Biosimilars and Biobetters, Sep 30 - Oct 1, 2015, London UK

Biosimilars and Biobetters

Sep 30, 2015 - Oct 1, 2015, London UK

 

The development of the Biosimilars market is growing exponentially with the industry forecast to be worth $25 billion by 2020. With the regulatory landscape evolving rapidly, it is important to understand the developments in the biosimilar guideline framework and the cohesion in legislation between Europe and the US.

 

With Europe leading the way in the field of Biosimilar development, it is important to get to grips with all areas in the 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. Every angle should be considered and taken account for through the development process and with the EU the most advanced market for biosimilars, accounting for 80% of global spending on these molecules, the learning curve for biosimilars is essentially still building and there are hurdles to overcome.

 

Unlocking the potential of biosimilars will require a focused strategy along the whole value chain, from optimising the clinical development program through developing the most suitable strategy for commercialisation.

 

Against this backdrop, SMi’s 6th annual Biosimilars and Biobetters conference features a distinguished line-up of speakers who are pioneering the way in biosimilars and biobetters, including MHRA, GfK, Teva, Harvest Moon Pharmaceuticals USA Inc and more, as they present on the latest development on key topics including regulatory landscape, pharmacovigilance of biosimilars, patent litigation, market access and EU & global market developments.

 

Business Benefits of attending SMi’s 6th annual Biosimilars and Biobetters conference:

        ·    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

 

Key Speakers include:

        ·    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 & Technology, Global R&D, 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

 

View the full speaker line-up, two-day conference programme and register online at http://www.biosimilars-biobetters.co.uk/bio-equip

 

For further information, please contact Fateja Begum on tel +44 20 7827 6184 or email fbegum@smi-online.co.uk

 

Plus, don’t miss the two half-day interactive conference workshops on:

A: Assessing the Regulatory Framework for Europe and the US – Developing Future Biologics

Workshop leaders: Lincoln Tsung, Daniel Kracov and Jennifer Sklenar, Arnold & Porter (UK) LLP

Tuesday 29th September 2015, 1.30pm - 5.30pm

 

B: 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