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 alos download the PDF of the agenda here)

 

AGENDA AT A GLANCE

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

Day 0: 16 November 2020
17:15 20:00 Diamond Sponsor Cocktail e-reception
Day 1: 17 November 2020
13:00 13:15 Getting started – Welcome
13:15 15:10 Day 1 – Plenary 1. A Pandemic Uniting us Behind Science
15:30 18:00 Day 1 – Breakout 1. Enhanced usage and recent developments in chromatographic separations (LC-MS and beyond)
15:30 17:00 Day 1 – Breakout 2. Enhanced usage of high sensitivity LBA technologies
Day 2: 18 November 2020
10:45 12:30 EU/ASIA time Zone Plenary Session 1. Global Engagement on Biomarker Context of Use
12:45 15:10 Day 2 – Breakout 1. Protein analysis by LC-MS(MS) – Applications
12:45 15:30 Day 2 – Breakout 2. Immunogenicity applied in the new regulatory landscape (building experience)
14:00 15:30 Day 2 – It’s Poster time. Dedicated session 5-min poster pitches
16:00 18:00 Day 2 – Breakout 3. Immunogenicity: strategies for non-mAb scaffolds
16:00 18:00 Day 2 – Workshop 1. The e-environment: towards a vendor neutral secure bi-directional data transfer process
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
Day 3: 19 November 2020
10:45 12:30 EU/ASIA time Zone Plenary Session 2. Protein Bioanalysis by LC-MS(MS)
13:15 15:10 Day 3 – Workshop 1. Best practices in MDEV and communications to drive successful assay transfer between BioA labs
13:15 15:10 Day 3 – Breakout 1. Applications of Biomarker Assays: success stories and challenges
12:45 15:30 Day 3 – Breakout 2. ADA – Case studies
16:00 17:30 Day 3 – Workshop 2. Regional Barriers and Global Interpretation of Guidelines
16:00 17:30 Day 3 – Breakout 3. Diagnostics and PD decision making in clinical studies: new frontiers
16:00 17:30 Day 3 – It’s Poster time. Dedicated session 5-min poster pitches
End of Day 3 for EU/Asia –
18:15 20:00 EU/NA time Zone Plenary Session 2 Protein Bioanalysis by LC-MS(MS)
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 14:40 Day 4 – Workshop 2. Managing GCP in the BioA lab – learning from the past for a better future
12:45 14:40 Day 4 – Breakout 1. Academia and young scientist: emerging talent for and new perspective on Bioanalysis
15:00 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
17:15 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
     
 12:3013:00 Coming online
 13:0013:15 Getting started – Welcome
Philip Timmerman – EBF
     
 13:1515:10 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
 13:3013:50 Melanie Anderson – MSD, for IQ
Patient Centric Sampling: How the COVID-19 Pandemic is Shifting the Landscape
 13:5014:10 Else Marie Agger – Novo Nordisk
SARS-CoV-2 assay development in a bioanalysis laboratory
 14:1014:30 Catherine Vrentas – PPD
Development and characterization of an MSD-ECL assay for the effective quantitation of anti-SARS-CoV-2 antibodies in human serum
 14:3014:50 Richard Hughes – LGC
New immunogenicity strategies to meet the needs of a developing pandemic.
 14:5015:10 Sarah Peters – Celerion
Opening Safely in the Face of a Global Pandemic.
  15:30 Zoom session will be closed by the meeting host
     
 15:3018:00 Day 1 – Breakout 1
Enhanced usage and recent developments in chromatographic separations (LC-MS and beyond)
 15:3015:40 Coming online
 15:4016:00 Aaron Ledvina – Covance
High-sensitivity workflow for LC-MS based analysis of GalNAc-conjugated oligonucleotides
 16:0016:20 Michael Blackburn – ARCINOVA
Assessment of fluoride exposure by GCMS: successes achieved and hard lessons learnt
 16:2016:40 Ariane Kahnt – Janssen R&D
Challenges in the quantitative analysis of Vitamin E TPGS in biological matrices using LC-MS/MS
     
 16:4017:00 short break
     
 17:0017:20 Esther van Duijn – TNO
Metabolic profiling and mass balance studies in pediatric patients using a microtracer approach – a proof of concept
 17:2017:40 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
 17:4018:00 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
     
