|
||||
|---|---|---|---|---|
| PDF renditions of the PowerPoint presentations can be viewed and downloaded from this page by clicking the specific point on the program. The program itself can be viewed and downloaded by clicking here. |
||||
| blanco | ||||
| 09:15 | 09:30 | Welcome and introduction to the 18th OS | blok-color | |
| Lights, Camera, Bioanalysis! | ||||
| blanco | ||||
| 09:30 | 10:30 | Session 1: Setting the scene | blok-color | |
| Opening the 18th OS with a forward-looking reflection on how bioanalysis connects science, innovation, and purpose. This session will explore the challenges shaping our future and the opportunities emerging as technology, collaboration, and curiosity redefine the boundaries of Pharma R&D, setting the scene for three days of shared vision and dialogue. | insprong | |||
| Keynote presentation - Introduction to the 18th OS | ||||
| 10:30 | 11:10 | Coffee break - Deadline for poster mounting | blok | |
| blanco | ||||
| 11:10 | 12:50 | Session 2: Biomarkers - Context-of-Use in High Definition | blok-color | |
| 11:10 | 11:30 | Toon Wauman, argenx (presentation was not released) | ||
| From Legacy to Innovation: lifecycle management of a target engagement PD biomarker within an integrated bioanalytical strategy | insprong | |||
| 11:30 | 11:50 | Pratiksha Gulati, F. Hoffmann-La Roche | ||
| Embedding Context in Biomarker Assays: Practical Implementation of Context of Use (CoU) through Case Studies that Highlight its Impact and Relevance | insprong | |||
| 11:50 | 12:10 | Katja Zeiser, Nuvisan | ||
| Biomarker analysis: Scientific ideas and approaches to address analytical challenges | insprong | |||
| 12:10 | 12:30 | Ulrich Kunz, Boehringer Ingelheim | ||
| Beyond One-Size-Fits-All: Adaptive Assay Validation for Biomarkers | insprong | |||
| 12:30 | 12:50 | Arundhuti Sen, GSK | ||
| Tales of Mystery and Imagination: Reagent Characterisation and the Context of Use for Biomarker Assays | insprong | |||
| blanco | ||||
| 11:10 | 12:50 | Session 3: The Wonderful world of NBE - Applications | blok-color | |
| 11:10 | 11:30 | Hanna Ritzén, Biovica International | ||
| Thymidine Kinase Activity as a Translational Biomarker to Support Dose Optimization in Oncology Drug Development | insprong | |||
| 11:30 | 11:50 | Adriano L. S. de Souza, Fresenius KabiSwissBioSim | ||
| Assessment of the biomarker response in the demonstration of biosimilarity of FKS518, a denosumab biosimilar: Case-study for the application ESC performance for run acceptance in regulated bioanalysis | insprong | |||
| 11:50 | 12:10 | Toon Babylon, argenx (presentation was not released) | ||
| Autoantibody Measurements: Tailored Testing for Different Contexts of Use | insprong | |||
| 12:10 | 12:30 | Linda Klauss, Gyros Protein Technologies | ||
| Enhancing assay sensitivity by incorporating signal amplification into a microfluidic immunoassay | insprong | |||
| 12:30 | 12:50 | Janett Schwarz, BioAgilytix Laboratories | ||
| Challenges and Successes in Total Target Biomarker Assay Establishment | insprong | |||
| blanco | ||||
| 11:10 | 13:00 | Session 4: Singlicate beyond PK in Prime Time | blok-color | |
| 11:10 | 11:20 | Mike Wright, on behalf of the EBF | ||
| Feedback from and next steps of EBF team - introduction to the Workshop on day 2 | insprong | |||
| 11:20 | 11:40 | Catrina Friedrich, Celerion | ||
| Case Study: Establishing a Singlicate Assay detecting Cross-Reactive Anti-Drug Antibodies Supporting Clinical Development of a Peptide Hormone Therapeutic | insprong | |||
| 11:40 | 12:00 | Martine Broekema, ICON | ||
| Singlicate well analysis: a reality or unfulfilled promise? | insprong | |||
| 12:00 | 12:20 | Susana Liu, Pfizer | ||
| A Data Driven Strategy for Implementation of ADA Singlicate Analysis | insprong | |||
| 12:20 | 12:40 | Laura Creed, Resolian | ||
| A Singlicate Cell-Based Neutralizing Antibody Assay with Bead Pre-Treatment: Achieving good Sensitivity and Precision | insprong | |||
| 12:50 | 14:00 | Lunch break and Poster Discussion/Viewing | blok | |
| blanco | ||||
| 14:00 | 15:40 | Session 5: Multiplexing | blok-color | |
| 14:00 | 14:20 | Valeria Castagna, Merck KGaA (presentation was not released) | ||
