European Bioanalysis Forum

BCN Slides 2014

Program of EBF 7th Open Conference  “Beyond the Horizon – Painting a new landscape”  November  19-21, 2014

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 – Wednesday 19 NOV 2014

08.30-08.40  Welcome     Philip Timmerman, on behalf of the EBF
08.40-10.20  Large molecules – LBA or LC-MS? Why and when
 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 & 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 (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 (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
 Panel Discussion 
10.20-11.00  Coffee break
11.00-12.40  Large molecules – LBA and LC-MS! How
 Matt Barfield (GlaxoSmithKline, on behalf of EBF TT-43)  
 How to develop Antibody Drug Conjugates – Recommendations from TT43 and
 survey results
 Charlotte Hagman (Novartis)  
 Characterization of Antibody-Drug Conjugates using Affinity Enrichment
 and High-Resolution Mass Spectrometry
 Fabio Garofolo (Algorithme Pharma Inc)  
 Recent Trends in Antibody-Drug Conjugate (ADC) Bioanalysis: Total
 Antibody Quantification by HRMS
 Ravindra Chaudhari (Thermo Fisher Scientific)  
 Highly Sensitive and Robust Workflow for Therapeutic Monoclonal
 Antibody Analysis from Complex Matrices
 Panel Discussion 
12.40-14.00  Lunch break
14.00-15.20  Looking Beyond the Horizon
 Philip Timmerman (Janssen R&D)  
 Making the impossible possible
 We are the future
 Zsofia Berke (AstraZeneca)  
 Analytical Comparison Between Point-of-Care Uric Acid Testing Meters
 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
15.20-16.00  Tea break
16.00-17.45  Scientific or Regulated Validation? AKA Tiered Approach
 Philip Timmerman (Janssen R&D, on behalf of EBF)  
 EBF proposals on balancing Scientific vs. Regulated Validation
 David Jones (MHRA)  
 An EU Regulator�s viewpoint as why Regulatory Guidelines should not be 
 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 (Harlan / Huntington Life Sciences) 
 A Tiered Approach to Bioanalysis: From Concept to Practice
 Panel discussion 
18.00-19.00  Cocktail reception
11.00-12.40  Spotlight on e-Data: towards a common standard
 Introduction to the workshop 
 Workshop chairs (Hans Mulder (Astellas) /David Van Bedaf (Janssen R&D))
 Jim Brennan (LabWare) 
 A perspective on paperless operations in a modern bioanalytical laboratory
 Gerhard Noelken (Allotrope)  
 Allotrope: An open ecosystem for seamless data management and exchange for 
 Peter Esch (Novartis)  
 Electronic Raw Data in a GLP Environment – Swiss AGIT Working Group 
 Panel discussion – workshop
 Gaps and practical steps towards a common e-standard for bioanalysis

