Therapeutic development for rare diseases faces challenges like limited resources, small patient populations, regulatory hurdles, and high costs. This session explores approaches to accelerating progress in rare disease research and therapeutic development through cross-disease collaborations, pooled resource-sharing models, and multi-stakeholder engagement. It will also examine innovative financing approaches and regulatory strategies to help advance rare disease drug development by de-risking development and attracting follow-on investment. Together, these strategies amplify impact, attract more industry participation, and accelerate breakthroughs, advancing treatments for underserved rare disease communities worldwide.