Biosimilars and Biobetters

With Europe leading the way in the field of Biosimilar development and accounting for 80% of global spending on these molecules, the 2015 agenda will feature sessions on all areas including of product lifecycle from early stage developments, protein characterisation and analytical comparability to patent litigation, market access, pricing and reimbursement through to emerging markets and global developments.

Benefits of attending:
Hear the latest on the evolving regulatory biosimilar landscape and review the guidelines
Gain understanding on the barriers being faced for market access and commercialisation of products through case-study led presentations
Focus on the global market developments with case studies on the emerging markets of biosimilars and assessing the trends we are currently seeing
Assess and review in-depth protein characterisation and analytical comparability to efficiently and effectively collect data

Speaker Panel includes:
Chairperson: Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc
Shahin Kauser, Senior Scientific Assessor, MHRA
Chris Teale, Vice President Europe, GfK NOP Ltd
Bracha Timan, Director, Israel Site Head, Global Bioassays and Technology, Global RandD, Teva
Takashi Kei Kishimoto, Chief Scientific Officer, Selecta Biosciences
Karsten Roth, Director Clinical Operations, Cinfa Biotech GmbH
Alan Sheppard, Principal, Global Generics and Biosimilars, IMS Health
Steinar Madsen, Medical Director, Norwegian Medicines Agency

Plus two half-day conference workshops:
Assessing the Regulatory Framework for Europe and the US – Developing Future Biologics
Workshop leaders: Lincoln Tsung and Daniel Kracov, Arnold and Porter (UK) LLP
Tuesday 29th September 2015, 1.30pm - 5.30pm

Biosimilars – Understanding the Regulatory Processes and the Commercial Realities
Workshop Leader: Peter Wittner, Senior Consultant, Interpharm Consultancy
Friday 2nd October 2015, 8.30am - 12.30pm