Teva to share a case study on how Biosimilarity has supported their Biosimilar projects | Biosimilars and Biobetters

This year’s conference will address recent regulatory updates, pharmacovigilance of biosimilars, patent litigation, market access & global market developments.

SMi’s 6th annual Biosimilars and Biobetters conference, taking place on 30th September – 1st October 2015 in London, will provide the ideal platform to engage in scientific discussions and debate the best practices and solutions to improve industry performance through technical case studies and practical advice from leading biosimilar and regulatory players from organisations including Harvest Moon Pharmaceuticals USA Inc, GfK, MHRA, Selecta Biosciences, Cinfa Biotech GmbH, Norwegian Medicines Agency and more. Unique perspectives will be shared on:

• Evolving biosimilar regulatory landscape
• Market access and product commercialisation barriers
• Global marketing developments, including a focus on emerging market trends
• In-depth protein characterisation and analytical comparability to efficiently and effectively collect data

Furthermore, SMi is pleased to announce that Teva‘s Head of Bioassays and Technology, Bracha Timan, will be leading a presentation titled ‘Leading the strategy to demonstrate Biosimilarity to Biosimilar projects’ at SMi’s Biosimilar and Biobetters conference on Day 2. She will be sharing her insight on the following topic areas:

• Biosimilarity assessment – from stepwise approach to fingerprint analysis
• Strategic considerations for successful support Biosimilar Development
• Totality of evidence – challenges and obstacles for setting an appropriate fingerprint model for biosimilarity assessment
• Case study: Monoclonal antibodies biosimilarity assessment

Speaker Panel includes:

• Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.
• Shahin Kauser, Senior Scientific Assessor, MHRA
• Chris Teale, Vice President Europe, GfK NOP Ltd
• 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

To view the full speaker line-up and conference programme, visit http://www.biosimilars-biobetters.co.uk/drugtargetreview