EBF
EBF Open Symposium
EBF Barcelona

N° 13 from Cyberspace – Staying Connected

Meeting will be organised in Cyberspace
(see also Covid-19 note in tab General/Covid-19)
17-20 November 2020

 

EBF 13th Open Symposium

 

AGENDA DETAILS
you can click on the agenda title to view the details of the session

Day 0: 16 November 2020
17:30 20:00 Diamond Sponsor Cocktail e-reception
Day 1: 17 November 2020
13:00 13:30 Getting started – Welcome
13:30 15:10 Day 1 – Plenary 1
A Pandemic Uniting us Behind Science
15:40 18:00 Day 1 – Breakout 1
Enhanced usage and recent developments in chromatographic separations
15:40 18:00 Day 1 – Breakout 2
Enhanced usage of high sensitivity LBA technologies
Day 2: 18 November 2020
11:00 12:30 EU/ASIA time Zone Plenary Session 1
Global Engagement on Biomarker Context of Use
13:00 14:40 Day 2 – Breakout 1
Hybrid Assays – Application
13:00 14:40 Day 2 – Breakout 2
Immunogenicity: strategies for non-mAb scaffolds
15:10 17:00 Day 2 – Workshop 1
Hybrid Assays – Workshop
15:10 18:00 Day 2 – Breakout 3
Immunogenicity applied in the new regulatory landscape (building experience)
16:20 18:00 Day 2 – Workshop 2
e-environment: towards a vendor neutral secure bi-directional data transfer process
End of Day 2 for EU/Asia
18:30 20:00 EU/US time Zone Plenary Session 1
Global Engagement on Biomarker Context of Use
Day 3: 19 November 2020
11:00 12:30 EU/ASIA time Zone Plenary Session 2
13:00 14:40 Day 3 – Workshop 1
Best practices in method development and communications to drive successful assay transfer between BioA labs
13:00 14:40 Day 3 – Breakout 1
Applications of Biomarker Assays: success stories and challenges
13:00 14:40 Day 3 Breakout 2
ADA – Case studies
15:10 17:00 Day 3 – Workshop 2
Managing GCP in the BioA lab – learning from the past for a better future
16:20 18:00 Day 3 – Workshop 3
Method development 2 – Worries for the future, or, can regional barriers or guideline expectations taken out of perspective?
15:10 17:00 Day 3 – Breakout 3
Diagnostics and PD decision making in clinical studies: new frontiers
End of Day 3 for EU/Asia –
18:30 20:00 EU/ASIA time Zone Plenary Session 2
Day 4: 20 November 2020
13:00 14:40 Day 3 – Workshop 1
Covid-19: challenges, experiences and impact on the BioA lab
13:00 14:40 Day 4 breakout 1
Biosimilars
15:10 16:50 Day 4 Plenary session
Feedback on ICH M10 – incl. Q&A
16:50 17:00 Closing remarks – Adjourn

 

