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The 2025 ISPE Pharma 4.0™ Conference International Program Committee are requesting proposals aligning with the following content areas. When formulating proposals the Program Committee desires to see the following approach included in the proposals: key success factors, roadmap for implementation, expected benefits, business case, and challenges:

Digital transformation is a mainstay of Pharma 4.0 and the advancement of the Life Sciences industry, and this track focuses on advances, achievements, and applications in this area. Organizations undergoing transformation can build digital maturity through a well-defined strategy, clear and consistent processes, provision of sufficient resources and competent personnel operating within a culture of operational excellence. For the safety of our patients, there can be no innovation without validation, and increasingly there are inventive and novel applications of GAMP principles to implementing and maintaining computerized systems including Artificial Intelligence and Machine Learning (AI/ML) subsystems. The careful application of data integrity by design within any process is needed to ensure available, abundant, and trustworthy data end-to-end flows to support informed decision making. Together, these elements facilitate breakthroughs and innovation within our industry.

As the pharmaceutical industry embraces digital transformation, sustainability remains a critical driver of long-term innovation and responsibility. From global ESG initiatives to site-level energy efficiency, companies are increasingly integrating sustainability and environmental goals into both strategic planning and daily operations.

This track will explore how organizations are applying new technologies, data-driven insights, and collaborative frameworks to meet evolving environmental expectations. Whether through green facility design, emissions tracking, or regulatory partnerships, the sessions will highlight practical approaches, lessons learned, and scalable solutions that contribute to a more sustainable future for pharma.

Submissions may include, but are not limited to:

• Emerging trends and frameworks in ESG and Scope 3 reporting
• Leveraging AI to support sustainability and environmental goals and enable actionable data insights
• Cross-sector collaboration with government and regulatory initiatives
• Green building practices and strategies for retrofitting existing facilities
• Implementation of digital tools and platforms to advance sustainability and green initiatives
• Digital technology in sustainable environments

A holistic control strategy in the pharmaceutical sector necessitates a comprehensive framework that encompasses quality management systems, digitalization processes, and continuous improvement methodologies. This strategy ensures that digital transformation initiatives are executed with precision, aligning with regulatory standards and enhancing overall operational efficiency. A key factor to be considered is the impact on the workforce, which can provide opportunities for new roles, as well as up-skilling or re-skilling employees.

This track will explore how intelligent automation and robotic technologies are transforming pharmaceutical operations—from manufacturing and warehousing to laboratories and material movement.

Sessions will highlight the benefits of automation, including increased plant capacity, improved productivity, enhanced OEE, reduced downtime, and improved operator safety. Case studies and technical presentations will also address key implementation challenges, such as the impact on facility design, the need to demonstrate business value to justify higher installation costs, and the complexity of integrating automation systems with digital infrastructure.

Topics may include the use of robots and collaborative robots (cobots), automated guided vehicles, and advanced material handling solutions in regulated environments.

Technological advancements and innovations, including the concept of Pharma 4.0, are redefining the landscape of Regulatory, Compliance, and Quality. The integration of AI/ML with advanced modeling techniques is accelerating drug development for both new and existing modalities. Participants in this track will hear from regulators pioneering innovative collaboration methods and exploring reliance initiatives with a global perspective. Industry leaders will discuss how Pharma 4.0 principles can help introduce complex technologies and innovative medicines to patients worldwide more rapidly. Engage with peers and regulators in discussions to explore solutions to these challenges!

Sessions will also explore how greater transparency in inspections and data—including audit trails, process mapping, and digital record management—is shaping regulatory expectations. Engage with peers and regulators to explore practical strategies for preparing your systems, processes, and people for this new era of digital oversight.

The integration of Pharma 4.0 strategies into facility design and construction requires a forward-thinking , scalable and transformative approach to pharmaceutical manufacturing. Embracing production and 'plug and produce' principles presents both opportunities for Smart Manufacturing, as well as challenges. It necessitates agile infrastructure capable of supporting modular and flexible production systems, seamless data interconnectivity, and integration across systems and sites

A data-driven approach is critical—not only to optimize design decisions but to enable robust digital continuity from concept through operations. Alignment with GAMP principles supports this transformation by ensuring that digital systems are implemented in a controlled, risk-based manner that supports quality and compliance.

Case studies reveal that while implementation complexity remains a hurdle, the benefits of enhanced efficiency, scalability, and operational resilience are compelling.

This track addresses the robustness and adaptive capability of the pharmaceutical industry’s supply chain to prepare for unexpected events, respond to disruptions, drug shortages and recover from them by maintaining continuity of operations at the desired levels of control over structure and function. For 2025, topics on how AI/Ml & Generative AI, supply chain risk management and cost-to-serve models are used to increase the robustness of the pharmaceutical clinical and/or commercial supply chain are encouraged.

As digital technologies become more embedded in facility development, virtual factory tools are transforming how capital projects are conceived, justified, and executed. While traditionally focused on facility layout, these tools are increasingly influencing process design, lifecycle planning, and operational scalability.

This track will explore the use of simulation, prediction, and modeling to inform early-stage decisions and support ongoing operations. Sessions will cover the integration of digital twins and 3D modeling into facility and process design, as well as how these tools are maintained and scaled over time.

Other focus areas include:

• Leveraging virtual tools for CapEx planning and project justification
• Data accessibility, engineering, and management to enable data-driven decision-making
• Predictive modeling for process flow, supply chain efficiency, and operational readiness
• Cross-functional collaboration enabled by shared digital environments