Archives: Agenda

Putting sites first in early oncology: What integrated site networks are telling us

  • Understanding the operational challenges, enrollment barriers, and patient engagement realities facing oncology sites today
  • Examining how stronger collaboration between sponsors, CROs, and sites can improve study execution and reduce operational risk
  • Identifying practical site-first approaches that accelerate start-up, enhance recruitment, and support patient retention
  • Exploring how integrated site networks can help deliver more efficient, patient-centric early phase oncology trials from planning through execution

Four studies, one year: The case for building your oncology engine in Europe

  • 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

KEYNOTE: Redefining eligibility in oncology trials: Ancestry-aware design for biologically valid and globally relevant drug approval

  • 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

Finding the perfect match: Selecting and supporting the right oncology sites in an increasingly competitive landscape by rethinking selection, readiness and partnerships

  • 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

 

What strategic investors want in 2027 and how smaller biotechs can compete

  • 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

From protocol design to operational reality: Making clinical trials work before they start

  • Transforming Protocol to Execution: How AIKA uses advanced AI to streamline protocol generation, enhance feasibility analysis, and reduce study start-up timelines.
  • Data-Driven Decision Support: Leveraging real-time operational insights and predictive analytics to improve trial performance and risk mitigation.
  • Scaling Clinical Operations: Practical examples of AIKA in action, from automated task orchestration to cross-functional collaboration that drives efficiency and quality.

Beyond expansion: Why Canada belongs in your primary trial strategy

With a disproportionately large number of patients willing to participate in global studies, Canada’s world-class researchers and diverse patient population, trial cost efficiency, robust health authority with reliable process times, consistent data quality, and national therapeutic expertise in oncology make it an attractive country for enrollment to your global clinical trial program. This presentation explores how to succeed with your oncology trial in Canada with insights on:

  • The Perception Gap
  • How Sponsors Receive: Predictability – Speed – Quality – Partner Accountability
  • Competitive Structural Advantages
  • Real-World Global Trial Examples
  • What to Expect in a Partner for the Region