Seminar

Recent Advancements and Hot Topics in Regulated Bioanalysis

Join us for a free seminar to learn about recent advances in regulated bioanalysis.

 

Date: Thursday, 28 April 2026

Time: 08:30 – 11:30 

In partnership with: One Nucleus

Location: Babraham Research Campus,
Cambridge UK
 

Room: Kings Hedges Room  

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Seminar Overview

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.

08:30 Arrival, Registration & Breakfast

 

09:15 Welcome to One Nucleus

One Nucleus


09:20 BioAgilytix introduction & updates

Valeria Ventura, Senior Director Business Development, BioAgilytix

 

09:25 Hot Topics in Regulated Bioanalysis 

Rob Nelson, PhD, Scientific Officer, BioAgilytix



09:45
Playing Catch-up: A Case Study on Maximising CRO-Pharma Interactions

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

Matthias Reichel, Scientific Operations, BioAgilytix

 

10:25 Q&A Session

 

10:45 Networking

 

11:30 End of One Nucleus Networking Morning Seminar

Moderator 

Valeria Ventura
Valeria Ventura, PhD, Senior Director Business Development, BioAgilytix

Valeria Ventura is the Senior Director of Business Development at BioAgilytix, leading efforts across the UK, Ireland, and Southern Europe. With a PhD in Biochemistry from Imperial College London, specializing in structural glycomics and proteomics, Valeria combines scientific expertise with over a decade of commercial experience in the CRO industry. Having started her career at the lab bench before moving into business development, she has supported preclinical and clinical drug development from discovery to market and partners with pharmaceutical and biotech sponsors to navigate complex bioanalytical challenges and drive successful development programs.

Speakers

Robert Nelson
Robert Nelson, PhD, Scientific Officer, BioAgilytix

Robert Nelson, PhD, provides scientific and regulatory consultation, focusing on our EU team and customers, to help guide bioanalysis supporting drug development. Spending over fifteen years working in regulated (GLP/GCP) laboratory environments, Dr. Nelson supports preclinical and clinical drug development programs, with broad experience in bioanalysis, immunogenicity, and biomarkers. He joined BioAgilytix from Labcorp Drug Development’s Scientific Affairs team, where he partnered with clients, operations, and other scientists to address science, technology, and regulatory challenges. Prior to this, he led the bioanalytical laboratory team at Swiss biotech company Novimmune. Dr. Nelson holds his PhD in Molecular Physiology and B.Sc. with Honours in Pharmacology from the University of Edinburgh. 

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

Gareth Satchell is an Associate Director at GSK, specializing in the support and oversight of outsourced PK, ADA, and soluble biomarker clinical assays across multiple therapeutic areas. After graduating from the University of Sheffield with a bachelor's degree in microbiology, he subsequently worked for 10 years within global clinical research organizations before joining the Bioanalytical External Study Monitor group at GSK. His work involves close collaboration both cross-functionally within GSK with clinical operations.

Matthias Reichel
Matthias Reichel, Scientific Operations, BioAgilytix

Matthias gained his bachelor's and master's degree in molecular biotechnology at Heidelberg University. He then took a research scientist role in Recombinant R&D Analytics at Octapharma Biopharmaceuticals, Heidelberg, developing immuno assays for product characterization and pre-clinical/clinical studies. Matthias joined the Hamburg laboratories of BioAgilytix in 2021 where he currently serves biotech and pharma sponsors as a Principal Investigator leading immunogenicity, PK and biomarker bioanalytical projects for numerous different biotherapeutic modalities.

About BioAgilytix

BioAgilytix is the trusted partner for bioanalytical services throughout every phase of the drug development process. As a leading global bioanalytical laboratory, the company provides established and emerging pharmaceutical and biotechnology organizations with pharmacokinetic (PK), immunogenicity, biomarker, and CMC analytical testing services in a GxP environment. BioAgilytix maintains state-of-the-art laboratories in Durham, North Carolina; Boston, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia; and Hamburg, Germany. For more information, please visit www.bioagilytix.com.

Have questions?

For further details or any inquiries regarding the seminar, please reach out to:

Valeria Ventura, Senior Director Business Development, BioAgilytix 
valeria.ventura@bioagilytix.de
 

Presenters

Amanda Hays-transparent
Lynn Kamen from BioAgilytix
Natalie Smith

Amanda Hays, PhD

Scientific Officer

Lynn Kamen, PhD

Scientific Officer

Natalie Smith, PhD

CLIA Lab Director

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Dinner Symposium - Live Stream Only

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