Maximizing AdComm Opportunities
BOLDAPPROVED Newsletter Issue 5:
Maximizing AdComm Opportunities
Recently, BOLDAPPROVALS was selected to speak alongside industry and FDA colleagues and share our best strategies, tips, and case studies for all types of FDA interactions, including formal FDA meetings, informal communications, and FDA Advisory Committee meetings (AdComms).
In contrast to formal FDA meetings and other types of regulatory interactions, most sponsors have little to no experience preparing for an AdComm. Furthermore, there is very little FDA guidance for sponsors preparing for AdComms, and what is available does not reflect the full extent of preparation required. Many sponsors lack the experience, knowledge, and resources needed to present their product, their company, and their people in the best possible light at an AdComm.
In this month’s newsletter we share the most important things that sponsors need to know about AdComm preparation, plus key insights to help you maximize your AdComm opportunity.
What Makes an AdComm Unique?
An AdComm is a public meeting that can have a direct effect on a regulatory decision and is highly visible. The meeting is broadcast via live webcast, and all meeting materials, including the video recording and transcript, are made publicly available and permanently archived on FDA’s website.
FDA often convenes AdComms to scrutinize the data included in an NDA or BLA and may ask the Committee to vote on whether the data support approval. The outcome can be crucial, potentially determining the success or failure of a new product, with years or decades of research hanging in the balance.
The role of the committee is to provide independent expert advice and recommendations to FDA. Although FDA generally follows the recommendations of the committee, they are not legally bound to do so, and ultimately it is up to FDA how they choose to use the committee’s advice. It is crucial to keep FDA in mind as an audience and work collaboratively with them throughout the process.
This makes an AdComm a high-stakes regulatory event that can draw the attention of the public, the media, patients, caregivers, health care professionals, drug developers, and other stakeholders. Although nerve-wracking, an AdComm presents a unique opportunity to influence the trajectory of your approval journey and the public perception of your product.
Your goal is to positively influence FDA's decision. This happens through two channels: productive private interactions with FDA beforehand (we'll dive into this in a future newsletter) and thorough preparation for the public AdComm.
What does it take to be prepared for an AdComm?
Early on, you need to establish your AdComm team and be realistic about the workload for each member. Most sponsors supplement their team with highly respected academic experts to provide perspectives on the data and disease state and to respond to questions. Many also engage an AdComm preparation company to guide them through the process and provide the necessary support and technical solutions.
Presenting your data, your company, and your team in the best light requires a dedicated, structured preparation process, typically over the course of 6 months.
Timeline and deliverables for an AdComm
If you are anticipating an AdComm, it is highly advisable to begin preparations long before you receive official confirmation from FDA. Most teams need at least 6 months to prepare, which means beginning preparations “at risk” and generally very soon after filing the submission.
Under Standard Review, AdComms to discuss NDAs or BLAs are usually scheduled approximately 8 weeks prior to the PDUFA date. You can use this rule of thumb to calculate when to begin preparations by working backward from your estimated AdComm date.
Briefing document
The AdComm briefing document is the first deliverable that must be provided to FDA prior to the meeting. Although the length can vary widely, the body is usually around 100 pages plus appendices. FDA and the Sponsor each provide a briefing document to the Committee that covers the background information the Committee needs to evaluate the topic at hand.
The briefing document is typically due to be submitted to FDA 22 business days prior to the AdComm. Approximately 1 week later, FDA will share a draft copy of their briefing document to the sponsor.
The Committee receives both briefing documents 2 weeks before the meeting, and the documents are released to the public 2 business days prior to the AdComm. The briefing document is therefore the first opportunity to convey your perspective on the AdComm to the Committee and the public.
Presentation
Presentation slides are typically due to FDA about a week prior to the meeting.
One way to think of the presentation is as a distillation of the briefing document’s essential points. It can set the tone or direction of the Q&A and, because it is sent to FDA later than the briefing document, may incorporate or address later developments. The length of time allowed for the presentation varies but is generally 1 or 1.5 hours.
Q&A
The meeting agenda will typically include 10–30 minutes for the Committee to ask clarifying questions of the sponsor. There is usually a separate clarifying Q&A session for questions to FDA. Toward the end of the meeting, there is a discussion period for the Committee, during which the sponsor can only speak at the discretion of the Committee Chair. The sponsor should be prepared for potential questions that might be directed at them during these sessions.
The Q&A back-up slides do not need to be provided ahead of the meeting, so teams can work on these until the day of the AdComm and potentially even generate slides live during the meeting. At the end of the meeting, however, any back-up slides shown during the Q&A must be provided to FDA.
Your credibility is truly on the line during the Q&A, so it is crucial to be thoroughly prepared.
AdComm IT and Audio-Visual Systems
Technology plays a crucial role in AdComms, facilitating both preparation and delivery. Essential elements include a collaboration portal for developing slides and Q&A content and a slide-switching system to call up slides during the Q&A.
Most sponsors either have or engage a technical team to provide the technology for the AdComm. Throughout the preparation process, it is important to rehearse extensively with the same technology and technical team you will use on the day of the meeting to ensure familiarity with the systems and to avoid any unexpected technology-related issues.
Maximizing Your AdComm Opportunity
An AdComm allows you to present your data to independent experts to help support a favorable FDA decision. This public forum provides an opportunity to reach a diverse array of stakeholders. Furthermore, it presents a chance to collaborate with FDA during both the preparation for and execution of the meeting. This collaborative effort can foster a high-level scientific dialogue, potentially leading to enhanced understanding of the issues at hand and greater alignment among all parties involved.
About the Authors
Angela W. Corona, PhD, is a Senior Scientific Director with BOLDAPPROVALS where she supports teams approaching new drug or biologics approvals. With 10 years of broad medical and regulatory communications experience across a range of therapeutic areas, including neurology/neurodegenerative disease, oncology, and immunology, she has played a key role in preparing teams for AdComms, strategic submission messaging, and other complex regulatory communication challenges. Her PhD training was in neuroscience at The Ohio State University, and she performed post-doctoral research in Alzheimer’s disease at Case Western Reserve University.
Steven C. Cohen is the Managing Director of BOLDAPPROVALS, the division of BOLDSCIENCE that prepares clients for AdComms, regulatory submissions for the approval of new therapeutics (NDAs/BLAs), FDA meetings, and label development. Steven has 33 years of leadership in communication consulting, strategy, and delivery coaching, including 117 AdComm preparations. He has supported numerous health authority interactions at key milestones and led submission messaging workshops. He has trained and coached over 1000 scientists, clinicians, and other leaders across disciplines. Steven earned a bachelor’s degree in French Literature from Wesleyan University. He studied medical science at NY Medical College and marketing, communication, and the Internet at Columbia University.
About BOLDAPPROVALS
BOLDAPPROVALS blends science, communication, and technology to support product approvals. We deliver comprehensive support for FDA Advisory Committee meetings (AdComms), submission messaging, labeling strategy, and health authority interactions.
Our proven methodology integrates in-house scientific expertise with communication consulting to develop compelling, data-driven arguments for persuasive presentations, responses to questions, and briefing materials.
Our highly experienced team has supported over 250 AdComm preparations and aligned teams on messages for regulatory submissions and interactions with health authorities. Our team can address the unique needs of your people, products, and circumstances.
To learn more about how BOLDAPPROVALS can help your team identify and overcome issues, please visit boldapprovals.com, email [email protected], or call Steven Cohen at +1 (646) 930-0453.