Pre-Conference Workshops (am) & Main Conference Day 1 Plenary (pm)Tuesday, 3 November 2026 - Europe/Amsterdam

Workshop Overview:

Getting oligonucleotide therapeutics from bench to patient requires more than scientific ingenuity — it demands a CMC strategy that is integrated, forward-looking, and built to survive regulatory scrutiny from preclinical to market. Too often, CMC functions are compartmentalized, reactive and even under-resourced until a filing deadline forces response. This workshop challenges that model. Several industry experts share perspectives on what it takes to build and sustain an oligonucleotide CMC program.

• A quality leader will make the case for early quality integration – why waiting until Phase I or Phase II to build your control strategy costs time, money, and even credibility with regulators.
• An analytical and bioanalytical expert will address the practical realities of method selection, qualification timelines, and the bioanalytical challenges unique to oligonucleotide modalities.
• A drug substance and drug product specialist will tackle how modification chemistry — 2'-substitutions, phosphorothioate stereochemistry, LNA, and conjugate architectures — can reshape the purification landscape, can redefine the impurity profile, can complicate formulation development, and alter specifications.
• A starting materials expert will address amidite sourcing, supplier qualification, and building a supply strategy resilient enough to survive scale-up and commercial demand.

Together, these perspectives frame oligonucleotide CMC not as a series of sequential handoffs, but as an integrated, lifecycle-spanning discipline.