12 @CCGlobalForum #13CCGF

10:45am Registration for Workshops C & D

11:00am -1:15pm Practical Cost and Risk Reduction Strategies in Cold Chain Distribution Anthony Alleva, Technical Director, Cryopak / TCP Reliable, Inc .Maurice Barakat, President and CEO, Cryopak / TCP Reliable, Inc .1:30pm Registration for Workshops E & F

1:45pm – 3:45pm Developing your TemperatureSensitive Logistics Strategy – Supply Chain Mapping & Transport Qualification Martin Peter, Vice President, ELPRO Michael Rohrig, Team Leader, GMP Services , ELPRO

4:00pm Registration for Workshops G & H

4:15 pm – 6:15 pm Practical Considerations for Freezing/Preparing PCM’s David Scott Farrar, Thermal Scientist/Chief Technology Officer, Farrar Scientific Corporation

Pre-Conference Master Classes

Pre-Conference Workshop Day

6:30pm – 7:30pm

Welcome Cocktail Reception After a full day of intense learning, get together to meet your speakers, sponsors, fellow workshop & conference attendees. Join your colleagues for some drinks and create valuable discussions and connections. Allow us to reward a long day of content with some cocktails as well as facilitate introductions to professionals with similar industry focus

Creating a Risk Model for the Development of Passive Shipping Systems: Linking Control and Risk to Total Cost Ken Maltas, Director of Engineering, Sonoco ThermoSafeIftekhar Ahmed, Senior Design Engineer, Sonoco ThermoSafeBryan Cardis, Cold Chain and Packaging Engineer, Eli Lilly and CompanyDr . Bernard McGarvey, Senior Engineering Advisor, Eli Lilly and Company

Qualification vs Continuous Monitoring Karin Torvenius, Cold Chain Specialist, Envirotainer Cold Chain ServicesDavid Graaf, Laboratory Manager, Envirotainer Cold Chain Services

How to Solve Common Shipping Problems Using Temperature Data Cyril Winkler, Team Leader, Product Management, ELPROMicalyn Harris, VP Sales & Marketing, ELPRO

Pushing what is Possible in Temperature Controlled Transportation Susan Li, Marketing Manager, Healthcare Strategy, UPS Tim Fosnough, Global Director, Freight Forwarding – Healthcare, UPS

a TCP Company

TRAINING BTRAINING AMonday, October 5th, 2015

Temperature-Controlled Clinical Trial Materials (CTMs) Packaging Essentials & GDP EssentialsTrainer: Steven Jacobs, President, Global BioPharm Solutions, LLC

Registration & Breakfast GDP – In-Depth Analysis and Comprehensive OverviewTrainer: Mary Foster, Chair, Packaging and Storage Expert Committee, United States Pharmacopeia

OR

9:00am- 4:30pm

8:30am

Tuesday, October 6th, 20157:45am Registration for Workshops A & B

8:30am -10:30am Best Practices in Sales Representative Sampling Scott Dyvig, Program Manager, Packaging Engineering and Technical Services, Jarden Life Sciences

WORKSHOP A

WORKSHOP C

WORKSHOP E

WORKSHOP G

WORKSHOP B

WORKSHOP D

WORKSHOP F

WORKSHOP H

OR

OR

OR

OR

Two workshops run concurrently during each time slot. Workshops were preselected at registration. Consult the back of your badge or a Cold Chain team member to confirm your workshop preselection.

CAMBRIDGE COMPLEX BEACON HILL COMPLEX

BEACON HILL COMPLEX

BEACON HILL COMPLEX

BEACON HILL COMPLEX

BEACON HILL COMPLEX

WATERFRONT BALLROOM 2

WATERFRONT BALLROOM 2

WATERFRONT BALLROOM 2

WATERFRONT BALLROOM 2

LIGHTHOUSE BALLROOM

CC13th Cold Chain

Global Forum

GDP & Temperature Management Logistics

13@CCGlobalForum #13CCGF

CC13th Cold Chain

Global Forum

GDP & Temperature Management Logistics

14 @CCGlobalForum #13CCGF

7:45am Coffee and Networking in in the Exhibition Hall Make sure to get your Bingo Card at registration for a chance to win prizes

8:45am Welcome Remarks by IQPC

8:55am Conference Chair Opening Remarks Kevin O’Donnell, Vice President Cold Chain Standards, Practices & Compliance, BioLife Solutions, Inc .

