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Main Conference Day Two

8:05 AM - 8:45 AM BREAKFAST BRIEFING: IATA Update on Dangerous Goods Regulations for the Transportation of Lithium Batteries

8:05 AM - 8:45 AM BREAKFAST BRIEFING B: NIIMBL’s Innovative Approach to Manufacturing and Supplying Existing and Emerging Biopharmaceuticals

Dr. Kelvin Lee, Professor of Chemical & Biomolecular Engineering, University of Delaware

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Dr. Kelvin Lee

Professor of Chemical & Biomolecular Engineering
University of Delaware

8:45 AM - 9:30 AM KEYNOTE: Bringing Healthcare to People and People to Healthcare: The Future of Clinical Trials & Vaccine Distribution

John S. Brownstein Ph.D, Chief Innovation Officer and Professor, Boston Children’ Hospital and Harvard Medical School

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John S. Brownstein Ph.D

Chief Innovation Officer and Professor
Boston Children’ Hospital and Harvard Medical School

9:30 AM - 10:15 AM Protecting Our Assets: Global Security’s Use of Intelligence and Analysis to Understand and Combat Threats

Brad Stewart, Global Security Operations Center Manager, Alexion Pharmaceuticals, Former Chief of Staff to the President’s Daily Brief

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Brad Stewart

Global Security Operations Center Manager, Alexion Pharmaceuticals
Former Chief of Staff to the President’s Daily Brief

10:30 AM - 11:15 AM Creating Cold Chain Sustainability: Reviewing the Return/Reuse of Temperature Assurance Packaging – Considerations to Make it Work

Ben Vanderplas, Global Product Manager, Sonoco Thermosafe

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Ben Vanderplas

Global Product Manager
Sonoco Thermosafe

11:00 AM - 11:10 AM Creating End-to-End Trust Across a Pharma Chain of Custody through Leveraging RFID & Data Analytics

Jason Weiss, Senior Vice President, Cloud Platform and Applications, SMARTRAC

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Jason Weiss

Senior Vice President, Cloud Platform and Applications
SMARTRAC
ROUNDTABLE 1: Passive VS Active Shippers
ROUNDTABLE 2: Innovations in Data Collection & Storage
ROUNDTABLE 3: Maintaining Optimal Risk Levels
ROUNDTABLE 4: Challenges and Opportunities for Inventory Management for High Value or Complex Product Supply Chains
ROUNDTABLE 5: Global Supply Chain Qualification Considerations
ROUNDTABLE 6: Shipping Outside of Label Claims
ROUNDTABLE 7: Strengthening the Weakest Link in the Cold Chain-Air Freight
ROUNDTABLE 8: Effective Transitioning from Clinical to Commercial Operations
ROUNDTABLE 9: Supplier Qualification & SOP Writing
ROUNDTABLE 10: Customs Documentation Issues for Air & Ocean Cargo

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Ben Romero

Director Logistics Temperature Control
Bristol-Myers Squibb
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Ingrid Freeland

Associate Director, Quality Operations
Astellas US Technologies, Inc.
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Lisa Sykes

VBF Quality Operations Director
Merck & Co., Inc.
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Thomas Scalone

Associate Director Logistics Supply Chain
Celgene
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Rafik Bishara

Technical Advisor & Former Director QKMTS
Eli Lilly & Company
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Mark Walls

Director, Clinical Supply Operations and Logistics
Tetraphase Pharmaceuticals
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Margaretha laseen

Director, Cargo Customer Solutions & Airline Partnerships, Americas
Cathay Pacific Airways Limited
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Dip Parikh

Associate Director, Supply Chain
Biogen
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Mark Grzeszkowiak

Chief Agriculture Specialist
U.S. Customs and Border Protection
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Lin-Mai Malmstrom

Supervisory Agriculture Specialist
U.S. Customs and Border Protection
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Saheed Muhammed

Supervisory Import Specialist, Pharmaceuticals, Health & Chemical Center
U.S. Customs and Border Protection

PACKAGING/LOGISTICS

1:50 PM - 2:30 PM CASE STUDY: Defining the Root Cause for Near -90°C Excursions for Dry Ice Shipments in Passive Parcel Shippers

