EBF
EBF Open Symposium
EBF Barcelona
EBF 8th Open Meeting
Into New Territories - Explore, Learn and Apply
EBF 2nd YSS
Hesperia Tower Conference Centre
Barcelona, Spain
November 17, 2015
YSS
November 18-20, 2015
Open Symposium

Program at a glance

A detailed program of each session can be found below and by clicking on the session.

Day 0 – Tuesday 17 nov 2015

 

14:00 19:00 Registration desk opens
16:00 19:00 Platinum Sponsors reception – Foyer
Day 1 – Wednesday 18 nov 2015

 

 Plenary sessions (in auditorium)                                        Workshops                                                                
08:30 08:40 Welcome
08:40 10:40 Biomarker Assay Validation Strategies
10:40 11:20 Coffee break
11:20 13:00 Proteins by LC-MS
13:00 14:10 Lunch break
14:10 15:30 LC-MS & LBA – two true values 14:10 15:30 Generic Data Transfer Agreement
15:30 16:10 Tea break 15:30 16:10 Tea break
16:10 17:50  Analytical Challenges for Novel Constructs 16:10 17:50 CRO-Pharma Partnerships
18:00 19:00 Cocktail reception
Day 2 – Thursday 19 nov 2015

 

 Break out sessions (in auditorium)                                 

 

 Break out sessions (in Jupiter)                           

 

08:30 10:10 Going Paperless 08:30 10:10 Biomarkersn & Flow Cytometry
10:10 11:00 Coffee break 10:10 11:00 Coffee break
11:00 12:40 Large Molecule LC-MS Applications 11:00 12:40 New Territories Applied
12:40 14:00 Lunch break 12:40 14:00 Lunch break
14:00 15:40 Microsampling – Where are we Today? 14:00 15:20 Biomarker Applications
15:40 16:20 Tea break 15:20 16:20 Tea break
16:20 18:00 Advances in Separation & MS 16:20 17:40 Varying Perspectives on ADAs
18:00 19:00 Cocktail reception incl. celebration of 2015 EBF Best Poster
Day 3 – Friday 20 nov 2015

 

 Plenary sessions (in auditorium)                                                                                                                                  
09:00 10:40 Dealing with issues in Clinical Studies
10:40 11:20 Coffee break
11:20 13:00 Scientific Validation
13:00 13:10 Plans for 2016 / Close out

Program details

Day 1 – Wednesday 18 nov 2015

 

Plenary session (in auditorium)                                                                                                          
 
08:30 08:40 Welcome
 
08:40 10:40 Biomarker Assay Validation Strategies
 
08:40 09:10 Keynote Speaker: David Perrett, St. Barts Hospital
Validating Biomarkers in the Clinic: Is it possible?
09:10 09:30 Patrick Bennett, PPD
Biomarkers: not just another bioanalytical challenge
09:30 09:45 Christian Herling, on behalf of the EBF TT-50 Clinical analysers
Clinical Analysers – feedback from EBF topic team
09:45 10:00 Philip Timmerman, on behalf of the EBF
EBF Position on need for tegulations in Biomarker Assay validation
10:00 10:20 Marianne Scheel-Fjording, on behalf of the EBF
Feedback from the AAPS Crystal City VI meeting on Biomarkers
10:20 10:40 Panel Discussion
 
10:40 11:20 Coffee Break
 
11:20 13:00 Proteins by LC-MS
 
11:20 11:40 Rand Jenkins, on behalf of the AAPS Bioanalytical Focus Group’s Protein
LC-MS Bioanalysis Subteam
Recommendations for validation of LC-MS/MS bioanalytical methods for protein
biotherapeutics
11:40 12:00 Erin Chambers, Waters
Practical Considerations for LC/MS Bioanalysis of Proteins via the Surrogate
Peptide Approach and Intact Analysis
12:00 12:20 Mike Oliver, Thermo Scientific
Improvement in full workflow capabilities to provide increased reproducibility, speed and throughput for quantitation and characterisation for bio-similars
12:20 12:40 Matt Ewles, Covance
High throughput, robust and cost-effective LC-MS/MS strategies for quantification of therapeutic monoclonal antibodies in human and animal plasma, to support clinical and preclinical studies
12:40 13:00 Ichiro Hirano, Shimadzu
Selective quantification of therapeutic monoclonal antibodies in blood by nano-surface and molecular-orientation limited (nSMOL) proteolysis using LC-MS/MS
 
