BCN Slides 2015
Program of EBF 8th Open Conference “Into New Territories – Explore, Learn and Apply” November 18-20, 2015
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-similars
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 (not released for publication)
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 (not released for publication)
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
