Featured Topics

This conference brings together diverse experts to share new developments, technologies, best practices, and benchmark solutions for new and existing facilities. ISPE will be the leader to set the pace for knowledge sharing that speaks to the current and future needs of the industry. 

This session will explore how digital transformation and AI technologies are reshaping the design and operation of pharmaceutical manufacturing facilities. Emphasis will be placed on the integration of AI, agentic AI, augmented/virtual reality, and advanced analytics to enable smarter, more agile manufacturing, the use of real-time data for performance optimization and quality improvement, and the application of digital tools and digital twins in production and lab environments to support predictive maintenance, automated documentation, and informed decision-making. Case studies and implementation strategies will illustrate how these innovations are driving efficiency, flexibility, and compliance in modern pharma facilities.

Attendees will leave with practical insights and actionable strategies based on real-world experiences applying digital technologies to streamline operations, enhance product quality, and future-proof their manufacturing and quality systems.

This session will explore cutting-edge technologies and strategies transforming pharmaceutical manufacturing into a more agile, intelligent, and contamination-resilient environment.

Key topics include the adoption of continuous manufacturing, closed systems, and modular production models. We’ll examine how robotics, automation, and digital twins are enhancing throughput, uptime, and quality assurance, while also supporting cleanroom development and contamination control. The sessions may also highlight the integration of autonomous mobile robots (AMRs) into shared human-robot workspaces, with a focus on safety, performance, and operational efficiency.

Additional topics include the role of advanced materials, smart sensors, and real-time release technologies in enabling predictive, data-driven manufacturing. Additional discussion will cover the application of Process Analytical Technology (PAT) and real-time analytics to support future-ready operations.

Attendees will gain insights into the convergence of digital and physical systems that are shaping the next generation of pharmaceutical manufacturing.  

This session will examine innovative approaches to pharmaceutical facility design and project delivery that are driving the next generation of development and manufacturing.

Key topics include agile, modular layouts; cleanroom efficiency; and digital integration. We’ll explore strategies for supporting new and resurgent therapeutic formats, new approaches to peptide and oligo API manufacturing, continuous processing, efficient tech transfer, and sustainable operations. The session will also address retrofitting and modernizing existing facilities, decentralized manufacturing models, and critical infrastructure needs such as cold storage, central utility buildings, warehouses, and IT infrastructure systems. The discussion will also include laboratory design and the evolving concept of the “lab of the future,” highlighting trends such as flexible lab spaces, digital integration, automation, and enhanced collaboration between process development, analytical, and manufacturing teams.

Attendees will gain insights into forward-looking facility designs and delivery models that enable innovation, adaptability, and long-term value.

As pharmaceutical facilities evolve with advanced technologies, automation, and data-driven systems, so must the workforce. This track explores how organizations are preparing teams to thrive in future-ready manufacturing environments—through capability building, digital fluency, inclusive team design, and bold shifts in how talent is developed and supported.

Sessions may cover immersive training models, upskilling for human-machine collaboration, and creating work environments centered on product and patient outcomes. Proposals are also encouraged that highlight non-traditional workforce pathways—such as biotech certificate programs, apprenticeships, and community-based partnerships—and how the industry is rethinking degree requirements and embracing broader entry points into the life sciences. This track will showcase what it takes to build a resilient, inclusive, and technically capable workforce for the future.

Key Topics:

• Upskilling and reskilling for digital and automated environments
• Human-AI collaboration: building digital fluency and confidence
• Inclusive team dynamics and neurodiverse approaches to problem-solving
• Rethinking degree requirements and embracing non-traditional pathways
• Collaborating with workforce programs, certificate models, and community partners

Regulatory expectations are evolving rapidly alongside innovation in facility design, advanced modalities, and manufacturing technologies. This inaugural track puts Quality and Compliance at the forefront of the conversation—emphasizing the need to build with compliance in mind, not bolt it on later.

Sessions in this track will explore how regulatory requirements and quality oversight can be effectively integrated across the full facility lifecycle—from early design and construction through commissioning, validation, and ongoing operations. Topics may include global regulatory trends, inspection readiness, quality oversight for new modalities and platforms, and compliance strategies for innovations such as single-use systems, multi-product suites, and evolving global supply chains. Digital tools and AI-enabled systems are part of this conversation, but so is the broader role of Quality in enabling speed, sustainability, and patient safety.

Key Topics:

• Embedding regulatory and quality principles into facility and process design
• Validation and commissioning strategies that anticipate evolving expectations
• Inspection readiness in future-state facilities (multi-product, modular, global)
• Compliance oversight for advanced technologies and modalities
• Regulatory considerations for digital systems, automation, and AI
• The role of Quality in accelerating innovation without compromising integrity

In today’s pharmaceutical landscape, designing and adapting facilities with supply chain resiliency in mind is more critical than ever. This track explores the ways supply chain considerations are shaping the planning, construction, and adaptation of pharmaceutical facilities to ensure robust, agile, and future-ready operations. Sessions may explore how facilities can be designed to anticipate and withstand future supply disruptions, enable rapid response and recovery, and maintain continuity of operations; examine the integration of Generative AI, risk management frameworks, and cost-to-serve models into facility design and operational planning.

Key topics include supply chain-informed facility layouts, modular and flexible infrastructure, sourcing strategies for critical materials, and ways new construction and retrofitting efforts are being aligned with the evolving needs of next generation therapies. Additionally, sessions that connect facility planning with broader supply chain network strategies—such as site selection aligned with logistics optimization, inventory positioning, and multi-site risk management—are encouraged. This includes how integrated supply chain approaches inform facility scalability and responsiveness in the face of evolving market and operational challenges. Presentations that provide case studies or actionable insights into optimizing facilities for supply chain performance and resilience—while supporting innovation, sustainability, and speed to market—are especially welcome.

The sustainability track will explore various initiatives that are essential for the future of manufacturing facilities. These initiatives will focus on how to minimize environmental impact, whilst ensuring compliance with regulations, and achieving cost efficiencies. Attendees will gain critical insights into the latest sustainability trends and practices in manufacturing, helping them enhance environmental efforts. Presentation and case studies will highlight long-term thinking into conceptualization and design of facilities that would lower resource demand, operational use and waste.

Key Topics:

• Sustainable design and operational strategies that reduce environmental impact across the manufacturing lifecycle.
• Energy-efficient systems and materials that support both operational reliability and quality assurance.
• Scalable solutions for green manufacturing that align with long-term regulatory and business goals.
  • Solvent capture or avoidance
  • SUT waste (application of bioplastics, downcycle or upcycle).
  • Reuse of facilities and flexible designs that allow simple adaptability (modular and other)
  • Scalable automated manufacturing processes.
• Real numbers on the benefits and investment
• Reduce operational footprint of manufacturing facilities by design and good engineering controls.
• Utility demands for new facilities and proportion of full electrification vs alternative fuel