Planning for a New Era: Commercial Strategy under the Lens of Public Scrutiny

In 2019, 44% of novel drugs approved in the U.S were classified with orphan designation.

60% of approved drugs fell into one or more expedited categories: Fast Track, Breakthrough, Priority Review, and/or Accelerated Approval.

• But how does public concern over increasingly high drug prices impact patients in need of newly available, life-altering medications?

• Does the political environment and legislation influence your business strategy?

Clinical stage companies must begin developing commercial strategies as early as Phase II to effectively meet these concerns and chart a course for a successful product launch.

We invite rare orphan and specialty biopharma manufacturers to contact joff@diligentiastrategy.com to learn how Diligentia can help you develop commercial strategies and tactical plans that enable patients and families to enjoy sustained access to novel, innovative therapies.