Focus Workshop Slides 2016 September
Program of EBF Workshop “Current analysis of immunogenicity – Best Practices and Regulatory Hurdles” September 27-28, 2016
PDF renditions of the powerpoint presentations can be viewed and downloaded from this page by clicking the specific point on the program. The program itself can be viewed and downloaded by clicking here.
| 27-Sep-2016 | |
| 08.45-09.00 | Welcome and aim of the meeting |
| 09:00-10.10 | The current landscape and future challenges on immunogenicity |
| 09:00–09:30 | The current regulatory landscape on immunogenicity |
| (Michaela Golob, on behalf of the EBF) | |
| 09:30–09:50 | EMA view on immunogenicity regulations |
| (Venke Skibeli, Avd. for legemiddelutredning, Norway) | |
| 09:50–10:10 | FDA Regulatory perspectives on therapeutic protein immunogenicity- an update |
| (João A. Pedras-Vasconcelos, FDA/CDER/OBP/DRR3, US) | |
| 10:40–12.30 | A rapidly changing regulatory environment |
| 10:40–11:00 | EBF’s feedback to the EMA and FDA draft guidance |
| (Jo Goodman, on behalf of the EBF) | |
| 11:00–12:30 | Panel discussion |
| 13:30–15:30 | Challenges of drug tolerance and interferences |
| 13:30–13:45 | Case study 1 – Strategies for improving ADA assay sensitivity, when high |
| drug or target concentrations cause interference | |
| (James Munday, Covance) | |
| 13:45–14:00 | Case study 2 – Overcoming drug & target interference in ADA and NAb assays |
| (Robert Nelson, Novimmune) | |
| 14:00–14:15 | Case study 3: Reflections on the use of acid treatment for improving drug |
| tolerance in ADA assays | |
| (Nicoline Videbæk, NovoNordisk) Slides not available | |
| 14:15–14:30 | Case study 4 – Pitfalls in ADA Analysis – |
| Workarounds for Clinical Meaningful Immunogenicity Assessment | |
| (Thomas Emrich, F. Hoffmann La Roche) | |
| 14:30–15:30 | Panel discussion |
| 16:00–18:00 | Alternatives for NAb assessment |
| 16:00–16:30 | Strategies to assess the neutralizing capacity of Biopharmaceuticals |
| (Daniel Kramer, Sanofi) | |
| 16:30–17:00 | Strategies to determine assay format for the assessment of neutralizing |
| Antibody responses to biotherapeutics | |
| (Jim McNally, Merck Serono, on behalf of the AAPS Immunogenicity DG) | |
| 17:00–18:00 | Panel discussion |
| 28-Sep-2016 | |
| 09:00–13:00 | Cut-point setting in ADA and NAb assays |
| 09:00–09:30 | Setting cut points – a statistician’s perspective |
| (Simon Cowen, LGC) | |
| 09:30–10:30 | Simplified strategy for immunogenicity cut point evaluations & some practical considerations |
| (Viswanath Devanarayan, Abbvie) Slides not available | |
| 11:00–11:20 | Pitfalls in cut-point setting |
| (Timo Piironen, Syrinx Bioanalytics) | |
| 11:20–11:40 | Challenges with pre-existing anti-drug antibodies |
| (Denise Sickert, Novartis) 16-denise-sickert | |
| 11:40–13:00 | Panel discussion |
| 14:00–15:00 | Closing focus workshop panel discussion |
| 15:30–16:00 | Summary, conclusion and next steps |
| 16:00 | Adjourn |
