Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics
Time: 12:00 pm
day: Day 2
Details:
- Considerations for new chemistries and indications for oligos, as well as considerations for common, rare and ultra-rare indications
- The FDAs views regarding platforms and platform technology
- Evaluate what kind of safety data needs to be shown to demonstrate safety
- Map out differences in regulatory requirements between US, Europe and more
