Archives: Agenda

• Aligning in-house capacity to outsourcing needs to ensure your biotech sticks to budget
• Understanding when it is time to outsource to ensure sufficient oversight and management of all vendors
• Looking ahead to identify your biotech needs to integrate services seamlessly into current processes

• 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

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

• 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