Annual Meeting Icon

Annual Meetings » Annual Meeting 2011 » Programme
eucraf 20111 20112 20113

Programme

Day 1. Thursday, 03. February 2011

Session 1: Monoclonal antibodies as attractive targets for development

10.30 - 10.45:

Prof. Dr. Johannes Löwer: Welcome and introduction

10.45 - 11.30:

Michael Reth, Max-Planck-Institut for Immunology, Freiburg, and Gabriele Schäffner-Dallmann, EUCRAF: Monoclonal antibodies in Europe - a historic review and future prospects

11.30 - 12.30:

Christian Schneider, PEI: What is special with monoclonal antibodies?

12.30 - 13.00:

Q&A

13.00 - 14.30:

Lunch

Session 2: Experience in the regulatory process of biosimilars

14.30 - 15.15:

Ann Johnsson, MPA: Experience on already authorized biosimilars – approaches taken to justify the biosimilarity

15.15 - 16.00:

Thomas Kirchlechner, Sandoz Biopharmaceuticals Development: Pioneering the development of biosimilars - lessons learnt and future challenges

16.00 - 16.30:

Coffee break

Session 3: Update on upcoming biosimilar guidelines

16.30 - 17.15:

Christian Schneider, PEI: Status update on the guideline on biosimilar monoclonal antibodies

17.15 - 18.00:

Martina Weise, BfArM: Update on WHO guideline

18.00 - 19.00:

Panel discussion with Ann Johnsson, Thomas Kirchlechner, John Purves, Janice Reichert, Christian Schneider, Thomas Schreitmüller and Martina Weise

19.30:               

Networking Dinner

Day 2. Friday, 04. February 2011

Session 4: Key elements in development of a monoclonal antibody

09.00 - 09.45:

Kowid Ho, AFSSAPS: Which attempts will be acceptable for a biosimilar monoclonal antibody - identical copy or altered manufacturing process?

09.45 - 10.30: Martin van der Plas, RIVM, The Netherlands:

CMC: what can be characterized well, where are the limitations and what is especial for introduction of changes in next generation vs biosimilar monoclonal antibodies

10.30 - 11.15: Karen de Smet, FAMHP Belgium:

Preclinical development: what are the challenges in development of a new monoclonal antibody and what need to be considered for next generation and biosimilar monoclonal antibodies

11.15 - 12.00:

Panel discussion with Karen de Smet, Kowid Ho, Jan Müller-Berghaus, John Purves, Janice Reichert, Frank Scappaticci, Thomas Schreitmüller and Martin van der Plas

12.00 - 13.30:

Lunch

Session 5: Clinical development

13.30 - 14.15:

Frank Scappaticci Roche/Genentech Inc.: What are the challenges in development of a new monoclonal antibody and what need to be considered for next generation and biosimilar monoclonal antibodies

14.15 - 15.00:

Jan Müller-Berghaus, PEI: Key clinical evidence – Key points to consider with regard to Surrogate endpoints - Immunogenicity – Extrapolation

15.00 - 15.20:

Coffee break

15.20 - 16.00:

Round table discussion with Karen de Smet, Kowid Ho, Jan Müller-Berghaus, John Purves, Janice Reichert, Frank Scappaticci, Thomas Schreitmüller and Martin van der Plas

16.00:

Gabriele Schäffner-Dallmann: Wrap up and concluding remark

16.30:

End of the meeting