EBF
EBF Open Symposium
EBF Barcelona

14th EBF Open Symposium

Science – Our Universal Language
24-26 November 2021 (Live at Hyatt Regency Barcelona Tower – Barcelona – Spain)
01-03 December 2021 (limited Cyberconnect event)

Agenda 14th EBF Open Symposium

version 08SEP2021

Program at a glance- click on the session title to see the details of the session

Day 1: 24 November 2021
10:00 10:20 Welcome
10:20 12:00 Session 1: Biomarkers – Organisational design driving CoU (Plenary)
13:40 15:00 Session 2: NCE/Chromatography (Parallel with session 3)
14:00 15:20 Session 3: New Modalities (Parallel with session 2)
16:00 18:00 Session 4: Workshop – Remote inspections by Health Authorities – experiences and challenges (Parallel with session 5)
16:20 18:10 Session 5: Workshop – Biomarkers – Organisational design driving CoU (Parallel with session 4)
Day 2: 25 November 2021
10:00 11:40 Session 6: Microsampling – recent technological developments – patient centric trials (Parallel with session 7)
10:20 12:00 Session 7: Immunogenicity Technology and Applications (Parallel with session 6)
13:40 15:20 Session 8: Biomarker – Technology and applications (Parallel with session 9)
14:00 15:40 Session 9: LBA/CBA – Technical Challenges (Parallel with session 8)
16:20 18:00 Session 10: Immunogenicity – Strategies (Parallel with sessions 11 and 12)
16:40 18:20 Session 11: Protein MS – Applications and EBF update (Parallel with sessions 10 and 12)
16:20 18:20 Session 12: Data (Parallel with sessions 10 and 11)
Day 3: 26 November 2021
09:40 11:00 Session 13: The patient (Parallel with session 14)
10:00 11:20 Session 14: NAb – Strategies and applications (Parallel with session 13)
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 14:00 Session 15: The future of BA – our ethical responsibility to the community (Plenary)
14:00 14:15 Closing remarks – Adjourn

Details of the sessions

  1. Additional presenters will be added when confirmed
  2. All presenters will need to present live in Barcelona. No online ore pre-recoderded presentations will be possible. All presenters will need to present live in Barcelona – no online presentations will be possible
  3. The Bioanalysis Zone Rising Star Award winner will be added to the program when announced to us. The Bioanalysis Zone Rising Star award winner will be added to the program when announced
  4. All presenters, delegates and meetings staff need to show proof of full vaccination to be allowed into the meeting. Recent negative PCR or post infection recovery will not be sufficient. Please check additional info on regional travel requirements or updates here
Day 1 – Wednesday 24 NOV 2021
     
 08:0010:00 Breakfast buffet in Conference Area
     
 10:0010:20 Welcome
     
 10:2012.10 Session 1: Biomarkers – Organisational design driving CoU (Plenary)
 10:2010:30 Philip Timmerman, on behalf of the EBF
    BM and CoU – where are we today and where are we going?
 10:3010:50 Kyra Cowan, on behalf of the EBF
    Organisational design driving/preventing CoU – a challenge or an opportunity – a stakeholder perspective – a Pharma/Sponsor perspective
 10:5011:10 Michaela Golob, on behalf of the EBF
    Organisational design driving/preventing CoU – a challenge or an opportunity – a stakeholder perspective – a CRO/vendor perspective
 11:1011:30 Peter Groenen, Idorsia
    Organisational design driving/preventing CoU – a challenge or an opportunity – a stakeholder perspective
 11:3011:50 Anna Laurén, Novo Nordisk
    Updating the organisational process and responsibility split for translational work with biomarkers and CoU – a pharma perspective
 11:5012.10 Q&A  and  Introduction to the workshop (Parallel to Session 5)
     
 12.1013.40 Lunch Break
     
 13.4015:20 Session 2: NCE/Chromatography (in parallel with session 3)
 13:4014:00 Nico van de Merbel, ICON
    A tiered approach to method validation for the support of a bioequivalence trial with ibuprofen
 14.0014:20 Petra Lewits, Merck KGaA
    Advances of Monolithic silica columns for the rapid, sensitive, and highly efficient separation of Biomolecules
 14:2014:40  Cathy Lane, Sciex
    Sub ng/mL quantification and characterization of oligonucleotides in plasma using microflow LC coupled to a novel QTOF mass spectrometer
 14:4015:00 Heike Wiese, Nuvisan
    Enzyme activity assays using LC-MS
 15:0015:20 Delphine Maux, Syneos Health
    Non liquid matrix analysis: challenge and approaches
     
