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EBF 5th Open Meeting

Old Battles, New Horizons

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Hesperia Tower Conference Center

Barcelona, Spain

November 14-16 2012

Day 1

Morning plenary

Increasing Challenges in Clinical Studies (Part I)

Richard Abbott (on behalf of EBF)
Richard Hucker (A4P Consulting Ltd)
Meeting the Bioanalytical Challenges of Global Multi-Centre Clinical Trials: Observations and Expectations
Bernd Matthes (on behalf of EBF)
Outcome of EBF Survey on Multi-center Trials
Vera Hillewaert (Janssen Research & Development)
Global Clinical Trials - Challenges for Bioanalysis
Hanneke van Asche (Abbott)
Bioanalytical Challenges from a Clinical Perspective

Increasing Challenges in Clinical Studies (Part II)

Carolyn Mailer (on behalf of EBF)
Case Example Highlighting Multi-center Clinical Trial Issues
Franck Picard (Novartis)
The Pre-Advance Platform: Sample Management and Processing by Mouse Click
Katja Heinig (on behalf of EBF)
Stabilisation of Clinical Samples in Practice
Philip Timmerman (on behalf of EBF)
EBF Recommendation on Method Establishment and Bioanalysis of Biomarkers in Support of Drug Development

Afternoon Plenary Sessions

A progress update since Large meets Small

Nico van de Merbel  (PRA)
The Importance of Sample Preparation for Protein Quantification by LC-MS
Erin Chambers & Kenneth J. Fountain (Waters) 
Development of a Bioanalytical Method for the Simultaneous Quantification of Synthetic Insulin Analogs in Human Plasma: Challenges of Working with Large Peptides
Lieve Dillen (Janssen Research & Development)
Bioanalysis of Peptides and Proteins in Drug Research and Development: from Strategy into Practice
Michael Blackburn
(Covance Laboratories Ltd)
Quantitation of a Therapeutic Insulin Analogue by Immuno-Affinity Extraction - LC-MS/MS
Magnus Knutsson (on behalf of EBF)
EBF Experiences on LC-MS Analysis of Peptides and Proteins

Technology updates I

Richard Kay (Quotient)
Development of an Immunoprecipitation and LC-MS/MS based Method for Quantifying the 105 kDa Recombinant Protein SXN101959 in Plasma
Luc-Alain Savoy (SGS Life Science Services)
LC-MS/MS for the quantification of Peptide biomarker and mixture of closely related Protein in formulation
Stephen McDonald (Waters)
Innovations for Biotherapeutics Bioanalysis

Day 2

Morning Breakout Sessions

Breakout session I
Micro sampling I - Updates on DBS 

Christoph Stove (Ghent University)
Prediction of the Hematocrit of Dried Blood Spots via Potassium Measurement on a Routine Clinical Chemistry Analyzer
Karl Sköld (Denator AB)
Heat Stabilization of Blood Spots for Metabolically Unstable Drugs
Ben van Baar, Zoe Cobb & Ronald de Vries (on behalf of EBF)
Feedback from the EBF DBS Micro Sampling Consortium

Breakout session II

Huub Schellekens
Who needs biosimilars?
James Munday (on behalf of EBF)
Outcome of EBF Survey on Biosimilars
Gregor Schaffar (Sandoz)
Bioanalytical Assessment of Biosimilars in Clinical and Pre-Clinical Studies
Melody Sauerborn (TNO Triskelion)
How safe is your Biosimilar? The Tiered Approach to Measure Immunogenicity of Biologics - also the Right Approach for Biosimilars?

