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BCN Slides 2019

Program of EBF 12th Open Conference  “Imagine! – A New Bioanalytical Earthrise”  November  20-22, 2019

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 20 NOV 2019
08:45 09:00 Welcome
09:00 10:40 Plenary session Day 1-01 (Implement): Ready for Launch
09:00 09:20 Philip Timmerman, EBF
Imagine: from Apollo 8 to bioanalysis today
09:20 09:40 Nils Boehm, Abbvie
Automation in a regulated bioanalytical lab – experience from a five-year journey from a manual to a 100% automated workflow
09:40 10:00 Arundhuti Sen, GlaxoSmithKline  (not released for publication)
Automated workflows for ligand-binding assays:  strategies for streamlined method development and rapid sample processing
10:00 10:20 Michael Wright, LGC
Automation in a CRO environment: the challenge to invest, implement and integrate
10:20 10:40 Michael Gröschl, Celerion
Implementation of laboratory automation in a CRO environment – from basic steps to advanced solutions
10:40 11:30 Coffee break – General Poster Session
11:30 12:50 Plenary session Day 1-02 (Influence): New (draft) Regulations – (potential) Areas of Biggest Impact
11:30 11:50 Tom Verhaeghe, on behalf of EBF
ICH M10 cross validation & documentation: what now?
11:50 12:10 Steve White, on behalf of EBF
ICH – other areas of biggest impact
12:10 12:30 Rob Nelson, on behalf of EBF
Did the FDA BMV change our view of biomarker validations?
12:30 12:50 Jason Wakelin-Smith, MHRA
MHRA Feedback on Regulated Bioanalysis
12:50 14:00 Lunch break
14:00 15:50 Plenary session Day 1-03 (Innovate): Patient Centric Sampling
14:00 14:20 Kevin Bateman, MSD
From Innovation to Implementation: Overcoming Challenges in Patient Centric Sampling in Clinical Trials
14:20 14:40 Lieve Dillen, Janssen R&D
The journey of microsampling in preclinical and clinical development
14:40 15:00 Remco Koster, PRA Health Sciences  (not released for publication)
Volumetric absorptive microsampling in a hospital setting: are we there yet?
15:00 15:20 Michele Protti, University of Bologna
Microsampling for the therapeutic drug monitoring of eating disorder patients under antidepressant treatment
15:20 15:40 Neil Spooner, on behalf of AAPS
An Update from the Community on Microsampling and Patient Centric Sampling – Turning Imagination into Reality
14:00 15:00 (NEW): EBF Satellite session Day 1-04 Aquila (Inspire): CRO – Pharma Collaboration
14:00 14:20 Debbie McManus, LGC  (not released for publication)
Challenges in standardizations and collaborations for CROs: understanding the lifecycles of evolving immunogenicity assays
14:20 14:40 Maria Heijer, AstraZeneca
Continued Strides to “Get it Right”—Further Tales of True Collaboration in Bioanalysis in the Covance Laboratory Partnership
14:40 15:00 Emmanuel Desmartin, Eurofins Amatsi Analytics
A CRO perspective of the Pharma-CRO relationship
15:40 16:40 Coffee break  – Poster Focus 1
16:40 18:00 (NEW) Launch Pad sessions:
Capitalising on the theme of the conference, we have included 3 strategic parallel discussion sessions. In each of the sessions, we start with a keynote speaker. From there we will engage the audience around some key questions on the challenges our industry faces today.
Session 1 –  Innovate: Enhancing scientific collaborations in industry – the journey has only just begone
In this session we will focus on innovation as a result of interaction/collaborations between Pharma/CRO and  academia/vendors
Introduction: Matthew Barfield, on behalf of the EBF
Keynote presenter: John Smeraglia, UCB Biopharma
Session 2 – Imagine: Value of doing things differently
In this session we will on the risk/value of doing things differently, with focus on risk-based approaches applicable to Bioanalysis
Introduction: Magnus Knutsson, on behalf of the EBF
Keynote presenter: Anja Gilis, Janssen R&D
Session 3 –  Inspire: Biomarker assay validation – are we ready for launch? 
