European Bioanalysis Forum

Science – Our Universal Language

24-26 November 2021

OS Agenda (Nov.) 2021

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.

Day 1 – Wednesday 24 NOV 2021
10:00 10:20 Welcome
10:20 12.10 Session 1: Biomarkers – Organisational design driving CoU (Plenary)
10:20 10:30 Philip Timmerman, on behalf of the EBF
BM and CoU – where are we today and where are we going?
10:30 10:50 Kyra Cowan, on behalf of the EBF
Organisational design driving/preventing CoU – a challenge or an opportunity – a stakeholder perspective – a Pharma/Sponsor perspective
10:50 11:10 Michaela Golob, on behalf of the EBF
Organisational design driving/preventing CoU – a challenge or an opportunity – a stakeholder perspective – a CRO/vendor perspective
11:10 11:30 Peter Groenen, Idorsia
Organisational design driving/preventing CoU – a challenge or an opportunity – a stakeholder perspective
11:30 11:50 Anna Laurén, Novo Nordisk
Updating the organisational process and responsibility split for translational work with biomarkers and CoU – a pharma perspective
11:50 12.10 Q&A  and  Introduction to the workshop (Parallel to Session 5)
12.10 13.40 Lunch Break
Poster viewing – click on link to see poster list
Day 1 Poster session requests authors of pasters 1-20 at their poster
13.40 15:20 Session 2: NCE/Chromatography (in parallel with session 3)
13:40 14:00 Nico van de Merbel, ICON
A tiered approach to method validation for the support of a bioequivalence trial with ibuprofen
14.00 14:20 Petra Lewits, Merck KGaA (Not released for publication)
Advances of Monolithic silica columns for the rapid, sensitive, and highly efficient separation of Biomolecules
14:20 14:40  Cathy Lane, Sciex
Sub ng/mL quantification and characterization of oligonucleotides in plasma using microflow LC coupled to a novel QTOF mass spectrometer
14:40 15:00 Heike Wiese, Nuvisan
Enzyme activity assays using LC-MS
15:00 15:20 Delphine Maux, Syneos Health
Non liquid matrix analysis: challenge and approaches
14:00 15:20 Session 3: New Modalities (in parallel with session 2)
14:00 14:20 Anna Laurén, on behalf of the EBF
Applying Context-of-Use to qPCR Method Validation and Analysis: A Recommendation from EBF
14:20 14:40 Marianne Scheel Fjording, BioAgilytix
Bioanalytical assay strategies for immunogenicity assessment of new modalities
14:40 15:00 Niels Nijstad, QPS
The development of a hybridization ECLIA assay for the determination of the payload of a oligonucleotide-antibody conjugate
15:00 15:20 Johannes Stanta, on behalf of the EBF C&GT team
EBF Feedback on ICH S12
15:00 16:20 Coffee break
16:00 18:00 Session 4: Workshop – Remote inspections by Health Authorities  – experiences and challenges (in parallel with session 5)
16:00 16:20 Tsvetelina Ivanova, on behalf of the EBF
Regulatory framework for Remote HA inspection: an overview
16:20 16:40 Robert Nelson, on behalf of the EBF
Practical considerations and challenges from industry
16:40 17:00 Iain Love, Charles River Laboratories
1.5y into remote HA inspections – learning together
17:00 17:20 Martijn Baeten, Sciensano (Belgian Institute for Health)
On: Experience and learnings from remote inspections.
17:20 17:50 Workshop discussion – building on a pre-meeting survey to all delegates
Preparing for best practices breakout – the Rosetta Stone for remote inspections by health authorities
17:50 18:00 Wrap up – preparing to continue the discussion at  the December Workshop
16:20 18:10 Session 5: Workshop – Biomarkers – Organisational design driving CoU (in parallel with session 4)
16:20 16:40 Kyra Cowan, on behalf of the EBF
Organisational design driving CoU – feedback from pre-meeting survey
16:40 18:00 Workshop discussion, incl. organisational design Case studies. Company perspectives from:
16:40 – 16:50   Laetitia Sordé, Sobi
16:50 – 17:00   Ulrich Kunz, Boehringer Ingelheim
17:00 – 18:00   Panel discussion
18:00 18:10 Wrap up
Day 2: 25 November 2021
10:00 11:40 Session 6: Microsampling – recent technological developments – patient centric trials (in parallel with session 7)
