EBF
EBF Open Symposium
EBF Barcelona

EBF 11th Open Symposium: Raise the Anchor - Set Sail for Science

NH Collection Tower
Barcelona, Spain
21 - 23 November 2018

z

11th EBF Open Symposium

Raise the Anchor – Set Sail for Science

Day 0 – Tuesday 20 NOV 2018

 
16:00 – 19:00 Complementary Platinum sponsor cocktail reception
 
 

Day 1 – Wednesday 21 NOV 2018

 
08:40 – 09:00 Welcome
 
09:00 – 10:40 session Day 1-01: Cell & Gene Therapies
09:00 – 09:40 Invited keynote speaker from academia
  Theme: Current progress in Cell & Gene Therapies
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 Amanda Turner, Bio-Rad
Bioanalysis assays and tools for the development of CAR-T cell therapies
 
10:40 – 11:30 Coffee break 
 
11:30 – 12:50 session Day 1-02: Future Bioanalytical Landscape
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 session Day 1-03:  Practical Implementation of FDA 2018 BMV Guidance
In this session, we plan to focus on Industry’s first experience of bringing the 2018-FDA BMV Guidance into practice. EBF is gathering relevant experience from their member companies to share and discuss at the meeting. We have invited FDA- and US industry experts to help us implement the 2018-FDA Guidance as harmonized as possible.
14:00 – 15:20 Case studies or survey results
15:20 – 15:50 Panel Discussion
 
15:50 – 16:40 Coffee break – poster focus 1
 
16:40 – 18:00 (parallel-)session Day 1-04 Auditorium: Practical application of HRMS
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 (parallel-)session Day 1-04 Jupiter: Immunogenicity 1
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 Debbie McManus, 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 (parallel-)session Day 2-01 Auditorium: Biomarkers Strategies
08:30 – 08:50 presenter identified
awaiting title
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 (parallel-)session Day 2-01 Jupiter: Sample Handling
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 (parallel-)session Day 2-02 Auditorium: Scientific Validation/Fit for Purpose Round table
11:00 – 12:40 Hans Stieltjes (Janssen R&D), Martine Broekman (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.
  
11:00 – 12:40 (parallel-)session Day 2-02 Jupiter: New Technologies: LBA
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 Nina Deppisch, 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 On Thursday afternoon before the coffee break, again, we will host 5 parallel workshops. In each of these short workshops, together with the individual workshop moderators, the EBF Open Symposium Organizing Committee is preparing for a discussion around themes relevant to our industry today – see listing below. More details on the questions asked and anticipated deliverable for each of these workshops will be shared as we move closer to the meeting.
 
session Day 2-WS 1: Technology Development
session Day 2-WS 2: e-Environment / Data Integrity
session Day 2-WS 3: Biomarkers
session Day 2-WS 4: Automation
session Day 2-WS 5: qPCR current application in bioanalysis – in collaboration with the JBF
 
15:30 – 16:20 Coffee break – poster focus 3
 
16:20 – 18:00 (parallel-)session Day 2-03 Auditorium: LC-MS Technology Advances
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 Simple solution for complex analysis; an assessment of Heat-stable trypsin for surrogate peptide quantitation and characterisation workflows
Jon Bardsley, Thermo Fisher Scientific
17:20 – 17:40 Takashi Shimada, Shimadzu
Validated bioanalysis for therapeutic antibodies by LC-MS: Fab-selective proteolysis nSMOL
17:40 – 18:00 Bioanalysis New Investigator Award Winner
 
16:20 – 18:00 (parallel-)session Day 2-03 Jupiter: Biomarker Applications
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 Phillip Bartlett, 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 (parallel-)session Day 3-01 Auditorium: LC-MS Technical Applications
08:40 – 09:00 John Kellie, GlaxoSmithKline
Turning Multiple Assays into One: Strategic LC-MS Data Acquisition for Antibody Drug Conjugates.
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 (parallel-)session Day 3-01 Jupiter: Immunogenicity 2
08:40 – 09:00 Presenter identified
awaiting title
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 Presenter identified
awaiting title
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 – 11:10 Coffee break – poster focus 4
 
11:10 – 12:55 session Day 3-02 Auditorium: Regulatory Feedback on and/or interactions with EMA, MHRA, ICH
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 and (iv) status update on ICH M10
 
12:55 – 13:00 Plans for 2019 and Adjourn
 

 

 

Sponsors