Pre-Conference Biomarker Focus Day
Tuesday, January 30, 2024
8:30 am Morning Registration
9:20 am Chair’s Opening Remarks
9:30 am Maximizing Specificity of Biomarkers for Novel DDR Inhibitor Target Engagement
Synopsis
• Benchmark the validity of existing biomarkers of cell stress and broad deficiencies in DDR for the development of the next wave of DDR inhibitors
• Explore development of biomarkers for specific targets in DDR pathways based on differential biology between targets
• Assess the current landscape of unique biomarkers that discriminate between highly diverse targets and inhibitors with unique mechanisms of action
10:00 am Roundtable: Recalibrating Biomarkers Amongst DDR Pathway Crosstalk for Quantified Target Interaction
Synopsis
• Re-examine how to identify biomarkers representing the impact of DDR inhibitors and identify potential crosstalk
• Investigate the spatial and temporal dynamics of cellular stress responses integral to DDR
• Establish how to navigate context dependency such as tumor microenvironment and the extent of DNA damage when utilizing biomarkers
11:00 am Morning Break
11:30 am Optimizing the Pharmacodynamic Biomarker Strategy for the DHX9 Inhibitor FTIH Study
Synopsis
• Describe rationale for pursuing DHX9 inhibitor as a novel therapeutic and relevance to DDR biology
• Investigate PK-PD assay methodologies for quantitatively measuring evidence of target inhibition in peripheral tissues
• Discuss trade-offs implementing a novel clinical PD biomarker strategy in a FTIH study
12:00 pm Panel Discussion: Balancing Novel Biomarkers for Multiple Cancer Types for DDR Inhibitor Development
Synopsis
• Can we repurpose biomarkers used by other areas of oncology?
• What do we need to know to develop and validate biomarkers amongst the complexity of DDR pathways?
• Are novel target specific biomarkers for every novel target a worthwhile pursuit or realistic goal? Should we aim for a universal DDR biomarker?
1:00 pm Lunch & Networking
2:00 pm Investigating Biomarker Strategies for Patient Stratification for DDR Inhibitor Monotherapies
Synopsis
• Review the predictive biomarkers that have been studied to identify patients most likely to respond to DDR inhibitor monotherapies
• Assess the validity and reproducibility of patient selection biomarkers for approved
monotherapies and apply these lessons to novel target monotherapies
• Reflect on the clinical relevance of biomarkers and concerns regarding tumor resistance
2:30 pm Establishing Clinical Relevance of Combinations of Biomarkers for Patient Stratification in Combination Therapy Clinical Trials
Synopsis
• Overcome challenges of developing biomarkers that capture the combinatorial effects of
different treatment modalities combined with DDR inhibitors
• Manage differential sensitivity and provide actionable insights for clinical developments to provide guidance in clinical trials
• Reflect on the utility of genomic biomarkers and their clinical relevance for patient stratification amongst variable tumor burden and metastases