Regulated bioanalysis continues to evolve alongside increasingly complex therapeutic modalities and the need to accelerate drug development without compromising data quality. Recent years have seen a shift toward more streamlined, fit-for-purpose bioanalytical strategies, prompting a re-evaluation of long-standing conventions while remaining firmly grounded in science. 

This seminar will highlight current hot topics in pharmacokinetic (PK), immunogenicity (ADA/NAb), and biomarker bioanalysis, with a focus on the practical application of scientific and regulatory principles in drug development programs. Presentations will explore how context-of-use, risk-based decision-making, and thoughtful assay design can be applied in practice, with case studies providing practical examples of bioanalytical approaches that support efficient and accelerated drug development. 

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Agenda:
08:30    Arrival, Registration & Breakfast (45 minutes)
09:15    Welcome from One Nucleus (5 minutes)
09:20    BioAgilytix introduction & updates (5 minutes)
Valeria Ventura, Senior Director Business Development, BioAgilytix 
09:25    Hot Topics in Regulated Bioanalysis (20 minutes)
Rob Nelson, PhD, Scientific Officer, BioAgilytix 
09:45    Playing Catch-up: A Case Study on Maximising CRO-Pharma Interactions (20 minutes)
Gareth Satchell, Associate Director, Biomarkers and Bioanalytical Platforms, GSK 
10:05    Developing an Ultra-Sensitive PK Assay: Pushing Analytical Limits Within a Traditional 
Immunoassay Framework (20 minutes)
Matthias Reichel, Scientific Operations, BioAgilytix  
10:25   Q&A (20 minutes)
10:45   Networking (45 minutes)
11:30    End of One Nucleus Networking Morning Seminar

Moderator
Valeria Ventura, PhD, Senior Directory Business Development, BioAgilytix 

Speakers
Rob Nelson, PhD, Scientific Officer, BioAgilytix  

Gareth Satchell, Associate Director, Biomarkers and Bioanalytical Platforms, GSK

Matthias Reichel, Scientific Operations, BioAgilytix

Attendance: This event is free of charge. 

For more details and to register, take a look here.