EBF
EBF Open Symposium
EBF Barcelona

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

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The agenda will become available end of June. We invite you to send an abstract before 24 May 2018

Agenda at a glance  (click on the session for the details)
     
Day 1 – Wednesday 20 NOV 2019
     
    Plenary session
09:00 10:40  – Day 1-01 Auditorium (Implement): Ready for Launch
     
    Coffee break  – General Poster Session
     
    Plenary session
11:30 12:40  – Day 1-02 Auditorium (Influence): New (draft) regulations – (potential) areas of biggest impact
     
    Lunch break
     
    Breakout sessions
14:00 15:50  – Day 1-03 Auditorium (Innovate): Patient Centric Sampling
14:00 15:00  – (NEW): EBF Satellite Session Day 2-01 Aquila (Inspire): CRO – Pharma Collaboration
     
    Coffee break  – Poster Focus 1
     
    Breakout sessions
16:40 18:00 (NEW): Launch Pad sessions:
     – Session 1: Innovate.
     – Session 2:  Imagine
     – Session 3:  Inspire.
     
18:00 19:00 Complementary Cocktail Reception
     
Day 2 – Thursday 21 NOV 2019
     
    Breakout sessions
08:30 10:10  – Breakout session Day 2-01 Auditorium (Implement): e-environment
08:30 10:10  – Breakout session Day 2-01 Jupiter (Innovate): Critical Reagents
     
    Coffee break  – Poster Focus 2
     
    Breakout sessions
11:00 12:40  – Day 2-02 Auditorium (Innovate): Taking Tech to the Moon and Back
11:00 12:40  – Day 2-02 Jupiter (Innovate/Inspire): Planet Immunogenicity
11:00 12:00  – (NEW): EBF Satellite session Day 2-02 Aquila (Innovate): Microsampling Applications
     
    Lunch break
     
    Parallel Workshops
14:00 15:30  – WS 1: Practical Application of FDA & EMA ADA Guidelines
     – WS 2: Microsampling: New Devices and Novel Challenges
     – WS 3: e-Environment WS on Data Integrity – Building Common Understanding for Future System Solutions
     – WS 4: Supporting Cell & Gene Therapies (CGT) in the Bioanalytical Laboratory
     – WS 5: qPCR in Regulated Bioanalysis
     
    Coffee break  – Poster Focus 3
     
    Breakout sessions
16:20 18:20  – Day 2-03 Auditorium (Influence/Inspire): Immunogenicity Strategies
16:20 18:20  – Day 2-03 Jupiter (Innovate/Implement): Other Tools to Reach the Moon
16:20 17:20  – (NEW): EBF Satellite session Day 2-03 Aquila (Inspire): Different Challenges
     
18:20 19:00 Complementary Cocktail Reception
     
     
Day 3 – Friday 22 NOV 2019
     
    Breakout sessions
09:00 10:40  – Day 3-01 Auditorium (Innovate/Implement): Further Applications of Mass Spectrometry
09:00 10:40  – Day 3-01 Jupiter (Inspire/Influence): Biosimilars
     
    Coffee break  – poster focus 4
     
    Plenary session
11:30 13:00  – Day 3-02 Auditorium (Innovate):  Cell & Gene Therapies
12:50 13:00  – Closing remarks: Safe Landing
     
  13:00 Adjourn
     
     
     
Agenda details:
     
Day 1 – Wednesday 20 NOV 2019
     
08:45 09:00 Welcome
     
09:00 10:40 Plenary session Day 1-01 (Implement): Ready for launch
     
09:00 09:20 Philip Timmerman, EBF
    Imagine: from Apollo 8 to bioanalysis today
09:20 09:40 Nils Boehm, Abbvie
    Automation in a regulated bioanalytical lab – experience from a five-year journey from a manual to a 100% automated workflow
09:40 10:00 Arundhuti Sen, GlaxoSmithKline
    Automated workflows for ligand-binding assays:  strategies for streamlined method development and rapid sample processing
10:00 10:20 Presenter identified
    Title TBD
10:20 10:40 Michael Gröschl, Celerion
    Implementation of laboratory automation in a CRO environment – from basic steps to advanced solutions
     
10:40 11:30 Coffee break – General Poster Session
     
11:30 12:50 Plenary session Day 1-02 (Influence): New (draft) Regulations – (potential) Areas of Biggest Impact
     
