EBF
EBF Open Symposium
EBF Barcelona

EBF 10th Open Meeting: 10 - A New Journey begins

EBF 4th YSS will be organized as a stand-alone meeting in 1Q2018
Hotel NH Collection Barcelona
Barcelona, Spain
November 15-17, 2017

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Meeting Agenda version 27 JUN 2017

 

Day 0 – Tuesday 14 November 2017

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16:00 19:00 Complementary Pt cocktail reception
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Day 1 – Wednesday 15 November 2017

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09:00 09:10 Welcome
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09:10 10:20 Quantitative Imaging – a reality?
09:10 09:40 Keynote Speaker: Steve Hood 
(GlaxoSmtihKline)
title: TBD
09:40 10:00 presenter TBD
Theme: Quantitative Imaging
10:00 10:20 Delphine Maux, Nestlé Skin Health  10:000  10:200  zzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzz
  MALDI imaging a new quantitative methodology approach for understanding drug distribution in skin.
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10:20 11:00 Coffee break – Poster viewing
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11:00 12:00 Ambiguities in dealing with regulations
11:00 11:20 Robert Nelson, on behalf of the EBF
Parallelism – Feedback from the AAPS/EBF/JBF sister meetings
11:20 11:40 Vera Hillewaert, Janssen R&D
Challenges in dealing with different regulations by different Health Authorities. (A challenge only becomes an obstacle when you bow to it – Ray A. Davis)
11:40 12:00 Magnus Knutsson, on behalf of the EBF
Co-med stability or interference testing –  Feedback from the AAPS/EBF/JBF sister meetings
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12:00 13:10 Why duplicates in PK LBAs?
12:00 12:10 Pascal Delrat/Gerhard Paul, on behalf 
of the EBF
Session Introduction including feedback from the AAPS/EBF/JBF sister meetings
 12:10 12:30 Enric Bertran, Roche
Single-Well Analysis in Ligand-Binding Assays: Retrospective Evaluation of Validation and Study Sample Data of PK and ADA Assays using ELISA
 12:30 12:50 Johannes Stanta, Covance
Single analysis in LBA put to the test across analytical designs and platforms
12:50 13:10 Craig Stovold, AstraZeneca
Right First Replicate?: Assessment of ligand binding assay single well analysis in support of therapeutic oligonucleotides
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13:10 14:20 Lunch break
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14:20 15:40 Assay transfer – a two way relationship 14:20 15:40 Re-visiting immunogenicity strategies
14:20 14:40 Luca Ferrari, Roche 14:20 14:40 Martine Broekema, PRA Health Sciences
Small molecule bioanalytical method development Increased need for ADA assays with enhanced
and transfer: is a “plug and play” approach drug tolerance and suggested strategies
possible?
14:40 15:00 Nico van de Merbel, PRA Health Sciences 14:40 15:00 Szilard Kamondi, Roche
Transfer or redevelop – that’s the question Evaluation of outlier detection methods for cut-point
determination of immunogenicity screening and confirmatory assays
15:00 15:20 Alessio Maiolica, Novartis 15:00 15:20 Corinna Krinos-Fiorotti, BioAgilytix
Small molecule LC-MS¬/MS assay Drug-Reactive Pre-existing Reactivity
transfer:  A journey through the Assessments: What are the Challenges?
method cross-validation challenges
15:20 15:40 Debbie McManus, Envigo 15:20 15:40 James Munday, on behalf of the EBF
Successful transfer of ligand binding assays between different laboratories Pre-clinical Immunogenicity assessment, what is the appropriate tiered analysis?
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15:40 16:20 Tea break  – Poster viewing
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16:20 18:00 New technologies applied 1 16:20  18:00 Biomarker case studies
16:20 16:40 Anne Kleinnijenhuis, Triskelion 16:20 16:40 Nick White, MedImmune
Multiplex LC-MS analysis to Confuddled by Confounders? That Target
selectively detect different collagen Engagement Biomarker Assay can be a
types in fibrotic tissue. Difficult Journey to Overcome
16:40 17:00 Farjana Mahammed, GlaxoSmithKline 16:40 17:00 Darshana Jani, Pfizer
Small & Fast – How to improve Considerations for successful biomarker
bioanalytical throughput whilst bioanalysis in regulated environment-
maintaining/improving quality Dive in Validation Challenges and
Solutions
17:00 17:20 Awaiting speaker confirmation 17:00 17:20 Michael Gröschl, Celerion
Biomarkers of glucose metabolism in human plasma and saliva
17:20 17:40 Morten Funch Carlsen, Leo Pharma 17:20 17:40 John Perkins, Q2 Solutions
The fairy-tale of a multi-analyte Applying the lessons learned from small
LC/MS/MS-assay for quantification molecule biomarker analysis to method
of low pg/mL levels of active drug development for xenobiotics
 compounds and metabolites of a topical fixed dose combination product.
17:40 18:00 Young Investigator Award – Presenter TBC 17:40 18:00 James Lawrence, Envigo
Title TBC The impact of using singlate analysis for the
measurement of exploratory biomarker endpoints
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18:00 19:00 Cocktail reception
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Day 2 – Thursday 16 November 2017

