Training Day Slides 2018 May
Program of the EBF Training Day “Critical reagents for LBA” May 14, 2018
PDF renditions of the powerpoint presentations given at the Training Day can be viewed and downloaded from this page. The program itself can be viewed and downloaded by clicking here
| 13 MAY 2018 | |
| 17:00 | Registration desk opens |
| 18:00 – 19:00 | Welcome reception – Altis Hotel |
| 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 |
| 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 (not released for publication) |
| Thomas Emrich (Roche Pharma Research and Early Development) | |
| 12:00 – 12:30 | Expert panel discussion |
| 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 |
