EBF
EBF Open Symposium
EBF Barcelona
EBF 6th Open Meeting
Moving Forward Together
Hesperia Tower Conference Centre
Barcelona, Spain
November 20-22, 2013

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

 

Day 1  – Wednesday 20 NOV 2013

z
PLENARY SESSION
z
08.30-08.35  Welcome
z
08.35-10.30  Assay transfer – Expectations & Practicalities
 Cheryl McAlpine (Merck-Millipore) 
 Challenges in assay transfer of complex assay formats
 Fabienne Deckert-Salva (Novartis) 
 Outsourcing and assay transfer strategies for biologics programs
 Graeme Smith (Huntingdon Life Sciences) 
 Fit for purpose method transfer
 Ronald de Vries (Janssen R&D) 
 Janssen strategy for bioanalytical assay transfer
 Steve White (GlaxoSmithKline) 
 Assay cross validation – Recent experiences in transfering bioanalytical assays from
 sponsor to CRO partners and between CROs
 Panel Discussion
z
10.30-11.00  Coffee break
z
11.00-12.15  From biomarker to diagnostics or personalized medicine: 
 is there a role for regulated bioanalysis?
 John Mills (AstraZeneca) 
 Delivering on the Promise of Personalized Healthcare
 Suntje Sander and Peter van Amsterdam (Abbott) 
 Successful treatment of maldigestion due to pancreatic exocrine insufficiency: 
 diagnosis, clinical picture and the challenges of measurements involved
 Joan-Carles Arce and Birgitte Buur Rasmussen (Ferring) 
 Individualized dosing regimen for fertility treatment based on a biomarker
 (Not released for publication)
z
12.15-12.45  Bioanalysis Young Investigator Award
 Peter van Amsterdam (on behalf of EBF) 
 Announcing the Young Investigator Award Winner
 Young Investigator (TBD)
 Young Investigator Award Winning Presentation
z
12.45-14.00  Lunch break
z
14.00-15.35  Interpretation and implementation of guidance on haemolysed / 
 hyperlipedemic plasma and co-administrated drugs
 Benno Ingelse (on behalf of EBF TT-15) 
 How to deal with haemolysed and hyperlipidaemic samples: an EBF perspective
 Fabio Garofolo (Algorithme Pharma) 
 Criteria for performing a scientifically meaningful lipemic plasma test during
 LC-MS/MS bioanalytical method validation (BMV): which type to choose?
 Martina Wein (Boehringer-Ingelheim) 
 How to investigate in the influence of hyperlipidemic samples on bioanalytical assays
 Tom Verhaeghe (Janssen R&D) 
 Co-stability assessment for fixed dose combinations: an additional burden to
 bioanalytical method validation
 Berthold Lausecker (on behalf of EBF TT-31) 
 Interaction compounds & comedication testing
 Panel Discussion
z
15.35-16.15  Coffee break
z
16.15-18.00  Peptide and protein analysis with LC-MS
 Nico van de Merbel (RUG) 
 The usefulness of LC-MS as a platform for protein quantification:
 from theory to practice
 Rand Jenkins (PPD Inc) 
 Application of LC-MS/MS and LBA methods in concert for bioanalysis of 
 monoclonal antibody oncology drugs and associated soluble target receptors
 William van Dongen (TNO Triskelion) 
 Low ng/ml bioanalysis of monoclonal antibody therapeutics using immuno 
 extraction and LC-MS
 Anders Sonesson (Ferring) 
 LC-MS/MS bioanalysis of peptides – How to manage non specific binding?
 Mireia Fernandez Ocaña (Pfizer) (Not released for publication)
 Sensitive peptide immunoaffinity LC-MS/MS quantification 
 of a membrane-bound target receptor from clinical biopsies
 Erin Chambers (Waters) 
 Ultra-sensitive simultaneous LC-MS/MS quantification of human insulin, glargine, lispro,
 aspart, detemir and glulisine in human plasma using 2D-LC and a novel high efficiency column
z
18.00-19.00  Cocktail reception
z

