Advisory Committee Preparation

Advisory Committee PreparationPharmApprove’s Advisory Committee Preparation Process is consistently praised as the best way to prepare teams to win at FDA Advisory Committees. Using tools and techniques honed over 200 projects, we break the complex task of preparation into four manageable steps.

1. We first help you define your path to success. We identify mission-critical issues, write a winning strategy, craft a series of compelling key messages, and compose a powerful Argument for Approvalsm.

2. We then work with you to develop the communications tools that will persuasively argue your case. These include an easy-to-read briefing document, tightly-knit core presentations, comprehensive answers to the questions you’ll face, and visually impactful slides that support your argument.

3. Our Communications Strategists and Coaches then help you deliver your argument. They write and refine scripts and rehearse key presenters on the art of powerful delivery. They also train team members on the science of Q&A, and help your spokespeople master the media.

4. Finally, our Principals and Project Associates drive the entire project from start to finish, managing all key areas of preparation. They help design timelines, engage and manage KOLs, and supervise mock panel production. PharmApprove remains with you the day of your hearing, available onsite to manage and respond to any questions or concerns.

Core deliverables include:

  • Strategy Development
  • Advisory Committee Intelligence
  • Expert Recruitment & Management
  • PR & Issues Management
  • Argument for Approvalsm
  • Briefing Document
  • Core Presentation
  • Q&A Development & Training
  • Speaker, Bullpen & Moderator Training
  • Slide Composition & Management
  • Technical Execution
  • Media Management & Training
  • Mock Panel Production & Management
  • Team Organization
  • Meeting Logistics
  • Open Public Hearing Support
  • Project Management

In every aspect of Advisory Committee preparation, PharmApprove prepares you to win.