| The bioanalytical strategy of a multi-domain biotherapeutic from early discovery to the clinics | insprong | |||
| 14:20 | 14:40 | Cara Smits, Sanofi | ||
| Multispecifics and multiplexing, an ideal match! | insprong | |||
| 14:40 | 15:00 | Maria Janeh, TATAA Biocenter | ||
| Robust Singlicate Performance in Olink Target 48 Panels | insprong | |||
| 15:00 | 15:20 | Andreas Wilhelm, CheckImmune | ||
| Comparison of ECLIA-, PEA-, and ELISA-based multiplex methods for the detection and quantification of protein biomarkers in clinical studies | insprong | |||
| 15:20 | 15:40 | Anna Laurén, Minervax | ||
| Multiplex immunogenicity assay for a multicomponent vaccine: focus on specificity | insprong | |||
| blanco | ||||
| 14:00 | 15:40 | Session 6: LC-MS in Wide Screen | blok-color | |
| 14:00 | 14:20 | Jun Qu, Dept. of Pharmaceutical Sciences of SUNY-Buffalo | ||
| An Antibody Cocktail-Based LBA-LC-MS Method Enabled Ultra-Sensitive and Robust Quantification of Circulating Proinsulin Proteoforms and C-peptide | insprong | |||
| 14:20 | 14:40 | Baubek Spanov, QPS Netherlands | ||
| Evaluation of mass spectrometric techniques for bioanalysis of biotherapeutics | insprong | |||
| 14:40 | 15:00 | Heike Wiese, Nuvisan | ||
| When Patient Samples Fight Back: Redesigning LC-MS Steroid Assays for the Real World | insprong | |||
| 15:00 | 15:20 | Eva Hanckmann, Byondis | ||
| Unmasking Therapeutic Antibodies: Comparative Evaluation of LBA and LC/MS for Pharmacokinetic Analysis | insprong | |||
| 15:20 | 15:40 | Davindera Sanghera, Moderna | ||
| Comparative Evaluation of Bioanalytical Techniques for Lipid Extraction from Lipid Nanoparticles in Human Plasma Using LC-MS/MS | insprong | |||
| blanco | ||||
| 14:00 | 16:20 | WS 1: AI …where no man has gone before WS moderators: Katja Zeiser and Conner Walker, on behalf of the EBF | blok-color | |
| The AI workshop will take place as a single 4-hour blended session with a 40-minute coffee break. Moderated by Katja Zeiser and Conner Walker (on behalf of the EBF AI team), the session will frame the “6 months ago vs. today” journey of AI in bioanalysis: What have we learned, and how are we progressing (or regressing)? Case studies will draw from the EBF community, the EBF Focus Workshop in Málaga (June 2025), and submitted abstracts by Norbert Bittner (up-to-data), Alex Behling (Ionis), and Enric Bertran (Moderna). These will illustrate changes in AI adoption across lab workflows, reporting, data review, efficiency, error reduction, internal uptake, and regulatory response Throughout the workshop, examples will be interspersed with moderated discussions and a panel, ensuring interactive exchange. The session will conclude with a visionary close, distilling key learnings, highlighting opportunities, and issuing a call to action for the community. | insprong | |||
| Slides from the workshop: | insprong | |||
| Introdcution to the workshop - Katja Zeiser and Conner Walker, on behalf of the EBF | insprong-2 | |||
| Case study Adrian Freeman, AstraZeneca | insprong-2 | |||
| Case study Norbert Bittner, Up to Data | insprong-2 | |||
| Case study Annika Carlsson, Mercodia | insprong-2 | |||
| Case study Cecilie Dalby, Novo Nordisk | insprong-2 | |||
| Case study Enric Bertran, Moderna | insprong-2 | |||
| Case study Alex Behling, Ionis | insprong-2 | |||
| Case study Gregor Jordan, Roche | insprong-2 | |||
| Case study Tsvetelina Ivanova, Comac Medical | insprong-2 | |||
| 15:40 | 16:20 | Coffee break and Poster Discussion/Viewing | blok | |
| blanco | ||||
| 16:20 | 18:20 | Session 7: Automation - session moderated by the EBF-YSS | blok-color | |
| 16:20 | 16:30 | Eva Hanckmann, on behalf of the EBF-YSS | ||
| Introduction to the session | insprong | |||
| 16:30 | 16:50 | Peter van Bommel, ICON | ||
| From Elbow Grease to Robotic Precision: Optimizing Bioanalytical Workflows with Automated Liquid Handling. | insprong | |||
| 16:50 | 17:10 | George Walters, Resolian | ||
| Strategies for Implementing Automation in Bioanalysis | insprong | |||
| 17:10 | 17:30 | Tom Zhang, Worldwide Clinical Trials | ||
| Unlocking the Potential of Bioanalytical Automation: Bridging the Gap between Development and Application | insprong | |||
| 17:30 | 17:50 | Ann-Charlott Steffen, Gyros Protein Technologies | ||
