Archives: Agenda

• Reframing clinical readiness in oncology: Why trial success is increasingly determined upstream—through mechanistic validation, patient stratification, and translational alignment before first-in-human dosing.
• Clinical Trials in a Dish platform: How patient-derived iPSC and organoid disease models can be deployed to predict responder populations, evaluate combination strategies, and inform biomarker-guided trial design.
• Leveraging academic ecosystems: Integrating biobanks, molecular datasets, and investigator networks to accelerate translational insight and enable more targeted, recruitment-efficient oncology trials.
• Capital-efficient development strategies: Using functional precision modeling to reduce late-stage attrition, optimize cohort sizing, and deploy clinical budgets with greater signal-to-cost discipline.

• A 50-year retrospective on the escalating costs, stagnant timelines, and the attrition crisis in general and oncology drug development
• An analysis of the “Biomarker Revolution” and its profound historical influence on phase transition success rates, clinical trial durations, and evolving reimbursement models
• How integrating predictive biomarkers into clinical design eliminates the “noise” of non-responders and can multiply the overall probability of drug approval by a factor of five
• The Omios Biologics Solution: How we are utilizing a proprietary computational platform to develop the first biomarker-guided, systemic oncolytic viruses

• Understanding the biological mechanisms that drive treatment resistance in oncology
• Using biomarkers to identify patients most likely to benefit from targeted therapies
• Applying functional genomics to uncover new therapeutic targets and resistance pathways

• Alternative data sources have the potential to strengthen clinical evaluation
• AI-assisted RECIST workflows can automate lesion identification and measurement along with human oversight
• Use of algorithmic approaches with RWD such as real-world Lugano may strengthen the bridge between clinical trials and RWE

Key Takeaways:

• Understand what oncology site networks are telling sponsors and CROs about enrollment, engagement and retention in early phase trials
• Learn why putting site needs and operational realities at the forefront of trial design improves execution and patient experience
• See how practical, site‑first operational design decisions can accelerate start‑up and improve overall trial performance

As oncology trials grow more complex, speed is increasingly determined by decisions made early — during protocol design, feasibility, and site engagement. This fireside chat explores how closer collaboration between sponsors, CROs, and sites can improve execution, accelerate activation, and sustain trial momentum without sacrificing scientific rigor.

Discussion highlights include:

• Designing operationally realistic oncology protocols
• Gaining meaningful feasibility insight from sites
• Engaging sites as strategic partners
• Reducing downstream friction through early alignment
• Real‑world lessons from U.S. and European oncology trials