Keep Calm and Moderate On – The Makings of a Successful Moderator

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 all 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. Even-keeled. Not an easy remit when one gets 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 hot-headed. 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.

It’s a balancing act.

Some specifics

• 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, 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 themselves 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 to…


Catherine Carlisle Leonard uses her background as an academic writer, political speechwriter, lecturer, and researcher to identify, synthesize, and articulate important information from complex research. Catherine’s unique background allows her to translate information across various subject areas into concise verbal and visual presentations. In addition to her writing and research abilities, Catherine uses her excellent organizational and people skills to unite diverse teams and manage multi-faceted projects. Connect with Cat on LinkedIn.