EBF Open Symposium
EBF Barcelona

Imagine! - A New Bioanalytical Earthrise

Hesperia Hotel
Barcelona, Spain
20 - 22 November 2019


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 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  
  Jason Wakelin-Smith and 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.  
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  
WS 2: e-Environment / Data Integrity – with contributions from Andrew Gray (MHRA) and Jason Wakelin-Smith (MHRA)   
WS 3: Biomarkers  
WS 4: Automation  
WS 5: qPCR current application in bioanalysis– in collaboration with the JBF (incl. Asako Uchiyama, SNBL Japan presenting on behalf ot the JBF)  
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) Feedback from US Bioanalytical community  
  Order and timing of contributions will be decided by all presenters shortly prior the meeting
  Case studies 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