Catalyze Annual Meeting 2024: How to Prepare for a Pre-IND and NTERACT Meeting (Breakout session)

Presenter: Dr. Elizabeth Mannick, M.D., M.S., RTI International
A pre-IND and/or INTERACT meeting with the FDA can be beneficial for many reasons including minimizing costs and unnecessary studies. In this presentation, Dr. Elizabeth Mannick (a technical project lead for the Catalyze program) helps investigators effectively prepare for a pre-IND and INTERACT meeting by clarifying the process from start to finish.
Presentation Bookmarks
0:50 Benefits of a pre-IND Meeting
3:56 Pre-IND Meeting Process & What to Discuss
6:18 INTERACT Meeting Process & What to Discuss
10:55 Asking FDA a Question
13:43 Submitting a Meeting Request
16:02 Creating your Briefing Book
17:40 Preparing for your Meeting
18:54 Meeting Conduct
20:11 What to do Post-Meeting
This webinar was presented on September 12, 2024 to an invited audience.
This video is for educational purposes only.
The Catalyze program utilizes a new approach to translational research by supporting both the technical needs of an innovation and the management, commercialization, regulatory, and training requirements of the innovators developing them. Projects supported by Catalyze receive funding and advisory support through the National Heart, Lung, and Blood Institute (NHLBI), as well as project management assistance, access to technical services and expertise, and training opportunities through the Catalyze Coordinating Center.
This research was funded, in part, by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions of the presenters are their own and should not be interpreted as representing the official policies, either expressed or implied, of the NIH.
NHLBI Catalyze Public Site: nhlbicatalyze.org