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HIE Highlighted at the FDA ADEPT 10 Workshop

March 1st, 2026  | News  | Research

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On February 5–6, 2026, leaders from the FDA, academia, industry, and advocacy convened for ADEPT 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks.

The workshop focused on overcoming barriers in neonatal drug development — from ethical complexity and small populations to innovative trial designs, real-world data, and regulatory pathways.

Importantly, HIE was recognized as a key neonatal diagnosis within these discussions, a result of the multi-factoral advocacy that Hope for HIE and collaborators have worked towards for the last several years.

Hope for HIE’s Executive Director, Betsy Pilon, served on the closing stakeholder panel alongside national leaders in rare disease and neonatology highlighting:

• The need for clarity and alignment at the FDA and other global regulatory agencies
• The need for patient-focused outcomes that are reflective of the community
• Long-term follow-up and outcomes beyond infancy
• Meaningful family partnership in trial design

The themes of ADEPT 10 directly align with Hope for HIE’s ongoing work to advance therapeutic development through:

• The HIE Registry
• The Neonatal Brain Injury Collaborative (NBIC) through INC/C-Path
• The Halo of Support™ framework integrating family voice into research

This workshop reinforced what we know: neonatal innovation requires regulatory flexibility, cross-sector collaboration, and authentic family partnership.

Hope for HIE will continue to advocate at the highest levels to ensure HIE remains visible — and that families are not an afterthought in therapeutic development.

Because progress for neonatal brain injury demands nothing less.

All sessions were recorded and are available below:

FDA Adept 10 Workshop Recordings