Companies often underestimate the time and effort it takes to prepare for an FDA Advisory Committee (ADCOM) meeting. A client recently told us, “I don’t know what I’m going to do with myself once the Advisory Committee meeting is over. I’m going to have so much free time!” ADCOM meeting preparation often becomes a full-time job, especially in the months leading up to the meeting. People are stretched and the team can get stressed. That’s why it’s critical to understand up-front the individual roles of an ADCOM prep team and the commitment involved for each role.
Below is a breakdown of the team roles and responsibilities. The key is to match the necessary skill set of each role to a team member with those strengths.
Core company presenters: Core presenters develop and deliver your 60- to 90-minute sponsor presentation, and are responders during Q&A. They are the key people representing the company that day, and therefore need to be credible and well acquainted with the data. Every speaker might not start off as an eloquent star presenter, but if they’re committed and receptive to training and advice, they’ll get there.
Core moderator: After the sponsor presentation concludes, the ADCOM will be invited to ask questions. The moderator then becomes the face of the sponsor and must confidently lead Q&A by clarifying questions, delivering key messages, and choosing the appropriate expert to respond. They are often the presenter who opens or closes the core presentation. The most important criteria for an effective moderator are someone who is knowledgeable about the data, is articulate, and is able to think quickly under pressure.
External presenters: Companies often invite external experts to present part of their core presentation, usually the unmet medical need, clinical relevance of study results, or specific safety concerns that may exist about the product. External experts should be well respected and well known in the field. It’s also critical that they are told about the commitment this will take and agree to dedicate enough time to practice their presentation and Q&A responses. External presenters need to be objective parties on your team but clearly supportive of your product.
Q&A responders: Q&A is where you can win (or lose) the day. It is critical to have a bullpen of responders who are rehearsed in answering the tough questions under pressure, in a credible and confident manner. Once you have done an analysis of the key issues related to your product, identify who on the team will be responsible for answering these questions. These speakers must articulate a focused and convincing answer quickly, so they should also be open to coaching.
Q&A triage leads and support: These are sometimes the unsung heroes of the day. There are typically two to four triage leads depending on the areas of focus for the meeting (efficacy, safety, and “other,” to include disease state, study design, mechanism of action, etc.). Each lead compiles and organizes large amounts of data to address the key issues in their section. They also sit behind the bullpen on ADCOM day to rapidly retrieve slides to support Q&A responses. They should be able to think fast on their feet, stay calm under pressure, and organize their slides for quick retrieval. It’s a BIG job so they need a dedicated support team to help find relevant data to answer questions. Support teams can overlap between sections and often include people with statistics, clinical, and regulatory focuses. Because they will be totally focused on quickly bringing up slides, they cannot also be responders.
Briefing book team: If you are writing the briefing book internally, you will need a team who can synthesize data in a clear and organized way. The briefing book is different from a submission document and needs to convey your key messages. Not surprisingly, this team needs to be able to write well. Remember, many ADCOM members only read the sponsor’s briefing book on a short plane ride, so it not only has to be clearly written, but also intuitively organized so it can be read quickly. Usually medical writers will drive the process with support from all areas.
Stakeholder engagement team: This area is often overlooked, but it’s extremely important on ADCOM day. This team must understand the strengths and weaknesses of the product as well at the external stakeholder environment and the company’s compliance policies. Since one of the stakeholder team’s key goals is to notify patients, medical associations, and physicians of the opportunity to speak at the Open Public Hearing, this group should consist of people who are experienced in outreach to advocacy groups and opinion leaders. Depending on the size of the company, this group may also be designated to proactively reach out to or be ready to respond to the media. For many companies, stakeholder and media engagement are areas that require outside consulting expertise and support.
Slide development team: Because slides are a critical part of both the core presentation and the Q&A, a strong slide team is essential. These people should be PowerPoint gurus, detail oriented, and able to work calmly when all other teams need slides quickly. They should be able to create, organize, and manage the core and backup slides and run an efficient system during practices and on ADCOM day. This team will usually need to be augmented by outside support.
Fearless leader: Last but not least, the project lead will set and enforce the daily activities that will lead to a win at the end of the process. This should be someone highly respected by the team who has a good understanding of the regulatory process. They will need to make strategic decisions and work well with people who are, at times, very stressed. Communication skills are paramount because the lead is often the key contact for everyone involved on the project – from the project manager of the FDA division to senior management and everyone on the prep team.
By understanding these roles, you can thoughtfully consider who will be a good fit and strategically build your winning team. Also, as the presentation and Q&A responses are tested, it’s important to look closely at inefficiencies and adjust your team if needed. Setting up clear expectations early and keeping all lines of communication open are essential in preparing your team for the big day.