Meetings with the FDA are a chance for sponsors to discuss their development plans with the people responsible for reviewing their program.
Pre-IND meetings present a valuable opportunity to minimize the potential risks that could arise from misaligned plans or expectations. At this stage there are often questions regarding minimum requirements for the quality and manufacturing of a new drug for trial—whether the proposed toxicology studies are sufficient to support the dose and duration of drug treatment, as well as the selection of patients for a first in human (FIH) study.
These meetings are also an opportunity to discuss the qualifications for expedited programs or accelerated development. Carefully constructed questions and meeting packages can facilitate meaningful responses beyond the typical advice to review guidance documents or a boiler plate answer, like it is premature to discuss. For instances in which a companion diagnostic will be used for patient identification or outcome assessment, plan the discussion around timing and validation to gain clarity on how best to proceed.
Formal meetings with the FDA have been the subject of the Prescription Drug User Fee Act (PDUFA) reauthorizations.
Goals for granting and conduct of meetings have been established, and the FDA has issued a formal (albeit still draft) guidance in 2017 describing the process for “requesting, preparing, scheduling, conducting, and documenting” such meetings.
A pre-IND meeting request is typically made 60 days prior to the proposed meeting date.
- The FDA has 21 days to decide whether to grant the meeting, and the format that it will take. Meetings can be face-to-face (hopefully, in a post-COVID world), as a teleconference, or as a written response only (WRO). Recent trends have been to provide feedback to pre-IND meeting requests in the WRO format, which is consistent with the Guidance document.
The briefing package for the meeting is due 30 days prior to the meeting date.
- Given the short time between when the meeting is granted and when the package is due, best practices are to have a good working draft of the package at the time of the initial request. This also helps to align the questions with the supporting information.
It is important to have sufficient data to allow FDA to answer the questions that are being asked.
- A typical package might have 6-10 questions organized by discipline (CMC, Nonclinical, Clinical, Regulatory), although there is no formal limit. If a teleconference or face-to-face meeting is granted, FDA will provide preliminary comments at least 2 days before the meeting. This allows the team to focus on the questions that need discussion at the meeting, and an opportunity to strategize and prepare for presentations.
- Common questions include things such as clarification of drug quality assays or stability, selection of species for GLP toxicology studies, or starting dose selection and dose escalation rules for clinical testing. If studies have been conducted ex-US, results from those would be included.
The timing for when to request a pre-IND meeting should be determined by when there is enough information to allow FDA to respond to the questions being asked, while still being early enough for the sponsor to implement advice from the FDA. Having a well-organized, reviewer-friendly meeting package helps facilitate discussion and establish a positive working relationship with the review division. Obtaining meaningful feedback for a program can accelerate the pathway to initiation of the clinical trial.
Guidance for your package preparation
The Center for Biologics Evaluation and Research (CBER) offers an earlier stage meeting program called INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER producTs). These are informal (non-PDUFA) meetings intended to provide preliminary guidance for innovative programs posing unique challenges that are not yet at the IND stage. A similar format no longer exists within the Center for Drug Evaluation and Research (CDER).
Additionally, Precision’s regulatory experts can support your IND and BLA submissions, as well as the development of a comprehensive regulatory strategy and documentation.
For more information on how Precision's regulatory experts can support your upcoming program, contact us.