Pre-Conference Workshop Day
Monday, December 9, 2024
Workshop A
9:00 am Pinpointing & Understanding the Contributions of LNP Components to Toxicity & Their Combined Impact
Synopsis
- Distinguishing the mechanism of toxicity of each individual nanoparticle component to determine the effect and degree each molecule contributes, as well as their combined impact
- Harnessing learnings to influence into novel LNP design with enhanced safety features
- Determining the levels of toxicity elicited by various lipid types within a nanoparticle to influence formulation ratios
- Which chemotypes and molecules should we avoid incorporating into nanoparticles to improve safety profiles? What molecules can we utilize as an alternative?
11 am Morning Break & Refreshments
Workshop B
11:30 am Characterizing the Immune Response to LNPs to Benchmark Strategy for Safety Studies & Immune Monitoring
Synopsis
- Revealing which components of the immune system are activated by lipid nanoparticles
- Measuring Ig and antibody levels to indicate level of immunogenic response
- Discussing the challenges that arise from working with a diverse array of immune systems among the population – how can we determine a control?
- Identifying which immune components are activated by LNPs to influence intervention methods to minimize side effects and unwanted infusion associated reactions
1:30 pm Lunch Break & Networking
Workshop C
2:30 pm Benchmarking Regulatory Requirements for Preclinical LNP Safety Testing & Strategy to Streamline Submissions & Support Approval
Synopsis
- Summarizing and interpreting current regulatory guidance to understand data and IND submission requirements
- Navigating differences in requirements for various modalities to
- Understanding the submission process to determine
- Uncovering regulatory learnings from clinical assets to influence regulatory strategy for earlier stage products