<p><b>Join us for a free seminar over a Bavarian Breakfast and learn about recent advances in immunogenicity assessments. As biotherapeutics become increasingly complex, the need for nuanced, rapid and robust determination of immunogenicity is critical for successful drug development. Learn how recent advances in immunogenicity evaluation can aid in moving molecules from early discovery to market approval.</b></p><p>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!</p><p><b>Date and Time: <br /></b>Thursday, 25th September 2025, 9.00 am - 1.00 pm</p><p><b>Location: <br /></b>BioM Biotech Cluster Development GmbH, Am Klopferspitz 19, 82152 Martinsried, Germany</p><p><b><br /></b></p><p><b>Overview:</b></p><p>There is a growing demand for sophisticated immunogenicity assessment strategies to enable more rapid and efficient development of novel biotherapeutics. Join us for an in-depth seminar that offers valuable insights into the current <b>regulatory landscape</b> for <b>immunogenicity assessments</b>, predictive methods for understanding <b>immunogenicity risk</b>, and <b>bioanalytical strategies</b> to detect immunogenicity of complex therapeutics. Stay up to date with the current immunogenicity trends that can help streamline your immunogenicity assessment and accelerate your therapeutic’s journey to market.</p><p><br /><b>Agenda:</b><br /><br /><b>09.00 – 10.00:</b> Light Bavarian Breakfast: Networking &amp; Registration<br /><br /><b>10.00 – 10.05:</b> Welcome and Introduction; BioM Biotech Cluster Development<br /><br /><b>10.05 – 10.15: </b>Short Introduction</p><p style="margin-left:25px;"><b>BioAgilytix – Global bioanalytical CRO with local Footprint</b></p><p style="margin-left:25px;"><i><b>Dr. Mark Spengler</b>, BioAgilytix</i></p><p style="margin-left:25px;"><i><br /></i></p><p><b>10.15 – 11.45: </b>Speaker Presentations</p><ul><li style="margin-left:25px;"><b>The current regulatory landscape for immunogenicity assessment<br /></b><i><b>Robert Nelson</b>, PhD, BioAgilytix</i></li><li style="margin-left:25px;"><b>Immunogenicity assessment: Can we harmonize immunogenicity assays?<br /></b><i><b>Gregor Jordan</b>, Roche Diagnostics</i></li><li style="margin-left:25px;"><b>Feasibility of singlicate analyses in regulated bioanalysis<br /></b><b><i>Ellen Gattkowski</i></b>, PhD, BioAgilytix</li></ul><p style="margin-left:25px;"><i><br /></i></p><p><b>11.45 – 12.00: Panel Discussion &amp; Q&amp;A Session</b></p><p>Closing Remarks, BioM Biotech Cluster Development</p><p><br /></p><p><b>12.00 – 13.00 pm: </b>Brunch Break: Networking &amp; Farewell</p><p><b>1.00 pm: </b>Goodbye</p><p><b><br />Moderator</b><br /><br /><i><b>Dr. Mark Spengler</b>, Director Business Development, BioAgilytix</i></p><p><img style="width:200px;" src="https://network.bio-m.org/ck-uploads/2025-07-23/Mark_Spengler.jpg" alt="Mark_Spengler.jpg" /><br /><br />Mark Spengler is the leading representative of BioAgilytix’s commercial team in the German-speaking Europe (D/A/CH) region, significantly enhancing the company’s presence in the region. With over 20 years of commercial experience in life sciences, his expertise encompasses Project Management, Operations, and Business Development. Dr. Spengler previously served at Chimera Biotec, a specialty bioanalytical CRO, where he advanced from Project Manager and Business Developer to Head of Project Management and Sales, and eventually CEO. During his 10 years tenure as CEO, he implemented a GLP-regulated lab and managed the GLP test facility, while also developing growth strategies and establishing a second regulated lab. Dr Spengler holds a Master (Diplom Biologe) in Biotechnology and Molecular Genetics from the University of Bremen and a Ph.D. (Dr. rer. Nat) in Directed Molecular Evolution from the University of Dortmund (Technische Universität Dortmund), Germany.<br /><br /><b>Speakers</b><br /><i><br /><b>Robert Nelson, PhD</b>, Scientific Officer, BioAgilytix</i></p><p><img style="width:200px;" src="https://network.bio-m.org/ck-uploads/2025-07-23/Robert_Nelson.jpg" alt="Robert_Nelson.jpg" /><i><br /></i><br />Robert Nelson, PhD, is a member of the BioAgilytix Scientific Office, focusing on our EU team to address science, technology, and regulatory challenges.  Spending over fifteen years working in regulated (GLP/GCP) laboratory environments, Dr. Nelson supports preclinical and clinical drug development programs, with broad experience in bioanalytical support for assessment of pharmacokinetics, immunogenicity, and biomarkers. Prior to BioAgilytix Dr. Nelson held senior scientific leadership roles with Covance/Labcorp Drug Development and Swiss biotech company Novimmune. Dr. Nelson holds a Ph.D. in Molecular Physiology from the University of Edinburgh.