5. Conclusion
The aim of this article was to increase understanding about the persistence of established practices and its effect on emerging innovations by combining the TIS approach with institutional logics. We studied the EPO potency testing practice in drug development as an exploratory case. By doing that we aimed to contribute to the theoretical understanding of how institutional logics hamper complex innovation processes. This study showed that the concept of institutional logic is a powerful heuristic to understand the lock-in of established practices in drug development and the effect of this lock-in on the innovation process of innovative methods. Firstly, the analysis of the institutional logic of medicine development provided insight in why the EPO potency test was implemented in regulation in the first place. The combined approached showed that chances for innovative animal-free testing methods and established practices are unequal as acceptance criteria for established practices are lower than for innovative methods. Due to the strong alignment of assumptions, values, beliefs and rules about the use and value of animal studies in drug development, animal studies retain their status as gold standard. Once the established practice is institutionalized, barriers to innovation increase further. This analysis showed that the implementation of established practices in new regulations should be prevented because formalization of established practices hampers the innovation process towards innovative methods.