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 |
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| 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 |
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| 13:15 | 15:10 | Day 1 – Plenary 1 A Pandemic Uniting us Behind Science |
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| 13:15 | Joanne Goodman – on behalf of the EBF Bioanalytical solutions in support of the COVID-19 global pandemic |
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| 13:30 | 13:50 | Melanie Anderson – MSD, for IQ Patient Centric Sampling: How the COVID-19 Pandemic is Shifting the Landscape |
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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 | Richard Hughes – 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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| 15:30 | 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) |
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| 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 |
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| 16:00 | 16:20 | Michael Blackburn – 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 | ||
| 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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| 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 |
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| 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 |
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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 | Daniel Creed – LGC The highs and lows of ultra-sensitive immunoassays: experiences from a CRO’s perspective |
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| 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 |
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| 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 |
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| 10:45 | Coming online | |||
| 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 | Matthias Sury – Celerion Biomarker Assay Development and Validation: Failing your Way to Success |
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| 11:50 | 12:10 | Lauren Stevenson – Immunologix Labs Feedback and reflections from the AAPS PharmSci360 Workshop on CoU |
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| 12:10 | 12:30 | Abbas Bandukwala – CDER-FDA A regulatory perspective |
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| 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 |
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| 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 |
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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 | 14:10 | short break | ||
| 14:10 | 14:30 | Corina Hunger – Sanofi Validation of a biotherapeutic ligand-binding-LC-MS/MS assay in monkey and mouse serum |
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| 14:30 | 14:50 | Fabrizia Fusetti – QPS Development and validation of a Trastuzumab/Pertuzumab Hybrid LC-MS assay for clinical development |
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| 14:50 | 15:10 | Eric Niederkofler – Thermo Fischer Scientific Validation of a Hybrid Assay for the Rapid Quantification of the Biologic, Insulin Degludec |
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| 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) |
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| 12:45 | Coming online | |||
| 13:00 | 13:20 | Boris Gorovits – Pfizer Should we learn more about characteristics of ADA response? |
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| 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. |
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| 13:40 | 14:00 | Johannes Stanta – Covance Singlicate analysis in ADA assays |
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| 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? |
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| 14:30 | 14:50 | Jacomijn Dijksterhuis – PRA-HS Different interpretations on new FDA guidance 2019 for ADA validations – a CRO’s perspective |
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| 14:50 | 15:10 | João Pedras-Vasconceles – FDA-CDER Immunogenicity Assessments for Biologics–Current Perspectives from FDA’s Office of Biotechnology Products |
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| 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 |
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| 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 |
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| 16:00 | Coming online | |||
| 16:10 | 16:30 | Bernd Potthoff – Novartis A cell based immunogenicity assay to detect antibodies against chimeric antigen receptor |
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| 16:30 | 16:50 | Anton Rosenbaum – AstraZeneca Immunogenicity Assessment for MEDI7219, an Oral GLP1 Agonist Peptide |
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| 16:50 | 17:10 | Nicoline Videbæk – Novo Nordisk Improvement of nAb assays with poor sensitivity and drug tolerance – challenges and solutions |
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| 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 |
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| 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 |
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| 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 |
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| Neil Loftus – Shimadzu A brief introduction on behalf of software developers on the EBF initiative |
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| 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 |
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| 17:00 | 17:20 | Jason Wakelin-Smith – MHRA Feedback from the regulators |
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| 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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| 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 |
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| 18:15 | Coming online | |||
| 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 | Matthias Sury – Celerion Biomarker Assay Development and Validation: Failing your Way to Success |
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| 19:20 | 19:40 | Lauren Stevenson – Immunologix Labs Feedback and reflections from the AAPS PharmSci360 Workshop on CoU |
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| 19:40 | 20:00 | Abbas Bandukwala – CDER-FDA A regulatory perspective |
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| 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 |
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| 11:10 | 12:10 | Matthew Barfield – on behalf of the EBF. EBF’s experiences, discussions and recommendations on Protein Bioanalysis by LC-MS(MS) |
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| Kelly Dong – for CBF Overview of CBF discussion on protein analysis by LC-MS(MS) |
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| Hisao Shimizu – for JBF Overview of JBF discussion on protein analysis by LC-MS(MS) |
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| Eric Woolf – MSD Overview of AAPS discussion on protein analysis by LC-MS(MS) |