<br /><br /><br /><i><b>Gregor Jordan</b>, Senior Principal Scientist, Roche Diagnostics</i></p><p><img style="width:200px;" src="https://network.bio-m.org/ck-uploads/2025-07-23/Gregor_Jordan.jpg" alt="Gregor_Jordan.jpg" /><i><br /></i><br />Gregor Jordan, a graduate chemical engineer, serves as a Senior Principal Scientist, Strategy Area Lead for Proteins and Subchapter Lead at Roche Pharma Research and Early Development (pRED) within the Roche Innovation Center Munich, Germany. His current work focuses on large molecule bioanalysis, including assay development for APIs, soluble target quantification, immunogenicity testing, and soluble biomarkers, all in support of pre-clinical and clinical projects.</p><p>Previously, Gregor honed his expertise in preparative chromatography (including simulated moving bed and recycling chromatography) and analytical bioanalysis for small molecules, specializing in chromatography, MS, GC, and atomic absorption spectrophotometry. His mathematical interests included the simulation and prediction of chromatographic elution profiles, as well as compartmental modeling in pharmacokinetics. Gregor has contributed to several publications and patents covering assay and technology development, modeling and simulation, in-solution KD determination, and free analyte quantification.<br /><br /></p><p><i><b>Ellen Gattkowski, PhD</b>, Scientist, BioAgilytix</i></p><p><img src="https://network.bio-m.org/ck-uploads/2025-07-31/Ellen_Gattkowski-2.jpg" style="width:200px;height:186px;border-width:0px;border-style:solid;border-color:#000000;margin:0px;" width="200" alt="Ellen_Gattkowski-2.jpg" /><b><i><br /></i></b></p><p>Ellen Gattkowski, PhD, has been working as Scientist at BioAgilytix in Hamburg since early 2023. She supports sponsors on their preclinical and clinical drug development programs and supervises routine sample analysis. She provides bioanalytical support for the assessment of pharmacokinetics and immunogenicity. Dr. Gattkowski has a strong background in protein biochemistry and structure biology and holds a Ph.D. in Molecular Life Sciences from the University of Hamburg.</p><div><br /></div><p><br /><b>BioAgilytix</b><br />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 <a href="www.bioagilytix.com" target="_blank">www.bioagilytix.com</a>. <br /><br /><b>Who Should Attend:</b><br /><br />This seminar is designed for <b>professionals and academics</b> in drug development, life sciences and pre-clinical &amp; clinical data analysis:</p><ul><li style="margin-left:25px;"><b>Life Sciences Professionals:</b> Biotech and pharma industry professionals who are interested in innovative drug development concepts.</li><li style="margin-left:25px;"><b>Academics and Researchers:</b> University and research institution members looking to stay abreast of the latest technological advancements and their applications in life sciences.</li></ul><p><b>Key Takeaways:</b><br /></p><ul><li>Gain insight into the vital role of immunogenicity evaluation in today’s drug development, helping to reduce study risks and maintain development timelines from early discovery through to rapid market approval.</li><li>Learn about the science, guidance and regulatory concepts in immunogenicity support for the biotech and pharmaceutical industry.</li><li>Network and discuss with industry leaders and experts, both from drug development as well as from service provider perspective.</li><li>Gain valuable insights that can be applied to your work, whether in research, development, or operational roles.  </li></ul><div><br /></div><p><br /><b>Registration Fees:</b><br /><br />    <b>Free of Charge</b><br /><br /><i>Please also note our cancellation deadlines in accordance with our <a href="https://www.bio-m.org/fileadmin/Webdata/Uploads/Angebote/AGB-BioM_190924_V2.1N.pdf" target="_blank">GTC</a>.<br /><br />After submitting the form, you will receive an electronic registration confirmation within 1-2 working days.<br /></i> <br /><br /><b>How to Register:</b><br /><br />Registration is simple and can be completed online. You can either register once for the event by <b>selecting the ticket below</b> and clicking on "confirm" or register first in our new system, the <a href="https://network.bio-m.org/registration" target="_blank">BioM Community Network</a>. 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.<br /><br /><b><i>Please register before the 24th of September 2025.</i></b><br /><br />Due to limited seating, we encourage early registration to secure your spot!<br /><br /><b>Contact Information:</b><br /><br />We are happy to assist you with any questions you may have.<br />For further details or any inquiries regarding the seminar, please reach out to: <br /><br />Melanie Greitl | Community Service &amp; Event Manager<br /><br />E-Mail: greitl@bio-m.org; Tel.: 089/89 96 79-35<br /><br />BioM Biotech Cluster Development GmbH<br /><br /> <br /><br /> </p>