DCAT Global Summit Agenda

KEYNOTE: SHAPING THE FUTURE: DIGITAL TOOLS FOR DURABLE TRANSFORMATION IN BIO/PHARMA

In this keynote, Dr. Christine Allen will share a practical vision for the future of bio/pharma: a digital-by-design approach to drug development where experiments, decisions, and supply chains are connected through a modern data backbone. She will explore how AI, high-throughput automation, and cloud-native infrastructure can expand the formulation and process design space while addressing what matters from the start, including patient experience, manufacturability, cost-per-dose, and supplier resilience across regions. Drawing on lessons from integrating AI into established development workflows, she will highlight what makes digital transformation durable: tools designed with domain experts, transparent trade-offs, and human-in-the-loop decision support that strengthens scientific judgment. The talk will also touch on how these approaches can identify critical issues earlier and strengthen the path from development to commercialization.

• Christine Allen, CEO & Co-founder, Intrepid Labs Inc., & Professor, University of Toronto

SESSION I: DIGITAL TRANSFORMATION THAT DELIVERS: HOW PHARMA LEADERS ARE BUILDING SMARTER, FASTER & MORE RESILIENT INTERNAL PROCESSES

Digital transformation is reshaping how bio/pharma companies operate, compete, and scale globally. In this session, industry leaders share real-world strategies for using automation, AI, and validated digital solutions to improve efficiency, compliance, and supply chain resilience.

Learn how organizations are modernizing manufacturing, quality and procurement processes to accelerate decision-making, enhance supply continuity, and enable faster execution. Attendees will gain practical insight for turning digital innovation into measurable business results – and building operations ready for the future.

• Thomas Altmann, Principal Global Technical Consultant, Ecolab Deutschland GmbH
• Clemente Aguila, Head of Operations & Corporate Procurement, Grifols
• To Be Announced

FEATURED PRESENTATION: SECURING EUROPE’S MEDICINES: THE EU CRITICAL MEDICINES ACT AND ITS GLOBAL IMPLICATIONS

• Steffen Denzinger, PhD, President, Board of Directors, European Fine Chemicals Group

SESSION II: AI-DRIVEN DRUG DEVELOPMENT: ACCELERATING DISCOVERY THROUGH SMARTER API DESIGN & MANUFACTURING

Discover how AI is transforming drug development from early route design through API manufacturing. Industry leaders will share real-world strategies for using data, machine learning, and advanced process design to reduce timelines, improve scalability, and strengthen supply reliability — helping organizations accelerate development while building more predictable, resilient pathways to commercial success.

• Roman Lagoutte, PhD, Senior Principal Scientist, Lonza
• Juan Piacquadio, DBA, MBA, MSIT, Chief Information Officer & VP IT/IS, Phlow Corp.
• Anil Kane, PhD, Global Head of Technical & Scientific Affairs Pharma Services, Thermo Fisher Scientific

CASE STUDIES: TECHNOLOGY IN ACTION

• Quotient Sciences & Intrepid Labs

• • Andrew Lewis, Chief Scientific Officer, Quotient Sciences
  • Christine Allen, CEO & Co-founder, Intrepid Labs Inc., & Professor, University of Toronto

• Made Scientific & Streamline Bio

• • Yaman Tobaje, Senior Engineer, MSAT, Made Scientific
  • Rodney Rietze, President & CEO, Streamline Bio

• mAbxience & HP

• • Timo Liebig, PhD, Chief Innovation Officer, Mabxience
  • Sergio Martinez, HP 

FEATURED PRESENTATION: TRUST BY DESIGN: APPLYING QUALITY BY DESIGN PRINCIPLES TO TRUSTWORTHY AI

As generative AI systems move into regulated, high‑risk environments, early success in pilot projects often breaks down at scale. In Retrieval‑Augmented Generation (RAG) and agentic AI systems, instabilities in embeddings and retrieval can lead to inconsistent answers, hallucinations, and compounding errors, undermining trust and making regulatory acceptance impossible. This session introduces Trust by Design (TbD), a practical framework that adapts proven Quality by Design (QbD) principles from pharmaceutical development (ICH Q8) to AI systems. Instead of treating trust as an afterthought, TbD embeds trustworthiness directly into system design. Using real‑world examples, the talk shows how AI output quality can be defined, measured, and controlled through concepts familiar to regulators: Target Product Profiles, Critical Quality Attributes, Critical Process Parameters, and validated design spaces. Particular focus is placed on output stability as a critical quality attribute for trustworthy AI.

• Michael Schorpp, Head of Digital Innovation & AI, Global Regulatory Affairs, Boehringer Ingelheim