FDA Advisory Committee Meeting Prep: How to Run an Efficient and Effective War Room
One of the most important rooms at an FDA Advisory Committee (ADCOM) meeting is one that neither the FDA, the Advisory Committee members, nor the public ever sees. It’s typically called the “War Room.” And it’s where drug and device sponsors locate data or conduct analyses for advisory committee members’ impromptu requests.
While some companies overlook the importance of the War Room at their ADCOM the best prepared ones know it is a critical component of Advisory Committee meeting preparation. Because when the War Room participants hear their moderator speak those three important words “AFTER THE BREAK” – they know it’s a signal for them to step into action and deliver on a promise.
No matter how extensive your Advisory Committee preparation is, chances are, at least one ADCOM Member will ask for a breakdown of data that just hasn’t been conducted the way they want to see it. And from years of experience preparing teams for Advisory Committee meetings, unanswered questions can leave panel members with concerns that result in a “NO” vote.
Structuring an efficient and effective team to deliver on the promise is as much an art as a science. It begins with structuring the best team dynamic. This includes identifying the right team members, assigning roles and responsibilities, and developing a flow that maximizes productivity. Here is the basic framework 3D uses when building our War Room teams.
Scribes – Capturing live transcripts of the meeting is a great way to make sure nothing is missed. This will allow the team to review the specifics of an after-the-break request, which can often be taken out of context or misunderstood.
Project Manager – Time management is absolutely key to success in a War Room at ADCOM. In a typical scenario the team will have less than one hour to answer a question (which often includes alignment/discussion on strategy, new data/analyses, and scripted responses). The project manager MUST be respected by the team and have the ability to manage timelines in an extremely high-stress atmosphere.
War Room Lead – Your fearless leader! The War Room lead could often fill the role as the backup moderator. This individual must understand the entire application, and be 100% invested in the ADCOM preparations. The War Room lead must have the ability to quickly identify what is being asked, how it can be answered, what data the team already have, and what additional data are needed. From there, the War Room lead clearly communicates these directions to a topic-specific clinical/stats lead who can begin to gather the needed information.
Stats/Clinical Lead – These individuals are topic-specific leaders. For companies with larger ADCOM teams, more topic-specific leaders are identified so that the directions from the War Room lead can be delegated and more efficiently managed. These leads must be able to quickly understand requests from the War Room lead and be trusted to deliver clear, concise and credible responses in a timely manner.
Slide Lead – Your slide lead must be a PowerPoint expert. The majority of time, after-the-break requests will require new slides, and often the data will come from a non-editable source. So the ability to quickly create clear and concise slides is vital to success.
Handler – You might be thinking – this is ridiculous. Why do our responders need an escort? At FDA advisory committee meetings, there are a lot of interested parties, from media to analysts to other competitors. And many will try to approach your responders during the break. With the limited amount of time available to agree on the strategy to answer new questions, no time can be wasted. The Handler must be able to identify the speakers, moderators, KOLs and key team members needed to address the questions and quickly escort them to the War Room.
While choosing the right members and organizing the right structure for the War Room is essential, no matter how great your War Room team is, it all comes down to practice, practice, and more practice. You must test your process (including setup, technology, team roles and workflow). After each rehearsal you will find yourself refining the flow and training team members.
So, next time you are planning for an FDA Advisory Committee meeting, don’t overlook the importance of organizing a successful War Room team. Be proactive with the planning and preparations – and PRACTICE. If you do, the next time you hear those three words, “AFTER THE BREAK,” you will be confident knowing there is no one better prepared to take on the challenge!
ABOUT THE AUTHOR
Mark Blecher is an experienced project manager and production specialist with a particular expertise in clinical slide development. Mark helps 3D’s clients prepare for mock rehearsals and FDA Advisory Committee meetings by leading teams in slide development and Q&A preparation and organization. Mark also helps manage the integration of technology into each project by directing technical trainings. Connect with Mark on LinkedIn.