Archives: Agenda

• Changing how researchers select potential patients for better success rates
• How has regulation changed and what to expect?
• How to improve drug efficacy and patient safety before it’s too late
• Back to square one: Differentiating with simpler, patient-centric protocols and optimized study design
• Avoiding disappointing results by implementing the right technology tools to advance your trial
• Lessons learned to mitigate trial failures

Moderator: Keya Watkins, President – Oncology, Worldwide Clinical Trials

• 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

• 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

• 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.

• 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

• 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