Pre-IND Meeting Guidance & Consulting
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 the design of your studies is valid. The necessary next step is a 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 The Weinberg 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
Considering the Pre-IND Meeting will likely be your first direct interaction with the FDA, there are a couple of things you should know and keep in mind during your preparation:
- The most effective Pre-IND meetings are focused on a specific regulatory or scientific issue (e.g., clinical trial design, toxicology studies, pharmacology studies, etc.).
- The goal of a Pre-IND Meeting is to receive confirmation from 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 with the FDA is necessary to obtain the maximum value from the meeting.
- Prior to the Pre-IND Meeting, you will be required to submit a briefing package with information such as a synopsis of the program and a full description of the development plan along with other relevant resources.
Benefits of Having a Pre-IND Meeting Consultant
Many companies entering the Pre-IND stages are “first-timers”, making it even more important that these initial conversations with the FDA are well planned and rehearsed to ensure things go smoothly. The Weinberg Group will help you prepare for your Pre-IND 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 that it includes appropriate clinical and manufacturing information and is free from any errors.
- Conduct a pre-meeting teleconference to make sure you are 100% ready to face the FDA. During this preparatory teleconference, we will review possible challenges that may be posed by the FDA and prepare your responses to address any concerns from the Agency.
- Hold a meeting dry run at our office in Washington, DC the day before your Pre-IND Meeting to reinforce objectives of the meeting and finish preparations of our arguments to potential questions or concerns from the FDA.
The Weinberg Group: Pre-IND Meeting Experts
The Weinberg Group has 37 years of experience working with clients to achieve FDA approvals and we’d love the opportunity to work with you. As IND submission experts, we will provide you with guidance through the entire Pre-IND process – from the initial meeting request all the way through preparation and execution of the meeting with the FDA. We will manage the timing and quality of IND submissions and regulatory interaction. Our goal is to help you meet this critical milestone.
To learn more about how The Weinberg Group can help you prepare for and conduct a successful Pre-IND Meeting, contact us today.