Precision medicine (PM) is “the treatment and prevention of disease that takes into account individual variability in genes, environment, and lifestyle for each person” (NIH, 2015). PM was poised to transform clinical practice in 2003 when the Human Genome Project reached completion but resistance to implementation at virtually all health care providers provides the basis for novel study on the diffusion of innovation as well as operational strategy. Existing studies on resistance to PM explore the role of reimbursement, economics, regulatory affairs, and public policies. Investigation into the antecedent conditions for implementation at the physician and organizational levels has been overlooked, a gap this study fills. The research captures the reasons for resistance at the physician and organizational levels and identifies operational strategies for successful implementation at three health care institutions with fully integrated PM programs. The research produced 42 findings with managerial implications and six testable propositions for future research. The dynamics of resistance to PM has revealed key implications for theories of organizational change. These include the observation that the formulation processes of clinical standards of practice in PM are not predicted by prevailing organizational theory; that conventional theories of resistance to change do not fully anticipate the effects of Kuhnian level historic paradigm shifts; and, that communities of practice play a critical role in transformational clinical change. Further, the research demonstrated that PM implementation is characterizable through reproducible organizational and cultural actions; that positive clinical outcomes are measurable and persuasive; and that the needs of stakeholders can be reconciled by aligning physician standards of practice with patient expectations and organizational needs. / Business Administration/Strategic Management

The value proposition of Personalized Medicine is to deliver the “right drug, to the right patient, at the right time”. Companion diagnostics is the required tool for Personalized Medicine used to aid clinical decision making with the aim to identify patients who are most suitable for a given treatment approach and to avoid adverse effects. However, even 16 years after the first co-approval of a therapeutic drug and an associated diagnostic test (trastuzumab (Herceptin1) from Genentech and the HercepTest1 from Dako), the co-development and co-approval of drug-diagnostic pairs is a challenging task.This study has the aim to identify major challenges for diagnostics companies when developing and commercializing companion diagnostics. This is achieved by (1) a literature research and (2) an empirical case study in form of interviews with diagnostics companies. The collected data is analyzed and discussed with focus on current regulatory and reimbursement frameworks in the USA and European Union. The co-development strategies and business models of companion diagnostics developers are identified.The conclusion of this study is that the major hurdles for companion diagnostics development and commercialization are gaps in scientific evidence and lacking regulatory guidelines for co-development and clinical biomarker studies. Companion diagnostics commercialization is further challenged by poor reimbursement levels. The main strategy of diagnostics companies to address these challenges is the demonstration of a beneficial outcome for patients in form of clinical studies. Small companies with limited resources for clinical research receive funding from academic research grants, patient support groups, pharmaceutical industry, and governmental Innovation agencies.Finally the formation of a new “pharma-diagnostics” sectoral innovation system as a result of the emerging paradigm of stratified medicine has been proposed.