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U.S. Market Access: Key learnings from a recent success story

57 minutes

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November 19, 2015

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The U.S. is the largest pharmaceutical market in the world, and the Affordable Care Act has brought new opportunities, by increasing the pool of insured people. Launching drugs in the U.S. offers huge prospects for biopharma companies to gain returns on their significant R&D investment, including those companies working in the orphan drug arena.

However, for small EU and U.S. biotechs, facing the challenges of reimbursement, access and distribution can be daunting. These are amplified by the Affordable Care Act's focus on paying for outcomes rather than just treatment.

To manage the challenges and make the most of the opportunities, effective planning for product launch is more important than ever. This webinar will explore key factors in addressing the needs of payers, and look at how to maximize patient value of your product in the U.S. market. This essential webinar will include speakers from Quintiles and Pierre Fabre to discuss a case study of a European specialty biopharma company launching successfully into this increasingly complex, dynamic and crucial market place.

Key Learning Objectives:

  • Understand the aspects of breaking into the U.S. for small biotechs:
    • Filing with the FDA
    • Gaining approval from the FDA
    • Obtaining licensing stocking and distribution
    • Conducting market research
    • Managed care strategy, achieve Formulary coverage, access and reimbursement
  • Learn how a specialty European based biopharma company successfully launched an orphan drug in the U.S. market