In this session, we will continue the discussion from the recent Autumn Focus Workshop on managing Biomarker Assay Validation
Introduction: Kyra Cowan, on behalf of the EBF
Keynote presenters: Lars Karlsson, Ferring and John Allinson, Immunologixlabs
18:00 19:00 Complementary Cocktail Reception
Day 2 – Thursday 21 NOV 2019
08:30 10:10 Breakout session Day 2-01 Auditorium (Implement): e-Environment
08:30 08:50 Cecilia Arfvidsson, on behalf of EBF
EBF and the e-environment: The Journey Continues
08:50 09:10 Jason Wakelin-Smith (MHRA)
The onward journey of your data
09:10 09:30 Scott Davis, PPD
Data Integrity On Large Networks
09:30 09:50 Willie van de Kerkhof, PRA Health Sciences
PRA’s Approach to Data Integrity – Scoring, Risks, Assessment and Implementation
09:50 10:10 Carina Ekström, Ferring Pharmaceuticals
How to ensure long-term readability of your electronic data/records when you decommission your LC-MS system?
08:30 10:10 Breakout session Day 2-01 Jupiter (Innovate): Critical Reagents
08:30 08:50 Susanne Pihl, on behalf of EBF
EBF Feedback on ADA critical reagents
08:50 09:10 Matt Horsham, LGC
Positive Thinking: The Use of “Brain Power” in Positive Control Selection for ADA
09:10 09:30 Chris Jones, AstraZeneca
Use of the Affinity Module on the Gyrolab Platform to Inform and Assess Critical Reagent Selection during Method Development and Beyond.
09:30 09:50 Matt Johnson, Avacta Life Sciences  (not released for publication)
Improved PK and Drug Monitoring Tools with the Affimer® Platform
09:50 10:10 Olivier Heudi, Novartis
Will plastic antibodies revolutionize the bioanalysis?
10:10 11:00 Coffee break  – Poster Focus 2
11:00 12:40 Breakout  session Day 2-02 Auditorium (Innovate): Taking Tech to the Moon and Back
11:00 11:20 Jan Hellemans, Biogazelle (on behalf of Bio-Rad)
The potential of ddPCR for clinical research
11:20 11:40 Gregor Jordan, Roche Diagnostics GmbH  (not released for publication)
Bioanalytical characterization of formed high molecular weight protein complexes to successfully support a clinical trial
11:40 12:00 Philippe Ancian, Charles River Laboratories
Challenges in qPCR assay development and validation for biodistribution and shedding evalution of Gene and Cell Therapies
12:00 12:20 Patrick Brennecke, Celerion
Tracing Biomarkers  with the top edge technologies Luminex, MSD and SIMOA
12:20 12:40 Martine Broekema, PRA Health Sciences
Efficient set-up of a cell-based neutralizing antibody assay using a flow cytometry-based Receptor Occupancy assay format
11:00 12:40 Breakout session Day 2-02 Jupiter (Innovate/Inspire): Planet Immunogenicity
11:00 11:20 Louise Jørgensen, Novo Nordisk
Anti-drug antibody analysis in non-clinical samples – a simplified strategy offering sufficient support for interpretation of toxicology studies
11:20 11:40 Laure Querel, Covance Huntingdon
No Cut-point, no cry- Validating pre-clinical ADA assays without generating a statistical cut-point.
