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2021 ISPE Annual Meeting & Expo

Concurrent Session: Drug Shortages and Meeting Supply Chain Challenges


Nov 1, 2021 1:00pm ‐ Nov 1, 2021 2:30pm


Description

Concurrent Session: Drug Shortages and Meeting Supply Chain Challenges|During the pandemic, supply chain issues and drug shortages were discovered across many industries, including biopharmaceuticals.  Drug shortages have the potential to be one of the most impactful supply chain challenges to the health of people throughout the world and are a topic of significant interest to manufacturers, regulators, policymakers, health care professionals, and, most importantly, patients.  The slow pace of post-approval changes can also impact the supply chain and has the potential to create drug shortages. While the purpose of post-approval changes is typically to improve the quality of the product by incorporating a new understanding of the drug or process, approval of these changes can take months or years. Using a Digitalization Toolbox beginning with Process Development and throughout the pharmaceutical lifecycle enables a flexible change management of the product through a robust Control Strategy.  The optimal toolbox includes software and analytical tools to address knowledge management, holistic process understanding and the process monitoring and quality control across the development steps; a Holistic Control Strategy approach. This session will cover these topics and discuss how experiences with the COVID-19 pandemic provided an opportunity to further reduce drug shortages and improve the time it takes for post-approval changes to be implemented.  Additionally, analytical models can help to maintain and manage complex supply chains from the start of development in order to shorten the time to patient.  Finally, the session will open the topic of Holistic Control Strategy approach to increase processing efficiency and control across drug development.

Leader/Speaker(s):

Speaker(s):

  • Drishya Nair, Manager, Life Sciences Consulting, Ernst & Young US LLP
  • Stephanie G. Garth, Vice President, Quality Assurance North America, The Binding Site
  • Jay Welsh, Partner & Supply Chain Leader, Ernst & Young US LLP

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