Pre-IND meeting timeline
Before requesting a Pre-IND meeting, it is highly recommended that you have a solid draft of your meeting information package (MIP) before you send the meeting request, as often decisions/questions are worked out as the MIP is being drafted. It is also possible to have a Written Response Only (WRO) in lieu of a meeting – you may request one, or the FDA might determine a WRO is more appropriate for providing feedback and advice.
So, what is the Pre-IND meeting information package (MIP)?
The MIP, sometimes known as a briefing package, is a detailed document sent to the FDA in support of the Pre-IND meeting request. The goal of the MIP is to provide information, relevant to the discussion topics of the meeting request, to not only enable the FDA to prepare adequately for the meeting but also to achieve a focused and productive exchange of information.
Additionally, the timely submission of the MIP is crucial to provide sufficient time for meeting preparation and for accommodating adjustments within the meeting agenda and pre-meeting communications. The FDA requires that the MIP be submitted 30 days prior to the scheduled meeting date (See figure above for a recommended timeline for Pre-IND meeting).
A Pre-Submission Tracking Number (PSTN) should be requested 30 days prior to the planned meeting request submission date. To do this, send an email to ‘cberrims@fda.hhs.gov’ and request this number. The emails should contain: Sponsor Name, Sponsor Address, Authorized Regulatory Contact, Name, Description, Code of Investigational Therapy, Indication and Anticipated Submission Date. CBER will respond with a unique PSTN that should be referenced in your paperwork when you are ready to submit the Meeting Request through the FDA Electronic Submission Gateway (FDA ESG). The timing for all this should occur approximately two months prior to your desired meeting time frame.
It is important to include enough information in order for the FDA to accept the Pre-IND meeting request and also identify the proper staff to discuss your proposed agenda items. Fortunately, the meeting request can be thought of as a summary version of your MIP – a lot of content may eventually go into the MIP and will set your team up well for the meeting.
Download the Pre-IND Meeting Request template below to prepare your meeting request.
Pro-tip
Unlike INTERACT, the FDA allows a Pre-IND meeting request to be requested without an accompanying briefing package. If the meeting is granted, the FDA will require submission of a complete briefing package 30 days prior to the scheduled meeting date. Rather than two submissions, the BGTC recommends an approach similar to the INTERACT submission process where the briefing package is provided along with the meeting request. This minimizes the number of submissions, reduces the potential for content discrepancies between the request and briefing package documents and offers an earlier opportunity for Agency reviewers to begin reviewing your information. If a briefing package is submitted with the request, that should be stated in the cover letter.
Consider including the following details about your program in the meeting request [3]:
The application number
The product name
The chemical name, established name, and/or structure
The proposed indication(s)
The meeting type being requested (i.e., Pre-IND is a Type B meeting)
Any proposed designations and general discussion about whether or not they are a value-added for acceleration or market access for rare gene therapies
The meeting request should also include key information about the meeting itself, such as:
Suggested dates and times (e.g., morning or afternoon) for the meeting that are consistent with the appropriate scheduling timeframe (see timeline) as well as dates and times when you/your team are not available
A list of proposed questions, grouped by FDA discipline, with some brief explanation for each question
The proposed meeting format:
The date you will send the MIP (see Pre-IND meeting timeline above for the range of time you can do this)
A brief statement of the purpose of the meeting. This statement should include a brief background of the issues you are facing with your program or outstanding concerns. It can include a summary of completed or planned studies or data that you intend to discuss at the meeting. You can also highlight the general nature of the questions to be asked, and where the meeting fits in the overall development plans. You don’t have to provide details of trial designs or completed studies – that should be included in the MIP – but you should provide enough information to facilitate the FDA’s understanding of the issues
A list of the specific objectives or outcomes you expect from the meeting
A proposed agenda, including estimated times needed for discussion of each agenda item
A list of planned attendees from your organization, including titles and affiliations
A list of requested FDA attendees and/or discipline representative(s)
Once you have submitted the request, the clock starts. If you are granted a meeting, you can expect to have it scheduled approximately 60 days from the request, and you may proceed to the next step.
If you are denied a meeting, the FDA will notify you according to the timeline described and provide reasoning for denial. For WRO requests or if the FDA determines a WRO would suffice, the FDA’s letter will include the date the FDA intends to send the written responses. See this figure for more information on these options for FDA responses.
For additional information please visit OTAT Pre-IND Meetings | FDA [10]