Follow us on Twitter Follow us on Blogspot Follow us on Facebook

EBF 5th Open Meeting

Old Battles, New Horizons

Register now

Hesperia Tower Conference Center

Barcelona, Spain

November 14-16 2012

Notice on Global Harmonization

Post conference, EBF will organize a 2h session on the current status of the GBC discussions. In this session, we will engage with the audience to gather input on the items where the GBC harmonisation team require your input because of their importance to the bioanalytical community or their continued ambiguity.
The session will be from 14h00 to 16h00 on Friday Nov. 16th and entrance is free for conference delegates.

Day 0 – 13 November 2012

  14.00h 20.00h   Registration and Information desk open in hotel lobby

Day 1 – 14 November 2012

  7.00h 18.00h   Registration and Information desk open

Morning plenary

  8.30h 8.45h   Welcome and opening remarks
  8.45h 10.15h  

Increasing Challenges in Clinical Studies (Part I)

  8.45h 8.50h   Richard Abbott (on behalf of EBF)
  8.50h 9.20h   Richard Hucker (A4P Consulting Ltd)
Meeting the Bioanalytical Challenges of Global Multi-Centre Clinical Trials: Observations and Expectations
   9.20h 9.35h    Bernd Matthes (on behalf of the EBF Topic Team)
Outcome of EBF Survey on Multi-center Trials
  9.35h 9.55h   Vera Hillewaert (Janssen Research&Development)
Global Clinical Trials - Challenges for Bioanalysis
  9.55h 10.15h   Hanneke van Assche (Abbott)
Bioanalytical Challenges from a Clinical Perspective
  10.15h 11.00h   Coffee Break
  11.00h 12.30h  

Increasing Challenges in Clinical Studies (Part II)

   11.00h 11.20h    Carolyn Mailer (on behalf of EBF TT12)
Case Example Highlighting Multi-center Clinical Trial Issues
  11.20h 11.40h   Franck Picard (Novartis)
The Pre-Advance Platform: Sample Management and Processing by Mouse Click
  11.40h 11.55h   Katja Heinig (on behalf of the EBF Topic Team)
Stabilisation of Clinical Samples
  11.55h 12.15h
Philip Timmerman (on behalf of EBF)
EBF Recommendation on Method Establishment and Bioanalysis of Biomarkers in Support of Drug Development
  12.15h 12.30h   Discussion
  12.30h 14.00h   Lunch and poster session

Afternoon Plenary Sessions

  14.00h 16.00h  

A progress update since Large meets Small

  14.00h 14.20h   Nico van de Merbel  (PRA)
It’s only just begun: The Importance of Sample Preparation for Protein Quantification by LC-MS
  14.20h 14.40h   Kenneth Fountain (Waters) 
Challenges in the Development of a Bioanalytical Method for the Simultaneous Quantification of Synthetic Insulin Analogs in Human Plasma
  14.40h 15.00h   Lieve Dillen (Janssen Research&Development)
Bioanalysis of Peptides and Proteins in Drug Research and Development: from Strategy into Practice
  15.00h  15.20h    Michael Blackburn (Covance Laboratories Ltd)
Quantitation of a Therapeutic Insulin Analogue by Immuno-Affinity Extraction - LC-MS/MS
  15.20h 15.40h
Magnus Knutsson (on behalf of the EBF Topic Team)
EBF Experiences on LC-MS/MS Analysis of Large Molecules
  15.40h 16.00h   Discussion
  16.00h 16.30h   Coffee break
  16.30h 18.00h  

Technology updates I

   16.30h 17.00h    Richard Kay (Quotient Bioresearch)
Development of an Immunoprecipitation and LC-MS/MS based Method for Quantifying the 105 kDa Recombinant Protein SXN101959 in Plasma
  17.00h 17.30h   Luc-Alain Savoy (SGS Life Science Services)
Selected Reaction Monitoring (SRM) for Quantification of Steroid and Peptide Biomarkers: Challenges & Benefit
  17.30h 18.00h   Catalin Duneanu (Waters)
A Universal Strategy for Quantification of Therapeutic Monoclonal Antibodies in Serum using Extended Isotopically Labeled Peptide Standards and 2DLC-SRM
   18.00h 19.00h    Cocktail Reception (sponsored by ABSciex)
        Enjoy a few drinks and the opportunity to discuss bioanalytical topics in a relaxed atmosphere

Day 2 – 15 November 2012

  07.00h 18.00h   Registration and Information desk open

Morning Breakout Sessions

Breakout sessions I and II are in parallel

  8.30h 10.15h  

Breakout session I
Micro sampling I - Updates on DBS 

  8.30h 8.50h   Christoph Stove (Ghent University)
Prediction of the Hematocrit of Dried Blood Spots via Potassium Measurement on a Routine Clinical Chemistry Analyzer
  8.50h 9.10h   Karl Sköld (Denator AB)
Heat Stabilization of Blood Spots for Metabolically Unstable Drugs
  9.10h 10.00h   Feedback from the EBF DBS/Micro sampling Consortium

