ElevateBio’s transition from CSV to CSA for MES and eBRs qualification showcased strategic adaptation amid challenges. Guided by innovation, ElevateBio’s decision-making emphasized agility and compliance with evolving standards. Meticulous execution enabled seamless integration of CSA principles, enhancing operational robustness. The key points of the preesentation are:

• How was the strategic adaptation to CSA managed?
• What were the Learnings of the transition?
• What is the approach guidance to qualify MES and eBRs?

As pharmaceutical manufacturers face rising cost pressures, supply chain disruptions, and increasing demands for efficiency, the industry must rethink its approach to operational excellence. A holistic strategy—one that integrates innovative business models, digitalization, and resilient supply chains—is essential to navigating these challenges. From supply chain resilience in an era of geopolitical uncertainty to the role of new ownership models like Dynamic Shared Ownership (DSO), panelists will discuss how companies can optimize efficiency while remaining agile and competitive. In this session, you will learn more about:

• Redefining Operational Excellence: Exploring new strategies to drive efficiency, cost-effectiveness, and continuous improvement in pharma manufacturing.
• Supply Chain Resilience in a Volatile World: Addressing geopolitical tensions, rising costs, and how to build a future-proof supply chain.
• The Role of Dynamic Shared Ownership (DSO): Understanding its impact on asset management, accountability, and lean manufacturing.
• Digitalization and AI in Manufacturing: Leveraging technology to optimize decision-making and streamline production.
• New Ways of Working: How evolving workforce models and collaboration approaches are reshaping the industry.