 14:0015:20 Session 3: New Modalities (in parallel with session 2)
 14:0014:20 Anna Laurén, on behalf of the EBF
    Applying Context-of-Use to qPCR Method Validation and Analysis: A Recommendation from EBF
 14:2014:40 Marianne Scheel Fjording, BioAgilytix
    Bioanalytical assay strategies for immunogenicity assessment of new modalities
 14:4015:00 Niels Nijstad, QPS
    The development of a hybridization ECLIA assay for the determination of the payload of a oligonucleotide-antibody conjugate
 15:0015:20 Johannes Stanta, on behalf of the EBF C&GT team
    EBF Feedback on ICH S12
     
 15:0016:20 Coffee break
     
 16:0018:00 Session 4: Workshop – Remote inspections by Health Authorities  – experiences and challenges (in parallel with session 5)
 16:0016:20 Tsvetelina Ivanova, on behalf of the EBF
    Regulatory framework for Remote HA inspection: an overview
 16:2016:40 Robert Nelson, on behalf of the EBF
    Practical considerations and challenges from industry
 16:4017:00 Iain Love, Charles River Laboratories
    1.5y into remote HA inspections – learning together
 17:0017:20 Martijn Baeten, Sciensano (Belgian Institute for Health)
    On: Experience and learnings from remote inspections.
 17:2017:50 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
 17:5018:00 Wrap up – preparing to continue the discussion at  the December Workshop
     
 16:2018:10 Session 5: Workshop – Biomarkers – Organisational design driving CoU (in parallel with session 4)
 16:2016:40 Kyra Cowan, on behalf of the EBF
    Organisational design driving CoU – feedback from pre-meeting survey
 16:4018:00 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
 18:0018:10 Wrap up
     
 18:0019:00 Day 1 reception – tentative –  Covid-19 restrictions permitting
     
     
Day 2: 25 November 2021
     
 08:0010:00 Breakfast buffet in Conference Area
     
 10:0011:40 Session 6: Microsampling – recent technological developments – patient centric trials (in parallel with session 7)
 10:0010:20 Franck Saint-Marcoux, Limoges University Hospital – for Shimadzu
    Measurement of tacrolimus in dried blood spots: a fully automated sample preparation and LCMS method
 10:2010:40 Bryan van den Broek, Sanquin Diagnostiek
    Home sampling as alternative to venepuncture: results, patient experience and implementation
 10:4011:00 Remco Koster, ICON
    Analytical evaluation of a device for volumetric absorptive microsampling for whole blood sampling from the upper arm
 11:0011:20 Liesl Heughebaert, U-Ghent
    Hematocrit prediction of DBS: current status and future outlook
 11:2011:40 Michele Protti, U-Bologna
    Advanced blood and tissue microsampling for biomarker investigation of neurodegenerative diseases
     
 10:2012:00 Session 7: Immunogenicity Technology and Applications (in parallel with session 6)
 10:2010:40 Annelies Turksma, Sanquin Diagnostiek
    Robust multi parameter immunomonitoring; Polyfunctional T cell analysis by FluoroSpot
 10:4011:00 Samuel Pine, Ablynx, a Sanofi company
    Accessible, adaptable and automated: having it all with an immunogenicity cut-point calculator
 11:0011:20 Laura Geary, LGC
    The importance of characterising critical reagents with a focus on bio-conjugated reagents
 11:2011:40 Sam Willcox, Labcorp Drug Development
    Development of an anti-PEG antibody assay for assessing immunogenicity of PEGylated proteins and lipid nanoparticles
 11:4012:00 Issa Jyamubandi, LGC
    Challenges of developing an ADA assay for Bispecific antibody therapeutic and further ADA characterisation
     
 11:4013:40 Lunch break
     
 13:4015:20 Session 8: Biomarker – Technology and Applications (in parallel with session 9)
 13:4014:00 Petia Doytcheva, Celerion
    A fully automated method for CD34+ cells enumeration by flow cytometry in stabilized whole blood
 14:0014:20 David Bettoun, Larimar Therapeutics
    Development of NanoString Gene Expression Assays for Studying Frataxin-sensitive Gene Markers in Clinical Samples
 14:2014:40 Kyra Gelderman, Sanquin Diagnostiek
    Biomarker assays: a take on optimization and validation in a regulated bioanalysis lab
 14:4015:00 Thomas Antoine, Ablynx, a Sanofi company
    Trust but verify: optimization of a multiplex cytokine kit to monitor preclinical CRS
 15:0015:20 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
     
