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Immunogenicity Part 1 » Programme
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Programme

DAY 1, Monday, 15 October 2012

12.00 - 13.00
Registration and welcome coffee
13.00 - 13.15 Welcome and introduction to the workshopIntroduction to Session 1, Gabriele Dallmann

SESSION 1: RISK IDENTIFICATION

13.15 - 14.15 The current regulatory environment for new therapeutic proteins and biosimilars exemplified by cases following a risk-based strategy, Paul Chamberlain (NDA Advisory Board)
14.00 - 15.00 Understanding the mechanisms involved in immune responses to therapeutic proteins, Matthew Baker (Antitope Ltd.)
15.00 - 15.30

Coffee Break

SESSION 2: BIOANALYTICAL STRATEGY

15.30 - 16.15 Bioanalytical method selection, Arno Kromminga (IPM Biotech)
16.15 - 17.00 Integrated data analysis, Andrew Warren (Novartis)
17.00 - 17.30 Panel Discussion: Priorities for early-stage development
17.30
Close of Day 1, followed by evening social event

DAY 2: Tuesday, 16 October 2012

SESSION 3: NON-CLINICAL MODELLING

09.00 - 09.45 Non-clinical modelling of identified risks, Birgit Reipert (Baxter BioScience)
09.45 - 10.15 Panel Discussion: Contribution of in silico, in vitro & non-clinical data to risk assessment
10.15 - 10.45
Coffee Break

SESSION 4: CLINICAL EVALUATION

10.45 - 11.30 Recognising and interpreting clinical signals, Jacques Descotes (Lyon University)
11.30 - 12.00 Panel Discussion: Balancing bioanalytical vs. clinical signals for immunogenicity risk assessment
12.00 - 13.00

Lunch 

SESSION 5: INTERACTIVE CASE STUDY TO ILLUSTRATE THE INTEGRADTED APPROACH

13.00 - 15.15 Group work on case studies and interactive result presentation: introduction, breakout groups, interactive discussion
15.30 End of the workshop