27-29 June, 2016
The Marker San Francisco, San Francisco, CA

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 - 11:00 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 - 11:45 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

11:45 - 13:30 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

13:30 - 14:15 Case Study: Compliance and Risk Levels for Shipping Biologics

14:15 - 15:30 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

15:30 - 16:15 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.

16:15 - 17:00 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