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EBF 7th Open Meeting

Beyond the Horizon - Painting a new landscape



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Hesperia Tower Conference Center

Barcelona, Spain

November 19-21 2014

Day 1

Plenary sessions

Philip_Timmerman_Welome
Philip Timmerman (EBF)
Welcome

Large molecules - LBA or LC-MS? Why and when

Roland_Staack
Roland Staack (Hoffmann-La Roche)
Protein Quantification by LBA or LC-MS: Key Criteria for the Definition of the Bioanalytical Strategy
Barry_van_der_Strate
Barry van der Strate & Nico van de Merbel (PRA Health Sciences)
Can 1+1 be 3? The combination of LBA and LC-MS to look beyond the horizon of large molecule quantification
Rand_Jenkins
Rand Jenkins (PPD, Inc.)
Immunogenicity assessments, an important aspect of biotherapeutic drug development: Can LC-MS technology be applied to complement traditional LBA-based approaches?
Ronald_de_Vries
Ronald de Vries (Janssen R&D)
Combined use LBA + LC-MS/MS in drug development of a 4kDa peptide: 1+1=3 or where complementary data made a difference

Large molecules - LBA and LC-MS! How

Matt_Barfield_TT43
Matt Barfield (GlaxoSmithKline, on behalf of EBF TT-43)
How to develop Antibody Drug Conjugates – Recommendations from TT43 and survey results
Charlotte_Hagman
Charlotte Hagman (Novartis)
Characterization of Antibody-Drug Conjugates using Affinity Enrichment and High-Resolution Mass Spectrometry
Fabio_Garofolo
Fabio Garofolo (Algorithme Pharma Inc)
Recent Trends in Antibody-Drug Conjugate (ADC) Bioanalysis: Total Antibody Quantification by HRMS
Ravindra_Chaudhari
Ravindra Chaudhari (Thermo Fisher Scientific)
Highly Sensitive and Robust Workflow for Therapeutic Monoclonal Antibody Analysis from Complex Matrices

Looking Beyond the Horizon

Philip_Timmerman_Horizon
Philip Timmerman (Janssen R&D)
Making the impossible possible
YSSOC
Aline Swinnen, Sheelan Ahmad, Jonathan Paraskos and Sufyan Maqbool
We are the Future... Hereís our Vision - A View from EBF YSSM
Zsofia_Berke
Zsofia Berke (AstraZeneca)
Analytical Comparison Between Point-of-Care Uric Acid Testing Meters
Daniela_Stoellner
Daniela Stoellner (Novartis, on behalf of EBF TT-20)
How the bioanalytical scientist plays a key role in interdisciplinary project teams in the development of biotherapeutics – a reflection of the European Bioanalysis Forum

Scientific or Regulated Validation? AKA Tiered Approach

Philip_Timmerman_Tiered
Philip Timmerman (Janssen R&D, on behalf of EBF)
EBF proposals on balancing Scientific vs. Regulated Validation
David_Jones
David Jones (MHRA)
An EU Regulatorís viewpoint as why Regulatory Guidelines should not be followed
Hans_Stieltjes
Hans Stieltjes (Janssen R&D)
Tiered Approach for Bioanalysis of Drugs and their Metabolites: Examples of the Use of Qualified Assays at Janssen R&D during the past decade
Graeme_Smith
Graeme Smith (Harlan / Huntington Life Sciences)
A Tiered Approach to Bioanalysis: From Concept to Practice

Spotlight on e-Data: towards a common standard

Jim_Brennan
Jim Brennan (LabWare)
A perspective on paperless operations in a modern bioanalytical laboratory
Gerhard_Noelken
Gerhard Noelken (Allotrope)
Allotrope: An open ecosystem for seamless data management and exchange for Bioanalysis
Peter_Esch
Peter Esch (Novartis)
Electronic Raw Data in a GLP Environment – Swiss AGIT Working Group Guidelines

Day 2

Parallel Sessions 1

LC-MS Applications for Large Molecules

Kevin_Bateman
Kevin Bateman (MSD)
Application of LC-MS for characterization and bioanalysis of therapeutic antibodies
Ludovicus_Staelens
Ludovicus Staelens (UCB Pharma)
Internal standard approaches in quantification of proteins by LC-MS/MS
Richard_Kay
Richard Kay (LGC)
Supercharging reagents - revving up peptide LC-MS analyses.
Vincent_Trinh
Vincent Trinh (inVentiv Health Clinical)
Insulin Glargine: From the Immunoassays to the More Specific LC-MS/MS Assay
Erin_Chambers
Erin Chambers (Waters Corporation)
Getting More with Less: Improving Sensitivity and Reducing Sample Consumption in LC/MS Assays for Endogenous and Injected Glucagon, 6 insulins, and Teriparatide

