Recent Advancements and Hot Topics in Regulated Bioanalysis

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 Good Morning Meeting 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

Date: Tuesday, 2 June 2026
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub 2

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Program

Moderator

	Konrad Jazgar, Business Development Manager, BioAgilytix. He works closely with biotech and pharmaceutical companies to support the planning and execution of bioanalytical strategies across preclinical and clinical development. As a first point of contact, he helps translate scientific, operational and regulatory considerations into practical study approaches covering pharmacokinetics, immunogenicity, biomarkers and CMC-related bioanalysis. Working closely with scientific and operational teams, he helps sponsors select appropriate assay strategies, anticipate development risks and align bioanalytical activities with program timelines. He has been with BioAgilytix for two years and combines scientific and business understanding. He holds a B.Sc. in Biochemistry from Jagiellonian University and an M.Sc. in Molecular Biotechnology from Jagiellonian and Heidelberg University.
Speakers
	Robert Nelson, PhD, Scientific Officer, BioAgilytix Robert 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.
	Tim Schauer, PhD, Scientific Operations, BioAgilytix Tim is an Associate Principal Investigator at BioAgilytix Europe in Hamburg, where he leads the development, validation, and application of bioanalytical assays for pharmacokinetics, pharmacodynamics, and immunogenicity supporting clinical and preclinical studies. He obtained his Bachelor’s and Master’s degree in Biotechnology from TU Braunschweig. He earned his PhD in Clinical Cancer Research at the Centre for Physical Activity Research in Copenhagen, examining the role of exercise on immune function in patients with cancer. Before joining BioAgilytix in 2023, Tim held a postdoctoral researcher position at the same institution, managing clinical studies and authoring several peer-reviewed publications.
	Laura von Berg, PhD, Scientific Operations, BioAgilytix Laura is a Principal Investigator at BioAgilytix Europe GmbH, Hamburg, where she leads the development, validation, and application of bioanalytical assays for pharmacokinetics, pharmacodynamics, and immunogenicity in support of clinical and preclinical studies. Laura obtained her bachelor’s degree in Biological Sciences from the University of Konstanz, followed by a master’s in molecular medicine from Charité – University Medicine Berlin. She earned her PhD in Biology and Biochemistry at Freie Universität Berlin for work conducted at the Robert Koch Institute. Before joining BioAgilytix in 2021, she was a Project Manager at the Joachim Herz Foundation in Hamburg.

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