So, you’re looking forward to sitting down with the FDA to get input on your planned drug development program. You’ll request a pre-investigational new drug application (pre-IND) meeting, you’ll meet with the regulators, you’ll get your questions answered, and you’ll get moving on your IND.
Unfortunately, it’s not that simple or straightforward. Here are a few things to know about making the pre-IND meeting a big step on the road to success, rather than a big misstep.
What Kind of Meeting and When
There are three types of pre-IND meetings a sponsor can request: A face-to-face meeting, a teleconference/video conference, or a written response only (WRO), which is, of course, not a meeting at all. Despite what you request, you may end up with a WRO. The FDA is simply too busy to keep up with all the demands on its time. As a result, it reserves the right to substitute a WRO for a meeting if it believes that will be adequate. Be prepared for the possibility.
While the FDA is granting face-to-face meetings less frequently, it’s also making sponsors wait longer. A 2017 FDA draft guidance document on meetings states that pre-INDs will be scheduled 60 days from the date of the request. Yet in October of 2019, some Divisions within the FDA were reportedly scheduling pre-INDs as much as five months out. If your timing is tight, request your meeting ASAP. And be certain to ask the right questions that will be helpful to your development strategy.
Note That You Get Just One
The pre-IND is considered a key milestone meeting. That’s important because you only get one key milestone meeting per milestone. Think carefully about your timing. For example, you might feel you should schedule a meeting very early on because you’re hoping to get information that will help in the design of your development plan. That’s fine, but if other concerns arise further down the road and you will need to ask for a Type C meeting, and even so your request could be denied.
Compose Your Background Document with Care
Go to the agency with a well-positioned development plan that you as a sponsor understand, can justify, and feel comfortable about. Use the meeting request briefing document and compose it carefully. Remember that although you need to be sufficiently detailed, you should not be too verbose. We recommend that your document be one that can be read in a couple hours. The regulators will appreciate you being succinct and well organized.
Remember that the response you get from the FDA is dependent on the quality of information you provide in your background document. The more detailed and complete it is, the better the FDA will be able to assess and answer your questions. If the agency thinks your information is inadequate, it will not render a decision and/or answer in a way that is helpful to you. Also, avoid general or philosophical questions like, “if the results of this study are positive, will it be adequate for approval?” The agency is likely to pass on that sort of question or tell you it’s a review issue.
Be Ready For a Curve Ball
Finally, know that the FDA might surprise you at any time. For example, recently when The Bracken Group submitted a pre-IND meeting request for a client, they received back from the agency, a directive to split their meeting into two. Obviously, this conflicts with the one-milestone-meeting rule, but in that case the agency was trying to meet the needs of the sponsor and manage its workload challenges at the same time. Collaborate with seasoned professionals, like The Bracken Group, and you’ll be prepared to handle whatever challenges come your way while building a productive relationship with the FDA.