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EBF
EBF
European
Bioanalysis
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BCN Slides 2017

Program of EBF 10th Open Conference  “10 – A New Journey begins”  November  15-17, 2017

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.

You can find the details for the Thursday parallel workshops and workshop meeting rooms in this link.   Tab 1 for WS 1-5, tab 2 for WS 6-10   

 

Day 1 – Wednesday 15 nov 2017

09:00 Welcome
     
Quantitative Imaging – a reality?
09:10 Keynote Speaker: Steve Hood, GlaxoSmithKline
Bioimaging – Answering the “What, Where and How Much?” of modern Drug Discovery.
09:40 Pete Watson, Cardiff University
FWM and CARS microscopy for the quantitative imaging of nanoparticles, drugs and biomarkers in living cells.
10:00 Delphine Maux, Nestlé Skin Health
MALDI imaging a new quantitative methodology approach for understanding drug distribution in skin.
     
10:20 Coffee break – Poster viewing
     
Ambiguities in dealing with regulations
11:00 Robert Nelson, on behalf of the EBF
Parallelism – Feedback from the AAPS/EBF/JBF sister meetings
11:20 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 Magnus Knutsson, on behalf of the EBF
Co-med stability or interference testing –  Feedback from the AAPS/EBF/JBF sister meetings
     
Why duplicates in PK LBAs?
12:00 Matthew Barfield, on behalf of the EBF
Session Introduction including feedback from the AAPS/EBF/JBF sister meetings
12:10 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 Johannes Stanta, Covance
Single analysis in LBA put to the test across analytical designs and platforms
12:50 Craig Stovold, AstraZeneca
Right First Replicate?: Assessment of ligand binding assay single well analysis in support of therapeutic oligonucleotides.
     
13:10 Lunch break
     
Parallel breakout session day 1 – 1a
Assay transfer – a two way relationship
14:20 Luca Ferrari, Roche 
Small molecule bioanalytical method development and transfer: is a “plug and play” approach possible?
14:40 Nico van de Merbel, PRA Health Sciences
Transfer or redevelop – that’s the question
15:00 Alessio Maiolica, Novartis 
Small molecule LC-MS¬/MS assay transfer:  A journey through the method cross-validation challenges.
15:20 Debbie McManus, Envigo
Successful transfer of ligand binding assays between different laboratories
     
Parallel breakout session day 1 – 1b
Re-visiting immunogenicity strategies
14:20 Martine Broekema, PRA Health Sciences
Increased need for ADA assays with enhanced drug tolerance and suggested strategies.
14:40 Szilard Kamondi, Roche
Evaluation of outlier detection methods for cut-point determination of immunogenicity screening and confirmatory assays
15:00 Corinna Krinos-Fiorotti, BioAgilytix
Drug-Reactive Pre-existing Reactivity Assessments: What are the Challenges?  (not released)
15:20 James Munday, on behalf of the EBF
Pre-clinical Immunogenicity assessment, what is the appropriate tiered analysis?
     
15:40 Tea break – Poster viewing
     
Parallel breakout session day 1 – 2a
New technologies applied 1
16:20 Anne Kleinnijenhuis, Triskelion
Multiplex LC-MS analysis to selectively detect different collagen types in fibrotic tissue.
16:40 Farjana Mahammed, GlaxoSmithKline
Small & Fast – How to improve bioanalytical throughput whilst maintaining/improving quality
17:00 EBF Young Scientist introducing the BioA Brain
YSS Organizers 
17:20 Vibeke Hougaard Sunesen, 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 Young Investigator Award – Presenter TBC
Title TBC
     
Parallel breakout session day 1 – 2b
Biomarker case studies
16:20 Nick White, MedImmune
Confuddled by Confounders? That Target Engagement Biomarker Assay can be a Difficult Journey to Overcome
16:40 Darshana Jani, Pfizer
Considerations for successful biomarker bioanalysis in regulated environment- Dive in Validation Challenges and Solutions
17:00 Michael Gröschl, Celerion
Biomarkers of glucose metabolism in human plasma and saliva
17:20 John Perkins, Q2 Solutions
Applying the lessons learned from small molecule biomarker analysis to method development for xenobiotics.
17:40 James Lawrence, Envigo
The impact of using singlate analysis for the measurement of exploratory biomarker endpoints
     
