EBF
EBF
EBF
European
Bioanalysis
Forum


EBF vzw is the registered non-profit organisation of the European Bioanalysis Forum

 

BCN Slides 2020

Program of EBF 13th Open Symposium From Cyberspace – Staying Connected.

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 0: 16 November 2020
17:15 20:00 Diamond Sponsor Cocktail e-reception
17:15 Coming online
17:30 17:45 Philip Timmerman, EBF Getting started
17:45 20:00 Diamond Sponsor connecting
Getting to know the scientific/process excellence of our Diamond sponsors and their e-booths
20:00 Announcement Winner of the Diamond sponsor e-reception teaser
20:30 Zoom session will be closed by the meeting host

 

Day 1: 17 November 2020
12:30 13:00 Coming online
13:00 13:15 Getting started – Welcome
Philip Timmerman – EBF
13:15 15:10 Day 1 – Plenary 1
A Pandemic Uniting us Behind Science
13:15 Joanne Goodman – on behalf of the EBF
Bioanalytical solutions in support of the COVID-19 global pandemic
13:30 13:50 Melanie Anderson – MSD, for IQ
Patient Centric Sampling: How the COVID-19 Pandemic is Shifting the Landscape
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 Richard Hughes – 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.
15:30 Zoom session will be closed by the meeting host
15:30 18:00 Day 1 – Breakout 1
Enhanced usage and recent developments in chromatographic separations (LC-MS and beyond)
15:30 15:40 Coming online
15:40 16:00 Aaron Ledvina – Covance
High-sensitivity workflow for LC-MS based analysis of GalNAc-conjugated oligonucleotides
16:00 16:20 Michael Blackburn – 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
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.
18:20 Zoom session will be closed by the meeting host
15:30 17:00 Day 1 – Breakout 2
Enhanced usage of high sensitivity LBA technologies
15:30 Coming online
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 Daniel Creed – LGC
The highs and lows of ultra-sensitive immunoassays: experiences from a CRO’s perspective
16:40 17:00 Daniel Sikkema – Quanterix
The most sensitive immunoassay just got more sensitive: how a 100-fold increase in sensitivity of Simoa was achieved
17:20 Zoom session will be closed by the meeting host
End of Day 1

 

