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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

Platinum Sponsors

 Atlanbio / CiToxLAB LGC Shimadzu Excellence in Science Thermo Scientific Waters

Gold Sponsors

AB Sciex AbD Accelera Agilent Technologies Amatsi Group Bertin Pharma Bioanalysis Bioanalysis Zone Biosims Biotage Biotrial CAMAG Celerion ATM Covance CRS EUROFINS GYROS Intertek InVentivHealth Clinical iStudy Reporter LabWare Lambda Luminex Nuvisan Peak Scientific PPD PRA Health Sciences QPS Quality Assistance Quintiles SGS Sigma Aldrich Singulex Spark Holland Swiss Bionanalytics Synlab Lab Services TNO Triskelion Unilabs

Program at a glance

A detailed program for each session can be found below, and by clicking on the sessions.

Day 1 overview - Wednesday 19 NOV 2014

Plenary sessions

  08:30 08:40   Welcome
  08:40 10:20   Large molecules - LBA or LC-MS? Why and when
  10:20 11:00   Coffee break
  11:00 12:40   Large molecules - LBA and LC-MS! How
  12:40 14:00   Lunch break
  14:00 15:20   Looking Beyond the Horizon
  15:20 16:00   Tea break
  16:00 17:45   Scientific or Regulated Validation? AKA Tiered Approach
  18:00 19:00   Cocktail reception

Spotlight Workshop

  11:00 12:40   Spotlight on e-Data

Day 2 overview - Thursday 20 NOV 2014

Parallel Sessions 1

  08:30 10:10   LC-MS Applications for Large Molecules
  10:10 11:00   Coffee break
  11:00 12:40   Diversity of the Bioanalytical Landscape
  12:40 14:00   Lunch break
  14:00 15:40   Low, Lower, Lowest
  15:40 16:15   Tea break
  16:15 17:55   Bioanalytical Assay Robustness
  18:00 19:00   Cocktail reception

Parallel Sessions 2

  08:30 10:10   Day to Day Challenges and Automation in Bioanalysis
  10:10 11:00   Coffee break
  11:00 12:40   Immunoassays for Biomarkers
  12:40 14:00   Lunch break
  14:00 15:40   New Technologies and Applications in Large Molecule Bioanalysis
  15:40 16:15   Tea break
  16:15 17:55   Biosimilars
  18:00 19:00   Cocktail reception

Day 3 overview - Friday 21 NOV 2014

Plenary sessions

  08:30 09:00   Consult the Doctor
  09:00 10:40   "Honey I Shrunk the Sample"
  10:40 11:15   Young Investigator Award
  11:15 11:55   Coffee & Snack break
  11:55 12:55   The Regulatory Landscape
  12:55 13:55   Diversity of the Bioanalytical Techniques
  13:55 14:00   Plans for 2015 / Close Out

Details of the sessions

Day 1 - Wednesday 19 NOV 2014

Plenary sessions

 08:3008:40 Welcome
 08:4010:20 Large molecules - LBA or LC-MS? Why and when
 08:4009:00 Roland Staack (Hoffmann-La Roche)
Protein Quantification by LBA or LC-MS: Key Criteria for the Definition of the Bioanalytical Strategy
 09:0009:20 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
 09:2009:40 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?
 09:4010:00 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
 10:0010:20 Panel Discussion
 10:2011:00 Coffee break
 11:0012:40 Large molecules - LBA and LC-MS! How
 11:0011:20 Matt Barfield (GlaxoSmithKline, on behalf of EBF TT-43)
How to develop Antibody Drug Conjugates – Recommendations from TT43 and survey results
 11:2011:40 Charlotte Hagman (Novartis)
Characterization of Antibody-Drug Conjugates using Affinity Enrichment and High-Resolution Mass Spectrometry
 11:4012:00 Fabio Garofolo (Algorithme Pharma Inc)
Recent Trends in Antibody-Drug Conjugate (ADC) Bioanalysis: Total Antibody Quantification by HRMS
 12:0012:20 Ravindra Chaudhari (Thermo Fisher Scientific)
Highly Sensitive and Robust Workflow for Therapeutic Monoclonal Antibody Analysis from Complex Matrices
 12:2012:40 Panel Discussion
 12:4014:00 Lunch break
 14:0015:20 Looking Beyond the Horizon
 14:0014:20 Philip Timmerman (Janssen R&D)
Making the impossible possible
 14:2014:40 John Varaklis (Abbott)
Beyond the Horizon: Convergence of Data-enabled Health Solutions and Clinical Development Models
 14:4015:00 Zsofia Berke (AstraZeneca)
Analytical Comparison Between Point-of-Care Uric Acid Testing Meters
 15:0015:20 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
 15:2016:00 Tea break
 16:0017:45 Scientific or Regulated Validation? AKA Tiered Approach
 16:0016:20 Philip Timmerman (Janssen R&D, on behalf of EBF)
EBF proposals on balancing Scientific vs. Regulated Validation
 16:2016:40 David Jones (MHRA)
An EU Regulatorís viewpoint as why Regulatory Guidelines should not be followed
 16:4017:00 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
 17:0017:20 Graeme Smith (Harlan / Huntington Life Sciences)
A Tiered Approach to Bioanalysis: From Concept to Practice
 17:2017:45 Panel discussion
 18:0019:00 Cocktail reception

