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