After the first successes of gene therapy for rare genetic diseases, the field has now reached maturity with multiple products registered not only for rare diseases but also for oncology indications, and many more under development. With the rapid development of the field, the issues linked to large-scale manufacturing, industrialization and pricing represent major challenges to allow broad access to patients of these groundbreaking therapies.

This session will be be the formal announcement of the 2022 category winners, selected by the FOYA judging committee. The session will include an overview of the winning projects and highlight specific areas of the project that impressed the judges most. You will also learn about the history and evolution of the FOYA program and how it has become the premier international awards program in the pharmaceutical industry. A short question and answer session will follow.

The aim of the presentation is to show the support provided from an Industry Regulatory Affairs function to sustainability. The presentation will include real life examples for synthetic molecules. The regulatory requirements and procedures will be identified for each case, on a high level.

Fresenius Kabi developed an artificial intelligence (AI) supported detection system which is capable to detect and classify interventions performed in the aseptic core of an isolator. Due to the current absence of detailled regulatory guidance targeting validation of AI powered systems in the GMP environment, Fresenius Kabi also developed a validation approach. This new approach does not rely on black box models but help users to understand how AI decided, where its limitations are but also which disruptive potential it has on the way we operate aseptic installations.

AI has been identified as a key science-technological field with high impact in Pharma 4.0, but how much real is this implementation in biopharma today? AI is being used to maximize the value proposal in other industries (e.g. retail, fintec). How can Pharma bring a differential value to patients? AI is being used today as a tool for applying scientific knowledge in complex problems, understanding the continuously changing reality from a multivariable perspective. This view is fully aligned with the Quality goals and the capabilities boosted by AI in areas like predictability, recommendations, human language processing or classification are bringing value to the classic Quality Control, building an holistic approach towards the Total Quality fully patient-centric oriented.

Presentation of Ninlaro project developed in Grange Castle Ireland

Establishment and activities of the WHO Prequalification Programme. WHO initiatives and support on local pharma production sustainability in low and middle income countries. WHO regulatory initiatives on sustainability.

Since the Eudralex Vol 4 came into operation, verification of cleaning of non-product contact surfaces and monitoring of air within the manufacturing area became part of the Quality Risk Management system. The risk assessment should consider operational controls to minimize and mitigate the risk to product quality, as well as risks related to the environment, health, and safety (EH&S). These key aspects are especially of interest in the manufacturing of highly potent APIs (HPAPIs), where high levels of cleanliness must be achieved. In this lecture, various scenarios in which a highly potent/toxic substance can spread within the isolator are presented. Additionally, a new innovative cleaning tool is introduced to help establish suitable contamination control strategies.