9:00am KEYNOTE: FDA’S Risk Based Strategy for the Life Science Supply Chain Ted Poplawski, Director, Divison of Import Operations, FDA

9:45am USP General Chapter: Good Distribution Practices Mary Foster, Chair, Packaging and Storage Expert Committee, United States Pharmacopeia

10:30am Evolution of the Supply Chain, Bulk through Last Mile: $21 Billion in Refrigerated Pharmaceuticals Distributed in Sustainable Solutions Ben VanderPlas, Global Product Manager, Sonoco ThermoSafe Chris Anderson, Director, Quality Operations, Cardinal Health11:05am Morning Networking Break in Exhibition Hall The Exhibit Hall will feature all the latest packaging/container, transportation, logistics, temperature monitoring, security, and data management solutions. Join your peers to browse the 2015 Solution Hall and participate in the Exhibit Hall Passport.

11:55am Transition to Roundtable Discussions

Main Conference Day OneWednesday, October 7th, 2015

12:55pm Networking Lunch

Minimizing the Impact of Harsh Winters – Building a Cold Chain Winning Strategy Robert Heinrich, Sr. Traffic Administration, Advisor, Novartis

Meeting the Regulatory Challenges of Managing Return & Reconciliation of Investigational MedicinesReynaldo Roman, Senior Manager of Regulatory Compliance, Marken

Establishing a Best Practices Supply Chain Security Maturity ModelPlease refer to addendum for updated information on this session

Monitoring Supply Chain Condition and Logistics across Land, Sea, and AirBill Wark, Director, IoT Vertical Solutions, AT&T

SINDUSFARMA Brazil GDP – Upcoming Requirement, Trends and Future OutlookJair Calixto, GMP and Audits Manager, SINDUSFARMA

Sensor-Based Logistics: Getting Near-Real Time Visibility on Location and Environmental Data in your Supply ChainChris Swearingen, Marketing Manager, FedEx Services – SenseAware

Practical Use and Strategies – Ambient Temperature Profiling Ingrid Freeland, Global Quality Assurance – Americas, Astellas US Technologies Inc .

Internal & External Networking for Optimal Supply Chain SecurityDavid Wilt, Chair / Global Supply Chain Security Manager, TAPA (The Americas) / XEROX Cororation

Warehousing Pain Points – TOR Challenges in the MFG EnvironmentBob Stoner, Warehouse/Logistics Manager, Baxter International

Fundamentals of Auditing External Suppliers and Quality Systems including SOP’s and Quality (Service) AgreementsPlease refer to addendum for updated information on this session

Mastering the Use of Passive Containers for an International MarketManuel Sardinas, Americas Regional Logistics CSO Manager, Bristol-Myers Squibb

Qualification of Thermal Shipping Systems to Meet Global Health Authority RequirementsJustin Bourret, Engineer II, Genentech

CEIV Pharma: Update and Impact on Brussels AirportRonald Schaefer, Project Lead, Center of Excellence for Pharma Logistics, IATASteven Polmans, Head of Cargo, Brussels Airport Company

Challenges and Benefits of using ISTA’ Standard 20 for the Development of ISC’sEdward A . Church, President, ISTA

With changes throughout the world in Good Distribution Practices, there are many critical areas of the temperature control supply chainthat need to be updated and in compliance . Choose from the GDP topics below that you’d like to share challenges, issues and commonideas/mistakes with your peers .

12:00pm CONCURRENT INTERACTIVE GDP ROUNDTABLE DISCUSSIONS

1

7

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12

13

14

2

3

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5

6

ROOM KEY- Find your roundtable

Divide and Conquer with Your Team – To ensure youare gaining the most value from the event, divideyour team members across different roundtables and tracks.