Rey Chern, Director, Engineering, Amgen

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Rey Chern

Director, Engineering
Amgen

QUALITY/DATA MANAGEMENT

1:50 PM - 2:30 PM Controlling Your Cold Chain Through The Last Mile: How a Cloud-Based Solution can Enhance Visibility, and Continuously Optimize your Entire Supply Chain

Vallý Helgadóttir, Director of Customer Service, Distica

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Vallý Helgadóttir

Director of Customer Service
Distica

SERIALIZATION & SECURITY

1:50 PM - 2:30 PM The DSCSA’s Impact on the Global Supply Chain: A Breakdown of the Regulations, Deadlines, and What the Supply Chain will Look Like in a Post- Serialized World

Matt Sample, Senior Director, Secure Supply Chain, AmerisourceBergen

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Matt Sample

Senior Director, Secure Supply Chain
AmerisourceBergen

BLUE SKY ROOM: Industry Think Tanks: Next Generation Of Cold Chain Management

1:50 PM - 2:30 PM Creating Industry Standards through End-to-End Integration & Effective Communication Between Key Stakeholders

Alan Kennedy, Founder, PHARMA TEAM UP

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Alan Kennedy

Founder
PHARMA TEAM UP

PACKAGING/LOGISTICS

2:35 PM - 3:15 PM CASE STUDY: Making the Case for Ocean: How a Modal Shift from Air to Ocean Freight Resulted in Cost Savings & Increased Quality

Bryan Cardis, Distribution Platform Steward, Eli Lilly & Company Steve Epperson, Consultant – QA, Materials and Operations, Eli Lilly and Company

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Bryan Cardis

Distribution Platform Steward
Eli Lilly & Company
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Steve Epperson

Consultant – QA, Materials and Operations
Eli Lilly and Company

QUALITY/DATA MANAGEMENT

2:35 PM - 3:15 PM Creating Strict Organizational Standards through Increased Supplier Visibility and Strong Quality Agreements in a Heavily Outsourced Environment

Rick Calabrese, Global Director of Corporate Quality Systems, Sartorius Stedim North America Inc

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Rick Calabrese

Global Director of Corporate Quality Systems
Sartorius Stedim North America Inc

SECURITY/SERIALIZATION

2:35 PM - 3:15 PM Fingerprinting Pharma: Ensuring Supply Chain Integrity Through Advanced Product Tracking Technologies

Ravi Kalyanaraman, Associate Director, Bristol Myers Squibb Jeremy Peters, Associate Scientist, Bristol-Myers Squibb

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Ravi Kalyanaraman

Associate Director
Bristol Myers Squibb
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Jeremy Peters

Associate Scientist
Bristol-Myers Squibb

BLUE SKY ROOM: Industry Think Tanks: Next Generation Of Cold Chain Management

2:35 PM - 3:15 PM PANEL DISCUSSION: Taking a Patient-Centric Approach to your Temperature Controlled Supply Chain Management

PACKAGING/LOGISTICS

3:50 PM - 4:30 PM PANEL DISCUSSION: Building Custom Packaging when Out of the Box Solutions are Not the Answer: Effective Co-planning with Supply Chain Partners to Create Specially Designed Packaging for Unique Situations

QUALITY/DATA MANAGEMENT

3:50 PM - 4:30 PM Building an Integrated Risk Management Framework in your Company to Allow for Increasingly Effective Decision Making

Lisa Wyman, Head of Quality Compliance & Data Analytics, Shire Pharmaceuticals

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Lisa Wyman

Head of Quality Compliance & Data Analytics
Shire Pharmaceuticals

SECURITY/SERIALIZATION

3:50 PM - 4:30 PM Utilizing a Risk-Based Approach to Ensure Global Supply Chain Security & GDP Compliance within a High Threat Market

Leo Vaytsman, Supply Chain Security Specialist, Takeda Pharmaceuticals

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Leo Vaytsman

Supply Chain Security Specialist
Takeda Pharmaceuticals

PACKAGING/LOGISTICS

4:35 PM - 5:15 PM Examining a Innovative Approach to Passive Cold Chain Logistics through Inorganic PCMs

Yasuhiro Suzue, Team Leader of PCM Business Promotion Team, Kaneka Corporation

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Yasuhiro Suzue

Team Leader of PCM Business Promotion Team
Kaneka Corporation

QUALITY/DATA MANAGEMENT

4:35 PM - 5:15 PM Data Optimization: How to Integrate and Analyze Temperature Data Stemming from Various Sources