Navigating Regulatory, Safety, and Market Access Challenges for Oligonucleotide & Peptide Therapeutics
26 Sep 2025
Regulatory, Safety & Market Access
- -Understand evolving global regulatory frameworks specific to oligonucleotides and peptides, including CMC expectations, accelerated pathways, and emerging guidance's
- Address key safety concerns such as immunogenicity, off-target effects, and delivery challenges that impact preclinical and clinical development
- Explore payer expectations, HTA requirements, and value demonstration approaches to ensure successful commercialization in a competitive and evolving landscape
