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


Meeting Agenda version 10 SEP 2017

Day 0 – Tuesday 14 November 2017

16:00 19:00 Complementary Pt cocktail reception

Day 1 – Wednesday 15 November 2017

09:00 09:10 Welcome
09:10 10:20 Quantitative Imaging – a reality?
09:10 09:40 Keynote Speaker: Steve Hood, GlaxoSmithKline
Bioimaging – Answering the “What, Where and How Much?” of modern Drug Discovery
09:40 10:00 Pete Watson, Cardiff University
FWM and CARS microscopy for the quantitative imaging of nanoparticles, drugs and biomarkers in living cells.
10:00 10:20 Delphine Maux, Nestlé Skin Health
  MALDI imaging a new quantitative methodology approach for understanding drug distribution in skin.
10:20 11:00 Coffee break – Poster viewing
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
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
13:10 14:20 Lunch break
Parallel breakout session day1-1a
14:20 15:40 Assay transfer – a two way relationship
14:20   14:40 Luca Ferrari, Roche
Small molecule bioanalytical method development and transfer: is a “plug and play” approach possible?
14:40   15:00 Nico van de Merbel, PRA Health Sciences
Transfer or redevelop – that’s the question
15:00   15:20 Alessio Maiolica, Novartis
Small molecule LC-MS¬/MS assay transfer:  A journey through the method cross-validation challenges
15:20   15:40 Debbie McManus, Envigo
Successful transfer of ligand binding assays between different laboratories
Parallel breakout session day1-1b
14:20 15:40 Re-visiting immunogenicity strategies
14:20   14:40 Martine Broekema, PRA Health Sciences
Increased need for ADA assays with enhanced drug tolerance and suggested strategies
14:40   15:00 Szilard Kamondi, Roche
Evaluation of outlier detection methods for cut-point determination of immunogenicity screening and confirmatory assays
15:00   15:20 Corinna Krinos-Fiorotti, BioAgilytix
Drug-Reactive Pre-existing Reactivity Assessments: What are the Challenges?
15:20   15:40 James Munday, on behalf of the EBF
Pre-clinical Immunogenicity assessment, what is the appropriate tiered analysis?
15:40 16:20 Tea break  – Poster viewing
Parallel breakout session day1-2a
16:20 18:00 New technologies applied 1
16:20   16:40 Anne Kleinnijenhuis, Triskelion
Multiplex LC-MS analysis to selectively detect different collagen types in fibrotic tissue.
16:40   17:00 Farjana Mahammed, GlaxoSmithKline
Small & Fast – How to improve bioanalytical throughput whilst maintaining/improving quality
17:00 17:20 EBF Young Scientist introducing the BioA Brain
YSS Organizers
17:20   17:40 Morten Funch Carlsen, Leo Pharma
The fairy-tale of a multi-analyte LC/MS/MS-assay for quantification of low pg/mL levels of active drug compounds and metabolites of a topical fixed dose combination product.
17:40   18:00 Young Investigator Award – Presenter TBC
Title TBC
Parallel breakout session day1-2b
16:20 18:00 Biomarker case studies
16:20   16:40 Nick White, MedImmune
Confuddled by Confounders? That Target Engagement Biomarker Assay can be a Difficult Journey to Overcome
16:40   17:00 Darshana Jani, Pfizer
Considerations for successful biomarker bioanalysis in regulated environment- Dive in Validation Challenges and Solutions
17:00   17:20 Michael Gröschl, Celerion
Biomarkers of glucose metabolism in human plasma and saliva
17:20   17:40 John Perkins, Q2 Solutions
Applying the lessons learned from small molecule biomarker analysis to method development for xenobiotics
17:40   18:00 James Lawrence, Envigo
The impact of using singlate analysis for the measurement of exploratory biomarker endpoints
18:00 19:00 Cocktail reception

