Concurrent Session: Advancing Pharmaceutical Quality - Quality Management Maturity|This session focuses on Advancing Pharmaceutical Quality (APQ) and specifically the APQ Quality Maturity Framework that has been developed by ISPE over the past 3 years evolving from ISPE’s research in response to FDA Quality Metrics draft guidance and ISPE’s Cultural Excellence report.  This industry-for-industry quality maturity framework provides an Assess, Aspire, Act and Advance model for quality management maturity.  In this session, industry experts will provide the APQ Quality Management Maturity Framework and will provide their learnings from the Quality Metrics Feedback Program.  FDA will present its journey toward assessing quality management maturity as well as their learnings from the FDA Quality Metrics Feedback Program.  Further, FDA will provide an update on the Quality Management Maturity Pilot.

Concurrent Session: ATMP - New Modality Processing Approaches|Innovative ATMP treatments for patients have come a long way since the first insertion gene therapy clinical trial in 1990. Since then over 3,000 clinical trials have been initiated with a growing number of therapeutics, addressing many complex and unmet needs, approved by regulators around the world. The technology platform is coming of age and this session shares some of the opportunities and challenges of bringing such processing to the next level.  From the challenges of developing and designing facilities and processes for personalised, single patient treatments to the development of uniquely agile quality management systems the presentations in this session will focus on how the industry is responding while remaining aligned with the emerging regulatory guidance on such processing.

Concurrent Session: Aseptic Facilities and Technologies|Focused on aseptic facilities and technologies, this session will take attendees through relevant and cutting edge topics currently affecting the production of parenteral products. Attendees will dive into the challenges which are often found in aging facilities and learn about strategies for the justification and execution of modernization projects. They will also uncover recent learnings from the practical application of Single Use Systems and find out whether this trend will continue as a viable option over stainless steel (or, is there another option…?) Finally, with the need for more vaccine and biological facilities, product safety and operator exposure are at the forefront of facility design requirements. This session will conclude with strategies for effective and repeatable Bio-decontamination cycles based on the analysis of available technologies.

Concurrent Session: Elements of Digitalization in the Pharma 4.0 Journey|The session will examine the components required as the industry progresses towards an implementation of the Pharma 4.0 concept where manufacturing is driven by the digitization of processes and methodologies.  The speakers will explore various aspects required in the realization of a Pharma 4.0 enabled facility including the building of digital solutions in a GMP environment, the digitization of SOPs, the elimination of paper and data capture to produce a digital batch record.  We will hear a case study that provides insight into the delivery of data as a validation package and the benefits that will transform the validation efforts moving forward.  Within the context of Pharma 4.0 we will also review the function of the operator in this new environment and how their role will change from one of system monitoring to the role of contributor and collaborator and the tools required to achieve this paradigm shift.

Concurrent Session: Project Management in a Warp Speed Environment|This session will look at and assess how Project Warp Speed has changed how projects are developed, assessed and executed.  Everything from how much risk the project contains to how much can be tolerated has given the industry a new definition of “fast”.  The session will discuss the efforts and overall project timeline as well how to maintain safety and improve supply chain.  The case study will provide specific examples of areas for awareness and potential pitfalls.  Leverage in the single use market to how decision makers and planners can use the technology to improve execution and production flow from APIs to vaccines.  This session will be vital to  how we as an industry can respond in the future.

Concurrent Session: Packaging and Supply Chain Improvement|Packaging Excellence is a critical aspect of drug manufacturing. A container closure system refers to the sum of packaging components that together contain and protect the dosage form. In this session, Container Closure Integrity (CCI) will be addressed, emphasizing balance and optimization of the critical variables using strong process information.  In a related topic, business continuity management (BCM) will be discussed.  BCM is critical to ensure that the necessary infrastructure and procedures are in place and personnel are prepared to appropriately respond when disruptive incidents do occur.

Concurrent Session: Lessons Learned on Virtual Inspections and What to Take Forward Post-Pandemic|This session will explore how both industry and regulatory authorities have adapted to manage our governance responsibilities during the COVID-19 pandemic when travel was restricted, and resources of many types were scarce.  We will discuss the Lessons we have Learned – what worked, what didn’t work so well, and what we feel is valuable to take forward as we move into the “new normal” with more remote work.  Speakers will represent a global perspective including the cross-industry collaboration on the IFPMA paper on Virtual Inspections, results from the EFPIA Survey on Inspection Practices, as well as insights from both MHRA and WHO.

Concurrent Session: Continuous Drug Substance Manufacturing - Coming of Age|Continuous processing (CP) has long been heralded as a breakthrough innovation for pharmaceutical processing.  The approach has been actively encouraged as a route to ‘cleaner, flexible and more efficient’ processing (Dr. Janet Woodcock, FDA, AAPS Meeting, 2011). While significant progress has been made in realising this objective in drug product manufacturing, progress on its application at a large scale in drug substance / API processing has lagged expectations. This session presents the experiences of two pharmaceutical companies who have made significant investments in this area for both small and large molecule therapies. Their insights into the challenges of such processing and especially as to how the digital technologies inherent in Pharma 4.0 can enable the CP vision will form an interesting and hopefully educational final session in the 2021 Annual Meeting Agile Innovation stream.

Concurrent Session: Data Analytics and AI|At the forefront of digital transformation in the pharmaceutical industry, Data Analytics and AI are among some of the key technologies involved. What makes AI a foundational element for advanced process control in biomanufacturing? How does predictive maintenance become a reality in process intensive aseptic operations? What are some regulatory challenges involved? And how can risks associated with a Big Data infrastructure be mitigated to drive Operational Excellence? These are the questions being addressed in this session. Three broad presentations will dive into the application challenges in a pharmaceutical manufacturing environment while highlighting some of the immense benefits and promises offered by Data Analytics and AI.

Concurrent Session: Trends and Use Cases for Blockchain in Biopharma Supply Chain|The application of blockchain technology to help the medical supply chain become more secure and resilient is increasingly gaining more traction in our industry.  During this session we will hear from three speakers exploring actual use cases of the technology and the benefits, and learnings, in their experience.