13:00 14:10 Lunch break
 
14:10 15:30 LC-MS & LBA – two true values!
 
14:10 14:30 Nico van de Merbel, PRA Health Sciences
Why do LC-MS and LBA results differ? A literature evaluation.
14:30 14:50 Daniela Stoellner, on behalf of the EBF TT-20: 
Challenges of total and free macromolecule quantification.  An update
14:50 15:10 Carsten Krantz, Novartis 
LC-MS for large molecules vs. Ligand Binding Assays-orthogonal readout or contradictory methods?
15:10 15:30 Roland Staack, F. Hoffmann-La Roche
Towards a differentiated PK Analysis for a better understanding of PK/PD/Safety relationship – Challenges and Technologies
 
15:30 16:10 Tea break
 
 16:10 17:50 Analytical Challenges for Novel Constructs
 
 16:10 16:30 Neil Henderson, AstraZeneca
Establishing strategies to meet the bioanalytical needs of Oligonucleotide Therapeutics in Pre-clinical Models and beyond
 16:30 16:50 Lieve Dillen, Janssen R&D
Challenges with a LCMS method for quantification of an oligonucleotide
16:50 17:10 Rand Jenkins, PPD
Direct Bioanalysis of ADCs using Affinity Capture-LC-HR/AMS Techniques for Characterization and Quantification—a Progress Update
 17:10 17:30 Jonathan St-Germain, Algorithme
Bioanalysis of PEGylated proteins using hybrid LBA/LCMS Method
 17:30 17:50 Winner of the 2015 – Bioanalysis YIA award: Xiwei (Emmi) Zheng
Analysis of Solute-Protein Binding in Solution by Ultrafast Affinity Extraction and Affinity Microcolumns
 18:00 19:00 Cocktail reception

 

Workshops                                                                                                                                               
14:00 15:20 Workshop 01:  Generic Data Transfer Agreement
 
14:00 14:20 Jose Groenboom – Nieuwenhuijzen, on behalf of the EBF TT-12: Clinical Multi Center Trials
Introduction: towards a generic data transfer agreement
14:20 14:40 Martina Wein, Boeringer Ingelheim
Introduction: towards a generic data transfer agreement
14:40 15:20 Workshop discussion
 
16:10 17:50 Workshop 02: CRO-Pharma Partnerships
 
16:10 16:30 Vera Hillewaert and Matthew Barfield, on behalf of the EBF
Importance of Innovation in Pharma-CRO scientific interface – Feedback from the EBF Focus Workshop on Optimizing the Pharma CRO scientific interface in bioanalysis.
16:30 16:50 Chris Jones, LGC
Enhancing the CRO-Pharma relationship with a focus on method transfer.
16:50 17:50 Workshop discussion

 

Day 2 – Thursday 19 nov 2015

 

Break out session (in auditorium)                                                                                                      
 .
08:30 10:10 Going Paperless
 
08:30 08:50 Tom Verhaeghe, Janssen R&D
eLN goes GLP: the journey of implementing an eLN system in a regulated environment –  experiences at the bioanalytical lab of Janssen Research and Development.
08:50 09:10 Peter Pruim, PRA Health Sciences
Towards a paperless laboratory – a CRO perspective
09:10 09:30 Gerhard Noelken, Allotrope
How the outcome of the combined EBF/ Allotrope Electronic Data Group can drive implementation of the Allotrope Framework in the Bioanalytical Laboratory?
09:30 09:50 David Van Bedaf , on behalf of the EBF – eData  team
EBF – Allotrope Collaboration: towards a common standard on e-data for real.
09:50 10:10 Panel discussion
 
