After much planning and strategizing, you are ready to begin testing your drug in humans but are unsure that your rationale is sound and that your studies’ design is valid. The necessary next step is a Food and Drug Administration Pre-IND Meeting, which will facilitate communication with the (FDA) and provide the advantage of early feedback on your drug development program.
Benefits of a Pre-IND Meeting with the FDA
Although they are not required, Pre-IND Meetings are highly recommended by both the FDA and ProPharma Group for the following reasons:
1. Early Feedback from the FDA
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 the FDA’s expectations are.
2. Advice to Fine-Tune Your Development Strategy
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 the 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.
3. Relationship Building
An often-overlooked benefit of the Pre-IND Meeting is that it helps you begin to build a working relationship with the FDA. Essentially, the 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 the it is for the entire process. It also helps if you have an experienced consultant like The Weinberg Group who has a long history working with the FDA.
4. Save Money and Reduce Time to Market
Pre-IND Meetings can potentially save you money and reduce your time to market based on the feedback you receive from the FDA.
For instance, if the FDA already knows what they want to see in your program, they can simply inform you of those items so you don’t waste time and preparing unnecessary resources such as extra studies you may have planned. Additionally, the FDA may have helpful feedback on how your upcoming studies should be designed. Streamlining your plan by eliminating studies, or better designing your studies, will have a direct effect on the resources you spend and the length of time it will take to bring your drug to market.
Important Considerations About Pre-IND Meetings
Although they are not required, Pre-IND Meetings are highly recommended by both the FDA and ProPharma Group. Among the many advantages of attending a Pre-IND Meeting is the fact that it gives the FDA the opportunity to confirm its requirements regarding the drug development process. The earlier this is done, the better it will ultimately be for the applicant, reducing the amount of time and money that must be spent.
The following are a few things to consider when planning a Pre-IND Meeting:
- The most effective Pre-IND Meetings are focused on a specific regulatory or scientific issue (eg, clinical trial design, toxicology studies, pharmacology studies, etc.)
- A Pre-IND Meeting’s goal is to receive confirmation from the FDA that the drug development plan and future clinical trials are acceptable to the Agency. As such, it is critical for Sponsors to remember that complete transparency is necessary to obtain the maximum value from the meeting
- When used appropriately, Pre-IND Meetings have the ability to reduce a product’s time to market, certifying that the proposed studies have been designed to return useful and necessary information
Benefits of Having a Pre-IND Meeting Consultant
Many companies entering the Pre-IND stage are “first-timers,” making it even more important that these initial conversations with the FDA are well planned and rehearsed. ProPharma Group will help you prepare for this meeting using a few proven steps:
- Formulate questions to the FDA that are prefaced by supportable information, ending with a simple question to the division, such as “Does the FDA agree?” The questions are sent to the FDA with the Pre-IND Meeting request
- Prepare the briefing package, making sure it includes an overview of your product, describes the purpose of the meeting, and includes appropriate clinical/manufacturing information
- Conduct a pre-meeting teleconference to make sure you are 100% ready to face the FDA. During this teleconference, we will review possible challenges by the FDA and prepare your responses
- Hold a meeting dry run at our office in Washington, DC, the day before your Pre-IND Meeting to reinforce the meeting’s objectives and finish preparations of our arguments to potential questions or concerns from the FDA
ProPharma Group: Pre-IND Meeting Experts
ProPharma Group will provide you with guidance through the entire Pre-IND process – from the initial meeting request all the way through the preparation and execution of the meeting itself. Our goal is to help you prepare for and conduct a successful Pre-IND meeting. Contact us today to learn more or get started.