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TIDES Insights: Your Year-Round Gateway to Oligonucleotide & Peptide Innovation
Browse key topics and session spotlights from our curated agenda including CMC efficiency, genome editing and the European regulatory landscape for oligonucleotides and peptides.
Hear from TIDES Europe's Project Manager and Conference Producer, Michael Keenan
Michael shares exciting key topics on the agenda, his standout sessions and what he is most looking forward to at this year's TIDES 2025!
Session Spotlights
Explore how AI foundation models are revolutionizing drug discovery by replacing narrow, task-specific approaches with comprehensive systems that benefit from breadth of application and task synergies. This session will demonstrate how these models scale accuracy with increasing data and apply to ASOs, siRNAs, mRNAs, DNA/RNA editing, and target discovery.
How do peptides unlock a new possibility for dissolving neurotoxic protein aggregates, which are a hallmark to various neurodegenerative disorders? This session will focus on the development of PRI-002 from discovery to phase II in Alzheimer’s disease.
Delve into the distinct approaches to process optimization across project phases, with early phase focusing on speed through innovative building blocks and non-standard oligonucleotide synthesis protocols. This session will look at how late phase optimization shifts priority to quality factors, cost reduction, scalability, and efficiency, leveraging accumulated process data and real-world evidence.
Uncover oligonucleotide therapeutics' potential for treating conditions with no current therapies, noting their recent approval surge and unique position between small molecules and biologicals. The presentation will introduce the European Medicines Agency's new draft "Guideline on the Development and Manufacture of Oligonucleotides," addressing the specific quality considerations essential for this innovative therapeutic class.
Key Topics Being Explored at TIDES Europe
What analytical methods will be discussed for characterizing oligonucleotide impurities?
The conference will cover advanced analytical techniques including ion-pair reversed-phase liquid chromatography coupled with mass spectrometry (IP-RP LC-MS), high-resolution accurate mass (HRAM) spectrometry, and data-dependent MS2 (ddMS2) methods. Sessions will specifically address how these techniques enable identification and quantification of oligonucleotide impurities and degradation products, even at very low levels.
How will the conference address oligonucleotide scale-up challenges?
Several sessions will focus on the transition from lab-scale to GMP manufacturing, addressing critical parameters that change during scale-up, equipment considerations, and process robustness strategies. Speakers from leading CDMOs will present case studies on overcoming yield limitations, managing phosphoramidite coupling efficiency at scale, and implementing continuous manufacturing approaches.
What content will be available on phosphorothioate oligonucleotide manufacturing?
The agenda includes specialized sessions on phosphorothioate oligonucleotide synthesis, covering oxidation vs. sulfurization strategies, stereochemical control approaches, and analytical methods for characterizing Rp/Sp diastereomeric mixtures. Presentations will address how manufacturing processes can be optimized to control impurity profiles specific to phosphorothioate backbones.
What guidance will be provided on CMC regulatory submissions for oligonucleotides?
The conference will feature sessions from regulatory experts and industry leaders who have successfully navigated oligonucleotide submissions. Speakers will discuss critical elements of oligonucleotide CMC packages, health authority expectations for characterization data, and starting material definitions and control strategies. Presentations will cover approaches for setting specifications based on clinical experience and strategies for addressing regional regulatory differences between FDA, EMA, and PMDA.
How will the conference address emerging delivery technologies for oligonucleotides?
Technical sessions will cover the latest advances in oligonucleotide delivery, including novel lipid nanoparticle formulations and conjugation strategies for targeted delivery. Experts will present analytical characterization methods for oligonucleotide-conjugates and manufacturing considerations for complex delivery systems. Discussions will address stability and compatibility challenges in drug product development and approaches to overcome delivery barriers.
