Regulatory agencies are not only now recognizing the use of clinical trial simulation in the drug development process as an effective trial design and outcome prediction tool, but are actively collaborating with biopharmaceutical clinical trialists in an effort to make available new and promising drugs to patients sooner. This transformative and collaborative way of developing new therapies has the potential to enable timely knowledge-based decision making and translate into more high-value therapies through increased development efficiencies. This session will explore some of the potential benefits of clinical trial simulation practices throughout the drug development process with expert speakers from the biopharmaceutical industry.