Call for Proposals

Innovative medicines across modalities—from small molecules and biologics to next-generation therapies like ATMPs, ADCs, Radiopharmaceuticals, mRNA —have the potential to transform patient outcomes. This track will explore the full pathway from discovery to delivery, emphasizing how scientific breakthroughs can be designed and developed to be manufacturable , scalable, and accessible. We will address practical manufacturing to fully automated/robotics and monitored applications and supply-chain challenges, differing global regulatory expectations, and strategies that accelerate responsible development, commercialization, and patient access.

This track focuses on the seamless integration of facilities, manufacturing, quality, supply chain and sustainability as interconnected systems that ensure reliable patient access to therapies. We invite proposals that demonstrate how sustainability is actively embedded into core manufacturing operations, facility design, and the broader product lifecycle. We invite submissions that demonstrate how Sustainability/Quality by Design (S/QbD) principles are operationalized in commercial manufacturing, facility design, and lifecycle management. Contributions should highlight measurable impact, including operational excellence, cost efficiency, emissions reduction, and enhanced supply resilience.

Furthermore, we seek contributions that illustrate how sustainable practices strengthen manufacturing and supply chain resiliency. We encourage topics exploring how circular economy models, Environmental, Social, and Governance (ESG)/Scope 3 data integration, and Generative AI can be leveraged to mitigate risks and enhance the adaptive capacity of the pharmaceutical value chain.

Examples of recommended sub-topics include:

• Digital Optimization: Deployment of digitalization and data-driven initiatives that reduce Greenhouse Gas (GHG) emissions in manufacturing and supply chain operations.
• SbD in Manufacturing: Integration of Green Chemistry, (e.g. solvent recovery, biocatalysis, elimination of substances of concern etc.) into commercial manufacturing and scale-up activities.
• Circular Supply Chains: Circular economy models to minimize waste and improve material resilience, incl. Extended Producer Responsibility (EPR) and programs that enable safe product disposal.
• Resource Stewardship: Implementation of water stewardship programs and other initiatives that lower resource consumption in facility operations.

This track invites industry submissions showcasing how organisations are advancing Pharma 4.0 principles by integrating compliant digital technologies, robust data governance, and trustworthy AI into regulated life-science environments. We welcome case studies, frameworks, and innovations aligned with ISPE’s Pharma 4.0 operating model, GAMP 5 aligned lifecycle and risk-based validation approaches, and contemporary AI lifecycle governance. Submissions may explore digital maturity enablement, data integrity by design, AI/ML lifecycle controls, autonomous or augmented decision-making, advanced analytics, digital twins, and smart/connected systems. Submissions should highlight proven frameworks, case studies, practical outcomes, compliance considerations, challenges overcome, and approaches that enhance product quality, patient safety, and organisational decision integrity within a regulated digital ecosystem.

The future of pharmaceutical manufacturing workforce development is being reshaped by the rapid integration of AI, automation, and advanced data analytics across the product lifecycle. As organizations accelerate toward digital, continuous, and personalized manufacturing paradigms, the industry faces significant challenges in closing critical skill gaps while enabling a high performing agile workforce. This track highlights key trends shaping workforce readiness, including the emergence of new roles created by digital transformation, best practices for human/AI collaboration, strategies for addressing skill gaps and ongoing talent shortages, and approaches to retaining and developing talent in a rapidly evolving manufacturing environment. Submissions focused on practical frameworks, case studies, and scalable workforce development models are encouraged, especially those demonstrating measurable impact on capability building, performance, or organizational culture.

Advances in technology and innovation are reshaping the landscape for Regulatory, Compliance and Quality. For example, the application of AI/ML alongside with sophisticated modeling techniques are catalyzing drug development for new and existing modalities. Participants in this track will hear from regulators working on novel ways to effectively collaborate and explore reliance initiatives that may benefit from a global perspective. Learn from industry leaders on approaches that may help introduce complex technologies and innovative medicines faster to patients around the world. Engage with peers and regulators in discussions that explore solutions to these challenges.

This area provides an opportunity for emerging and exploratory topics that may extend beyond the scope of the other five areas. We invite proposals addressing forward-looking developments and transformative ideas shaping the future of pharmaceutical engineering. Sessions may highlight new approaches, production models, or operational concepts; early-stage innovations; strategies for disaster recovery, business continuity, and operational resiliency; and other late-breaking topics. Cross-sector inspiration is also encouraged, including lessons, tools, or frameworks adapted from other industries. Submissions tackling pressing, real-world industry challenges—particularly those not squarely aligned with the other tracks—are also welcome. Presenters should clearly articulate the scientific, technical, or strategic foundation of the innovation, its relevance to pharmaceutical engineering, and its potential impact on patient-centered delivery of medicines.