide one-stop 3PL logistical services from thepoint of manufacture, in Cavalier validated refrigerated equipment. We also havevalidated 5°-C, -10°-C to -40°-C, -80°-C and -156°-C storage at our Washington D.C.Headquarters. Our Washington Headquarters is licensed by the United States DrugEnforcement Agency and the Commonwealth of Virginia Board of Pharmacy to houseand distribute schedule 2-6 pharmaceutical products. We provide seamless third partylogistical services for high value vaccines, clinical trial samples, specimens, reagents anda multitude of products that require expert handling. https://www.cavlog.com

Bilcare Global Clinical Supplies serves the Americas, Europe, andAsia with clinical trial materials support, services and completeproject management. Our services for solid, semi-solid, liquid, DEA

(CI-V) and biotech clinical trial materials (CTM) satisfy a broad range of requirements;from pre-formulation research and development, analytical services and clinical suppliespackaging and labeling, to IVRS, controlled temperature (cold and frozen chain) CTMstorage, distribution worldwide, and returns and destructions accountability. Our

integrated approach provides you with seamless service throughout your entire project.We combine our industry experience and our total clinical supply chain service anddelivery to provide smart, efficient and innovative solutions. www.bilcare.com

World Courier has set the benchmark for worldwide time &temperature sensitive transportation. We remain the only specialistcourier company with its own global company network .Each

office ISO 9001 certified with the same operating standards dedicated to treating everyshipment on an individual, priority basis. World Courier is utilized in approximately 80%of the world’s clinical trials requiring the use of a specialty courier. With experience inmanaging the logistics of over 7,500 clinical trials worldwide, we are the acknowledgedexperts in handling temperature-sensitive specimen and drug shipments. 24 x 7 x 365.www.worldcourier.com

Although the Tegrant name was established in 2007, the rootsof its portfolio of brands can be traced back over 40 years tosome of the pioneering companies in protective, thermal and

consumer packaging. Today, Tegrant maintains facilities in over 20 states and Mexico,and many of its employees are considered leading experts in the markets they serve.Their focus is on providing single-source access to a broad range of packaging materialsand solutions. Tegrant , combines a material-neutral approach with applicationengineering capabilities and problem-solving expertise. This allows Tegrant to draw ontheir extensive resources to meet customer requirements and achieve supply chainefficiencies.

TCP Reliable specializes in the field of temperature controlledpackaging and services including package design, qualification,testing manufacturing insulated shippers, refrigerants, phase

change materials and temperature monitors. All services are provided in strictconformance with ISO 9001:2000, ISTA and ASTM test methodology, and FDA goodmanufacturing practices. TCP maintains facilities in New Jersey, British Columbia, andQuebec.

Sensitech - The leading provider of cold chain visibility solutions thatenable our customers to track and monitor assets across the supplychain, protecting the quality, efficacy, and integrity of their

temperature-sensitive products. Our product portfolio includes comprehensive analyticservices, enterprise software systems and validated data acquisition devices. We addressour customers’ most complex perishable cold chain problems and deliver powerfulinsights that drive measurable process improvement. Sensitech supports cold chainmonitoring programs in 18 of the top 20 multi-national pharmaceutical companies and9 of the top 10 biopharmaceutical companies. Sensitech is a business unit of CarrierCorp. Website: www.sensitech.com

Polyair is one of the largest manufacturers and distributors ofprotective packaging products in North America – continuallyoutpacing the growth of the competition. Inspired to make adifference, we have formed strong relationships with customers in

all major industries, including pharmaceutical, automotive, fulfillment,computers/electronics, catalog and mail order, furniture, online retail, householdproducts, books and publishing, moving and storage, cosmetics…and the list keeps ongrowing. With such a diverse list of clients, we make sure to listen to your needs andmake proposals that take into consideration savings and opportunities beyond the initialscope of the challenge. Polyair helps you feel protected.

