Developing effective cancer therapies poses numerous challenges. This session will address obstacles in drug discovery, preclinical testing, and clinical trial design. Speakers will discuss strategies for accelerating the translation of promising preclinical findings into safe and efficacious therapies for patients. Topics will include innovative trial designs, biomarker-driven drug development, and regulatory considerations impacting drug approval processes. The session aims to foster dialogue among researchers, pharmaceutical industry leaders, and regulatory authorities to optimize drug development pipelines and enhance patient access to innovative treatments.