Concurrent Session: 3 in 1 - Assets, Sustainability & Social Impact | With the advancement and continuous emerging technologies, a lot of biopharmaceutical industries have started incorporating them to optimize equipment maintenance, meet sustainability goals, and reduce project delivery times. In this session, we will have speakers from leading companies share their lessons learned, tips, insights, and technologies used to solve difficult problems and meet their goals.

In the first quarter of 2022 drafts of ICH Q2(R2) and Q14 were released for public comment. This is the first time there have been significant changes to the guidance for analytical methods since the release of Q2 in the 1990's. Stop and think for a moment how much change there has been in the past several decades. The speed of development has increased, the diversity of therapeutic products has changed, and the technology employed (including use of multivariate methods) to test these materials has continued to evolve. 

This session will bring together the opinions of thought leaders in this area (EWG industry, EWG regulatory, and the practitioner) to share their perspectives and lead a discussion on the new operating system that is possible given the new draft ICH guidelines. 

Presentations will be followed by a roundtable/panel discussion to address questions and obtain feedback on the guidance documents (including implementation and case studies) and/or solicit input on any available feedback from the EWG.

Digitalization opens new horizons to achieve new levels of connectivity, transparency, agility and productivity through the application of faster and more accurate information to enable (automated) decision-making. The fundamentals of the digitalization process lies in in the structure underneath the data being created, used, reported, stored, and destroyed. 

Currently, in the Pharma 3.0 environment the approach for automation is in a process-centric environment. However, moving to Pharma 4.0™, a different approach in which the data life cycle is centralized, will lead to a data-centric approach. Each data life cycle needs to be completed and aligned to be considered a data set. In current production processes different data sets are created for each process. Visualizing the data sets amongst different process steps will automatically trigger missing data, misaligned data or duplicate data. Moving to Pharma 4.0™, each data set will need to be assessable at any time in any business layer. 

Therefore, a system needs to be in place to show the data architecture and how it interacts with various processes. This session will discuss the status and examples of practical transformational methodologies to a digitalized Pharma 4.0™ Operating Model-based organization.

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.

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.

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.

Concurrent Session: Moving from Pharma 3.0 to 4.0™ and Harnessing the Power of the Pharma 4.0™ Vision | Digitalization opens new horizons to achieve new levels of connectivity, transparency, agility and productivity through the application of faster and more accurate information to enable (automated) decision-making. The fundamentals of the digitalization process lies in in the structure underneath the data being created, used, reported, stored, and destroyed.  Currently, in the Pharma 3.0 environment the approach for automation is in a process-centric environment. However, moving to Pharma 4.0™, a different approach in which the data life cycle is centralized, will lead to a data-centric approach. Each data life cycle needs to be completed and aligned to be considered a data set. In current production processes different data sets are created for each process. Visualizing the data sets amongst different process steps will automatically trigger missing data, misaligned data or duplicate data. Moving to Pharma 4.0™, each data set will need to be assessable at any time in any business layer. Therefore, a system needs to be in place to show the data architecture and how it interacts with various processes. This session will discuss the status and examples of practical transformational methodologies to a digitalized Pharma 4.0™ Operating Model-based organization.

Concurrent Session: Meeting Increasing Sustainability Expectations within the Pharmaceutical Manufacturing Environment | 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.

Concurrent Session: New Paradigm for Analytical Methods - ICH Q2(R2) & Q14 | In the first quarter of 2022 drafts of ICH Q2(R2) and Q14 were released for public comment. This is the first time there have been significant changes to the guidance for analytical methods since the release of Q2 in the 1990's. Stop and think for a moment how much change there has been in the past several decades. The speed of development has increased, the diversity of therapeutic products has changed, and the technology employed (including use of multivariate methods) to test these materials has continued to evolve. This session will bring together the opinions of thought leaders in this area (EWG industry, EWG regulatory, and the practitioner) to share their perspectives and lead a discussion on the new operating system that is possible given the new draft ICH guidelines. Presentations will be followed by a roundtable/panel discussion to address questions and obtain feedback on the guidance documents (including implementation and case studies) and/or solicit input on any available feedback from the EWG.