Panther Expedited Services is the premier transportationprovider supporting the life sciences and pharmaceuticalindustries. We are experts when it comes to Cold Chain

Relocation: our temperature-control and temperature-validated equipment is extensivelyqualified and monitored both centrally and via satellite to ensure that accuratetemperatures are constantly maintained. To further ensure the pedigree, efficacy andsafe transit of your temperature-sensitive, high value, high risk, and highly regulatedproducts, we are proud to provide shipment solutions that include companion securityservices, shipment monitoring and tracking 24/7/365, theft alert services, and a qualitymanagement system to facilitate compliance with all regulatory and documentationrequirements. We also ensure our drivers are uniquely qualified and security cleared toensure all legal and safety measures are in place to prevent any delays in transit. TrustPanther to deliver on time, every time, anytime, anywhere. 1.866.445.8204www.pantherexpedite.com/ind_lifesciences.aspx

Minnesota Thermal Science, LLC develops unique storage andshipping systems that address the challenges of maintaining constantand predictable temperatures when transporting temperature sensitivemedical materials.

Founded in 2004 following an industry wide search by the Walter Reed Army Instituteof Research for a more effective combat environment container, MTS has continued toapply its technology to handle other important medical materials including all types ofbiomaterials and pharmaceuticals that require controlled temperatures.Its patent pending Golden Hour® Technology, winner of a "U.S. Army GreatestInventions" award, is credited with saving soldier's lives on the battlefield and withrevolutionizing the methods used for distributing temperature sensitive medical supplies.

Marken is one of the leading suppliers of cold-chain logistics forclinical supplies worldwide. Temperature-control during thehandling, storage and distribution of cold-chain products is a

critical element of the clinical trial process. Our expertise is of critical importance toensuring the safe arrival of high value shipments to sites. We provide:• Global distribution of temperature controlled trial medication, vaccines & CTM. • Temperature control monitoring for ambient, 2-8C and frozen products to maintain

integrity of supplies. • Advice on packaging materials and provision of containers for global transportation • Refrigerated trucking services • Customs brokerage accelerating clearance www.marken.com

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Lifoam is a leading manufacturer and distributor of EPS(expanded polystyrene) insulated shippers for the safetransit of temperature sensitive and delicate products.

Our extensive line of thick and thin walled shippers and reusable refrigerant gel packsoffer a cost-effective solution to all of your shipping needs. Whether your industry isPharmaceutical, Biotech or Specialty Items, Lifoam can design and manufacture thermalpackaging solutions and ship it to you from one of our 7 strategically located facilitiesthroughout the United States. www.propakproducts.com

KryoTrans is a system of temperature-controlled, passive, tamper-evident containers that provide a complete audit trail for thetransportation of products and samples for the pharmaceutical andbiotechnology industries. Whether shipping samples, clinical trials

materials, vaccines, inoculants, blood fractions or any other temperature sensitivebiologicals, KryoTrans delivers an unbroken cold chain and assured low temperaturetransit at -80, -20, 2 to 8 and controlled ambient. Containers come in 26, 70 and 400liter capacities and are robustly constructed to deal comfortably with the rigors ofinternational transportation. www.kryotrans.com

FedEx Custom Critical offers a complete array of surface and airsolutions to safely and securely ship temperature-sensitive products.You can choose from exclusive-use vehicles with temperature-

controlled cargo boxes to airfreight solutions utilizing temperature-controlled aircontainers. With our Temp-Assure Validated services, you also receive hard-copydocumentation of the temperature inside the vehicle or container throughout transport.This assists our pharmaceutical customers with their compliance needs through adocumented audit trail of their products’ temperature throughout the shipping process.FedEx Custom Critical services are available 24/7/365 with surface solutions throughoutthe U.S. and Canada and air solutions across the globe. www.customcritical.fedex.com

Entropy Solutions is the industry’s innovation leader in thermaltechnology. With the introduction of the GREENBOX ThermalManagement system, Entropy has once again revolutionized how

thermally sensitive products are shipped and maintained. Our 100% organic,sustainable, passive thermal solution can maintain precise target temperatures forunprecedented periods of time. Through a unique combination of technology anddesign, GREENBOX™ delivers the industries most effective and cost efficient shippingmethod on the market today. www.greenboxsystems.com

