Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics

Time: 11:30 am
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

Speakers: