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EBF 6th Open Meeting

Moving Forward Together



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Hesperia Tower Conference Center

Barcelona, Spain

November 20-22 2013

Day 1

PLENARY SESSION

Assay transfer - Expectations & Practicalities

Cheryl McAlpine (Merck-Millipore)
Challenges in assay transfer of complex assay formats
Fabienne Deckert-Salva (Novartis)
Outsourcing and assay transfer strategies for biologics programs
Graeme Smith (Huntingdon Life Sciences)
Fit for purpose method transfer
Ronald de Vries (Janssen R&D)
Janssen strategy for bioanalytical assay transfer
Steve White (GlaxoSmithKline)
Assay cross validation - Recent experiences in transfering bioanalytical assays from sponsor to CRO partners and between CROs

From biomarker to diagnostics or personalized medicine: is there a role for regulated bioanalysis?

John Mills (AstraZeneca)
Delivering on the Promise of Personalized Healthcare
Suntje Sander and Peter van Amsterdam (Abbott)
Successful treatment of maldigestion due to pancreatic exocrine insufficiency: diagnosis, clinical picture and the challenges of measurements involved
Joan-Carles Arce and Birgitte Buur Rasmussen (Ferring)
Individualized dosing regimen for fertility treatment based on a biomarker

Interpretation and implementation of guidance on haemolysed / hyperlipedemic plasma and co-administrated drugs

Benno Ingelse (on behalf of EBF TT-15)
How to deal with haemolysed and hyperlipidaemic samples: an EBF perspective
Fabio Garofolo (Algorithme Pharma)
Criteria for performing a scientifically meaningful lipemic plasma test during LC-MS/MS bioanalytical method validation (BMV): which type to choose?
Martina Wein (Boehringer-Ingelheim)
How to investigate in the influence of hyperlipidemic samples on bioanalytical assays
Tom Verhaeghe (Janssen R&D)
Co-stability assessment for fixed dose combinations: an additional burden to bioanalytical method validation
Berthold Lausecker (on behalf of EBF TT-31)
Interaction compounds & comedication testing

Peptide and protein analysis with LC-MS

Nico van de Merbel (RUG)
The usefulness of LC-MS as a platform for protein quantification: from theory to practice
Rand Jenkins (PPD Inc)
Application of LC-MS/MS and LBA methods in concert for bioanalysis of monoclonal antibody oncology drugs and associated soluble target receptors
William van Dongen (TNO Triskelion)
Low ng/ml bioanalysis of monoclonal antibody therapeutics using immuno extraction and LC-MS
Anders Sonesson (Ferring)
LC-MS/MS bioanalysis of peptides - How to manage non specific binding?
Mireia Fernandez Ocaña (Pfizer)
Sensitive peptide immunoaffinity LC-MS/MS quantification of a membrane-bound target receptor from clinical biopsie
Erin Chambers (Waters)
Ultra-sensitive simultaneous LC-MS/MS quantification of human insulin, glargine, lispro, aspart, detemir and glulisine in human plasma using 2D-LC and a novel high efficiency column

Day 2

SPOTLIGHT WORKSHOP: CONTINUED DEVELOPMENTS IN DBS

Philip Timmerman (on behalf of the EBF Consortium)
Introduction and recap of EBF Recommendation on DBS
Bert Ooms (Spark Holland)
Towards unbiased Dried blood spot analysis using temperature-enhanced flow-through desorption coupled online to solid phase extraction and mass spectrometry
Kevin Bateman (Merck & Co.)
Dried blood spot (DBS) sample collection for drug development: recent experience at Merck
Jack Henion (Quintiles Bioanalytical and ADME Labs)
Recent Developments in Dried Plasma Spot Analysis Using a Novel Red Blood Cell Filtration Card
Ynze Mengerink (Chemelot)
New Ht independent dried blood spot cards

Is validation really needed for all assays: taking tiered approach outside the world of MIST

Philip Timmerman (on behalf of EBF)
The MIST concept taken beyond metabolite quantification: overview of EBF discussions on applying tiered approach
Jaap Wieling (QPS)
Can we validate an assay for a biomarker that we have not identified ?
Vera Hillewaert
A complex problem: what (and how) should we quantify?
Neil Henderson (AstraZeneca)
Characterising the performance of in situ hybridisation (ISH) methodologies in order to demonstrate fit-for-purpose assays for clinical deployment

BREAKOUT SESSIONS
SMALL MOLECULES / CHROMATOGRAPHY BASED

Consult the doctor

Alex Muntendam (ABL)
Positive control group samples in a toxicity study. Now what?
Ann Lévesque (inVentiv Health clinical)
How problematic situations can become positive ones: case studies of bioanalytical Issues
David Neville (Quotient Bio Analytical Sciences)
Non-specific binding, Non-linearity or Nonsense?
Iain Love (Huntingdon Life Sciences)
Viewing the big picture through a keyhole: providing context to Bioanalytical challenges
Nico van de Merbel (PRA)
Blood is no plasma: failing long-term frozen stability results for cyclosporin A in diluted whole blood

Interpretation and implementation of Guidance expectations: Internal Standard variability

Olivier Le Blaye (ANSM)
Examples of IS variations seen during inspections
Aimin Tan (BioPharma Services Inc)
Leveraging Successful Troubleshooting Experiences for the Prevention or Reduction of Internal Standard Response Variations during LC-MS Bioanalysis
John Allanson (Unilabs York Bioanalytical Solutions)
Challenges and solutions in the application IS variability criteria
Luc Bouchard (inVentiv Health clinical)
Internal standard variation during routine sample analysis: investigation of case studies
Steve White (on behalf of EBF TT-07)
Dealing with internal standard variability - Towards a recommendation

