Archives: Agenda

• Integrating patient insights early in protocol and endpoint design
• Partnering with advocacy organizations to reach diverse and underrepresented populations
• Aligning patient engagement strategies with regulatory and ethical expectations
• Measuring the impact of patient-centric approaches on trial outcomes

• All sites are equal, but some sites are more equal than others: How uneven site distribution limits patient access and what coordinated sponsor, site, and community partnerships can realistically change
• Mapping what regulators, sponsors, CROs, and patients each expect from sites and where misalignment slows progress
• Practical strategies to strengthen site readiness, streamline operations, and activate local patient populations in underserved regions
• How sponsors can provide targeted support to elevate under-resourced sites by recognizing that while not all sites start equally, investment can close critical capability gaps

• 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

• 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: TBC

• Navigating the VC & strategic investment landscape: Understanding fund priorities, timing, and risk thresholds to position your trial and company for maximum appeal amid intense competition for limited budgets
• Crafting a compelling narrative, highlighting niche advantages, and strengthening your pipeline to secure funding partnerships that bridge financial gaps and accelerate oncology innovation
• How adaptive designs, decentralized elements, synthetic control arms, and AI-driven efficiencies can make oncology studies more capital-efficient and more attractive to venture capital and strategic investors
• Avoiding bankruptcy risk for biotechs with clear early efficacy signals, validated biomarkers and programs with strong regulatory alignment