The 7 Mistakes Teams Make When Preparing for an FDA Advisory Committee Presentation
Lessons from twenty-five years supporting more than 100 sponsor teams through AdCom preparation.
Free PDF, 14 pages
In March 2005, an FDA advisory committee heard two sponsors on the same day. The morning team caucused at the podium while the panel waited, misheard questions, and at one point asked the FDA whether they had the answer. The afternoon team fielded multi-part questions one by one, handed off between responders smoothly, and had every data visual to hand. A panel member stopped to congratulate them on the record.
Same committee. Same day. The difference was preparation, and it is more predictable than most teams expect.
At a glance
Drawn from twenty-five years and more than 100 sponsor teams
Want all seven?
The fourteen-page paper works through each mistake in turn, with the strategies effective teams use to avoid it.
Where AdCom preparation goes wrong
Q&A often gets serious attention too late. Preparation naturally gravitates toward the briefing document and the core presentation, even though unresolved issues are likely to surface during questioning.
Activity can look like preparedness. Producing hundreds or thousands of backup slides can create enormous activity without necessarily making the team better prepared to respond.
Data needs a message. The most useful supporting visuals are developed around the issues, positions and messages the team expects to defend.
A slide is almost never the answer to a question. The data supports the answer.
Teams are successful when they prepare and deliver both their core presentation and their Q&A in a way that gives their data its very best chance for success.
The paper sets out all seven mistakes, including the ones that have less to do with slides than with how a team runs itself: meetings that debate nuance without reaching decisions, rehearsals that are too few and too loose, and the near-universal tendency of senior presenters and outside experts to rate themselves more highly than their audiences do.
Inside the full white paper
The fourteen-page paper works through each mistake in turn, with the strategies effective teams use to avoid it:
- Overemphasis on the core presentation
- Tactics without a strategy
- Data without a message
- Constant churn in creating data visuals
- Endless discussion, no decisions
- Insufficient and ineffective rehearsals
- Overestimating presenter effectiveness
The paper also explores why defining success as more than the vote changes how an effective team prepares.
The full white paper
The 7 Mistakes Teams Make When Preparing for an FDA Advisory Committee Presentation
The fourteen-page paper works through all seven mistakes in turn, with the strategies effective teams use to avoid each one. The download starts right away, and we will email you a copy so you can pass it on.
Common questions
Why can teams overemphasize the core presentation?
Because preparation naturally centers first on the briefing document and core presentation, Q&A development can begin too late. Yet unresolved committee concerns frequently surface during questioning, making early Q&A preparation critical.
Can having too many backup slides actually hurt preparedness?
Yes. A large inventory is useful only if the team can rapidly find the right evidence, understands how it supports the response, and has rehearsed using it under pressure. The white paper examines how teams can mistake slide volume for readiness.
What does success look like at an advisory committee meeting?
Not simply a favorable vote. A team can perform exceptionally well and still lose the vote because the data does not support the outcome. A more useful definition is that a team succeeds when it prepares and delivers both its core presentation and its Q&A in a way that gives its data its very best chance.
Preparing for an advisory committee meeting?
SlideSource supports sponsor teams through AdCom preparation: core and backup slides, scientific graphics, rehearsal and meeting-day execution.
Explore FDA Advisory Committee Support