You should leave an FDA meeting with answers to critical questions and an understanding of the FDA’s expectations. To the best extent possible, any meeting with the FDA should end in clarity and whoever is working on your project must ensure this happens.
To achieve your goals at a meeting with the FDA, the interaction must be carefully planned and executed flawlessly, leaving the FDA with a good impression of your product and company. This requires experts with prior regulatory experience who know the appropriate time to request a meeting, what is needed to prepare the necessary paperwork, what to expect when meeting with the FDA, and what steps should be taken post-meeting.
As frequent advocates for companies before the FDA, The Weinberg Group takes your product and combines our knowledge of science, medicine, ethics, and regulations to prepare for each meeting. We will guide you step-by-step through FDA meetings during each phase of the development process including:
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 specific regulatory and/or scientific issues (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 nonclinical, clinical, and 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.
The time will come when you need to review and obtain agreement from the FDA on your Phase 3 plan and protocols and an End of Phase 2 meeting is necessary. During this meeting you need to effectively present your Phase 3 and submission strategy and ensure that you are aligned with the FDA prior to the start of Phase 3.
Preparation for End of Phase 2 Meeting
To move you to the next clinical trial phase, The Weinberg Group will diligently work with you to prepare for the End of Phase 2 meeting. With your input, we will:
- Request the End of Phase 2 meeting
- Develop the End of Phase 2 briefing package to be sent to FDA in advance of the meeting
- Determine meeting objectives and agenda, and script the participants
- Conduct a meeting rehearsal at our headquarters in Washington, DC
- Attend the meeting with you, and summarize results in formal notes
- Conduct a debriefing session to discuss accomplishment of meeting objectives and finalize meeting minutes to be sent to the FDA
The Weinberg Group: Continuing to Phase 3
Our team of experts will work closely with you to ensure your End of Phase 2 meeting with the FDA delivers the feedback necessary so you may continue with your Phase 3 clinical trials.
You and your firm have spent thousands of hours and millions of dollars assuring your product is safe and effective. Now, you need to make sure it will receive FDA approval. The key to achieving this is a perfectly executed Pre-NDA Meeting.
When you leave your Pre-NDA Meeting you should have an understanding of the FDA’s expectation for content and formatting of the NDA submission, and a firm estimation of your product application’s readiness for filing and likelihood of approval.
During the Pre-NDA Meeting, you must make the most of the opportunity to solicit comments and clarification from the FDA on the acceptability of:
- Pivotal clinical data, including late-breaking data that might become available for submission during the FDA’s review of the NDA.
- CMC information and, in particular, the extent of stability data.
- Content of the ISE and ISS sections.
When is a Pre-NDA Meeting needed?
Developing and submitting an NDA requires significant investments of both time and money. As such, when preparing to submit an NDA it is in your best interest to assure that your application does not land cold at FDA. At the same time, it is in the FDA’s best interest to be aware of upcoming work so it can be prepared with the required resources. The Pre-NDA Meeting allows each party to accomplish its objective.
Although a Pre-NDA Meeting is not a requirement, we would not recommend submitting an NDA without first meeting with the Agency. Drug development rarely goes exactly as planned, and keeping communication open with the Agency increases your chances of achieving success the first time around. Accordingly, we advise anyone that is preparing to submit an NDA to schedule and attend a Pre-NDA Meeting.
Benefits of Having a Pre-NDA Meeting Consultant
Partnering with an FDA consulting firm when preparing for and conducting a Pre-NDA Meeting with the FDA offers a number of benefits. We have the necessary experience and knowledge to ensure that your Pre-NDA Meeting goes as smoothly as possible, leaving you in a position to succeed. By partnering with The Weinberg Group, some of the benefits you will receive include:
- We have been working with the FDA for more than 33 years and have prepared for and attended countless meetings with the FDA. As such, we know what is needed to achieve a successful interaction with the Agency, and are uniquely qualified to help you achieve this.
- Diversity of knowledge. The Weinberg Group’s scientific and regulatory experts specialize in a variety of disciplines and stay abreast of changing trends and current events. In short, we bring a unique and extensive range of knowledge and skills to the table, which is what you need to achieve a successful Pre-NDA Meeting with FDA.
- The key to completing your Pre-NDA Meeting successfully is adequate preparation. However, this can be tricky if you are unsure of what is needed. That is why The Weinberg Group is here to help. Due to the abundance of meetings that we have attended with the FDA, we know what is required and can help ensure that you are as prepared as possible for anything the Agency may throw your way.
The Weinberg Group: NDA Regulatory Experts
The Weinberg Group will guide you through the Pre-NDA process by working with you to develop a clear, concise strategy, deliver complex information, and carefully execute all responses to the FDA. Our goal is to make your product successful. In addition, we will attend the Pre-NDA Meeting with you and hold a post-meeting debriefing session to discuss meeting takeaways, lessons learned, and next steps.
You can hear the fireworks, taste the champagne, all that’s left is an FDA Advisory Committee meeting. Your success now depends on the flawless execution of your meeting strategy.
We have pioneered a unique marketing-based approach to FDA Advisory Committee meetings to get you through this high-stakes interaction. Each Advisory Committee is different and has specific needs and concerns, and you must keep these in mind as you discuss your product.
After learning about key issues in your product’s history and identifying critical issues in your current application, The Weinberg Group will create a strategy for your meeting that is predicated on concerns likely to be raised by the FDA Advisory Committee, and the data necessary to address them. With this strategy in place, we will help you to prepare a slide presentation that presents all information in a complete, understandable, and simple manner. Since most Committee members will review this information before the meeting, we must make it easy for them to understand why approval is rational. Next, we will make sure all participants are prepped for the meeting by conducting a rehearsal to train the speakers. Finally, we will attend the meeting with you, along with select Key Opinion Leaders (KOLs), providing data and presentations, as needed during the meeting.