Identifying a lead indication, development candidate selection and pipeline prioritization are critical decisions for all biotech companies. This panel will focus on key strategies and considerations to optimize the transition from the preclinical stage in development to clinical stage. Critical topics this discussion will cover highlight data-driven approaches to increase probability of success, with particular attention to trade-offs between speed to clinic and additional data, attention to capital needs/constraints, speed to market and market size, appropriate and timely regulatory path identification, strategies to engage with the FDA, as well as some IRA considerations.