Day One

• Establishing early-phase impurity characterization and analytical strategies to inform downstream manufacturing control decisions
• Translating analytical methods into GMP-ready assays to ensure consistency, robustness, and regulatory compliance in manufacturing environments
• Addressing common disconnects between development and manufacturing teams to enable effective tech transfer and reduce scale-up risk

• Comparing yield efficiency, impurity formation profiles, and sequence-length constraints across different phase oligo platforms
• Assessing platform readiness for GMP control, stereochemical management, and regulatory acceptance when introducing alternative synthesis technologies
• Determining when transitioning synthesis routes materially improves long-term scalability and manufacturing flexibility

This informal session provides the perfect opportunity to connect with industry pioneers and key

opinion leaders in the oligonucleotide therapeutics field. Establish meaningful connections to build

upon at the rest of the conference and gain exclusive first-hand insights into the latest research

and developments driving progress in the space

• Designing robust enzymatic ligation workflows to enable scalable, high-fidelity oligonucleotide assembly to reduce sequence-dependent variability and improve overall product quality compared to traditional synthesis routes
• Translating enzymatic ligation into GMP-ready processes through validation, control strategy design, and comparability frameworks to ensure regulatory alignment and seamless progression from development to clinical manufacturing
• Evaluating enzymatic vs solid-phase synthesis through a CMC lens, including impurity profiles, process economics, and scalability constraints to inform platform selection decisions and future-proof oligonucleotide manufacturing strategies

• When heterogeneity is inherent, how is “chemical consistency” realistically defined for AOCs and conjugated oligonucleotides?
• Beyond OAR, what additional structural, positional, and linker-level controls are necessary to demonstrate reproducibility?
• How should long and highly modified oligo constructs be characterized to prove structural integrity?

• Establishing robust analytical strategies to resolve and characterize stereoisomeric heterogeneity to ensure batch consistency and strengthen structure–activity understanding
• Leveraging orthogonal characterization techniques to decode phosphorothioate stereochemistry to de-risk impurity profiles and inform control strategy development
• Defining stage-appropriate stereochemical specifications based on characterization data to align with regulatory expectations and enable scalable, reproducible manufacturing

• Why is stereochemistry becoming a critical component of demonstrating chemical consistency for modified oligonucleotides?
• What analytical and process chemistry approaches are emerging to characterize and control stereochemical variability?
• How can developers demonstrate stereochemical consistency in a way that is practical, scalable, and acceptable to regulators?

The Scientific Poster Session is your prime time to share your work with peers from various

backgrounds, all focused on analytical development & CMC for oligonucleotide drugs. Gain

feedback on how you can accelerate the progression of your drug pipelines and build connections

for potential collaborations to take your therapeutic from clinic to market.

Key questions to be addressed:

• Defining lifecycle management strategies to extend product longevity and delay generic entry while maintaining regulatory compliance
• Leveraging CMC changes and control strategy evolution to support product differentiation and sustain competitive advantage
• Aligning scientific, regulatory, and commercial priorities to maximize product value across late-stage development and commercialization
• Identifying key risks and trade-offs when implementing lifecycle strategies, including comparability, regulatory burden, and market impact

• Stress-testing analytical methods under increased batch size, material variability, and extended campaign manufacturing to ensure consistent performance
• Quantifying and controlling method-to-method and site-to-site variability during scale expansion
• Designing analytical performance criteria that remain robust under commercial throughput demands