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Main Conference Day 1


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Jeffery Carrico

Pharm.D., USP General Chapters- Packaging and Storage Expert Committee
USP
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Myriam Antoun

Director, Global Regulatory Affairs
PPD
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Louie Burks

Project Management Analyst
Intarcia Therapeutics, Inc.

09:45 AM - 11:00 AM USP's New General Chapter on Storage and Distribution of Investigational Drug Product

Jeffery Carrico, Pharm.D., USP General Chapters- Packaging and Storage Expert Committee, USP

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Jeffery Carrico

Pharm.D., USP General Chapters- Packaging and Storage Expert Committee
USP

11:00 AM - 11:45 AM Creating a Stability Budget to Support the Packaging and Distribution of Biological Products

Rebecca Gentile, Senior Specialist, Quality, Vaccine and Biological Stability, Merck

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Rebecca Gentile

Senior Specialist, Quality, Vaccine and Biological Stability
Merck

CASE STUDY

11:45 AM - 1:30 PM A Successful Ocean Transportation Conversion that Saved Over 50% in Transportation Costs while Maintaining Product Quality

Bill Mcgillian, Associate Director, Global Logistics Product Handling and Technology, Merck

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Bill Mcgillian

Associate Director, Global Logistics Product Handling and Technology
Merck

CASE STUDY

1:30 PM - 2:15 PM Case Study: Compliance and Risk Levels for Shipping Biologics

CASE STUDY

2:15 PM - 3:30 PM Biologistics and Biopreservation – Optimizing Quality, Risk, and Cost of Goods “NIST Efforts in Regenerative Medicine”

Jean-Louis Staudenmann, Project Manager, Technology Innovation Program, NIST

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Jean-Louis Staudenmann

Project Manager, Technology Innovation Program
NIST

ROUNDTABLE DISCUSSIONS

3:30 PM - 4:15 PM Overcoming Obstacles to Improve Cold Chain Management of Biologics, Updates to Lithium Battery Requirements, and Qualification of Thermal Shipping Systems

Chris Anderson, Quality Systems Director, CardinalHealth Philip Chou, Associate Director of Global Clinical Supply, Onyx Pharmaceuticals Inc.

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Chris Anderson

Quality Systems Director
CardinalHealth
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Philip Chou

Associate Director of Global Clinical Supply
Onyx Pharmaceuticals Inc.

4:15 PM - 5:00 PM Setting up your Supply Chain: Challenges of Scale-Up and Commercialization

Umar Hayat, Senior Director, Product Development And Manufacturing, Relypsa Inc

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Umar Hayat

Senior Director, Product Development And Manufacturing
Relypsa Inc