10:10 11:00 Coffee break
 
11:00 12:40 Large Molecule LC-MS Applications
 
11:00 11:20 Michael Blackburn, Covance
‘’How low can you go:  Driving down limits of quantitation for peptide biomolecules by hybrid IA-LC/MS’
11:20 11:40 Ann Lévesque, InVentivHealth
Hybrid LBA-LC/MS/MS assays:  From the new technologies to the high throughput implementation
11:40 12:00 Matt Barfield, GlaxoSmithKline
Utilising automation for complex protein assays to increase robustness and reduce cycle times
12:00 12:20 Richard Kay, LGC
Developing LC-MS/MS methods for quantifying mAbs: Transitioning from pre-clinical to clinical matrices.
12:20 12:40 Suma Ramagiri, ABSciex
A Functionalized Assay – Hyphenating LBA with LC/MS: How far can we push to accomplish anything meaningful?
12:40 14:00 Lunch break
 
14:00 15:40 Microsampling – Where are we Today?
 
14:00 14:20 Sara Capiau, Ghent University
Different strategies for coping with the hematocrit effect in dried blood micro-sampling.
14:20 14:40 Shinobu Kudoh, Shimadzu Techno-Research
Introduction of MSW2, a handy and facile device specialized for serum and plasma microsampling
14:40 15:00 Hans Stieltjes, Janssen R&D
Experiences with (non-)capillary microsampling in preclinical GLP studies
15:00 15:20 Steve White, on behalf of the EBF LMS Consortium
Update from the EBF Liquid Microsampling Consortium
15:20 15:40 Panel Discussion
15:40 16:20 Tea break
 
16:20 18:00 Advances in Separation & MS
 
16:20 16:40 Liesbeth Vereyken, Janssen R&D
Ultra high sensitivity bioanalyis by 2D-microUHPLC to overcome ion suppression with large volume injections.
16:40 17:00 Mohammed Abrar, Unilabs
UPC2 for Bioanalysis – “Providing Diversity for Chromatographic Separation”
17:00 17:20 Walid Elbast, Novartis 
Novel quantitative approach for biodistribution of drug-related compounds in tissues using micro Liquid Chromatography – Liquid Extraction Surface Analysis – tandem Mass Spectrometry (mLC-LESA-MS/MS)
17:20 17:40 Lester Taylor, Agilent
2D LC/Q-TOF and SFC/QQQ for Stereospecific Drug Metabolite Analysis
17:40 18:00 Diego Rodriguez Cabaleiro, Waters
Applications of novel acquisition modes and instrument geometries in Time-of-Flight Mass Spectrometer for Targeted Quantitation
18:00 19:00 Cocktail reception incl. celebration of 2015 EBF Best Poster

 


Break out session (in Jupiter)                                                                                                           
   
08:30 10:10 Biomarkersn & Flow Cytometry
   
08:30 08:50 Afshin Safavi, BioAgilytix
Assay and Kit Lot Bridging Considerations for Multiplex Biomarker Analysis in Support of Preclinical and Clinical Studies
08:50 09:10 Robert Nelson, NovImmune
Fit-for-purpose inflammatory biomarker assay development and validation
09:10 09:30 John Allinson, LGC
Multiplexed Biomarker Methods – Platforms, methods and special considerations for method validation
09:30 09:50 Jennifer Hincks, Envigo
Flow Cytometry Biomarker Assays, Validation Criteria vs. Biology.
09:50 10:10 Kurt Sales, Charles River
Development and Validation of in vitro flow cytometry-based assays for preclinical immunology.
 
