FOLLOW EBF ON:
Follow us on Twitter Follow us on Blogspot Follow us on Facebook

EBF 6th Open Meeting

Moving Forward Together



Register now

Hesperia Tower Conference Center

Barcelona, Spain

November 20-22 2013

Program at glance

A detailed program for each session can be found below, and by clicking on the sessions.

Day 1 overview - Wednesday 20 NOV 2013

  08.35h 10.30h   Assay transfer - Expectations & Practicalities
  10.30h 11.00h   Coffee break
  11.00h 12.15h   From biomarker to diagnostics or personalized medicine:
is there a role for regulated bioanalysis?
  12.15h 12.45h   Bioanalysis Young Investigator Award
  12.45h 14.00h   Lunch break
  14.00h 15.35h   Interpretation and implementation of guidance on haemolysed /
hyperlipedemic plasma and co-administrated drugs
  15.35h 16.15h   Coffee break
  16.15h 18.00h   Peptide and protein analysis with LC-MS
  18.00h 19.00h   Cocktail reception

Day 2 overview - Thursday 21 NOV 2013

 

Breakout Session


Spotlight Workshops

Small Molecules / Chromatography based

Large Molecules / Ligand Binding based

  08.30h 10.00h   Continued developments in DBS

  10.00h 10.45h   Coffee break
 




  12.30h 14.00h   Lunch break
  13.30h 15.40h   Defining raw data in regulated bioanalysis


  15.40h 16.15h   Coffee break
  16.15h 18.00h   Is validation really needed for all assays: taking tiered approach outside the world of MIST
  18.00h 19.00h   Cocktail reception. Including Best Poster Contest Winner
 
Spotlight workshops are organised in parallel to the conference sessions and have limited attendance capabilities. You will need to sign up at the registration desk to allow us to manage properly. Admission is included in the registration fee of the conference.
  08.30h 10.00h   Consult the doctor


  10.00h 10.45h   Coffee break
  10.45h 12.30h   Interpretation and implementation of Guidance expectations: Internal Standard variability
  12.30h 14.00h   Lunch break
  14.00h 15.40h   Innovative applications in sampling & extraction

  15.40h 16.15h   Coffee break
  16.15h 18.00h   Innovative applications in separation & quantification

 
18.00h

19.00h
 
Cocktail reception. Including Best Poster Contest Winner
  08.30h 10.00h   Analysis of parallelism for biomarkers and therapeutic proteins
  10.00h 10.45h   Coffee break
  10.45h 12.30h   Challenges for flow cytometry in regulated bioanalysis


  12.30h 14.00h   Lunch break
  14.00h 15.40h   Interferences & surprises ligand binding assay method development
  15.40h 16.15h   Coffee break
  16.15h 18.00h   Analytical challenges of antibody-drug conjugates (ADCs)


  18.00h 19.00h   Cocktail reception. Including Best Poster Contest Winner

Day 3 overview - Friday 22 NOV 2013

Breakout sessions

  08.30h 10.20h   Promises of new technology: sense and nonsense of HR-MS
  08.30h 10.20h   Issues & solutions in sample logistics

Plenary sessions

  10.20h 11.00h   Coffee break
  11.00h 14.15h   2013 draft FDA Guidance for Industry on Bioanalytical Method Validation - preparing for Crystal City V
  14.15h 14.30h   Plans for 2014 and adjourn