11:30 11:50 Tom Verhaeghe, on behalf of EBF
    ICH M10 cross validation & documentation: what now?
11:50 12:10 Steve White, on behalf of EBF
    ICH – other areas of biggest impact
12:10 12:30 Rob Nelson, on behalf of EBF
    Did the FDA BMV change our view of biomarker validations?
12:30 12:50 MHRA contribution – awaiting confirmation
    Title TBD
     
12:50 14:00 Lunch break
     
14:00 15:50 Plenary session Day 1-03 (Innovate): Patient Centric Sampling
     
14:00 14:20 Kevin Bateman, MSD
    From Innovation to Implementation: Overcoming Challenges in Patient Centric Sampling in Clinical Trials
14:20 14:40 Lieve Dillen, Janssen R&D
    The journey of microsampling in preclinical and clinical development
14:40 15:00 Remco Koster, PRA Health Sciences
    Volumetric absorptive microsampling in a hospital setting: are we there yet?
15:00 15:20 Michele Protti, University of Bologna
    Microsampling for the therapeutic drug monitoring of eating disorder patients under antidepressant treatment
15:20 15:40 Neil Spooner, on behalf of AAPS
    An Update from the Community on Microsampling and Patient Centric Sampling – Turning Imagination into Reality
     
14:00 15:00 (NEW): EBF Satellite session Day 2-01 Aquila (Inspire): CRO – Pharma Collaboration
     
14:00 14:20 Debbie McManus, LGC
    Challenges in standardizations and collaborations for CROs: understanding the lifecycles of evolving immunogenicity assays
14:20 14:40 Maria Heijer, AstraZeneca
    Continued Strides to “Get it Right”—Further Tales of True Collaboration in Bioanalysis in the Covance Laboratory Partnership
14:40 15:00 Emmanuel Desmartin, Eurofins Amatsi Analytics
    A CRO perspective of the Pharma-CRO relationship
     
15:40 16:40 Coffee break  – Poster Focus 1
     
16:40 18:00 (NEW) Launch Pad sessions:
    Capitalising on the theme of the conference, we have included 3 strategic parallel discussion sessions. In each of the sessions, we start with a keynote speaker. From there we will engage the audience around some key questions on the challenges our industry faces today.
     
    Session 1 –  Innovate:
    In this session we will focus on innovation as a result of interaction/collaborations between Pharma/CRO and  academia/vendors (Auditorium)
    Session 2 – Imagine:
    In this session we will on the risk/value of doing things differently (Jupiter)
    Session 3 –  Inspire:
    In this session we will focus on how adjacent areas of drug development and our stakeholders can inspire us to ensure our deliverable meets their scientific expectations (Aquila)
     
18:00 19:00 Complementary Cocktail Reception
     
     
Day 2 – Thursday 21 NOV 2019
     
08:30 10:10 Breakout session Day 2-01 Auditorium (Implement): e-Environment
     
08:30 08:50 Cecilia Arfvidsson, on behalf of EBF
    EBF and the e-environment: The Journey Continues
08:50 09:10 MHRA contribution confirmed
    Presenter and title TBC
09:10 09:30 Scott Davis, PPD
    Data Integrity On Large Networks
09:30 09:50 Micha van Hout, PRA Health Sciences
    PRA’s Approach to Data Integrity – Scoring, Risks, Assessment and Implementation
09:50 10:10 Carina Ekström, Ferring Pharmaceuticals
    How to ensure long-term readability of your electronic data/records when you decommission your LC-MS system?
     
     
08:30 10:10 Breakout session Day 2-01 Jupiter (Innovate): Critical Reagents
     
08:30 08:50 Susanne Pihl, on behalf of EBF
    EBF Feedback on ADA critical reagents
08:50 09:10 Matt Horsham, LGC
    Positive Thinking: The Use of “Brain Power” in Positive Control Selection for ADA
09:10 09:30 Chris Jones, AstraZeneca
    Use of the Affinity Module on the Gyrolab Platform to Inform and Assess Critical Reagent Selection during Method Development and Beyond.
09:30 09:50 Matt Johnson, Avacta Life Sciences
    Improved PK and Drug Monitoring Tools with the Affimer® Platform
09:50 10:10 Olivier Heudi, Novartis
    Will plastic antibodies revolutionize the bioanalysis?
     
