European Bioanalysis Forum

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
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.
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