Diversity of the Bioanalytical Landscape

Ann_Levesque
Ann Lévesque (inVentiv Health Clinical)
Determination of Testosterone in Plasma instead of Serum: When is it needed? Is it accepted?
Susan_Pang
Susan Pang (LGC)
The development of robust cortisol assays for sports-based applications
Vincenzo_Pucci
Vincenzo Pucci (Merck)
Merck global bioanalytical strategy to ensure data quality in the discovery space and successful LC-MS/MS methods transfer to preclinical GLP and clinical bioanalytical groups
David Bonnel (ImaBiotech)
Applications of Quantitative Mass Spectrometry Imaging in drug development
Mohammed_Abrar
Mohammed Abrar (Unilabs York Bioanalytical Solutions)
Vitamin D3 Determination- Automated, Streamlined, Robust and Reliable

Low, Lower, Lowest

William_van_Dongen
William van Dongen (TNO Triskelion)
Nano-UPLC and Chip-based LC-MS methods for the sensitive determination of therapeutic monoclonal antibodies in serum
Mark_Wrona
Mark Wrona (Waters Corporation)
Integration of microfluidics with High Resolution Mass Spectrometry (HRMS) for DMPK Studies
Tom_Verhaeghe
Tom Verhaeghe (Janssen R&D)
LC-MS/MS as an enabler for a broader application of microdose studies in drug development; the Janssen experience
Adrian_Pereira
Adrian Pereira (GlaxoSmithKline)
Validation of a clinical assay with LLoQ of 350 fg/mL by Liquid Chromatography + Accelerator Mass Spectrometry in support of dermal dosing
Stephen_English
Stephen English (Xceleron)
Tiered validation of LC+AMS Assays: Recommendations for best practices

Bioanalytical Assay Robustness

Steve_White
Steve White (GlaxoSmithKline)
Measuring assay robustness across the life cycle of a bioanalyical method
Amanda_Wilson
Amanda Wilson (AstraZeneca, on behalf of EBF TT-41)
EBF Topic Team-41; Processed Sample Reproducibility and Stability
David_Bakes
David Bakes (Harlan / Huntington Life Sciences)
An industry consensus towards baseline assignment – where do we draw the line?
Luc_Bouchard
Luc Bouchard (inVentiv Health Clinical)
Importance of End-to-End Robustness when dealing with Glucuronide Metabolites
Susanne_Pihl
Susanne Pihl (Lundbeck, on behalf of EBF TT-47)
EBF recommendation on practical management of critical reagents for ligand-binding assays

Parallel Sessions 2

Day to Day Challenges and Automation in Bioanalysis

Raymond_Farmen
Raymond Farmen (Celerion)
Integrating automated systems for regulated bioanalysis
Christophe_Zickler
Christophe Zickler (Novartis)
Automated bioanalysis of PK, PD and immunogenicity in a GLP/GCLP regulated environment
Craig_Stovold
Craig Stovold (LGC)
Assessing Carryover in the Immunoassay Laboratory
Matt_Bentley
Matt Bentley (Eurofins Pharma Bioanalysis Services)
Practical solutions to the optimisation of drug tolerance in ADA method Development
Gert_Hendriks
Gert Hendriks (PRA Health Sciences)
Matrix effects in lipemic plasma: practical solutions to additional issues in bioanalytical method development and validation

Immunoassays for Biomarkers

Dominique_Gouty
Dominique Gouty (BioAgilytix)
Selecting the right strategy for Biomarkers
Karen_Elsby
Karen Elsby (AstraZeneca)
The MULTIple trials of generating a SINGLE data set: taking biomarker assays through the clinical phases
James_Lawrence
James Lawrence (Harlan / Huntington Life Sciences)
Adapting Commercial Immunoassay Kits for Pre-Clinical Biomarkers: Challenges and Solutions.
Jo_Goodman_Biomarkers
Jo Goodman (MedImmune)
The changing face of the immunoassay landscape for soluble target engagement biomarkers quantification
Marianne_Scheel_Fjording
Marianne Scheel Fjording (Novo Nordisk)
Gold, Silver, Bronze

