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Programme
May 28th 2013, Vinci International Congress Centre, Tours
8.30–9.00: Welcome
9.00–9.30: Introduction
9.30–11.00: 1st session – Market and regulatory issues
Brief overview of the IP landscape in the medical field. When do (Biotech) patents actually expire? Of SPCs, PEs and PTEs.
André Bourgouin, Partner, Grosset-Fournier & Demachy, Paris, France
Regulatory perspective on biosimilar in the EU
Kowid Ho, ANSM, Department for evaluation of biological products, France
Challenges to Develop and Implement a Manufacturing Process for Biosimilars
Steve Flatman, Head of Biosimilars R&D at Lonza, UK
11.00–11.30: Coffee break
11.30–13.00: 2nd Session – Quality control attributes, bioequivalence and formulation
Acceptable changes in quality attributes of antibodies and assimilated biopharmaceuticals
Hansjörg Toll, Analytical Characterization group, Sandoz Biopharmaceuticals, Kundl, Austria
(Comparative stability studies)
Thomas Schreitmuller, Hoffmann-La Roche, Basel (to be confirmed)
Functional in vitro assays for evaluating the Fc function of therapeutic monoclonal antibodies: issues and proposed strategies
Chritian Behrens, LFB Biotechnologies, Les Ulis, France
13.00–14.30: Lunch
14.30–16.00: 3rd session – Development of biosimilars
EU clinical requirements
Marie-Christine Bielsky, Medicines and Healthcare products Regulatory Agency, London, UK
Clinical evaluation of Remsima®, an infliximab biosimilar
Dae Hyun Yoo, Department of Internal Medicine, Hospital for rheumatic Diseases, Hanyang University, South Korea
Indication extrapolation for biosimilar monoclonal antibodies
Jaap Venema, Senior Director Biotherapeutics, Global Head and US Lead, Abbvie
16.00–16.30: Coffee break
16.30–17.30: 4th session – Societal issues
Pressure on the Health Economy – why we need Biosimilars
Paul Greenland, Vice President Biologics, Hospira UK
Ethical issues about clinical evaluation of biosimilars
Emmanuel Gyan, CHRU and Université François-Rabelais de Tours, France
