Isabella Presch/LinkedIn
Aug 26, 2026, 18:27
Isabella Presch: Not Every Genome-Editing Program Needs to Start From Zero
Isabella Presch, Senior Medical Director Rare diseases, Advanced therapies and Pediatrics at Fortrea, shared a post on LinkedIn:
“An important signal from the FDA: not every genome-editing program needs to start from zero.
The new draft guidance highlights how prior knowledge can be responsibly leveraged to advance development while maintaining rigorous standards for quality, safety, and efficacy. Encouraging progress for the future of rare disease innovation.
Potential Strategic Implications for Sponsors:
- Enable faster development across multiple genome-editing programs
- Reduce redundant CMC and nonclinical work
- Encourage early platform planning
- Increase the value of robust platform datasets
- particularly beneficial for rare disease, pediatric, and individualized therapy programs”
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