European Bioanalysis Forum

BCN Slides 2018

Program of EBF 11th Open Conference  “Raise the Anchor – Set Sail for Science”  November  21-23, 2018

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 21 NOV 2018

08:40 – 09:00 Welcome
09:00 – 10:40 Day 1-01: Cell & Gene Therapies
  Session chair: Matthew Barfield (GlaxoSmithKline)
09:00 – 09:40 Steve Hyde, Radcliffe Department of Medicine, University of Oxford
  Cell & Gene Therapy, Where are we and where are we going?
09:40 – 10:00 Patrick Bennett, PPDi 
Exploring the Changing Bioanalytical Solutions in Gene and Cellular Therapies
10:00 – 10:20 Fiona Campbell, Charles River
When the Cell is the drug, challenges for Bioanalysis
10:20 – 10:40 Michael Schwenkert, Bio-Rad
Bioanalysis assays and tools for the development of CAR-T cell therapies
10:40 – 11:30 Coffee break 
11:30 – 12:50 Day 1-02: Future Bioanalytical Landscape
  Session chair: Magnus Knutsson (Ferring Pharmaceuticals)
11:30 – 11:50 Philip Timmerman, EBF
Future challenges for BioA
11:50 – 12:10 Hisanori Hara, Novartis
Acceptance criteria for method validation and sample analyses of a protein by LC-MS/MS
12:10 – 12:30 Matthew Barfield, on behalf of the EBF
Singlet or Duplicate analysis in LBA? 
12:30 – 12:50 Marianne Scheel Fjording, on behalf of the EBF
EBF Biomarker Strategies – a new deal?
12:50 – 14:00 Lunch break
14:00 – 15:50 Day 1-03:  Regulatory Feedback on and/or interactions with FDA, MHRA, ICH
Session chair: Steve White (GlaxoSmithKline)
In this session, we will discuss recent developments in the regulatory landscape. Invitations to HA representatives are in progress. Discussions will focus on (i) Industry experience with ambiguously interpreted chapters/paragraphs of Bioanalytical Guidelines, (ii) FB from industry and regulators to understand regulatory feedback, (iii) GcLP and recent data integrity guidelines or expectations, (iv) status update on ICH M10 (as appropriate) and Feedback from regulatory discussions at the EBF Autumn Focus Workshop on Immunogenicity.
  contribution and themes – order and timing will be decided at the meeting
  Sriram Subramaniam, FDA
  Feedback on regulatry process
  Andrew Gray, MHRA
  Data Integrity and GcLP: the essence of the Guidelines and sharing of findings during inspections
  Jo Goodman, on behalf of the EBF
  Updates on the Immunogencity Guidelines (EMA/FDA) and feedback from regulatory discussions from the recent EBF Autumn Focus Workshop
  Philip Timmerman, EBF
  ICH M10: Updates on the process and progress
15:50 – 16:40 Coffee break – poster focus 1
16:40 – 18:00 Day 1-04 Auditorium: Practical application of HRMS
  Session chair: Johannes Stanta (Covance)
16:40 – 17:00 Richard Snell, GlaxoSmithKline
Jack of all Trades or Master of None? The Role of High Resolution Mass Spectrometry in Quantitative Bioanalytical Lab
17:00 – 17:20 Chris Beaver, Syneos Health
Assuring Quality and Consistency of Critical Reagents Using HRMS
17:20 – 17:40 Ils Pijpers, Janssen R&D
High resolution quantification in preclinical studies: impact evaluation of different data processing software packages.
17:40 – 18:00 Rob Wheller, LGC
Diversifying the bioanalytical toolkit for protein LC-MS: Improving selectivity with 2D-LC and HR-MS
16:40 – 18:00 Day 1-04 Jupiter: Immunogenicity 1
  Session chair: Joanne Goodman (MedImmune)
16:40 – 17:00 Barry van der Strate, on behalf of the EBF
Critical Reagents for ADA assays: an EBF perspective
17:00 – 17:20 Nicoline Videbæk, Novo Nordisk
Careful handling of sample pre-treatment in an antibody analysis assay determines how drug tolerance and sensitivity may be improved
17:20 – 17:40 Laura Coch, Envigo
Assay overkill:- Practical solutions for development and validation of fit-for-purpose pre-clinical immunogenicity assays
17:40 – 18:00 Jessica St Charles, MPI Research
Challenges of Immunogenicity Testing for Fusion Protein Biotherapeutics
18:00 – 19:00 Cocktail reception

