In this webinar, experts from L.E.K. and Greenberg Traurig discuss prevailing trends and anticipated shifts across market access and pricing, regulatory affairs, and deal activity in the U.S. biopharmaceutical market and their impact on APAC companies. The webinar explores critical questions facing our clients, including:

  • What are the implications of recent FDA decisions around the use of non-U.S. data for supporting regulatory applications and the approval of beta amyloid-targeted Alzheimer's disease treatments?

  • What should life sciences companies expect from the FDA under Robert Califf’s leadership and the coming enactments of User Fee programs, as well as the 21st Century Cures Act version 2.0?

  • What risks and upsides do we see around U.S. medicinal product pricing as the Biden administration enters its second year?

  • What opportunities are available, given recent declines in the share prices of publicly traded life sciences companies?

  • What is the price of entry – time, risk, capital – for newcomers to participate in the U.S. marketplace?

Watch the webinar for more insights.

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