Details of the sessions

Day 1 - Wednesday 20 NOV 2013

Plenary session

  08.30h 08.35h   Welcome
  08.35h 10.30h   Assay transfer - Expectations & Practicalities
  08.35h 08.55h   Cheryl McAlpine (Merck-Millipore)
Challenges in assay transfer of complex assay formats
  08.55h 09.15h   Fabienne Deckert-Salva (Novartis)
Outsourcing and assay transfer strategies for biologics programs
  09.15h 09.35h   Graeme Smith (Huntingdon Life Sciences)
Fit for purpose method transfer
  09.35h 09.55h   Ronald de Vries (Janssen R&D)
Janssen strategy for bioanalytical assay transfer
  09.55h 10.15h   Steve White (GlaxoSmithKline)
Assay cross validation - Recent experiences in transfering
bioanalytical assays from sponsor to CRO partners and between CROs
  10.15h 10.30h   Panel Discussion
  10.30h 11.00h   Coffee break
  11.00h 12.15h   From biomarker to diagnostics or personalized medicine:
is there a role for regulated bioanalysis?
  11.00h 11.25h   John Mills (AstraZeneca)
Delivering on the Promise of Personalized Healthcare
  11.25h 11.50h   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
  11.50h 12.15h   Joan-Carles Arce and Birgitte Buur Rasmussen (Ferring)
Individualized dosing regimen for fertility treatment based on a biomarker
  12.15h 12.45h   Bioanalysis Young Investigator Award
  12.15h 12.20h   Peter van Amsterdam (on behalf of EBF)
Announcing the Young Investigator Award Winner
  12.20h 12.45h   Young Investigator (TBD)
Young Investigator Award Winning Presentation
  12.45h 14.00h   Lunch break
  14.00h 15.35h   Interpretation and implementation of guidance on haemolysed /
hyperlipedemic plasma and co-administrated drugs
  14.00h 14.20h   Benno Ingelse (on behalf of EBF TT-15)
How to deal with haemolysed and hyperlipidaemic samples: an EBF perspective
  14.20h 14.35h   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?
  14.35h 14.50h   Martina Wein (Boehringer-Ingelheim)
How to investigate in the influence of hyperlipidemic samples on bioanalytical assays
  14.50h 15.05h   Tom Verhaeghe (Janssen R&D)
Co-stability assessment for fixed dose combinations: an additional burden to bioanalytical method validation
  15.05h 15.20h   Berthold Lausecker (on behalf of EBF TT-31)
Interaction compounds & comedication testing
  15.20h 15.35h   Panel Discussion
  15.35h 16.15h   Coffee break
  16.15h 18.00h   Peptide and protein analysis with LC-MS
  16.15h 16.35h   Nico van de Merbel (RUG)
The usefulness of LC-MS as a platform for protein quantification: from theory to practice
  16.35h 16.55h   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
  16.55h 17.15h   William van Dongen (TNO Triskelion)
Low ng/ml bioanalysis of monoclonal antibody therapeutics using immuno extraction and LC-MS
  17.15h 17.30h   Anders Sonesson (Ferring)
LC-MS/MS bioanalysis of peptides - How to manage non specific binding?
  17.30h 17.45h   Mireia Fernandez Ocaña (Pfizer)
Sensitive peptide immunoaffinity LC-MS/MS quantification
of a membrane-bound target receptor from clinical biopsies
  17.45h 18.00h   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
  18.00h 19.00h   Cocktail reception

Day 2 - Thursday 21 NOV 2013

Spotlight Workshop: Continued developments in DBS

  08.30h 10.30h   Continued developments in DBS
  08.30h 08.40h   Philip Timmerman
(on behalf of the EBF Consortium)

Introduction and recap of EBF Recommendation on DBS
  08.40h 09.00h   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
  09.00h 09.20h   Kevin Bateman (Merck & Co.)
Dried blood spot (DBS) sample collection for drug development: recent experience at Merck
  09.20h 09.40h   Jack Henion (Quintiles Bioanalytical and ADME Labs)
Recent Developments in Dried Plasma Spot Analysis Using a Novel Red Blood Cell Filtration Card
  09.40h 10.00h   Ynze Mengerink (Chemelot)
New Ht independent dried blood spot cards
  10.00h 10.30h   Workshop discussion (coffee will be served in workshop room)
Moderator: Steve White (on behalf of the EBF Consortium)

Spotlight Workshop: Defining raw data in regulated bioanalysis

  13.30h 15.40h   Defining raw data in regulated bioanalysis
  13.30h 15.40h   Introduction to the Workshop: categorizing raw data
  13.40h 13.55h   Proposed way forward on 'Organization/system related Data (non-laboratory)'
  13.55h 14.10h   Proposed way forward on 'Non-study related Data (general laboratory equipment/tools)'
  14.10h 14.25h   Proposed way forward on 'Study related Data (non-laboratory)'
  14.25h 14.40h   Proposed way forward on 'Study related Data (laboratory)'
  14.40h 15.10h   Discussion
  15.10h 15.40h   Prerequisites for successful use of e-data (in regulated bioanalysis)
 

Spotlight Workshop: Is validation really needed for all assays: taking tiered approach outside the world of MIST

  16.15h 18.00h   Is validation really needed for all assays: taking tiered approach outside the world of MIST
  16.15h 16.35h   Philip Timmerman (on behalf of EBF)
The MIST concept taken beyond metabolite quantification: overview of EBF discussions on applying tiered approach
  16.35h 16.55h   Jaap Wieling (QPS)
Can we validate an assay for a biomarker that we have not identified ?
  16.55h 17.15h   Vera Hillewaert
A complex problem: what (and how) should we quantify?
  17.15h 17.35h   Neil Henderson (AstraZeneca)
Characterising the performance of in situ hybridisation (ISH) methodologies in order to demonstrate fit-for-purpose assays for clinical deployment
  17.35h 18.00h   Panel Discussion

