Archives: Agenda

• Synthetic populations and AI-simulated control arms are already reducing reliance on traditional randomization
• Real-time, adaptive approval models could replace rigid phase boundaries
• Continuous post-market learning may become as important as pre-market proof
• Decision-making authority shifts as AI accelerates evidence generation beyond human-paced review cycles

• Integrating the right biomarker to narrow relevant patient groups and optimize and personalize disease management
• Engaging with the oncology community and advocacy groups to grow involvement of well-informed patients
• Leveraging investigator expertise for pragmatic trial designs and patient identification
• Building the evidence, from natural history to endpoint development, to support informed decisions by health authorities
• Modernizing criteria: Moving beyond traditional cut-offs to include underrepresented populations safely

Moderator: Nekia Clark, Director of Community Engagement & Outreach, Ellie Fund

• Shift trial success toward speed and quality of decisions, not just endpoints, by embedding patient journey insights early.
• Enable precision enrollment and site activation through integrated data (EHR, genomics, biomarkers) and real-time feasibility.
• Use Biomarkers/MRD/ctDNA and real-time data flows to drive adaptive treatment decisions and improve patient outcomes.
• Operate within a connected partner ecosystem (sponsor-CRO-diagnostics) to deliver faster, more reliable, decision-grade evidence.

• Recognizing how the geographic concentration of oncology trials can limit the global relevance of regulatory evidence
• Understanding the role of genomic and epigenomic variation across ancestries in driving treatment response and toxicity
• Identifying how environmental and contextual factors interact with biology to influence therapeutic outcomes
• Evaluating how conventional eligibility criteria may exclude biologically relevant patient populations
• Learning the principles of ancestry-aware eligibility design as a scientifically rigorous approach to trial inclusion
• Assessing how eligibility reform can improve the predictive validity of clinical trial data for regulators and sponsors
• Applying ancestry-aware trial design concepts to support equitable, efficient, and globally applicable drug approvals

• Challenging the perception of Europe as a backup option for oncology trials rather than a strategic development partner
• Sharing practical lessons from running four concurrent Phase II oncology studies across Europe, with a strong focus on Poland
• Examining the operational, recruitment, and cost advantages that can make Europe a compelling choice for clinical-stage biotechs
• Highlighting what worked, what didn’t, and the key considerations sponsors should evaluate before defaulting to traditional trial geographies
• Exploring how early integration of European sites can strengthen global development strategies and accelerate clinical progress

• Overcoming site readiness challenges through targeted education, certification, and operational support, ensuring sites are equipped and committed from day one
• Competing smarter in a crowded oncology landscape by making your trial more attractive to sites through simplified protocols, better support, and stronger partnerships
• Moving beyond traditional site selection to identify truly trial-ready sites, assessing infrastructure, staff capacity, competing studies, and long-term engagement potential
• Redefining sponsor–site collaboration with more flexible, locally informed strategies that prioritize feasibility, performance, and sustainable site relationships
• Addressing the growing divide between academic and community sites, and unlocking new models to expand access, improve recruitment, and reduce site drop-off