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.
Important Considerations About Pre-IND Meetings
Although they are not required, Pre-IND Meetings are highly recommended by both the FDA and The Weinberg 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 (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 is necessary to obtain the maximum value from the meeting.
- When used in an appropriate manner, 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 stages are “first-timers”, making it even more important that these initial conversations with the FDA are well planned and rehearsed. The Weinberg 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 that it 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 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 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 itself. We will manage the timing and quality of IND submissions and regulatory interaction. Our goal is to help you meet this critical milestone.