Breakout sessions
Small Molecules / Chromatography based

  08.30h 10.00h   Consult the doctor
  08.30h 08.45h   Alex Muntendam (ABL)
Positive control group samples in a toxicity study. Now what?
  08.45h 09.00h   Ann Lévesque (inVentiv Health clinical)
How problematic situations can become positive ones: case studies of bioanalytical Issues
  09.00h 09.15h   David Neville (Quotient Bio Analytical Sciences)
Non-specific binding, Non-linearity or Nonsense?
  09.15h 09.30h   Iain Love (Huntingdon Life Sciences)
Viewing the big picture through a keyhole: providing context to Bioanalytical challenges
  09.30h 09.45h   Nico van de Merbel (PRA)
Blood is no plasma: failing long-term frozen stability results for cyclosporin A in diluted whole blood
  09.45h 10.00h   First Aid: last minute submitted cases (Panel)
  10.45h 12.30h   Interpretation and implementation of Guidance expectations: Internal Standard variability
  10.45h 11.05h   Olivier Le Blaye (ANSM)
Examples of IS variations seen during inspections
  11.05h 11.20h   Aimin Tan (BioPharma Services Inc)
Leveraging Successful Troubleshooting Experiences for the Prevention or Reduction of Internal Standard Response Variations during LC-MS Bioanalysis
  11.20h 11.35h   John Allanson (Unilabs York Bioanalytical Solutions)
Challenges and solutions in the application IS variability criteria
  11.35h 11.50h   Luc Bouchard (inVentiv Health clinical)
Internal standard variation during routine sample analysis: investigation of case studies
  11.50h 12.10h   Steve White (on behalf of EBF TT-07)
Dealing with internal standard variability - Towards a recommendation
  12.10h 12.30h   Panel Discussion
  12.45h 14.00h   Lunch break
  14.00h 15.40h   Innovative applications in sampling & extraction
  14.00h 14.20h   Kathryn Chapman (NCR3s)
Overcoming the barriers for uptake of microsampling techniques in regulatory toxicology
  14.20h 14.40h   Stephen Williams (Charles River)
Small samples, large molecules and bigger benefits
  14.40h 15.00h   Neil Spooner (GlaxoSmithKline)
Latest developments in microsampling for regulated quantitative bioanalysis
  15.00h 15.20h   Craig Aurand (Supelco/Sigma-Aldrich)
Investigation of solid phase micro extraction as an alternative to dried blood spot
  15.20h 15.40h   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
  15.40h 16.15h   Coffee break
  16.15h 17.55h   Innovative applications in separation & quantification
  16.15h 16.35h   Gert Hendriks (PRA)
Old school derivatization in modern LC-MS analysis
  16.35h 16.55h   Jim Settlage (inVentiv Health clinical)
The re-emergence of GC-MS/MS as a tool for the analysis of small molecule biomarkers
  16.55h 17.15h   Paul Rainville (Waters)
Critical evaluation of common sample preparation techniques for bioanalysis on microfluidic LC/MS performance
  17.15h 17.35h   Lester Taylor (Agilent Technologies)
High-Throughput SPE-MS/MS - A Viable Approach For Validated Bioanalytical Analysis?
  17.35h 17.55h   Sega Ndiaye (Innate Pharma / Proteomic Platform Innovation Technologic Timone PIT2) - Shimadzu
Free MMAE toxin quantitation by triple quadrupole in Antibody drug Conjugate analysis

