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
AGENDA AT A GLANCE
you can click on the agenda title to view the details of the session
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 | ||||
| 12:30 | 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) | ||||
| 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) | ||||
| 12:10 | 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) | ||||
| 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) | ||||
| 19:40 | 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 | ||||
| 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 | ||||
| 16:00 | 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 | |||
Diamond sponsors
Emerald sponsors
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