Novel therapies often don’t meet their revenue expectations. In an environment where regulatory approvals are increasing, but funding is decreasing, how do biotech innovators prioritize decision-making from pre-clinical phases to set up clinical development for the best chance of commercial success? This session explores the business-critical actions at key milestones that ultimately determine a product’s value story. Through an informed perspective on the impact of market dynamics on early-stage development, experts will discuss critical steps for biotech sponsors to mitigate technical, safety, efficacy, and commercial risks, to maximize the probability of success. Focusing on pre-clinical and pre-proof of concept phases in product development, the panel will discuss 1) due diligence and early considerations for prioritizing assets and indications; 2) capital-efficient ways of generating preclinical and clinical data; 3) how to drive value, by quickly proving clinical differentiation; 4) how to translate science to clinical applications and communicate it to investors, investigators and regulators; and 5) the importance of building integrated evidence at the earliest stages of development to satisfy the needs of multiple stakeholders.