Archives: Agenda

PANEL DISCUSSION Bridging the early-phase divide: advancing equity by including women in drug development

  • Exploring how and why women continue to be excluded from early-phase (Phase I) clinical trials
  • Examining the historical, regulatory, and ethical reasons driving this underrepresentation
  • Identifying the risks of overlooking sex-based differences in drug metabolism, response, and adverse events
  • Assessing how incomplete data is impacting downstream development, post-market safety, and healthcare outcomes
  • Promoting actionable strategies for building equity into trial design, recruitment, and data reporting
Moderator

Sonnika Lamont, Senior Analyst, GlobalData

AI-Powered trials: transforming design and execution

  • Case studies demonstrating use of AI, predictive analytics and data-driven approaches to increase the likelihood of technical and regulatory success and to execute with greater speed and accuracy
  • Mitigating risks across the trial lifecycle to improve efficiency and outcomes
  • Streamlining operations to meet rising demands for faster, more cost-effective, and compliant trial
  • Harnessing site- and patient-level intelligence to enable smarter patient and site-centric protocol design and improved study performance

FIRESIDE CHAT Establishing and expanding registries for global impact

  • Understanding the purpose and value of registries in healthcare
  • Setting up new registries from design to implementation
  • Collaborating with existing registries for data integration and efficiency
  • Developing an umbrella approach for local teams to connect under a global protocol
  • Defining key operational aspects
  • Determining registry duration and appropriate patient enrollment numbers
  • Identifying opportunities for continuous improvement and innovation in registry operations
Moderator

Sonnika Lamont, Senior Analyst, GlobalData

CLOSING KEYNOTE: Effective inclusion of the patient and patient voice in clinical research

  • Integrating patient perspectives with those of healthcare professionals to create an effective and executable clinical trial
  • Redefining the patients’ role as active collaborators
  • Inclusion of the patient lived experience in clinical trial design, outcome measures, and trial success
  • Listening to patient priorities and fostering ongoing communication and transparency
  • Improving accessibility through digital tools, remote visits and flexible scheduling to help reduce patient burden