Explore the Agenda
8:30 am Registration & Morning Coffee
9:25 am Chairs Opening Remarks
Workshop A
9:30 am Impurity Profiling Across ASO, siRNA, gRNA, & Conjugates to Prioritize Control Strategies for Product Quality & Regulatory Confidence
Oligonucleotide modalities are diversifying and impurity profiles are changing at the same rate, depending on chemistry and synthesis route.
With regulatory scrutiny intensifying and oligonucleotide therapies advancing toward late-stage development, this workshop is designed for teams to not only detect impurities but accurately characterize their structure, origin, and potential impact on product quality.
Join three leading industry experts across oligonucleotide platforms to overcome persistent challenges and build regulatory ready impurity control strategies at scale.
Key Questions to be Addressed:
- How reliably can emerging analytical strategies detect and characterize low‑level or novel impurities?
- How to leverage understanding the chemical origins of oligonucleotide impurities to strengthen early-stage control strategy?
- How dose, duration, chemical modifications, conjugation type, and biotransformation pathways influence impurity criticality, especially in light of EMA’s 2024 draft guideline?
12:00 pm Lunch Break & Refreshments
Workshop B
1:00 pm Lessons from a Recently Approved Oligo: What the Data Package & Regulations Actually Looked Like
As oligonucleotide therapies advance into larger indications and later-stage development, regulatory expectations around CMC documentation, control strategy justification, and comparability evidence are intensifying. However, with limited precedent and evolving guidance, many developers remain uncertain about how regulatory agencies interpret oligonucleotide data packages in practice.
This workshop will unpack what a successful regulatory submission for an approved oligonucleotide therapy actually looked like, exploring how key elements of the CMC strategy were justified, and how regulatory expectations differ across global agencies.
Join this workshop to establish industry standards for oligonucleotide regulatory specifications:
- What did the overall CMC data package look like in a successful regulatory submission for an approved oligonucleotide therapy?
- How were comparability evidence, stereochemical control, and phase-appropriate specifications justified within the final regulatory data package?
- How do expectations differ between the FDA, EMA, and other regulatory agencies, and how should developers adapt their strategies to satisfy multiple global regulators?
Integrated Regulatory Panel
The workshop will conclude with an interactive regulatory panel to benchmark interpretation of current expectations and discuss areas of continued ambiguity.
Please send in questions you’d like to see addressed in the panel to info@hansonwade.com