Spotlight Workshop

 11:0012:40 Spotlight on e-Data: towards a common standard
 11:0011:05 Introduction to the workshop
Workshop chairs (Hans Mulder (Astellas) /David Van Bedaf (Janssen R&D))
 11:0511:25 Jim Brennan (LabWare)
A perspective on paperless operations in a modern bioanalytical laboratory
 11:2511:45 Gerhard Noelken (Allotrope)
Allotrope: An open ecosystem for seamless data management and exchange for Bioanalysis
 11:4512:05 Peter Esch (Novartis)
Electronic Raw Data in a GLP Environment – Swiss AGIT Working Group Guidelines
 12:0512:40 Panel discussion - workshop
Gaps and practical steps towards a common e-standard for bioanalysis

Day 2 - Thursday 20 NOV 2014

Parallel Sessions 1

 08:3010:10 LC-MS Applications for Large Molecules
 08:3008:50 Kevin Bateman (MSD)
Application of LC-MS for characterization and bioanalysis of therapeutic antibodies
 08:5009:10 Ludovicus Staelens (UCB Pharma)
Internal standard approaches in quantification of proteins by LC-MS/MS
 09:1009:30 Richard Kay (LGC)
Supercharging reagents - revving up peptide LC-MS analyses.
 09:3009:50 Vincent Trinh (inVentiv Health Clinical)
Insulin Glargine: From the Immunoassays to the More Specific LC-MS/MS Assay
 09:5010:10 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
 10:1011:00 Coffee break
 11:0012:40 Diversity of the Bioanalytical Landscape
 11:0011:20 Ann Lévesque (inVentiv Health Clinical)
Determination of Testosterone in Plasma instead of Serum: When is it needed? Is it accepted?
 11:2011:40 Susan Pang (LGC)
The development of robust cortisol assays for sports-based applications
 11:4012:00 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
 12:0012:20 Jonathan Stauber (ImaBiotech)
Applications of Quantitative Mass Spectrometry Imaging in drug development
 12:2012:40 Mohammed Abrar (Unilabs York Bioanalytical Solutions)
Vitamin D3 Determination- Automated, Streamlined, Robust and Reliable
 12:4014:00 Lunch break
 14:0015:40 Low, Lower, Lowest
 14:0014:20 William van Dongen (TNO Triskelion)
Nano-UPLC and Chip-based LC-MS methods for the sensitive determination of therapeutic monoclonal antibodies in serum
 14:2014:40 Mark Wrona (Waters Corporation)
Integration of microfluidics with High Resolution Mass Spectrometry (HRMS) for DMPK Studies
 14:4015:00 Tom Verhaeghe (Janssen R&D)
LC-MS/MS as an enabler for a broader application of microdose studies in drug development; the Janssen experience
 15:0015:20 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
 15:2015:40 Stephen English (Xceleron)
Tiered validation of LC+AMS Assays: Recommendations for best practices
 15:4016:15 Tea break
 16:1517:55 Bioanalytical Assay Robustness
 16:1516:35 Steve White (GlaxoSmithKline)
Measuring assay robustness across the life cycle of a bioanalyical method
 16:3516:55 Amanda Wilson (AstraZeneca, on behalf of EBF TT-41)
EBF Topic Team-41; Processed Sample Reproducibility and Stability
 16:5517:15 David Bakes (Harlan / Huntington Life Sciences)
An industry consensus towards baseline assignment – where do we draw the line?
 17:1517:35 Luc Bouchard (inVentiv Health Clinical)
Importance of End-to-End Robustness when dealing with Glucuronide Metabolites
 17:3517:55 Susanne Pihl (Lundbeck, on behalf of EBF TT-47)
EBF recommendation on practical management of critical reagents for ligand-binding assays
 18:0019:00 Cocktail reception

