从所有权到自动化：驱动 Pharma 4.0™ 的运营模式——2026 ISPE Pharma 4.0™ 与生物制药大会专场
From Ownership to Automation: The Operating Model Driving Pharma 4.0™
拜耳全球工程与维护卓越高级副总裁 Christopher Grail 将在 2026 年 12 月 10-11 日于柏林及线上举行的 2026 ISPE Pharma 4.0™ 与生物制药大会上主讲“从所有权到自动化：驱动 Pharma 4.0™ 的运营模式”。
These topics will take center stage at the 2026 ISPE Pharma 4.0™ and Biopharma Conference, taking place 10-11 December 2026 in Berlin, Germany, and virtually. Bringing together pharmaceutical and biopharmaceutical manufacturers, technology partners, academic experts, and regulators, the conference will explore how organizations can turn digital ambition into measurable operational impact.
One of the featured general sessions, "From Ownership to Automation: The Operating Model Driving Pharma 4.0," will be presented by Christopher Grail, Senior Vice President, Head of Global Engineering and Maintenance Excellence at Bayer AG. Drawing on lessons learned from Bayer's transformation journey and real-world examples from two ISPE Facility of the Year Awards (FOYA)-category award winning facilities, attendees will gain practical insights into how organizations can align people, technology, and data to accelerate innovation and improve manufacturing performance.
The following Q&A highlights several of the key themes that will be explored during Christopher Grail’s session, including scaling AI and automation, building operating models that support Pharma 4.0, and transforming digital investments into measurable business and patient value.
Insights from Christopher Grail, Bayer AG
1. What key industry challenges is your session addressing?
The industry's challenge is no longer identifying new technologies. The challenge is scaling them. Pharmaceutical manufacturers must move beyond isolated AI and automation pilots and deploy these capabilities consistently across global manufacturing networks while maintaining the highest standards of quality and compliance.
At the same time, this transformation requires more than technology implementation. Organizations need new skills, new mindsets, and greater ownership at the team level. As companies pursue increasingly digital operating environments, they must also rethink how teams work, make decisions, and collaborate across functions.
My key message is simple: Pharma 4.0 is not primarily a technology transformation. It is an operating-model transformation that enables people, technology, and data to work together to create value faster and more effectively. Technology can be a powerful enabler, but sustainable results depend on creating the organizational structures, culture, and capabilities necessary to scale innovation successfully.
2. What are a few new and exciting topics that will be covered at the in your session?
One of the most exciting developments is that the industry is moving beyond the concept of the smart factory and beginning to see Pharma 4.0 deliver tangible results. Organizations are increasingly applying digital technologies not as isolated initiatives, but as integrated capabilities that improve manufacturing performance, operational flexibility, and business outcomes.
In my session, I will share examples from two ISPE FOYA category award winning facilities, SOLIDA-1 and Bayer's Cell Therapy Facility (CCTC). These examples demonstrate how modular facility concepts, advanced robotics, autonomous material flow, and deeply integrated digital systems can work together to support modern pharmaceutical manufacturing. They also illustrate how organizations can successfully implement advanced automation technologies while supporting innovation in highly complex manufacturing environments.
Another important topic is the growing role of AI in pharmaceutical operations. We are increasingly implementing AI solutions that support data analysis, troubleshooting, decision-making, and knowledge management. These capabilities have the potential to help organizations operate more efficiently while making better use of the information generated throughout the manufacturing lifecycle.
Most importantly, I will talk about how empowered, interdisciplinary teams connect engineering, automation, IT/OT, quality, and manufacturing. That combination of human ownership and advanced technology is what turns Pharma 4.0 from an ambition into real performance. While much attention is given to emerging technologies, it is ultimately the people behind these systems who determine whether transformation efforts succeed.
3. What will this conference/conference track/your session help attendees solve for their employers?
Attendees should leave with a clearer view of how to convert Pharma 4.0 investments into measurable business and patient value. While many organizations understand the potential benefits of digital transformation, there is often uncertainty around how to scale these initiatives and deliver meaningful results. My goal is to help attendees better understand the organizational and technical foundations required for success.
That includes learning how to organize interdisciplinary teams, establish clear ownership, and connect data, automation, and operational expertise around a shared outcome. These elements are essential for creating sustainable improvements and ensuring that technology investments drive real business impact.
In our SOLIDA-1 example, this approach supports high levels of end-to-end automation, more efficient documentation, increased equipment effectiveness, greater flexibility, and faster progression from clinical to commercial manufacturing. The session will provide practical examples of how operating-model transformation and digital technologies can work together to improve performance and accelerate innovation.
The return is not only lower cost. It is faster execution, more reliable operations, better use of scarce capabilities, and, most importantly, the ability to bring innovative medicines to patients sooner. Participants will gain practical ideas they can take back to their organizations and apply to their own digital transformation initiatives. My goal is that attendees return to their companies with actionable strategies for aligning technology, people, and operating models around value creation.
Learn more about the 2026 ISPE Pharma 4.0™ and Biopharma Conference and discover how industry leaders are turning digital ambition into operational impact.
Several other Bayer subject matter experts were recently featured in ISPE Podcast: Shaping the Future of Pharma for the team’s 2026 FOYA-category award winning SOLIDA-1 project.
来源：ISPE iSpeak 专家博客 · ispe.org