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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
Industry Expert
Catherine Campbell, Vice President, Regulatory Affairs, Quality Assurance and GxP Compliance, Gene Therapy - 4D Molecular Therapeutics