  Ben van Baar
Internal Standard Addition in DBS
    Zoe Cobb
Homogeneity and Stability: The Results

  Ronald de Vries
EBF and Dried Blood Spots – Status Update from the Hematocrit EBF Topic Sub-Team
  10.00h 10.15   Panel Discussion
  8.30h 10.15h  

Breakout session II

   8.30h 9.00h    Huub Schellekens (Utrecht University)
EU regulations of biosimilars: will developments in quality testing reduce the need for clinical data?
  9.00h 9.20h   James Munday (on behalf of EBF)
Outcome of EBF Survey on Biosimilars
  9.20h 9.40h   Gregor Schaffar (Sandoz)
Pharmacokinetic and Immunogenicity Assessing of Biosimilars in Clinical and Pre-Clinical Studies
  9.40h 10.00h
Melody Sauerborn (TNO Triskelion)
How safe is your Biosimilar? The Tiered Approach to Measure Immunogenicity of Biologics - also the Right Approach for Biosimilars?
  10.00h 10.15h
Panel Discussion
  10.15h 10.45h   Coffee break

Morning breakout sessions (continued)

Breakout sessions III and IV are in parallel

  10.45h 12.30h  

Breakout session III
Micro sampling II - Recent developments 

   10.45h 11.05h    Sue Sparrow (GlaxoSmithKline)
Microsampling – Toxicology Considerations
  11.05h 11.20h   Bart Remmerie (Janssen Research & Development)
Can finger-prick sampling replace venous sampling ? A Pharmacokinetic Perspective
  11.20h 11.40h   Timothy Sangster (Charles River Laboratories)
Global Implementation of Microsampling – A Case Study
  11.40h 12.00h   Michael Spreadborough (AstraZeneca)
Plasma Microsampling – have we already reached the Horizon?
  12.00h 12.15h   Pierre Picard (Phytronix Technologies Inc)
Less than a Microliter needed: Blood PK Study, Microsomal Samples  and other Matrices analyzed by LDTD-MS/MS
  12.15h 12.30h   Panel Discussion
  10.45h 12.30h

Breakout session IV
Emerging Technologies and Innovative Applications for Large Molecules

   10.45h 11.10h    Jamie Sawyer (SQI Diagnostics, Inc.)
Ig_ plex: a Novel Automated Platform for Bioanalytics 
  11.10h 11.35h   Julie de Gagné (Novartis)
Challenges in Developing a Sensitive PD Assay – from Tool Selection to Technologies Evaluation
  11.35h 12.00h   Rohan de Silva (University of London)
Do Pathological Changes in Tau Protein Isoforms manifest in Cerebrospinal Fluid of Tauopathy Patients? Development and Validation of Sensitive Immuno-PCR Assays
  12.00h 12.25h
Clare Kingsley (Quotient Bioresearch)
Analytical Strategies for PK and Immunogenicity Testing for a Novel Recombinant Decoy Biopharmaceutical
  12.25h 12.30h   Discussion
  12.30h 14.00h   Lunch and poster session

Afternoon breakout sessions
and ELN workshop

Breakout session V and VI as well as ELN workshop are in parallel

   14.00h 15.30h   

Breakout session V
Is Quantitative Bioanalysis ready for High Resolution Mass Spectrometry 

  14.00h 14.30h   Kevin Bateman (Merck & Co)
HRMS in Regulated Bioanalysis ?
  14.30h 14.50h   William van Dongen (TNO Triskelion)
LC–MS Systems for Quantitative Bioanalysis
  14.50h 15.10h   Mark Wrona (Waters / Vertex Pharmaceuticals)
Accurate Mass Quantitation of in Vivo Plasma Samples using High Resolution QTof and MSE Data Analysis
  15.10h 15.30h   Fabio Garofolo (Algorithme Pharma)
Challenges and Solutions in Large Molecule Regulated Bioanalysis using High Resolution Mass Spectrometry
  14.00h 15.30h  

Breakout session VI
Wanted and unwanted Immunogenicity

  14.00h 14.25h   Stefan Kostense (Crucell)
Challenges of Wanted and Unwanted Immunogenicity Assays
  14.25h 14.40h   Nicolas Sabarth (Baxter)
Assessing Immunogenicity of Influenza Vaccines
  14.40h 14.55h
Sylvain Fleury (Mymetics Corporation)
Phase-I “Proof of Principle”: Immunization with Virosome-Gp41-Derived Antigen Induces Mucosal Antibodies with Antiviral Properties to Reduce Risk of HIV-1 Infection
  14.55h 15.10h   Clare Kingsley (Quotient Bioresearch)
Development and Validation of Neutralising Anti-Drug Antibody (Nabs) Assays
  15.10h 15.30h   Panel Discussion
   14.00h 15.30h   

