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Webinar: Designing a Turnkey Orphan Drug Program

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Date: Wednesday, February 19, 2020
Time: 2:00 pm EST

 

The orphan drug designation is a vital regulatory pathway, responsible for a substantial portion of all new approvals at the FDA. Just how are today’s drug developers navigating the incentives and challenges that come with following this route? In this Endpoints News webinar, we talk to four experts who represent some of the key constituencies when developing a modern orphan program – from early research through approval. What are the latest approaches in achieving proof-of-concept in orphan populations? How will your program evolve between IND through NDA? What are regulators looking for? And how do we do all of this while keeping a laser focus on the patient?

 

Speakers:

Cornell Stamoran
VP, Strategy & Corporate Development
Catalent

 

 

Ethan Perlstein
Chief Scientific Office
Christopher & Dana Reeve Foundation

 

 

Terry Jo Bichell
Founder and Director
Combinedbrain

 

 

Josh Lehrer
Chief Medical Officer
Global Blood Therapeutics

 

 

 

Moderator:

Arsalan Arif
Founder & CEO
Endpoints News

 

 

 

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