Day One - Tuesday August 26, 2025

7:30 am Check In & Light Breakfast

8:25 am Chair’s Opening Remarks

Investigating the Future of Oligonucleotide Drug Development

8:30 am Panel Discussion: Exploring Novel Oligonucleotide Drug Development: Unlocking New Opportunities, Overcoming Market Challenges & Advancing Innovative Oligos Through Pipelines

Synopsis

• Validating strengths and new opportunities that have emerged in the space

• Analyzing weaknesses and threats that oppose commercial market access 

• Overview of different oligo modalities and their positioning in clinical development 

Innovating Analytical Techniques for Impurity Profiling & Separation to Boost Yield, Ensure Safety & Maximize Efficacy

9:00 am Analytical Method Bridging for Denaturing HPLC: A Case Study in Oligonucleotide Purity

  • Matthew McQueen Associate Director, Analytical Development, Avidity Biosciences, Inc.

Synopsis

• Overview of the design and execution of bridging studies for denaturing HPLC methods 

in oligo analysis

• Discussion of method optimization and laboratory transfer strategies to support 

analytical continuity as oligonucleotide drugs progress through development and 

manufacturing

• Presentation of case studies and best practises to ensure successful method bridging 

and maintain analytical consistency

9:30 am Orthogonal Method Strategies for Oligo Impurity Profiling

Synopsis

• Exploring the source of oligo impurities and categorizing them effectively 

• Considerations for oligo impurity profiling to meet regulatory expectations

• Case study: oligo impurity profile by orthogonal UV method and characterization by UV

10:00 am Speed Networking

Synopsis

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

10:30 am Morning Break

11:00 am AEX & IPRP Orthogonal Method Explorations for Critical Impurity Profiling of Late-Stage siRNA Oligonucleotides

Synopsis

• Development and optimization of Anion Exchange Chromatography (AEX) and Ion Pair 

Reversed phase (IPRP) methods for profiling critical impurities in oligos

• Instrumentation considerations and procedural harmonization to support robust, 

reproducible methods for quality control release and stability testing under stringent 

regulatory requirements

• Targeted strategies for method corrections and refinements of AEX and IPRP 

techniques for siRNAs to ensure accurate impurity detection

11:30 am Session Reserved for Hongene

12:00 pm Lunch & Networking Break

Advanced Analytical Solutions for Complex Oligos Modalities to Ensure Quality & Expedite Development

1:30 pm Advanced Analytical Solutions for Complex Oligos Modalities to Ensure Quality & Expedite Development

  • Benjamin Rogers Associate Director/Principal Scientist, Oligonucleotide and Small Molecule CMC, Denali Therapeutics Inc.

Synopsis

Analytical Strategies for Oligonucleotide Impurity Monitoring & Control in 

Oligonucleotide Conjugates

• A series of vignettes for approaches to monitoring oligonucleotides critical quality 

attributes in oligonucleotide conjugates

• Monitoring of impurity identity and quantities in OTVs with LC-MS

• Use of 31P NMR for orthogonal impurity detection, assay and impurity identification

• Use of 31P NMR for monitoring diastereomer ratios

2:00 pm Session Reserved for WuXiSTA

2:30 pm Afternoon Networking Break & Scientific Poster Session

Synopsis

Want to share your work but not ready for the big stage just yet? 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.

3:00 pm Session reserved for Asymchem

Optimizing Scalable GMP Complaint Manufacturing by Controlling Critical Process Parameters & Innovating Early-Stage Oligo Models

3:30 pm Critical Process Parameters in Oligonucleotide Manufacturing: Strategies for Control During Scale-Up

Synopsis

• Emphasizing the importance of early identification of Critical Process Parameters 

(CPP) to enable effective control strategies that ensure consistent product quality and 

compliance

• Developing robust and predictive down-scale models to accurately illustrate large scale 

manufacturing and minimize risk of unexpected results during scale up

• Case studies highlighting the impact of insufficient CPP control: common pitfalls and 

establishing effective control frameworks 

4:00 pm Continuous Process Improvement: Limitations of an Early-Stage Manufacturing Process Addressed By Innovative Chemistry

  • Debasis Patra Vice President, Director & Head of Chemistry, Manufacturing, & Controls, OliX Pharmaceuticals

Synopsis

• Due to some unique structural characteristics, appropriate process parameters were 

developed for the first GMP delivery 

• Cleavage and Deprotection conditions were carefully designed to generate material 

meeting desired specifications 

• A deeper understanding of the chemical process led to development of a robust protocol 

that is amenable to large-scale synthesis using typical oligo plant equipment

4:30 pm Breakout Roundtable Discussions

Synopsis

Uncover the story behind leaps and setbacks from the movers and shakers of oligo analytical development & CMC. Each roundtable will be hosted by a leader in the space who will share a challenge, question or case study to discuss.

Round table 1: Integrating Novel Analytical Techniques into a GMP Compliant Lab

Round table 2: Utilising Software & Analytics to Improve Accuracy of Impurity Profiling & Separation

5:00 pm Chairs Closing Remarks & End of Conference Day One