EUCRAF is pleased to announce the names of the speakers of Seminar 4.2. Seminar 4 is composed of two parts.

Part I is held in January 2012 on Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier.

Part II is held in March 2012 on the non-clinical and clinical development of biopharmaceuticals, immunogenicity, biosimilars and the Module 4 and 5 requirements. Case studies on monoclonal antibodies, erythropoietin and a biosimilar and a case presentation on the tri-functional monoclonal antibody Catumaxomab are also presented.

Speakers of Part II:

Dr. Roland Grobe-Einsler (formerly Bayer) and Dr. Simon Day from Roche are the Course Leaders of Seminar 4.2.

Dr. Bernd Müller-Beckmann (formerly Roche Penzberg) presents the principals of non-clinical development, the non-clinical CTD and explaines what special is in the non-clinical development of biopharmaceuticals.

Dr. Jennifer Sims, from Novartis, discusses the Tegenero case and its implications for the development of new biopharmaceuticals.

Dr. Paul Chamberlain from NDA Advisory Board gives a talk about immunogenicity and erythropoeitin.

Dr. Simon Day from Roche presents the principle of clinical development of biopharmaceuticals.

Dr. Ronald Grobe-Einsler (formerly Bayer) gives an insight to reserach to  early developmet: a clinical pharmacology perspective.

Dr. Simon Day and Dr. Gabriele Dallmann from EUCRAF introduces together a group workabout benefit-risk assessment for monoclonal antibodies.

Dr. Diane Seimetz from Fresenius Biotech holds a presentation: From scientific advice to successful marketing authorization - experience with the European authorization of the bispecific monoclonal antibody Removab.

Dr. Thomas Kirchlechner from Sandoz Biopharmaceuticals Development talks on regulatory principles of development of biosimilar medicinal products in the various regions: EU, FDA and WHO; global development, experience with submissions in different regions; experience with Sandoz biosimilars and current considerations on regulatory requirements for monoclonal antibodies developed as biosimilars. He also presents a biosimilar case study.