Day 2 – Thursday 22 NOV 2018

08:30 – 10:10 Day 2-01 Auditorium: Biomarkers Strategies
  Session chair: Michaela Golob (Nuvisan)
08:30 – 08:50 Steve Piccoli (GlaxoSmithKline)
Consensus Framework for Assay Validation for Biomarker Qualification
08:50 – 09:10 Stephanie Traub, Cancer Research UK
Fit-for-purpose Biomarker validation of non-LBA assays and new technologies
09:10 – 09:30 Marianne Scheel Fjording, Novo Nordisk
Is the Biomarker World more simple after – Gold, Silver, Bronze?
09:30 – 09:50 Yoshinobu Yokota, SNBL on behalf of the JBF
Recommendations for regulated biomarker analysis using LBA kits
09:50 – 10:10 Panel Discussion
08:30 – 10:10 Day 2-01 Jupiter: Sample Handling
  Session chair: Matthew Barfield (GlaxoSmithKline)
08:30 – 08:50 Nico van de Merbel, PRA-HS
Instability of biological matrices and its effect on bioanalytical method performance
08:50 – 09:10 Sune Sporring, Novo Nordisk
When in-vivo sample handling issues cannot be predicted using spiked samples.
09:10 – 09:30 Annick de Vries, Sanquin
Support PK and ADA of biologics using finger prick sampling; a real-life example of infliximab in IBD-patients
09:30 – 09:50 Lisa Delahaye, Ghent University
Volumetric absorptive microsampling as an alternative sampling strategy for cerebrospinal fluid
09:50 – 10:10 Kevin Bateman, MSD
Smart Trials:  Assessment of At-Home Sampling and Digital Health Technologies in a Clinical Pilot Trial
10:10 – 11:00 Coffee break  – poster focus 2
11:00 – 12:40 Day 2-02 Auditorium: Scientific Validation/Fit for Purpose Round table
  Session chair: Philip Timmerman (EBF)
11:00 – 12:40 Hans Stieltjes (Janssen R&D), Martine Broekema (PRA-HS), James Lawrence (Envigo), Steve White (GlaxoSmithKline), Timothy Sangster (Charles River), Morten Anders Kall (Lundbeck)
Scientific Validation/Fit for Purpose Validation – Panel Discussion
In this session, a panel discussion will be held focusing on the key questions of practical implementation of Scientific Validation/Fit-for-Purpose. An expert panel of EBF leaders will prepare panel questions, give feedback on the hurdles and/or advantages they have seen based on their experience in the lab, with the end users of the data or with regulators. It is the intention to share the questions beforehand with all registered delegates in order to get maximum value from the session.
  Introduction to the session
  Martine Broekema, PRA-HS
  Morten Anders Kall, Lundbeck
  Timothy Sangster, CRL
  Hans Stieltjes, Janssen R&D
  Steve White, GlaxoSmithKline
11:00 – 12:40 Day 2-02 Jupiter: New Technologies: LBA
  Session chair: Robert Nelson (Novimmune)
11:00 – 11:20 Mikko Hölttä, Astra Zeneca
Pre-clinical bioanalytical strategies to support the hVEGF-A modified mRNA program (AZD8601)
11:20 – 11:40 Uwe Wessels, Roche
Application of the ProteinSimple ELLA platform for PK and ADA analysis in preclinical studies.
11:40 – 12:00 Eva Vieser, Amgen
High sensitive PK analysis of BiTE® molecules using SIMOA technology
12:00 – 12:20 Kees Mulder, PRA-HS
Implementation of an ultrasensitive Single Molecule Counting Immunoassay for determination of pharmacokinetics in a regulated environment
12:20 – 12:40 Bernd Potthoff, Novartis
Determination of a first in human dose at the minimum anticipated biological effect level with an in vitro receptor occupancy assay
12:40 – 14:00 Lunch break
14:00 – 15:30 In each of the short workshops, the EBF Open Symposium Organizing Committee together with the individual workshop moderators, has prepared discussions around themes relevant to our industry today. More details on the questions asked, anticipated deliverables for each of these workshops can be found on the conference website (program). The meeting rooms for the workshops will be posted in all areas of the venue. 
WS 1: Technology Development
– EBF Intro
– Shimadzu
– ThermoFisher
– Merck
– Janssen R&D
WS 2: e-Environment / Data Integrity 
EBF Intro
WS 3: Biomarkers
EBF intro and case studies
WS 4: Automation
– Mario Richter – Abbvie
– EBF Survey data
– Petra Struwe – Celerion
WS 5: qPCR current application in bioanalysis
  EBF intro and survey
  – Asako Uchiyama, SNBL Japan presenting on behalf ot the JBF
  – Lydia Michaut A – Novartis
15:30 – 16:20 Coffee break – poster focus 3
16:20 – 18:00 Day 2-03 Auditorium: LC-MS Technology Advances
  Session chair: Tim Sangster (Charles River)
16:20 – 16:40 Pegah Jalili, Merck KGaA
Optimization of Easy to Use Plate-based Immunoaffinity LC-MS/MS Workflow for Preclinical Monoclonal Antibody Quantification
16:40 – 17:00 Jordane Biarc, Atlanbio
Quantification of therapeutic antibodies in plasma for pre-clinical and clinical studies: Comparison of different technologies and protocols. 
17:00 – 17:20 Jon Bardsley, Thermo Fisher Scientific
Simple solution for complex analysis; an assessment of Heat-stable trypsin for surrogate peptide quantitation and characterisation workflows
17:20 – 17:40 Takashi Shimada, Shimadzu
Validated bioanalysis for therapeutic antibodies by LC-MS: Fab-selective proteolysis nSMOL
17:40 – 18:00 Jing Tu, PPDI
  Bioanalysis Rising Star Award Winner
16:20 – 18:00 Day 2-03 Jupiter: Biomarker Applications
  Session chair: Marianne Scheel Fjording (Novo Nordisk)
16:20 – 16:40 Yoshiaki Ohtsu, Astellas – on behalf of the JBF
Biomarker calibration standards in ligand binding assays: Feedback from JBF
16:40 – 17:00 Emmanuel Njumbe Ediage, Janssen R&D
Scientific validation of an LC-MS/MS method for coproporphyrin I and III as endogenous biomarkers for transporter-mediated Drug-Drug Interactions
17:00 – 17:20 James Beecroft, LGC
Problems that arise during long term biomarker studies
17:20 – 17:40 Michael Naughton, GlaxoSmithKline
Assessment of Parallelism in Biomarker Support: Strategies for application and real-life data interpretation
17:40 – 18:00 Laure Queyrel, Envigo
To sensitivity or too sensitivity.   Case studies on challenges and trends in bioanalytical assay sensitivity
18:00 – 19:00 Cocktail reception

