Concerns about high costs of therapy and value received for resources spent are leading to increased restrictions on biologics by payers in the U.S. and other Western health care systems — trends which can significantly impact product and company valuations, and have broad implications for patients and trial design. A robust pipeline of new products and expanding indications for existing therapies only increases decision making pressure. Additionally, the safety and security of these drug products is vital from both the product and IP perspective. Panelists will share their views on current coverage of biologics and the process of gaining patient access to therapies, as well as offer insight on the statement, "Opportunities to spend are unlimited; resources are not, yet decisions must be made."

• Provide framework of current biologic coverage, access hurdles and utilization in US, UK and France
• Encourage strategic thinking on impact of biologics on health-care budgets and access restrictions implications
• Enable biotech executives to identify strategic options for patient access to biologic products, as well as global regulatory aspects of product safety