Biomarker Focus Day

• Exploring the evolving role of biomarkers in DDR therapy, from predictive tools to dynamic response monitors

• Evaluate the challenges of biomarker complexity, standardization, and clinical implementation

• Sharing cross-sector insights on integrating biomarkers into trial design, dosing strategies, and regulatory pathways

• Evaluating Project Optimus implications for DDR programs and how proactive pharmacological modeling accelerates clinical success

• Highlighting the challenges of dose selection in DDR inhibitor combinations, balancing efficacy with tolerability

• Showcasing how model-based drug development leverages preclinical and clinical data to guide smarter escalation and expansion strategies

• Diagnosing why single-gene mutation biomarker approaches often underperform, highlighting the need for additional predictors of response

• Presenting combination biomarker concepts, e.g., CCNE-amp + co-alterations and pathway-level logic

• Exploring adaptive enrichment designs for DDR therapies with consideration of prevalence and implementation feasibility

• See how Step Pharma is leveraging data-driven discovery of replication stress as a predictive biomarker, linking novel agents with ATR and WEE1 synergy

• Sharing preclinical insights while outlining the translational challenges of moving from complex preclinical signatures to clinical assays

• Balancing biomarker complexity with clinical feasibility to inform future DDR combination strategies

• Demonstrating how ALC1 inhibition enhances PARP trapping and PARP inhibitor responses in HR-deficient cancers
• Establishing FANCM dependency as a therapeutic vulnerability in ALT-positive tumors, unlocking new synthetic lethality opportunities
• Highlighting biomarker strategies to identify HR-deficient and ALT-driven patients for precision deployment of ALC1 and FANCM–targeted therapies

• See how Merck is demonstrating durable responses with ATR inhibition in ATRX-mutant gliomas, a poor-prognosis subtype

• Outlining the synthetic lethality rationale linking ATRX loss, alternative lengthening of telomeres (ALT), and ATR dependency

• Presenting ongoing studies confirming early signals and discussing opportunities to integrate biomarker-driven patient selection into glioma trial design

• See how Sumitomo Pharma America is enhancing tumor targeting with their novel liposomal CHK1 inhibitor, SMP-3124.

• Highlighting translational research insights that improve the likelihood of tumor response while mitigating toxicity limitations seen with earlier CHK1 programs

• Providing a trials-in-progress update on the ongoing Phase I study, sharing design, patient cohorts, and a general summary

Balancing Efficacy & Safety Through Biomarker-Guided Dosing

• How can predictive, pharmacodynamic, and longitudinal biomarkers be integrated to define the therapeutic window across dose-escalation and expansion phases?
• What are the major challenges in translating preclinical biomarker signatures into patient-ready dosing strategies, and how can teams improve assay readiness, sampling timing, and clinical decision-making?

Designing & Deploying Combination Biomarkers to Guide DDR Combination Therapies

• How can combination biomarkers be structured to improve predictive accuracy, while maintaining patient eligibility and minimizing operational complexity in trials?
• What practical and regulatory-aligned strategies support the development, validation, and clinical feasibility of multi-analyte or pathway-level biomarker panels in DDR combination studies?

• Following the separate roundtable discussions, this session is dedicated to the roundtable leaders to share insights, outcomes, and further questions raised on each table

• This will be a panel format, taking audience questions to close off the day