| Utilizing a fully automated microfluidic immunoassay system to measure picomolar levels of antisense-oligonucleotide drugs | insprong | |||
| 17:50 | 18:20 | Closing panel discussion | ||
| Integrating the discussions from 10th and 11th YSS into the 18th OS discussions | insprong | |||
| blanco | ||||
| 16:20 | 18:20 | Session 8: New modalities | blok-color | |
| 16:20 | 16:40 | Cecilia Arfvidsson, on behalf of the EBF | ||
| Feedback and next steps EBF team | insprong | |||
| 16:40 | 17:00 | Luca Ferrari, F. Hoffmann-La Roche | ||
| Challenges and pitfalls in the development of quantitative bioanalytical methods for small molecule covalent inhibitors | insprong | |||
| 17:00 | 17:20 | Foka Venema, Ardena | ||
| Integrated LC-MS/MS and LBA Strategies for Quantitative Determination of Encapsulated Nanoparticle Payloads in Plasma: Challenges and Innovations in Method Development | insprong | |||
| 17:20 | 17:40 | Cathy Lane, Sciex | ||
| Sensitive LC-MS/MS Quantitation of Targeted Protein Degraders for Advancing Protein Degradation Studies | insprong | |||
| 17:40 | 18:00 | John Perkins, KCAS | ||
| The Importance of Considering Environmental Factors During LC-MS/MS Method Development of Biomarkers | insprong | |||
| 18:00 | 18:20 | Daniel Waldera-Lupa, ProtaGene | ||
| Advancements in Biopharmaceutical Development: Leveraging Mass Spectrometry for Oligonucleotide Therapeutics and Vaccines | insprong | |||
| blanco | ||||
| 16:20 | 18:00 | WS 1, cntd | blok-color | |
| blanco | ||||
| 16:20 | 18:20 | Session 9: PCR Unplugged: Amplifying What Matters | blok-color | |
| 16:20 | 16:40 | Robert Nelson, on behalf of the EBF | ||
| Feedback and next steps EBF team | insprong | |||
| 16:40 | 17:00 | Hala Ismael, J&J IM | ||
| Development and cross-validation of a triplex qPCR assay for high throughput transgene quantification, normalization, and monitoring inhibition in clinical samples | insprong | |||
| 17:00 | 17:20 | Amélie Kasperek, Charles River (presentation was not released) | ||
| Validation of a triplex ddPCR assay in support of gene therapy biodistribution testing- a case study | insprong | |||
| 17:20 | 17:40 | Alfredo Rios-Ocampo, ICON | ||
| Rethinking qPCR Validation in Regulated Bioanalysis? Practical Guidance Beyond LBA Principles. | insprong | |||
| 17:40 | 18:00 | Elena Vicentini, Aptuit, an Evotec Company | ||
| qPCR assay for ASO quantification under GLP: out of ICH M10 scope | insprong | |||
| 18:00 | 18:20 | Jianbo Diao, WuXi AppTec | ||
| Development and validation of sensitive qPCR assays for quantifying circulating tumor DNA and mRNA expression biomarkers in human blood samples | insprong | |||
| 19:00 | End of day 1 | blok | ||
| blanco | ||||
| 09:00 | 10:40 | Session 10: Non-standard matrices-analytes / CHROM | blok-color | |
| 09:00 | 09:20 | Sergio Menta, F. Hoffmann-La Roche | ||
| Quantification of a protein biomarker in human sputum using LC-MS: Issues, challenges and solutions. | insprong | |||
| 09:20 | 09:40 | Rebecca Fennessy, Charles River | ||
| Method Establishment for the Qualification of Analytes in Tissue using LC-MS/MS | insprong | |||
| 09:40 | 10:00 | Michael Blackburn, Arcinova Alnwick | ||
| A Bioanalytical Assay for Poloxamer 188 in Human Plasma Using LC-HR-MS | insprong | |||
| 10:00 | 10:20 | Minh-Trang Phan, Sanofi (presentation was not released) | ||
| Comprehensive optimization of a bottom-up LC-HRMS workflow for biotherapeutic quantification in preclinical plasma and tissue samples using Pembrolizumab as mAb model | insprong | |||
| 10:20 | 10:40 | Neil Walsh, Waters | ||
| Is MS Imaging Ready For Prime Time in DMPK Studies ? | insprong | |||
| blanco | ||||
| 09:00 | 10:40 | Session 11: General ADA/Nab | blok-color | |
| 09:00 | 09:20 | Kyra Cowan, on behalf of the EBF | ||
| ADA/Nab and EBF - past, present and future at a glance | insprong | |||
| 09:20 | 09:40 | Michael Partridge, Regeneron Pharmaceuticals | ||
| The Next Generation of Immunogenicity Assessment: Regeneron’s Approach for ADA and NAb testing | insprong | |||
| 09:40 | 10:00 | Marit Lichtfuss, CSL Innovation | ||
| Breaking the NAb Habit: Drug Approval Through Integrated Immunogenicity | insprong | |||
| 10:00 | 10:20 | Roland F. Staack, F. Hoffmann-La Roche (presentation was not released) | ||