10:10 11:00 Coffee break  – Poster Focus 2
     
11:00 12:40 Breakout  session Day 2-02 Auditorium (Innovate): Taking Tech to the Moon and Back
     
11:00 11:20 Jan Hellemans, Biogazelle (on behalf of Bio-Rad)
    The potential of ddPCR for clinical research
11:20 11:40 Gregor Jordan, Roche Diagnostics GmbH
    Bioanalytical characterization of formed high molecular weight protein complexes to successfully support a clinical trial
11:40 12:00 Charles River Laboratories
    Title to be confirmed
12:00 12:20 Patrick Brennecke, Celerion
    Tracing Biomarkers  with the top edge technologies Luminex, MSD and SIMOA
12:20 12:40 Martine Broekema, PRA Health Sciences
    Efficient set-up of a cell-based neutralizing antibody assay using a flow cytometry-based Receptor Occupancy assay format
     
11:00 12:40 Breakout session Day 2-02 Jupiter (Innovate/Inspire): Planet Immunogenicity
     
11:00 11:20 Louise Jørgensen, Novo Nordisk
    Anti-drug antibody analysis in non-clinical samples – a simplified strategy offering sufficient support for interpretation of toxicology studies
11:20 11:40 James Lawrence, Covance Huntingdon
    No Cut-point, no cry- Validating pre-clinical ADA assays without generating a statistical cut-point.
11:40 12:00 Riejanne Bax-Seigers, PRA Health Sciences
    A solution to overcome interference in a method to measure anti-drug antibodies
12:00 12:20 Darshana Jani, Pfizer
    Strategies for Clinical assessment of immunogenicity for Emerging Modalities including Multidomain Therapeutics, Oligonucleotides and Gene Therapy
12:20 12:40 Anna Laurén, on behalf of EBF
    Current and future considerations for Neutralising antibody assays
     
     
11:00 12:00 (NEW): EBF Satellite session Day 2-02 Aquila (Innovate): Microsampling Applications
     
11:00 11:20 Elizabeth Osborne, LGC
    Challenges with extensive sample pre-treatment in a microsampling study
11:20 11:40 Annick de Vries, Sanquin Diagnostic Services
    Support PK and ADA of biologics using finger prick sampling; a comparison of multiple devices which are on the market to sample capillary blood or serum
11:40 12:00 Jeff Plomley, Altasciences
    The Application of Impact-Assisted Extraction to Overcome Hematocrit Recovery Bias and Age-Related Extractability in Mitra® Volumetric Absorptive Microsampling: Towards a Universal Sample Preparation Approach
     
12:40 14:00 Lunch break
     
14:00 15:30 Again, we will host 5 parallel workshops. In each of these short workshops, the workshop moderators will prepare  a discussion around themes relevant to our industry today. More details on the questions asked and anticipated deliverable for each of these workshops will be shared as we move closer to the meeting.
     
    WS 1: Practical application of FDA & EMA ADA Guidelines
    Moderators = Joanne Goodman (AstraZeneca) and Michaela Golob (Nuvisan)
    Workshop includes following presentations:
     – Sebastien Boridy, Charles River Laboratories
    How low is too low: assessing cut points in anti-drug antibody assay validation based on recommendations in the Final FDA guidance
     – Floris Loeff, Sanquin Research
    Multi-tiered versus semi-quantitative single-tiered immunogenicity testing in real-life datasets
     
    WS 2: Microsampling: New Devices and Novel Challenges
    Moderators = Matthew Barfield (GlaxoSmithKline)/Kevin Bateman (MSD)
     
    WS 3: e- Environment WS on Data Integrity – Building Common Understanding for Future System Solutions
    Moderators = Cecilia Arfvidsson (AstraZeneca)/Magnus Knutsson (Ferring Pharmaceuticals)
     
    WS 4: Supporting Cell & Gene Therapies in the Bioanalytical Laboratory
    Moderators =  Johannes R Stanta (Covance) / Timothy Sangster (Charles River Laboratories)
     
    WS 5: qPCR in regulated bioanalysis
    Moderators =  Chris Cox (PsiOxus)/Milena Blaga (Charles River Laboratories)/Robert Nelson (Novimmune)
     
     
15:30 16:20 Coffee break break  – Poster Focus 3
     
16:20 18:20 Breakout session Day 2-03 Auditorium (Influence/Inspire): Immunogenicity Strategies
     
16:20 16:40 Heather Myler, on behalf of the AAPS
    ADA Validation Testing and Reporting Harmonization Recommendations
16:40 17:00 Joao Pedras-Vasconcelos, FDA
    Title TBC
17:00 17:20 Anna Laurén​, on behalf of EBF
    Preclinical Immunogenicity Assessment – When to include and what to include?
17:20 17:40 Omnia Ismaiel, PPD
    Is ADA by LBA/LC–MS/MS Realistic for Routine Analysis?  – “A Practical Rout for a Validated LCMS Assay“
17:40 18:20 Panel Discussion
     
