Pharmaceutical manufacturing faces ever increasing demands to improve sustainability in the manufacturing environment all with an awareness of the social impact within the broader community. These presentations will provide detailed case studies that will outline the methodologies used to both improve environmental sustainability and to reduce costs and variability in the manufacturing processes. 

Michele Schio will present a case study for the improvement of an existing water-cooling system at a facility in Northern Italy using AI to monitor and model the water demands in order to improve control and minimize variations within the process. 

Blaine Krause will provide details of a case study at GSK using digitization of the processes to optimize energy usage and efficiency within their water systems. 

Lindsay Smart’s presentation will focus on the design and implementation of energy optimization for decarbonization at the concept stage of facility design to address not only current sustainability expectations but to anticipate future demands. 

Janssen Biologics will be giving a brief overview of their vaccines facility in Leiden, the Netherlands, and its success in addressing and winning the FOYA for Project Execution and Social Impact.

The supply chain for cellular therapies has a unique aspect of starting with a patient undergoing a procedure and ending with another procedure. This session will provide case studies and best practices around the demarcation of clinical practice with GMP for cellular therapies, orchestration of patient procedures, defining chain of identify information, and clarifying the differences between chain of identity and lot genealogy. These are major issues that are unique to the cellular ATMP supply chain. 

Our presentations will address these aspects by providing both a basis level of understanding of the topics and best practices. These points will be supported with real life experiences. By presenting the why (basis understanding), the how (best practices), and the what (experiences), we aim to provide attendee with the tools to navigate these unique aspects of the supply chain for ATMPs.

Globalization, pandemic, and digital transformation have been the key players of the past decade within the pharma manufacturing environment, generating a complex landscape to navigate. While regulated firms are forced to rely on suppliers and outsourced processes, it is also true that digitization is never really over: to manage and meet realistic product and technology expectations, companies should leverage strong supplier knowledge, data integrity surveillance programs, and avoid bottlenecks in their decision-making processes. Emphasizing the current impact and stress on the supply chain, the presentations of this session are intended to offer a concrete holistic approach to guarantee resilience, product quality, the accelerated construction of the facilities for new therapies, and last but not least, patient safety. 

The speakers will provide a clear overview of the main lessons learned, new approaches for business plans, and case studies related to fast-track projects designed to provide manufacturing capacity for a growing market such as virotherapy.

Open to all Attendees. No Extra Fee

Data really is the new oil, but how can we effectively rely on digital transformation as a business advantage? Applying efficient analytics methods unleash a complex amount of opportunities in root cause analysis and accelerate the decision-making processes within an organization to help us navigate better solutions. But as data relevance increase, regulations do too.

Understanding new requirements in data trends and best practices in quality and security will help you thrive in process control and patients' safety. 

This session will disclose critical elements in Digital Transformation to accelerate the adoption of new analytical models and data collection strategies for the betterment of our processes and quality control, while keeping compliance with the latest regulatory requirements on data trending. 

The speakers will also discuss actual case studies and encourage discussions around new modelling approaches to systems predictions and applications within the manufacturing process.

In the ever changing landscape of the biopharmaceutical industry, new technologies are being created to evaluate the effectiveness of company procedures and overall performance. During this session, we will hear from leaders in the industry about how developmental technology have helped improved financial analysis to support decision making, the digitization of workflow in cleanrooms, pharma 4.0 implementation, and digital control systems used for manufacturing/traceability of gene-based medicines.

ICH Q12 is a truly transformational guideline that has a wide scope of applicability across the pharmaceutical development lifecycle and can help streamline the post-approval change management process by promoting the adoption of flexible science- and risk-based approaches. While in some markets full ICH Q12 implementation is well underway, in other markets ICH Q12 adoption has been partial or lagging. Further, potential lack of global convergence and alignment on ICH Q12 implementation approaches creates a risk of divergent implementation strategies among health authorities, placing an additional burden on the applicants and making the overall process less efficient. This session will summarize progress made to date on the global implementation of ICH Q12 and reflect on the remaining challenges and future opportunities to accelerate its adoption across the different regions. Featuring both industry and regulatory presenters, the session will help foster the open industry-regulator dialogue on the path forward to the global ICH Q12 adoption and help draw attention to the remaining implementation challenges and roadblocks.

Blockchain applications in pharma and biopharma are becoming more mainstream; for the past 4 years we have held a blockchain session at the annual meeting where we seek to educate and inform our members about the most significant applications of the technology. In this session we will hear from three speakers, each covering a component of industry trends - pragmatic use case of how blockchain is improving operations; industry consortia and foundations, guidance on utilizing blockchain in regulated environments. These different points of view will combine to help the audience understand what is actually happening with the technology and will prepare listeners as their organizations continue (or begin) to leverage decentralized ledger technology.

Continuous manufacturing has been the dominant OSD industry buzz for years, yet its acceptance into the manufacturing business has been less than expected. This session will provide the attendee with insights based on financial modelling and case studies. This session will begin with a business model comparing CM with traditional batch manufacturing. Then two case studies will be presented which will provide the advantages, disadvantages, and benefits of each program, major challenges, and lessons learned. 

This session will provide the attendee with valuable information regarding its justification, major challenges, benefits, and lessons learned when evaluating and considering the use of continuous manufacturing.