EBF
EBF Open Symposium
EBF Barcelona

EBF 9th Open Meeting:

Reaching Utopia - The Kaleidoscope of Bioanalysis

EBF 3rd YSS:

In Unity Lies Power; Building a Better Bioanalytical World Together
Hesperia Tower Conference Centre
Barcelona, Spain
November 15, 2016
YSS
November 16-18, 2016
Open Symposium

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 16 nov 2016

08:40

Towards Utopia

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Keynote Speaker: Norberto A. Guzman, Princeton Biochemicals
A Rapid, Sensitive and High-Throughput Affinity-Capture-Separation Technique for
Bioanalytical Applications – Monitoring Wellness, Disease, and Treatment Effectiveness
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Scott Summerfield, GlaxoSmithKline
LC-MS Bioanalysis:  From minutes to seconds
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Renuka Pillutla, Bristol Myers Squibb
Managing the challenges of technology changes in regulated bioanalysis of biotherapeutics
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Ann-Christin Niehoff, Shimadzu (not released for publication)
Mass Spectrometry Imaging of Human Brain Tumors Resected by Fluorescence-Guided Surgery
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10:10 Coffee break
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10:50 

Regulatory Interpretation

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Paul Morgan, AstraZeneca
Tailoring bioanalytical science strategies to support PKPD understanding at
different stages of project lifecycle
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Ian Waterson, MHRA
Bioanalysis and GLP: A Regulatory Perspective
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Yoshiaki Ohtsu, on behalf of the Japan Bioanalysis Forum
Scientific Validation: Feedback from JBF Discussion Group
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Marianne Scheel Fjording, on behalf of the EBF
Feedback from the EBF Focus Workshop on Biomarker Assay validation and analysis
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Philip Timmerman, on behalf of the EBF
What does GLP mean in regulated Bioanalysis or Biomarker Bioanalysis”
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panel discussion
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12:50 Lunch break
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14:00 

Coping with Rare Matrices

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Hans Stieltjes, Janssen R&D
Evaluation of adsorption of various analytes in cerebrospinal fluid
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Michael Gröschl, Celerion
Saliva – a reliable sample matrix in bioanalytics
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Jamil Hantash, Intertek
Method Development and Validation of Biologics and Small Molecules in Ocular Tissues –
Focusing on Bioanalytical Challenges and Foreseeing Regulatory Concerns
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Enric Bertran, F. Hoffmann La Roche
Challenges in Ocular Bioanalysis
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15:20 Tea break
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16:00 

Exploring the Challenges of ADCs

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Rand Jenkins, PPD
ADCs Bioanalysis—LBA and LC-MS methods, a changing paradigm?
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Astrid Leegte, PRA Health Sciences
Total and conjugated PK LBA assays and ADA assay for Antibody-Drug Conjugates (ADC)
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Ranbir Mannu, Covance
LC-MS/MS based strategies for quantification of therapeutic antibody drug conjugates in 
clinical and preclinical studies. 
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John Gebler, Waters
LC/MS Quantification of Critical Components of Antibody Drug Conjugates (ADCs)
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Corinna Krinos-Fiorotti, BioAgilytix
Considerations for the development and validation of cell based neutralization assays for antibody-drug conjugates
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18:00 Cocktail reception
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PARALLEL SESSION —-Day-1

14:00 

Discussion Forum: OECD17

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David Van Bedaf & Eva Lindqvist, for EBF
Introduction and Feedback from EBF team discussing harmonized implementation of OECD-17
Moderators: David Van Bedaf & Eva Lindqvist, for EBF
Forum discussion: towards harmonized implementation of OECD-17
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15:20 Teabreak
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SHOW AND TELL : Feedback from EBF Topic Teams

(pre-registration required when picking up your badge at the registraion desk)
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16:00 

Show and tell 1: Towards a harmonized Data Transfer Agreement (DTA), 

Feedback and recommendation from EBF Topic Team 12

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Moderators from TT-12
Sharing the EBF team recommendation and discussion
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16:00 

Show and tell 2: A harmonized Certificate of Analysis (CoA): Utopia? 

