Recent changes in FDA’s leadership and approach have caused some concern among industry leaders and patients about the stability, predictability, and reliability of our regulatory framework. While our existing framework is dependable, there have been concerns with it being slow and unwilling to embrace emerging regulatory science. The change in leadership’s perspective and approach, however, offers a unique opportunity to reform FDA and modernize our current regulatory paradigm. Concepts such as shifting to dynamic, real-time data exchange from current practice of static, paper-based reviews; de-risking by offering actionable feedback earlier in development and empowering patients by embracing transparency are all ideas that industry and patients can support. Speakers will examine how industry can seize the current moment as an opportunity to build a modern FDA that is patient-centric, technologically enabled, and scientifically sound.