Day 2  – Thursday 21 NOV 2013

z
08.30-10.30  SPOTLIGHT WORKSHOP: CONTINUED DEVELOPMENTS IN DBS
 Philip Timmerman (on behalf of the EBF Consortium) 
 Introduction and recap of EBF Recommendation on DBS
 Bert Ooms (Spark Holland) 
 Towards unbiased Dried blood spot analysis using temperature-enhanced flow-
 through desorption coupled online to solid phase extraction and mass spectrometry
 Kevin Bateman (Merck & Co.) (Not released for publication)
 Dried blood spot (DBS) sample collection for drug development: recent experience at Merck
 Jack Henion (Quintiles Bioanalytical and ADME Labs) (Not released for publication)
 Recent Developments in Dried Plasma Spot Analysis Using a Novel Red Blood Cell Filtration Card
 Ynze Mengerink (Chemelot) 
 New Ht independent dried blood spot cards
 Workshop discussion (coffee will be served in workshop room)
 Moderator: Steve White (on behalf of the EBF Consortium)
z
13.30-15.40  SPOTLIGHT WORKSHOP: DEFINING RAW DATA IN REGULATED BIOANALYSIS
 -Introduction to the Workshop: categorizing raw data
 -Proposed way forward on ‘Organization/system related Data (non-laboratory)’
 -Proposed way forward on ‘Non-study related Data (general laboratory equipment/tools)’
 -Proposed way forward on ‘Study related Data (non-laboratory)’
 -Proposed way forward on ‘Study related Data (laboratory)’
 -Discussion
 -Prerequisites for successful use of e-data (in regulated bioanalysis)
z
16.15-18.00  SPOTLIGHT WORKSHOP: IS VALIDATION REALLY NEEDED FOR ALL ASSAYS:
 TAKING TIERED APPROACH OUTSIDE THE WORLD OF MIST
 Philip Timmerman (on behalf of EBF) 
 The MIST concept taken beyond metabolite quantification: overview of
 EBF discussions on applying tiered approach
 Jaap Wieling (QPS) 
 Can we validate an assay for a biomarker that we have not identified ?
 Vera Hillewaert 
 A complex problem: what (and how) should we quantify?
 Neil Henderson (AstraZeneca) 
 Characterising the performance of in situ hybridisation (ISH) methodologies in
 order to demonstrate fit-for-purpose assays for clinical deployment
 Panel Discussion
z
BREAKOUT SESSIONS SMALL MOLECULES / CHROMATOGRAPHY BASED
z
08.30-10.00  Consult the doctor
 Alex Muntendam (ABL) 
 Positive control group samples in a toxicity study. Now what?
 Ann Lévesque (inVentiv Health clinical) 
 How problematic situations can become positive ones: case studies of bioanalytical Issues
 David Neville (Quotient Bio Analytical Sciences) 
 Non-specific binding, Non-linearity or Nonsense?
 Iain Love (Huntingdon Life Sciences) 
 Viewing the big picture through a keyhole: providing context to Bioanalytical challenges
 Nico van de Merbel (PRA) 
 Blood is no plasma: failing long-term frozen stability results for cyclosporin A in diluted whole blood
 First Aid: last minute submitted cases (Panel)
z
10.45-12.30  Interpretation and implementation of Guidance expectations: 
 Internal Standard variability
 Olivier Le Blaye (ANSM) 
 Examples of IS variations seen during inspections
 Aimin Tan (BioPharma Services Inc) 
 Leveraging Successful Troubleshooting Experiences for the Prevention or
 Reduction of Internal Standard Response Variations during LC-MS Bioanalysis
 John Allanson (Unilabs York Bioanalytical Solutions) 
 Challenges and solutions in the application IS variability criteria
 Luc Bouchard (inVentiv Health clinical) 
 Internal standard variation during routine sample analysis: investigation of case studies
 Steve White (on behalf of EBF TT-07) 
 Dealing with internal standard variability – Towards a recommendation
 Panel Discussion
z
12.45-14.00  Lunch break
z
14.00-15.40  Innovative applications in sampling & extraction
 Kathryn Chapman (NCR3s) 
 Overcoming the barriers for uptake of microsampling techniques in regulatory toxicology
 Stephen Williams (Charles River) 
 Small samples, large molecules and bigger benefits
 Neil Spooner (GlaxoSmithKline) 
 Latest developments in microsampling for regulated quantitative bioanalysis
 Craig Aurand (Supelco/Sigma-Aldrich)  (withdrawn)
 Investigation of solid phase micro extraction as an alternative to dried blood spot
 Ranbir Mannu (Covance) 
 Development of a capillary micro-sample bioanalytical method for quantification of
 an phosphorothioated 18-mer oligonucleotide in human plasma using LC-MS/MS
z
15.40-16.15  Coffee break
z
16.15-17.55  Innovative applications in separation & quantification
 Gert Hendriks (PRA) 
 Old school derivatization in modern LC-MS analysis
 Jim Settlage (inVentiv Health clinical) 
 The re-emergence of GC-MS/MS as a tool for the analysis of small molecule biomarkers
 Paul Rainville (Waters) 
 Critical evaluation of common sample preparation techniques for bioanalysis
 on microfluidic LC/MS performance
 Lester Taylor (Agilent Technologies) 
 High-Throughput SPE-MS/MS – A Viable Approach For Validated Bioanalytical Analysis?
 Sega Ndiaye (Innate Pharma / Proteomic Platform Innovation Technologic
 Timone PIT2) – Shimadzu 
 Free MMAE toxin quantitation by triple quadrupole in Antibody drug Conjugate analysis
z
BREAKOUT SESSIONS LARGE MOLECULES / LIGAND BINDING BASED
z
08.30-10.00  Analysis of parallelism for biomarkers and therapeutic proteins
 Edwin Janssen (on behalf of EBF TT-35) 
 Validation of ligand-binding assays: the Importance parallelism
 Clare Kingsley (Associate Director) 
 A Global view on paralelism.
 Ulrich Kunz (Boehringer-Ingelheim) 
 Case studies of non-parallelism in various biomarker assays
 Bruno Boulanger (Arlenda)  (Not released for publication)
 How to develop and assess the parallelism in a bioassays: a fit-for-purpose strategy
 Panel Discussion
z
10.00-10.45  Coffee break
z
10.45-12.30  Challenges for flow cytometry in regulated bioanalysis
 Barry van der Strate (on behalf of EBF TT-32) 
 Short introduction the increased use of flow cytometry to support clinical studies
 Minesh Patel (Merck-Millipore) 
 Challenges for Flow Cytometry in regulated Bioanalysis
 Nora Bachmayer (Crucell) 
 Encountered challenges during the standardization of the ICS assay
 Robin Longdin (Quotient Bio Analytical Sciences) 
 Challenges for flow cytometry in regulated Bioanalysis;
 quality assurance and regulatory considerations
 Virginia Litwin (Covance) 
 Analytical Method Validation: Perspectives from the Flow Cytometry Action
 Programming Committee of the AAPS
 Panel Discussion
z
12.30-14.00  Lunch break
z
14.00-15.30  Interferences & surprises ligand binding assay method development
 Helen Young (Quotient Bio Analytical Sciences) (Not released for publication)
 Implementation of Critical Reagent Monitoring in a Clinical Laboratory
 Martin Nemansky (PRA) (Not released for publication)
 Guidelines at work – Examples of theoretical considerations versus practical
 solutions in Immunogenicity assays
 Matthew Bentley (Merck-Millipore) (Not released for publication)
 Immunogenicity analysis challenges and solutions for PEGylated biopharmaceuticals
 Roland Staack (F. Hoffmann-La Roche) (Not released for publication)
 Free analyte QC concept – a novel approach for qualification/validation of free drug assays
 Open Discussion
z
15.40-16.15  Coffee break
z
16.15-18.00  Analytical challenges of antibody-drug conjugates (ADCs)
 Bernhard Beckermann (Bayer) 
 Introduction to ADC Bioanalysis
 Steffen Groß (Paul-Ehrlich-Institut) 
 Regulatory expectations for the characterisation of ADCs
 Stefanie Fischmann (AbbVie) (Not released for publication)
 Strategy for bioanalysis of ADCs along project development stages
 Marie-Hélène Pascual (Sanofi) 
 Selective immunoassay of the naked antibody as a new tool for pharmacokinetic
 interpretation of an antibody drug conjugate
 Jasja Wolthoorn (TNO Triskelion) 
 Novel Platform Using LC-MS and Ligand Binding Assays for Characterization and
 PK analysis of ADCs
 Panel discussion
z