International Foam Packaging, LLC. (the"Company"), a Virginia corporation, is a privately ownedcorporation with both its corporate office and

manufacturing facility located in Richmond, Virginia. The Company manufactures ashipping package that is unique in the small package industry. The Xpander Pak®product, with its patented construction and foam cushioning, provides much greaterprotection against the shock and vibration encountered in shipping than ordinaryshipping materials including bubble or padded envelopes. Xpander Pak® productsprotect fragile contents with thick, flexible polyurethane foam; yet, they are light inweight and reduce shipping costs significantly. In 2000, the Company transitioned fromits manufacturing operations into a newly renovated warehouse. Recognizing theimportance of maintaining the highest quality production standards, the Company tookover the manufacturing of its entire product line, which is now handled from a 40,000-square-foot facility in Richmond, Virginia. Consequently, all functions from new productdevelopment, to manufacturing and shipping, to sales and marketing-are handleddirectly by Company personnel, resulting in better quality, quicker response to customerneeds, and innovative solutions for just about any packaging need. www.intfoam.com

IDGLOBAL offers the world's most effective total solution forbrand authentication, anti-counterfeiting and chain supplymanagement. An IDGLOBAL solution authenticates marked

products instantly, on-site with 100% accuracy. IDGLOBAL has a universal track andtrace mass serialization technology with plug and play adaptability. We provide the mostthorough and reliable forensic marker system available at the lowest per unit cost. Wecustom design each application to meet clients’ specific needs for safeguarding brandedproducts, assets and documents worldwide. An IDGLOBAL solution integrates auniquely coded, tamper-proof forensic marker with next generation scanningtechnology that allows field reading anywhere, anytime with 100% accuracy.

Midnite Express offers effective, efficient solutions tailored to yourunique global shipping needs. Whether you require International sameday or overnight services, late night, early morning pick ups or

weekend deliveries, Midnite's flexibility works to your schedule and requirements. Witha complete portfolio of services including same day and overnight courier, air freight,fulfillment and distribution, warehousing inventory control and satellite transmissionMidnite provide an integrated solution to all your transportation needs. Our customerservice and on-line monitoring systems puts you the client in control.

NanoCool is a leader in advanced controlled temperaturepackaging (CTP) solutions. Our systems provide simple and costeffective thermal protection that is smaller and lighter than

conventional CTP. These features translate into significant savings in transportation aswell as cold storage, and warehousing costs.

Plastilite Corporation has been a manufacturer and supplierof insulative and protective packaging for nearly 50 years. Wework extensively, and nationally, with cost conscious food,

pharmaceutical, bio-tech companies seeking dependable packaging for the safe transitof their perishable products. We strive to find the most cost effective means that willproduce dependable and certifiable results, Working in partnership with our clients, wehelp them make informed choices which can avoid over-priced, over-engineered, orcookie cutter packaging solutions that are not necessarily effective for every situation orproduct. We also pride ourselves in building and maintaining relationships, and neverforce our clients to shuffle through a maze of uninformed customer service people oncea protocol is established. www.plastilite.com

Blue Vector provides rapidly-deployable "sense and respond"software solutions that enable our customers to get the most outof their supply chain initiatives such as serialization, shipping

accuracy, and remote inventory management. Our solutions push contextual, real-timebusiness intelligence to the edge of our customers' operations, enabling critical businessdecisions to be made where the work is done. Our appliance-based software is plug-and-play, scales to support even the largest operations, can manage a wide variety ofwireless sensors, and integrates with enterprise applications such as ERP and warehousemanagement solutions. Our solutions have helped organizations tighten sales cycles,realize supply chain efficiencies, and comply with pending legislation such as ePedigreemandates. www.bluevector.com

Sentry Logistic Solutions® is a cGMP, fully validated, state-of-the-art facility with executable redundancy plans for power,environmental control, information technology, and security.

