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 |