The Rare Disease Innovation Hub, established by the FDA in 2024, serves as a pivotal point of collaboration between the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) and across all FDA centers. This fireside chat will feature the Director of the FDA’s Rare Disease Innovation Hub, Amy Comstock Rick, J.D. and BIO’s Director of Science & Regulator Affairs, E’Lissa Flores, Ph.D. They will discuss the Hub’s new strategic agenda and how it will enhance the development and approval of therapies for rare diseases. The focus will be on key priorities of the Hub including Advancing Regulatory Science through novel endpoints and trial designs, Enhancing Coordination and Consistency across the FDA centers, Centralized Engagement for external stakeholders, and Community Outreach with the rare disease community through events and educational initiatives. This session will also highlight the Hub’s efforts to address the unique challenges faced by the rare disease community, such as patient population sizes and types and the need for innovative approaches. Attendees will gain insights into the Hub's strategic actions, including the Rare Disease Innovation, Science, and Exploration (RISE) workshop series, and the ongoing efforts to enhance patient and respective organizational engagement in regulatory processes. Join us for an in-depth discussion on the future of rare disease therapy development and the collaborative efforts driving innovation in this critical field.