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 | |