| Investigation of ADA-drug complex formation - its impact on active drug exposure and bioanalytical considerations | insprong | |||
| 10:20 | 10:40 | Lynn Kamen, on behalf of AAPS | ||
| To NAb or not to NAb: Is a stand-alone NAb assay required for your program? | insprong | |||
| blanco | ||||
| 09:00 | 10:40 | WS 2: GCP Sample Reconciliation | blok-color | |
| 5' | Introduction from Tsvetelina Ivanova, on behalf of the EBF-GCP Sample reconciliation team | |||
| 15' | Feedback from dissusion and (draft) recommendations related to data reconsiliation and in clinical PK studies (work in progress - slides included in introduction slides) | |||
| Presentation of discussion outcomes and preliminary recommendations addressing challenges in data and sample reconciliation — focusing on ownership, system integration, and alignment between bioanalytical and clinical data flows. | insprong | |||
| Continue with Panel/Round table | ||||
| Interactive exchange on key pain points, practical implementation examples, and opportunities for harmonisation. Participants will explore how to move from guidance to operational solutions. | insprong | |||
| Conclude and next steps | ||||
| Wrap-up of agreed priorities, identification of areas requiring further alignment, and planning for 2026 activities. | insprong | |||
| blanco | ||||
| 09:40 | 10:40 | Session 12: Mini-Omics session | blok-color | |
| 09:40 | 10:00 | Corinne Ramos, Aliri | ||
| Enabling Clinical Adoption of Omics: Fit-for-Purpose Validation and a Spatial Biomarker Case Study | insprong | |||
| 10:00 | 10:20 | Ian D. Wilson, Imperial College London | ||
| What can and should be validated in metabolic phenotyping (metabolomics/metabonomics).? | insprong | |||
| 10:20 | 10:40 | Oleksandr Boychenko, Bayer | ||
| Fully Automated Sample-to-Data Platform for Comprehensive Proteomics, Metabolomics, and Lipidomics of Biofluids | insprong | |||
| 10:40 | 11:20 | Coffee break and Poster Discussion/Viewing | blok | |
| blanco | ||||
| 11:20 | 13:00 | Session 13: Pharma/CRO: Bioanalysis in co-production | blok-color | |
| 11:20 | 11:40 | Magnus Knutsson, on behalf of the EBF | ||
| Learnings from the Autumn FW (Sept 2025), FB from EBF team discussions and next steps | insprong | |||
| 11:40 | 12:00 | Gareth Satchell, GSK | ||
| Playing Catch-Up: A Case Study on Maximising CRO-Pharma interactions | insprong | |||
| 12:00 | 12:20 | Claire Seal, Myricx Bio | ||
| Outsourcing Success for Biotechs – Quality over Quantity | insprong | |||
| 12:20 | 12:40 | Sofiya Matviykiv, Novartis | ||
| Novartis's Journey in Bioanalytical Outsourcing: Strategic Partnerships Driving Efficiency, Quality, and Innovation in Biomarker Development | insprong | |||
| 12:40 | 13:00 | Sebastian Zimmermann, Nuvisan | ||
| Optimizing Data Reconciliation in Bioanalysis: Increasing Efficiency and Reducing Risks | insprong | |||
| blanco | ||||
| 11:20 | 13:00 | WS 3: Kits and Reagent Bridging | blok-color | |
| 10' | Richard Hughes, on behalf of the EBF | |||
| Feedback from preliminary EBF discussions and experience | insprong | |||
| 10' | Ellen Gattkowski, BioAgilytix Laboratories | |||
| Bridging PK Reference Standards Across Global Bioanalytical Studies: Strategies and Lessons Learned | insprong | |||
| 10' | Kathryn Little, Medicines Evaluation Unit (MEU) | |||
| Bridging strategies in LBA assay reagents and kits | insprong | |||
| 10' | Stefanie Siegert, AC Immune | |||
| Case studies: lessons learned from material and reagent lot to lot variability | insprong | |||
| Continue with Panel/Round table | ||||
| blanco | ||||
| 11:20 | 13:00 | Session 14: ADC Session Chair: Lee Goodwin | blok-color | |
| 11:20 | 11:40 | Robert Wheller, on behalf of the EBF ADC team | ||
| Feedback from the first steps and plans of the EBF ADC team | insprong | |||
| 11:40 | 12:00 | Federico Riccardi Sirtori, Merck KGaA | ||
| Enhancing Antibody-Drug Conjugates Development: A Novel LC-HRMS Approach for Accurate Drug-to-Antibody Ratio Determination With Reactive Payloads | insprong | |||
| 12:00 | 12:20 | Issa Jyamubandi, Intertek | ||
| Acid Over Enzymes: Rethinking Intact ADC Quantification via Hybrid LC–MS | insprong | |||
| 12:20 | 12:40 | Dave Beyerlein, BioAgilytix Laboratories | ||
