The role of the sponsor moderator at an FDA advisory committee is to confidently and concisely respond to panel questions. The Q&A portion of the day is often a make or break for sponsors: if the panel’s questions and concerns aren’t addressed, they may be more inclined to vote NO. Therefore, the moderator is not only key to the Q&A process, but to the overall success of the day.
Table Stakes: Knowing the Data
In addition to being adept with the data, the best moderators anticipate the questions that are most likely to be asked, and plan and practice precise responses. They know when to delegate questions to other responders and know when enough has been said. They also know how to credibly and directly answer the question asked without providing too much tangential information that could prompt additional questions. Finally – they think about the question behind the question, anticipate pitfalls, and remind the panel of key messages when appropriate. With thorough preparation and practice, this is the easy part.
The X Factor
Emotional intelligence is an essential trait in a good moderator. That means having an innate demeanor and presence to effectively command the lectern during Q&A. In short, the moderator should be: moderate, balanced, and even-keeled. Not an easy remit when you get barraged with question after challenging question.
Don’t Take It Personally
The Q&A portion of the day is high stakes and not for the faint of heart. This is not the time to fold under pressure or get hotheaded. Remember, the panel is doing its job: trying to understand the data to advise the FDA.
Negative, probing questions that critique the clinical program, pick apart the statistical plan, or challenge the overall outcomes are guaranteed. It’s how the moderator reacts to the question that is telling. Credibility is not only earned by the data provided but also HOW the response is delivered. Remember, the panelists are people and people make first impressions quickly. They need to trust you, like you, believe you. The best way to achieve this is to answer the question honestly while remaining poised.
The best moderators are calm, collected, and confident. They don’t get aggressive, defensive, or dismissive. They know that the panel seeks clarity and understand that transparency is key. They also aren’t timid or quiet. They don’t waver in their response.
Here are some specific guidelines to follow:
- When a panelist is speaking, the moderator shouldn’t interrupt. This doesn’t mean to be meek, just respectful.
- If a panelist misstates data, politely correct. Use phrases like, “Actually …” or “Let me clarify …”
- If asked an unanticipated question, pause and reflect. Take just a moment to gather your thoughts before you respond and know you can always defer a question to after the lunch break if you don’t immediately have the answer.
- Getting fatigued? Use your fellow responders not only because they have extensive knowledge, but to give yourself a moment to breathe.
- When a panelist is critical and even if they get aggressive, rely on the responses you’ve prepared and practiced, further enabling you to remain cool and collected.
At the end of the day, the most important thing for a successful moderator to do is …