Roundtable 1 Beacon Hill 1Roundtable 2 Beacon Hill 2Roundtable 3 Beacon Hill 3Roundtable 4 Cambridge 1Roundtable 5 Cambridge 2

Roundtable 6 Waterfront Ballroom 1 ARoundtable 7 Waterfront Ballroom 1 BRoundtable 8 Waterfront Ballroom 1 CRoundtable 9-10 Waterfront Ballroom 2Roundtable 11-14 Commonwealth Hall D & E

EXHIBIT HALL PASSPORT

COMMONWEALTH ABC

HARBORVIEW BALLROOM & CITYVIEW BALLROOM

COMMONWEALTH DE

COMMONWEALTH DE

COMMONWEALTH DE

COMMONWEALTH DE

COMMONWEALTH DE

CC13th Cold Chain

Global Forum

GDP & Temperature Management Logistics

15@CCGlobalForum #13CCGF

Main Conference Day One (Continued)

7:00pm POST MAIN DAY ONE RECEPTION 3 Hour Boat Cruise around the Boston Harbor (Invite Only)

Please see page 9 for location details and departure time .

2:45pm

5:05pm

4:20pm

2:40pm

3:25pm4:15pm

5:00pm

5:45pm

5:50pm

Track Session Transition

Afternoon Networking Break in The Exhibition hallTrack Session Transition

Track Session Transition

End of Main Conference Day 1

13th Annual - Networking Drinks Reception in Exhibition HallJoin your peers to browse the 2015 Exhibit Hall where you’ll be able to find all the latest packaging/container, transportation, logistics, temperature monitoring and data management solutions. The ideal place to meet existing and new partners! Be sure to stick around for the Tissot Watch Giveaway during the reception!

CASE STUDY: Why settle? How the Right Packaging and Partner Resulted in Better Solutions for the Same PriceJay McHarg, President, American AerogelDarold Hill, Director of Manufacturing & Validation, Gilead Sciences

Packaging Advances for Frozen ShipmentsDoug Smith, President, NanoCool

Ambient Temperature Profile Generation and its Effect on Passive ShippersDr . Bernard McGarvey, Senior Engineering Advisor, Engineering Technology Center, Eli Lilly & Co .Geoff Kaiser, Director of Engineering & Technical Services, Cold Chain TechnologiesShreyas Panse, Thermal/CFD Engineer, Cold Chain Technologies

Expanding the Use of Ocean Freight Beyond CRT/Ambient ProductsMike Broughton, Director - Global Logistics, Eli Lilly and Company

PANEL DISCUSSION: Temperature Control Road Transport Carrier StandardsArminda O . Montero, Manager, Global Supply Chain Quality, AbbVie Inc .Jason Sawicki, Senior Manager Operational Excellence and Packaging, GenentechBryan Cardis, Consultant Cold Chain and Packaging Engineer, Eli Lilly and CompanyScott Emery, Manager of Global Transportation, Priority Solutions International

Four Essentials Every Supply Chain Executive Must Adopt when Creating the Smarter Cold ChainLuis Hernandez, Sr. Logistic Validation Manager, BaxaltaNigel Wing, Global Head of Life Sciences and Healthcare, DHL Global Forwarding

Packaging Fundamentals and Related Industry Best Practices and Packaging TechnologiesPlease refer to addendum for more information on this session

Enabling a Pharmaceutical Sales Force with the Ability to Hand Carry Cold Chain Sampled ProductsMichael DeMartin, Program Manager, Sanofi-Aventis

Shipping at Expanded Temperature Ranges: Challenges and Success StoriesRebecca E . Gentile, Senior Specialist, Quality Vaccine and Biological Stability, Merck

Concurrent Sessions . Please Choose Track A, B, C or Blue Sky Room Discussions

2:00pm PART 2 FOLLOW UP CASE STUDY FROM 2014 - Sustainable Cost Effective Temperature Controlled Packaging SolutionsLisa Barbieri Moher, Deputy Director of Distribution Packaging, Sanofi

Data Integrity: Where Does it Start and What Are the Boundaries?Sue Soderholm, Global Complaints Management – Manager, Hospira

CASE STUDY: Global Transport of Ambient Products: From Risk Assessment to ValidationEmilie Déglise, Asst. Manager QA Logistics, QA Logistics, Celgene International

Establishing a Global Shipping Qualification, Monitoring and Control StrategyCarolyn Williamson, MBA, Scientist; Manufacturing Sciences, Bristol Myers Squibb

Track A: PACKAGING/CONTAINERS Robust and Customizable Solutions for your Supply

Chain Needs

Track A: COLD CHAIN PACKAGING/

CONTAINERS

BLUE SKY ROOM DISCUSSIONSParticipate in lively high level

discussions designed to identify real solutions for timely industry

verticals and challenges .

