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September 27, 2022 Regulatory Affairs

What You Need to Know About CBER Pre-IND Meetings


The FDA provides several opportunities to hold meetings with Sponsors to gain clarification and agreement on the development of medicinal products. At the preliminary stages of development, one such option is a Type B Pre-IND (or PIND) meeting. The primary goal of a PIND meeting, whether for a drug through the Center for Drug Evaluation and Research (CDER) or for a biologic through the Center for Biologics Evaluation and Research (CBER), is to allow for discussion and agreement on a path forward for development of an original Investigational New Drug (IND) application. The process for a PIND meeting is effectively the same between the two FDA divisions, with a few key differences, as discussed below.

What Needs to be Completed Prior to Requesting a PIND Meeting?

The first step to prepare for a PIND meeting is to request a pre-assigned application number. For CDER, this is considered the PIND number. The PIND number can be requested in one of two ways for a drug: Using the FDA’s NextGen Portal, or via email. Once a PIND number is assigned for a drug product and the IND is opened, the same number becomes the IND number, with subsequent sequences submitted within the same application.

Pre-submission numbers through CBER are requested differently than CDER. While the FDA website notes that IND numbers can be requested for biologics (and subsequently BLA numbers) through the NextGen Portal, this component of the portal is not yet available. PIND requests for CBER must be submitted via email to CBERRIMS@fda.hhs.gov. CBER uses the term “Submission Tracking Number” (STN) to define the IND pre-application number for biologics. Unlike a PIND number, the STN assigned as the pre-application number for a biologic is considered an entirely different application than the IND.

Requesting a PIND Meeting

Once an STN number is assigned to the biologic, the process for the PIND meeting is very similar between CDER and CBER. The next step in preparation for a PIND meeting is to submit a Meeting Request Letter (MRL). The MRL introduces the proposed product, provides a short background of the product and the objectives of the meeting, and outlines the questions that are intended for discussion with the Agency. PIND meetings are generally held early in development, with little to no clinical data yet available. Therefore, PIND meeting questions often focus on the adequacy of the nonclinical program support clinical studies, the current and proposed manufacturing details surrounding the drug substance and drug product, and requests for feedback on the adequacy of the IND-opening clinical study protocol.

Once an MRL is submitted to the application, the Agency should respond within 21 days to grant or deny a meeting. The COVID-19 pandemic halted all face-to-face meetings; therefore PIND meetings are most often granted as a teleconference with the Agency. The Meeting Granted Letter in response to an MRL dictates the date and time of the meeting – approximately 60 days after the MRL has been submitted.

Developing a PIND Meeting Information Package

The next step is to develop a Meeting Information Package for the PIND meeting. This document provides the same information in the MRL, in addition to extensive details surrounding the current and proposed development program plans as they relate to the specific questions to be asked at the meeting. For a PIND meeting, the Meeting Information Package is required to be submitted at least 30 days prior to the scheduled meeting, as dictated in the Meeting Granted Letter.

Preparation for the PIND Meeting

Just prior to the meeting date, the FDA will provide Preliminary Responses to the questions from the Meeting Information Package to the sponsor no later than two calendar days before the meeting date. These Preliminary Responses will provide FDA’s initial replies to the proposed questions. For CBER PIND meetings, the Agency will also send a Sample Agenda for the sponsor to populate which questions are still needed to be discussed at the meeting, how long each question is anticipated for discussion, and in what order the questions should be discussed. The Sample Agenda should be provided to the Agency no later than 24 hours prior to the scheduled meeting time. If the totality of the FDA Preliminary Responses are adequate and no longer require discussion, the sponsor also has the option to cancel the meeting. If a meeting is cancelled, the Preliminary Responses will serve as the official PIND meeting minutes.

If the PIND meeting is held, the sponsor should prepare Sponsor Meeting Minutes to outline the sponsor’s interpretation of the discussion and/or agreements made at the meeting. For CBER PIND meetings, the Sample Agenda is used and amended with the discussion points held at the meeting to serve as the Sponsor Meeting Minutes. Within 30 days of the meeting date, the FDA will provide the sponsor with the FDA Meeting Minutes, which serve as the “official” meeting minutes.

An overview of the timelines associated with CBER PIND meetings is presented in Table 1 below.

Table 1:          Type B PIND Meeting Timeline Overview

Activity
Timeline
Meeting Request Letter (MRL)
No required timeline for submission
Meeting Granted Letter (from FDA)
Within 21 days of submission of the MRL
Meeting Scheduled Date
Within 60 days of the receipt of the MRL
Meeting Information Package
No later than 30 days before the scheduled date of the meeting
FDA Preliminary Responses and Sample Agenda
No less than 2 days prior to the scheduled meeting
Sample Agenda Response
No less than 24 hours prior to the scheduled meeting (this will be stipulated in the Preliminary Responses document)
Sponsor Meeting Minutes
As soon as possible (dictated by FDA Project Manager)
FDA (official) Meeting Minutes
Within 30 days of the meeting

 

The key differences between CBER and CDER PIND meetings are outlined in Table 2 below.

Table 2:          Differences Between CDER and CBER PIND Meetings

CDER
CBER
Request PIND number either via email or using the NextGen Portal
Request STN via email
Preliminary Responses from the FDA are used as the template to provide Sponsor Responses to Preliminary Comments to the FDA1
Sample Agenda is used as the template to outline which questions are to be discussed2
Historical suggestion from FDA is to submit the Sponsor Meeting Minutes via email and electronically to the PIND application
Current experience with CBER PIND meetings does not require electronic submission of the Sample Agenda to the STN application, however both email and electronic submission are acceptable

1 All questions, whether discussion at the meeting is still needed, should be included in CDER Sponsor Responses to Preliminary Comments.  Questions that do not require discussion at the meeting should state “The FDA response is clear. No further discussion is needed.”

2 Only the questions that still warrant discussion at the PIND meeting should be included in CBER Sample Agenda (serving as the “Sponsor Responses to Preliminary Comments” document)

Overall, the process for PIND meetings is very similar between CDER and CBER. CBER PIND meetings provide an opportunity to ensure that sponsors are on an appropriate trajectory for success in the unique development of biologics. As PIND meetings in general are one of the first interactions with the FDA, they serve as the starting point for open communication and developing a positive relationship with the Agency surrounding the development of biologics. ProPharma Group’s extensive expertise is an invaluable opportunity for sponsors seeking assistance throughout the comprehensive PIND meeting process and beyond.

Interested in learning more? Contact us today to find out how we can help with your global regulatory needs.

 



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