As biotherapeutics become more complex, bioanalytical strategies must keep pace. Recent years have seen a shift toward more streamlined, fit-for-purpose approaches, prompting a re-evaluation of long-standing conventions while remaining firmly grounded in science. Delays in assay development, troubleshooting and poorly aligned plans can quickly slow a program.
This seminar will explore how scientific and regulatory strategies can accelerate assay implementation, address challenges earlier and keep development moving efficiently. Through expert insights and real-world case studies, we will cover practical approaches to PK and immunogenicity bioanalysis that help reduce risk, streamline development and support a faster path from preclinical studies to the clinic and market.
Date: Thursday, 1 October 2026
Time: 8:30 – 11:30
Venue: Medicon Village, Building Inspira, Room MAXI, Scheeletorget 1. Lund, Sweden
Program
| 8:30 | Arrival, registration and light breakfast |
| 9:00 | Welcome and introduction to Medicon Valley Alliance David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 9:05 | BioAgilytix introduction & updates Ymke var der Geld, PhD, Senior Director, Business Development Manager, BioAgilytix |
| 9:10 | Hot Topics in Regulated Bioanalysis: What Sponsors Should Be Thinking About Rob Nelson, PhD, Scientific Officer, BioAgilytix |
| 9:40 | Case Studies in Smarter Preclinical PK and Immunogenicity Strategies Janett Schwarz, PhD, Scientific Operations, BioAgilytix |
| 10:10 | Q & A |
| 10:30 | Networking |
| 11:30 | End of Good Morning Meeting |
Moderator
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Ymke van der Geld, PhD, Senior Director, Business Development Europe, BioAgilytix
Ymke van der Geld manages the Business Development for BioAgilytix in the Nordics region. She is your point of contact for BioAgilytix Bioanalytical offering including tailored services for biomarker, immunogenicity, pharmacokinetics (PK), and cell-based assays. This includes cell- & gene therapy, monoclonal antibodies, complex bi-/tri-specific and other fusion molecule/ protein formats and Antibody Drug Conjugates. Ymke has a background in medical biology with a PhD in Immunology. She has over 20 years of experience within Bioanalytical contract research. |
Speakers |
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Rob 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. |
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Janett Schwarz, PhD, Scientific Operations, BioAgilytix
Dr. Janett Schwarz is an Associate Director at BioAgilytix Laboratories, Hamburg, where she leads one business unit supporting the development, validation, and application of bioanalytical assays for pharmacokinetics, pharmacodynamics, and immunogenicity in clinical and preclinical studies. Janett obtained her Diploma’s degree in Biochemistry from the University of Hannover. She earned her PhD in Toxicology at Hannover Medical School. Before joining BioAgilytix in 2017, she was a Scientist in Preclinical Development at Syntab Therapeutics in Aachen. |
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