Track B: GLOBAL LOGISTICS Improving Industry Standards .

Track B: GLOBAL LOGISTICS Improving Industry Standards .

Track B: OCEAN FREIGHT Cost Effective Solution for your

Supply Chain

Track C: CRT/AMBIENT Addressing CRT Logistics,

Compliance, Costs and Risk .

Track C: LAST MILE - Improving Sample Quality & Delivery

Track C: SUPPLY CHAIN OPTIMIZATION

TRACK C: Packaging Design Essentials 101

Sponsored by:

GENERAL SESSION ROOM CAMBRIDGE COMPLEXWATERFRONT BALLROOM 2 & 3 BEACON HILL COMPLEX

End of Blue Sky Room Track

Sponsored by:

CC13th Cold Chain

Global Forum

GDP & Temperature Management Logistics

16 @CCGlobalForum #13CCGF

Main Conference Day TwoThursday, October 8th, 20158:00am – Breakfast Briefings8:45am Breakfast Briefing A: How to Gain Competitive Advantage by Applying Data Analytics to Your Temperature Controlled Supply Chain Boriana Cavicchia, Program Analyst, Office of Research & Development, US Department of Veterans Affairs

8:00am Networking and Coffee in the Exhibition Hall

8:55am Opening Remarks by Chairman

9:00am Keynote: New Challenges in the European Union GMP Guide Michael Zwitkovits, MSc, GDP & GMP Inspector, Austrian Federal Office for Safety in Health Care

9:45am Blending of GMP, GDP and GIP Into Your Quality Management System (QMS) David A Ulrich, QA Director - Supply Chain Compliance, AbbVie Inc .

10:25am Morning Networking Break in the Exhibition Hall Join your peers to browse the 2015 Exhibit Hall . Participate in the Live Technology/ Services Demo Drive to learn more about the newest and most innovative solutions in the market today.

These presentations will showcase participating sponsor products/services. Each delegate will be given a map of the Exhibit booths running a live demo of their products for the first 15 minutes of the networking break. Select a booth and gather around to hear about the participating sponsor products/services. The demos that will run are staggered across two groups; the first group will have 7 minutes before handing over to the second group. Get the most out of the world’s largest exhibition of solutions for temperature controlled life science products!

11:25am Reliability, Quality, and Sustainability Goran Rydin, CTO, Envirotainer12:05pm COLD CHAIN GLOBAL FORUM EXCELLENCE AWARDS WINNERS ANNOUNCEMENT IN THE GENERAL SESSION ROOM

12:20pm Moving from Good to Great: Distribution Practices in the Supply Chain Thomas Grubb, Manager, Cold Chain Strategy, American Airlines Cargo1:00pm Networking Lunch1:55pm Transition to the Afternoon Tracks

OR

Concurrent Sessions . Please Choose Track A, B, C or Blue Sky Room Discussions

2:00pm CASE STUDY: Cold Chain challenges: A -60C to -80C Ebola Vaccine Phase 3 Clinical Trial in Sierra LeoneGeoffrey Glauser, Vaccine & therapeutic product supply chain Executive Consultant at Conceptual Mindworks in support of Health & Human Services, Assistant Secretary for Preparedness and Response Biomedical Advanced Research and Development Authority (BARDA)

Stability Budget and the GDP - Creating and Using a “Stability Budget” for Your Shipping ProcessesColleen Hutter, Director – GTO Packaging Technical Operations – Logistics & Distribution Technology, Merck

Results of GDP Inspections Based on the New EU GDP GuidelinesRiekert Bruinink, Senior GMP/GDP Inspector, Dutch Healthcare Inspectorate

Ocean Freight - Eliminating the Risk of Failure for you CRT & Cold Chain ProductsJames Jean, Global Logistics Temperature Control Manager, Bristol-Myers Squibb

Track A: CLINICAL TRIALS

GDP Compliance for Global Distribution

BLUE SKY ROOM DISCUSSIONSParticipate in lively high level

discussions designed to identify real solutions for timely industry

verticals and challenges .

