European Bioanalysis Forum

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.

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10:40–11:00 EBF’s feedback to the EMA and FDA draft guidance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
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


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