 15:3017:00 Day 1 – Breakout 2
Enhanced usage of high sensitivity LBA technologies
 15:30  Coming online
 15:4016:00 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
 16:0016:20 Chris Fox – Gyros Protein Technologies AB
The efficient generation of pharmacokinetics data using affinity flow-through nanoliter format immunoassays
 16:2016:40 Daniel Creed – LGC
The highs and lows of ultra-sensitive immunoassays: experiences from a CRO’s perspective
 16:4017:00 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
     
 10:4512:30 EU/ASIA time Zone Plenary Session 1
Global Engagement on Biomarker Context of Use
 10:45  Coming online
 11:0011:10 Kyra Cowan – on behalf of the EBF
Introduction into the session
 11:1011:30 Joanne Goodman – on behalf of the EBF
The 2020 EBF Recommendation on BM Assay Validation – key points to consider when implementing CoU practices
 11:3011:50 Matthias Sury – Celerion
Biomarker Assay Development and Validation: Failing your Way to Success
 11:5012:10 Lauren Stevenson – Immunologix Labs
Feedback and reflections from the AAPS PharmSci360 Workshop on CoU
 12:1012:30 Abbas Bandukwala – CDER-FDA
A regulatory perspective
  12:45 Zoom session will be closed by the meeting host
     
 12:4515:10 Day 2 – Breakout 1
Protein analysis by LC-MS(MS) – Applications
 12:45  Coming online
 13:0013:20 Nico van de Merbel – PRA-HS
The best of both worlds: developments in hybrid ligand-binding / LC-MS approaches for peptide and protein quantification
 13:2013:40 Ashley Phillips – LGC
Next Gen Trypsin: Large Molecule LC-MS/MS Bioanalysis Today, Not Tomorrow
 13:4014:00 Luca Ferrari – F. Hoffmann – La Roche
Therapeutic/biomarker protein quantification in tissues: method development strategies to overcome sensitivity & selectivity issues using hybrid LBA-LCMS
     
 14:0014:10 short break
     
 14:1014:30 Corina Hunger – Sanofi
Validation of a biotherapeutic ligand-binding-LC-MS/MS assay in monkey and mouse serum
 14:3014:50 Fabrizia Fusetti – QPS
Development and validation of a Trastuzumab/Pertuzumab Hybrid LC-MS assay for clinical development
 14:5015:10 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
     
 12:4515:30 Day 2 – Breakout 2
Immunogenicity applied in the new regulatory landscape (building experience)
 12:45  Coming online
 13:0013:20 Boris Gorovits – Pfizer
Should we learn more about characteristics of ADA response?
 13:2013:40 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.
 13:4014:00 Johannes Stanta – Covance
Singlicate analysis in ADA assays
     
 14:0014:10 Short Break
     
 14:1014:30 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?
 14:3014:50 Jacomijn Dijksterhuis – PRA-HS
Different interpretations on new FDA guidance 2019 for ADA validations – a CRO’s perspective
 14:5015:10 João Pedras-Vasconceles – FDA-CDER
Immunogenicity  Assessments for Biologics–Current Perspectives from FDA’s Office of Biotechnology Products 
 15:1015:30 Q&A / Panel Discussion
  15:50 Zoom session will be closed by the meeting host
     
 13:1515:30 Day 2 – It’s Poster time.
Dedicated session on posters
 13:15  Coming Online
 13:3015:30 5-minute poster pitch for Scientific posters
 15:50  Zoom session will be closed by the meeting host
     
 16:0018:00 Day 2 – Breakout 3
Immunogenicity: strategies for non-mAb scaffolds
 16:00  Coming online
 16:1016:30 Bernd Potthoff – Novartis
A cell based immunogenicity assay to detect antibodies against chimeric antigen receptor
 16:3016:50 Anton Rosenbaum – AstraZeneca
Immunogenicity Assessment for MEDI7219, an Oral GLP1 Agonist Peptide
 16:5017:10 Nicoline Videbæk – Novo Nordisk
Improvement of nAb assays with poor sensitivity and drug tolerance – challenges and solutions
 17:1017:30 Anna Laurén – on behalf of the EBF
EBF consideration for NAb assay development and design with emphasis on matrix, sensitivity and sample pre-treatment
 17:3018:00 Panel discussions
  18:20 Zoom session will be closed by the meeting host
     
