Bioanalysis of Oligonucleotides: Strategies, Applications, and Regulatory Considerations

December 8-9, 2025 | 8:30 AM – 1:00 PM PT

SPEAKERS
Aaron Anderson Avidity Bio
Kelly Colleti, PhD, MBA Beam Therapeutics
An Zhao, PhD Regeneron
Maral Llewellyn, PhD Ionis
Stephanie Pasas-Farmer, PhD BioData Solutions

ORGANIZERS
Stephanie Pasas-Farmer, PhD BioData Solutions  |  Shichang Miao, PhD PBSS

This virtual workshop will provide a comprehensive overview of current bioanalytical approaches supporting the development of therapeutic oligonucleotides. As oligo-based therapies evolve — introducing novel delivery systems and molecular modalities — the need for innovative, fit-for-purpose bioanalytical methods grows. Experts will present emerging techniques and best practices in pharmacokinetics (PK), anti-drug antibody (ADA) detection, and biomarker analysis, alongside regulatory considerations unique to oligonucleotides. Topics include metabolism, advanced assay platforms (LC-MS, qPCR, HELISA), and the impact of delivery technologies such as lipid nanoparticles (LNPs) and antibody-oligonucleotide conjugates (AOCs).

Ideal for scientists and regulatory professionals, this session bridges cutting-edge science with practical implementation in a rapidly advancing therapeutic space.