8:00 am Check-In & Welcome
9:00 am Chair’s Opening Remarks
Charting the Uncharted: Regulatory Guidance for a New Era of Oligonucleotide Development
9:10 am Panel Discussion: Outlining Current Industry Trends in Oligonucleotide Development
Synopsis
- Discussing the movement away from the development of oligonucleotides for rare diseases
- Capitalizing on opportunities and changes we anticipate in the future and newer complex oligos coming into pipelines
- Outlining challenges of scale, impurity characterization and qualification
10:00 am The Use of Risk Assessment to Evaluate the Quality Impact of Raw & Starting Materials Used in mRNA Manufacturing
Synopsis
- Understanding the quality requirements and analytical testing panels for raw and starting material used in mRNA manufacturing
- Assessment product quality and impact of raw material related risks and develop risk mitigation strategies to support mRNA manufacturing
10:30 am Speed Networking & Coffee Break
Synopsis
Dive into this speed networking session to meet 100+ fellow colleagues and break the ice. This is your opportunity to meet like-minded fellow colleagues, share your challenges and spark collaborations.
Debating Analytical Methods & Validity for Alternate Oligonucleotide Types
11:30 am Advancing Oligo-Conjugates Through Analytical Development
Synopsis
- Reimagining analytical development methods based on structure of the conjugated moiety
- Exploring functional assays to measure activity of the conjugate to ensure complete regulatory compliance and efficacy
- Validating methods to quantify the conjugate and potential degradation products with HPLC or LC-MS
12:00 pm Ensuring Sequence Specificity as ASO Production Increases
Synopsis
- Assessing and maintaining sequence specificity to ensure ASO activity and gene-silencing
- Rethinking formulation and characterization methods
12:30 pm Lunch & Networking
Upstream Innovation: Analytical Development of Oligonucleotides to Enhance Processes
1:30 pm Strategies for Enhancing Oligonucleotide Drug Formulation With Patient Adherence in Mind
Synopsis
- Conducting stability assessments to address potential degradation products and de-risk larger scale production
- Optimizing process and excipient selection for potential novel formulas to ensure safety
- Navigating formulations, such as choice of salt and pH, to increase administration options and improve patient adherence
2:00 pm Application of NMR for PMO Characterization & Process Control Strategy
Synopsis
Characterizing phosphorodiamidate morpholino oligomer chemistries to improve product consistency and efficacy
2:30 pm Session Reserved for Wuxi Tides
3:00 pm Afternoon Break & Scientific Poster Session
Synopsis
This is an informal session to help you connect with your peers in a relaxed atmosphere and forge new and beneficial relationships. With an audience of oligonucleotide enthusiasts eager to hear the latest cutting-edge advancements, you will have the opportunity to display a poster presenting your own work. Additionally, you will have the chance to review others’ posters displaying novel approaches to impurity assessments, analytical tools, and manufacturing for IND submission and post-regulatory approval into market.
Delving Into Downstream AD & CMC Toolboxes
4:00 pm Development of AEX & HILIC as Orthogonal Separation Methods to IPRP for the Characterization of Purity & Impurities in Oligonucleotide Products to Ensure Quality
Synopsis
- Exploring novel chromatography protocols to improve separation and purification in CMC
- Finding the right methods to separate nucleotides with minimal damage that maintains yield integrity
- Establishing quantity and quality of oligonucleotides within a drug product for continuous quality control and process monitoring
5:00 pm Development & Application of 2D HPLC for PMO Analysis & Impurity Profiling
Synopsis
- Introducing advanced analytical techniques for comprehensive analysis and separation of complex mixtures in PMO formulations, aiding in the identification and quantification of impurities with high resolution and sensitivity