Day 3  – Friday 22 NOV 2013

z
BREAKOUT SESSIONS
z
08.30-10.20  Promises of new technology: sense and nonsense of HR-MS
 Suma Ramagiri (AB SCIEX) 
 ADC quantitation using HRMS
 Lieve Dillen (Janssen R&D) s68 B3-HRMS-2 Lieve Dillen EBF_BCN2013_LDIL
 High resolution mass spectrometry for bioanalysis at Janssen.
 Current experiences and future perspectives
 Mark Wrona (Waters) 
 Moving forward on Quan-Qual, perspectives on using TOFs for bioanalytical work
 Mohammed Abrar (Unilabs York Bioanalytical Solutions) 
 The comparison of high resolution MS with triple quadrupole MS for the analysis of oligonucleotides
 Hongxia Wang (Thermo Fisher Scientific) (Not released for publication)
 Quantification of protein biotherapeutics by a universal LC-high resolution/accurate
 mass based approach: intact protein or proteolytic peptides?
 z
08.30-10.20  Issues & solutions in sample logistics
 Jose Groenboom (on behalf of EBF TT-12) 
 Sample logistics: problems and solutions in multi-center clinical trials
 Rebecca Sleigh (on behalf of EBF TT-12) 
 Proposed generic lab manual
 Scott Vincent (A4P Consulting) 
 Bio-logistical considerations in planning and executing early phase bioanalytical components
 Jean-Guy de Gruben (World Courier) 
 Issues within the context of Clinical Trials Logistics. Practical examples and solutions
 Bärbel Wilke (LKF – Laboratorium für Klinische Forschung) 
 Logistics within a Central Laboratory – From Specimen Receipt to Result Reporting
 Introducing the Focus Workshop
z
10.20-11.00  Coffee break
z
PLENARY SESSIONS
z
11.00-14.15  2013 draft FDA Guidance for Industry on Bioanalytical Method Validation –
 preparing for Crystal City V
 -Each session will consist of a short introduction summarizing the EBF consolidated
   comments on the draft Guidance on the specific chapter, followed by plenary discussion.
 -Timing of the sessions is indicative and depends on extent of comments.
 -Introduction and background
 -Chromatographic methods
 -Ligand Binding Assays
 -Incurred Sample Reanalysis
 -Additional issues: endogenous compounds, biomarkers, diagnostic kits and new technologies
 -Documentation and glossary
 -Wrap up
z
14.15-14.30  Plans for 2014 and adjourn