AGENDA DETAILS

Day 0: 16 November 2020
17:30 20:00 Diamond Sponsor Cocktail e-reception
17:30 17:45 Philip Timmerman, EBF
Getting started
17:45 20:00 Introductions to scientific/process excellence of our Diamond sponsors and quick guide to their e-booths
20:00 Announcement Winner of the Diamond sponsor e-reception teaser
Day 1: 17 November 2020
13:00 13:30 Getting started – Welcome
Philip Timmerman – EBF
13:30 15:10 Day 1 – Plenary 1
A Pandemic Uniting us Behind Science
13:30 13:50 Joanne Goodman – on behalf of the EBF
Intro about the type of assays used
13:50 14:10 Else Marie Agger – Novo Nordisk
SARS-CoV-2 assay development in a bioanalysis laboratory
14:10 14:30 Catherine Vrentas – PPD
Development and characterization of an MSD-ECL assay for the effective quantitation of anti-SARS-CoV-2 antibodies in human serum
14:30 14:50 Presenter tbc – LGC
New immunogenicity strategies to meet the needs of a developing pandemic.
14:50 15:10 Sarah Peters – Celerion
Opening Safely in the Face of a Global Pandemic.
15:10 15:40 Coffee break
15:40 18:00 Day 1 – Breakout 1
Enhanced usage and recent developments in chromatographic separations (LC-MS and beyond) – Part 1
15:40 16:00 Aaron Ledvina – Covance
High-sensitivity workflow for LC-MS based analysis of GalNAc-conjugated oligonucleotides
16:00 16:20 Michael Blackburne – ARCINOVA
Assessment of fluoride exposure by GCMS: successes achieved and hard lessons learnt
16:20 16:40 Ariane Kahnt – Janssen R&D
Challenges in the quantitative analysis of Vitamin E TPGS in biological matrices using LC-MS/MS
16:40 17:00 short break
Day 1 – Breakout 1
Enhanced usage and recent developments in chromatographic separations (LC-MS and beyond) – Part 2
17:00 17:20 Esther van Duijn – TNO
Metabolic profiling and mass balance studies in pediatric patients using a microtracer approach – a proof of concept
17:20 17:40 Catherine DelGuidice – PPD, in collaboration with Sciex and Virginia Commonwealth University
Lowering the LC-MS/MS Assay Quantitation Limit to 50 pg/mL for Ranibizumab in Human Plasma after Intravitreal Administration, by Using SCIEX Triple Quad™ 7500 LC-MS/MS System – QTRAP® Ready
17:40 18:00 Nikunj Tanna – Waters
Advantages of a novel bridged ethyl hybrid surface technology to improve chromatographic efficiency and reduce analyte loss.
15:40 18:00 Day 1 – Breakout 2
Enhanced usage of high sensitivity LBA technologies – Part 1
15:40 16:00 Stephanie Vauleon – F. Hoffmann-La Roche
Tricky analyte, challenging matrix and a new high sensitivity analytical platform: How to overcome major challenges for a successful biomarker assay validation on the SMCxPRO platform
16:00 16:20 Chris Fox – Gyros Protein Technologies AB
The efficient generation of pharmacokinetics data using affinity flow-through nanoliter format immunoassays
16:20 16:40 Presenter tbc – LGC
The highs and lows of ultra-sensitive immunoassays: experiences from a CRO’s perspective
16:40 17:00 short break
Day 1 – Breakout 2
Enhanced usage of high sensitivity LBA technologies – Part 2
17:00 17:20 Presenter tbc – Quanterix
The most sensitive immunoassay just got more sensitive: how a 100-fold increase in sensitivity of Simoa was achieved
17:20 17:40 Open slot
17:40 18:00 Open slot
Note: The 2020 BSRA Winner is not known yet. When the winner is announced, we will include the BRSA presentation in the session having he closest scientific fit.
End of Day 1
Day 2: 18 November 2020
11:00 12:30 EU/ASIA time Zone Plenary Session 1
Global Engagement on Biomarker Context of Use
11:00 11:10 Kyra Cowan – on behalf of the EBF
Introduction into the session
11:10 11:30 Joanne Goodman – on behalf of the EBF
The 2020 EBF Recommendation on BM Assay Validation – key points to consider when implementing CoU practices
11:30 11:50 Samuel Pine – Ablynx, A sanofi company
Case study 1
11:50 12:10 Presenter from PharmScie360 0rganiser committee – tbc
Feedback and reflections from the AAPS PharmSci360 Workshop on CoU
12:10 12:30 Presenter from HA – tbc
A regulatory perspective
13:00 14:40 Day 2 – Breakout 1
Hybrid Assays – Application
13:00 13:20 Nico van de Merbel – PRA-HS
The best of both worlds: developments in hybrid ligand-binding / LC-MS approaches for peptide and protein quantification
13:20 13:40 Ashley Phillips – LGC
Next Gen Trypsin: Large Molecule LC-MS/MS Bioanalysis Today, Not Tomorrow
13:40 14:00 Luca Ferrari – F. Hoffmann – La Roche
