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

Program at a glance

A detailed program of each session can be found below and by clicking on the session.
The program details can be downloaded by clicking here.

Day 0 – Tuesday 15 nov 2016

16:00 19:00 Complementary Pt cocktail reception during registration
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Day 1 – Wednesday 16 nov 2016

08:30 08:40 Welcome
08:40 10:10 Towards Utopia
10:10 10:50 Coffee break
10:50 12:50 Regulatory Interpretation
12:50 14:00 Lunch break
14:00 15:20 Coping with Rare Matrices 14:00 15:20 Discussion Forum: OECD17
15:20 16:00 Tea break 15:20 16:00 Tea break
16:00 17:45  Exploring the Challenges of ADCs 16:00 17:00 SHOW AND TELL : 
Feedback from EBF Topic Teams
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18:00 19:00 Cocktail reception
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Day 2 – Thursday 17 nov 2016

08:30 10:10 Spotlight on Microsampling 08:30 10:10 Biomarker Parallelism
10:10 11:00 Coffee break 10:10 11:00 Coffee break
11:00 12:40 The e-environment 11:00 12:20 Pushing the boundaries of Large 
Molecule Analysis
12:40 14:00 Lunch break 12:20 14:00 Lunch break
14:00 15:40 What makes Bioanalysis Fun  – 1 14:00 15:40 What makes Bioanalysis Fun  – 2
15:40 16:15 Tea break 15:40 16:15 Tea break
16:15 17:55  Large Molecule LC-MS 16:15 17:55 Immunogenicity
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18:00 19:00 Cocktail reception
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Day 3 – Friday 18 nov 2016

09:00 10:40 The Broad Utility of HRMS 09:00 10:40 Abnormal PK
10:40 11:25 Coffee break 10:40 11:25 Coffee break
11:25 12:55 UTOPIA: the science of a  
modern Guideline
12:55 13:00 Plans for 2017 / Close Out

PROGRAM DETAILS

 

———————-Day 1 – Wednesday 16 nov 2016———————-

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08:30 08:40 Welcome
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08:40

10:10

Towards Utopia

08:40 09:10 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
09:10 09:30 Scott Summerfield, GlaxoSmithKline
LC-MS Bioanalysis:  From minutes to seconds
09:30 09:50 Renuka Pillutla, Bristol Myers Squibb
Managing the challenges of technology changes in regulated bioanalysis of biotherapeutics
09:50 10:10 Ann-Christin Niehoff, Shimadzu
Mass Spectrometry Imaging of Human Brain Tumors Resected by Fluorescence-Guided Surgery
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10:10 10:50 Coffee break
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10:50

12:40

Regulatory Interpretation

10:50 11:10 Paul Morgan, AstraZeneca
Tailoring bioanalytical science strategies to support PKPD understanding at
different stages of project lifecycle
11:10 11:30 Ian Waterson, MHRA
Bioanalysis and GLP: A Regulatory Perspective
11:30 11:50 Yoshiaki Ohtsu, on behalf of the Japan Bioanalysis Forum
Scientific Validation: Feedback from JBF Discussion Group
11:50 12:10 Marianne Scheel Fjording, on behalf of the EBF
Feedback from the EBF Focus Workshop on Biomarker Assay validation and analysis
12:10 12:30 Philip Timmerman, on behalf of the EBF
What does GLP mean in regulated Bioanalysis or Biomarker Bioanalysis”
12:30 12:50 Panel discussion
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12:50 14:00 Lunch break
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14:00

15:20

Coping with Rare Matrices

14:00 14:20 Hans Stieltjes, Janssen R&D 
Evaluation of adsorption of various analytes in cerebrospinal fluid
14:20 14:40 Michael Gröschl, Celerion
Saliva – a reliable sample matrix in bioanalytics
14:40 15:00 Jamil Hantash, Intertek
Method Development and Validation of Biologics and Small Molecules in Ocular Tissues –
Focusing on Bioanalytical Challenges and Foreseeing Regulatory Concerns
15:00 15:20 Enric Bertran, F. Hoffmann La Roche
Challenges in Ocular Bioanalysis
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15:20 16:00 Tea break
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16:00