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| 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 |
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| 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 |
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| 13:50 | 14:10 | Stephanie Cape – Covance A method development case study highlighting successes and learnings from a CRO – pharma alliance |
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| 14:10 | 14:30 | Lieve Dillen – Janssen R&D Pharma/CRO alliance: what are the keys of success in transfer of assays. |
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| 14:30 | 14:50 | Jean-Christophe Genin – F. Hoffmann-La Roche Successes and learnings: an example from industry |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 14:50 | 15:10 | Robert Nelson – Covance Making haste, slowly, in bioanalysis of biomarkers |
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| 15:30 | Zoom session will be closed by the meeting host | |||
| 12:45 | 15:30 | Day 3 Breakout 2 ADA – Case studies |
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| 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 |
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| 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 |
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| 13:40 | 14:00 | Janett Schwarz – Bioagilytix ADA/NAB Drug and Target tolerance by SPEAD treatment |
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| 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 |
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| 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 |
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| 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 |
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| 16:00 | Coming online | |||
| 16:10 | 16:30 | Steve White- on behalf of EBF Method development documentation; Interpretation of guidelines |
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| 16:30 | 16:50 | Cecilia Arfvidsson, – on behalf of EBF A recent EBF survey on regional barriers |
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| 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 |
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| 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 |
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| 16:00 | Coming online | |||
| 16:10 | 16:30 | Anna Laurén – SVAR Clia/ISO or BMV for Biomarkers and Diagnostics: two worlds? |
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| 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 |
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| 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 |
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| 17:10 | 17:30 | Jeffrey Wallin – Gilead The TLR7 agonist vesatolimod induces dose-dependent immune responses in HIV controllers |
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| 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 |
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| 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) |
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| 18:15 | Coming online | |||
| 18:30 | 18:40 | Matthew Barfield – on behalf of the EBF Introduction to the session |
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| 18:40 | 19:40 | Matthew Barfield – on behalf of the EBF EBF’s experiences, discussions and recommendations on Protein Bioanalysis by LC-MS(MS) |
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| Kelly Dong – for CBF Overview of CBF discussion on protein analysis by LC-MS(MS) |
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| Hlsao Shimizu – for JBF Overview of JBF discussion on protein analysis by LC-MS(MS) |
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| Faye Vazvaei – MSD Overview of AAPS discussion on protein analysis by LC-MS(MS) |
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| 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 |
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| 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 |
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| 13:20 | 13:40 | Michael Wright- LGC Bad Blood? An Evolving Tale of Risk Within a COVID-19 World |
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| 13:40 | 14:00 | Scott Summerfield – GlaxoSmithKline Lab set up challenges and UK regional requirements ? |
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| 14:00 | 14:20 | Guillaume Couffe – Covance Central labs Running Clinical Trials with agility during COVID-19 pandemic |
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| 14:20 | 14:40 | Amy Lavelle – PPD COVID in North America: impact on the bioanalytical and drug development community |
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| 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 |
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| 12:45 | Coming online | |||
| 13:00 | 13:20 | Tom Verhaeghe – on behalf of the EBF Feedback from EBF Survey – sharing experiences of GCP inspections |
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| 13:20 | 13:40 | Philip Timmerman – EBF GCP – From challenges into opportunities |
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| 13:40 | 14:00 | Tsvetelina Ivanova – on behalf of the EBF Towards and EBF recommendation of sustainable GLP compliance in the BA lab |
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| 14:00 | 14:20 | Jason Wakelin-Smith – MHRA Feedback from the regulators |
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| 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 |
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| 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 |
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| 13:20 | 13:40 | Connor Walker – on behalf of the EBF-YSS Feedback from the 6th YSS Science Café – A Sustainable Future |
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| 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. |
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| 14:00 | 14:20 | Salvatore Calogero – Swiss BioQuant The rise of “non-standard” techniques in regulated environment |
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| 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 |
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| 15:00 | Coming online | |||
| 15:20 | 16:00 | Jo Goodman – AstraZeneca A status update on ICH M10 |
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| Philip Timmerman – EBF A draft Guideline is a draft Guideline |
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| ICH M10 Public Consultation – our concerns confirmed Steve White – on behalf of the EBF Scope of the Guideline and Chromatographic assays |
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| Mark Gnoth – on behalf of the EBF Surrogate matrix – a recent survey from the EBF |
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| Michaela Golob – on behalf of the EBF Ligand Binding Assays and Endogenous |
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| Tom Verhaeghe – on behalf of the EBF ISR and Documentation, incl a recent survey on FDA documentation |
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| 16:00 | 16:20 | Dulcyane Mendes – Anvisa ICH M10 GUIDANCE adoption by ANVISA |
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| 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 | |||