 16:0018:00 Day 2 – Workshop 1
e-environment: towards a vendor neutral secure bi-directional data transfer process
 16:00  Coming online
 16:1017:00 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
 17:0017:20 Jason Wakelin-Smith – MHRA
Feedback from the regulators
 17:2017:40 Burkhard Schaefer – Merck
Meeting regulatory requirements in long-term storage and processing of HPLC-MS e-data
 17:4018:00 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
     
 18:1520:00 EU/NA time Zone Plenary Session 1
Global Engagement on Biomarker Context of Use
 18:15  Coming online
 18:3018:40 Joanne Goodman – on behalf of the EBF
Introduction into the session
 18:4019:00 Kyra Cowan – on behalf of the EBF
The 2020 EBF Recommendation on BM Assay Validation – key points to consider when implementing CoU practices
 19:0019:20 Matthias Sury – Celerion
Biomarker Assay Development and Validation: Failing your Way to Success
 19:2019:40 Lauren Stevenson – Immunologix Labs
Feedback and reflections from the AAPS PharmSci360 Workshop on CoU
 19:4020:00 Abbas Bandukwala – CDER-FDA
A regulatory perspective
  20:20 Zoom session will be closed by the meeting host
 
Day 3: 19 November 2020
     
 10:4512:30 EU/ASIA time Zone Plenary Session 2
    Protein Bioanalysis by LC-MS(MS)
 10:45  Coming online
 11:0011:10 Matthew Barfield – on behalf of the EBF
Introduction to the session
 11:1012:10 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)
    Presenter tbc – 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)
 12:1012:30 Panel discussion
  12:45 Zoom session will be closed by the meeting host
     
 13:1515:10 Day 3 – Workshop 1
Best practices in method development and communications to drive successful assay transfer between BioA labs
 13:15  Coming online
 13:3013:50 Rachel Green – on behalf of the EBF
A recap of EBF discussions and recommendations on Pharma-CRO partnership best practices for Method Development
 13:5014:10 Stephanie Cape – Covance
A method development case study highlighting successes and learnings from a CRO – pharma alliance
 14:1014:30 Lieve Dillen – Janssen R&D
Pharma/CRO alliance: what are the keys of success in transfer of assays.
 14:3014:50 Jean-Christophe Genin – F. Hoffmann-La Roche
Successes and learnings: an example from industry
 14:5015:30 Q&A / panel discussion
  15:30 Zoom session will be closed by the meeting host
     
 13:1515:10 Day 3 – Breakout 1
Applications of Biomarker Assays: success stories and challenges
 13:15  Coming online
 13:3013:50 Jade Louber – UCB Biopharma
Implementation of a Fit for Purpose Clinical Biomarker Assay using High-Quality Flow Cytometry
 13:5014:10 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
 14:1014:30 Benedicte Brackeva – Ablynx, a Sanofi company Regulatory feedback on context of use biomarker validation for caplacizumab
 14:3014:50 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
 14:5015:10 Robert Nelson – Covance
Making haste, slowly, in bioanalysis of biomarkers
  15:30 Zoom session will be closed by the meeting host
     
 12:4515:30 Day 3 Breakout 2
ADA – Case studies
 12:45  Coming online
 13:0013:20 Susanne Pihl – on behalf of the EBF
EBF feedback for ADA in non-clinical studies focusing on sampling, communication and evaluation of TK/PK
 13:2013:40 Eugenia Hoffmann – Roche pRED
Impact of drug/anti-drug antibody complexes on drug PK: advanced bioanalysis for a better understanding of immunogenicity
 13:4014:00 Janett Schwarz – Bioagilytix
ADA/NAB Drug and Target tolerance by SPEAD treatment
     
 14:0014:10 Short Break
     
 14:1014:30 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
 14:3014:50 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
 14:5015:10 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
     
 16:0017:30 Day 3 – Workshop 2
Regional Barriers and Global Interpretation of Guidelines
 16:00  Coming online
 16:1016:30 Steve White- on behalf of EBF
Method development documentation; Interpretation of guidelines
 16:3016:50 Cecilia Arfvidsson, – on behalf of EBF
A recent EBF survey on regional barriers
 16:5017:10 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
 17:1017:30 Q&A
  17:50 Zoom session will be closed by the meeting host
     
