World Orphan Drug Congress USA 2018
community download

World Orphan Drug Congress 2018 Premier Research Whitepaper

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.
 
For more info, visit our website
 

Some quick details

Email Address:*
First name:*
Last name:*
Job Title:*
Company:*
Industry:
Country:*

Remember my details Information

Information
Remember my details
We place a 'cookie' on your computer so next time you visit us you don't need to fill in all these details


Privacy statement »
Manage your email preferences »
 

You will be emailed the document as an attachment (306Kb in size)