17:45 

Exploring the Challenges of ADCs

16:00 16:20 Rand Jenkins, PPD
ADCs Bioanalysis—LBA and LC-MS methods, a changing paradigm?
16:20 16:40 Astrid Leegte, PRA Health Sciences
Total and conjugated PK LBA assays and ADA assay for Antibody-Drug Conjugates (ADC)
16:40 17:00 Ranbir Mannu, Covance
LC-MS/MS based strategies for quantification of therapeutic antibody drug conjugates in 
clinical and preclinical studies. 
17:00 17:20 John Gebler, Waters
LC/MS Quantification of Critical Components of Antibody Drug Conjugates (ADCs)
17:20 17:40 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 19:00 Cocktail reception
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—————————————————-Parallel session —-Day-1 ————————————————-

14:00

15:20

Discussion Forum: OECD17

14:00 14:20 David Van Bedaf & Eva Lindqvist, for EBF
Introduction and Feedback from EBF team discussing harmonized implementation of OECD-17
14:20 15:20 Moderators: David Van Bedaf & Eva Lindqvist, for EBF
Forum discussion: towards harmonized implementation of OECD-17
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15:20 16:00 Teabreak
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16:00

17:00

SHOW AND TELL : Feedback from EBF Topic Teams

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

17:00

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

Feedback and recommendation from EBF Topic Team 12

16:00 16:10 Introduction
Moderators from TT-12
16:10 17:00 Sharing the EBF team recommendation and discussion
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16:00

17:00

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

Feedback and recommendation from EBF Topic Team 40

16:00 16:10 Introduction
moderators: topic team leaders
16:10 17:00 Sharing the EBF team recommendation and discussion
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—————————-Day 2 – Thursday 17 nov 2016———————

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08:30

10:10

Spotlight on Microsampling

08:30 08:50 Urs Duthaler, UH Basel
A fully automated extraction method to overcome methodological drawbacks of
antiretroviral drug analysis in dried blood spots 
08:50 09:10 Karien Bloem, Sanquin
Dried blood spots obtained by finger prick facilitates therapeutic drug monitoring in 
adalimumab treated patients
09:10 09:30 Sheelan Ahmad, GlaxoSmithKline
Will Zero Blood Withdrawal Make SPME a Microsampling Hero?
09:30 09:50 Glen Hawthorne, on behalf of the EBF LMS Consortium
Update from the EBF Liquid Microsampling Consortium
09:50 10:10 Panel discussion
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10:10 11:00 Coffee break
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11:00

12:40

The e-environment

11:00 11:20 Andreas Henrichs, Sanofi
Current practice of archiving e-data in the GLP environment at SANOFI
11:20 11:40 David Van Bedaf, Janssen R&D (in collaboration with BSSN-Sciex)
Strategies for long-term preservation of analytical e-data using the AnIML format
11:40 12:00 Anne Kruse Lykkeberg, Lundbeck
Study Master: Management of clinical samples in phase III studies using advances Excel.
12:00 12:20 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.
12:20 12:40 Louise Radzikowski, Novo Nordisk
SEND implementation in NN – story, status and challenges from a Bioanalytical point of view
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12:40 14:00 Lunch break
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14:00

15:40

What makes Bioanalysis Fun  – 1

14:00 14:20 Teresa Heslop, GlaxoSmithKline
 “Old Dogs, New Tricks!”:  HILIC Chromatography with Deuterium Exchange for the Quantification
of Ribarvirin from Human Plasma and Bronchoalveolar Lavage Fluid
14:20 14:40 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!
14:40 15:00 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..
15:00 15:20 Lieve Dillen, Janssen R&D
Standardized approach to assess light stability of drugs in blood and plasma and subsequent impact
on pharmacokinetic sampling procedures.
15:20 15:40 Sara Stensson, Ferring
Bioanalysis of potent small cyclic peptides  – Ways to reach the LLQ Utopia
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15:40 16:15 Tea break
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16:15

17:55 

Large Molecule LC-MS

 16:15 16:35 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
16:35 16:55 Szabolcs Szarka, LGC
Glu-C – an orthogonal and alternative enzyme for protein quantitation by LC-MS/MS
16:55 17:15 Daniel Wilffert, QPS
Antibody-free LC-MS/MS protein analysis of TRAIL
17:15 17:35 Nikunj Tanna, Waters
Large Molecule Bioanalysis – Tools and workflows to simplify method development for targeted MRM methods
17:35 17:55 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 19:00 Cocktail reception
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—————————————————-Parallel session —-Day-2 ————————————————-

08:30

10:10

Biomarker Parallelism

08:30 08:50 Robert Nelson, on behalf of EBF TT-61
Non-parallelism in biomarker assays
08:50 09:10 Afshin Safavi, BioAgilytix
Considerations for Evaluation of Parallelism in Biomarker Ligand-Binding Assays:
Case Studies of Failed Biomarker Assay Parallelism
09:10 09:30 Julie De Gagné, Novartis
The use of parallelism to define biomarker assay parameters: a case study
09:30 09:50 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
09:50 10:10 Panel discussion
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10:10 11:00 Coffee break
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11:00