 16:0017:30 Day 3 – Breakout 3
Diagnostics and PD decision making in clinical studies: new frontiers
 16:00  Coming online
 16:1016:30 Anna Laurén – SVAR
Clia/ISO or BMV for Biomarkers and Diagnostics: two worlds?
 16:3016:50 Yue Huang – AstraZeneca
Novel Approach to Qualify for Clinical Application a High Throughput HILIC-MRM Method for the Quantification of Human Plasma Phosphatidylinositols
 16:5017:10 Martha Miles – Quanterix
The Urgency of Diagnostics – Increased Specificity, Increased Sensitivity and Reduced Invasiveness are the Road to the Hallmark Diagnostic
 17:1017:30 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
     
 16:0017:30 Day 3 – It’s again Poster time
Dedicated session on posters
 16:00  Coming online
 16:1017:30 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 –
     
 18:1520:00 EU/ASIA time Zone Plenary Session 2
Protein Bioanalysis by LC-MS(MS)
 18:15  Coming online
 18:3018:40 Matthew Barfield – on behalf of the EBF
Introduction to the session
 18:4019:40 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)
    Presenter tbc – 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)
 19:4020:00 Panel discussion
  20:20 Zoom session will be closed by the meeting host
 
Day 4: 20 November 2020
     
 12:4515:00 Day 4 – Workshop 1
Covid-19: challenges, experiences and impact on the BA lab
 12:45  Coming online
 13:0013:20 Anna Laurén – on behalf of the EBF
The Tale of the Virus and Sample: Considerations from Expert Groups
 13:2013:40 Michael Wright- LGC
Bad Blood? An Evolving Tale of Risk Within a COVID-19 World
 13:4014:00 Scott Summerfield – GlaxoSmithKline
Lab set up challenges and UK regional requirements ?
 14:0014:20 Guillaume Couffe – Covance Central labs
Running Clinical Trials with agility during COVID-19 pandemic
 14:2014:40 Amy Lavelle – PPD
COVID in North America: impact on the bioanalytical and drug development community
 14:4015:00 Q&A and panel discussion
  15:00 Zoom session will be closed by the meeting host immediattly after the Q&A
     
 12:4514:40 Day 4 – Workshop 2
Managing GCP in the BioA lab – learning from the past for a better future
 12:45  Coming online
 13:0013:20 Tom Verhaeghe  – on behalf of the EBF 
Feedback from EBF Survey – sharing experiences of GCP inspections
 13:2013:40 Philip Timmerman – EBF
GCP – From challenges into opportunities
 13:4014:00 Tsvetelina Ivanova – on behalf of the EBF
Towards and EBF recommendation of sustainable GLP compliance in the BA lab
 14:0014:20 Jason Wakelin-Smith – MHRA
Feedback from the regulators
 14:2014:40 Q&A and panel discussion
  15:00 Zoom session will be closed by the meeting host
     
 12:4514:40 Day 4 – Breakout 1
Academia and young scientist: emerging talent for and new perspective on Bioanalysis
 12:45  Coming online
 13:0013:20 2020 BRSA – winner: Sooraj Baijnath, University of KwaZulu-Natal (South Africa)
Technological advances in mass spectrometry imaging driving preclinical drug discovery
 13:2013:40 Connor Walker – on behalf of the EBF-YSS
Feedback from the 6th YSS Science Café – A Sustainable Future
 13:4014:00 Robert Stewart – Covance
Investigating generic PK methods of quantifying human monoclonal antibodies in pre-clinical species by LC-MS and ligand-binding assays.
 14:0014:20 Salvatore Calogero – Swiss BioQuant
The rise of “non-standard” techniques in regulated environment
 14:2014:40 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
     
 15:0016:50 Day 4 Plenary session
Feedback on ICH M10 – incl. Q&A
 15:00  Coming online
 15:2016:00 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
    Jean-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
 16:0016:20 Dulcyane Mendes  – Anvisa
ICH M10 GUIDANCE adoption by ANVISA
 16:2016:50 Q&A from audience (live and chat) and pre-meeting survey to registered delegates
     
 16:5017:00 Closing remarks – Adjourn
  18:00 Zoom session will be closed by the meeting host
 

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