| Insights into the development and validation of a total LC/MS approach for a PK assay for an ADC | insprong | |||
| 12:40 | 13:00 | Panel discussion - next steps | ||
| blanco | ||||
| 11:20 | 13:00 | Session 15: Flow Cytometry: from Black & White to Technicolor | blok-color | |
| 11:20 | 11:40 | Anna Laurén, on behalf of the EBF | ||
| EBF Project Team 32 on Flow Cytometry: Focus on Spectral Flow Cytometry assays and Receptor Occupancy assays | insprong | |||
| 11:40 | 12:00 | Yang Liu, Novartis | ||
| Flow-based immunogenicity assays in support of CAR-T cell therapy | insprong | |||
| 12:00 | 12:20 | Enrique Gomez Alcaide, F. Hoffmann-La Roche (presentation was not released) | ||
| High-Parameter Flow Cytometry in the Clinic: A Modular Approach. | insprong | |||
| 12:20 | 12:40 | Thea Hogan, GSK | ||
| Spectral Flow Cytometry to Support Clinical Trials: A 30 Colour Immunophenotyping Panel | insprong | |||
| 12:40 | 13:00 | Panel discussion | ||
| blanco | ||||
| 13:00 | 14:00 | Lunch break and Poster Discussion/Viewing | blok | |
| blanco | ||||
| 14:00 | 18:00 | Workshop afternoon | blok-color | |
| blanco | ||||
| 14:00 | 15:40 | WS 4: IVDR - and what if the assay is in scope? WS moderator: Matthew Barfield, on behalf of the EBF | blok-color | |
| This workshop will focus on the practical impact of IVDR implementation for bioanalytical laboratories, i.e. what if an assay really is in scope of IVDR.... Building on the discussions and learnings from the recent EBF roadshows, we will address how IVDR is reshaping daily practice, highlighting regulatory expectations, challenges, and opportunities for early development assays. Delegates are invited to share their own experiences and cases for interactive discussion. In addition, insights and examples from the wider EBF community will be presented to stimulate reflection and identify pragmatic approaches for moving forward. | insprong | |||
| Introduction to the workshop - Matthew Barfield, on behalf of the EBF | ||||
| blanco | ||||
| 14:00 | 15:40 | WS 5: Singlicate/Duplicate - the Workshop WS moderator: Mike Wright, on behalf of the EBF | blok-color | |
| The workshop will focus on how laboratories transition from using duplicate assays to adopting singlicate assays, whether in individual projects or larger studies. We will discuss lessons learned, regulatory feedback, and both challenges and opportunities. Discussions will centre on a set of pre-defined issues and practical challenges, guided by a panel of moderators, while allowing participants to contribute additional perspectives and experiences. Delegates are encouraged to bring their own cases for discussion, and members of the EBF community will share real-world examples and insights. | insprong | |||
| Introduction to the workshop - Mike Wright, on behalf of the EBF | ||||
| blanco | ||||
| 14:00 | 15:40 | WS 6: The Green Reel: Bioanalysis in 3R Motion WS moderator: Lee Goodwin, on behalf of the EBF | blok-color | |
| This workshop will revisit the 3R principles in bioanalysis, with a particular focus on the use of surrogate matrices as discussed in recent EBF publications. We will explore to what extent laboratories are adopting these approaches in practice and how they are addressing remaining scientific and regulatory challenges. Discussions will be organised around pre-defined questions and case examples, moderated by a panel, while leaving room for participant-driven input and debate. Delegates are encouraged to share their experiences, successes, and obstacles to help identify opportunities, limitations, and next steps for broader implementation. | insprong | |||
| Introduction to the workshop - Lee Goodwin, on behalf of the EBF | ||||
| blanco | ||||
| 14:00 | 15:40 | WS 7: PCR - The Workshop WS moderator: Robert Nelson, on behalf of the EBF | blok-color | |
| 10' | Introduction Robert Nelson, on behalf of the EBF PCR team | |||
| 10' | Rebecca Sanders, Moderna (presentation was not released) | |||
| Beyond Biomarkers: Building Fit-for-Purpose Context of Use for Molecular Assays in Regulated Bioanalysis | insprong | |||
| 10' | Tracy Iles, Labcorp | |||
| The use of qPCR, ddPCR and dPCR in cell and gene therapy drug development | insprong | |||
