Transforming Biopharma: AI and Digital Transformation Center Stage at 2025 ISPE Biotechnology Conference

Michelangelo Canzoneri

Global Head of Group Smart Manufacturing

Merck KGaA Darmstadt, Germany

Michelangelo Canzoneri, PhD, is the 2025 ISPE Biotechnology Conference Planning Chair. He offers advice and shares what attendees can expect at the upcoming conference.

Why attend the conference?

First, one of the themes of this conference is shaping the future of biopharma with AI, digital innovation, and regulatory excellence. Biotechnology is undergoing a profound transformation, with AI, automation, and digitalization playing an increasingly central role in drug development and manufacturing. This conference is a platform to explore how these technologies are being applied in real-world scenarios, whether in process control, regulatory compliance, or next-generation manufacturing. With expert insights from industry leaders and regulatory authorities, attendees will gain a deeper understanding of how digital business tools, AI-driven analytics, and data governance are redefining biotechnology.

Second, you’ll have the opportunity to engage in critical industry discussions. We are at an inflection point where innovation must go hand in hand with compliance, operational efficiency, and sustainability. This conference brings together experts to address some of the most pressing challenges, including process intensification, facility lifecycle improvements, and supply chain resilience. Through interactive discussions, panels, and case studies, participants will gain actionable insights into the strategies shaping the next era of biotechnology.

The third reason is you’ll have unparalleled networking and learning opportunities. Beyond the sessions, this conference is about connecting people. With dedicated networking opportunities, interactive discussions, and informal gatherings, attendees will have the chance to engage with regulators, industry pioneers, and technology leaders who are at the forefront of biotechnology transformation. Whether it’s learning from peers or building new collaborations, these conversations will extend far beyond the conference itself.

What are you most looking forward to?

What excites me most is the opportunity to bring together a diverse group of professionals from across the biotechnology ecosystem to exchange ideas, challenge perspectives, and push the boundaries of innovation. I am particularly interested in the discussions around how, based on the ISPE Baseline® Guide: Pharma 4.0™ approach, AI and automation are accelerating biopharmaceutical manufacturing, how regulatory expectations are evolving in a digital age, and how sustainability can be embedded into process design. These conversations will be key to ensuring that we not only innovate but do so in a way that is scalable, compliant, and impactful.

I am also looking forward to the Women in Pharma® session, which highlights the importance of fostering diverse leadership and collaboration in our industry.

Any tips for making the most of the conference?

Come with an open mind and a willingness to engage. Conferences like this are not just about listening to presentations, they are about active participation, discussion, and building relationships. Take the time to connect with colleagues, attend discussions that challenge your thinking, and explore topics that may be outside of your immediate area of expertise. Some of the most valuable takeaways often come from unexpected conversations and cross-disciplinary insights.

Biotechnology is advancing at an unprecedented pace, and the only way to stay ahead is through continuous learning and adaptation.

Why is professional development important?

Biotechnology is advancing at an unprecedented pace, and the only way to stay ahead is through continuous learning and adaptation. The emergence of AI, automation, and digital twins means that we must rethink traditional approaches to manufacturing and quality. At the same time, global regulatory landscapes are evolving, requiring us to stay informed and agile. Beyond staying current with technical advancements, professional growth is about building a network of peers and mentors who challenge us to think differently and inspire new ways of working. Conferences like this provide an essential space for that kind of learning and collaboration.

Why did you agree to be conference chair?

The biotechnology conference is not about any one individual, it is the result of a collective effort by an outstanding program committee, ISPE leadership, and industry experts who have worked together to create a meaningful, high-impact event. I accepted this role because I believe in the power of collaboration and knowledge-sharing to drive progress. The conversations happening here will shape the future of our industry, and I am honored to play a role in facilitating those discussions. Most importantly, I want to recognize the program committee for their dedication in curating an agenda that reflects the biggest opportunities and challenges in biotechnology today. Their expertise, insights, and hard work have been instrumental in making this event a success.

Any final thoughts?

This conference is about more than just presentations and panels, it is about shaping the future of biotechnology together. The challenges we face today require collective intelligence, bold thinking, and strong collaboration. A sincere thank you to the program committee, ISPE leadership, and every contributor who has made this event possible. Your efforts are what make this conference a success. I look forward to engaging discussions, fresh perspectives, and an event that will inspire all of us to continue pushing the boundaries of biotechnology.