Welcome to the Virtual Summit: Manufacturing

The NEW Virtual Summit is a one-day virtual program on different hot topics with four sessions of speaker presentations and panel discussions.

This Virtual Summit on "Opportunities and Challenges of Expanding US-based Pharmaceutical Manufacturing" will convene thought leaders to discuss the latest developments and future considerations that will support participants with navigating the dynamic US manufacturing environment. The Summit will bring together diverse perspectives, aiming to identify actionable strategies and highlighting valuable lessons learned from both US and non-US regions. View the full Summit abstract below.

The full scientific program will be available soon.

Summit Abstract

The global pharmaceutical manufacturing landscape is undergoing a significant transformation, driven by the strategic imperative to enhance supply chain resilience and onshore critical manufacturing capabilities. This has created an unprecedented focus by the US government aimed at promoting the construction and expansion of domestic pharmaceutical manufacturing sites. While these developments present significant opportunities, they also require deep understanding and critical evaluation of the complex underlying logistical, technical, and regulatory hurdles that can impact progress.

This Summit will convene thought leaders to discuss the latest developments and future considerations that will support participants with navigating the dynamic US manufacturing environment. The forum will address challenges and opportunities, with sessions dedicated to:

• Foundational Strategy: Addressing upfront challenges in infrastructure planning, site selection, permitting, and building a skilled workforce.
• Regulatory Engagement and Innovation: Discussions regarding US FDA’s evolving role and new policies, including aspects such as preoperational meetings, and how industry can build regulatory confidence in a new site through scientifically sound approaches.
• Lifecycle Management: Considerations including technology transfers, and managing regulatory requirements, such as requirements for process validation, implications of post-approval changes, and aligning on expectations for maintaining compliance and considerations for dossier content.

The Summit will bring together diverse perspectives, aiming to identify actionable strategies and highlighting valuable lessons learned from both US and non-US regions. Participants will come away with a deeper appreciation of these perspectives, preparing them to contribute to and benefit from the ongoing evolution of the US framework for pharmaceutical manufacturing. The Summit will be forward looking and seek to shed light on how best to navigate the future path based on current knowledge and best practices, especially based on the informed perspectives offered by multidisciplinary expert panels.