European Bioanalysis Forum

16-18 November 2022 – Barcelona (Spain)

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.

Program @ a glance

Day 1 – Wednesday 16 NOV 2022
09:00 09:20 Welcome (Plenary)
09:20 10:40 Starting Big on Small (Plenary) – incl. Introduction to Pier 1-4 Workshops
11:20 13:00 Biomarkers CoU – Strategy
14:00 15:40 The e-Environment parallel with Immunogenicity – Strategy
16:20 18:00 Microsamping / Clinical & Patient Centric Consideration (ends 18:20) parallel with CGT and Beyond – Strategy
Day 2 – Thursday 17 NOV 2022
09:00 10:20 Smaller, Lower, Higher, Faster, More, Less….Just Better parallel with CGT – Applications
11:00 12:20 Microsampling and Academia: Where New Ideas are Born parallel with When it’s Neither Large nor Small
14:00 16:00 Interesting Challenges in Clinical Studies and Beyond parallel with Biomarkers Tech
16:40 18:00 Protein MS parallel with Immunogenicity Technology – interference focus
00:00 Parallel Workshops in the Harbour
09:00 10:20 Pier 1: Challenges in Patient Centric Trials
11:00 12:40 Pier 2: e-Environment Workshop
14:00 16:00 Pier 3: 3R Workshop
16:40 18:00 Pier 4: GCP Workshop
Day 3 – Friday 18 NOV 2022
09:00 10:00 “Beyond BA” parallel with Immunogenicity Tech
10:10 11:00 Regulatory updates (Plenary)
11:00 13:00 Challenges for the Future Landscape (Plenary)

Details of the sessions

Day 1 – Wednesday 16 NOV 2022
09:00 09:20 Welcome
09:20 10:00 Starting Big on Small (Plenary) – Auditorium
Session chair: Steve White, GSK
09:20 09:40 Kevin Bateman, MSD (Merck & Co., Inc.)
Patient Centric Sampling and Multi-Omics for Biomarkers in Clinical Development
09:40 10:00 Liselotte Björsson, AstraZeneca
Microsampling and Singlicate Analysis for Large Molecules delivering Scientific, Ethical and Cost Benefits
10:00 10:20 Neil Spooner, Patient Centric Sampling Interest Group and University of Hertfordshire
An Overview of Patient Centric Sampling – Overcoming the Hurdles to Implementation
10:20 10:40 We meet at the Pier? – Auditorium
00:00 Short 5-min introduction to the 4 workshops on day 2 by the moderators (all on behalf of the EBF) to introduce the plans and anticipated deliverables
Pier 1: Challenges in Patient Centric Trials – Matthew Barfield
Pier 2: e-Environment Workshop – Cecilia Arfvidsson
Pier 3: 3R Workshop – Amanda Wilson (in collaboration with NCR3s)
Pier 4: GCP Workshop – Tsvetelina Ivanova
10:40 11:20 Coffee break
11:20 13:00 Biomarkers CoU – Strategy (Plenary) – Auditorium
Session chair: Michaela Golob, Nuvisan
11:20 11:40 Nico van de Merbel, ICON plc & U. Groningen
Inspiration from another world; validation of LC-MS/MS assays for protein biomarkers in clinical chemistry
11:40 12:00 Carmen Fernandez-Metzler, on behalf of the AAPS
Does ISR apply for Biomarker Assays?
12:00 12:20 Kyra Gelderman, Sanquin Diagnostic Services
Complement biomarkers; challenges and solutions around complement measurements.
12:20 12:40 Kyra Cowan, on behalf of the EBF
Past current and future of EBF discussions, challenges and recommendations on Biomarker/CoU
12:40 13:00 Panel Discussion
13:00 14:00 Lunch break
14:00 15:40 The e-Environment (Parallel) – Auditorium
Session chair: Cecilia Arfvidsson, AstraZeneca
14:00 14:20 Cecilia Arfvidsson, on behalf of the EBF
Past, current and future of EBF discussions, challenges and recommendations on secure data transfer
14:20 14:40 Norbert Bittner, up to data
Applying Software as a Service (SaaS) to Enhance Productivity and Compliance in the End-to-End Workflows of Bioanalytical Labs
14:40 15:00 Federico Pastori, Labware
A complete Method e-Validation process for all molecules
15:00 15:40 Burkhard Schäfer, on behalf of the data transfer vendor consortium
The product pathway; a vendor-neutral secure data transfer process between LIMS/ELN and LC-MS/MS instruments for bioanalysis.
