How to Identify and Organize a Winning Team for Your FDA ADCOM Meeting
Companies often underestimate the time and effort it takes to prepare for an FDA Advisory Committee meeting. Resources are precious, and preparing for an Advisory Committee meeting can take a lot of time and resources. A client recently said to me, “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!” And it’s true. FDA ADCOM Meeting preparation often becomes a full time job, especially in the last months leading up to the meeting. People become stretched, and the team can get stressed. That’s why it is critical to understand up front what the individual roles of an ADCOM prep team are and the commitment that is 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: The core presenters develop and deliver your 60 to 90 minute sponsor presentation, and in turn become responders during the Q&A period. 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 that’s OK. If they’re committed and receptive to speaker training and advice, they’ll get there.
Core Moderator: After the sponsor presentation concludes, the Advisory Committee 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. He or she is 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, articulate, and able to think quickly under pressure.
External Presenters: Very often, companies invite external experts to present part of their core presentation. This is usually the unmet medical need, clinical relevance of the 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 during the preparation process 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, you should 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, but they are imperative to Advisory Committee success. There are typically two to four triage leads depending on the areas of focus for the meeting (e.g. Efficacy, Safety and “Other” to include disease state, study design, mechanism of action, etc). Each lead will compile and organize large amounts of data to address the key issues in their section. They will also sit behind the bullpen on Advisory Committee day to rapidly retrieve slides to support the 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 the questions. Support teams can overlap between sections and often include people with statistics, clinical, and regulatory focus. Note: 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 is able to synthesize data in a clear and organized way. The briefing book is different from a submission document and needs to convey your key messages; so not surprisingly, this team needs to be able to write well. Remember, many Advisory Committee members may 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 is one area that is often overlooked in Advisory Committee preparation teams, and it is extremely important on Advisory Committee 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 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, having a strong slide team goes without saying. 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 the day of the Advisory Committee meeting. This team will usually need to be augmented by outside support.
Fearless Project Lead: And last, but certainly 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 who is highly respected by the team and has a good understanding of the regulatory process. He or she 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 up front, 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 keep all lines of communication open are essential in preparing your team for the big day.
ABOUT THE AUTHOR
Michelle Zucatti combines her expertise in clinical trials and academia with public communications and training. As a project leader and scientific slide expert, Michelle excels at running projects and making scientific data relevant to both clinical and lay audiences. She has coordinated federally-funded randomized controlled trials, established partnerships with community organizations, and developed and delivered educational training programs to medical practices. Connect with Michelle on LinkedIn.