ISPE Announces its 2025 ISPE Annual Meeting & Expo Keynote Speakers

The 2025 ISPE Annual Meeting & Expo will take place from 26–29 October in Charlotte, North Carolina, USA, and virtually.

NORTH BETHESDA, Md., Sept. 15, 2025 /PRNewswire/ -- The International Society for Pharmaceutical Engineering (ISPE) has announced its planned keynote speakers for the 2025 ISPE Annual Meeting & Expo, ISPE's largest event of the year. The conference will take place from 26–29 October in Charlotte, North Carolina, USA, and virtually.

Confirmed featured speakers and keynotes include:

• "Transforming Pharma Manufacturing: Sanofi's Journey Towards Digital Excellence in the Pharma 4.0™ Era," presented by Brendan O'Callaghan, Executive Vice President, Manufacturing and Supply, Sanofi
• "Unlocking Excellence: Takeda's Quality Transformation," presented by Elaine Shannon, Global Quality Officer, Takeda
• "Scaling mRNA Impact Through Platform, Culture, and Digital," presented by Jerh Collins, PhD, Chief Technology Operations and Quality Officer, Moderna
• "Crisis Management and Partnership with the US Food and Drug Administration (US FDA)," presented by Jerry Greco, PhD, Chief Quality Officer, Baxter International Inc., and Emily Thakur, Team Leader, Drug Shortages Staff, US FDA
• "One Billion More Heartbeats: My Journey Through Heart Transplantation," presented by John Daniel, Veteran HR Executive and Author, Retired from First Horizon Bank

This year's theme centers on Pharma 4.0™. Gunter Baumgartner, Senior Vice President Head of Global Engineering at Takeda Pharmaceuticals International AG, and Executive Chair of the 2025 ISPE Annual Meeting & Expo, discusses this year's theme, key industry challenges the conference will address, and more in a recent episode of ISPE Podcast: Shaping the Future of Pharma.

"ISPE is committed to providing impactful content that will help advance the field of life sciences and create communities for professionals to come together to share ideas and innovate," said Mike Martin, President and CEO of ISPE. "We're particularly excited to spotlight digital transformation initiatives through the lens of Pharma 4.0, including AI, blockchain, digital twins, and more."

AI-focused sessions include:

• "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," key insights from the ISPE GAMP^® Guide: Artificial Intelligence
• "Beyond the Pilot: The AI Adoption Playbook"

This year's event will also feature interactive, hands-on workshops, including:

• "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," powered and led by ISPE's Women in Pharma^®

To learn more and register for the 2025 ISPE Annual Meeting & Expo, visit ISPE.org/AM25.

About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 23,000+ members of ISPE provide solutions to complex pharmaceutical industry challenges through innovation, member and workforce development, and technical, regulatory, and compliance collaborations in more than 120 countries worldwide. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA. For more information, visit ISPE.org.

SOURCE ISPE