00:00 Followed by Panel Discussion on Vendor Neutral Data Transfers – Challenges & Opportunities
14:00 15:40 Immunogenicity – Strategy (Parallel) – Jupiter
Session chair: Robert Nelson, Labcorp Drug Development
14:00 14:20 Robert Nelson, on behalf of the EBF
Past, current and future of EBF discussions and recommendations on Immunogenicity
14:20 14:40 Amanda Hays, on behalf od the AAPS Nab team
Neutralizing Anti‐drug Antibody Validation Testing and Reporting Harmonization: Status Update from AAPS
14:40 15:00 Dorte Kornerup Ditlevsen, H. Lundbeck A/S
A new structured approach to working cross-functionally with immunogenicity
15:00 15:20 Jo Goodman, on behalf of the EBF
Past, current and future of EBF discussions and recommendations on Cut Points
15:20 15:40 Panel Discussion
15:40 16:20 Coffee break
16:20 18:20 Microsamping / Clinical & Patient Centric Considerations (Parallel) – Auditorium
Session chair: Matthew Barfield, F. Hoffmann La Roche
16:20 16:40 Ryan Lutz, MSD (Merck & Co., Inc.)
Evaluation of a Novel Microsampling Device – Tasso-M20 in Support of Clinical PK Studies
16:40 17:00 Sofiya Matviykiv, Novartis (Not released for publication)
Evaluation of a Tasso blood microsampling device for clinical trial sample collection and biomarker analysis
17:00 17:20 Heike Wiese, Nuvisan
Comparability of PK data obtained from plasma and whole blood collected with VAMS devices
17:20 17:40 Hans Stieltjes, Janssen R&D
Practical and Logistical Challenges for Bioanalysis with Dried Patient Centric Sampling devices
17:40 18:00 Maurice Steenhuis, Sanquin Diagnostic services
Towards the use of fingerprick blood sampling for therapeutic drug monitoring
18:00 18:20 Richard Hughes, Drug Development Solutions – Part of Alliance Pharma
Micro-managing: exploring the potential to use microsampling technology for quantitation of large molecules
16:20 18:00 CGT and Beyond – Strategy (Parallel) – Jupiter
Session chair: Anna Laurén, Novo Nordisk
16:20 16:40 Johannes Stanta, on behalf of the EBF CGT team
Past, current and future of EBF discussions, challenges related to CGT
16:40 17:00 Amanda Hays, on behalf of the AAPS qPCR team
qPCR in Regulated Bioanalysis- current discussions in the industry
17:00 17:20 Teona Roschupkina, Drug Development Solutions – Part of Alliance Pharma
Gate that cell: Requirement for analysing Flow Cytometry Data reflection on H62 document
17:20 17:40 Anna Laurén, on behalf of the EBF
Applying context of use to qPCR method validation and analysis – a progress update.
17:40 18:00 Panel Discussion
Day 2 – Thursday 17 NOV 2022
09:00 10:00 Smaller, Lower, Higher, Faster, More, Less….Just Better (Parallel) – Auditorium
Session chair: Tsvetelina Ivanova, Comac Medical
09:00 09:20 Egidijus Machtejevas, Merck KGaA
Analysis of Biomacromolecules by LC-MS Utilizing Novel, Narrow-bore, Wide Pore Monolithic and Superficially Porous Stationary Phases
09:20 09:40 Cathy Lane, Sciex
Achieve sensitive quantification of complex peptides with disulfide bridging in rat plasma using a high-end triple quadrupole mass spectrometer
09:40 10:00 George Walters, Drug Development Solutions – Part of Alliance Pharma
Exploring the Benefits and Challenges of Universal Automated Methods.
09:00 10:20 CGT – Applications (Parallel) – Jupiter
Session chair: Anna Laurén, Novo Nordisk
09:00 09:20 Michael Schwenkert, SVAR
Development of an iLite® Reporter Cell Platform for the Quantification of Anti-AAV Neutralizing Antibodies.