Innovative applications in sampling & extraction

Kathryn Chapman (NCR3s)
Overcoming the barriers for uptake of microsampling techniques in regulatory toxicology
Stephen Williams (Charles River)
Small samples, large molecules and bigger benefits
Neil Spooner (GlaxoSmithKline)
Latest developments in microsampling for regulated quantitative bioanalysis
Craig Aurand (Supelco/Sigma-Aldrich)
Investigation of solid phase micro extraction as an alternative to dried blood spot
Ranbir Mannu (Covance)
Development of a capillary micro-sample bioanalytical method for quantification of an phosphorothioated 18-mer oligonucleotide in human plasma using LC-MS/MS

Innovative applications in separation & quantification

Gert Hendriks (PRA)
Old school derivatization in modern LC-MS analysis
Jim Settlage (inVentiv Health clinical)
The re-emergence of GC-MS/MS as a tool for the analysis of small molecule biomarkers
Paul Rainville (Waters)
Critical evaluation of common sample preparation techniques for bioanalysis on microfluidic LC/MS performance
Lester Taylor (Agilent Technologies)
High-Throughput SPE-MS/MS - A Viable Approach For Validated Bioanalytical Analysis?
Sega Ndiaye (Innate Pharma / Proteomic Platform Innovation Technologic Timone PIT2) - Shimadzu
Free MMAE toxin quantitation by triple quadrupole in Antibody drug Conjugate analysis

BREAKOUT SESSIONS
LARGE MOLECULES / LIGAND BINDING BASED

Analysis of parallelism for biomarkers and therapeutic proteins

Edwin Janssen (on behalf of EBF TT-35)
Validation of ligand-binding assays: the Importance parallelism
Clare Kingsley
A global view on parallelism
Ulrich Kunz (Boehringer-Ingelheim)
Case studies of non-parallelism in various biomarker assays
Bruno Boulanger (Arlenda)
How to develop and assess the parallelism in a bioassays: a fit-for-purpose strategy

Challenges for flow cytometry in regulated bioanalysis

Barry van der Strate (on behalf of EBF TT-32)
Short introduction the increased use of flow cytometry to support clinical studies
Minesh Patel (Merck-Millipore)
Challenges for Flow Cytometry in regulated Bioanalysis
Nora Bachmayer (Crucell)
Encountered challenges during the standardization of the ICS assay
Robin Longdin (Quotient Bio Analytical Sciences)
Challenges for flow cytometry in regulated Bioanalysis; quality assurance and regulatory considerations
Virginia Litwin (Covance)
Analytical Method Validation: Perspectives from the Flow Cytometry Action Programming Committee of the AAPS

Interferences & surprises ligand binding assay method development

Helen Young (Quotient Bio Analytical Sciences)
Implementation of Critical Reagent Monitoring in a Clinical Laboratory
Implementation of Critical Reagent Monitoring in a Clinical Laboratory
Guidelines at work - Examples of theoretical considerations versus practical solutions in Immunogenicity assays
Matthew Bentley (Merck-Millipore)
Immunogenicity analysis challenges and solutions for PEGylated biopharmaceuticals
Roland Staack (F. Hoffmann-La Roche)
Free analyte QC concept - a novel approach for qualification/validation of free drug assays

Analytical challenges of antibody-drug conjugates (ADCs)

Bernhard Beckermann (Bayer)
Introduction
Steffen Groß (Paul-Ehrlich-Institut)
Regulatory expectations for the characterisation of ADCs
Stefanie Fischmann (AbbVie)
Strategy for bioanalysis of ADCs along project development stages
Marie-Hélène Pascual (Sanofi)
Selective immunoassay of the naked antibody as a new tool for pharmacokinetic interpretation of an antibody drug conjugate
Jasja Wolthoorn (TNO Triskelion)
Novel Platform Using LC-MS and Ligand Binding Assays for Characterization and PK analysis of ADCs

Day 3

Breakout sessions

Promises of new technology: sense and nonsense of HR-MS

Suma Ramagiri (AB SCIEX)
ADC quantitation using HRMS
Lieve Dillen (Janssen R&D)
High resolution mass spectrometry for bioanalysis at Janssen. Current experiences and future perspectives
Mark Wrona (Waters)
Moving forward on Quan-Qual, perspectives on using TOFs for bioanalytical work
Mohammed Abrar (Unilabs York Bioanalytical Solutions)
The comparison of high resolution MS with triple quadrupole MS for the analysis of oligonucleotides
Hongxia Wang (Thermo Fisher Scientific)
Quantification of protein biotherapeutics by a universal LC-high resolution/accurate mass based approach: intact protein or proteolytic peptides?

Issues & solutions in sample logistics

Jose Groenboom (on behalf of EBF TT-12)
Sample logistics: problems and solutions in multi-center clinical trials
Rebecca Sleigh (on behalf of EBF TT-12)
Proposed generic lab manual
Scott Vincent (A4P Consulting)
Bio-logistical considerations in planning and executing early phase bioanalytical components
Jean-Guy de Gruben (World Courier)
Issues within the context of Clinical Trials Logistics. Practical examples and solutions
Bärbel Wilke (LKF - Laboratorium für Klinische Forschung)
Logistics within a Central Laboratory - From Specimen Receipt to Result Reporting