Conference Day Two
7:30 am Morning Refreshments
7:55 am Chairs Opening Remarks
From Biomarkers to Endpoint & Even Clinical Trial Design: Innovations in Clinical Development Strategies to Advance Inflammasome Therapeutics
8:00 am Leveraging Inflammatory Induced Pain as an Innovative & Alternative Endpoint for a Time-Effective Measurement of Therapeutic Benefit
Synopsis
- Examine the traditional endpoints used in clinical trials for inflammatory diseases and their limitations in demonstrating therapeutic efficacy within practical timeframes
- Exploring alternative endpoints that offer meaningful signals of therapeutic effectiveness while minimizing trial duration
- Detailing innovative approaches to optimize clinical trial outcomes, balancing the need for meaningful signals with cost-effective trial design
8:30 am Examining Clinical Biomarkers for Patient Selection & Stratification for Inclusion & Exclusion Criteria
Synopsis
- Discuss the integration of inflammasome biomarker data into clinical decision-making processes
- Investigate the utility of inflammasome-related biomarkers in stratifying patient populations based on disease severity, progression, and therapeutic responsiveness
- Explore the potential of predicting therapeutic outcomes in inflammasome-targeted interventions to enable personalized treatment approaches form optimized patient selection criteria in clinical trials
9:00 am Optimizing Clinical Trial Design & Outcomes for Inflammasome-Targeted Therapies
Synopsis
- Investigate innovative methodologies for enhancing trial efficiency without sacrificing data quality
- Delve into the utilization of biomarkers and surrogate endpoints to enable faster assessments of therapeutic efficacy and safety, facilitating expedited decision-making in clinical trials
- Examine strategies for enhancing patient recruitment and retention, addressing common challenges to ensure timely completion of trials and robust data interpretation
9:30 am Navigating Clinical & Post-Approval Considerations for Inflammasome Inhibitors with Diverse Uses and Future Implications
Synopsis
- Gain insights into the advanced stage of development for novel inflammasome inhibitors
- Examine the broader implications of inflammasome inhibitor approvals, including offlabel usage considerations, insurance coverage challenges, and their impact on existing treatment paradigm
- Explore how the approval and widespread adoption of inflammasome inhibitors may disrupt traditional therapeutic approaches, particularly in comparison to corticosteroids
10:00 am Morning Break
10:30 am Panel & Audience Discussion: Exploring the Implications of the Nuanced Clinical & Regulatory Considerations for Inflammasome Therapeutics Across Different Diseases
Synopsis
- This panel gathers industry leaders and seasoned regulatory experts to dive into the nuanced requirements of different disease types with regard to patient selection criteria in clinical trials, the nuances of trial design, considerations for study endpoints, treatment duration, dosing regimens, comparator arms and beyond
- Engage in this interactive session, ask your pressing questions to experts
Navigating the Complexity of Preclinical Development in Inflammasome Research: From Drug Discovery to Translational Models
11:00 am Addressing the Challenge of Studying Non-Conserved Inflammasome Pathways in Preclinical Development
Synopsis
- Explore the discrepancies between human and murine inflammasome pathways and their implications for recapitulating human-specific inflammatory responses
- Exploring the impact of replicating human heterogeneity in relative homogeneous mice to validate human systems
- Leveraging modeling techniques including humanized mouse models, advanced genetic engineering, and computational modeling to better mimic human immune responses and dissect pathway intricacies
11:30 am Selecting Translational Preclinical Models for Studying Inflammasomes
Synopsis
- Considerations for selecting the most appropriate model for studying inflammasomes based on disease pathology, genetic background, target tissue involvement and desired outcomes in different disease indications
- Strategies for standardizing translation across laboratories and industries to improve reproducibility and reliability of preclinical data for comparison across the industry
- Importance of selecting animal models that recapitulate human disease pathology to improve the predictiveness of preclinical studies and better align with clinical outcomes
12:00 pm Gasdermin-Mediated Pyroptosis: From Noncanonical Inflammasome Activation to Tumor Immunity
Synopsis
- Exploring the functions of noncanonical inflammasome in epithellial cells, in which IL-18 maturation acts as a link between pyroptotic cell death and activation of type I immunity
- Uncover noncanonical inflammasome-induced GSDMD pore formation in brain endothellial cells as the cause for BBB breakdown in bacteremia and sepsis; highlight the concept that gasdermin pore could open the BBB
- Discuss antitumor immune responses triggered by gasdermin activation in tumor cells and the role of gasdermin-mediated pyroptosis as an effector mechanism in tumor immunity and lymphocyte cytoxicity
12:30 pm Lunch Break
1:30 pm Delving into the Intricacies of Preclinical Development of Inflammasome Inhibitors for Neuroinflammatory Conditions
Synopsis
- Addressing optimization challenges for achieving brain exposure
- Illustrating the journey to efficacy in mouse models of human disease and validating target engagement in the central nervous system
2:00 pm Unveiling the Power of Bat Biology in Drug Discovery: Leveraging Comparative Genomics for Novel Inflammasome Targets
Synopsis
- Harnessing the unique adaptive biology of bats, tapping into millions of years of natural evolution to identify potential therapeutic targets
- Uncover comparative genomics from over 50 bat species, providing insights into disease resistance and physiological adaptations
- Explore the integration of cell biology, genomics, and bioinformatics to translate bat-derived insights into novel targets for human diseases, with a particular focus on inflammation and metabolism
Examining the Future Directions of the Inflammasome Therapeutics Landscape to Bring Better Drugs to Patients Faster
2:30 pm Panel Discussion: What are the Future Directions of the Inflammasome Therapeutics Landscape? A Glimpse into the Next 5 Years
Synopsis
- Reflecting on all the incredible insights shared today and our key takings, where do we see the inflammasome landscape going?
- Does commercial opportunity lie in tackling metabolic diseases or even with combination therapies?
- What is the feasibility and efficacy of targeting alternative inflammasomes across diverse disease sets?
- Discuss the areas of unmet needs with opportunity to be addressed by emerging therapeutics and modalities