Rare Disease Innovation, Science, and Exploration (RISE) Workshop Series

The Rare Disease Innovation Hub sponsors the Rare disease Innovation, Science, and Exploration (RISE) Workshop series. RISE workshops bring together innovators in drug development, rare disease research, patient advocacy, and regulatory science to discuss challenges in the development of medical products for rare diseases that are common to multiple rare diseases or a class of diseases and for which evolving science offers innovative solutions.

RISE workshops are open to the public and designed for interaction, sharing of perspectives, and discourse between the various rare disease community members, including medical product developers, drug developers, patients and patient/disease organizations, academics, FDA regulators and reviewers, and relevant staff from other federal agencies. The workshops focus on cross-cutting or common issues and do not cover specific products under review by the Agency.

Topics for RISE Workshops are based on proposals submitted by the rare disease community via a public docket. In reviewing the proposals, preference will be given to those submitted as collaborative efforts between multiple other organizations, individuals, or companies.