Therapeutic/biomarker protein quantification in tissues: method development strategies to overcome sensitivity & selectivity issues using hybrid LBA-LCMS
14:00 14:20 Fabrizia Fussetti – QPS
Development and validation of a Trastuzumab/Pertuzumab Hybrid LC-MS assay for clinical development
14:20 14:40 Eric Niederkofler – Thermo Fischer Scientific
Validation of a Hybrid Assay for the Rapid Quantification of the Biologic, Insulin Degludec
13:00 14:40 Day 2 – Breakout 2
Immunogenicity: strategies for non-mAb scaffolds
13:00 13:20 Bernd Potthoff – Novartis
A cell based immunogenicity assay to detect antibodies against chimeric antigen receptor
13:20 13:40 Anton Rosenbaum – AstraZeneca
Immunogenicity Assessment for MEDI7219, an Oral GLP1 Agonist Peptide
13:40 14:00 Nicoline Videbæk – Novo Nordisk
Improvement of nAb assays with poor sensitivity and drug tolerance – challenges and solutions
14:00 14:20 Open slot
Presenter tentatively identified
14:20 14:40 Panel discussions
14:40 15:10 Coffee break
15:10 17:00 Day 2 – Workshop 1
Hybrid Assays – Workshop – session building in progress
15:10 15:30 Presenter tbc
Recap of applications with focus on needed versus achieved A&P
15:30 15:50 Presenter tbc – on behalf of the EBF
EBF’s experience. discussions and Recommendation
15:50 16:10 Presenter tbc – representing the AAPS
An AAPS perspective on hybrid assays
16:10 16:30 Open slot
Presenter tentatively identified – tbc
16:30 17:00 Panel discussion
15:10 18:00 Day 2 – Breakout 3
Immunogenicity applied in the new regulatory landscape (building experience) – Part 1
15:10 15:30 Boris Gorovits – Pfizer
Should we learn more about characteristics of ADA response?
15:30 15:50 Roland Staack – F. Hoffmann-La Roche
Are immunogenicity assay results really “incomparable”? The critical role of Bioanalysis to bring immunogenicity testing to the next level.
15:50 16:10 Presenter tbc – AstraZeneca
Assessment of Anti-drug Antibodies to evaluate the immunogenicity in AstraZeneca’s leading clinical ASO program using methods that meet regulatory guidance
16:10 16:40 short break
Day 2 Breakout 3
Immunogenicity applied in the new regulatory landscape (building experience) – Part 2
16:40 17:00 Johannes Stanta – Covance
Singlicate analysis in ADA assays
17:00 17:20 Jacomijn Dijksterhuis – PRA-HS
Different interpretations on new FDA guidance 2019 for ADA validations – a CRO’s perspective
17:20 17:40 João Pedras-Vasconceles – CBER
tentative title – A view from the regulators
17:40 18:00 Q&A / Panel Discussion
16:20 18:00 Day 2 – Workshop 2
e-environment: towards a vendor neutral secure bi-directional data transfer process – session building in progress
16:20 16:40 Presenter tbc – on behalf of the EBF
Feedback from the EBF – The historical discussions (OS 2018/2019) and interactions with software developers
16:40 17:00 Rapid fire session – Multiple presenters – tbc
Feedback/comments from software developers on the EBF suggested template for vendor neutral secure LC/MS-IM bi-directional data transfer
17:00 17:20 Feedback from the regulators – a follow-up on the Data Integrity guidance in relation to the session theme
17:20 17:40 Burkhard Schaefer – Merck
Meeting regulatory requirements in long-term storage and processing of HPLC-MS e-data
17:40 18:00 Panel discussions, incl.
1. Q&A on the implementation of a vendor neutral secure LC/MS-IM bi-directional data transfer process
2. Feedback from outside EBF on the EBF proposal
3. Can other areas/platforms benefit form a vendor neutral secure bi-directional data transfer process template?
End of Day 2 for EU/Asia
18:30 20:00 EU/US time Zone Plenary Session 1
Global Engagement on Biomarker Context of Use
18:30 18:40 Joanne Goodman – on behalf of the EBF
Introduction into the session
18:40 19:00 Kyra Cowan – on behalf of the EBF
The 2020 EBF Recommendation on BM Assay Validation – key points to consider when implementing CoU practices
19:00 19:20 Bert Rutten – AstraZeneca
Case study 2
19:20 19:40 Presenter from PharmScie360 0rganiser committee – tbc
Feedback and reflections from the AAPS PharmSci360 Workshop on CoU
19:40 20:00 Presenter from HA – tbc
A regulatory perspective
Day 3: 19 November 2020
11:00 12:30 EU/ASIA time Zone Plenary Session 2
session not assigned yet
13:00 14:40 Day 3 – Workshop 1
Best practices in method development and communications to drive successful assay transfer between BioA labs – – session building in progress
13:00 13:20 Presenter tbc – on behalf of the EBF