Parallel Sessions 2

 08:3010:10 Day to Day Challenges and Automation in Bioanalysis
 08:3008:50 Raymond Farmen (Celerion)
Integrating automated systems for regulated bioanalysis
 08:5009:10 Christophe Zickler (Novartis)
Automated bioanalysis of PK, PD and immunogenicity in a GLP/GCLP regulated environment
 09:1009:30 Craig Stovold (LGC)
Assessing Carryover in the Immunoassay Laboratory
 09:3009:50 Matt Bentley (Eurofins Pharma Bioanalysis Services)
Practical solutions to the optimisation of drug tolerance in ADA method Development
 09:5010:10 Gert Hendriks (PRA Health Sciences)
Matrix effects in lipemic plasma: practical solutions to additional issues in bioanalytical method development and validation
 10:1011:00 Coffee break
 11:0012:40 Immunoassays for Biomarkers
 11:0011:20 Dominique Gouty (BioAgilytix)
Selecting the right strategy for Biomarkers
 11:2011:40 Karen Elsby (AstraZeneca)
The MULTIple trials of generating a SINGLE data set: taking biomarker assays through the clinical phases
 11:4012:00 James Lawrence (Harlan / Huntington Life Sciences)
Adapting Commercial Immunoassay Kits for Pre-Clinical Biomarkers: Challenges and Solutions.
 12:0012:20 Jo Goodman (MedImmune)
The changing face of the immunoassay landscape for soluble target engagement biomarkers quantification
 12:2012:40 Marianne Scheel Fjording (Novo Nordisk)
Gold, Silver, Bronze
 12:4014:00 Lunch break
 14:0015:40 New Technologies and Applications in Large Molecule Bioanalysis
 14:0014:20 Michael Przybylski (University of Konstanz)
Online SAW-Biosensor-Mass Spectrometry: Simultaneous Detection, Structure Determination and Affinity Quantification of Protein-Ligand Interactions
 14:2014:40 Robert Nelson (NovImmune SA)
Evaluating multiple technology platforms in the development of large molecule bioanalytical assays
 14:4015:00 Clare Kingsley (LGC)
Ultrasensitivity immunoassays
 15:0015:20 Nick Pearson (CiToxLAB)
Quantifying short RNA molecules in a regulatory environment
 15:2015:40 Ashleigh Wake (Intertek Life Sciences)
Alternative Methods to LC-MSMS and Immunochemistry Based Method in Bioanalysis
 15:4016:15 Tea break
 16:1517:55 Biosimilars
 16:1516:35 Timo Piironen (Syrinx Bioanalytics)
Challenges and strategies of developing and validating immunogenicity assays for biosimilars
 16:3516:55 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.
 16:5517:15 Ricardo Gutierrez-Gallego (Anapharm Biotech)
Biosimilarity assessment - impact on safety and efficacy
 17:1517:30 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
 17:3017:45 Birgitte Buur Rasmussen (Ferring Pharmaceuticals, on behalf of EBF)
Recommendations from EBF biosimilars evaluation group
 17:4518:00 Panel Discussion
 18:0019:00 Cocktail reception

Day 3 - Friday 21 NOV 2014

Plenary sessions

  08:30 09:00   Consult the Doctor
  08:30 08:45   Martijn Hilhorst (PRA Health Sciences)
Selectivity issues during the determination of resolvin E1 in human plasma
  08:45 09:00   Matt Barfield (Glaxo SmithKline)
Issues with transferring Gyrolab preclinical assays to human.
  09:00 10:40   "Honey I Shrunk the Sample"
  09:00 09:20   Maryann Ngeny (AstraZeneca)
Pushing the Boundaries of Microsampling – Realising and Understanding the Full Potential
  09:20 09:40   Jo Goodman (MedImmune)
One Mouse, One PK: the Magic of Capillary Microsampling in Combination with the Gyrolab TM Assay Platform
  09:40 10:00   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
  10:00 10:20   Vera Hillewaert (Janssen R&D)
Assessment of capillary microsampling of blood in a healthy volunteer study
  10:20 10:40   Zoe Cobb (LGC, on behalf of the EBF Liquid Microsampling Consortium)
Feedback from EBF Liquid Microsampling Consortium
  10:40 11:15   Young Investigator Award
  10:40 10:45   Introduction
  10:45 11:15   Presentation by the 2014 Young Investigator Award winner
  11:15 11:55   Coffee & Snack break
  11:55 12:55   The Regulatory Landscape
  11:55 12:15   Michaela Golob (on behalf of EBF)
Feedback from AAPS Open Forum
  12:15 12:35   Akiko Ishii (National Institute of Health Science)
Japan LBA guideline
  12:35 12:55   Margarete Brudny-Kloeppel (Bayer Pharma AG, on behalf of EBF)
Feedback form China Days knowledge exchange meeting
  12:55 13:55   Diversity of the Bioanalytical Techniques
  12:55 13:15   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
  13:15 13:35   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
  13:35 13:55   Johannes Stanta (Covance)
Comparing time-of-flight mass spectrometry with triple quadrapole mass spectrometry for small molecule, peptide and oligonucleotide bioanalysis
  13:55 14:00   Plans for 2015 / Close Out