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.
2026 Working Group B:
35 experts from biopharma, patient advocacy, clinical research and regulatory affairs convened at the 2026 Summit to set out how children can be included in clinical trials at the earliest appropriate point.
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.