 14:0015:40 Session 9: LBA/CBA – Technical Challenges (in parallel with session 8)
 14:0014:20 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
 14:2014:40 Sarah-Jane Kellmann, Bio-Rad Laboratories
    Faster Generation of Anti-Drug Antibodies using SpyTag Technology
 14:4015:00 Richard Hughes, LGC
    Pushing the limits of PK analysis: can we meet BMV PK criteria with high sensitivity LBAs
 15:0015:20 John Chappell, Gyros Protein Technologies
    Advances in ADA, PK, and biomarker immunoassays to meet demands for assay speed and performance
 15:2015:40 Birgitte Stoevring, SVAR Life Science
    Functional potency assay feasibility of therapeutics and new modality drug candidate targeting the complement cascade.
     
 15:2016:20 Coffee break
     
 16:2018:00 Session 10: Immunogenicity Strategies (in parallel with sessions 11 and 12)
 16:2016:40 Michaela Golob, on behalf of the EBF
    Immunogenicity Strategies: cross-industry, cross-functional approaches to understand immunogenicity potential from discovery through launch
 16:4017:00 Annelies Coddens, Argenx
    Immunogenicity strategies across programs: risk-based approaches and challenges
 17:0017:20 Yvonne Katterle, Bayer
    How immunogenicity risk assessment can translate into an immunogenicity testing strategy
 17:2018:00 panel discussion
     
 16:4018:20 Session 11: Protein MS – Applications and EBF update (in parallel with sessions 10 and 12)
 16:4017:00 Dominic Foley, Waters
    Analysis of SARS-CoV-2 using LC-MS Peptide Enrichment for Clinical Research
 17:0017:20 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
 17:2017:40 Richard Lucey, LGC
    Missed cleavages in bottom-up protein LC-MS workflows: ‘Breaking Bad’-ly cleaved surrogate peptides
 17:4018:00 Matthew Barfield, on behalf of the EBF
    Status update from EBF Protein MS team
 18:0018:20 2021 BRSA winner
    Winner will be announced on stage
     
 16:2018:10 Session 12: Data (in parallel with sessions 10 and 11)
 16:2016:40 Presenter from the team, on behalf of the vendor-neutral secure data transfer team
    Solution towards a vendor-neutral and secure transfer of data between LIMS and Instruments
 16:4017:00 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)
 17:0017:20 Oriol Peris, Charles River Laboratories
    Impact of the data variability due to different patterns of bioanalytical bias – Pharmacokinetic assessment through simulation
 17:2017:40 Luca Ferrari, on behalf of the EBF
    EBF feedback to industry and FDA on FDA Bioanalytical Method Template
 17:4018:10 Panel Discussion on FDA Bioanalytical Method Template
     
 18:1019:00 Day 2 reception – tentative –  Covid-19 restrictions permitting
     
     
Day 3: 26 November 2021
     
 08:0010:00 Breakfast buffet in Conference Area
     
 09:4011:00 Session 13: the patient (in parallel with session 14)
 09:4010:00 Julian Freen-van Heeren, Sanquin Diagnostiek
    Investigating antibody effector mechanisms: how to monitor (unwanted) effects of your therapeutic antibodies
 10:0010:20 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
 10:2010:40 Floris Loeff, Sanquin Diagnostiek
    TDM of biologics reassures clinicians in personalised dosing
 10:4011:00 Coral Munday, LGC
    Cryoactivation, CRESS, and the Importance of Preanalytics
     
 10:0011:20 Session 14: NAb – Strategies and applications (in parallel with session 13)
 10:0010:20 Maija Pfenniger, Celerion
    How to deal with the challenges of NAb assays: case studies evaluated
 10:2010:40 Johannes Stanta, Freeline therapeutics
    Novel approaches for a neutralising anti-capsid assay to detect pre-existing antibodies
 10:4011:00 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)
 11:0011:20 Q&A and sharing experience on NAb strategies by the audience
     
     
 11:0012:00 Coffee break
     
 12:0012:10 Feedback from Workshop Session 4: Remote HA inspections (Plenary)
     
 12:1012:20 Feedback from Workshop Session 5: Biomarkers – Organisational design driving CoU (Plenary)
     
 12:2014:15 Session 15: The future of BA – our ethical responsibility to the community (Plenary)
 12:2012:40 Connor Walker, on behalf of the EBF-YSS community
    Sustainable Bioanalysis: Where are we now, where are we going?
 12:4013:00 Coral Munday, on behalf of the EBF-YSS community
    How Covid-19 impacted our day to day work – learnings for the future
 13:0014:00 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
     
 14:0014:15 Closing remarks – Adjourn