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08:30 10:10 “Hybrid” assays – science or just semantics? 08:30 10:10 Immunogenicity In action
08:30 08:50 Rainer Bischoff, University of Groningen 08:30 08:50 Issa Jyamubandi, LGC
Immunoaffinity mass spectrometry Approaches to improve the ADA drug tolerance
– The best of both worlds? of Monoclonal Antibody Therapeutic.
08:50 09:10 John Gebler, Waters Corporation 08:50 09:10 Chris Jones, MedImmune
Protein Biotherapeutic Quantification: Does platform matter for ADA assessment?
A Comparison of LC-MS Techniques Validation and sample data revisited across
for both Digested and Intact Quantification multiple platforms.
09:10 09:30 Lorella Di Donato, Caprion Biosciences 09:10 09:30 Lieselot Bontinck, Ablynx
Absolute Quantitation of biotherapeutic drug product and its endogenous protein by immunoaffinity-LC-MS/MS in human plasma An innovative approach for detecting neutralizing antibodies directed to antibody-derived therapeutics based on the conventional bridging
ADA assay format
09:30 09:50 Rand Jenkins, PPD 09:30 09:50 Marco Michi, Aptuit
Addressing method development and ADA analysis: Use of LC/MS in support to
validation challenges with high sensitivity specific case study issues
assays for antibody fragment drugs using LBA and hybrid LBA/LC-MS technologies
09:50 10:10 Richard Snell, GlaxoSmithKline 09:50 10:10 Carles Morte, Kymos Pharma Services
The Utility of Magnetic Beads as an Extraction Technique for Small Molecule Bioanalysis by LC-MS/MS Assessment of the Immunogenicity of gonadotrophins during Controlled Ovarian stimulation
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10:10 11:00 Coffee break  – Poster viewing
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11:00 12:40 Microsampling… What can the future 11:00 12:40 Can flow fly?
look like?
11:00 11:20 Amanda Wilson, AstraZeneca 11:00 11:20 Peter Rhein, Merck
Capillary Plasma Microsampling – Imaging Flow Cytometry Enhances the Detection
Letting the data speak for itself of Small Particles and Rare Events Enabling
Emerging Applications in Immunology and Oncology
11:20 11:40 Neil Spooner, in collaboration with   11:20 11:40 Stephanie Traub, Cancer Research UK
the University of Hertfordshire
Patient centric microsampling – Validation of flow cytometry assays for monitoring
What is it, where are we up to and where of immune cells in hematological malignancies
might it be leading us? and immuno-oncology trials
11:40 12:00 Richard Lucey, LGC 11:40 12:00 Richard Hughes, GlaxoSmithKline
Optimising recovery from volumetric absorptive Imaging cytometry: the advantages of hybrid
microsampling (VAMS) devices, to overcome technology in support of drug discovery
the hematocrit issue for dried samples
12:00 12:20 Martijn Hilhorst, PRA Health Sciences 12:00 12:20 Richard Heideman, Charles River
“Pros and cons of conventional and Immunomodulatory Drug Immunotoxicity;
microsampling techniques for Using Scientific Expertise and State of the Art
quantitative bioanalysis” (TBC) Technology to Address Intractable Problems
12:20 12:40 Panel discussion 12:20 12:40 Hervé Farine, Actelion
Transfer of a receptor occupancy assay in phase I clinical trial: a sponsor’s perspective
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12:40 14:00 Lunch break
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14:00 18:00 On Thursday afternoon, there will be no plenary nor breakout sessions.
Instead, 2 blocks of 5 parallel workshops will be organized. In each of these short workshops, together
with the individual workshop moderators, the EBF Open Symposium Organizing Committee is preparing for a discussion around themes relevant to our industry today – see listing below. More details on the questions asked and anticipated deliverable for each of these workshops will be shared as we move closer to the meeting
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From 14:00 – 15:30 From 16:30 – 18:00
Parallel workshops 1-5 Parallel workshops  6-10
WS 1 Life beyond MS-MS WS 6 Approaches on implementing OECD17
WS 2 Bioanalysis for Biosimilars WS 7 Complex delivery systems – effect on BA
WS 3 Validation approaches in ED (usage of WS 8 Single vs. Duplicates
surrogate matrix (human) in all nonclinical species)
WS 4 Standardised ADA assays cont´d WS 9 Calibration concepts in LBA
WS 5 Pharma/CRO relation – PART 1 WS 10 Pharma/CRO relation – PART 2
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EBF presentation: Philip Timmerman, EBF Optimizing the Pharma / CRO interface. Introduction and goals of the Workshop
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JBF presentation: Masanari Mabuchi, Mitsubishi Tanabe Pharma Corporation/ Japan Bioanalysis Forum

