Companion Diagnostics Development and Commercialization : A Case Study from the Diagnostics’ Perspective

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