Leader: Maria Eugenia RIVEIRO
This WG will be devoted to the necessary steps to foster the translation of the developed nanomedicine cancer drug to bed/market. Specifically:
- Guidelines and documents describing in details the objectives, protocol design, methodology, statistical consideration and organization of eventual early clinical trials in oncology of the selected nanotechnology will be prepared.
- Challenges in nanomedicines regulatory science will be tackled by solving prototypical translational issues: like fostering a suitability dose scaling technique for estimation of clinical first-in-man dosed from preclinical data for nanotechnology cancer drugs, validation of adequate preclinical and toxicologic models and a deeper understanding of the PK/PD relationship will allow an adequate drug positioning in oncology targeting a relevant disease stage and disease evolution conditions, within the current setting to address appropriate personalized medicine questions.
