Preparing, Initiating, and Approaching the Pre-IND Meeting

Presenter: Dr. Carmella Moody, RTI International

What is a pre-IND? Why have a pre-IND? What goes into preparing for a pre-IND? And, what documents are required? All of these questions and more will be answered in this webinar presented by Dr. Carmella Moody, a regulatory affairs specialist at RTI International. Dr. Carmella Moody brings her expertise in regulatory affairs and the development of small molecules to the Catalyze program, where she serves as a technical project lead. In this 1-hour webinar, Dr. Moody will explain the process of preparing and approaching an effective pre-IND meeting, but also what to expect from FDA feedback and how to incorporate it into your project to ultimately save time and money.

This seminar was presented on May 18, 2022 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.

Presentation Bookmarks:
0:00 Presentation/Pre-IND Overview
3:13 What is a Pre-Ind Meeting?
4:34 Why Have a Pre-IND Meeting?
4:55 What a Pre-IND Meeting is Not
5:58 When Does FDA Suggest a Pre-IND Meeting is Beneficial
6:32 FDA Perspective on Benefits of a Pre-IND Meeting
7:40 Will FDA Tell Us What to Do?
8:20 Is the FDA Feedback Binding?
10:00 Preparation
12:30 FDA Preliminary Comments
14:10 Meeting Conduct
16:15 Post Meeting
17:45 Information to Include in Pre-IND Meeting Request
20:35 Information to Include in a Briefing Document
22:25 Target Product Profile
24:00 Clinical Study Synopsis/Draft Protocol for IND Clinical Study
26:45 Nonclinical Information
28:35 Distribution Metabolism, and Pharmacokinetics
29:05 Safety/Toxicology
29:15 Quality/CMC
31:35 How Can the Catalyze Program Help?
34:00 Helpful Links
35:35 Questions and Answers