10:00 10:20 Franck Saint-Marcoux, Limoges University Hospital – for Shimadzu
Measurement of tacrolimus in dried blood spots: a fully automated sample preparation and LCMS method
10:20 10:40 Bryan van den Broek, Sanquin Diagnostiek
Home sampling as alternative to venepuncture: results, patient experience and implementation
10:40 11:00 Remco Koster, ICON (Not released for publication)
Analytical evaluation of a device for volumetric absorptive microsampling for whole blood sampling from the upper arm
11:00 11:20 Liesl Heughebaert, U-Ghent
Hematocrit prediction of DBS: current status and future outlook
11:20 11:40 Michele Protti, U-Bologna
Advanced blood and tissue microsampling for biomarker investigation of neurodegenerative diseases
10:20 12:00 Session 7: Immunogenicity Technology and Applications (in parallel with session 6)
10:20 10:40 Annelies Turksma, Sanquin Diagnostiek
Robust multi parameter immunomonitoring; Polyfunctional T cell analysis by FluoroSpot
10:40 11:00 Samuel Pine, Ablynx, a Sanofi company
Accessible, adaptable and automated: having it all with an immunogenicity cut-point calculator
11:00 11:20 Laura Geary, LGC
The importance of characterising critical reagents with a focus on bio-conjugated reagents
11:20 11:40 Sam Willcox, Labcorp Drug Development
Development of an anti-PEG antibody assay for assessing immunogenicity of PEGylated proteins and lipid nanoparticles
11:40 12:00 Issa Jyamubandi, LGC
Challenges of developing an ADA assay for Bispecific antibody therapeutic and further ADA characterisation
11:40 13:40 Lunch break
Poster viewing – click on link to see poster list
Day 2 Poster session requests authors of pasters 21-40 at their poster
13:40 15:20 Session 8: Biomarker – Technology and Applications (in parallel with session 9)
13:40 14:00 Petia Doytcheva, Celerion
A fully automated method for CD34+ cells enumeration by flow cytometry in stabilized whole blood
14:00 14:20 David Bettoun, Larimar Therapeutics
Development of NanoString Gene Expression Assays for Studying Frataxin-sensitive Gene Markers in Clinical Samples
14:20 14:40 Kyra Gelderman, Sanquin Diagnostiek
Biomarker assays: a take on optimization and validation in a regulated bioanalysis lab
14:40 15:00 Thomas Antoine, Ablynx, a Sanofi company
Trust but verify: optimization of a multiplex cytokine kit to monitor preclinical CRS
15:00 15:20 Michael Blackburn, Quotient Sciences
Direct LC-ICP-MS / ICP-MS assay for measurement of Non-ceruloplasmin bound copper in Wilsons Disease (a biomarker) with confirmatory High Res MS proteomics
14:00 15:40 Session 9: LBA/CBA – Technical Challenges (in parallel with session 8)
14:00 14:20 Martin Schaefer, F. Hoffmann – La Roche
One plate ahead of the unspecific binding: An innovative approach to solve obinutuzumab interference in a glofitamab-specific PK-Assay
14:20 14:40 Sarah-Jane Kellmann, Bio-Rad Laboratories
Faster Generation of Anti-Drug Antibodies using SpyTag Technology
14:40 15:00 Richard Hughes, LGC
Pushing the limits of PK analysis: can we meet BMV PK criteria with high sensitivity LBAs
15:00 15:20 John Chappell, Gyros Protein Technologies
Advances in ADA, PK, and biomarker immunoassays to meet demands for assay speed and performance
15:20 15:40 Birgitte Stoevring, SVAR Life Science
Functional potency assay feasibility of therapeutics and new modality drug candidate targeting the complement cascade.
15:20 16:20 Coffee break
16:20 18:00 Session 10: Immunogenicity Strategies (in parallel with sessions 11 and 12)
16:20 16:40 Michaela Golob, on behalf of the EBF
Immunogenicity Strategies: cross-industry, cross-functional approaches to understand immunogenicity potential from discovery through launch
16:40 17:00 Annelies Coddens, Argenx
Immunogenicity strategies across programs: risk-based approaches and challenges
17:00 17:20 Yvonne Katterle, Bayer
How immunogenicity risk assessment can translate into an immunogenicity testing strategy
17:20 18:00 panel discussion
16:40 18:20 Session 11: Protein MS – Applications and EBF update (in parallel with sessions 10 and 12)
