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
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 |
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| 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 |
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| 13:30 | 15:10 | Day 1 – Plenary 1 A Pandemic Uniting us Behind Science |
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| 13:30 | 13:50 | Joanne Goodman – on behalf of the EBF Intro about the type of assays used |
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| 13:50 | 14:10 | Else Marie Agger – Novo Nordisk SARS-CoV-2 assay development in a bioanalysis laboratory |
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| 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 |
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| 14:30 | 14:50 | Presenter tbc – LGC New immunogenicity strategies to meet the needs of a developing pandemic. |
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| 14:50 | 15:10 | Sarah Peters – Celerion Opening Safely in the Face of a Global Pandemic. |
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| 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 |
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| 15:40 | 16:00 | Aaron Ledvina – Covance High-sensitivity workflow for LC-MS based analysis of GalNAc-conjugated oligonucleotides |
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| 16:00 | 16:20 | Michael Blackburne – ARCINOVA Assessment of fluoride exposure by GCMS: successes achieved and hard lessons learnt |
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| 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 |
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| 16:40 | 17:00 | short break | ||
| Day 1 – Breakout 1 Enhanced usage and recent developments in chromatographic separations (LC-MS and beyond) – Part 2 |
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| 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 |
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| 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 |
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| 17:40 | 18:00 | Nikunj Tanna – Waters Advantages of a novel bridged ethyl hybrid surface technology to improve chromatographic efficiency and reduce analyte loss. |
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| 15:40 | 18:00 | Day 1 – Breakout 2 Enhanced usage of high sensitivity LBA technologies – Part 1 |
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| 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 |
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| 16:00 | 16:20 | Chris Fox – Gyros Protein Technologies AB The efficient generation of pharmacokinetics data using affinity flow-through nanoliter format immunoassays |
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| 16:20 | 16:40 | Presenter tbc – LGC The highs and lows of ultra-sensitive immunoassays: experiences from a CRO’s perspective |
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| 16:40 | 17:00 | short break | ||
| Day 1 – Breakout 2 Enhanced usage of high sensitivity LBA technologies – Part 2 |
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| 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 |
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| 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 |
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| 11:00 | 11:10 | Kyra Cowan – on behalf of the EBF Introduction into the session |
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| 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 |
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| 11:30 | 11:50 | Samuel Pine – Ablynx, A sanofi company Case study 1 |
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| 11:50 | 12:10 | Presenter from PharmScie360 0rganiser committee – tbc Feedback and reflections from the AAPS PharmSci360 Workshop on CoU |
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| 12:10 | 12:30 | Presenter from HA – tbc A regulatory perspective |
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| 13:00 | 14:40 | Day 2 – Breakout 1 Hybrid Assays – Application |
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| 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 |
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| 13:20 | 13:40 | Ashley Phillips – LGC Next Gen Trypsin: Large Molecule LC-MS/MS Bioanalysis Today, Not Tomorrow |
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| 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 |
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| 14:00 | 14:20 | Fabrizia Fussetti – QPS Development and validation of a Trastuzumab/Pertuzumab Hybrid LC-MS assay for clinical development |
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| 14:20 | 14:40 | Eric Niederkofler – Thermo Fischer Scientific Validation of a Hybrid Assay for the Rapid Quantification of the Biologic, Insulin Degludec |
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| 13:00 | 14:40 | Day 2 – Breakout 2 Immunogenicity: strategies for non-mAb scaffolds |
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| 13:00 | 13:20 | Bernd Potthoff – Novartis A cell based immunogenicity assay to detect antibodies against chimeric antigen receptor |
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| 13:20 | 13:40 | Anton Rosenbaum – AstraZeneca Immunogenicity Assessment for MEDI7219, an Oral GLP1 Agonist Peptide |
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| 13:40 | 14:00 | Nicoline Videbæk – Novo Nordisk Improvement of nAb assays with poor sensitivity and drug tolerance – challenges and solutions |
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| 14:00 | 14:20 | Open slot Presenter tentatively identified |
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| 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 |
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| 15:10 | 15:30 | Presenter tbc Recap of applications with focus on needed versus achieved A&P |
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| 15:30 | 15:50 | Presenter tbc – on behalf of the EBF EBF’s experience. discussions and Recommendation |
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| 15:50 | 16:10 | Presenter tbc – representing the AAPS An AAPS perspective on hybrid assays |
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| 16:10 | 16:30 | Open slot Presenter tentatively identified – tbc |
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| 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 |
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| 15:10 | 15:30 | Boris Gorovits – Pfizer Should we learn more about characteristics of ADA response? |