Sentry has four validated storage environments and exclusively stores temperature-sensitive pharmaceutical and biotech finished products, semi-finished products,intermediates, and API. Sentry has personnel and programs to manage stabilitysamples, escrow samples, high risk products, high volume fulfillment, batch labeling(FDA labeler code), and packaging needs. Sentry incorporates validated inventorymanagement and building management systems, robust training programs to facilitateGMP and GDP operations, and VAWD® accreditation (8281-31487) & State Licensingto ensure product integrity throughout the supply chain.

Log-ic is the world's only EN12830 certified wireless RFIDTemperature Logger. Priced at a fraction of the cost of traditional,non-wireless loggers, Log-ic is ultra-light (under 1/4 oz), 2 inch square,

thin (0.1 inch), bsolutely watertight (IP68/Nema 6P), and capable of processing up to 16Million readings per trip. It is offered in calibration ranges from +/- 0.25, both as single-trip disposable as well as re-usable versions. Log-ic tags process all temperature eventsin real time. Package status, Min/Max temp, MKT, temperature minute histograms andexcursions are downloadable in under 0.5 second via the CertiScan wireless 13.56 MHzRFID reader solution. Log-ic devices are available in fully customized and specializedconfigurations, such as probed, dry-ice (-67 C), high-temp (+140 C) and gamma-shielded versions. An EPC compliant UHF frequency tag is currently under development.

Sponsorship and Exhibition OpportunitiesSponsorships and Exhibits are excellent opportunities for your company toshowcase its products and services to high-level, targeted decision markersattending the conference. Pharma IQ and the 6th Cold Chain Distribution forPharmaceuticals conference will help companies like yours, achieve sales,marketing and branding objectives by setting aside a limited number of eventsponsorships and exhibit spaces - all of which are custom-tailored to help yourcompany create a platform to maximize its exposure at the event.

For more information on Sponsoring and Exhibiting at the 6th Cold ChainDistribution for Pharmaceuticals event, please contact Mario Matulich at 1-866-232-8660, [email protected].


Other Upcoming PharmaIQ Events:

6th Lean Six Sigma for Pharmaceutical,Biotech, and Medical Device ExcellenceJuly 28 - 31, 2008www.iqpc.com/us/LSSP

4th Annual Compound Management &IntegritySeptember 22 - 24, 2008www.iqpc.com/us/CM2008

12th IT Infrastructure Qualification andApplication ValidationSeptember 22 - 24, 2008www.iqpc.com/us/ITIQ

About the OrganizerPharma IQ, the Pharmaceutical division of IQPC, provides aforum to address the critical issues facing the PharmaceuticalIndustry today. Pharma IQ utilizes workshop, conference andtraining course formats to facilitate a learning environment forpharmaceutical professionals working in all areas of drugdevelopment: from Discovery to Post-Marketing.

Venue and AccommodationVenue:

Philadelphia Convention Center12th & Arch Street (WestEntrance)

Philadelphia, PA 19107Tel: 215-418-4700The Pennsylvania Convention Center (PCC) isconveniently located in the heart of downtownPhiladelphia. For more information about thePennsylvania Convention Center, please visitwww.paconvention.com.

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Accommodation:

1200 Market StPhiladelphia, PA 19107(215) 627-1200

IQPC has a reduced rate room block for participantsof Cold Chain 2008 at the Loews Philadelphia Hotel.This hotel is located across the street from thePhiladelphia Convention Center. For roomreservations please call the hotel directly at 215-627-1200. Be sure to mention that you are attendingIQPC’s Cold Chain Distribution 2008 for the grouprate when making your reservation.

Payment Terms:Please note that multiple discounts cannot be combined.

A $99 processing charge will be assessed to all registrations not accompanied by creditcard payment at the time of registration.

MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC* CT residents or people employed in the state of CT must add 6% sales tax.

TEAM DISCOUNTS:For information on team discounts, please contact IQPC Customer Service at 1-800-882-8684. Only one discount may be applied per registrant.

Details for making payment via EFT or wire transfer: JPMorgan Chase – Penton Learning Systems LLC dba IQPC: 957-097239 –ABA/Routing #:021000021Reference: Please include the name of the attendee(s) and the event number: 10366.002

Payment Policy: Payment is due in full at the time of registration and includes lunches,refreshments and detailed conference materials. Your registration will not be confirmeduntil payment is received and may be subject to cancellation.

