Unlock rare value. De-risk your program. Attract the right partners.
The Challenge
Biotech companies working on niche indications often miss the opportunity to position their program for Orphan Drug Designation (ODD), Breakthrough Therapy Designation (BTD), or Priority Review Voucher (PRV). For APAC-originated programs, the challenge is greater—lack of U.S. regulatory familiarity, limited access to rare disease KOLs, and no U.S.-compatible data strategy.
JRC’s Solution
- Rapid orphan indication mapping based on preclinical or early clinical profile
- ODD/BTD/Fast Track application strategy and documentation
- U.S. PI and rare disease expert engagement
- U.S.-APAC dual submission (IND + local CTA)
- Cross-border trial design and FDA-compatible data structure
Results We Deliver
- Achieved ODD designation within 60 days
- Structured “Orphan-first” strategy for BD and investor decks
- Enabled licensing discussions with rare disease-focused MNCs
Have a promising but under-positioned asset?
Let us reframe it through the rare disease lens.