10:10 11:00 Coffee break
 
11:00 12:40 New Territories Applied
 
11:00 11:20 Adrian Pereira, GlaxoSmithKline
The Challenges associated with Dermal Dosing to Humans and Plasma Analysis for a Novel therapeutic agent when administered to Healthy Volunteers
11:20 11:40 Esther van Duijn, TNO
Excellent linearity between automated CO2 combustion AMS and (low level) liquid scintillation counting for plasma, blood, urine and feces samples
11:40 12:00 Jonathan Stauber, ImaBiotech
MALDI Imaging application from preclinical to clinical stages
12:00 12:20 Karen Woods, AstraZeneca
Challenges and Strategies for  Bioanalysis following Nanoparticle drug delivery
12:20 12:40 Feedback from 2nd YSS
& Winner 2nd YSS best presentation: James Howard (LGC)
YSS Organizing Commitee presenter
 
12:40 14:00 Lunch break
 
14:00 15:20 Biomarker Applications
 
14:00 14:20 Raymond Farmen, Celerion
Further refinement and validation of the only ultrasensitive biomarker method for benzo[a]pyrene exposure by urinary metabolite.
14:20 14:40 Richard Hughes, LGC
Sample volume – does it need to restrict your biomarker strategy?
14:40 15:00 Sven Pötzsch, Merck 
Bioanalysis of Metabolic Biomarkers during Drug Discovery and Early Preclinical Development – Challenges and Solutions
15:00 15:20 Martine Broekema,  PRA Health Sciences
Immuno-PCR (Imperacer®) in a GLP-Regulated Environment – Examples and Lessons Learned
 
15:20 16:20 Tea break
 
16:20 17:40 Varying Perspectives on ADAs
 
16:20 16:40 Nicolas White, MedImmune
CBA, LBA or NA – Regulatory Sense on Non-Sense
16:40 17:00 Gregor Jordan, F. Hoffmann-La Roche
Development of a bioanalytical method for the characterization of immune complexes
17:00 17:20 Lydia Michaut, Novartis
Anti-Vector antibody assays for gene therapy projects: analytical challenges
17:20 17:40 Ludovicus Staelens, UCB BioPharma
Approach to simultaneous detection, (semi-)quantification and isotyping of ADA in plasma samples by LC-MS/MS

 

Day 3 – Friday 20 nov 2015

 


Plenary session (in auditorium)                                                                                                         
    
09:00 10:40 Dealing with issues in Clinical Studies
    
09:00 09:20 Jose Groenboom – Nieuwenhuijzen, PRA Health Sciences
A phase III sample analysis study: challenges and solutions
09:20 09:40 Katja Heinig, F. Hoffmann-La Roche
Stability Issues in Bioanalysis: New Case
09:40 10:00 Brigitte Pellerin, InVentivHealth
Bioanalytical Issues when Dealing with Phase II/III Studies
10:00 10:20 Timothy Sangster, on behalf of the EBF TT-45: Defining the right control matrix
What Matrix, Which Matrix!
10:20 10:40 Daniela Stoellner, Novartis
Incidence of drug treatment in placebo subjects – how bioanalytics helped to understand this case
 
10:40 11:20 Coffee break
   
11:20 13:00 Scientific Validation
   
11:20 11:40 Eva Lindqvist, AstraZeneca
A journey from Exploratory to Regulatory Bioanalysis
11:40 12:00 Yoshihisa Sano (Sunplanet/Eisai, on behalf of the Japan Bioanalysis Forum)
Tiered Approach to Metabolite Quantification: An Outcome from JBF Discussion Group
12:00 12:20 Faye Vazvaei, F. Hoffmann-La Roche
Feedback from the 2015 AAPS Open Forum
12:20 12:40 Philip Timmerman, on behalf of the EBF
EBF Tiered approach final recommendation of Scientific Validation criteria
12:40 13:00 Panel Discussion
 .
13:00 13:10 Plans for 2016 / Close Out