Feedback and recommendation from EBF Topic Team 40

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moderators: topic team leaders
Sharing the EBF team recommendation and discussion
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Day 2 – Thursday 17 nov 2016

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08:30 

Spotlight on Microsampling

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Urs Duthaler, UH Basel  (not released for publication)
A fully automated extraction method to overcome methodological drawbacks of
antiretroviral drug analysis in dried blood spots 
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Karien Bloem, Sanquin (not released for publication)
Dried blood spots obtained by finger prick facilitates therapeutic drug monitoring in 
adalimumab treated patients 
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Sheelan Ahmad, GlaxoSmithKline
Will Zero Blood Withdrawal Make SPME a Microsampling Hero?
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Glen Hawthorne, on behalf of the EBF LMS Consortium
Update from the EBF Liquid Microsampling Consortium
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Panel discussion
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10:10 Coffee break
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11:00 

The e-environment

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Andreas Henrichs, Sanofi
Current practice of archiving e-data in the GLP environment at SANOFI
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David Van Bedaf, Janssen R&D (in collaboration with BSSN-Sciex)
Strategies for long-term preservation of analytical e-data using the AnIML format
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Anne Kruse Lykkeberg, Lundbeck
Study Master: Management of clinical samples in phase III studies using advances Excel.
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Nicola Stacey, LGC
A risk-based approach to validation of Commercial off the Shelf (COTS) Computerised Systems
in a GxP environment – The challenge of balancing efficiency with integrity.
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Louise Radzikowski, Novo Nordisk
SEND implementation in NN – story, status and challenges from a Bioanalytical point of view
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12:40 Lunch break
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14:00 

What makes Bioanalysis Fun  – 1

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Teresa Heslop, GlaxoSmithKline  (not released for publication)
“Old Dogs, New Tricks!”:  HILIC Chromatography with Deuterium Exchange for the Quantification
of Ribarvirin from Human Plasma and Bronchoalveolar Lavage Fluid
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Morten Funch Carlsen, Leo Pharma
Biosynthesis, structural identification and quantification of low pg/mL levels of a major human 
metabolite of a dermal drug candidate – a multidisciplinary challenge!
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Amedeo De Nicolò, Università degli Studi di Torino in collaboration with Shimadzu
Evaluation of Internal Standard Normalized Matrix Effects (IS-nME) for mass spectrometry method
validation: examples of clinical application.
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Lieve Dillen, Janssen R&D
Standardized approach to assess light stability of drugs in blood and plasma and subsequent impact
on pharmacokinetic sampling procedures.
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Sara Stensson, Ferring
Bioanalysis of potent small cyclic peptides  – Ways to reach the LLQ Utopia
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15:40 Tea break
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16:15 

Large Molecule LC-MS

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Leo Kirkovsky, Pfizer
Dual “Hybrid” and Regular LC-MS/MS Assay for the Quantitation of Unconjugated and Conjugated
Calicheamicin  in Support of Mylotarg (gemtuzumab ozogamicin) Pediatric Study
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Szabolcs Szarka, LGC
Glu-C – an orthogonal and alternative enzyme for protein quantitation by LC-MS/MS
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Daniel Wilffert, QPS
Antibody-free LC-MS/MS protein analysis of TRAIL
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Nikunj Tanna, Waters
Large Molecule Bioanalysis – Tools and workflows to simplify method development for targeted MRM methods
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Kevin Ray, MilliporeSigma / Merck KGaA
  Quantitation of Proteins and Monoclonal Antibodies In Serum by LC-MS/MS Using Full-Length
Stable Isotope Labeled Internal Standards
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18:00 Cocktail reception
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PARALLEL SESSION —-Day-2 

08:30 

Biomarker Parallelism

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Robert Nelson, on behalf of EBF TT-61
Non-parallelism in biomarker assays
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Afshin Safavi, BioAgilytix
Considerations for Evaluation of Parallelism in Biomarker Ligand-Binding Assays:
Case Studies of Failed Biomarker Assay Parallelism
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Julie De Gagné, Novartis
The use of parallelism to define biomarker assay parameters: a case study
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Jing Tu, PPD
A Soluble Receptor (sBCMA) Biomarker Parallelism Case Study – Using Parallelism Experiments to
z Effectively Evaluate Matrix Effects and Selectivity in the Early Stage of LBA Method Development
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Panel discussion
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10:10 Coffee break
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11:00

