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From Bench to Bedside: Bioanalysis and Translational Science
Keynote

Keynote: Where the Patients Are: Bioanalytical Strategies Enabling Global Clinical Trials

Tuesday, May 6, 2025
1:00 PM - 2:00 PM ET
Location:Commonwealth Ballroom

Bench to Bedside

Multi-country trials inevitably introduce logistics challenges, contributing to preanalytical variables for bioanalysis. Incorporating anticipated issues into bioanalytical method development is advantageous to better support drug development.

This presentation outlines key principles for integrating preanalytical logistical considerations into bioanalytical strategies ahead of global clinical trials. Through three case studies, we illustrate how objective-driven, customized approaches can effectively incorporate supply chain logistics, patient-centric solutions, enabling technologies, and regulatory feedback. The case studies highlight both successful implementations and ongoing challenges, offering practical insights for optimizing bioanalysis in complex, real-world settings.

Learning Objectives:

  • assess global logistics preanalytical variables and associated risks.
  • consider patient centric approaches to enable global enrollment.
  • proactively engage internal and external collaborators to mitigate risk.
  • incorporate preanalytical variables in assay development and validation.