Day Two
Wednesday, December 13
8:00 am
Morning Registration & Coffee
8:45 am Chair’s Opening Remarks
Enhancing Assessment of Immunogenicity & Toxicity for Safer Therapeutic Interventions
9:00 am Strategic Consideration to Leverage the Translatability From Preclinical Assessments to Clinical Trial Through Implementation of Appropriate Assays
Synopsis
- In vitro cytokine release assay in hPBMC and in vivo toxicity assessment with characterization of drug exposure
- Immune response under repeated dosing modality of PEGylated LNP through systemic delivery and mitigation strategies
- Regulatory perspective of toxicity assessment on the LNP with different API entities
9:30 am Leveraging Animal Models for Comprehensive Immunogenicity & Toxicity Assessment
Synopsis
- Administering the therapeutic intervention to animal models and monitoring their immune responses, including cytokine production, immune cell activation, and antibody generation
- Assessing the biodistribution of the therapeutic intervention in animal models using imaging techniques or tissue sampling
- Evaluating the potential systemic and local toxic effects of the therapeutic intervention in animal models through histopathology, organ function tests, and biomarker analysis
Exploring the Structural Analysis of LNP & Its Impact on Immunogenicity for Amplified Therapeutic Potential
10:15 am Exploring the Effect of LNP Composition on Immunogenicity
Synopsis
- Investigating the impact of different lipid nanoparticle compositions on the immunogenicity of therapeutic interventions
- Comparing the immunogenicity profiles of different LNP compositions in preclinical and clinical studies
- Exploring the impact of LNP composition on the duration and magnitude of immune responses to mRNA and other payloads
10:45 am
Morning Refreshments & Speed Networking
11:45 am Exploring Novel Biodegradable LNPs & Their Effect on Pharmacokinetics & Toxicity
Synopsis
- Investigating the effect of LNP chemistry on pharmacokinetics and toxicity
- Developing new ionizable lipids for rapid clearance
- Comparing optimal LNP compositions for RNA vaccines and therapeutics
Optimizing Therapeutic Safety: Unveiling the Impact of Diverse LNP Payloads on Immunogenicity & Toxicity
12:15 pm The Effect of DNA as an LNP Payload on Immunogenicity & Toxicity
Synopsis
- Investigating the impact of using DNA as a payload within LNP delivery systems on immunogenicity and toxicity
- Assessing the potential immune responses triggered by the presence of DNA components within LNPs
- Assessing the role of different LNP formulations and DNA payload designs in modulating the immune response and minimizing adverse reactions
12:45 pm Non-clinical & Clinical Safety Profiles of Two LNP-Adjuvanted Vaccines
Synopsis
- Characterization of the immune response in nonclinical species following administration of two different LNP-adjuvanted vaccines
- Non-clinical toxicity profiles of two different vaccines with the same LNP adjuvant
- Disparate clinical safety profiles of two vaccines adjuvanted with the same LNP
1:15 pm
Lunch & Networking
2:15 pm Round Table Discussion: Maximizing Benefits: Unravelling the Impact of Diverse Payloads on Immunogenicity &Toxicity for Safer & More Effective Therapies
Synopsis
Payloads to consider – mRNA, RNA, DNA, SiRNA, CRISPR etc.
- Differences and similarities across different payloads
- How is the payload impacting the immunogenic response
- Understanding the toxicity of the payload
- How are we reducing/enhancing immunogenic responses
- Innovations in alternative payloads being considered for drug development
3:00 pm Impact of LNP Based Therapies on Off-Target Effects for Targeted Therapeutic Interventions
Synopsis
- Investigating the potential off-target effects of LNP delivery systems in therapeutic interventions
- Assessing unintended interactions and effects of LNPs with non-target cells or tissues
- Investigating the potential immunogenicity triggered by off-target effects of LNPs, leading to unwanted immune responses