18:00 Cocktail reception
     

Day 2 – Thursday 16 nov 2017

     
Parallel breakout session day 2 – 1a
“Hybrid” assays – science or just semantics?
08:30 Rainer Bischoff, University of Groningen
Immunoaffinity mass spectrometry – The best of both worlds?
08:50 John Gebler, Waters Corporation
Protein Biotherapeutic Quantification: A Comparison of LC-MS Techniques for both Digested and Intact Quantification
09:10 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 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 Richard Snell, GlaxoSmithKline 
The Utility of Magnetic Beads as an Extraction Technique for Small Molecule Bioanalysis by LC-MS/MS
     
Parallel breakout session day 2 – 1b
Immunogenicity In action
08:30 Issa Jyamubandi, LGC
Approaches to improve the ADA drug tolerance of Monoclonal Antibody Therapeutic.
08:50 Chris Jones, MedImmune
Does platform matter for ADA assessment? Validation and sample data revisited across multiple platforms.
09:10 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 Marco Michi, Aptuit
ADA analysis: Use of LC/MS in support to specific case study issues
09:50 Carles Morte, Kymos Pharma Services
Assessment of the Immunogenicity of gonadotrophins during Controlled Ovarian stimulation
     
10:10 Coffee break – Poster viewing
     
Parallel breakout session day 2 – 2a
Microsampling… What can the future look like?
11:00 Amanda Wilson, AstraZeneca
Capillary Plasma Microsampling – Letting the data speak for itself
11:20 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 Richard Lucey, LGC
Optimising recovery from volumetric absorptive microsampling (VAMS) devices, to overcome the hematocrit issue for dried samples  (not released)
12:00 Martijn Hilhorst, PRA Health Sciences
“Pros and cons of conventional and microsampling techniques for quantitative bioanalysis” (TBC)  (not released)
12:20 Panel discussion
     
Parallel breakout session day 2 – 2b
Can flow fly?
11:00 Peter Rhein, Merck
Imaging Flow Cytometry Enhances the Detection of Small Particles and Rare Events Enabling Emerging Applications in Immunology and Oncology  (not released)
11:20 Stephanie Traub, Cancer Research UK
Validation of flow cytometry assays for monitoring of immune cells in hematological malignancies and immuno-oncology trials
11:40 Richard Hughes, GlaxoSmithKline  
Imaging cytometry: the advantages of hybrid technology in support of drug discovery.
12:00 Richard Heideman, Charles River
Immunomodulatory Drug Immunotoxicity; Using Scientific Expertise and State of the Art Technology to Address Intractable Problems.
12:20 Hervé Farine, Actelion
Transfer of a receptor occupancy assay in phase I clinical trial: a sponsor’s perspective
     
12:40 Lunch break
     
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. For room assignments, see in attached document or ad valvas at the registration desk, in the foyer and at the auditorium entrance from Thursday morning onwards.
     
From 14:00 until 15:30    Parallel workshop 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
     
From 16:30 until 18:00    Parallel workshop 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
     
Included in  WS-5: 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 Cocktail reception
     
     

Day 3 – Friday 17 nov 2017

     
Parallel breakout session day 3 – 1a 
ISR, ISR, ISR 
09:30 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 Tom Verhaeghe, Janssen R&D
ISR: what have we learned after a decade of experience?
10:10 Morten Anders Kall, on behalf of the EBF
EBF View on ISR
10:30 Panel discussion
     
Parallel breakout session day 3 – 1b
New technologies applied 2
09:30 Amanda Wilson, on behalf of the EBF
Implementation of New Technology – feedback from the EBF mini workshop
09:50 Pauline Bros, Sanofi
Innovative combination of ImmunoCapture LC-HRMS approaches for the quantitative analysis of therapeutic monoclonal antibody
10:10 Ken Cook, Thermo Fisher Scientific
New Workflows for Biotherapuetic LCMS Analysis.
10:30 Jerome Vialaret, CHU Montpellier 
Comparison of sample preparation for mAbs quantitation by LC-MRM: Protein A cartridges vs. nSMOL
     
10:50 Tea break – poster focus 4
     
Future challenges we cannot deny
11:30 Tim Sangster, on behalf of the EBF
Bioanalytical Support to In Vitro Studies
11:50 Susanne Pihl on behalf of the EBF
Critical Reagents
12:10 David Van Bedaf,  Janssen R&D
Future Challenges We Cannot Deny: e-data readability and exchangeability
12:30 Adam Hughes, GlaxoSmithKline
“I want to break free” – The implementation of scientific validation
     
12:50 Plans for 2018 / Close Out