Director Bristol-Myers Squibb Company Princeton, New Jersey
This presentation will delve into the direct experiences of assessing the feasibility of novel liquid capillary micro-sampling technologies in regulated bioanalysis, illustrated through multiple case studies. We will explore the rationale for adopting micro-sampling technologies, review the current status of micro-sampling bioanalysis, and discuss the opportunities and challenges associated with these methods. The presentation will also highlight the reinforcement of the 3R principles by ICH M10, and the enhancement of patient-centricity to accelerate drug development. By evaluating innovative micro-sampling devices in proof-of-concept or bridging studies, we aim to share valuable lessons learned and promote the broader adoption of micro-sampling techniques, such as clinical site preparation, sample collection issues and mitigation, and regulatory interactions and feedback. Additionally, we will share future perspectives to further embrace a patient-centric culture in clinical research.
Learning Objectives:
Understand the approaches and options for microsampling to facilitate patient-centricity and 3Rs benefits.
Identify potential risks and resolutions for implementing new microsampling devices in regulated studies.
Apply lessons learned from case studies to promote broader adoption of microsampling techniques, enriching drug development processes.