16:40 17:00 Dominic Foley, Waters
Analysis of SARS-CoV-2 using LC-MS Peptide Enrichment for Clinical Research
17:00 17:20 Alessandro Greco, Evotec (Aptuit, an Evotec company)
Quantification of two mAbs using both ELISA and LC-MS/MS generic methods. Comparison of in-vivo sample results
17:20 17:40 Richard Lucey, LGC
Missed cleavages in bottom-up protein LC-MS workflows: ‘Breaking Bad’-ly cleaved surrogate peptides
17:40 18:00 Matthew Barfield, on behalf of the EBF
Status update from EBF Protein MS team
18:00 18:20 Zhuo Chen – GllaxoSmithKline – 2021 2021 BRSA winner
The Versatility of Q-TOF HRMS in Bioanalysis: From Small Peptides Quantitation to Protein Complexes Characterization
16:20 18:10 Session 12: Data (in parallel with sessions 10 and 11)
16:20 16:40 Gidion de Boer, on behalf of the vendor-neutral secure data transfer team
Solution towards a vendor-neutral and secure transfer of data between LIMS and Instruments
16:40 17:00 Norbert Bittner, up to data
Time to bring it all together: From data transfer to processing to full reporting under ICH M10 based on the EBF Data Integrity Initiative (LCMS)
17:00 17:20 Oriol Peris, Charles River Laboratories
Impact of the data variability due to different patterns of bioanalytical bias – Pharmacokinetic assessment through simulation
17:20 17:40 Luca Ferrari, on behalf of the EBF
EBF feedback to industry and FDA on FDA Bioanalytical Method Template
17:40 18:10 Panel Discussion on FDA Bioanalytical Method Template
Day 3: 26 November 2021
08:00 10:00 Breakfast buffet in Conference Area
09:40 11:00 Session 13: the patient (in parallel with session 14)
09:40 10:00 Julian Freen-van Heeren, Sanquin Diagnostiek (Not released for publication)
Investigating antibody effector mechanisms: how to monitor (unwanted) effects of your therapeutic antibodies
10:00 10:20 Katja Heinig, F. Hoffmann – La Roche
Overcoming bioanalytical challenges during the preclinical and clinical development of risdiplam (Evrysdi®) for the treatment of spinal muscular atrophy in children and adults
10:20 10:40 Floris Loeff, Sanquin Diagnostiek
TDM of biologics reassures clinicians in personalised dosing
10:40 11:00 Coral Munday, LGC
Cryoactivation, CRESS, and the Importance of Preanalytics
10:00 11:20 Session 14: NAb – Strategies and applications (in parallel with session 13)
10:00 10:20 Maija Pfenniger, Celerion
How to deal with the challenges of NAb assays: case studies evaluated
10:20 10:40 Johannes Stanta, Freeline therapeutics
Novel approaches for a neutralising anti-capsid assay to detect pre-existing antibodies
10:40 11:00 Robert Nelson, on behalf of the EBF NAb team
Feedback from EBF discussion on NAb strategies (Note: the presentation includes an introduction in the feedback from AAPS, which will be provided in more detail by AAPS NAb leaders in the 01-03 December NAb session)
11:00 11:20 Q&A and sharing experience on NAb strategies by the audience
11:00 12:00 Coffee break
12:00 12:10 Feedback from Workshop Session 4: Remote HA inspections (Plenary)
12:10 12:20 Feedback from Workshop Session 5: Biomarkers – Organisational design driving CoU (Plenary)
12:20 14:15 Session 15: The future of BA – our ethical responsibility to the community (Plenary)
12:20 12:40 Connor Walker, on behalf of the EBF-YSS community
Sustainable Bioanalysis: Where are we now, where are we going?
12:40 13:00 Coral Munday, on behalf of the EBF-YSS community
How Covid-19 impacted our day to day work – learnings for the future
13:00 14:00 All-delegates interactive brain storm and panel discussion on future challenges for the Bioanalytical community
Moderator: Philip Timmerman, EBF
Panel: SMEs from 14th OS organising committee
Themes at least include
 – New modalities, old modalities
 – Avoiding unnecessary experimental animal usage
 – Is every patient/volunteer sample needed? Learnings from Covid-19
Additional themes may be identified with input from a pre-meeting survey to EBF members and meeting delegates
14:00 14:15 Closing remarks – Adjourn
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