Day 2: 18 November 2020

10:45 12:30 EU/ASIA time Zone Plenary Session 1
Global Engagement on Biomarker Context of Use
10:45 Coming online
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 Matthias Sury – Celerion
Biomarker Assay Development and Validation: Failing your Way to Success
11:50 12:10 Lauren Stevenson – Immunologix Labs
Feedback and reflections from the AAPS PharmSci360 Workshop on CoU
12:10 12:30 Abbas Bandukwala – CDER-FDA
A regulatory perspective
12:45 Zoom session will be closed by the meeting host
12:45 15:10 Day 2 – Breakout 1
Protein analysis by LC-MS(MS) – Applications
12:45 Coming online
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 14:10 short break
14:10 14:30 Corina Hunger – Sanofi
Validation of a biotherapeutic ligand-binding-LC-MS/MS assay in monkey and mouse serum
14:30 14:50 Fabrizia Fusetti – QPS
Development and validation of a Trastuzumab/Pertuzumab Hybrid LC-MS assay for clinical development
14:50 15:10 Eric Niederkofler – Thermo Fischer Scientific
Validation of a Hybrid Assay for the Rapid Quantification of the Biologic, Insulin Degludec
15:30 Zoom session will be closed by the meeting host
12:45 15:30 Day 2 – Breakout 2
Immunogenicity applied in the new regulatory landscape (building experience)
12:45 Coming online
13:00 13:20 Boris Gorovits – Pfizer
Should we learn more about characteristics of ADA response?
13:20 13:40 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.
13:40 14:00 Johannes Stanta – Covance
Singlicate analysis in ADA assays
14:00 14:10 Short Break
14:10 14:30 Tobias Haslberger – on behalf of the EBF
A Chinese NMPA draft technical guideline on immunogenicity of therapeutic agents: difference and similarities to existing EMA and FDA Guidelines or a new global challenge for harmonisation?
14:30 14:50 Jacomijn Dijksterhuis – PRA-HS
Different interpretations on new FDA guidance 2019 for ADA validations – a CRO’s perspective
14:50 15:10 João Pedras-Vasconceles – FDA-CDER
Immunogenicity Assessments for Biologics–Current Perspectives from FDA’s Office of Biotechnology Products
15:10 15:30 Q&A / Panel Discussion
15:50 Zoom session will be closed by the meeting host
13:15 15:30 Day 2 – It’s Poster time.
Dedicated session on posters
13:15 Coming Online
13:30 15:30 5-minute poster pitch for Scientific posters
15:50 Zoom session will be closed by the meeting host
16:00 18:00 Day 2 – Breakout 3
Immunogenicity: strategies for non-mAb scaffolds
16:00 Coming online
16:10 16:30 Bernd Potthoff – Novartis
A cell based immunogenicity assay to detect antibodies against chimeric antigen receptor
16:30 16:50 Anton Rosenbaum – AstraZeneca
Immunogenicity Assessment for MEDI7219, an Oral GLP1 Agonist Peptide
16:50 17:10 Nicoline Videbæk – Novo Nordisk
Improvement of nAb assays with poor sensitivity and drug tolerance – challenges and solutions
17:10 17:30 Anna Laurén – on behalf of the EBF
EBF consideration for NAb assay development and design with emphasis on matrix, sensitivity and sample pre-treatment
17:30 18:00 Panel discussions
18:20 Zoom session will be closed by the meeting host
16:00 18:00 Day 2 – Workshop 1
e-environment: towards a vendor neutral secure bi-directional data transfer process
16:00 Coming online
16:10 17:00 Cecilia Arfvidsson – on behalf of the EBF
Feedback from the EBF – The historical discussions (OS 2018/2019) and interactions with software developers
Neil Loftus – Shimadzu
A brief introduction on behalf of software developers on the EBF initiative
Gidion de Boer – Thermo Scientific and Burkhard Schaefer – Merck
A vendor-neutral prototype for a secure data transfer – Feedback/proposed solution from the software developer
17:00 17:20 Jason Wakelin-Smith – MHRA
Feedback from the regulators
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?
18:20 Zoom session will be closed by the meeting host
End of Day 2 for EU/Asia
18:15 20:00 EU/NA time Zone Plenary Session 1
Global Engagement on Biomarker Context of Use
18:15 Coming online
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 Matthias Sury – Celerion
Biomarker Assay Development and Validation: Failing your Way to Success
19:20 19:40 Lauren Stevenson – Immunologix Labs
Feedback and reflections from the AAPS PharmSci360 Workshop on CoU
19:40 20:00 Abbas Bandukwala – CDER-FDA
A regulatory perspective
20:20 Zoom session will be closed by the meeting host

 

