FDA APPROVALS
“Senior management support is critical. You want all levels to be working as a team. Set up a ‘war room’ where the entire team works every day.”
ensure you include any questions that may come up. Practise! Practise! Practise! You cannot
practise too much. Mock panels can be helpful; standard practice is to hold at least two of these. You should script your core presentation to ensure coverage of all relevant topics. 3D Communications, a panel prep company I’ve worked with in the past, frequently tells their clients that “a panel meeting is not the time for an original thought” – thus, the script. Presenters should work with the script to ensure it sounds like they’re presenting and not just reading it. You should have frequent internal rehearsals of your core presentation and Q&A. Have people ask questions during rehearsals who are both knowledgeable of the data and new to the data. Consider having a single moderator for all questions. This person can answer many questions and delegate to the appropriate expert for specific topics. You’ll want a team pulling up Q&A slides. They should rehearse with the moderator so much that they’re in tune with what slide(s) the Q&A moderator will want for specific questions and pull them quickly. Adapt constantly based on rehearsal experience and obtain speaker training for your moderator and all speakers. There are multiple logistics that you’ll want to address with the FDA. The panel pack will need to be prepared. When will you swap executive summaries with the FDA? You’ll each have 24 hours to review each other’s draft executive summaries before they’re finalised. Typically, this will be your first look at the FDA’s draft questions for panel consideration. The sponsor will be responsible to create binders with e-copies of sponsor documents, leaving room for the FDA to add their e-copies and distribute to the committee members. You’ll need to provide a redacted copy (if needed) for public posting. You as the sponsor will receive a copy of the final panel pack from the FDA. It is the sponsor’s responsibility to ensure that the industry
64 | Outsourcing in Clinical Trials Handbook
representative receives a copy of the panel pack. An exchange of presentations will occur with
the FDA a few days before the panel meeting. This is your opportunity to provide editorial feedback or corrections. There should be no surprises! Do not include any data in your presentation that the FDA hasn’t already seen. If you absolutely must include data or analyses that it hasn’t seen, include a footnote in your slides documenting any data or analyses that the FDA hasn’t previously reviewed. Work with the designated federal officer
(DFO) for any other logistics as needed. For instance, ask the DFO for a list of panel members confirmed for the meeting and request the number of reserved seats you need for sponsor attendees.
A few points of additional advice: senior management support is critical. You want all levels to be working as a team. Talk to your highest levels of management to request that they stop by to support the panel prep team and ask that they join in Q&A practices, too. Set up a ‘war room’ where the entire team works every day. They can work as a team or individually as needed, but by having a war room, everyone is there for impromptu practices. When cross-functional info is needed, the appropriate team member is right there to help. This also provides for team bonding and mutual support, which is vital to the team; panels can be stressful. Consider enlisting the help of a panel prep company. There are multiple companies out there, and they have staff experienced with many panel meetings. They tend to have dossiers on panel members, obviating the need for you to research each of them. Most of the panel prep companies also have technology to enable the team to bring up Q&A slides quicker than using standard PowerPoint, and they have presentation training and coaching resources readily available.
Further reading FDA Advisory Committees:
https://www.fda.gov/ AdvisoryCommittees/
default.htm Advisory Committee Membership:
https://www.fda.gov/ advisory-committees/advisory-committee-membership/ advisory-committee-membership-types Advisory Committee Guidance:
https://www.fda.gov/regulatory- information/search-fda-guidance-documents/advisory-committee- guidance-documents 3D Communications Blog:
https://3dcommunications.us/ latest-thinking Preparing for an FDA Advisory Committee Meeting: https://www.
mddionline.com/preparing-fda-advisory-committee-meeting
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