Abstract:
Drug development is an incredibly costly process that involves a diverse range of experts from different domains collaborating. However, expertise is notoriously hard to communicate and deficiencies in communication often lead to inefficiencies in team performance. This study explored expert knowledge surrounding the preclinical development process of small molecule entities in an attempt to find a shared mental model for the process. The literature surrounding this area is relatively nascent and thus an exploratory qualitative approach was necessary. An initial mental model was formed through a comprehensive semi-structured interview with an industry expert before this model was put forward to four further experts for review and critique. Experts were defined as individuals who had 10 years' experience or more within preclinical drug development management. The findings of the study seem to indicate that there is a transferable approach to the preclinical development of small molecule entities. Participants agreed with the overall structure of the proposed mental model while noting that each drug development project will have its own variances. The participants identified the factors of drug type, indication, delivery method, and disease area as possible introductions of variances between any developed mental models. The research also seemed to show the presence of certain rate-limiting steps within the preclinical development process, which are likely to be more transferable between development projects. The outcomes of this study are: 1) the development of a loose mental model of the preclinical development of small molecule entities to aid in team communication and performance, 2) the identification of further factors to refine the formation of mental models within this process to a more transferable entity, and 3) the identification of mental models to have transferability potential between projects.
