Main Conference Day 1
09:00 - 09:45 Optimizing and Advancing Clinical Supply Chain Processes by Defeating Key InhibitorsMyriam Antoun - Director, Global Regulatory Affairs PPD
Jeffery Carrico - Pharm.D., USP General Chapters- Packaging and Storage Expert Committee USP
Louie Burks - Project Management Analyst Intarcia Therapeutics, Inc.
09:45 - 11:00 USP's New General Chapter on Storage and Distribution of Investigational Drug ProductJeffery 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 ProductsRebecca 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 QualityBill 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
15:30 - 16:15 Overcoming Obstacles to Improve Cold Chain Management of Biologics, Updates to Lithium Battery Requirements, and Qualification of Thermal Shipping SystemsChris Anderson - Quality Systems Director CardinalHealth
Philip Chou - Associate Director of Global Clinical Supply Onyx Pharmaceuticals Inc.