12:20

Pushing the boundaries of Large Molecule Analysis

11:00 11:20 Gregor Jordan, F. Hoffmann La Roche
Improved ELISA performance by simple switching from a colorimetric to fluorimetric HRP substrate
11:20 11:40 Christian Pieper, Chimera Biotec
Biologics – Biomarker – Bioanalysis. Challenges followed by solution – What to do when new drug
programs reach technical limitations in target quantification
11:40 12:00 Craig Stovold, AstraZeneca
Amplification Challenge: Comparison of bDNA and PCR-based analytical methods for the determination
of nucleotide-based therapeutics
12:00 12:20 Bert Rutten, LGC
Comparison of Critical Method Validation Parameters on the Quanterix Simoa and the Singulex Erenna.
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12:20 12:40 Bioanalysis Zone New Investigator Award Winner
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12:40 14:00 Lunch break
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14:00

15:40

What makes Bioanalysis fun  – 2

14:00 14:20 Roland Staack, F. Hoffmann La Roche
Importance of fully characterized bioanalytical methods –  the bioanalytical challenges to
support the develpment of a lipidated fusion protein 
14:20 14:40 Hanna Ritzen, Mercodia
Life cycle management of biomarker assays a route to improved patient outcome.
14:40 15:00 Martine Broekema, PRA Health Sciences
Challenges in receptor occupancy determination assays by flow cytometry in drug development
15:00 15:20 Christele Gonneau, Covance CLS
Paving the road to Utopia through instrument standardization
15:20 15:40 Anne Incamps, Thermo Fisher Scientific 
Biomarkers Validation : an Orthogonal approach using Mass Spectrometry and Immunoassays
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15:40 16:15 Tea break
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16:15

17:55

Immunogenicity

16:15 16:35 Jo Goodman, on behalf of the EBF
Feedback from the EBF Focus Workshop  (September 2016, Lisbon) on Current Analysis of Immunogenicity
16:35 16:55 James Munday, Covance
Pre-clinical Immunogenicity assessment – Scientific validation versus Regulatory validation approach.
What is the appropriate tiered analysis?
16:55 17:15 Robert Nelson, Novimmune
The best-laid schemes o’ mice an’ men: when clinical assumptions go awry
17:15 17:35 Viswanath Devanarayan, Abbvie
Clinical Interpretation of ADA
17:35 17:55 Panel Discussion
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————————-Day 3 – Friday 18 nov 2016—————————-

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09:00

10:40

The Broad Utility of HRMS

09:00 09:20 Esther van Duijn, TNO
The combined use of HRMS and AMS for simultaneous metabolite quantification and identification
09:30 10:00 Nico van de Merbel, PRA Health Sciences
A practical comparison of triple-quadrupole and high-resolution mass spectrometry for peptide and protein quantification
10:00 10:20 Barry Jones, Q2 Solutions
LC-HRMS for Quantitative Bioanalysis in the Regulated Contract Research Laboratory:
Small, Medium, and Large Molecule Applications
10:20 10:40 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

10:40

Abnormal PK

09:00 09:20 Daniela Stoellner, on behalf of EBF TT-63
TT-63: Handling of PK data from ADA positive animals
09:20 09:40 Nick White, MedImmune
Abnormal PK; Even With Informed Predictions it Happens to the Best of Us!
09:40 10:00 Sherri Dudal, UCB BioPharma
Challenge of PKPD of biologics in preclinical disease models: PK and BA perspectives
10:00 10:20 Anne Larvor, Amatsigroup
Management of abnormal PK profiles:s BA and PK point of view through several examples.
10:20 10:40 Panel discussion
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10:40 11:25 Coffee break
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11:25

12:55

UTOPIA: THE SCIENCE OF A MODERN GUIDELINE

Interactive session  (Each sub-session consists of a short introduction followed
by an interactive discussion involving all conference delegates)
11:25 11:30 General Introduction – aim of the session
11:30 11:50 The science of a modern guidance – focus on The common themes
moderated  panel session
11:50 12:20 The science of a modern guidance – focus on Ligand binding assays
moderated  panel session
12:20 12:50 The science of a modern guidance – focus on Chromatography based assays
moderated  panel session
12:50 12:55 Closing comments and next steps
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12:55 13:00 Plans for 2017 / Close Out
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