15th EBF Open Symposium
Towards harmonised implementation of the ICH M10 Guideline
15 November 2022
The Bioanalytical Compass - Navigating to our True North
16-18 November 2022
Agenda 14th EBF Open Symposium
version 08SEP2021
Program at a glance- click on the session title to see the details of the session
Details of the sessions
- Additional presenters will be added when confirmed
- 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
- 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
- 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 | ||||
| 08:00 | 10:00 | Breakfast buffet in Conference Area | ||
| 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 | ||
| 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 | ||
| 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> 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 | ||
| 18:00 | 19:00 | Day 1 reception – tentative – Covid-19 restrictions permitting | ||
| Day 2: 25 November 2021 | ||||
| 08:00 | 10:00 | Breakfast buffet in Conference Area | ||
| 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 | ||
| 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 | ||
| 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 | 2021 BRSA winner | ||
| Winner will be announced on stage | ||||
| 16:20 | 18:10 | Session 12: Data (in parallel with sessions 10 and 11) | ||
| 16:20 | 16:40 | 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 | ||||
| 16:40 | 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 | ||
| 18:10 | 19:00 | Day 2 reception – tentative – Covid-19 restrictions permitting | ||
| 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 | ||
| 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 | ||
Sponsors
Copyright 2020 EBF
EBF vzw is the registered non-profit organisation of the European Bioanalysis Forum
Read more about EBF at our community site: www.e-b-f.eu