Track B: STABILITY DATA & LANE QUALIFICATION - Working

Towards an Industry Consensus

Track C: REVIEW OF NEW EU GDP GUIDELINES

GENERAL SESSION ROOM CAMBRIDGE COMPLEXWATERFRONT BALLROOM 2 - 3 BEACON HILL COMPLEX

w w w . C o l d C h a i n G l o b a l F o r u m . c o m@CCGlobalForum #13CCGF Cold Chain & GDP Global Forum

Live Technology/Services Demo DriveParticipate in this morning’s Live Technology/Services Demo Drive to learn about the latest and most innovative solutions available in your ever evolving industry. Rotate around the exhibit hall watching live technology demonstrations and take away even more ideas, knowledge and information that will allow you to address your supply chain needs.

Listed on the back are our participating sponsors and an outline of their products/services along with key information takeaways to be presented during the sponsored live demos. The demos that will run are staggered across two groups, the fi rst green group will have 15 minutes before handing over to the second blue group.

GROUP 1: Thursday, October 8th between 10:35-10:50am (Indicated by a Green Dot)

GROUP 2: Thursday, October 8th between 10:55-11:10am (Indicated by a Blue Dot)

Sponsor Exhibitor

Zone

A B

C D

Cold Chain Presentation

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F&B

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F&B

F&B

Sponsored by:

WiFi Lounge

Entrance to Conference Room

Entrance into Expo Hall

Entrance to Conference Room

335

313

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536634

E

F&BC434

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REGISTRA

TION

SELECT 1 VENDOR FROM EACH GROUP

PLEASE REMEMBER TO TURN IN YOUR EVALUATION FORM .

IQPC values customer

feedback and will translate improvement

ideas into action for 2016 .

Breakfast Briefing B: Supply Chain Management – Leveraging Collaboration for Cold Chain OptimizationSurendra Deodhar, Head, Supply Chain Management, Reliance Life Sciences

LIVE DEMO DRIVE

WATERFRONT BALLROOM 2 - 3 BEACON HILL COMPLEX

COMMONWEALTH DE

COMMONWEALTH DE

COMMONWEALTH DE

COMMONWEALTH DE

COMMONWEALTH DE

COMMONWEALTH DE

COMMONWEALTH ABC

HARBORVIEW BALLROOM & CITYVIEW BALLROOM

CC13th Cold Chain

Global Forum

GDP & Temperature Management Logistics

17@CCGlobalForum #13CCGF

Main Conference Day Two (Continued)

2:45pm

4:00pm

4:45pm

2:40pm

3:55pm

4:40pm

5:25pm

3:25pm

Track Session Transition

Track Session Transition

Track Session Transition

End of Main Conference Day 2

Afternoon Networking Break

2020 Trends and How They will Impact Supply Chain LogisticsAriette Van Strien, Chief Commercial Officer, MARKENDan Bell, Vice President of Regulatory Compliance and Technical Affairs, MARKEN

PANEL DISCUSSION: Finding an Industry Consensus for Lane QualificationJohn Heller, Principal Packaging Engineer Global Packaging Technology, Bristol-Myers SquibbColleen Hutter, Director – GTO Packaging Technical Operations – Logistics & Distribution Technology, MerckVenkat Venugopal, Principal Packaging Engineer, Bristol-Myers Squibb .