| Continue with Panel/Round table | ||||
| 15:40 | 16:20 | Coffee break and Poster Discussion/Viewing | blok | |
| blanco | ||||
| 14:00 | 18:00 | Workshop afternoon | blok-color | |
| blanco | ||||
| 16:20 | 18:00 | WS 8: WS - ICH M10/CoU/SV - re-interpreted for LBA? WS moderator: Matthew Barfield, on behalf of the EBF | blok-color | |
| While ICH M10 brought alignment, there is growing debate in our community about whether, as for chromatographic assays, it is always necessary to do everything strictly “by the guideline” for LBA assays. Although all agree there are clear differences between LBA and chromatographic methods, this session explores the need and value of developing fit-for-purpose, context-driven strategies for PK assays—maintaining scientific and regulatory rigor while working leaner. | insprong | |||
| 10' | Introduction by Matthew Barfield, on behalf of the EBF | |||
| 10' | Margo Notebaert, Argenx (presentation was not released) | |||
| Unlocking Mechanistic Insights: Bioanalytical Strategy for an Anti-Cytokine mAb Development | insprong | |||
| 10' | Thomas Wilford, Resolian | |||
| Issues with Tissues: Strategies for developing fit-for-purpose PK immunoassays in tissue | insprong | |||
| Continue with Panel/Round table | ||||
| blanco | ||||
| 16:20 | 18:00 | WS 9: ADA for ASO and Peptides WS moderator: Cecilia Arfvidsson, on behalf of the EBF | blok-color | |
| 10' | Introduction by Cecilia Arfvidsson, on behalf of the EBF | |||
| 10' | Anita Auger Sarrazin, Novartis | |||
| Anti-drug antibodies (ADA) to antisense oligonucleotides (ASO) and their impact on pharmacokinetics (PK) and pharmacodynamics (PD) in non-human primates. | insprong | |||
| 10' | Blandine Dumont, KCAS Bio | |||
| Developing an ADA assay to a therapeutic peptide-One size does not fit all | insprong | |||
| Continue with Panel/Round table | ||||
| blanco | ||||
| 16:20 | 18:00 | WS 10: X-Validation for CHROM WS moderator: Tom Verhaeghe, on behalf of the EBF | blok-color | |
| Cross-validation remains an area of uncertainty and debate even after the release of ICH M10. This workshop will address the points of confusion that many laboratories still face, including interpretation of requirements, practical implementation, and regulatory expectations. Delegates are invited to bring their own cases and questions for discussion. Drawing on experiences from the EBF community, we will share examples and lessons learned to clarify challenges and explore pragmatic approaches moving forward. | insprong | |||
| Introduction by Tom Verhaeghe, on behalf of the EBF | ||||
| blanco | ||||
| 16:20 | 18:00 | WS 11: Flow Cytometry - The Workshop WS moderator: Anna Laurén, on behalf of the EBF | blok-color | |
| 10' | Introduction by Anna Laurén, on behalf of the EBF | |||
| This workshop will focus on the challenges and solutions applicable to flow cytometry sample analysis ranging from the harmonized experience for Flow Cytometry Receptor Occupancy Assays in recent complex multidomain biologics to evaluate the merging technologies such as Spectral Flow of high dimensional analysis. The workshop will engage the delegates in round table/panel discussions on questions and answers as an open discussion on challenges and possible solutions. | insprong | |||
| Conclusion - next steps | ||||
| 19:00 | End of day 2 | blok | ||
| blanco | ||||
| 09:20 | 10:20 | Session 16: BioA supporting PK - non-standard approaches | blok-color | |
| 09:20 | 09:40 | Khem Bahadur Adhikari, Scantox | ||
| Capillary microsampling planning, bioanalysis method optimization for capillary microsampling | insprong | |||
| 09:40 | 10:00 | Helena Vostiarova, Novartis | ||
| An in vivo PK cassette dosing approach for biologic compounds using a target-based ligand binding assays to assess the PK profiles and parameters in hFcRn transgenic mice | insprong | |||
| 10:00 | 10:20 | Adnan Mohamed Abdi, F. Hoffmann-La Roche | ||
| Near patient sampling (NPS) - A Clinical Case Study on Microsampling Implementation | insprong | |||
| blanco | ||||
| 09:00 | 10:20 | Session 17: Immunogenicity - Technology Session chair: Richard Hughes | blok-color | |
| 09:00 | 09:20 | Sergio Serafini, Novartis | ||
| ADA Assay Format Assessment and Positive Control Selection for Clinical siRNA Programs | insprong | |||
