Improvement of a pharmaceutical enterprise’s business processes at the stage of preclinical development of new drugs

Abstract

The rapid increase of the population, as well as the high rate of urbanization, are leading to an increased need for medical supplies, as well as the need for faster release of new drugs to the market. In this article, the authors analyze and aggregate the activities of a number of pharmaceutical companies at the preclinical stage of drug development to identify optimal management models at the stage of each operational iteration. The work methodology is based on an empirical study based on two progressive stages: a qualitative analysis of the business processes of pharmaceutical enterprises, reflected in regulatory rules and company reports, as well as in-depth interviews with representatives of these commercial organizations. Based on the results obtained at the end of the first stage, the authors established the problem of the lack of a unified presentation of standardized operating procedures, as well as an aggregated representation of the stage of research work on the production of the drug. When considering each business process of this stage, the authors presented a model of the minimum unit of integrated activity (MUnIA). This model most optimally describes local operational business processes during drug development, and can also serve as an instrumental framework for guiding preclinical studies in the formation of a document on standardization of operational procedures. The results of the first stage of the empirical analysis were verified during the second part of the work - in-depth interviews with industry representatives. The findings of this study can be used by project managers at the preclinical testing stage to reduce the time spent on operating procedures.