Day 3: 19 November 2020

10:45 12:30 EU/ASIA time Zone Plenary Session 2
Protein Bioanalysis by LC-MS(MS)
10:45 Coming online
11:00 11:10 Matthew Barfield – on behalf of the EBF
Introduction to the session
11:10 12:10 Matthew Barfield – on behalf of the EBF.
EBF’s experiences, discussions and recommendations on Protein Bioanalysis by LC-MS(MS)
Kelly Dong – for CBF
Overview of CBF discussion on protein analysis by LC-MS(MS)
Hisao Shimizu – for JBF
Overview of JBF discussion on protein analysis by LC-MS(MS)
Eric Woolf – MSD
Overview of AAPS discussion on protein analysis by LC-MS(MS)
12:10 12:30 Panel discussion
12:45 Zoom session will be closed by the meeting host
13:15 15:10 Day 3 – Workshop 1
Best practices in method development and communications to drive successful assay transfer between BioA labs
13:15 Coming online
13:30 13:50 Rachel Green – on behalf of the EBF
A recap of EBF discussions and recommendations on Pharma-CRO partnership best practices for Method Development
13:50 14:10 Stephanie Cape – Covance
A method development case study highlighting successes and learnings from a CRO – pharma alliance
14:10 14:30 Lieve Dillen – Janssen R&D
Pharma/CRO alliance: what are the keys of success in transfer of assays.
14:30 14:50 Jean-Christophe Genin – F. Hoffmann-La Roche
Successes and learnings: an example from industry
14:50 15:30 Q&A / panel discussion
15:30 Zoom session will be closed by the meeting host
13:15 15:10 Day 3 – Breakout 1
Applications of Biomarker Assays: success stories and challenges
13:15 Coming online
13:30 13:50 Jade Louber – UCB Biopharma
Implementation of a Fit for Purpose Clinical Biomarker Assay using High-Quality Flow Cytometry
13:50 14:10 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
14:10 14:30 Benedicte Brackeva – Ablynx, a Sanofi company Regulatory feedback on context of use biomarker validation for caplacizumab
14:30 14:50 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
14:50 15:10 Robert Nelson – Covance
Making haste, slowly, in bioanalysis of biomarkers
15:30 Zoom session will be closed by the meeting host
12:45 15:30 Day 3 Breakout 2
ADA – Case studies
12:45 Coming online
13:00 13:20 Susanne Pihl – on behalf of the EBF
EBF feedback for ADA in non-clinical studies focusing on sampling, communication and evaluation of TK/PK
13:20 13:40 Eugenia Hoffmann – Roche pRED
Impact of drug/anti-drug antibody complexes on drug PK: advanced bioanalysis for a better understanding of immunogenicity
13:40 14:00 Janett Schwarz – Bioagilytix
ADA/NAB Drug and Target tolerance by SPEAD treatment
14:00 14:10 Short Break
14:10 14:30 Craig Stovold – AstraZeneca
Assessment of Anti-drug Antibodies to evaluate the immunogenicity in AstraZeneca’s leading clinical ASO program using methods that meet regulatory guidance
14:30 14:50 Craig Stovold – AstraZeneca
Assessment of Anti-drug Antibodies to evaluate the immunogenicity in AstraZeneca’s leading clinical ASO program using methods that meet regulatory guidance
14:50 15:10 Gregor Jordan – F. Hoffmann La Roche High drug tolerant immunogenicity testing: Is there space for improvement?
15:30 Q&A
Zoom session will be closed by the meeting host
16:00 17:30 Day 3 – Workshop 2
Regional Barriers and Global Interpretation of Guidelines
16:00 Coming online
16:10 16:30 Steve White- on behalf of EBF
Method development documentation; Interpretation of guidelines
16:30 16:50 Cecilia Arfvidsson, – on behalf of EBF
A recent EBF survey on regional barriers
16:50 17:10 Matthew Barfield – on behalf of the EBF.
To Ship or Not to Ship – Results from a recent EBF survey exploring the trends in supporting the Bioanalysis of China studies
17:10 17:30 Q&A
17:50 Zoom session will be closed by the meeting host
16:00 17:30 Day 3 – Breakout 3
Diagnostics and PD decision making in clinical studies: new frontiers
16:00 Coming online
16:10 16:30 Anna Laurén – SVAR
Clia/ISO or BMV for Biomarkers and Diagnostics: two worlds?
16:30 16:50 Yue Huang – AstraZeneca
Novel Approach to Qualify for Clinical Application a High Throughput HILIC-MRM Method for the Quantification of Human Plasma Phosphatidylinositols
16:50 17:10 Martha Miles – Quanterix
The Urgency of Diagnostics – Increased Specificity, Increased Sensitivity and Reduced Invasiveness are the Road to the Hallmark Diagnostic
17:10 17:30 Jeffrey Wallin – Gilead
The TLR7 agonist vesatolimod induces dose-dependent immune responses in HIV controllers
17:50 Zoom session will be closed by the meeting host
16:00 17:30 Day 3 – It’s again Poster time
Dedicated session on posters
16:00 Coming online
16:10 17:30 5-minute poster pitch for Scientific posters
17:50 Zoom session will be closed by the meeting host
End of Day 3 for EU/Asia –
18:15 20:00 EU/ASIA time Zone Plenary Session 2
Protein Bioanalysis by LC-MS(MS)
18:15 Coming online
18:30 18:40 Matthew Barfield – on behalf of the EBF
Introduction to the session
18:40 19:40 Matthew Barfield – on behalf of the EBF
EBF’s experiences, discussions and recommendations on Protein Bioanalysis by LC-MS(MS)
Kelly Dong – for CBF
Overview of CBF discussion on protein analysis by LC-MS(MS)
Hlsao Shimizu – for JBF
Overview of JBF discussion on protein analysis by LC-MS(MS)
Faye Vazvaei – MSD
Overview of AAPS discussion on protein analysis by LC-MS(MS)
19:40 20:00 Panel discussion
20:20 Zoom session will be closed by the meeting host

