Running a Realistic Mock FDA Advisory Committee Meeting

“Perfect practice” is one of the most critical steps in the preparation process for pharmaceutical and medical device company teams going before an FDA Advisory Committee (ADCOM). There is no better way to run a team through rigorous practice than with realistic mock ADCOM meetings. A mock meeting that truly mimics what your team will face will challenge and truly prepare them. In our article on Recruiting for a Realistic Mock Advisory Committee Meeting, we offered tips on getting the right people to your meeting. Here we discuss how to run a mock meeting like the real thing, and in the process, maximize its success.

1. Assign a meeting chair. Before the meeting, determine who should act as chair of your committee. Ideally, this person will mimic the chair of your actual committee and run the mock from that perspective. Some ADCOM chairs are very involved in making comments and asking questions. Others focus more on running the meeting and getting insight from the rest of the committee. Whatever their style, for the mock meeting, the chair will be in charge of keeping to the set agenda, moderating the Q&A portion, and providing the structure needed for a realistic mock meeting.

2. Provide mock committee members with appropriate preparation materials. Actual committee members receive sponsor and FDA briefing documents prior to attending the meeting. To ensure that mock committee members have the same background information and enough time to review it, provide your draft briefing document to them at least one week before your mock meeting, along with a cover letter explaining how you would like to obtain comments or edits to the briefing document. To ensure that your mock committee members challenge your team and ask questions the way the real committee will provide a biography and detailed background information on the actual committee member your mock panelist is supposed to mimic. This information should include how the member voted at past meetings, what they said at meetings about similar products or similar issues, and any specific interests or biases. Recall from Recruiting for a Realistic Mock Advisory Committee Meeting that all mock committee members should be chosen because their experience parallels that of an actual committee member. Instruct your mock panel members that their job is not only to question the team about what interests THEM, but more importantly, with questions that reflect what the actual ADCOM member is likely to ask.

3. Have an agenda that reflects the real day. A well-organized agenda is a must to manage a realistic mock. The FDA ADCOME will strictly keep to the day’s agenda. Your final agenda will not be posted until 48 business hours prior to the ADCOM meeting. Look at past committee meetings to see what a typical day is for your committee. Determine the allowed timing of your presentation and prepare for that time. (Half-day meeting presentations are often about 30 to 45 minutes, while full-day meetings can vary between 60 and 90 minutes.) After the sponsor presentation, schedule time for “in-role” Q&A. Have the chair keep the other committee members in their roles to ensure that your team gets adequate and realistic Q&A practice, rather than just receiving informal advice. You can allot time later in the day for committee members to provide their personal feedback.

4. Set your meeting room in the same layout as that of the ADCOM meeting. ADCOMs have a different layout than typical meetings: U-style seating in front, which opens to the audience (it’s a public meeting so the FDA wants to ensure all those speaking can be seen). The sponsor sits to the left of the U and the ADCOM members sit to the right. The audience sits behind the U in classroom seating. Because of this layout, your presenters and responders will be talking to the backs of some committee members. Having the team practice with the correct layout will help them feel more comfortable at the real meeting. Drug and device layouts, as well as those at FDA’s White Oak headquarters, vary slightly from meetings that the FDA holds in hotels. Set up your mock space specific to your product and your ADCOM meeting location, once confirmed.

5. Dress for success. In line with the formal agenda and formal layout, have your team dress the part so they feel more in role. At the end of the day, the focus should be on your messages, not on your dress, so avoid distracting prints or jewelry and stick to conservative professional attire.

6. Practice with the same technology. Technology can go a long way in helping your team present in a professional way and call up slides quickly and confidently. But this only works if your team members are comfortable using the technology. Use the same technology at your mock meetings that you are going to use at the ADCOM meeting. That may include a teleprompter, confidence monitors, microphones for the core presentation, and iPads to view slides for Q&A. Whatever it may be, have your team practice with the actual equipment.

7. Be sure all who have a key role attend the mock. All presenters, responders, and triage members (those assisting with slide recall for Q&A) who will have a key role in the actual meeting should attend your mock preparations to gain experience. Even the most experienced presenters, including outside key opinion leaders, need practice – and grilling – when preparing for an ADCOM meeting. For those team members who have never faced an ADCOM, practicing with a mock meeting is even more important. There is nothing like a room full of critical peers to provide a dose of reality and set expectations.

Following these steps will ensure a realistic mock rehearsal. Ultimately, this “perfect practice” will result in a team that is ready to face the challenges on the day of the ADCOM meeting – so that their worst day is at a rehearsal, and not at the real meeting!