Day 2 – Thursday 16 November 2017

Parallel breakout session day2-1a
08:30 10:10 “Hybrid” assays – science or just semantics?
08:30   08:50 Rainer Bischoff, University of Groningen
Immunoaffinity mass spectrometry – The best of both worlds?
08:50   09:10 John Gebler, Waters Corporation
Protein Biotherapeutic Quantification: A Comparison of LC-MS Techniques for both Digested and Intact Quantification
09:10   09:30 Lorella Di Donato, Caprion Biosciences
Absolute Quantitation of biotherapeutic drug product and its endogenous protein by immunoaffinity-LC-MS/MS in human plasma
09:30   09:50 Rand Jenkins, PPD
Addressing method development and validation challenges with high sensitivity assays for antibody fragment drugs using LBA and hybrid LBA/LC-MS technologies
09:50   10:10 Richard Snell, GlaxoSmithKline
The Utility of Magnetic Beads as an Extraction Technique for Small Molecule Bioanalysis by LC-MS/MS
Parallel breakout session day2-1b
08:30 10:10 Immunogenicity In action
08:30   08:50 Issa Jyamubandi, LGC
Approaches to improve the ADA drug tolerance of Monoclonal Antibody Therapeutic.
08:50   09:10 Chris Jones, MedImmune
Does platform matter for ADA assessment? Validation and sample data revisited across multiple platforms.
09:10   09:30 Lieselot Bontinck, Ablynx
An innovative approach for detecting neutralizing antibodies directed to antibody-derived therapeutics based on the conventional bridging ADA assay format
09:30   09:50 Marco Michi, Aptuit
ADA analysis: Use of LC/MS in support to specific case study issues
09:50   10:10 Carles Morte, Kymos Pharma Services
Assessment of the Immunogenicity of gonadotrophins during Controlled Ovarian stimulation
10:10 11:00 Coffee break  – Poster viewing
Parallel breakout session day2-2a
11:00 12:40 Microsampling… What can the future look like?
11:00   11:20 Amanda Wilson, AstraZeneca
Capillary Plasma Microsampling – Letting the data speak for itself
11:20   11:40 Neil Spooner, in collaboration with  the University of Hertfordshire
Patient centric microsampling – What is it, where are we up to and where might it be leading us?
11:40   12:00 Richard Lucey, LGC
Optimising recovery from volumetric absorptive microsampling (VAMS) devices, to overcome the hematocrit issue for dried samples
12:00   12:20 Martijn Hilhorst, PRA Health Sciences
“Pros and cons of conventional and microsampling techniques for quantitative bioanalysis” (TBC)
12:20   12:40 Panel discussion
Parallel breakout session day2-2b
11:00 12:40 Can flow fly?
11:00   11:20 Peter Rhein, Merck
Imaging Flow Cytometry Enhances the Detection of Small Particles and Rare Events Enabling Emerging Applications in Immunology and Oncology
11:20   11:40 Stephanie Traub, Cancer Research UK
Validation of flow cytometry assays for monitoring of immune cells in hematological malignancies and immuno-oncology trials
11:40   12:00 Richard Hughes, GlaxoSmithKline
Imaging cytometry: the advantages of hybrid technology in support of drug discovery
12:00   12:20 Richard Heideman, Charles River
Immunomodulatory Drug Immunotoxicity; Using Scientific Expertise and State of the Art Technology to Address Intractable Problems
12:20   12:40 Hervé Farine, Idorsia
Transfer of a receptor occupancy assay in phase I clinical trial: a sponsor’s perspective
12:40 14:00 Lunch break
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
14:00   15:30    Parallel workshops 1-5
WS-1 Life beyond MS-MS
WS-2 Bioanalysis for Biosimilars
WS-3 Validation approaches in ED (usage of surrogate matrix (human) in all nonclinical species)
WS-4 Standardised ADA assays cont´d
WS-5 Pharma/CRO relation – PART 1
16:30   18:00    Parallel workshops  6-10
WS-6 Approaches on implementing OECD17
WS-7 Complex delivery systems – effect on BA
WS-8 Single vs. Duplicates
WS-9 Calibration concepts in LBA
WS10 Pharma/CRO relation – PART 2
EBF presentation: Philip Timmerman, EBF Optimizing the Pharma / CRO interface. Introduction and goals of the Workshop
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
18:00 19:00 Cocktail reception

Day 3 – Friday 17 November 2017

Parallel breakout session day3-1a
09:30 10:50 ISR, ISR, ISR
09:30   09:50 Cecilia Arfvidsson, AstraZeneca
ISR included in every clinical study for 5 years – What have we done … what can we learn …and how do we go from here!?
09:50   10:10 Tom Verhaeghe, Janssen R&D
ISR: what have we learned after a decade of experience?
10:10   10:30 Morten Anders Kall, on behalf of the EBF
EBF View on ISR
10:30   10:50 Panel discussion
Parallel breakout session day3-1b
09:30 10:50 New technologies applied 2
09:30   09:50 Amanda Wilson, on behalf of the EBF
Implementation of New Technology – feedback from the EBF mini workshop
09:50   10:10 Pauline Bros, Sanofi
Innovative combination of ImmunoCapture LC-HRMS approaches for the quantitative analysis of therapeutic monoclonal antibody
10:10   10:30 Rory Doyle, Thermo Fisher Scientific
Quantitative analysis of IgF-1 using triple quadrupole and a quadrupole orbitrap MS
10:30   10:50 Jerome VIALLARET, CHU Montpellier
Comparison of sample preparation for mAbs quantitation by LC-MRM: Protein A cartridges vs. nSMOL
10:50 11:30 Tea break  – poster focus 4
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
12:50 13:00 Plans for 2017 / Close Out