New Technologies and Applications in Large Molecule Bioanalysis

Michael_Przybylski
Michael Przybylski (University of Konstanz)
Online SAW-Biosensor-Mass Spectrometry: Simultaneous Detection, Structure Determination and Affinity Quantification of Protein-Ligand Interactions
Robert_Nelson
Robert Nelson (NovImmune SA)
Evaluating multiple technology platforms in the development of large molecule bioanalytical assays
Clare_Kingsley
Clare Kingsley (LGC)
Ultrasensitivity immunoassays
Nick_Pearson
Nick Pearson (CiToxLAB)
Quantifying short RNA molecules in a regulatory environment
Ashleigh_Wake
Ashleigh Wake (Intertek Life Sciences)
Alternative Methods to LC-MSMS and Immunochemistry Based Method in Bioanalysis

Biosimilars

Timo_Piironen
Timo Piironen (Syrinx Bioanalytics)
Challenges and strategies of developing and validating immunogenicity assays for biosimilars
James_Munday
James Munday (Covance)
The use of PK, PD and ADA bioanalysis for evaluation of the overall Immunogenicity of biosimilars and the bioanalytical challenges for determining if there are equivalent safety risks.
Ricardo_Gutierrez_Gallego
Ricardo Gutierrez-Gallego (Anapharm Biotech)
Biosimilarity assessment - impact on safety and efficacy
Joe_Marini
Joseph C. Marini (Janssen R&D, on behalf of AAPS LBABFG)
Recommendations from the AAPS LBABFG Biosimilars Action Program Committee on the Development and Validation of PK and ADA assays for Biosimilar Drug Development
Birgitte_Buur_Rasmussen
Birgitte Buur Rasmussen (Ferring Pharmaceuticals, on behalf of EBF)
Recommendations from EBF biosimilars evaluation group

Day 3

Plenary sessions

Consult the Doctor

Martijn_Hilhorst
Martijn Hilhorst (PRA Health Sciences)
Selectivity issues during the determination of resolvin E1 in human plasma
Matt_Barfield_Doctor
Matt Barfield (Glaxo SmithKline)
Issues with transferring Gyrolab preclinical assays to human.

"Honey I Shrunk the Sample"

Maryann_Ngeny
Maryann Ngeny (AstraZeneca)
Pushing the Boundaries of Microsampling – Realising and Understanding the Full Potential
Jo_Goodman_Microsampling
Jo Goodman (MedImmune)
One Mouse, One PK: the Magic of Capillary Microsampling in Combination with the Gyrolab TM Assay Platform
Beena_Punnamoottil
Beena Punnamoottil (Chimera Biotec)
LBA testing in the fraction of a drop: Case studies for ultra-sensitive assays in 1 to 5 microliter sample volume
Vera_Hillewaert
Vera Hillewaert (Janssen R&D)
Assessment of capillary microsampling of blood in a healthy volunteer study
Zoe_Cobb
Zoe Cobb (LGC, on behalf of the EBF Liquid Microsampling Consortium)
Feedback from EBF Liquid Microsampling Consortium

Young Investigator Award

YIA_Introduction
Introduction
Presentation by the 2014 Young Investigator Award winner

The Regulatory Landscape

Michaela_Golob
Michaela Golob (on behalf of EBF)
Feedback from AAPS Open Forum
Akiko_Ishii
Akiko Ishii (National Institute of Health Science)
Japan LBA guideline
Margarete_Brudny_Kloeppel
Margarete Brudny-Kloeppel (Bayer Pharma AG, on behalf of EBF)
Feedback form China Days knowledge exchange meeting

Diversity of the Bioanalytical Techniques

Gerard_Hopfgartner
Gérard Hopfgartner (University of Geneva)
Quantification of endogenous and exogenous metabolites in small samples using parallel narrow bore to capillary LC with fast polarity switching MRM
Jim_Settlage
Jim Settlage (inVentiv Health Clinical)
Using Supercritical Fluid Chromatography coupled with Tandem Mass Spectrometry to Provide Easier Solutions to Old Problems and New Solutions to Previously Unsolved Problems
Johannes_Stanta
Johannes Stanta (Covance)
Comparing time-of-flight mass spectrometry with triple quadrapole mass spectrometry for small molecule, peptide and oligonucleotide bioanalysis