Participate In Initial Industry-FDA Meetings

Learn about Pre-IND Meetings

A pre-IND meeting is a Type B FDA meeting which occurs early in the therapy development process to help to guide trial strategies. These meetings can help facilitate faster therapy approval processes. Pre-IND meetings greatly increase the likelihood of a program’s success by allowing concerns to be addressed early in the trial process. Pre-IND meetings are also a great opportunity to build a relationship with the FDA, minimize costs, and identify preclinical studies that have already been conducted. They are especially important when the therapy is intended to treat a serious or life-threatening disease.

Note: A pre-IND meeting is for drug development. A pre-BLA meeting is for licensing of biologics. For device development, the process, when required is called “pre-submission”, but is very similar.

Understand the purpose of pre-IND meetings:
- Identify supporting preclinical trials.
  - A preclinical trial is a trial that tests the proposed therapy in animal or cell models.
  - A preclinical study is required before clinical trials in humans can be started.
  - By identifying these studies, you and the therapy Sponsor can gain access to feasibility, testing, and safety data that has already been generated.
- Identify possible designations and development and review statuses that may accelerate or enhance the clinical trial or marketing review process. The FDA provides information about each of the available programs:
  - Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review
  - Developing Products for Rare Diseases & Conditions
Consider the main goals of a pre-IND meeting:
- Reduce time to market.
- Address novel qualities of application.
- Provide guidance to industry/small business Sponsors new to process.
Be aware of recurrent problems at pre-IND meetings, especially problems that your group may be able to address prior to the meeting. Identified problems include:
- Inadequate chemical, manufacturing, and controls (CMC) information .
- Insufficient preclinical support.
- Unacceptable clinical trial design.
- Noncompliance with Good Clinical Practices (GCPs ).
- Lack of information on selection of dosage.
Review the list of frequently asked questions the FDA has prepared for Sponsors about pre-IND meetings. Although written for small business and industry, the information answers many of the questions you may be asking as well: Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting (updated periodically).

Resources

Overview

How to Study and Market Your Device U. S. Food and Drug Administration (FDA) (link)

The Device Development Process U. S. Food and Drug Administration (FDA) (link)

Learn about Pre-IND Meetings

Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review U. S. Food and Drug Administration (FDA) (link)

Developing Products for Rare Diseases & Conditions U. S. Food and Drug Administration (FDA) (link)

Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting U. S. Food and Drug Administration (FDA) (link)

Prepare for the Meeting

Working with Regulators: A Focus on the FDA Cancer Policy Institute at the Cancer Support Community (link)

FDA Patient Affairs U. S. Food and Drug Administration (FDA) (link)

Biologics License Applications (BLA) Process (CBER) U. S. Food and Drug Administration (FDA) (link)

Target Product Profile Template Health and Human Services (HHS) ASPR (link)

The Target Product Profile Webinar Center for Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) (link)

Tips for Success

Making Data Talk: A Workbook by the National Cancer Institute National Cancer Institute (NCI) (link)

FDA Patient Affairs U. S. Food and Drug Administration (FDA) (link)