The Importance of 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. There is no better way to run a team through rigorous practice than with realistic Mock Advisory Committee meetings. A mock meeting that truly mimics what your team will face on the day of the Advisory Committee meeting will challenge and truly prepare them. In Part 1 of this series, we offered tips on how to recruit a realistic mock Advisory Committee for your mock meeting. In this post, we discuss how to run a mock meeting like the real thing, and in the process, maximize its success.
- 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 Advisory Committee 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 his or her style, for the mock meeting, the chair will be in charge of keeping to the set agenda, moderating the Q&A portion of the day and providing the structure needed for a realistic mock meeting.
- Provide mock committee members with appropriate preparation materials. Actual committee members receive the sponsor and FDA briefing documents prior to attending the meeting. To ensure that the mock committee members have the same background information and enough time to review it, provide your draft briefing document to the mock committee members at least one week before your mock meeting. You should also provide a cover letter explaining how you would like to obtain comments or edits to the briefing document. To ensure that your mock committee members are challenging your team and asking questions the way the real committee would, provide a biography and detailed background information on the actual committee member your mock panelist is supposed to mimic. This information should include: how he or she voted at past meetings, what he or she said at meetings with similar products or similar issues, and any specific interests or biases. Recall from Part 1 of this article, 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 to not only question the team with questions that interest THEM, but more importantly, those questions that reflect what the actual Advisory Committee member would ask.
- Have an agenda that reflects the real day. A well-organized agenda is a must to manage a realistic mock. The FDA strictly keeps to their day’s agenda. Your final agenda will not be posted until 48 business hours prior to the Advisory Committee meeting. Look back to 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 to 90 minutes.) After the Sponsor presentation, schedule time for ‘in-role’ Q&A. Have the Chair keep the other committee members ‘in role’ to ensure 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.
- Set your meeting room in the same layout as that of the Advisory Committee meeting. Advisory Committees have a different layout than typical meetings. When looking into the room, there is ‘U’ style seating in front, which opens to the audience. (It’s a public meeting so FDA wants to ensure all those speaking at the ‘U’ can be seen.) The Sponsor sits to the left of the ‘U’ and FDA 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 Advisory Committee meeting. Drug and device layouts, as well as those at FDA’s White Oak headquarters, vary slightly from meetings that FDA holds in hotels. Set up your mock space specific to your product and your Advisory Committee meeting location, once confirmed.
- 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.
- 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 Advisory Committee meeting. That may include a teleprompter, confidence monitors, and 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.
- All who have a key role should 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 Advisory Committee meeting. For those team members who have never faced an Advisory Committee, 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 level set expectations.
Following these steps will ensure a more realistic mock rehearsal. Ultimately, this “Perfect Practice” will result in a team that is ready to face the challenges on the day of the Advisory Committee meeting – so that their worst day is at a rehearsal, and not at the real meeting!
ABOUT THE AUTHOR
Catherine Carlisle 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.