How to Maximize Your FDA Advisory Committee Preparation Team Regardless of Size

One of the most common questions we get when preparing a company for an FDA Advisory Committee (ADCOM) meeting is, “How many people do I need for my preparation team?” The answer may surprise you. While many companies think they need large teams to adequately prepare, a team that’s too large is often as problematic as one that’s too small.

While there is no “magic number” for a typical team, we usually recommend having 10 to 20 people. Below we’ve outlined how to distribute those people across the team.

1. Calculate the numbers needed to adequately staff your team. The core presentation team typically consists of three to five people – several internal team members and one outside key opinion leader (KOL). That translates to one presenter per section of the core presentation. The responder team may vary in number. A good rule of thumb is to only add people who are subject matter experts in areas that are not already represented by core presenters. Another way to optimize responders is to choose external experts who are well known and respected in areas that are likely to be of interest to ADCOM members. Three to four triage leads are needed to be in charge of calling up slides. These members can’t overlap with presenters or responders. The backroom usually requires at least two team members, who also can’t overlap with presenters or responders.

While this may stretch the limits of smaller teams, some team members can perform “double duty” and wear multiple hats:

• • • The moderator can overlap with one of the presenters.

    • While each core presenter should have a designated understudy in case of a last-minute emergency, understudies can also be core presenters for other sections or can be responders.

    • Triage support team members support triage leads throughout the preparation process in finding data and updating slides. During the ADCOM meeting, they can be assigned to the back room.

    • Briefing book and stakeholder engagement teams may involve those already identified, but if you have additional support, staff dedicated team members to these important roles.

2. Be realistic about the time commitment needed for preparation. ADCOM prep often becomes a full-time job at some point in the preparation process. It’s important for each team member to understand the time commitment needed based on their defined role.

Every ADCOM has three deliverables: the core presentation, Q&A – both of which involve extensive slide development – and briefing book. Each deliverable requires a team to produce, review, and revise. To complete these deliverables, your team should plan for approximately four to six months of preparation time from submission to ADCOM meeting. This includes attendance at multiple mock rehearsals.

Some roles require a greater time commitment than others. For example, presenters commit more time up-front to drafting the core presentation, while responders and triage leads commit more time after the focus shifts to Q&A (from midway until the end of preparations), and the moderator will have to commit time throughout the process to be involved with both the core presentation and Q&A. Review the necessary roles to ensure your team members understand their individual responsibilities before taking on the job.

3. Devise solutions to your team’s challenges.

Smaller teams may not have enough team members to fill all necessary roles and complete all deliverables. Possible solutions:

• • • Use the above guide to determine appropriate staffing and possible overlapping roles.

    • Use outside KOLs as presenters and additional responders.

    • Outsource triage leads and/or triage support from external experts such as the contract research organization (CRO) that previously worked on the product, regulatory colleagues familiar with the product, or internal or external statisticians.

    • Establish realistic timelines to effectively accomplish tasks.

Larger teams may have “too many cooks in the kitchen,” complicating communications and slowing progress. Too many people may result in some team members lacking clear roles and leave them disengaged. More people can also result in additional monetary costs. Possible solutions:

• • • Assign clear roles early.

    • Identify a “core team” of decision-makers who establish timelines and agree on starting strategy and iterations.

    • Name a strong project lead to ensure deliverables are understood and on time.

    • Position some team members as understudies in cases of emergencies.

    • Avoid having team members with overlapping expertise unless there is a clear delineation of roles and responsibilities.

    • Ensure all members have a role and are on task during mock rehearsals. Not all team members need to attend the mocks.

    • Discuss timelines and deliverables and consider staffing your ADCOM team with only those who have the time to commit.

Your prep team is the foundation for a successful ADCOM meeting. Establishing that team early is essential. Whether your team is small or large, maximize your human resources by understanding the roles, responsibilities, and time commitment upfront and build a winning team.