AccelerateRARE Working Groups
Developing stakeholder consensus on rare disease clinical development topics to meaningfully accelerate the development of new therapies.
2026 Working Group A:
35 experts from biopharma, patient advocacy, academia and regulatory science convened at the 2026 Summit, chaired by Dr. Janet Woodcock, to propose a predictable evidence framework for rare and individualized therapies beyond the conventional trial.
2025 Working Group:
37 experts from biopharma and patient advocacy convened at the 2025 Summit to draft the priorities of the rare disease clinical development community ahead of the upcoming PDUFA VIII reauthorization.