OBJECTIVES: The COVID-19 pandemic has sent shock waves through our health systems and will potentially leave a long-lasting impact on the drug development process. The emergency pressure has encouraged unprecedented speed, innovation, and collaboration in antiviral drug development, and highlighted the shortcomings of traditional development. This research aims to: (1) explore qualitative stakeholder perspectives, in the context of IMI CARE (a European public-private antiviral drug development consortium) on how the drug development process is impacted by the time pressure caused by COVID-19 and by the steep learning curve that comes with a new disease, (2) translate these insights into a qualitative model, and (3) generate learnings from this model to improve future drug development.

METHODS: Conceptual model building workshops and semi-structured interviews have been conducted with stakeholders across the drug life cycle, including developers, regulators, HTA bodies/payers, HCPs and patients, to build an end-to-end conceptual model of the health system. The systems model represents the combined mental models of stakeholders across the drug life cycle and shows the overall perceived impact of the pandemic on collaboration, governance and patient-centredness of drug development, in a public-private-academic consortium.

RESULTS: The conceptual modeling process confirmed that pandemic pressure promoted successful collaboration and positive momentum in drug development. The model has identified important variables and mechanisms that facilitated collaboration and innovation during the pandemic such as; an influx in availability of budget, more willingness to share information and resources the establishment of parallel validation tracks in development. Challenges were identified related to the uncertainty of project planning and intermediate results with effect on the progress and allocation of work packages to consortium partners.

CONCLUSIONS: This model can be used to facilitate better informed and strategic decision making throughout the drug life cycle, contributing to more sustained responsiveness to emergencies in drug development going forward.