Investigational New Drug Application (IND): When Required and Content of Submission-Louise Johnson, M.S.-05/18/2010 - 8:30am

Event Information
Event Topic: 
Investigational New Drug Application (IND): When Required and Content of Submission
Event Date: 
05/18/2010 - 8:30am
Event Location: 
Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA
Speaker Information
Event Speaker: 
Louise Johnson, M.S.
Event Speaker Title: 
Senior Consultant
Event Speaker Company: 
Biologics Consulting Group
Event Speaker Bio: 

Louise C. Johnson has over 28 years experience in the biotechnology and pharmaceutical industry. Prior to joining Biologics Consulting Group, Louise spent the past 17 years in regulatory leadership roles at Renovis, Elan Pharmaceuticals, Athena Neurosciences, and DuPont Pharmaceuticals. She has worked with small molecule, monoclonal antibody, and vaccine submissions and has experience with FDA, Health Canada's HPFB, and the UK's MHRA. Her previous work includes the initial IND filing for Tysabri for Athena Neurosciences, approval of 2 anticonvulsants in the US and Canada for Elan Pharmaceuticals, and the initial IND filing a therapeutic vaccine for Alzheimer's disease for Elan Pharmaceuticals.

Event Details
Event Details: 

Combination products and personalized medicine often require firms to be knowledgeable about the different regulatory requirements for devices, drugs, and biologics. Historically, these different product types have been developed and marketed completely independently, resulting in very little cross-over among industries. Learn when an Investigational New Drug application is required for your product, what is required for an IND , and how to write, compile, and submit an IND. This presentation will also discuss FDA’s approach to reviewing INDs and their general expectations of sponsors.