1. IntroductIon 9
1.1 Background 9
1.2 objectives and research question 15
1.3 thesis outline 16
2. theoretIcal background 17
2.1 insights from innovation theory 17
2.2 Lock-in, institutional theory and innovation 19
3. research desIgn 23
3.1 substituting animal studies in established drug development processes 23
3.2 Adopting innovative methods in novel drug development processes of new drug classes 25
4. conclusIon & dIscussIon 28
4.1 Understanding the lock-in of animal studies in drug development 28
4.2 escaping the lock-in of animal studies in drug development 37
4.3 theoretical contribution 40
4.4 Final considerations 42
5. references 43
annexes 53
How institutional logics hamper innovation: the case of animal testing 55
How institutional logics influence innovation: the case of animal testing 83
the value of nonhuman primates in the development of monoclonal antibodies 115
immunogenicity of mAbs in non-human primates during nonclinical safety assessment 133
thirty years of preclinical safety evaluation of biopharmaceuticals: did scientific progress lead to appropriate regulatory guidance? 151
the risk-based approach to Atmp development – Generally accepted by regulators but infrequently used by companies 163