Connecting the Dots for a Proactive Approach to Cold Chain SecurityJohn Dwiggins, Director of Life Science, Panther Premium LogisticsBill Rambo, Director of Global Commercial Operations and Strategy, Priority Solutions International

Virtual Supply ChainComplexities – KeyConsiderations for CostEffective Operations andPartnershipsRandall SittnerSenior Manager, Global Cold Chain Logistics, Seattle Genetics

Biologistics and Biopreservation – Optimizing Quality, Risk, and Cost of GoodsDr . Jean-Louis Staudenmann, Project Manager, Technology Innovation Program, NISTAby Mathew, Senior Vice President & Chief Technology Officer, BioLife Solutions

Meeting GDP Requirements for APIs and Room Temperature Products: Using Existing Profiles and Qualification to Avoid CostKarl Kussow, Manager, Quality, FedEx Custom Critical

Keynote Session Follow-Up: European GDP & GMP Updates and Q&A Michael Zwitkovits, MSc, GDP & GMP Inspector, Austrian Federal Office for Safety in Health Care

Track A: BIOLOGICS

Track B: GLOBAL LOGISTICS

Ensuring Cost Effective Compliance

TRACK C: EUROPEAN REGULATION UPDATES

TRACK C: SUPPLY CHAIN INTEGRITYSupply Chain Integrity: Standards,

Quality & Robustness

PANEL DISCUSSION: Risk Mitigation – Truth or Fiction? Les Sparrow, Manager Technical Support & Analytical Services, World CourierAnthony Leone, International Customer Service Manager, World CourierPlease see addendum for more information on this session

How Technology is Being Used to Enhance Global Supply Chains and Mitigate Risk for Temperature Controlled ShipmentsJeff Clark, Founder & CEO, 7PSolutions, LLC

TRACK A: QUALITY AND RISK MANAGEMENTEstablishing Compliant Processes

TRACK B: COLD CHAIN PACKAGING/CONTAINERS

Robust and Customizable Solutions for your Supply Chain Needs

End of Track C

Access the Powerpoint Presentations Online!As an event attendee, you have complimentary access to the approved sessions PowerPoints after the event.

Download avaiable presentations from:www .coldchainglobalforum .com/presentations

Username: ColdChain2015Password: 10366009

Site will be live on October 20, 2015 | Expires on January 20, 2016

End of Blue Sky Room TrackCOMMONWEALTH ABC

CC13th Cold Chain

Global Forum

GDP & Temperature Management Logistics

18 @CCGlobalForum #13CCGF

Friday, October 9th, 20158:15am Coffee and Networking

8:55am Opening Remarks by Chairman

9:00am GDP - Gain a Deeper Understanding on GDP Inspections from the (Austrian) Regulator’s Perspective Michael Zwitkovits, MSc, GDP & GMP Inspector, Austrian Federal Office for Safety in Health Care

9:45am SINDUSFARMA Perspective - Brazil’s GDP Guidelines and Requirements Jair Calixto, GMP and Audits Manager, SINDUSFARMA

10:30am Morning Networking Break

11:00am Maneuvering India’s Landscape – Sharing Local Experiences Surendra Deodhar, Head - Supply Chain Management, Reliance Life Sciences

11:45am Brazil Inbound Logistics- Cold Chain Challenges for Biologics Marcelo Couto, Regional Director, Global Logistics Services, Bristol-Myers Squibb

12:30pm Networking Lunch

1:30pm Risk Based Approach for Global Distribution of Room Temperature Clinical Trial Investigational Products Lisa R . Ray, Advisor: Distribution CoE and Process Ownership, Eli Lilly and Company Sébastien Delporte, QA Packaging and Logistics Manager, Eli Lilly European Clinical Trial Services S .A . Austin Walker, Manager Clinical Trial Manufacturing, Eli Lilly and Company

2:15pm Creating North American Synergy – Leveraging Canada as a Gateway to the North American Market Jon Saunders, Vice President, Finance, Polaris Transportation Group

3:00pm Afternoon Networking Break

3:15pm PANEL DISCUSSION: Supply Chain Partner Collaboration – Improving Last Mile Visibility and Timely Delivery in Challenging Regions of the World Emilie Déglise, Ass. Manager QA Logistics, QA Logistics, Celgene International Manuel Sardinas, Americas Regional Logistics CSO Manager, Bristol-Myers Squibb

4:00pm Regulations and Future GDP Initiatives in China Yonghua Gao, Deputy, Secretary General, China National Pharmaceutical Packaging Association CHPRepresentative

4:35pm End of Conference

International Focus Day

If you are not yet registered for our International Focus Day its not too late! Register and network with +80 industry thought leaders focused on international supply chains .

HARBORVIEW BALLROOM II