Pushing the boundaries of Large Molecule Analysis

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Gregor Jordan, F. Hoffmann La Roche  (not released for publication)
Improved ELISA performance by simple switching from a colorimetric to fluorimetric HRP substrate
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Christian Pieper, Chimera Biotec
Biologics – Biomarker – Bioanalysis. Challenges followed by solution – What to do when new drug
programs reach technical limitations in target quantification
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Craig Stovold, AstraZeneca
Amplification Challenge: Comparison of bDNA and PCR-based analytical methods for the
determination of nucleotide-based therapeutics
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Bert Rutten, LGC
Comparison of Critical Method Validation Parameters on the Quanterix Simoa and the Singulex Erenna.
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Bioanalysis Zone New Investigator Award Winner
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12:40 Lunch break
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14:00

What makes Bioanalysis fun  – 2

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Roland Staack, F. Hoffmann La Roche
Importance of fully characterized bioanalytical methods –  the bioanalytical challenges to
support the develpment of a lipidated fusion protein 
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Hanna Ritzen, Mercodia
Life cycle management of biomarker assays a route to improved patient outcome.
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Martine Broekema, PRA Health Sciences
Challenges in receptor occupancy determination assays by flow cytometry in drug development
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Christele Gonneau, Covance CLS
Paving the road to Utopia through instrument standardization
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Anne Incamps, Thermo Fisher Scientific
Biomarkers Validation : an Orthogonal approach using Mass Spectrometry and Immunoassays
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15:40 Tea break
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16:15

Immunogenicity

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Jo Goodman, on behalf of the EBF
Feedback from the EBF Focus Workshop  (September 2016, Lisbon) on Current Analysis of Immunogenicity
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James Munday, Covance
Pre-clinical Immunogenicity assessment – Scientific validation versus Regulatory 
validation approach. What is the appropriate tiered analysis?
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Robert Nelson, Novimmune
The best-laid schemes o’ mice an’ men: when clinical assumptions go awry
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Viswanath Devanarayan, Abbvie
Clinical Interpretation of ADA
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Panel discussion
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Day 3 – Friday 18 nov 2016

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09:00 

The Broad Utility of HRMS

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Esther van Duijn, TNO
The combined use of HRMS and AMS for simultaneous metabolite quantification and identification
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Nico van de Merbel, PRA Health Sciences
A practical comparison of triple-quadrupole and high-resolution mass spectrometry for peptide and protein quantification
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Barry Jones, Q2 Solutions
LC-HRMS for Quantitative Bioanalysis in the Regulated Contract Research Laboratory:
Small, Medium, and Large Molecule Applications
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Keeley Murphy, Thermo Fisher Scientific
Comprehensive workflows for high performance quantitation utilizing high resolution accurate mass
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PARALLEL SESSION —-Day-3 

09:00

Abnormal PK

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Daniela Stoellner, on behalf of EBF TT-63
TT-63: Handling of PK data from ADA positive animals
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Nick White, MedImmune
Abnormal PK; Even With Informed Predictions it Happens to the Best of Us!
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Sherri Dudal, UCB BioPharma  (not released for publication)
Challenge of PKPD of biologics in preclinical disease models: PK and BA perspectives
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Anne Larvor, Amatsigroup
Management of abnormal PK profiles:s BA and PK point of view through several examples.
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Panel discussion
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10:40 Coffee break
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11:25 

UTOPIA: THE SCIENCE OF A MODERN GUIDELINE

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Interactive session  (Each sub-session consists of a short introduction followed
by an interactive discussion involving all conference delegates)
General Introduction – aim of the session
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The science of a modern guidance – focus on The common themes
moderated panel session
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The science of a modern guidance – focus on Ligand binding assays
moderated panel session
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The science of a modern guidance – focus on Chromatography based assays
moderated panel session
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Closing comments and next steps
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12:55 Plans for 2017 / Close Out