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Elaine Shannon, Global Quality Officer at Takeda, provides a high-level overview of her upcoming presentation at the 2025 ISPE Annual Meeting & Expo. Shannon shares how Takeda’s approach to pharmaceutical quality has evolved over the years, how the company is shifting toward a more agile and digitally enabled quality model, how they are addressing fortifying data, where they see friction when it comes to teams adopting digital tools, and how they are managing balancing agility and compliance.

ISPE’s largest event of the year—the 2025 ISPE Annual Meeting & Expo—will take place from 26–29 October in Charlotte, North Carolina, USA. The following article outlines some of the conference’s planned keynote speakers and key topics that will be discussed, with an overview of sessions that will specifically focus on artificial intelligence.

Brendan O’Callaghan, Executive Vice President, Head of Manufacturing and Supply at Sanofi, previews the insights he plans to share at the 2025 ISPE Annual Meeting & Expo in the article that follows. O’Callaghan outlines a few of Sanofi’s flagship digitalization initiatives, as well as the company’s approach to standardization, its modernization push with SMS2.0 and smart factory initiatives, and its partnership approach. He also provides recommendations for smaller companies to consider for their digitalization efforts.

CSL Behring is a 2025 ISPE Facility of the Year Awards (FOYA) category winner. The article that follows features an interview with Anthony Kaye, Senior Director of Base Fractionation at CSL Behring, on CSL Behring's unique initiative, Project Aurora, which has received Pharma 4.0™ category-winning recognition. 

The overall FOYA winner will be announced on Sunday, 26 October in Charlotte, North Carolina, USA at the 2025 FOYA Banquet and Awards Celebration, taking place at the 2025 ISPE Annual Meeting & Expo.

Category winners for the 2025 Facility of the Year Awards (FOYA) category winners have been announced. Pharmaceutical Online recaps the category winning projects in the article that follows, noting: “These distinguished companies were selected not only for their outstanding achievements in engineering and design but also for their commendable contributions to their communities and profound impact on human lives.”

ISPE has announced the 2025 Facility of the Year Awards (FOYA) category winners. The article that follows, published by BioProcess International, highlights two honorees, Bayer and Touchlight.

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.

In the article that follows, they outlined the novel statistical approach to stability that they presented at the conference and discussed the purpose of Pfizer’s Accord for a Healthier World program, which aims to address healthcare disparities in lower income countries. Brown and Niu, along with their colleague Paul Gerst, Senior Principal Scientist with Pfizer, explain the program and describe how their statistical approach accounts for the higher temperatures and humidity conditions that many lower income countries experience, how they are balancing prediction model innovation with the need for global regulatory acceptance, and more.