Day 3 – Friday 23 NOV 2018

08:40 – 10:20 Day 3-01 Auditorium: LC-MS Technical Applications
  Session chair: Cecilia Arfvidsson (Astra Zeneca)
08:40 – 09:00 Organisers of the 5th EBF Young Scientist Symposium
To Bioanalysis and Beyond!
09:00 – 09:20 Omnia Ismaiel, PPDi
  LBA/LC–MS/MS methodology for Protein based therapeutics bioanalysis-Current and Evolving trends.
09:20 – 09:40 Marco Michi, Aptuit
Development of a hybrid assay for the quantification of a mAb drug in human serum at the low ng/mL levels.
09:40 – 10:00 Jeroen Kooistra, Charles River
Taking Insulin analysis to the next level, application of new science in advanced LC-MS based workflows.
10:00 – 10:20 Ian Edwards, Waters
Automated protein digestion: Does it add value?
08:40 – 10:20 Day 3-01 Jupiter: Immunogenicity 2
  Session chair: Michaela Golob (Nuvisan)
08:40 – 09:00 Lone Hummelshøj Landsy, Novo Nordisk
Stability of anti-drug antibodies in human samples
09:00 – 09:20 Rebecca O’Donnell, LGC
  The impact on biological variability when introducing improvements to assay sensitivity and drug tolerance for Immunogenicity assays
09:20 – 09:40 Alexander Poehler, Roche
Evaluation of potential biotin interference in immunogenicity testing
09:40 – 10:00 Lydia Michaut, Novartis
Determination the acceptance range of the titer positive control in clinical ADA assays: practical examples
10:00 – 10:20 Nick White, MedImmune
Just how low-a-level of ADA can you detect? And just because you can, does it mean you should?
10:20 – 11:00 Coffee break – poster focus 4
11:00 – 12:55 Day 3-02 Auditorium: Practical Implementation of FDA 2018 BMV Guidance
Session chair: Philip Timmerman (EBF)
In this session, we plan to focus on Industry’s first experience of bringing the 2018-FDA BMV Guidance into practice. From a recent survey, EBF delegates will present their current experience or share the ambiguities they have on 6 themes areas. We have invited FDA- and US industry experts to help us implement the 2018-FDA Guidance as harmonized as possible.
  EBF Case studies and/or survey results
  Presentations from Sriram Subramaniam (CDER-FDA) and Lakshmi Amaravadi (Shire/ AAPS) 
  Panel Discussion
12:55 – 13:00 Plans for 2019 and Adjourn
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