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| 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. |
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| 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 |
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| 16:10 | 16:40 | short break | ||
| Day 2 Breakout 3 Immunogenicity applied in the new regulatory landscape (building experience) – Part 2 |
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| 16:40 | 17:00 | Johannes Stanta – Covance Singlicate analysis in ADA assays |
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| 17:00 | 17:20 | Jacomijn Dijksterhuis – PRA-HS Different interpretations on new FDA guidance 2019 for ADA validations – a CRO’s perspective |
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| 17:20 | 17:40 | João Pedras-Vasconceles – CBER tentative title – A view from the regulators |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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? |
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| 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 |
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| 18:30 | 18:40 | Joanne Goodman – on behalf of the EBF Introduction into the session |
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| 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 |
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| 19:00 | 19:20 | Bert Rutten – AstraZeneca Case study 2 |
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| 19:20 | 19:40 | Presenter from PharmScie360 0rganiser committee – tbc Feedback and reflections from the AAPS PharmSci360 Workshop on CoU |
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| 19:40 | 20:00 | Presenter from HA – tbc A regulatory perspective |
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| 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 |
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| 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 |
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| 13:20 | 13:40 | Presenter tbc – from Covance/AstraZeneca Successes and learnings: an example from industry |
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| 13:40 | 14:00 | Presenter tbc – Janssen R&D/PRA-HS Successes and learnings: an example from industry |
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| 14:00 | 14:20 | Jean Christophe – F. Hoffmann-La Roche Successes and learnings: an example from industry |
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| 14:20 | 14:40 | Q&A / panel discussion | ||
| 13:00 | 14:40 | Day 3 – Breakout 1 Applications of Biomarker Assays: success stories and challenges |
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| 13:00 | 13:20 | Jade Louber – UCB Biopharma Implementation of a Fit for Purpose Clinical Biomarker Assay using High-Quality Flow Cytometry |
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| 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 |
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| 13:40 | 14:00 | Matthias Sury – Celerion Biomarker Assay Development and Validation: Failing your Way to Success |
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| 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 |
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| 14:20 | 14:40 | Robert Nelson – Covance Making haste, slowly, in bioanalysis of biomarkers |
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| 13:00 | 14:40 | Day 3 Breakout 2 ADA – Case studies – session building in progress |
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| 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 |
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| 15:10 | 15:30 | Tsvetelina Ivanova – on behalf of the EBF Feedback from EBF Survey – sharing experiences of GCP inspections |
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| 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 |
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| 15:50 | 16:10 | Presenter tbc – on behalf of the EBF Towards and EBF recommendation of sustainable GLP compliance in the BA lab |
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| 16:10 | 16:30 | Presenters from HA presenters (MHRA/EMA) Feedback from our regulators |
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| 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 |
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| 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 |
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| 16:40 | 17:00 | Presenter tbc – on behalf of EBF Method development challenges across regions |
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| 17:00 | 17:20 | Matthew Barfield – on behalf of the EBF A recent EBF Survey on regional barriers |
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| 17:20 | 18:00 | Q&A or panel discussion Covering session themes and including pre-meeting survey to delegates |
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| 15:10 | 17:00 | Day 3 – Breakout 3 Diagnostics and PD decision making in clinical studies: new frontiers – session building in progress |
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| 15:10 | 15:30 | Introduction | ||
| 15:30 | 15:50 | Yue Huang – AstraZeneca title tbc |
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| 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 |
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| 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 |
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| 13:00 | 13:20 | Presenter tbc – expert in virology, epidemiology A Covid-19 safety perspective from the expert |
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| 13:20 | 13:40 | Presenter from Pharma – tbc lab set up challenges and UK regional requirements ? |
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| 13:40 | 14:00 | Presenter from CRO – tbc Organisation pressures re. reorganising labs etc… etc… |
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| 14:00 | 14:20 | Presenters and theme identified, awaiting confirmation – (Global) Central lab perspective – A perspective from across the ocean |
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| 14:20 | 14:40 | see 14:00 – 14:20 | ||
| 13:00 | 14:40 | Day 4 break out 1 Biosimilars – session building in progress |
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| 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 |
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| 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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