Satya Kuchimanchi
Senior Vice President - Technical Operations, Chemistry, Manufacturing, & Controls CAMP4 Therapeutics
Seminars
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
- Defining the critical analytical, process, and raw material requirements across DS and DP to support IND submission
- Designing scaled-down models and analytical strategies to build process understanding and de-risk scale-up
- Overcoming technical and organizational challenges in early CDMO partnerships and technology transfer to ensure alignment on methods, specifications, and accelerate GMP readiness
