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

  • Hua Gong SVP, Translational Medicine and Clinical Biomarker, ZaiLaboratory


• 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


• 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


• 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


• 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


• 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


• 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

3:00 pm End of Pre-Conference Biomarkers Day