11:40 12:00 Riejanne Bax-Seigers, PRA Health Sciences
A solution to overcome interference in a method to measure anti-drug antibodies
12:00 12:20 Darshana Jani, Pfizer
Strategies for Clinical assessment of immunogenicity for Emerging Modalities including Multidomain Therapeutics, Oligonucleotides and Gene Therapy
12:20 12:40 Anna Laurén, on behalf of EBF
Current and future considerations for Neutralising antibody assays
11:00 12:00 (NEW): EBF Satellite session Day 2-02 Aquila (Innovate): Microsampling Applications
11:00 11:20 Elizabeth Osborne, LGC  (not released for publication)
Challenges with extensive sample pre-treatment in a microsampling study
11:20 11:40 Annick de Vries, Sanquin Diagnostic Services
Support PK and ADA of biologics using finger prick sampling; a comparison of multiple devices which are on the market to sample capillary blood or serum
11:40 12:00 Jeff Plomley, Altasciences  (not released for publication)
The Application of Impact-Assisted Extraction to Overcome Hematocrit Recovery Bias and Age-Related Extractability in Mitra® Volumetric Absorptive Microsampling: Towards a Universal Sample Preparation Approach
12:40 14:00 Lunch break
14:00 15:30 Again, we will host 5 parallel workshops. In each of these short workshops, the workshop moderators will prepare  a discussion around themes relevant to our industry today. More details on the questions asked and anticipated deliverable for each of these workshops will be shared as we move closer to the meeting.
WS 1: Practical application of FDA & EMA ADA Guidelines
Moderators = Joanne Goodman (AstraZeneca) and Michaela Golob (Nuvisan)
Includes contribution from Joao Pedras-Vasconceles (FDA-CDER) and Meenu Wadha (NIBSC)
Workshop includes following presentations:
 – Sebastien Boridy, Charles River Laboratories
How low is too low: assessing cut points in anti-drug antibody assay validation based on recommendations in the Final FDA guidance
 – Floris Loeff, Sanquin Research
Multi-tiered versus semi-quantitative single-tiered immunogenicity testing in real-life datasets
WS 2: Microsampling: New Devices and Novel Challenges
Moderators = Matthew Barfield (GlaxoSmithKline)/Kevin Bateman (MSD)
WS 3: e- Environment WS on Data Integrity – Building Common Understanding for Future System Solutions
Moderators = Cecilia Arfvidsson (AstraZeneca)/Magnus Knutsson (Ferring Pharmaceuticals)
WS 4: Supporting Cell & Gene Therapies in the Bioanalytical Laboratory
Moderators =  Johannes Stanta (Covance) / Paula Miranda (UniQure)
WS 5: qPCR in regulated bioanalysis
Moderators =  Chris Cox (PsiOxus)/Milena Blaga (Charles River Laboratories)/Robert Nelson (Novimmune)
15:30 16:20 Coffee break break  – Poster Focus 3
16:20 18:20 Breakout session Day 2-03 Auditorium (Influence/Inspire): Immunogenicity Strategies
16:20 16:40 Heather Myler, on behalf of the AAPS
ADA Validation Testing and Reporting Harmonization Recommendations
16:40 17:00 Joao Pedras-Vasconcelos, FDA-CDER  (not released for publication)
The Harmonized ADA Assay Validation Template – an “Immunerdy’s “ Perspective from FDA’s Side of the Dance Floor
17:00 17:20 Anna Laurén​, on behalf of EBF
Preclinical Immunogenicity Assessment – When to include and what to include?