Morning breakout sessions (continued)

Breakout session III
Micro sampling II - Recent developments 

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

Breakout session IV
Emerging Technologies and Innovative Applications for Large Molecules

Jamie Sawyer (SQI Diagnostics, Inc.)
Ig_ plex: a Novel Automated Platform for Bioanalytics 
Julie de Gagné (Novartis)
Challenges in Developing a Sensitive PD Assay – from Tool Selection to Technologies Evaluation
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
Clare Kingsley (Quotient Bioresearch)
Analytical Strategies for PK and Immunogenicity Testing for a Novel Recombinant Decoy Biopharmaceutical

Afternoon breakout sessions and ELN workshop

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

Kevin Bateman (Merck & Co)
HRMS in Regulated Bioanalysis ?
William van Dongen (TNO Triskelion)
LC-MS Systems for Bioanalysis
Mark Wrona
Accurate Mass Quantitation of in Vivo Plasma Samples using High Resolution QTof and MSE Data Analysis
Fabio Garofolo (Algorithme Pharma)
Challenges and Solutions in Large Molecule Regulated Bioanalysis using High Resolution Mass Spectrometry

Breakout session VI
Wanted and unwanted Immunogenicity

Stefan Kostense (Crucell Holland BV)
Challenges of Wanted and Unwanted Immunogenicity Assays
Nicolas Sabarth (Baxter)
Assessing Immunogenicity of Influenza Vaccines
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
Clare Kingsley (Quotient Bioresearch)
Development and Validation of Neutralising Anti-Drug Antibody (Nabs) Assays

Breakout session VII
ELN Workshop

Hans Mulder (on behalf of EBF)
Outcome of the EBF survey on Electronic Laboratory Notebook

Young Investigator Award

Peter van Amsterdam
(on behalf of EBF)
Introduction of Award winner
Maria Rambla Alegre
Experiences with MicellarLiquid Chromatography (MLC) and Immobilized Artificial Membrane Liquid (IAM) Chromatography

Technology updates II

Lester Taylor (Agilent Technologies)
The expanding Role of Triple Quadrupole Mass Spectrometry for Bioanalytical Applications 
Simon Szwandt
(Thermo Fisher Scientific)
The Q Exactive -A Benchtop Orbitrap Mass Spectrometer for DMPK
Steve Taylor (AB Sciex)
IonDrive Technology: A diversified Approach to Peptide Quantitation

Day 3

Morning BREAKOUT and Plenary SESSIONS

Breakout VIII
BA Clinic - Consult the doctor

David Neville (Quotient Bioresearch)
Right Brain Thinking in a Left Brain Environment; Troubleshooting Bioanalytical Methods
Fabio Garofolo (Algorithme Pharma)
A Current Hot Topic in Regulated Bioanalysis: Impact of Hemolysis on Drug Stability
Tom Verhaeghe (Janssen Research & Development)
Evaluation of Hemolysis in Assay Validation and the Impact on the Analysis of Study Samples
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
Iris Vanwelkenhuysen (Janssen Research & Development)
Which Steps to Take if Re-Analysis Results do not Confirm the Result of the First Analysis?

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

David Jones (MHRA)
GLP or Not GLP, That Is The Question! (How to handle non-GLP data in Regulatory Submissions)
Brigitte Buscher (on behalf of EBF)
Plasma Protein Binding Studies including Bioanalysis in Drug Discovery and Development
John Smeraglia
(Huntingdon Life Sciences)
Method Validation Status versus Regulatory Compliance Status
Philip Timmerman (on behalf of EBF)
Towards a Recommendation on Tissue Analysis

Plenary Sessions

Updates from the globe

Michaela Golob (on behalf of GBC)
Updates from the GBC Activities
Noriko Katori (National Institute of Health Sciences)
Regulated Bioanalysis Status in Japan and Notable Points of the Draft Japanese Guideline
Joao Tavares (ANVISA)
ANVISA's Bioanalytical Guidance
Pei Hu (PUMCH)
Bioanalysis in Clinical Trials in China
Peter van Amsterdam
(on behalf of EBF)
The EMA Bioanalytical Method Validation Guideline: process, history, discussions and evaluation of its content.


GBC Round table

Stuart McDougal (on behalf of GBC
Outcomes of the Global Bioanalysis Consortium's Recommendations: Small Molecule and All Molecules Harmonization teams
Sherri Dudal (on behalf of GBC)
Outcomes of the Global Bioanalysis Consortium's Recommendations: Large Molecule Discussion Topics