| 09:20 | 09:40 | Valérie Boutet, Sanofi | ||
| Overcoming Analytical Challenges: Novel Solutions for PK and ADA Assays in the Presence of High-Concentration Soluble Targets | insprong | |||
| 09:40 | 10:00 | Candy Fox, Gyros Protein Technologies | ||
| Drug-Tolerant Generic Assays to Detect Rodent Antibodies for Preclinical Immunogenicity Assessment | insprong | |||
| 10:00 | 10:20 | Elisa Bertotti, Merck KGaA | ||
| Anti-ID generation for a tetra-specific therapeutic: an outstanding case study | insprong | |||
| blanco | ||||
| 09:00 | 10:20 | WS 12 – The Collaboration Compass: From Reflection to Action in Pharma–CRO Partnerships WS moderator: Iain love, on behalf of the EBF | blok-color | |
| Following the EBF publication “Beyond Contracts: Principles for Pharma–CRO Collaboration” and the round-table insights from the Málaga Focus Workshop, this session reconnects the Pharma–CRO community to turn reflection into action. Together, we will identify and prioritise practical next steps to strengthen collaboration — from lean governance to transparent communication and continuity of people. The goal is not to create new procedures, but to define tangible, measurable initiatives for 2026 and lay the foundation for an EBF Collaboration Compass and potential 2027 roadshow | insprong | |||
| Introduction by Iain Love, on behalf of the EBF | ||||
| blanco | ||||
| 09:00 | 10:20 | WS 13: e-data - 'the cloud' | blok-color | |
| 15' | Cecilia Arfvidsson, on behalf of the EBF | |||
| Progress since 2024, share draft EBF paper highlights for input | insprong | |||
| 10' | Harm Buddiger, Genmab | |||
| From Paper to Platform: Transforming Bioanalytical Operations through a Centralized LIMS-ELN Ecosystem | insprong | |||
| 30' | Short (10 min) pitches | |||
| Four concise case study pitches showcasing how digital and cloud-based solutions are reshaping bioanalytical operations and data management practices: contributions from Waters, AB Sciex, Thermo Fisher Scientific and Up-to-Data | insprong | |||
| Continue with Panel/Round table taking in suggestions to refine an upcoming EBF publication on challenges and benifits related to cloud based solutions in the bioanalytical lab | ||||
| 10:20 | 11:10 | Coffee break and Poster Discussion/Viewing | blok | |
| blanco | ||||
| 11:10 | 12:50 | Session 18: ICH M10 embracing CoU | blok-color | |
| 11:10 | 11:25 | Philip Timmerman, EBF | ||
| Embracing a CoU-Driven Validation for Chromatographic Assays in Alignment with ICH M10 - part 1 - the Why? | insprong | |||
| 11:25 | 11:50 | Stuart McDougall, on behalf of the EBF (included in previous presentation) | ||
| Embracing a CoU-Driven Validation for Chromatographic Assays in Alignment with ICH M10 - part 2 - the How? | insprong | |||
| 11:50 | 12:05 | Fabian Gärtner, Nuvisan | ||
| PK as a context of use | insprong | |||
| 12:05 | 12:20 | Rebecca Paterson, Charles River | ||
| Context Driven Use of LC-MS in Protein Bioanalysis | insprong | |||
| 12:20 | 12:50 | Short pitches on examples of CoU validation | ||
| Concise case study pitches highlighting how Context of Use (CoU) approaches have provided practical value in evolving beyond the strict application of ICH M10 for PK assays. | insprong | |||
| Lee Goodwin, Labcorp | ||||
| Tsvetelina Ivanova, Comac Medical | ||||
| blanco | ||||
| 11:10 | 12:50 | Session 19: 1-Tier Technology: Single-Tier Prime-Time | blok-color | |
| 11:10 | 11:30 | Amber Bennett, Synexa Life Sciences | ||
| Assessing S/N as a quasi-quantitative ADA endpoint: evidence across five clinical programs | insprong | |||
| 11:30 | 11:50 | Hannah Higgins, Labcorp | ||
| A comparative review of three clinical trials which use the same Analytical Method: Do we come to the same conclusion? | insprong | |||
| 11:50 | 12:10 | Marie-Eve Lane, Charles River | ||
| What if we could move away from the 3-tiers approach? | insprong | |||
| 12:10 | 12:30 | Tim Schauer, BioAgilytix Laboratories | ||
| 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 | insprong | |||
| 12:30 | 12:50 | Karien Bloem, Sanquin | ||
| Choosing a 1-tiered or a 3-tiered approach has no impact on the detection of clinical relevant antibodies | insprong | |||
| blanco | ||||