17:20 17:40 Omnia Ismaiel, PPD
Is ADA by LBA/LC–MS/MS Realistic for Routine Analysis?  – “A Practical Rout for a Validated LCMS Assay“
17:40 18:20 Panel Discussion
16:20 18:20 Breakout session Day 2-03 Jupiter (Innovate/Implement): Other Tools to Reach the Moon
16:20 16:40 David Rowe, University of Southampton  (not released for publication)
Optimising antimicrobial dosing with mid-infrared spectroscopy: a proof of concept study
16:40 17:00 Michael Blackburn, ARCINOVA
New hybrid immuno-affinity mass spectrometric method for dosed or endogenous human insulin in clinical samples
17:00 17:20 Moon Jung, Waters
A Systematic Approach for Improving the Recovery of Hydrophobic Peptides during LC-MS Analyses
17:20 17:40 Steve Murphy, Agilent
Highly Selective Phosphopeptide Enrichment Workflow
17:40 18:00 BSRA Rising star award winner – announced in Barcelona
Rising Star Award
18:00 18:20 Esther van Duijn, TNO  (not released for publication)
AMS in drug development; The current situation within the regulatory space
16:20 17:20 (NEW): EBF Satelite session Day 2-03 Aquila (Inspire): Different Challenges
16:20 16:40 James Howard, LGC
Development of a sensitive antibody drug conjugate free-payload methodology and its application within a preclinical micro-sampling study
16:40 17:00 Urs Duthaler, Basel University  (not released for publication)
Pharmacokinetics and drug-drug interactions of ivermectin in yellow fever mosquitoes
17:00 17:20 Lee Boyling, Arcinova on behalf of the Gadolinium Based Contrast Agent Consortium
Scientific Validation: A Case Study for Quantification of Gadolinium in Multiple Tissue Types Using One Tissue as the Calibration and QC Matrix
18:20 19:00 Complementary Cocktail Reception
Day 3 – Friday 22 NOV 2019
09:00 10:40 Breakout session Day 3-01 Auditorium (Innovate/Implement): Further Applications of Mass Spectrometry
09:00 09:20 Julien Peltier, GlaxoSmithKline
An intact protein LC-MS assay for pharmacokinetic concentration determination of a mAb: validation experiments, sample results, and assay comparisons
09:20 09:40 Jordane Biarc, Charles River-Saint Nazaire
Pembrolizumab method validation in human serum: Comparison of Triple quadrupole and High resolution instrument.
09:40 10:00 Mohammed Abrar, BioApp Solutions Ltd  (not released for publication)
The Use of High-Resolution MS for Bioanalysis: – “Are we There Yet”?
10:00 10:20 Michael Buonarati, Intertek Pharmaceutical Services
Development and Validation of a LC-MS/MS Hybrid Assay using nSMOL for Bevacizumab Quantification in Human Serum
10:20 10:40 Naomi Teekamp, PRA Health Sciences
LC-MS/MS quantification of M254, a hyper-sialylated endogenous IgG biotherapeutic: analytical pitfalls and solutions
08:30 10:50 Breakout session Day 3-01 Jupiter (Inspire/Influence): Biosimilars
08:30 08:50 René Anour, AGES  (not released for publication)
An introduction to Biosimilars – Basics and new developments
08:50 09:10 Johann Poetzl, Sandoz
Learnings and emerging trends in bioanalytical assay development for Biosimilars
09:10 09:30 Todd Lester, BioAgilytix
What the New AAPS White Paper Recommends for Development and Validation of ADA Assays in Support of Biosimilar Programs
09:30 09:50 Janka Ryding, SVAR Life Science
Design of Biosimilar Bioanalytical Programs – Assay Strategy perspectives
09:50 10:10 Joao Pedras-Vasconceles, FDA-CDER  (not released for publication)
FDA Regulatory Perspectives on Immunogenicity Testing for Biosimilars
10:10 10:30 Essam Kerwash, MHRA
Biosimilar Pharmacokinetics Considerations
10:30 10:50 Panel discussion (break starts at 10:50)
10:40 11:30 Coffee break  – Poster Focus 4
11:30 13:00 Plenary session Day 3-02 Auditorium (Innovate):  Cell & Gene Therapies
11:30 11:50 Paula Miranda, UniQure  (not released for publication)
Bioanalytical strategies to support CGT: a stakeholder perspective
11:50 12:10 Lisa Seavers, Covance Huntingdon
Immunogenicity strategies for gene therapies
12:10 12:30 Fabrizia Fusetti, QPS
Bioanalytical monitoring of gene therapy trials: methodologies for PK-PD assessment and patient eligibility
12:30 12:50 Johannes R Stanta, on behalf of EBF
CGT discussion points from EBF
12:50 13:00 Closing remarks: Safe Landing
13:00 Adjourn

BCN Slides 2019