After making a lot of plans and strategies, you are ready to start testing your drug in humans, but be confident that your rationale is sound and your study design is valid. I can’t have it. Now you needed is a Pre-IND Meeting with the FDA to facilitate communication and get the benefits of early feedback on the drug development program.
Pre- IND meeting is the first in a three-part series on plans for successful application of investigational drug (IND). If you are considering a meeting with the FDA to get feedback on your development program before submitting your investigational drug (IND) application, there are some ideas and reasons to not miss this valuable opportunity.
While it can take months after you submit a meeting request to get feedback, Pre-IND Meeting can save you time in the long run and actually implement your overall strategy for complex drug development.
If you’re wondering how adding a Pre-IND Meeting can reduce time to market, you’re not alone. The FDA is actually addressing this question on its website and shows that they can save time in the following ways:
- Identify and avoid unnecessary investigations
- Make sure the research you need is designed to provide useful information
- Get FDA support for the proposed strategy
- Possibility to minimize the possibility of the clinical hold
- Providing opportunities for creative idea exchange
- Gain regulatory insights
- Minimize cost
- Clearly define development program endpoints and goals
- Allows early interaction/negotiation with the FDA
Important considerations for pre-IND meetings
Although not required, Pre-IND Meeting is highly recommended by both the FDA and the Weinberg Group. Among the many benefits of attending a Pre-IND conference is the fact that the FDA allows considering the requirements of the drug development process. The sooner this is, the better it will ultimately be for the applicant and the less time and money will be spent.
Below are some things to consider when planning a Pre-IND Meeting.
- The most effective Pre-IND Meeting focus on specific regulatory or scientific issues (clinical trial design, toxicology research, pharmacology research, etc.).
- The goal of the Pre-IND Conference is to receive confirmation from the FDA that drug development plans and future clinical trials will be accepted by the FDA. Therefore, it is important for sponsors to remember that they need full transparency to get the most value out of their meetings.
- Using Pre-IND Meeting in the right way can help reduce time-to-market for your product and prove that the proposed research is designed to return useful and necessary information.
Also Read: Know about the Pre- Submission Meeting
Benefits of having a pre-IND conference consultant
Many companies entering the Pre-IND phase are the first time and it is even more important that these first conversations with the FDA are well planned and rehearsed. The Weinberg Group will assist you in preparing for this conference using several proven procedures.
Create a question with the FDA to request Pre-IND Meeting before any additional information that ends with a simple question such as “Do you agree with the FDA?”
Prepare the briefing package and make sure it contains the product overview, meeting objectives, and appropriate clinical / manufacturing information.
Conduct a pre-meeting conference call to make sure you are 100% ready to face the FDA. This conference call will review the challenges the FDA may face and prepare answers.
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