Breakout sessions
Large Molecules / Ligand Binding based

  08.30h 10.00h   Analysis of parallelism for biomarkers and therapeutic proteins
  08.30h 08.50h   Edwin Janssen (on behalf of EBF TT-35)
Validation of ligand-binding assays: the Importance parallelism
  08.50h 09.10h   Ulrich Kunz (Boehringer-Ingelheim)
Case studies of non-parallelism in various biomarker assays
  09.10h 09.30h   Bruno Boulanger (Arlenda)
How to develop and assess the parallelism in a bioassays: a fit-for-purpose strategy
  09.30h 09.50h   Speaker to be confirmed
Title to be confirmed
  09.50h 10.00h   Panel Discussion
  10.00h 10.45h   Coffee break
  10.45h 12.30h   Challenges for flow cytometry in regulated bioanalysis
  10.45h 10.55h   Barry van der Strate (on behalf of EBF TT-32)
Short introduction the increased use of flow cytometry to support clinical studies
  10.55h 11.15h   Minesh Patel (Merck-Millipore)
Challenges for Flow Cytometry in regulated Bioanalysis
  11.15h 11.35h   Nora Bachmayer (Crucell)
Encountered challenges during the standardization of the ICS assay
  11.35h 11.55h   Robin Longdin (Quotient Bio Analytical Sciences)
Challenges for flow cytometry in regulated Bioanalysis; quality assurance and regulatory considerations
  11.55h 12.15h   Virginia Litwin (Covance)
Analytical Method Validation: Perspectives from the Flow Cytometry Action Programming Committee of the AAPS
  12.15h 12.30h   Panel Discussion
  12.30h 14.00h   Lunch break
  14.00h 15.30h   Interferences & surprises ligand binding assay method development
  14.00h 14.20h   Helen Young (Quotient Bio Analytical Sciences)
Implementation of Critical Reagent Monitoring in a Clinical Laboratory
  14.20h 14.40h   Martin Nemansky (PRA)
Guidelines at work - Examples of theoretical considerations versus practical solutions in Immunogenicity assays
  14.40h 15.00h   Matthew Bentley (Merck-Millipore)
Immunogenicity analysis challenges and solutions for PEGylated biopharmaceuticals
  15.00h 15.20h   Roland Staack (F. Hoffmann-La Roche)
Free analyte QC concept - a novel approach for qualification/validation of free drug assays
  15.20h 15.40h   Open Discussion
  15.40h 16.15h   Coffee break
  16.15h 18.00h   Analytical challenges of antibody-drug conjugates (ADCs)
  16.15h 16.35h   Bernhard Beckermann (Bayer)
Introduction
  16.35h 16.55h   Steffen Groß (Paul-Ehrlich-Institut)
Regulatory expectations for the characterisation of ADCs
  16.55h 17.10h   Stefanie Fischmann (AbbVie)
Strategy for bioanalysis of ADCs along project development stages
  17.10h 17.25h   Marie-Hélène Pascual (Sanofi)
Selective immunoassay of the naked antibody as a new tool for pharmacokinetic interpretation of an antibody drug conjugate
  17.25h 17.40h   Jasja Wolthoorn (TNO Triskelion)
Novel Platform Using LC-MS and Ligand Binding Assays for Characterization and PK analysis of ADCs
  17.40h 18.00h   Panel discussion

Day 3 - Friday 22 NOV 2013

Breakout sessions

  08.30h 10.20h   Promises of new technology: sense and nonsense of HR-MS
  08.30h 08.50h   Suma Ramagiri (AB SCIEX)
ADC quantitation using HRMS
  08.50h 09.15h   Lieve Dillen (Janssen R&D)
High resolution mass spectrometry for bioanalysis at Janssen. Current experiences and future perspectives
  09.15h 09.40h   Mark Wrona (Waters)
Moving forward on Quan-Qual, perspectives on using TOFs for bioanalytical work
  09.40h 10.00h   Mohammed Abrar (Unilabs York Bioanalytical Solutions)
The comparison of high resolution MS with triple quadrupole MS for the analysis of oligonucleotides
  10.00h 10.20h   Hongxia Wang (Thermo Fisher Scientific)
Quantification of protein biotherapeutics by a universal LC-high resolution/accurate mass based approach: intact protein or proteolytic peptides?
  08.30h 10.20h   Issues & solutions in sample logistics
  08.30h 08.50h   Jose Groenboom (on behalf of EBF TT-12)
Sample logistics: problems and solutions in multi-center clinical trials
  08.50h 09.10h   Rebecca Sleigh (on behalf of EBF TT-12)
Proposed generic lab manual
  09.10h 09.300h   Scott Vincent (A4P Consulting)
Bio-logistical considerations in planning and executing early phase bioanalytical components
  09.30h 09.50h   Jean-Guy de Gruben (World Courier)
Issues within the context of Clinical Trials Logistics. Practical examples and solutions
  09.50h 10.10h   Bärbel Wilke (LKF - Laboratorium für Klinische Forschung)
Logistics within a Central Laboratory - From Specimen Receipt to Result Reporting
  10.10h 10.20h   Introducing the Focus Workshop
  10.20h 11.00h   Coffee break

Plenary sessions

  11.00h 14.15h   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.
  11.00h 11.15h   Introduction and background
  11.15h 12.00h   Chromatographic methods
  12.00h 12.45h   Ligand Binding Assays
  12.45h 13.00h   Incurred Sample Reanalysis
  13.00h 13.30h   Additional issues: endogenous compounds, biomarkers, diagnostic kits and new technologies
  13.30h 14.00h   Documentation and glossary
  14.00h 14.15h   Wrap up
  14.15h 14.30h   Plans for 2014 and adjourn