ICH M10 - Public consultation & Industry Feedback
Towards a Science based Global Bioanalytical Guideline
Hesperia Tower
Barcelona, Spain
20-22 May 2019
Program Training day
Critical reagents for LBA
| 13 MAY 2018 | |
| 17:00 | Registration desk opens |
| 18:00 – 19:00 | Welcome reception – Altis Hotel |
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| 14 MAY 2018 | |
| 07:30 | Registration desk opens |
| 08:45 – 09:00 | Welcome and introduction |
| 09:00 – 10:30 | Session 1 – Critical reagents for PK assays: general & regulatory framework |
| 09:00 – 09:15 | Introduction to the session – Susanne Pihl (on behalf of the EBF) |
| 09:15 – 09:45 | Update on the guidelines and current practice in industry |
| Michaela Golob (on behalf of the EBF) | |
| 09:45 – 10:15 | The EBF decision tree on CR for PK assays, in perspective of current industry practices |
| Susanne Pihl (on behalf of the EBF) | |
| 10:15 – 10:30 | Q&A |
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| 10:30 – 11:00 | Coffee break & networking |
| 11:00 – 12:30 | Session 2 – Case studies on alternative approaches to manage critical reagents (PK assays) |
| 11:00 – 11:20 | Case study: The importance of quality critical reagents for the entire developmental life cycle of a biopharmaceutical: A PK Case Study |
| Andrew Mayer (GlaxoSmithKline) | |
| 11:20 – 11:40 | Characterization of critical reagents – FB from the AAPS ADA community |
| Jonathan Haulenbeek (BMS, on behalf of the AAPS) | |
| 11:40 – 12:00 | Critical reagents for PK assessment – How reagent characteristics can impact your result interpretation |
| Thomas Emrich (Roche Pharma Research and Early Development) | |
| 12:00 – 12:30 | Expert panel discussion |
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| 12:30 – 13:30 | Lunch |
| 13:30 – 15:00 | Session 3 – Critical reagents for immunogenicity assays – general & regulatory framework |
| 13:30 – 13:45 | Introduction to the session – Birgit Jaitner (on behalf of the EBF) |
| 13:45 – 14:05 | Update on the guidelines and current practice in industry |
| Jo Goodman (on behalf of the EBF) | |
| 14:05 – 14:40 | Recommendations on CR for immunogenicity assays, in perspective of current industry practices |
| Barry van der Strate (on behalf of the EBF) | |
| 14:40 – 15:00 | Q&A |
| . | |
| 15:00 – 15:40 | Coffee break & networking |
| 15:40 – 17:15 | Session 4 – Case studies on alternatives approaches to manage critical reagents (immunogenicity assays) |
| 15:40 – 16:00 | Qualification of new lots of critical reagents for IG assays: Some practical examples |
| Lydia Michaut (Novartis) | |
| 16:00 – 16:20 | Management of an ADA critical reagent issue during a clinical study support |
| Laurent Vermet (Sanofi) | |
| 16:20 – 16:40 | ADA Case study: Generation and characterization of critical reagents supporting immunogenicity assays: Case studies on how to navigate challenging drug modalities |
| Terri Caiazzo (Pfizer) | |
| 16:40 – 17:15 | Expert panel discussion |
| 17:15 – 17:30 | Closing Questions & Answers session |
| Panel of presenters answering delegate’s pre-submitted questions | |
| 17:30 | Adjourn |
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