ALS 432: Writing an Orphan Drug Application
Course Number: ALS 432
Course Name: Writing an Orphan Drug Application
Year: Second-year
Semester: Fall
No. Units: 0.5
Faculty/Instructor(s): Ian Phillips
Description
This course will equip students with an understanding on how to write an orphan drug designation application. The course will begin with a FDA Workshop on September 13, 2010 on how to write an orphan drug designation application. This workshop will be held at KGI and conducted by Dr. Matthew Thomas from the FDA. Students will receive further information from Dr Phillips on how to write their own orphan drug applications.
Prerequisites
FDA Workshop to be scheduled
Learning Objectives
The students will learn about the Orphan Drug Act 1983 and the problems of developing therapies for rare diseases. The class will be sub divided into teams of 4-5 students. The teams will work on developing a professional, high standard, application. All participants will meet together with Dr Phillips for Q&A once a week. There will be regular meetings between each team and Dr Phillips to discuss progress.
Grading
The final product of the course is a complete application in a folder following all the FDA requirements. Companies / sponsors will be contacted by the teams to discuss their interest in sponsoring the proposal for submission to the FDA .
Required Texts