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

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

Program details Open Symposium 2015

Day 1 – Wednesday 18 nov 2015   Plenary session (in auditorium)

08:40 10:20 Biomarker Validation Strategies

David Perrett, St. Barts Hospital
Validating Biomarkers in the Clinic: Is it possible?

Patrick Bennett, PPD
Biomarkers: not just another bioanalytical challenge

Christian Herling, on behalf of the EBF TT-50 Clinical analysers
Clinical Analysers – feedback from EBF topic team

Philip Timmerman, on behalf of the EBF
EBF Position on need for regulations in Biomarker validation

Marianne Scheel-Fjording, on behalf of the EBF
Feedback from the AAPS Vrystal City VI meeting on Biomarkers

11:00 12:40 Proteins by LC-MS

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

Erin Chambers, Waters
Practical Consideraations for LC/MS Bioanalysis of Proteins via the Surrogate Peptide Approach and Intact Analysis

Mike Oliver, Thermo Scientific
Improvement in full workflow capabilities to provide increased reproducibility, speed and throughput for quantitation and characterisation for bio-similarsos-2015-D1A2_3-Mike Oliver

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

Ichiro Hirano, Shimadzu
Selective quantification of therapeutic monoclonal antibodies in blood by nano-surface and molecular-orientation limited (nSMOL) proteolysis using LC-MS/MS

14:00 15:20 LC-MS & LBA – two true values!

Nico van de Merbel, PRA Health Sciences
Why do LC-MS and LBA results differ? A literature evaluation

Daniela Stoellner on behalf of the EBF TT-20:
Challenges of total and free macromolecule quantification.  An update

Carsten Krantz, Novartis
LC-MS for large molecules vs. Ligand Binding Assays-orthogonal readout or contradictory methods?

Roland Staack, F. Hoffmann-La Roche
Towards a differentiated PK Analysis for a better understanding of PK/PD/Safety relationship – Challenges and Technolo

16:10 17:50 Analytical Challenges for Novel Constructs

Neil Henderson, AstraZeneca
Establishing strategies to meet the bioanalytical needs of Oligonucleotide Therapeutics in Pre-clinical Models and beyond

Lieve Dillen, Janssen R&D
Challenges with a LCMS method for quantification of an oligonucleotide

Rand Jenkins, PPD
Direct Bioanalysis of ADCs using Affinity Capture-LC-HR/AMS Techniques for Characterization and Quantification—a Progress Update

Jonathan St-Germain, Algorithme
Bioanalysis of PEGylated proteins using hybrid LBA/LCMS Method

Winner of the 2015 – Bioanalysis YIA award: Xiwei (Emmi) Zheng
Analysis of Solute-Protein Binding in Solution by Ultrafast
Affinity Extraction and Affinity Microcolumns

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Workshops                                                                                                                                               

14:00 15:20 Workshop 01:  Generic Data Transfer Agreement

Jose Groenboom – Nieuwenhuijzen, on behalf of the EBF TT-12: Clinical Multi Center Trials
Introduction: towards a generic data transfer agreement

Martina Wein, Boehringer Ingelheim
Introduction to CDISC for the Bioanalyst

16:10 17:50 Workshop 02: CRO-Pharma Partnerships

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.

Chris Jones, LGC
Enhancing the CRO-Pharma relationship with a focus on method transfer.

Day 2 – Thursday 19 nov 2015,  Breakout session (in auditorium)                                                  .

08:30 10:10 Going Paperless                              

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

Peter Pruim, PRA Health Sciences
Towards a paperless laboratory – a CRO perspective

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?

David Van Bedaf , on behalf of the EBF – eData  team
EBF – Allotrope Collaboration: towards a common standard on e-data for real

11:00 12:40 Large Molecule LC-MS Applications

Michael Blackburn, Covance
‘’How low can you go:  Driving down limits of quantitation for peptide biomolecules by hybrid IA-LC/MS’

Ann Lévesque, InVentivHealth
Hybrid LBA-LC/MS/MS assays:  From the new technologies to the high throughput implementation

Matt Barfield, GlaxoSmithKline
Utilising automation for complex protein assays to increase robustness and reduce cycle times

Richard Kay, LGC
Developing LC-MS/MS methods for quantifying mAbs: Transitioning from pre-clinical to clinical matrices.

Suma Ramagiri, ABSciex
A Functionalized Assay – Hyphenating LBA with LC/MS: How far can we push to accomplish anything meaningful?

                                                                 

14:00 15:40 Microsampling – Where are we Today?