09:20 09:40 Lydia Michaut, Tataa
Beyond genetic medicine quantification in plasma: validating PCR assays for biodistribution and pharmacodynamic biomarkers
09:40 10:00 Zhe Liu, Labcorp Drug Development
Detection of Antibodies to AAVs using Gyrolab
10:00 10:20 Axel Meyer, Abbvie
From quantitative to digital: Validation of a droplet digital (dd)PCR assay
09:00 10:20 Pier 1: Workshop on Challenges in Patient Centric Trials (Parallel) – Eiffel/Jin Mao
00:00 Workshop moderator: Matthew Barfield
Short presentations and discussions to discuss the ‘non-lab’ related issues, i.e. focus on logistic challenges and opportunities for patient centric sampling/trials
10:20 11:00 Coffee break
11:00 12:20 Microsampling and Academia: Where New Ideas are Born (Parallel). – Eiffel/Jin Mao
Session chair: Steve White, GSK
11:00 11:20 Dries Vloemans, KU Leuven
Novel self-powered microfluidic platform for advanced remote microsampling applications
11:20 11:40 Michele Protti, Unibo
Exploring the cannabinoid space with second-generation blood microsampling
11:40 12:00 Laura Boffel, Ghent University
In-depth evaluation of automated non-contact reflectance-based hematocrit prediction of dried blood spots
12:00 12:20 Open Forum: Microsampling in acadamia supporting technology development and new applications
11:00 12:20 When it’s Neither Large nor Small (Parallel) – Auditorium
Session chair: Anna Laurén, Novo Nordisk
11:00 11:20 Mohammed Abrar, BioApp Solutions Limited (Not released for publication)
Bioanalysis of Inbetweeners- (Challenges & Solutions)
11:20 11:40 Frida Löthberg, Gyros
Strategies for measuring oligonucleotides using a fully automated micro-fluidic immunoassay system
11:40 12:00 Michael Blackburn, Quotient Sciences
Changing to a Physicochemical Format from Hybrid for a Large Peptide Assay: Pros and Cons
12:00 12:20 John Perkins, KCAS Bioanalytical & Biomarker Services
Addressing the Impact of Structure on Bioanalysis of Polypeptides & Oligonucleotides
11:00 12:20 Pier 2: e-Environment Workshop (Parallel) – Jupiter
Workshop moderator: Cecilia Arfvidsson
Hosted by the EBF e-environment team. During the workshop, the discussion will focus on solutions for secure data transfer for the LBA toolbox and cloud based approaches for the (regulated) BA lab.
12:20 13:30 Lunch break
13:30 15:30 Interesting challenges in clinical studies and beyond (Parallel) – Auditorium
Session chair: Robert Nelson, Labcorp Drug Development
13:30 13:50 Roland Staack, Roche Diagnostics (Not released for publication)
Evaluation of free drug/target concentrations by bioanalyis or M&S – do we apply double standards?
13:50 14:10 John Chappell, Gyros
Development of an assay to measure free IgE as a solution for PK/PD assessment of Omalizumab
14:10 14:30 Gareth Whitaker, Quotient Sciences
Interim PK analysis and decision making in Translational Pharmaceutics programs
14:30 14:50 Aparna Kasinath, Syngene International
A simple complex: GLP/GCLP PK, PD and Immunogenicity analysis for GCP clinical studies
14:50 15:10 Floris Loeff, Sanquin Diagnostic Services
TDM of biologics reassures clinicians in personalised dosing
15:10 15:30 Bioanalysis Zone BRSA Winner 2022: Shelby Barnett, Newcastle University (Newcastle, UK)
Development of a national therapeutic drug monitoring programme in childhood cancer in the UK
13:30 15:30 Biomarkers technical (Parallel) – Jupiter
Session chair: Kyra Cowan, Merck KGaA
13:30 13:50 Ulrich Kunz, Boehringer Ingelheim
Equilibrium (MSD) versus kinetic (Gyrolab) immunoassay in the quantification of a free soluble target – it makes a difference.
13:50 14:10 Katja Zeiser, Nuvisan
Diving deeper into data: investigation of a CV% issue during a biomarker study using Gyrolab
14:10 14:30 Elena Vicentini, Aptuit (Verona) Srl, an Evotec Company
High-sensitivity immunoassays for biomarkers of Huntington’s disease
14:30 14:50 Yetrib Hathout, Binghamton University
Blood accessible biomarkers for Duchenne muscular dystrophy.
14:50 15:10 Wikke Berg-Koopmans, ICON plc
Challenges and opportunities for determining the dynamics of an unstable cell-membrane marker on a rare cell population by flow cytometry.
15:10 15:30 Peter Blattmann, Idorsia Pharmaceuticals
Biologically active CXCL12α plasma concentrations increase after multiple-dose treatment with an ACKR3 antagonist in humans
13:30 15:30 Pier 3: 3R Workshop (Parallel) – Eiffel/Jin Mao
Workshop moderator: Amanda Wilson
The discussions will focus on identifying opportunities and solutions to minimise usage of experimental animals for in vivo tox/PK studies and how the BA community can reduce usage of blank (rodent) matrices after ICH M10 implementation.
15:30 16:20 Coffee Break
16:20 18:00 Protein MS (Parallel) – Auditorium
Session chair: Matthew Barfield, F. Hoffmann La Roche
16:20 16:40 Matthew Barfield, on behalf of the EBF
Past, current and future of EBF discussions, challenges and recommendations on Protein MS
16:40 17:00 Szabolcs Szarka, Drug Development solutions
Design of Experiment – a Powerful Tool to Optimise Sample Preparation in Bottom-up Targeted Protein LC-MS Workflows
17:00 17:20 Ilse De Salve, Merck KGaA
Combined affinity capture LC-MS/MS method, for total antibody and conjugated payload quantitation from in-vivo and in-vitro ADC samples.
