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, having a team that is too large is often as problematic as having one that is too small. Understanding how to appropriately staff a project will alleviate concerns about smaller teams and will prevent possible overstaffing for larger teams.

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

  • 1. Understand the numbers needed to adequately staff your team.
    • The Core Presentation Team typically consists of three to five people. That translates to one presenter per section of the core presentation. This team usually consists of several internal team members and one outside Key Opinion Leader.
    • 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.
    • Companies usually need three or four Triage Leads to be in charge of calling up slides. These members can’t overlap with presenters or responders.
    • The War Room Team usually requires at least two team members. These members also can’t overlap with presenters or responders.

While this scheduling may stretch the limits of smaller teams – there are some ways to have team members perform “double duty” and wear multiple hats.

The following roles may be staffed with already identified team members.

  • The Moderator role may 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 the Triage Leads throughout the preparation process in finding data and updating slides. During the ADCOM meeting they can be assigned to the War Room.
  • Briefing Book and Stake Holder Engagement teams may involve those already identified, but if you have additional support, it is advisable to staff dedicated team members to these important roles.

Therefore, an effective FDA Advisory Committee team can be as small as 10 to 12 individuals.

  • 2. Understand the time commitment needed for FDA Advisory Committee preparation.
    • ADCOM prep often becomes a full time job; if not at first, then 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, Question and Answers [both of which involve extensive slide development] and the 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 the ADCOM meeting. This should include attendance at multiple mock rehearsal meetings in order to gain feedback necessary to advance each deliverable.
    • Some roles require a greater time commitment than others. For example, the presenters will commit more time upfront to drafting the core presentation, the responders and triage leads will commit more time after the focus shifts to Q&A (midway until the end of preparations), and the moderator will have to commit time throughout the process as he or she is typically 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. Understand the challenges that exist based on your team’s size, and solutions to those challenges.
    • Main Challenges Faced by Smaller Teams
      • Not having enough team members to fill all necessary roles and fewer team members to 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 CRO who previously worked on the product, regulatory colleagues familiar with the product, and internal or external statisticians.
      • Establish realistic timelines for the few to effectively accomplish tasks.
    • Main Challenges Faced by Large teams
      • Too many cooks in the kitchen can complicate communications and slow down progress.
      • Too many people may result in some team members lacking clear roles, and leave them disengaged.
      • More people results in additional monetary costs.
    • Possible Solutions
      • Identify a full team and assign clear roles early.
      • Identify a ‘core team’ of decision makers who establish timelines, and agree on starting strategy and iterations in strategy.
      • Identify a strong project lead to ensure deliverables are understood and on time.
      • Position some team members as understudies only to participate 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 necessary time to commit.

The ADCOM prep team is the foundation for a successful FDA Advisory Committee meeting, and establishing that team early is essential. Whether your team is small or large, maximizing your human resources by understanding the roles, responsibilities, and time commitment up front will get you one step further in building your winning team.

 

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.