| 11:10 | 12:50 | Session 20: Biosimilars | blok-color | |
| 11:10 | 11:30 | Michaela Golob, on behalf of the EBF | ||
| Feedback and next steps EBF team | insprong | |||
| 11:30 | 11:50 | Anabel Lermo, Kymos | ||
| Overcoming the challenges of LBA biosimilar drug method development for PK and implications for clinical sample analysis - Insights from a case study. | insprong | |||
| 11:50 | 12:10 | Amandine Berthet, Fresenius KabiSwissBioSim | ||
| Challenges and Opportunities in demonstrating bioanalytical comparability for the PK assay of FKS518 a denosumab biosimilar | insprong | |||
| 12:10 | 12:50 | Panel Discussion | ||
| 12:50 | 14:00 | Lunch break and Poster Discussion/Viewing | blok | |
| blanco | ||||
| 14:00 | 15:40 | Session 21: More on Hybrid assays | blok-color | |
| 14:00 | 14:20 | Gregor Jordan, F. Hoffmann-La Roche (presentation was not released) | ||
| Choosing the Right Tool: A Case Study on Hybrid LC-MS Assay Selection for PK support | insprong | |||
| 14:20 | 14:40 | Ilse De Salve, Merck KGaA (presentation was not released) | ||
| Immunoaffinity Liquid CHROM-Mass Spectrometry (IA-LC-MS) Techniques: A Strategy for Quantifying Mutated Antibody Therapeutics. | insprong | |||
| 14:40 | 15:00 | Nico van de Merbel, ICON | ||
| A quantitative LC-MS/MS method for distinguishing the tau protein isoforms phosphorylated and non-phosphorylated at serine-396 | insprong | |||
| 15:00 | 15:20 | Carole Legeay, Sanofi (presentation was not released) | ||
| “Uncharted territory: Innovative bioanalysis for challenging PK scenarios” | insprong | |||
| 15:20 | 15:40 | Ashley Phillips, Resolian (presentation was not released) | ||
| Moo-ve over BSA – Challenges and Solutions in Developing a Quantitative Biomarker Assay for Total IgG and IgG subtypes by LC-MS | insprong | |||
| blanco | ||||
| 14:00 | 15:40 | Session 22: 1-Tier: Strategic discussions | blok-color | |
| 14:00 | 14:20 | Kyra Cowan, on behalf of the EBF | ||
| Feedback and next steps EBF team | ||||
| 14:20 | 14:40 | Lauren Stevenson, Immunologix Laboratories | ||
| One Tier, Many Truths: Bringing a biomarker mindset to immunogenicity analysis | insprong | |||
| 14:40 | 15:00 | Annelies Coddens, Argenx (presentation was not released) | ||
| Changing the 3-tiered ADA testing approach – case studies and regulatory feedback | insprong | |||
| 15:00 | 15:20 | Laura von Berg, BioAgilytix Laboratories (presentation was not released) | ||
| Evaluation of a 1-Tiered Versus 3-Tiered Approach in ADA Assay Validation and Application in a Clinical Phase I Study | insprong | |||
| 15:20 | 15:40 | Katherine Sime, Charles River | ||
| Crystal Clear? Data-Driven Predictions for Lean Immunogenicity Assessment | insprong | |||
| 15:40 | 16:20 | Coffee break | blok | |
| blanco | ||||
| 16:20 | 17:20 | Session 23: Closing session - from Learnings to Action Panel: key contributors to the symposium | blok-color | |
| As the 18th OS comes to a close, this session reconnects the threads of discussion from across workshops and presentations, translating insights into concrete actions for the EBF and the wider bioanalytical community. Together, we’ll highlight emerging priorities, identify areas requiring deeper focus, and define the next steps to strengthen scientific impact and patient relevance in the years ahead. | insprong | |||
| Closing session | ||||
| blanco | ||||
| 17:20 | 17:30 | Closing remarks - Stay Tuned for Season 19! | blok-color | |
| 17:30 | Adjourn | |||
| MEETING ORGANISATION | blok |
| Organising committee (OC): | |
| Steve White, GSK; Kyra Cowan, Merck KGaA; Michaela Golob, Nuvisan; Matthew Barfield, F. Hoffmann-La Roche and Philip Timmerman, EBF | |
| Scientific committee: | |
| OC + Robert Nelson, BioAgilytix; Luca Ferrari and Connor Walker, F. Hoffmann-La Roche; Richard Hughes, Alchemab (Resolian until e.o. OCT 2025); Stuart McDougall, Arcinova; Anna Laurén, MinervaX; Lee Goodwin, Labcorp; Cecilia Arfvidsson, AstraZeneca; Mike Wright, GSK; Nico van de Merbel, ICON; Katja Zeiser, Nuvisan; Tsvetelina Ivanova, Comac-Medical | |
| blanco | |
| The conference is organised as a non-profit event by the EBF vzw. The organisation of the conference is independent from all EBF member companies and conference sponsors. | blok center |