Featured Topics

Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury.  Technical challenges in the manufacture of these products are at the forefront of this complex environment, compounded by different health authority expectations from around the world.  Opportunity for international harmonization, alignment, and best practice application exists as this novel area continues to grow within the industry to ultimately help serve patients in need.

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 approaches to managing and maintaining computerized systems including artificial intelligence and machine learning subsystems. The careful application of data integrity by design within any process is needed to ensure available, abundant, and trustworthy data to support informed decision making. Together, these elements facilitate breakthroughs and innovation within our industry.

Applying innovative approaches to manufacturing and design solutions to ensure quality therapeutic products are brought to market in an efficient and cost-effective manner to improve patient health and access to new therapies. This includes streamlining operations and support functions, process improvements, incorporating quality by design, efficient project and change management, and ensuring relevant technologies are implemented, while focusing on upskilling and reskilling the workforce to support the future state of our industry.

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!

This content area combines Supply Chain Resiliency with Sustainability to create an opportunity for these closely related topics. Submissions can address one topic or both.

Supply Chain Resiliency addresses the robustness and adaptive capability of the pharmaceutical industry’s supply chain to prepare for unexpected events, respond to disruptions, and recover from them by maintaining continuity of operations at the desired levels of control over structure and function. For 2025, topics on how 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.

Sustainability is a central focus for many companies and a key goal for numerous projects. Whether building at a new site or implementing a global sustainability policy, there are approaches and lessons learned that can benefit the industry. This track focuses on the challenges and successes of projects and corporate actions that address sustainability. Submissions that cover the following areas are recommended:

• Trends in ESG/Scope 3
• Use of AI in creating innovative sustainability approaches and data analysis
• How Pharma is working with government initiatives
• Green building practices and retrofitting
• Use of technology to implement sustainability initiatives