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

Workshop Day

09:00 - 12:00 Strategies for Mitigating and Assessing Risk during Development of Packaging Design

Christopher Lyons - Package Engineering, North American Logistics Operations, Eli Lilly and Company
  • Utilizing risk management strategies to properly assess risk for packaging of biologic based products
  • Addressing temperature variables including vibration, shock, humidity, and light exposure to protect and preserve your product
  • Discovering unique primary packaging to differentiate your product and delivery to bring an effective and safe drug product to market
  • Considering all characteristics of your biological product to ensure best product delivery methods
  • Recognizing how your dose size may affect your packaging decisions
  • Qualifying your package design with simulated transit tests

Christopher Lyons

Package Engineering, North American Logistics Operations
Eli Lilly and Company

12:00 - 15:00 Continuous Process Improvement: Adjusting on The Fly to Ensure You Keep Up with Time to Market

  • Evaluating innovations in the US as a downfall due to lack of international technologies and global standardization
  • Understanding how moving at a slower global market pace is just as beneficial
  • Increasing yield and decreasing variability in complex supply chains
  • Ensuring deep review to gain insight for your biannual validation.
  • Mastering adjustments on the fly in order to keep up with the global standardization of your commercial supply chain
  • Taking advantage of technology such as mobility, warehouse automation systems and management systems to improve efficiency and minimize costs and inaccuracies
  • Implementing a system to continuously measure, improve, and if need be replace supply chain partners

15:00 - 17:30 Overcoming Logistical Challenges for Global Clinical Trials

Steven Jacobs - President, Global BioPharm Solutions, LLC
  • Reviewing logistical strategies for the shipping of temperature sensitive products during your clinical trials to protect the integrity of your shipments
  • Discussing flexible and cost effective approaches for complex global clinical trial supply chains
  • Ensuring global compliance for your clinical trial markets
  • Defining all potential hurdles in delays of clinical trial imports and exports
  • Ensuring seamless supply of clinical materials, such as label management, label requirements in different countries, translation management of labels and inserts, and the critical documents required
  • Identifying global clinical trial security challenges

Steven Jacobs

Global BioPharm Solutions, LLC