Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug development plan and future clinical trials are acceptable to the Agency.
Here are four benefits of requesting an FDA Pre-IND Meeting:
One of the most valuable benefits of the Pre-IND Meeting is that you are able to receive early feedback directly from FDA regarding the requirements associated with your drug development program. That’s because the underlying purpose of the meeting is to gain an understanding as to what FDA’s expectations are.
The nature of the feedback, of course, depends on the nature of your drug development program. For instance, if you are developing a drug in an area where there are plenty of products on the market, FDA will certainly have specific expectations about what they need to see from your program. That’s because of the many clinical trials that already exist in the corresponding patient population.
On the other hand, if you are developing a product in a novel therapeutic area, or one where there are no approved drugs or current guidance documents, selection and agreement with FDA of a measurable clinical benefit may require the generation of actual data before this can be determined. Consequently, the Pre-IND Meeting provides FDA with the opportunity to begin thinking about the type of program you are running. This means that the meeting has value for both you and FDA.
It’s easy to look at the Pre-IND Meeting as one small administrative step in a long line of administrative steps. That view is mistaken. This meeting is a strategic imperative, not administrative. When conducted effectively, you can use the feedback you receive from FDA to fine-tune your program development strategy, saving time and money.
As you move through the process of creating a product concept and developing a program, you need a strategy for success at many different points throughout the program. Having discussions with FDA allows you to leverage their feedback. You’ll have helpful information regarding such things as what studies you must conduct and other strategic decisions surrounding timelines and budgets.
An often-overlooked benefit of the Pre-IND Meeting is that it helps you begin to build a working relationship with FDA. Essentially, FDA is an agency made up of individuals who work together to get things done; and you have to work closely with those individuals to get your drug approved. The earlier each side gains an understanding of the other side’s needs, the better it is for the entire process.
There is always the potential that the Pre-IND Meeting will have the impact of reducing time to market. This benefit relates to the feedback FDA may give during the meeting.
For instance, if FDA already knows what they want to see in your program, they can simply inform you of those items. Perhaps one or more of the studies you’ve planned are unnecessary. Additionally, FDA may have helpful feedback on how your studies should be designed. Streamlining your plan by eliminating studies, or better designing your studies, will have a direct effect on the length of time it will take to bring your drug to market.
It’s never too early to begin communicating with the FDA about what your product concept looks like. ProPharma Group is here to provide you with guidance throughout the entire Pre-IND process. As regulatory scientists and experts, our team will work with you from the initial meeting request through preparation and execution of the meeting with the goal of helping you get the most out of this critical milestone. Contact us today to learn how we can help you achieve successful interactions with FDA.
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