Individualized Therapies on the RISE November 20, 2025 — 9:30AM–5:00PM

https://healthpolicy.duke.edu/events/individualized-therapies-rise?utm_medium=email&utm_source=govdelivery Registration is now open to attend the FDA Rare Disease Innovation Hub’s November 20th Rare Disease Innovation, Science, and Exploration (RISE) Workshop on individualized therapies. Register here. This public workshop will examine the emerging science and regulatory environment for individualized medicine programs, including nonclinical data recommendations, clinical assessments, regulatory submission structure, and additional information necessary to support the development, evaluation, and potential commercialization of these treatments. The workshop will also provide opportunities for members of the rare disease community, including researchers, sponsors, patients, patient advocates, and regulators, to share their experiences with individualized medicine approaches. The goal of this workshop is to enhance understanding of regulatory considerations for individualized treatments and to inform future policy around individualized treatments.