Day 2 – Thursday 20 NOV 2014

08.30-10.10  LC-MS Applications for Large Molecules
 Kevin Bateman (MSD)  
 Application of LC-MS for characterization and bioanalysis of therapeutic 
 Ludovicus Staelens (UCB Pharma)  
 Internal standard approaches in quantification of proteins by LC-MS/MS
 Richard Kay (LGC)  
 Supercharging reagents – revving up peptide LC-MS analyses.
 Vincent Trinh (inVentiv Health Clinical)  
 Insulin Glargine: From the Immunoassays to the More Specific LC-MS/MS Assay
 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
10.10-11.00  Coffee break
11.00-12.40  Diversity of the Bioanalytical Landscape
 Ann Lévesque (inVentiv Health Clinical)  
 Determination of Testosterone in Plasma instead of Serum: 
 When is it needed? Is it accepted?
 Susan Pang (LGC)  
 The development of robust cortisol assays for sports-based applications
 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
 Jonathan Stauber (ImaBiotech)  
 Applications of Quantitative Mass Spectrometry Imaging in drug development
 Mohammed Abrar (Unilabs York Bioanalytical Solutions) 
 Vitamin D3 Determination- Automated, Streamlined, Robust and Reliable
12.40-14.00  Lunch break
14.00-15.40  Low, Lower, Lowest
 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 (Waters Corporation)  
 Integration of microfluidics with High Resolution Mass Spectrometry (HRMS) 
 for DMPK Studies
 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 (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 (Xceleron)  
 Tiered validation of LC+AMS Assays: Recommendations for best practices
15.40-16.15  Tea break
16.15-17.55  Bioanalytical Assay Robustness
 Steve White (GlaxoSmithKline) 
 Measuring assay robustness across the life cycle of a bioanalyical method
 Amanda Wilson (AstraZeneca, on behalf of EBF TT-41)  
 EBF Topic Team-41; Processed Sample Reproducibility and Stability
 David Bakes (Harlan / Huntington Life Sciences)  
 An industry consensus towards baseline assignment – where do we draw the line?
 Luc Bouchard (inVentiv Health Clinical)  
 Importance of End-to-End Robustness when dealing with Glucuronide 
 Susanne Pihl (Lundbeck, on behalf of EBF TT-47) 
 EBF recommendation on practical management of critical reagents for 
 ligand-binding assays
18.00-19.00  Cocktail reception
08.30-10.10  Day to Day Challenges and Automation in Bioanalysis
 Raymond Farmen (Celerion)  
 Integrating automated systems for regulated bioanalysis
 Christophe Zickler (Novartis)  
 Automated bioanalysis of PK, PD and immunogenicity in a GLP/GCLP 
 regulated environment
 Craig Stovold (LGC)  
 Assessing Carryover in the Immunoassay Laboratory
 Matt Bentley (Eurofins Pharma Bioanalysis Services)  
 Practical solutions to the optimisation of drug tolerance in ADA method Development
 Gert Hendriks (PRA Health Sciences)  
 Matrix effects in lipemic plasma: practical solutions to additional issues in 
 bioanalytical method development and validation
10.10-11.00  Coffee break
11.00-12.40  Immunoassays for Biomarkers
 Dominique Gouty (BioAgilytix)  
 Selecting the right strategy for Biomarkers
 Karen Elsby (AstraZeneca)  
 The MULTIple trials of generating a SINGLE data set: taking biomarker assays 
 through the clinical phases
 James Lawrence (Harlan / Huntington Life Sciences)  
 Adapting Commercial Immunoassay Kits for Pre-Clinical Biomarkers:  
 Challenges and Solutions.
 Jo Goodman (MedImmune)  
 The changing face of the immunoassay landscape for soluble target engagement
 biomarkers quantification
 Marianne Scheel Fjording (Novo Nordisk)  
 Gold, Silver, Bronze
12.40-14.00  Lunch break
14.00-15.40  New Technologies and Applications in Large Molecule Bioanalysis
 Michael Przybylski (University of Konstanz)  
 Online SAW-Biosensor-Mass Spectrometry: Simultaneous Detection, Structure 
 Determination and Affinity Quantification of Protein-Ligand Interactions
 Robert Nelson (NovImmune SA)  
 Evaluating multiple technology platforms in the development of large molecule 
 bioanalytical assays.
 Clare Kingsley (LGC)  
 Ultrasensitivity immunoassays
 Nick Pearson (CiToxLAB)  
 Quantifying short RNA molecules in a regulatory environment
 Ashleigh Wake (Intertek Life Sciences)  
 Alternative Methods to LC-MSMS and Immunochemistry Based Method in 
15.40-16.15  Tea break
16.15-17.55  Biosimilars
 Timo Piironen (Syrinx Bioanalytics)  
 Challenges and strategies of developing and validating immunogenicity assays 
 for biosimilars
 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 (Anapharm Biotech)  
 Biosimilarity assessment – impact on safety and efficacy
 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 (Ferring Pharmaceuticals, on behalf of EBF)  
 Recommendations from EBF biosimilars evaluation group
 Panel Discussion 
18.00-19.00  Cocktail reception

Day 3 – Friday 21 NOV 2014

08.30-09.00  Consult the Doctor
 Martijn Hilhorst (PRA Health Sciences)  
 Selectivity issues during the determination of resolvin E1 in human plasma
 Matt Barfield (Glaxo SmithKline)  
 Issues with transferring Gyrolab preclinical assays to human
09.00-10.40  “Honey I Shrunk the Sample”
 Maryann Ngeny (AstraZeneca)  
 Pushing the Boundaries of Microsampling – Realising and Understanding the 
 Full Potential
 Jo Goodman (MedImmune)  
 One Mouse, One PK: the Magic of Capillary Microsampling in Combination 
 with the Gyrolab TM Assay Platform
 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 (Janssen R&D)  
 Assessment of capillary microsampling of blood in a healthy volunteer study
 Zoe Cobb (LGC, on behalf of the EBF Liquid Microsampling Consortium)  
 Feedback from EBF Liquid Microsampling Consortium
10.40-11.15  Young Investigator Award
 Presentation by the 2014 Young Investigator Award winner  
11.15-11.55  Coffee & Snack break
11.55-12.55  The Regulatory Landscape
 Michaela Golob (on behalf of EBF 
 Feedback from AAPS Open Forum
 Akiko Ishii (National Institute of Health Science)  
 Japan LBA guideline
 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
 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 (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 (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


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