     
16:20 18:20 Breakout session Day 2-03 Jupiter (Innovate/Implement): Other Tools to Reach the Moon
     
16:20 16:40 David Rowe, University of Southampton
    Optimising antimicrobial dosing with mid-infrared spectroscopy: a proof of concept study
16:40 17:00 Michael Blackburn, ARCINOVA
    New hybrid immuno-affinity mass spectrometric method for dosed or endogenous human insulin in clinical samples
17:00 17:20 Moon Jung, Waters
    A Systematic Approach for Improving the Recovery of Hydrophobic Peptides during LC-MS Analyses
17:20 17:40 Shuai Wu, Agilent
    Highly Selective Phosphopeptide Enrichment Workflow
17:40 18:00 Bioanalysis Zone
    Rising Star Award
18:00 18:20 Esther van Duijn, TNO
    AMS in drug development; The current situation within the regulatory space
     
16:20 17:20 (NEW): EBF Satelite session Day 2-03 Aquila (Inspire): Different Challenges
     
16:20 16:40 James Howard, LGC
    Development of a sensitive antibody drug conjugate free-payload methodology and its application within a preclinical micro-sampling study
16:40 17:00 Urs Duthaler, Basel University
    Pharmacokinetics and drug-drug interactions of ivermectin in yellow fever mosquitoes
17:00 17:20 Lee Boyling, Arcinova on behalf of the Gadolinium Based Contrast Agent Consortium
    Scientific Validation: A Case Study for Quantification of Gadolinium in Multiple Tissue Types Using One Tissue as the Calibration and QC Matrix
     
18:20 19:00 Complementary Cocktail Reception
     
     
Day 3 – Friday 22 NOV 2019
     
09:00 10:40 Breakout session Day 3-01 Auditorium (Innovate/Implement): Further Applications of Mass Spectrometry
     
09:00 09:20 Julien Peltier, GlaxoSmithKline
    An intact protein LC-MS assay for pharmacokinetic concentration determination of a mAb: validation experiments, sample results, and assay comparisons
09:20 09:40 Jordane Biarc, Atlanbio
    Pembrolizumab method validation in human serum: Comparison of Triple quadrupole and High resolution instrument.
09:40 10:00 Mohammed Abrar, BioApp Solutions Ltd
    The Use of High-Resolution MS for Bioanalysis: – “Are we There Yet”?
10:00 10:20 Michael Buonarati, Intertek Pharmaceutical Services
    Development and Validation of a LC-MS/MS Hybrid Assay using nSMOL for Bevacizumab Quantification in Human Serum
10:20 10:40 Naomi Teekamp, PRA Health Sciences
    LC-MS/MS quantification of M254, a hyper-sialylated endogenous IgG biotherapeutic: analytical pitfalls and solutions
     
09:00 10:40 Breakout session Day 3-01 Jupiter (Inspire/Influence): Biosimilars
     
09:00 09:20 Michaela Golob, Nuvisan
    Title TBD
09:20 09:40 Dominique Gouty,  BioAgilytix
    What the New AAPS White Paper Recommends for Development and Validation of ADA Assays in Support of Biosimilar Programs
09:40 10:00 Janka Ryding, SVAR Life Science (Wieslab)
    Design of Biosimilar Bioanalytical Programs – Assay Strategy perspectives
10:00 10:20 FDA speaker identified – awaiting confirmation
    Title TBC
10:20 10:40 EMA speaker identified – awaiting confirmation
    Title TBC
     
10:40 11:30 Coffee break  – Poster Focus 4
     
11:30 13:00 Plenary session Day 3-02 Auditorium (Innovate):  Cell & Gene Therapies
     
11:30 11:50 Speaker identified – awaiting confirmation
    Bioanalytical strategies to support CGT: a stakeholder perspective
11:50 12:10 Lisa Seavers, Covance Huntingdon
    Immunogenicity strategies for gene therapies
12:10 12:30 Fabrizia Fusetti, QPS
    Bioanalytical monitoring of gene therapy trials: methodologies for PK-PD assessment and patient eligibility
12:30 12:50 Johannes R Stanta, on behalf of EBF
    CGT discussion points from EBF
     
12:50 13:00 Closing remarks: Safe Landing
     
  13:00 Adjourn