 

Day 4: 20 November 2020
12:45 15:00 Day 4 – Workshop 1
Covid-19: challenges, experiences and impact on the BA lab
12:45 Coming online
13:00 13:20 Anna Laurén – on behalf of the EBF
The Tale of the Virus and Sample: Considerations from Expert Groups
13:20 13:40 Michael Wright- LGC
Bad Blood? An Evolving Tale of Risk Within a COVID-19 World
13:40 14:00 Scott Summerfield – GlaxoSmithKline
Lab set up challenges and UK regional requirements ?
14:00 14:20 Guillaume Couffe – Covance Central labs
Running Clinical Trials with agility during COVID-19 pandemic
14:20 14:40 Amy Lavelle – PPD
COVID in North America: impact on the bioanalytical and drug development community
14:40 15:00 Q&A and panel discussion
15:00 Zoom session will be closed by the meeting host immediattly after the Q&A
12:45 14:40 Day 4 – Workshop 2
Managing GCP in the BioA lab – learning from the past for a better future
12:45 Coming online
13:00 13:20 Tom Verhaeghe – on behalf of the EBF
Feedback from EBF Survey – sharing experiences of GCP inspections
13:20 13:40 Philip Timmerman – EBF
GCP – From challenges into opportunities
13:40 14:00 Tsvetelina Ivanova – on behalf of the EBF
Towards and EBF recommendation of sustainable GLP compliance in the BA lab
14:00 14:20 Jason Wakelin-Smith – MHRA
Feedback from the regulators
14:20 14:40 Q&A and panel discussion
15:00 Zoom session will be closed by the meeting host
12:45 14:40 Day 4 – Breakout 1
Academia and young scientist: emerging talent for and new perspective on Bioanalysis
12:45 Coming online
13:00 13:20 2020 BRSA – winner: Sooraj Baijnath, University of KwaZulu-Natal (South Africa)
Technological advances in mass spectrometry imaging driving preclinical drug discovery
13:20 13:40 Connor Walker – on behalf of the EBF-YSS
Feedback from the 6th YSS Science Café – A Sustainable Future
13:40 14:00 Robert Stewart – Covance
Investigating generic PK methods of quantifying human monoclonal antibodies in pre-clinical species by LC-MS and ligand-binding assays.
14:00 14:20 Salvatore Calogero – Swiss BioQuant
The rise of “non-standard” techniques in regulated environment
14:20 14:40 Rebecca Paterson (Charles River Laboratories) – tbc Antibody Drug Conjugate Bioanalysis – An opportunity for LBA and LC-MS Synergy?
15:00 Zoom session will be closed by the meeting host
15:00 16:50 Day 4 Plenary session
Feedback on ICH M10 – incl. Q&A
15:00 Coming online
15:20 16:00 Jo Goodman – AstraZeneca
A status update on ICH M10
Philip Timmerman – EBF
A draft Guideline is a draft Guideline
ICH M10 Public Consultation – our concerns confirmed
Steve White – on behalf of the EBF Scope of the Guideline and Chromatographic assays
Mark Gnoth – on behalf of the EBF
Surrogate matrix – a recent survey from the EBF
Michaela Golob – on behalf of the EBF
Ligand Binding Assays and Endogenous
Tom Verhaeghe – on behalf of the EBF
ISR and Documentation, incl a recent survey on FDA documentation
16:00 16:20 Dulcyane Mendes – Anvisa
ICH M10 GUIDANCE adoption by ANVISA
16:20 16:50 Q&A from audience (live and chat) and pre-meeting survey to registered delegates
16:50 17:00 Closing remarks – Adjourn
18:00 Zoom session will be closed by the meeting host

BCN Slides 2020