Medicon Valley Alliance and BioAgilytix would like to welcome you to a Good Morning Meeting 4th of June 2025.
In recent years, we have seen changes in regulations that affect bioanalytical strategies for drug development. Moving towards using leaner approaches, building in efficiencies, and simplifying overall strategies with the ultimate goal of reducing the time it takes to get drugs from discovery to the patient.
Please join us for this Good Morning Meeting, where scientific experts from BioAgilytix will share their experience with advancements in the bioanalytical industry including discussions on singlicate analysis for ligand binding assays, alternatives to standard tiered immunogenicity analysis and impact on animal testing on bioanalysis and drug development. Case studies will take a deeper dive into the bioanalytical aspects for some of these assays and alternative strategies towards an accelerated drug development pathway.
Date: Tuesday, 9th September 2025
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub 2
Program
| 8:30 | Networking, 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 van der Geld, Business Development Director, Scandinavia, BioAgilytix |
| 9:10 | Recent Discussion Topics in Regulated Bioanalysis Amanda Hays, PhD, Scientific Officer, BioAgilytix |
| 9:30 | Case Study: Evolution of Preclinical Immunogenicity Assessments into Leaner Fit-for-Purpose Approache Matthias Reichel, Scientific Operations, BioAgilytix |
| 9:50 | Case study: Application of SPR Technology for Assessment of Immunogenicity of a Dual- Peptide Cancer Vaccine Daniel Worms, PhD, Scientific Operations, BioAgilytix |
| 10:10 | Q&A |
| 10:30 | Networking |
| 11:00 | End of Good Morning Meeting |
Speakers
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Amanda Hays, PhD, Scientific Officer, BioAgilytix Amanda Hays, PhD, offers more than a decade of lab experience in multiple fields, including pharmacology, drug metabolism, immunoassays, immunogenicity, biomarkers, flow cytometry and qPCR. She has expertise in providing guidance for programs through all stages in the drug development process. In her current role she provides global scientific leadership and technical guidance at BioAgilytix. Dr. Hays is the Chair of several AAPS working groups, among other volunteer leadership positions. She earned her Ph.D. in pharmacology from the University of Kansas Medical Center in Kansas City (KS, USA). |
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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. |
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Daniel Worms, PhD, Scientific Operations, BioAgilytix Dr. Daniel Worms is a Principal Investigator at BioAgilytix Europe, Hamburg where he oversees the conduct of pharmacokinetic, immunogenicity and SPR-based bioanalytical assay establishment, validation, and sample analysis in support of sponsors’ drug development program. Daniel obtained his Bachelor’s and Master’s degree in Biology from the Ruhr-Universität Bochum (RUB), then joined Cube Biotech, Monheim am Rhein, as Application Specialist for membrane protein services. Before joining BioAgilytix in Spring 2018, Daniel had completed a doctorate in Biophysics and Structural Biology at the Heinrich-Heine Universität (HHU), Düsseldorf, and Research Center Jülich (FZJ). |
| 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. |
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