17:20 17:40 Lieve Dillen, Janssen R&D (Not released for publication)
Calibration of clinical ELISAs to evaluate immune response by quantitative MS
17:40 18:00 Ana Villar Garea, Sanofi (Not released for publication)
Comparison of ligand-binding assays and hybrid LC-MS (intact protein) bioanalytical strategies for small therapeutic proteins
16:20 18:00 Immunogenicity Technology – Interference Focus (Parallel) – Jupiter
Session chair: Jo Goodman, AstraZeneca
16:20 16:40 Nick White, AstraZeneca
An Old Dog with New Tricks? Resurrection, Reoptimisation and Refinement to Render Drug and Target Interference Redundant
16:40 17:00 Presentation cancelled by author
cancelled
17:00 17:20 Laura Geary, Drug Development Solutions – Part of Alliance Pharma
Pushing the Limits of Immunogenicity Assay Drug Tolerance
17:20 17:40 Karien Bloem, Sanquin Diagnostic Services
Anti-drug antibody testing of therapeutic monoclonal antibodies, have we gone too far?
17:40 18:00 Panel Discussion
16:20 18:00 Pier 4: GCP Workshop (Parallel) – Eiffel/Jin Mao
Workshop moderator: Tsvetelina Ivanova
Hosted by the EBF GCP team. During the workshop, we plan to focus on the learnings and Outcome of the GCP Focus Workshop (15-16 September 2022, Malaga) and design/refine recommendations on how to implement GCP requirements into the BA workflows.
Day 3 – Friday 18 NOV 2022
09:00 10:00 “Beyond BA” (Parallel) – Auditorium
Session chair: Tsvetelina Ivanova, Comac Medical
09:00 09:20 Claire Szuster, Drug Development Solutions – Part of Alliance Pharma
Plasma Protein Binding: On RED alert!
09:20 09:40 Humaira Naseer, AstraZeneca (Not released for publication)
Overcoming the bioanalytical complexities of nucleotide based biotherapeutics and antibody drug conjugates in tissues derived from non-clinical PK/PD, biodistribution and safety studies
09:40 10:00 Gregor Jordan, Roche Diagnostics (Not released for publication)
How can the BA expert assist in improving data interpretation and contribute holistically to project support?
09:00 10:00 Immunogenicity Tech (Parallel) – Jupiter
Session chair: Jo Goodman, AstraZeneca
09:00 09:20 Sara Ongay, HEXAL AG (Sandoz a Novartis division) (Not released for publication)
Insights into some of the method capabilities and bottlenecks of hybrid LBA-LC-MS/MS for ADA analysis: a case study for a monoclonal antibody (IgG1)
09:20 09:40 Phillip Bartlett, Crescendo Biologics (Not released for publication)
Detection of Anti-Ig light chains as an immunogenicity assay strategy for novel therapeutic proteins.
09:40 10:00 Elisa Bertotti, Merck KGaA
Pre-Existing Anti-Drug Antibody evaluation: a standard workflow to support drug candidates selection
10:00 10:10 Logistic Break
10:10 11:00 Regulatory updates (Plenary) – Auditorium
During the session, we will give an update on recent/upcoming regulatory requirements or challenges for the BA community. The session will build on a pre-meeting survey and ad hoc Q&A.
11:00 11:30 Coffee Break
11:30 13:00 Challenges for the Future Landscape (Plenary) – Auditorium
Session chair: Kyra Cowan, Merck KGaA
11:30 11:50 Foka Venema, Ardena
The impact of COVID-19 on BA: accelerating assay development without compromising quality
11:50 12:10 Radoiane Helbaj, F. Hoffmann La Roche
Biosample Operation Specialist and Bioanalytical manager combined role
12:10 12:30 Mari Enoksson, NovoNordisk
Challenges and Opportunities for future BA scientists
12:30 12:45 Matthew Barfield, on behalf of the EBF
View on the changing world and future challenges for the bioanalytical community
12:45 13:00 Philip Timmerman, EBF
The YSS fueling our future
13:00 Closing Remarks & Adjourn
Meeting organisation: Cecilia Arfvidsson (AstraZeneca), Matthew Barfield (F. Hoffmann – La Roche), Kyra Cowan (Merck KGaA), Michaela Golob (Nuvisan), Jo Goodman (AstraZeneca),Tsvetelina Ivanova (Comac-Medical), Anna Laurén (NovoNordisk), Robert Nelson (Labcorp), Steve White (GSK) and Philip Timmerman (EBF)
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