Beginner’s Guide to Pre-IND Meetings

New to the process of helping to bring a drug to market? As intimidating as the Food and Drug Administration (FDA) might seem, they do a lot to support research sponsors. One example is the pre-investigational new drug (IND) meeting.

The pre-IND meeting is usually a drug sponsor’s first formal meeting with the FDA as they begin the process of bringing a drug to market. The meeting provides sponsors the opportunity to discuss their IND plans prior to the full IND submission. This interaction is where the drug sponsor can receive insight into the FDA’s current thinking. Sponsors who factor this valuable input into their drug development efforts early on may benefit by receiving fewer FDA requests for changes.

The pre-IND meeting is designed to address questions related to the initial clinical study design, as well as answer other important questions potentially affecting the IND application. Discussion topics usually include adequacy of nonclinical data to support the duration of the clinical study, and current good manufacturing practice (cGMP) issues relating to manufacturing for and product quality of the IND.

The Pre-IND Meeting: Don’t Miss This Opportunity

While sponsors are not required to pursue a pre-IND meeting, experts strongly recommend it for multiple reasons:

• Information the meeting provides can help ensure the subsequent IND application is complete, helping to avoid clinical holds
• The meeting provides sponsors with the opportunity to understand the FDA’s perspectives and recommendations, as well as gain preliminary agreement on critical aspects of the proposed development program
• The meeting gives sponsors the opportunity to build a relationship with FDA

Also, it’s important to remember there are no fees associated with the pre-IND meeting.

Three Types of Pre-IND Meetings

There are three categories of formal FDA meetings: Types A, B, and C. Most pre-IND meetings are Type B meetings, and occur at predefined time points. For a pre-IND meeting, there are three meeting formats: face-to-face, teleconference, or written response only (WRO). However, due to the FDA’s increased, pandemic-related workload, it is far more likely you will receive a WRO no matter which format you requested.

According to the 2017 FDA draft guidance document, pre-IND meetings will be scheduled 60 days from the date of confirmed receipt of the request. However, due to the COVID-19 pandemic, FDA reallocated some review staff elsewhere, resulting in pre-IND meetings and written responses taking place much further out.

Dos and Don’ts

If you and your team decide to pursue a pre-IND meeting with the FDA, consider following the hard-won advice from meeting veterans:

• Make the pre-IND meeting as beneficial as possible by creating a plan and rehearsing with stakeholders ahead of the official meeting
• Select an experienced facilitator for your meeting: someone who will take charge, assign meeting roles, and make sure everyone is well rehearsed
• Appoint a primary voice for the company, usually the chief executive officer (CEO). One additional voice (the chief scientific officer [CSO], for example) might be useful for deeply scientific questions. Also, assign someone the role of taking meeting notes
• Always respond to the FDA’s questions with the minimal amount of information necessary, and remember, less is more in these circumstances. Be succinct, honest, and transparent – and respect the silence after you answer their question
• Don’t go off-topic during the meeting. You are required to stick to the questions you have submitted. After all, the agency personnel with the authority to respond to your new questions might not be in the room. In any event, this is not the time for an open dialogue
• Don’t be unnerved if there are more people in the room than you expected. Some agency staff might simply be there for training. No matter the number present, only one FDA representative will speak to you at a time
• Expect your meeting to last about an hour or less and be fairly low-key

No Second Chances to Make a Good First Impression

You only get one shot at a pre-IND meeting, so it is vital to plan carefully and time the meeting appropriately. For instance, you might think it would be best to schedule your meeting very early, because you would like to get information to help in the design of your development plan. That’s not a good idea, because FDA will not simply tell you what to do; instead, they will provide insight on what you propose.

Remember: your reputation with the agency is formed with this first impression. It’s critical to thoroughly prepare for any question the FDA might ask. Know your position and science clearly.

Commit to Creating a Scientifically Sound Document

Of utmost importance is to present a well-laid-out clinical development plan backed up by scientific justification. The initial briefing document must provide adequate detail so the FDA can comprehend and answer your questions. Ensure the document conforms to regulatory guidelines, or the FDA can refuse to accept it.

Requesting Your Pre-IND Meeting

Be sure to adhere to guidelines when submitting a pre-IND meeting request. Adjust your expectations regarding when the actual meeting will occur, as specified in the appropriate FDA guidance document, and be certain all the required documents are submitted to the FDA by the designated date. For more information, see the relevant sections of the FDA website.

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