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

Abstract

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.