Context-aware modeling for knowledge-intensive medicinal product development processes

Due to their unique characteristics, knowledge-intensive processes (KiPs) are difficult to capture with conventional modeling and management approaches. One such KiP is the advanced therapy medicinal product (ATMP) development process. ATMPs are highly innovative medicinal products that are based on biomedical technology. ATMP development processes need to comply with complex regulatory frameworks. Currently, biomedical scientists that develop ATMPs manage the regulatory aspects of the ATMP development processes in an ad hoc fashion, resulting in inefficiencies such as reworks or even withdrawal of ATMPs from the market. This paper presents an explorative case study in which we use Enterprise Modeling and Context aware Business Processes to support ATMP scientists in managing the regulatory aspects of ATMP development processes more efficiently and effectively. In our explorative case study, we use enterprise models to describe the important concepts and views in ATMP development processes. By introducing context-awareness to the models, we support ATMP scientists in performing relevant tasks to address the regulatory requirements efficiently and effectively under different contexts. We introduce the novel concept of execution-dependent dynamic context to properly define the context in ATMP development processes. Additionally, this paper takes a broader perspective on the case study by discussing the relevance of the solutions derived for the case study for other KiPs. Thereby this paper aims to present an exemplary approach for context-aware modeling of KiPs. The practical contribution of this paper are the models realized in a real-life ATMP development project. The scientific contribution of this paper is providing an exemplary approach for supporting knowledge workers who perform flexible, KiPs under dynamic contexts and introducing the notion of execution-dependent dynamic context.

Automated summary

This paper presents an explorative case study using enterprise modeling and context-aware business processes to support ATMP scientists in managing the regulatory aspects of ATMP development processes more efficiently and effectively. By introducing context-awareness to the models, relevant tasks can be performed under different contexts to address regulatory requirements efficiently and effectively, with the introduction of the novel concept of execution-dependent dynamic context.