Patient-centric approaches to vaccine development

Vaccine Insights has brought together R&D experts from GSK to discuss patient-focused approaches to vaccine development. This approach represents a paradigm shift in chemistry, manufacturing and controls (CMC) processes for vaccine development, by emphasizing the understanding of a vaccine’s critical quality attributes (CQAs) and their impact on patient safety and efficacy. Implementing this requires cross-functional expertise. Beyond traditional in vitro and in vivo/clinical studies, patient-centricity allows for model-based approaches to analyze data and perform predictive simulations. This leverages prior knowledge and new insights to enhance decision-making, flexibility, and robustness from design to market launch, while reducing the need for animal and human data. Ultimately, patient-centricity aligns vaccine attributes with patient needs, efficacy, and safety, thus ensuring robust and effective vaccine development. In this expert roundtable, the panel explored the foundational aspects of implementing a patient-centric approach from a vaccine developer’s perspective.