Biosimilars Congregation 2012

24th February - 24th February 2012 | UK


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Category: R&D

Address: Thistle Marble Arch Hotel, London, UK

Organiser: Virtue Insight

Website: CLICK HERE to open.

Key Themes Discussed:

• Reviewing some of the challenges in clinical study design for biosimilar development arising from endpoint variability, changes in clinical practice, and evolution in understanding of the biology of the disease

• How should the pharma and generics industries approach the rapidly emerging and developing biosimilar market? The future of next generation Biosimilars

• How are policy makers shaping the contours of this new generic frontier, and what implications they have for current biologic drug development and patent protection?

• Identifying issues and solutions surrounding biosimiliars and clinical trials.

• Next generation monoclonal antibody development and clinical challenges with biosimilar drug development

• Overcoming pricing and reimbursement challenges to maximise the ROI

• Determining the right investments & potential returns from Biosimilars

• Commercial challenges and opportunities - strategies to develop Biosimilars

• Biosimilars Vs Bio-betters – positioning for a new market with lucrative prospects

• Learn to implement best practices through recent successful strategies and business models – real time case studies

• Analyze the FDA's current view of biosimilars

• The developing regulatory framework in advanced and developing markets

• EMA Regulatory Opinions on Treatment of mAbs

• Critical issues in demonstrating biosimilarity and maintaining diligent quality control

• Be part of a major networking opportunity

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