Clinical research and drug development have never been so much at the center of regulatory sciences. Biomarkers play a central role in the understanding of the biology of tumors and while mechanism based treatments become gradually the rule rather than the exception, all challenges are far than being addressed, leaving all professional stakeholders and patients with many uncertainties. IBCD 2018 will embrace the full environment and explore routes through the constantly evolving scientific, methodological and regulatory environment. The combined efforts of the EORTC, NCI, EMA, and AACR with the involvement of FDA and PMDA and Health Technology Assessment specialists will result in a unique program. The 2018-edition will build upon the recommendations and action points decided upon at the IBCD2016-edition. Topics, which will be developed, will include items like Health Technology Assessment (HTA) of biomarker assays, comparative effectiveness research and the translation of findings of clinical trials into daily practice. New regulatory routes to approve new anti-cancer agents based on a biomarker, possibly in a histology agnostic approach are emerging, demonstrating the relevance and feasibility of innovative clinical trial designs aiming to deliver added value to patients in a more effective way.
Do not miss IBCD 2018!