Please go online to: www.iqpc.com/cancellation to view our cancellation policy

Scholarships Available: IQPC sets aside a limited number of discounts that may beapplied to its conferences for delegates from the non-profit sector, government andmilitary organizations and academia. For more information about scholarships to thisevent, please call Customer Service at 1-800-882-8684.

Special Dietary Needs: If you have a dietary restriction, please contact Customer Serviceat 1-800-882-8684 to discuss your specific needs.

©2008 IQPC. All Rights Reserved. The format, design, content and arrangement of thisbrochure constitute a trademark of IQPC. Unauthorized reproduction will be actionableunder the Lanham Act and common law principles.

5 EASY WAYS TO REGISTER:

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Web: www.coldchainpharma.com

Call: 1-800-882-8684 or 1-646-378-6026

Email: [email protected]

Fax: 1-646-378-6025

Mail: IQPC535 5th Avenue, 8th Floor, New York, NY 10017

Registration InformationRegistration Information

Pricing

Conferences and Webinarsavailable:Visit us at www.iqpc.com and see what otherexciting and information-packed conferencesand webinars being offered by the InternationalQuality & Productivity Center.

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Register by Register by Standard July 11, 2008 Aug. 25, 2008 Price

Conference Only $1,999 (save $400) $2,199 (save $200) $2,399

Conference $2,548 (save $400) $2,748 (save $200) $2,948+ 1 Workshop

Conference $3,097 (save $400) $3,297 (save $200) $3,497+ 2 Workshops

Conference $3,546 (save $500) $3,746 (save $300) $3,946 (save $100)+ 3 Workshops



Workshops Only $549 each $549 each $549 each

Masterclass $699 each $699 each $699 each

VIP All Access PassIncludes all workshops,2 day conference, and $4,899 (save $1,000) $4,899 (save $1,000) $4,899 (save $1,000)master class

The World's Largest Global Forum for ColdChain Specialists - Sold Out in the US, UK,Belgium, Brazil, Singapore and Germany

September 22-25, 2008 Philadelphia Convention Center • Philadelphia, PA

10366.002/D/AL

International Quality & Productivity Center535 5th Avenue, 8th FloorNew York, NY 10017YES! Please register me for

❑ Conference Only❑ Conference + Workshops❑ Workshops Only

See Page 15 for pricing details.

REGISTRATION CARD

Your customer registration code is:

When registering, please provide the code above.

Name__________________________________ Job Title ________________________

Organization____________________________________________________________

Approving Manager______________________________________________________

Address_______________________________________________________________

City__________________________________State______________Zip___________

Phone________________________________Fax_______________________________

E-mail__________________________________________________________________

❑ Please keep me informed via email about this and other related events.

❑ Check enclosed for $_________ (Payable to IQPC)

❑ Charge my __Amex __Visa __Mastercard __Diners Club

Card #____________________________________Exp. Date___/___

Details for making payment via EFT or wire transfer can be found onpreceding page.

❑ I cannot attend, but please keep me informed of all future events.

5 EASY WAYS TO REGISTER:

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1

445

Web: www.coldchainpharma.com

Call: 1-800-882-8684 or 1-646-378-6026

Email: [email protected]

Fax: 1-646-378-6025

Mail: IQPC535 5th Avenue, 8th Floor, New York, NY 10017

Choose your workshops❑ A ❑ B ❑ C ❑ D ❑ E ❑ F

❑ G ❑ H ❑ I ❑ J ❑ K ❑ Master Class

Register by 7/11/08

and SAVE $400

Cold Chain Distribution for PharmaceuticalsCold Chain Distribution for Pharmaceuticals TM

Gaining Greater Control of Your Global Cold Chain and Ensuring InternationalRegulatory Compliance

for PharmaceuticalsDistributionCold Chain Cold Chain

TM


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6th Annual Cold Chain Distribution for Pharmaceuticals

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Transcript of 6th Annual Cold Chain Distribution for Pharmaceuticals