Relationship between Pharma and CRO in method development and transfer – based on the survey by JBF Discussion Group

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18:00 19:00 Cocktail reception
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Day 3 – Friday 17 November 2017

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09:30 10:50 ISR, ISR, ISR 09:30 10:50 New technologies applied 2
09:30 09:50 Cecilia Arfvidsson, AstraZeneca 09:30 09:50 Amanda Wilson, on behalf of the EBF
ISR included in every clinical study Implementation of New Technology –
for 5 years – What have we done … feedback from the EBF mini workshop
what can we learn …and how do we go from here!?
09:50 10:10 Tom Verhaeghe, Janssen R&D 09:50 10:10 Pauline Bros, Sanofi
ISR: what have we learned after a Innovative combination of ImmunoCapture
decade of experience? LC-HRMS approaches for the quantitative
 analysis of therapeutic monoclonal antibody
10:10 10:30 Morten Anders Kall, on behalf of the EBF 10:10 10:30 Rory Doyle, Thermo Fisher Scientific
EBF View on ISR Quantitative analysis of IgF-1 using triple
quadrupole and a quadrupole orbitrap MS
10:30 10:50 Panel discussion 10:30 10:50 Jerome VIALLARET, CHU Montpellier
Comparison of sample preparation for mAbs quantitation by LC-MRM: Protein A cartridges vs. nSMOL
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10:50 11:30 Tea break  – poster focus 4
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11:30 12:50 Future challenges we cannot deny
11:30 11:50 Tim Sangster, on behalf of the EBF
Bioanalytical Support to In Vitro Studies
11:50 12:10 Susanne Pihl/Michaela Golob on behalf of 
the EBF
Critical Reagents
12:10 12:30 David Van Bedaf, on behalf of Janssen 
R&D, BSSN Software and SCIEX
The next step for analytical e-data: CRO collaboration and long-term preservation using the AnIML format
12:30 12:50 Adam Hughes, GlaxoSmithKline
“I want to break free” – The implementation of scientific validation
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12:50 13:00 Plans for 2017 / Close Out