EBF
EBF Open Symposium
EBF Barcelona
EBF 5th Open Meeting
Old Battles, New Horizons
Hesperia Tower Conference Centre
Barcelona, Spain
November 14-16, 2012
Open Symposium

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 14:00 to 16:00 on Friday Nov. 16th and entrance is free for conference delegates.

Day 0 – 13 November 2012

14.00- 20.00  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)
Introduction
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
Biosimilars

 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
Presentation
 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 (www.globalbioanalysisconsortium.com) from end of October onwards.