Sara Capiau, Ghent University
Different strategies for coping with the hematocrit effect in dried blood micro-sampling

Shinobu Kudoh, Shimadzu Techno-Research
Introduction of MSW2, a handy and facile device specialized for serum and plasma microsampling 

Hans Stieltjes, Janssen R&D
Experiences with (non-)capillary microsampling in preclinical GLP studies

Steve White, on behalf of the EBF LMS Consortium
Update from the EBF Liquid Microsampling Consortium     

16:20 18:00 Advances in Separation & MS

Liesbeth Vereyken, Janssen R&D
Ultra high sensitivity bioanalyis by 2D-microUHPLC to overcome ion suppression with large volume injections

Mohammed Abrar, Unilabs
UPC2 for Bioanalysis – “Providing Diversity for Chromatographic Separation”

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)

Lester Taylor, Agilent
2D LC/Q-TOF and SFC/QQQ for Stereospecific Drug Metabolite Analysis

Diego Rodriguez Cabaleiro, Waters
Applications of novel acquisition modes and instrument geometries in Time-of-Flight Mass Spectrometer for Targeted Quantitation

Break out session (in Jupiter)                                                                                                          

08:30 10:10 Biomarkersn & Flow Cytometry

Afshin Safavi, BioAgilytix
Assay and Kit Lot Bridging Considerations for Multiplex Biomarker Analysis in Support of Preclinical and Clinical Studies

Robert Nelson, NovImmune
Fit-for-purpose inflammatory biomarker assay development and validation

John Allinson, LGC
Multiplexed Biomarker Methods – Platforms, methods and special considerations for method validation

Jennifer Hincks, Harlan / Huntington Life Sciences
Flow Cytometry Biomarker Assays, Validation Criteria vs. Biology

Kurt Sales, Charles River
Development and Validation of in vitro flow cytometry-based assays for preclinical immunology

11:00 12:40 New Territories Applied

Adrian Pereira, GlaxoSmithKline
The Challenges associated with Dermal Dosing to Humans and Plasma Analysis for a Novel therapeutic agent when administered to Healthy Volunteers

Esther van Duijn, TNO
Excellent linearity between automated CO2 combustion AMS and (low level) liquid scintillation counting for plasma, blood, urine and feces samples

Jonathan Stauber, ImaBiotech
MALDI Imaging application from preclinical to clinical stages

Karen Woods, AstraZeneca
Challenges and Strategies for  Bioanalysis following Nanoparticle drug delivery

Feedback from 2nd YSS
& the Winner 2nd YSS best presentation: James Howard (LGC)
his presentation

14:00 15:20 Biomarker Applications

Raymond Farmen, Celerion
Further refinement and validation of the only ultrasensitive biomarker method for benzo[a]pyrene exposure by urinary metabolite

Richard Hughes, LGC
Sample volume – does it need to restrict your biomarker strategy?

Sven Pötzsch, Merck
Bioanalysis of Metabolic Biomarkers during Drug Discovery and Early Preclinical Development – Challenges and Solutions

Martine Broekema,  PRA Health Sciences
Immuno-PCR (Imperacer®) in a GLP-Regulated Environment – Examples and Lessons Learned

16:20 17:40 Varying Perspectives on ADAs

Nicolas White, MedImmune
CBA, LBA or NA – Regulatory Sense on Non-Sense

Gregor Jordan, F. Hoffmann-La Roche
Development of a bioanalytical method for the characterization of immune complexes

Lydia Michaut, Novartis
Anti-Vector antibody assays for gene therapy projects: analytical challenges

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

Jose Groenboom – Nieuwenhuijzen, PRA Health Sciences
A phase III sample analysis study: challenges and solutions

Katja Heinig, F. Hoffmann-La Roche
Stability Issues in Bioanalysis: New Case

Brigitte Pellerin, InVentivHealth
Bioanalytical Issues when Dealing with Phase II/III Studies

Timothy Sangster, on behalf of the EBF TT-45: Defining the right control matrix
What Matrix, Which Matrix!

Daniela Stoellner, Novartis
Incidence of drug treatment in placebo subjects – how bioanalytics helped to understand this case

11:20 13:00 Scientific Validation

Eva Lindqvist, AstraZeneca
A journey from Exploratory to Regulatory Bioanalysis

Yoshihisa Sano (Sunplanet/Eisai, on behalf of the Japan Bioanalysis Forum)
Tiered Approach to Metabolite Quantification: An Outcome from JBF Discussion Group

Faye Vazvaei, F. Hoffmann-La Roche
Feedback from the 2015 AAPS Open Forum (awaiting for permission)

Philip Timmerman, on behalf of the EBF
EBF Tiered approach final recommendation of Scientific Validation criteria

13:00 13:10 EBF 8th OS best poster and plans for 2016 / Close Out