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BCN Slides 2012

Program of EBF 5th Open Conference  “Old Battles, New Horizons”  November 14-16, 2012

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 – 14 November 2012
 
MORNING PLENARY
 
08.30-08.45 Welcome and opening remarks
08.45-10.15 Increasing Challenges in Clinical Studies (Part I)
Richard Abbott (on behalf of EBF) 
Introduction 
Richard Hucker (A4P Consulting Ltd) 
Meeting the Bioanalytical Challenges of Global Multi-Centre Clinical Trials:
Observations and Expectations
Bernd Matthes (on behalf of the EBF Topic Team) 
Outcome of EBF Survey on Multi-center Trials
Vera Hillewaert (Janssen Research&Development) 
Global Clinical Trials – Challenges for Bioanalysis
Hanneke van Assche (Abbott) 
Bioanalytical Challenges from a Clinical Perspective
 
11.00-12.30 Increasing Challenges in Clinical Studies (Part II)
Carolyn Mailer (on behalf of EBF TT12) 
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 the EBF Topic Team) 
Stabilisation of Clinical Samples
Philip Timmerman (on behalf of EBF) 
EBF Recommendation on Method Establishment and Bioanalysis of
Biomarkers in Support of Drug Development
 
AFTERNOON PLENARY SESSIONS
 
14.00-16.00 A progress update since Large meets Small
Nico van de Merbel  (PRA) 
It’s only just begun: The Importance of Sample Preparation for 
Protein Quantification by LC-MS
Kenneth Fountain (Waters) 
Challenges in the Development of a Bioanalytical Method for the Simultaneous
Quantification of Synthetic Insulin Analogs in Human Plasma
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 the EBF Topic Team) 
EBF Experiences on LC-MS/MS Analysis of Large Molecules
 
16.30-18.00 Technology updates I
Richard Kay (Quotient Bioresearch) 
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) 
Selected Reaction Monitoring (SRM) for Quantification of Steroid and
Peptide Biomarkers: Challenges & Benefit
Stephen McDnald (Waters)  
A Universal Strategy for Quantification of Therapeutic Monoclonal Antibodies in
Serum using Extended Isotopically Labeled Peptide Standards and 2DLC-SRM
 
Day 2 – 15 November 2012
 
 MORNING BREAKOUT SESSIONS
  Breakout sessions I and II are in parallel
 
08.30-10.15 Breakout session I
Micro sampling I – Updates on DBS 
 
Christophe 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
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
 
08.30-10.15 Breakout session II
Biosimilars
 
Huub Schellekens (Utrecht University) 
EU regulations of biosimilars: will developments in quality testing reduce the
need for clinical data?
James Munday (on behalf of EBF) 
Outcome of EBF Survey on Biosimilars
Gregor Schaffar (Sandoz)  (Not released for publication)
Pharmacokinetic and Immunogenicity Assessing 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
Breakout sessions III and IV are in parallel
 
10.45-12.30 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
 
10.45-12.30 Breakout session IV
Emerging Technologies and Innovative Applications for Large 
Molecules
 
Jaymie 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)  (Not released for publication)
Analytical Strategies for PK and Immunogenicity Testing for a
Novel Recombinant Decoy Biopharmaceutical
 
AFTERNOON BREAKOUT SESSIONS AND ELN WORKSHOP
Breakout session V and VI as well as ELN workshop are in parallel
 
14.00-15.30 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 Quantitative Bioanalysis
Mark Wrona (Waters / Vertex Pharmaceuticals) 
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
 
14.00-15.30 Breakout session VI
Wanted and unwanted Immunogenicity
 
Stefan Kostense (Crucell) 
Challenges of Wanted and Unwanted Immunogenicity Assays
Nicolas Sabarth (Baxter) 
Assessing Immunogenicity of Influenza Vaccines
Sylvain Fleury (Mymetics Corporation)  (Not released for publication)
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)  (Not released for publication) 
Development and Validation of Neutralising Anti-Drug Antibody (Nabs) Assays
 
14.00-15.30 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.
Hans Mulder on behalf of the EBF TT 30 
Outcome of the EBF survey on Electronic Laboratory Notebook
 
 16.00-16.30  Young Scientist Award
EBF Steering Committee member  
Introduction of Award winner
Award winner Maria Rambla Alegre
Presentation 
 
16.30-18.00 Technology updates II
Lester Taylor (Agilent Technologies) (Not released for publication)
The expanding Role of Triple Quadrupole Mass Spectrometry for Bioanalytical Applications 
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
Steve Taylor (AB Sciex) 
IonDrive Technology: A diversified Approach to Peptide Quantitation
 
Day 3 – 16 November 2012
 
 MORNING BREAKOUT AND PLENARY SESSIONS
Breakout session VIII and IX are in parallel
 
09.00-10.30 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?
 
09.00-10.30 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 the EBF Topic Team) 
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 the EBF Topic Team) 
Towards an EBF Recommendation on Quantification of Drugs and Metabolites in Tissues
 
PLENARY SESSIONS
11.15-13.30 Updates from the globe
Michaela Golob (on behalf of GBC) 
Updates from the GBC Activities & Progress
Noriko Katori (National Institute of Health Sciences) 
Regulated Bioanalysis Status in Japan and Notable Points of the Draft Japanese BMV Guideline
Joao Tavares (ANVISA) 
New BMV Guideline in Brazil
Hu Pei (PUMCH) 
Bioanalysis in Clinical Trials in China
Peter van Amsterdam (on behalf of EBF) 
Feedback on EMA Guideline Workshop
 
13.40-13.50 EBF Plans for 2013 and 2014, close out and adjourn
 
POST EBF CONFERENCE EVENT GBC ROUND TABLE
14.00-16.00 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.
Stuart McDougal  Small Molecule and All Molecules Harmonization teams
Sherri Dudal Large Molecule Discussion Topics