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Main Conference Day Two

8:05 AM - 8:45 AM BREAKFAST BRIEFING: USP <1079> and the Evolution of Good Distribution Processes: Enhancing Quality Assured Processes to Maintain Product and Supply Chain Integrity through Advanced Risk Mitigation Techniques

Chris Anderson, Director, Quality Systems, USP Packaging and Distribution Expert Committee Member, USP <1079> Sub-Committee Co-Chair, Cardinal Health, U.S. Pharmacopeia

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Chris Anderson

Director, Quality Systems, USP Packaging and Distribution Expert Committee Member, USP <1079> Sub-Committee Co-Chair
Cardinal Health, U.S. Pharmacopeia

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

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Ben Vanderplas

Global Product Manager
Sonoco Thermosafe
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Lisa Ray

Advisor For Global Clinical Trial Distribution
Eli Lilly and Company
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Chris Anderson

Director, Quality Systems, USP Packaging and Distribution Expert Committee Member, USP <1079> Sub-Committee Co-Chair
Cardinal Health, U.S. Pharmacopeia

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: The Pros & Cons of Leasing Vs. Purchasing
ROUNDTABLE 9: Supplier Qualification & SOP Writing
ROUNDTABLE 10: Customs Documentation Issues for Air & Ocean Cargo

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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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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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Lori Kreidermacher-Carter

Senior Import Specialist, Pharmaceuticals, Health & Chemicals CEE
U.S. Customs and Border Protection
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Parag Vapiwala

Global Logistics & Supply Logistics Manager
Bristol-Myers Squibb
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Alan Kennedy

Founder
PHARMA TEAM UP
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Viliam Kovac

Head of Global Supply Quality
Roche Diagnostics GmbH
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Vishal Khushalani

Director of Marketing and Business Development
Sonoco Thermosafe

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 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

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

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 A Deep Dive into the Transformative Power of Evolving Technology in Life Science

Julie Hurley, Industry Director, Enterprise Solutions, Unisys

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Julie Hurley

Industry Director, Enterprise Solutions
Unisys

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

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

Taylor Clark, Vice President of Marketing and Sales, RNC Industries Inc. Regis Gautier, Director, Global Packaging Technology, Bristol-Myers Squibb Lisa moher, Head Of Distribution Packaging & Labeling, NA Supply Chain, Sanofi

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Taylor Clark

Vice President of Marketing and Sales
RNC Industries Inc.
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Regis Gautier

Director, Global Packaging Technology
Bristol-Myers Squibb
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Lisa moher

Head Of Distribution Packaging & Labeling, NA Supply Chain
Sanofi

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

PACKAGING/LOGISTICS

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

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

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Yasuhiro Suzue

Manager of PCM Business Promotion Team
Kaneka Corporation

SERIALIZATION/SECURITY

4:35 PM - 5:15 PM Utilizing a Risk-Based Approach to Ensure Global Supply Chain Security & GDP Compliance within a High Threat Market

Leo Vaytsman, Regional Manager,Global Product Protection, Global Quality, Takeda Pharmaceuticals

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Leo Vaytsman

Regional Manager,Global Product Protection, Global Quality
Takeda Pharmaceuticals