Slides – EBF Spring Focus Workshop 2023
Scientific, Regulatory and Technology Challenges
in the Development of Oligonucleotide and Peptide Drugs
08-09 June 2023 – NH Malaga, Spain
PDF renditions of the powerpoint presentations given at the Focus Workshop can be viewed and downloaded from this page.
The agenda as executed can be viewed and downloaded by clicking here
Final Agenda
| Thursday 08-JUN-2023 | |||
| 09:20 | 09:30 | Welcome and aim of the meeting | |
| 09:30 | 11:00 | Session 1: Setting the scene | |
| 09:30 | 09:55 | Anna Laurén – on behalf of the EBF | |
| Peptides aren’t neither proteins or small molecules… | |||
| 09:55 | 10:20 | Cecilia Arfvidsson – on behalf of the EBF | |
| Just as oligonucleotides aren’t peptides either… | |||
| 10:20 | 10:40 | Philip Timmerman – EBF | |
| Metabolite quantification recommendation – fit for purpose | |||
| 10:40 | 11:00 | Q&A | |
| 11:00 | 11:30 | Coffee break | |
| 11:30 | 12:30 | Session 2: Preparing for success = preparing early | |
| 11:30 | 11:50 | Mikko Hölttä – AstraZeneca | |
| Oligonucleotide bioanalysis in early drug development | |||
| 11:50 | 12:10 | Mariann Fagernæs Hansen – NovoNordisk | |
| PK/PD assay strategy for a therapeutic peptide inhibitor: Meaningful PD marker contra PK and free/total target analyte | |||
| 12:10 | 12:30 | Davy Guignard- Aptuit (An Evotec Company) | |
| Comparison of Quantigene and LCMS technologies for quantification of antisense oligonucleotides in tissue and plasma matrices | |||
| 12:30 | 13:40 | Lunch break | |
| 13:40 | 15:00 | Session 3: More than one way to skin a cat… | |
| 13:40 | 14:00 | Robert Nelson – on behalf of the EBF | |
| Setting the scene – dealing with tissues and/or non-standard MS approaches | |||
| 14:00 | 14:20 | Jill Uhlenkamp – Labcorp Drug Development | |
| The Pursuit of Robust Quantitation of Oligonucleotides by Hybridization Assays | |||
| 14:20 | 14:40 | Daniel Schulz-Jander – QPS | |
| Quantitation of siRNA’s and Metabolites in Plasma, Excreta and Tissues by LC/ToF-MS in Regulated Studies | |||
| 14:50 | 15:00 | Carrie Vyhlidal – KCAS Bio | |
| Quantification of Synthetic DNA Aptamers in Plasma with qPCR | |||
| 15:00 | 15:40 | Coffee break | |
| 15:40 | 18:00 | Session 4: Immunogenicity or what if the cat gives you allergies | |
| 15:40 | 16:00 | Jo Goodman – on behalf of the EBF | |
| Survey – immunogenicity related to Oligonucleotide and Peptide Drugs – current practices in industry, incl. Risk assessment | |||
| 16:00 | 16:20 | Chris Jones – AstraZeneca | |
| Immunogenicity assessment of incretin mimetics; a review of recently approved molecules with a view to technical, regulatory and strategic considerations | |||
| 16:20 | 16:40 | Foka Venema – Ardena | |
| How to increase assay sensitivity of oligonucleotide Ligand Binding pharmacokinetic assay and how to develop strategies on dealing with ADA challenges of oligonucleotides | |||
| 16:40 | 18:00 | Breakout round tables on immunogenicity strategies for oligonucleotide and peptide drugs | |
| Pre-meeting survey questions and workshop discussions will be the basis for round table | |||
| Friday 09-JUN-2023 | |||
| 09:00 | 10:00 | Session 5: Skinning the cat with LC/MS… | |
| 09:00 | 09:20 | Emmanuel Njumbe Ediage – Janssen R&D | |
| Bioanalytical challenges for analysis of oligonucleotides with LC-MS/MS | |||
| 09:20 | 09:40 | Alexandra Bushby – Labcorp Drug Development | |
| Development of an LC-MS/MS method for GSK3389404, a GalNAc conjugated oligonucleotide and it’s non-conjugated metabolite in pre-clinical and clinical studies – challenges and strategies | |||
| 09:40 | 10:00 | Matthijs Pijnappel – Recipharm | |
| Technical challenges in method development for quantification of oligonucleotides by LC-MS in biological samples | |||
| 10:00 | 10:40 | Coffee break | |
| 10:40 | 11:30 | Session 6: Do metabolites quantification strategies need to change? | |
| 10:40 | 11:00 | Anna Laurén, on behalf of the EBF | |
| Setting the scene: metabolites & oligonucleotide and peptide drugs = a different story | |||
| 11:00 | 11:20 | Zoltan Timar – Charles River Laboratories | |
| High-throughput LC-MS/MS method for therapeutic oligonucleotides | |||
| 11:20 | 11:40 | Charlotte Hagman – Novartis | |
| Leqvio A Novartis Cholesterol-Lowering Drug | |||
| 11:40 | 12:00 | Anna Laurén – on behalf of the EBF | |
| Preparing the session round table metabolites & tissues | |||
| 12:00 | 13:00 | Lunch | |
| 13:00 | 15:00 | Session 6: cntd | |
| 13:00 | 13:20 | Luca Ferrari – F. Hoffmann-La Roche | |
| Selectivity and sensitivity challenges in the bioanalysis of oligonucleotides and their metabolites | |||
| 13:20 | 13:40 | Craig Stovold – AstraZeneca | |
| Interfacing Bioanalysis and Biotransformation Strategies for Oligonucleotide Therapeutics | |||
| 13:40 | 14:00 | Solvej Lund Lippert – NovoNordisk | |
| siRNA PK hybridisation assay | |||
| 14:00 | 15:00 | Breakout round tables on metabolite quantification strategies & tissue analysis | |
| Pre-meeting survey questions and workshop discussions will be basis for round table | |||
| 15:00 | 15:30 | Coffee break | |
| 15:30 | 16:30 | Close out session – strategising for the future | |
| Wrapping up and connecting all dots on strategies for metabolites, tissues, immunogenicity and/or PK/PD for oligonucleotide and peptide drugs | |||
| 17:00 | Adjourn | ||
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Meeting Organisation: Anna Laurén (NovoNordisk), Matthew Barfield (F. Hoffman La Roche), Robert Nelson (BioAgilytix), Jo Goodman (AstraZeneca), Cecilia Artvidsson (AstraZeneca) and Philip Timmerman (EBF) | ||
| EBF Focus workshops are organised by the EBF vzw as non-sponsored non-profit events and are independent from EBF member companies. | |||
