Next generation and biosimilar monoclonal antibodies – essential considerations towards regulatory acceptance in Europe

3-4 February 2011 - Freiburg im Br., Germany

Chair: Prof. Dr. Johannes Löwer

 

 

Day 1: Thursday, 03.02.2011

10.00-10.30: Registration coffee

Monoclonal antibodies as attractive targets for development

10.30-10.45: Welcome and introduction (Gabriele Schäffner-Dallmann, EUCRAF)

10.45-11.30: Monoconal antibodies in Europe - a historic review and future prospects (Gabriele Schäffner-Dallmann & Michael Reth, Max-Planck-Institut for Immunology Freiburg)

11.30-12.30: What is special with monoclonal antibodies? (Christian Schneider, PEI)

12.30-13.00: Questions and Answers

13.00-14.30: Lunch buffet

Experience in the regulatory process of biosimilars

14.30-15.15: Experience on already authorized biosimilars-approaches taken to justify the biosimilarity (Ann Johnsson, MPA)

15.15-16.00: Pioneering the development of biosimilars-lessons learnt and future challenges (Thomas Kirchlechner, Sandoz Biopharmaceuticals Development)

16.00-16.30: Coffee break

Update on upcoming biosimilar guidelines

16.30-17.15: Status update on the guideline on biosimilar monoclonal antibodies (Christian Schneider, PEI)

17.15-18.00: Update on WHO guideline (Martina Weise, BfArM)

18.00-19.00: Panel discussion (panelists are representatives of agencies and industry)

19.30: Networking dinner

 

Day 2: Friday, 04.02.2011

 

08.30-09.00: Welcome coffee

Key elements in development of a monoclonal antibody

09.00-09.45: Which attempts will be acceptable for a biosimilar monoclonal antibody-identical copy or altered manufacturing process? (Kowid Ho, AFSSAPS)

09.45-10.30: 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 (Martin van der Plas, RIVM)

10.30-11.15: 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 (Karen de Smet, FAMHP)

11.15-12.00: Panel discussion (panelists are representatives of agencies and industry)

12.00-13.30: Lunch buffet

Clinical development

13.30-14.15: What are the challanges in development of a new monoclonal antibody and what need to be considered for next generation and biosimilar monoclonal antibodies (Frank Scappaticci, Roche/Genentech Inc.)

14.15-15.00: Key clinical evidence-Key points to consider with regard to Surrogate endpoints-Immunogenicity-Extrapolation (Jan Müller-Berghaus, PEI)

15.00-16.00: Round tabel discussion with coffee served

16.00-16.30: Wrap up and concluding remark (Gabriele Schäffner-Dallmann)