Day 1 - Sunday 2 October 2022
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12.00 - 13.00
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Lunch & registration
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13.00 - 13.10
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Workshop introduction
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Session 1 |
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Overview of landscape |
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13.10 - 13.40 |
Peptide talk |
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PepTherDia -
Overview of the landscape of marketed peptides
Vera D'Aloisio, AmbioPharm, US
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13.40 - 14.10 |
Oligo talk |
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Overview of the oligo landscape & ADME strategy for GalNAc-siRNAs
Jesper K Christensen, Novo Nordisk, Denmark
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14.10 - 14.20
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Break
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Session 2 |
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Metabolism & modelling |
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14.20 - 14.50 |
Peptide talk |
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Comparison of hepatic and extrahepatic
in vitro models for peptide metabolism identification
Ari Tolonen, Admescope, Finland
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14.50 - 15.20 |
Oligo talk |
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Physiologically Based Pharmacokinetic Modelling of Oligonucleotide, Bepirovirsen: Exploration of Pharmacokinetic and Dose Adjustment In Hepatitis B Patients
Farzaneh Salem, GSK, UK
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15.20 - 15.50
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Break
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Session 3 |
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Analytical challenges |
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15.50 - 16.20 |
Peptide talk |
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Perspectives on the past and future of large peptides bioanalysis: with reference to insulins
Michael Blackburn, Quotient Sciences, UK
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16.20 - 16.50 |
Oligo talk |
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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
Alex Bushby, LabCorp, UK
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16.50 - 17.30
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Discussion
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17.30 - 19.00
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Hit the bar
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Day 2 - Monday 3 October 2022
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08.30 - 08.40
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Day 1 recap & Day 2 agenda
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Session 4 |
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DDI |
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08.40 - 09.10 |
Peptide talk |
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EFPIA peptide DDI survey/white paper update
Constanze Hilgendorf, AZ, Sweden
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09.10 - 09.40 |
Oligo talk |
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Considerations & Recommendations for Therapeutic siRNA Plasma Protein Binding Evaluation & Drug-Drug Interaction Risk Assessment
Jan Snoeys, JNJ, Belgium
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09.40 - 10.00
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Break
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Session 5 |
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Regulatory interactions |
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10.00 - 10.30 |
Peptide/
Oligo talk |
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Regulatory perspectives of peptides and oligos
Michelle McDonald-Alexis, Parexel, UK (MHRA 2009-2019)
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10.30 - 11.30
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Incoming Qs/hot topics/meeting roundup
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11.30
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Delegates depart
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