Improving Regulatory and Operational Performance in Orphan Drug Development
The environment for developing and marketing orphan drugs is more favorable than at any time in history, thanks largely to a regulatory climate that offers a progressive platform for innovation.
In a new Premier Research white paper, Improving Regulatory and Operational Performance in Orphan Drug Development, we look at how sponsors can optimize the regulatory pathway and maximize revenue by expanding or protecting drug sales through:
Early access:
starting with an orphan disease as the primary indication and then adding a non-orphan indication.
Multiple designations:
simultaneously pursuing orphan designations in multiple indications.
Sub-indications:
beginning with a non-orphan disease as the primary indication, then adding an orphan indication.
The fast-growing market for orphan drugs is expected to hit $127 billion this year — so for the latest intel and insights, download this white paper.