Registration to BioAgilytix Breakfast Seminar at BioM: Recent Advancements and Hot Topics in Regulated Bioanalysis
Join us for a free seminar over a Bavarian Breakfast and learn about recent advances in immunogenicity assessments. BioM Biotech Cluster Development and BioAgilytix are pleased to invite you to a bioanalytical seminar focused on current trends and evolving best practices in regulated bioanalysis.
Whether you're in academia, industry, or a related field, this seminar offers actionable insights and essential knowledge you can apply directly to your work!
Date and Time:
Thursday, 24th September 2026, 9.00 am - 1.00 pm
Location:
BioM Biotech Cluster Development GmbH, Am Klopferspitz 19, 82152 Martinsried, Germany
Overview:
As therapeutic modalities continue to increase in complexity, bioanalytical strategies for pharmacokinetics (PK), immunogenicity (ADA), and biomarker assessment are evolving toward more streamlined, fit-for-purpose approaches. There is growing emphasis on simplifying assay strategies, improving efficiency, and applying scientific and risk-based justification, with the shared goal of accelerating drug development without compromising data quality.
During this seminar, scientific experts will share perspectives on hot topics in PK, immunogenicity (ADA/NAb), and biomarker bioanalysis, including singlicate analysis for ligand-binding assays and alternatives to traditional tiered immunogenicity testing strategies. Case studies will provide practical examples of how bioanalytical approaches can be adapted to support efficient study design and accelerated development pathways across a range of therapeutic programs.
Agenda:
09:00 – 10:00 Networking, Registration and Light Bavarian Breakfast
10:00 – 10:15 Welcome and Introduction
Mark Spengler, PhD, Senior Business Development Director, DACH, BioAgilytix
10:15 – 10:45 Current Hot Topics in Regulated Bioanalysis
Robert Nelson, PhD, Scientific Officer, BioAgilytix
10:45 – 11:15 Case Study: Immunogenicity Assessment for Tarlatamab, a Novel BiTE Antibody for Treatment of Small Cell Lung Cancer
Andreas Wolf, PhD, Global Head Bioanalytical Sciences, Amgen
11:15 – 11:45 Re-evaluating the 3-Tier ADA Paradigm: A Case Study Supporting a 1-Tier Signal to-Noise Ratio (SNR)-Based Strategy for Low-Risk Biotherapeutics
Tim Schauer, PhD, Scientific Operations, BioAgilytix
11:45 – 12:00 Panel Discussion & Q&A
12:00 – 13:00 Networking, Brunch and Farewell
Moderator:
Mark Spengler, PhD, Senior Director Business Development, BioAgilytix
Speakers:
Robert Nelson, PhD, Scientific Officer, BioAgilytix
Andreas Wolf, PhD, Global Head Bioanalytical Sciences, Amgen
Tim Schauer, PhD, Scientific Operations, BioAgilytix
BioAgilytix
BioAgilytix is the trusted partner for bioanalytical services throughout every phase of the drug development process. As a leading global bioanalyticallaboratory, the company provides established and emerging pharmaceutical and biotechnology organizations with pharmacokinetic (PK), immunogenicity, biomarker, and CMC analytical testing services in aGxP environment. BioAgilytix maintains state-of-the-art laboratories inDurham, North Carolina; Boston, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia; and Hamburg, Germany. For more information, please visit bioagilytix.com.
Registration Fees:
Free of Charge
Please also note our cancellation deadlines in accordance with our GTC.
After submitting the form, you will receive an electronic registration confirmation within 1-2 working days.
How to Register:
Registration is simple and can be completed online. You can either register once for the event by selecting the ticket below and clicking on "confirm" or register first in our system, the BioM Community Network. With your login you can then register for further events more quickly and easily, but also post job adverts and press releases and much more.
Please register before the 23rd of September 2026.
Due to limited seating, we encourage early registration to secure your spot!
Contact Information:
We are happy to assist you with any questions you may have.
For further details or any inquiries regarding the seminar, please reach out to:
Mark Spengler | Senior Director Business Development, BioAgilytix
Email: mark.spengler@bioagilytix.de
or
Melanie Greitl | Senior Community & Event Manager
Email: events@bio-m.org
BioM Biotech Cluster Development GmbH