A recap of EBF discussions and recommendations on Pharma-CRO partnership best practices for Method Development
13:20 13:40 Presenter tbc – from Covance/AstraZeneca
Successes and learnings: an example from industry
13:40 14:00 Presenter tbc – Janssen R&D/PRA-HS
Successes and learnings: an example from industry
14:00 14:20 Jean Christophe – F. Hoffmann-La Roche
Successes and learnings: an example from industry
14:20 14:40 Q&A / panel discussion
13:00 14:40 Day 3 – Breakout 1
Applications of Biomarker Assays: success stories and challenges
13:00 13:20 Jade Louber – UCB Biopharma
Implementation of a Fit for Purpose Clinical Biomarker Assay using High-Quality Flow Cytometry
13:20 13:40 Berthold Lausecker – AZ Biopharma
Method development and validation of an ultra-sensitive LC-MSMS assay for the quantification of estradiol on the basis of an existing assay for ethinylestradiol
13:40 14:00 Matthias Sury – Celerion
Biomarker Assay Development and Validation: Failing your Way to Success
14:00 14:20 Sebastiaan Bijttebier – Janssen R&D
Development of IP-LC-TQMS methodology as biomarker read-out to quantify tau phosphorylation around T217 in CSF clinical study samples from Alzheimer diseased patients
14:20 14:40 Robert Nelson – Covance
Making haste, slowly, in bioanalysis of biomarkers
13:00 14:40 Day 3 Breakout 2
ADA – Case studies – session building in progress
13:00 13:20
13:20 13:40
13:40 14:00
14:00 14:20
14:20 14:40
14:40 15:10 Coffee break
15:10 17:00 Day 3 – Workshop 2
Managing GCP in the BioA lab – learning from the past for a better future
15:10 15:30 Tsvetelina Ivanova – on behalf of the EBF
Feedback from EBF Survey – sharing experiences of GCP inspections
15:30 15:50 Presenter tbc
Areas we want to challenge in current interpretation of GCP by HA
Areas we want to challenge ourselves in over-interpretation
15:50 16:10 Presenter tbc – on behalf of the EBF
Towards and EBF recommendation of sustainable GLP compliance in the BA lab
16:10 16:30 Presenters from HA presenters (MHRA/EMA)
Feedback from our regulators
16:30 17:00 Q&A and panel discussion
16:20 18:00 Day 3 – Workshop 3
Method development 2 – Worries for the future, or, can regional barriers or guideline expectations taken out of perspective? – session building in progress
16:20 16:40 Presenter tbc – on behalf of EBF
FDA/ICH M10 – diving deeper and identifying opportunities or hurdles – what if taken out of intentional purpose or perspective
16:40 17:00 Presenter tbc – on behalf of EBF
Method development challenges across regions
17:00 17:20 Matthew Barfield – on behalf of the EBF
A recent EBF Survey on regional barriers
17:20 18:00 Q&A or panel discussion
Covering session themes and including pre-meeting survey to delegates
15:10 17:00 Day 3 – Breakout 3
Diagnostics and PD decision making in clinical studies: new frontiers – session building in progress
15:10 15:30 Introduction
15:30 15:50 Yue Huang – AstraZeneca
title tbc
15:50 16:10 Presenter tbc – Quanterix
The Urgency of Diagnostics – Increased Specificity, Increased Sensitivity and Reduced Invasiveness are the Road to the Hallmark Diagnostic
16:10 16:30 Open slot
16:30 17:00 Open slot or panel discussion
End of Day 3 for EU/Asia –
18:30 20:00 EU/ASIA time Zone Plenary Session 2
not assigned yet
Day 4: 20 November 2020
13:00 14:40 Day 3 – Workshop 1
Covid-19: challenges, experiences and impact on the BA lab – session building in progress
13:00 13:20 Presenter tbc – expert in virology, epidemiology
A Covid-19 safety perspective from the expert
13:20 13:40 Presenter from Pharma – tbc
lab set up challenges and UK regional requirements ?
13:40 14:00 Presenter from CRO – tbc
Organisation pressures re. reorganising labs etc… etc…
14:00 14:20 Presenters and theme identified, awaiting confirmation
– (Global) Central lab perspective
– A perspective from across the ocean
14:20 14:40 see 14:00 – 14:20
13:00 14:40 Day 4 break out 1
Biosimilars – session building in progress
14:40 15:10 Coffee break
15:10 16:50 Day 4 Plenary session
Feedback on ICH M10 – incl. Q&A
– session building in progress
15:10 16:50 Contributions from industry and HA (presentations/Panels) are being identified to discuss key areas of interest and importance, identify/Suggest modus operandi for need for training and how to manage industry-regulator once interactions ICH M10 is implemented
Session may be preceded by a survey to all delegates to identify key areas
16:50 17:00 Closing remarks – Adjourn

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