Minimizing Chemistry, Manufacturing & Controls (CMC) Burden for Rare & Ultra-Rare Disease Programs to Enable Small Company Success
3:30 pm - Wednesday 24th February 2027
- Streamlining validation package requirements and Process Performance Qualification (PPQ) batch strategies to reduce multi-million-dollar costs that threaten program viability for single-asset developers
- Balancing regulatory compliance with practical cost constraints for small companies, implementing efficient approaches that meet agency standards without excessive financial burden
- Implementing efficient process development strategies that achieve regulatory approval while preserving capital for clinical trials and commercial launch preparation
