In the latest episode of the ISPE Podcast: Shaping the Future of Pharma, host Bob Chew sits down with David Estapé, Chair of the Conference International Program Committee and Technology Manager for Biotechnology at CRB Group GmbH. Their wide ranging conversation offers a preview of what attendees can expect in Copenhagen—and why this year’s conference is raising the bar once again for Europe.
From Stability to Acceleration: A Changed Industry Landscape
As David Estapé reflects during the episode, the pharmaceutical industry spent years operating in a relatively stable “comfort zone.” Prior to the COVID era, progress was steady but incremental, with familiar business models, established regulatory pathways, and predictable manufacturing approaches.
Today, that plateau is long gone.
The industry is now responding to:
- New product modalities such as advanced therapy medicinal products, mRNA, antibody-drug conjugates, and radiopharmaceuticals
- Rapid digitization and automation of manufacturing operations
- Artificial intelligence reshaping discovery, development, and engineering
- Growing expectations around sustainability, particularly in Europe
- Intensifying pressure to deliver therapies faster than ever before
As Estapé puts it, the challenge is no longer what to do—but how to do everything at once without compromising quality, compliance, or patient safety. This reality shaped the 2026 conference agenda from the ground up.
A Highly Competitive Program, Curated for Impact
One of the most striking insights from the episode is the sheer level of interest in contributing to the conference. With roughly 200 presentation proposals submitted for just over 60 available speaking slots, the program committee faced the difficult task of selection.
That competition, however, has resulted in something attendees truly value: depth and quality. Each session was carefully chosen to reflect real-world challenges, practical experience, and forward-looking perspectives from across the industry.
“The quality of the content,” Estapé explains, “comes directly from the people who decide to participate.” It’s a reminder that this conference is shaped not only by topics, but by the collective expertise of the ISPE community itself.
Five Tracks, One Integrated View of the Industry
The 2026 ISPE Europe Annual Conference is organized around five interrelated tracks, designed to encourage cross-disciplinary learning rather than siloed thinking:
1. Pharma 4.0™ in Action
Moving beyond theory into real-world implementation, this track explores plug-and-produce systems, robotics, connected equipment, and interoperable manufacturing. Practical examples highlight how automation and data integration are already transforming production environments.
2. Digital Transformation
From cloud platforms to AI-driven decision-making, this track addresses both opportunity and risk. A key takeaway from the podcast conversation is that trust—especially trust in data, models, and AI outputs—remains one of the biggest barriers to adoption.
3. Engineering and Project Delivery
Digital twins, model-based design, and advanced simulation tools are becoming standard—but tools alone don’t guarantee success. Estapé emphasizes that engineering excellence, knowledge, and judgment remain critical, especially as project timelines continue to compress.
4. Sustainability
Sustainability is no longer confined to facilities or utilities. This track dives into deeper questions: How sustainable are our processes? How do resource use, chemicals of concern, and waste factor into long-term viability—and even product approval?
5. Regulatory and Quality
With evolving guidance, new interpretations, and a growing need for early dialogue, this track brings regulators and industry together to explore how oversight can both protect patients and enable innovation.
Just as important as the tracks themselves is the message Estapé repeatedly reinforces: don’t stay in one lane. The most successful professionals today understand how engineering, quality, digital, and regulatory perspectives intersect.
Eight Keynotes You Won’t Want to Miss
The episode also offers a preview of the eight keynote sessions, carefully balanced between industry leaders and regulatory voices.
Among the standout speakers:
- Lars Fruergaard Jørgensen, former CEO of Novo Nordisk and Chair of Healthcare Denmark, who will open the conference with insights shaped by decades at the highest levels of pharma leadership
- Brendan Cuddy from the European Medicines Agency, who will provide an overview of regulatory initiatives, guidance updates, inspectorate priorities, and global collaboration
- Lars Peterson with FUJIFILM Biotechnologies, who will encourage the industry to rethink manufacturing itself—arguing that true industrialization is essential if innovative therapies are ever to reach all patients who need them
These keynotes, as highlighted in the conversation, are less about technical detail and more about direction and mindset—the ideas that will define where the industry goes next.
A New Format Designed for Dialogue
New for 2026 is the introduction of interactive forums, an evolution of last year’s workshop concept. These sessions are designed not as panels, but as conversations.
Short expert introductions set the stage, followed by open dialogue where attendees are encouraged to ask questions, share experiences, and challenge assumptions. The goal is simple: break the ice early and foster meaningful engagement that carries into the rest of the conference.
As Estapé notes, learning doesn’t only happen at the podium—it happens when professionals talk honestly with one another.
Why This Episode—and This Conference—Matter
Toward the close of the episode, Estapé offers one of the most important reminders for conference attendees: conferences are about recharging.
They’re about stepping outside daily roles, gaining perspective beyond one’s discipline, and connecting with peers who are facing the same pressures and questions. Whether through keynotes, interactive forums, or spontaneous hallway conversations, the 2026 ISPE Europe Annual Conference is designed to spark insight and momentum.
Learn more and register
Listen to the Latest Episode
In this episode of the ISPE Podcast: Shaping the Future of Pharma, listeners gain insight into the thinking behind the 2026 ISPE Europe Annual Conference and the topics expected to drive meaningful discussion.
Listen to the full episode.