Breakout session VII
ELN Workshop

        This session will be a workshop without plenary lectures. The aim of the workshop is to provide a forum for questions and discussion on ELN, and share the outcome of an EBF survey on ELN with the participants as well as experience of EBF members who already have implemented an ELN. As seats are limited for the workshop participants who would like to join will have to fill-in a dedicated registration form at the registration desk in Barcelona.    
  15.30h 16.00h   Coffee break
  16.00h 16.30h  

Young Scientist Award

  16.00h 16.05h   EBF Steering Committee member 
Introduction of Award winner
  16.05h 16.30h   Award winner
   16.30h 18.00h   

Technology updates II

   16.30h 17.00h    Lester Taylor (Agilent Technologies)
The expanding Role of Triple Quadrupole Mass Spectrometry for Bioanalytical Applications 
  17.00h 17.30h   Simon Szwandt (Thermo Fisher Scientific)
A Validated Method for the Definitive Quantitation of Hepcidin-25 in Rat Serum by LC/MS/MS using High Resolution, Accurate Mass MS
  17.30h 18.00h   Mauro Aiello (AB Sciex)
IonDrive Technology: A diversified Approach to Peptide Quantitation
   18.00h 19.00h   

Cocktail Reception (sponsored by ABSciex)

        Enjoy a few drinks and the opportunity to discuss bioanalytical topics in a relaxed atmosphere

Day 3 – 16 November 2012

Morning BREAKOUT and Plenary SESSIONS

Breakout session VIII and IX are in parallel

  9.00h 10.30h  

Breakout VIII
BA Clinic - Consult the doctor

  9.00h 9.15h   David Neville (Quotient Bioresearch)
Right Brain Thinking in a Left Brain Environment; Troubleshooting Bioanalytical Methods
  9.15h 9.30h   Fabio Garofolo (Algorithme Pharma)
A Current Hot Topic in Regulated Bioanalysis: Impact of Hemolysis on Drug Stability
  9.30h 9.45h
Tom Verhaeghe (Janssen Research&Development)
Evaluation of Hemolysis in Assay Validation and the Impact on the Analysis of Study Samples
  9.45h 10.00h   Alex Muntendam (ABL B.V.)
Betahistine in Human Plasma by LC-MS/MS: An Example of a Low Range Analytical Range, with a Low Molecular Weight Compound and its Peculiarities
  10.00h 10.15h   Iris Vanwelkenhuysen (Janssen Research&Development)
Which Steps to Take if Re-Analysis Results do not Confirm the Result of the First Analysis?
  10.15h 10.30h   Panel Discussion
  9.00h 10.30h  

Breakout IX
Tiered Approach in Practice - are our Minds Ready for it?

  9.00h 9.30h   David Jones (MHRA)
GLP or Not GLP, That Is The Question! (How to handle non-GLP data in Regulatory Submissions)
  9.30h 9.50h   Brigitte Buscher (on behalf of the EBF Topic Team)
Plasma Protein Binding Studies including Bioanalysis in Drug Discovery and Development
  9.50h 10.10h
John Smeraglia (Huntingdon Life Sciences)
Method Validation Status versus Regulatory Compliance Status
  10.10h 10.30h   Philip Timmerman (on behalf of the EBF Topic Team)
Towards an EBF Recommendation on Quantification of Drugs and Metabolites in Tissues
  10.30h 11.15h   Coffee break

Plenary Sessions

   11.15h 13.30h   

Updates from the globe

  11.15h 11.30h   Michaela Golob (on behalf of GBC)
Updates from the GBC Activities & Progress
  11.30h 12.00h   Noriko Katori (National Institute of Health Sciences)
Regulated Bioanalysis Status in Japan and Notable Points of the Draft Japanese BMV Guideline
  12.00h 12.30h   Joao Tavares (ANVISA)
New BMV Guideline in Brazil
  12.30h 13.00h   Hu Pei (PUMCH)
Title to be announced
  13.00h 13.25h   Peter van Amsterdam (on behalf of EBF)
Feedback on EMA Guideline Workshop
  13.25h 13.40h   Panel discussion
  13.40h 13.50h   EBF plans for 2013 and 2014, close out  and adjourn

Post EBF Conference event
GBC Round Table

  14.00h 16.00h   GBC Round table

In this session, we will engage with the audience to gather input on the items where the GBC Harmonisation Teams require your input because of their importance to the bioanalytical community or their continued ambiguity.

Entrance to this session is free for registered conference delegates.

The discussion points will become available on the GBC website ( from end of October onwards.