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The Upcoming 2025 ISPE Annual Meeting & Expo

The International Society for Pharmaceutical Engineering (ISPE) is gearing up for its largest event of the year—the 2025 Annual Meeting & Expo, which is scheduled from October 26 to 29 in Charlotte, North Carolina. This event serves as a vital platform for professionals in the pharmaceutical industry to network, share insights, and discuss the latest advancements.

Keynote Speakers

The lineup of keynote speakers promises to be both inspiring and informative, focusing on transformative experiences in the pharmaceutical industry. Here are some confirmed prominent figures to speak:

• - Brendan O'Callaghan, Executive Vice President at Sanofi, will discuss "Transforming Pharma Manufacturing: Sanofi's Journey Towards Digital Excellence in the Pharma 4.0™ Era".
• - Elaine Shannon, Global Quality Officer at Takeda, will present "Unlocking Excellence: Takeda's Quality Transformation".
• - Jerh Collins, PhD, Chief Technology Operations and Quality Officer at Moderna, will address "Scaling mRNA Impact Through Platform, Culture, and Digital".
• - Jerry Greco, Chief Quality Officer at Baxter International Inc., alongside Emily Thakur from the US FDA, will share insights on "Crisis Management and Partnership with the US FDA".
• - Finally, John Daniel, a retired HR executive and author, will share his personal journey in "One Billion More Heartbeats: My Journey Through Heart Transplantation".

Theme and Focus

The overarching theme for this year’s conference is Pharma 4.0™. This year, ISPE aims to focus heavily on the challenges and opportunities presented by the digital transformation in the pharmaceutical industry. Gunter Baumgartner, Senior Vice President and Head of Global Engineering at Takeda Pharmaceuticals, explains that this year's sessions are designed to address key industry challenges, such as compliance and innovation in regulatory frameworks.

Mike Martin, President and CEO of ISPE, emphasizes the organization’s commitment to impactful content, remarking, "We are particularly excited to spotlight digital transformation initiatives through the lens of Pharma 4.0, including AI, blockchain, and digital twins."

AI-Focused Sessions

A substantial portion of the meeting will feature sessions centered around artificial intelligence and its applications in pharma. Attendees can look forward to:

• - Managing the Compliance of Agentic AI in GxP Process
• - A Practical Guide to AI Deployment in a GMP Environment
• - AI/ML in Regulatory Decisions Compliance and Innovations
• - New GAMP® AI Guide Overview and Key Concepts
• - Beyond the Pilot: The AI Adoption Playbook

Interactive Workshops

Beyond keynotes and panels, this year’s meeting will also include interactive workshops designed to provide hands-on experience and practical insights:

• - Facilitating Analytical Procedure Changes via ICH Q14
• - Integrated Process for Drug-Device Combination Products
• - The Decision Process for Continuous Biomanufacturing
• - Implementing an AI Solution in a Pharma 4.0™ Context
• - From Imposter to Impact: Reinventing Your Career with Confidence, led by ISPE's Women in Pharma®.

Registration and Additional Information

For those looking to be part of this significant event, registration is now open. Attendees are encouraged to visit ISPE.org/AM25 for registration details and further information.

About ISPE

Founded in 1980, the International Society for Pharmaceutical Engineering is a global nonprofit organization that provides services to its members through technical, scientific, and regulatory advancements across the pharmaceutical lifecycle. With over 23,000 members in more than 120 countries, ISPE is dedicated to solving complex challenges within the industry, fostering innovation, and driving sustainable practices in pharmaceutical engineering.

In summary, the 2025 ISPE Annual Meeting & Expo not only promises to be a premier gathering for thought leaders in the pharmaceutical sector but also serves as a crucial stepping stone towards the future of pharmaceutical manufacturing and engineering. Don’t miss out on this opportunity to learn, connect, and innovate in the field.