Day 2 Congress

• Attitudes and acceptance in clinical practice
• Uptake in clinical practice
• Nor-switch Study and other clinical trials
• Switching and interchangeability

Dr Steinar Madsen, Medical Director, Norwegian Medicines Agency

• Updates on the latest EU regulatory guidelines
• In what capacity should EMA act on switching and interchangeability?
• Close collaboration with HTA’s for patients benefit
• Current challenges to make sure the development pathways are ready for the latest scientific development

Cecil Nick, Vice President, Technical, PAREXEL International

• Dealing with current issues on interchangeability and extrapolation
• Different approaches for interchangeability based on individual product characterization
• What are the challenges and latest guidelines
• Challenges encountered and opportunities in global Biosimilars market
• Current trends in global industry of Biosimilars
• Priorities of investments and opportunity for market growth
• Marketing strategies to guarantee market success

Paul Harmon, Senior Director, European Oncology Biologics Lead, Mylan

• Share experiences of creating an educational resource for the research workforce
• Hear case studies of biosimilar clinical research trials being delivered within the NHS
• Understand how a network approach can be deployed to overcome unexpected challenges

Divya Chadha Manek, Head of Business Development, NIHR Clinical Research Network

• Regulatory and clinical considerations in emerging markets
• Operational issues in emerging markets
• Challenges and opportunities in emerging market countries

Dr. Haleh Hamedifar, CEO, CinnaGen Co.

• Key success principles for biosimilar utilization have been identified
• The focus in now shifting towards sustainable market environments
• Key factor for sustainability are responsible procurement practices

Prof. Dr. Florian Turk, Head Global Payor Marketing, Sales and Relations, Sandoz Biopharmaceuticals

• Special trends impacting market access in Europe and globally
• Evolving methods for managing specialty product utilization and reimbursement toward ensuring appropriate access
• Ways of balancing rewards of access and inherent risk between manufacturers and insurers
• Challenges in ensuring market access and reimbursement

Adam Levysohn, Head of Global Market Access, Biosimilars Business Unit, Biogen

• Impact of pharma pricing on pharmaceutical innovations
• Biosimilars influence on pricing and reimbursement
• How to ensure market access success
• Patient centric approach in driving market access growth
• Is there an alternative payment model?

Moderator: Ian Henshaw, VP, Global Head, Biosimilar’s Business Unit, Biogen

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