FDA Advisory Committee Meeting Preparation
We have been helping drug development teams prepare for FDA Advisory Committee Meetings since the 1980s.
We excel in AdComm prep, guiding our clients through this crucial process by using our accumulated experience and proven methodologies. Our strategic, thorough, and timely approach delivers positive results. To date, we have helped prepare teams for over 90 FDA Advisory Committee Meetings.
Integrated Communication Strategy
Working with stakeholders, we design an integrated communication plan, one that evolves as the preparation process progresses. The essential characteristic of this plan is the accurate, consistent, and emphatic articulation of product messages and issues through various forms of delivery and to various audiences.
We work with the team to create key messages, both those generated in response to FDA concerns and those the company wants to deliver in the Advisory Committee Meeting forum. We cascade these messages into the briefing document, the presentation, and Q & A Books to strengthen accuracy, consistency, and emphasis throughout the process.
Simultaneously, we supply or can help the team develop a committee profile in order to shape a communication strategy that addresses audience needs.
From ECG Message Matrix℠ to Delivery
Using these messages and likely audience response to them, we isolate issues, construct resolutions, and identify data to support the team's scientific argument, building an ECG Message Matrix℠. Together we prototype the presentation, using the Matrix to emphasize briefing document messages and to build a Q & A Books to ensure that no issue goes unaddressed.
Through rehearsals and mock advisory meetings we test arguments and their delivery as well as the slide support system, adjusting or revising as necessary. By managing messages and issues in the Matrix, we help the team track the evolution of the scientific argument and retain control of its iterations.
Our goal is to help a team achieve a well-planned, practiced, and precise delivery of strategically focused messages and responses to issues during the Advisory Committee Meeting. Our experience and expertise position us to meet that goal.
Amongst the many proprietary tools we have developed over the years to help our clients, components of ECG's full AdComm Preparation Program include:
- Integrated Communication Strategy and Plan
- Messages, Issues, Resolution, and Support Matrix and its Management
- Profiles of Advisory Committee and its Members
- Presentation Prototyping and Effectiveness
- Presentation Training and Coaching
- Q & A Database and Book
- Q & A Response Rehearsal
- Series of Mock Panels
- Recruitment of Mock Panel Members and External Experts
- Slide Design
- Guided Slide Retrieval and Drilling
- Vendor Management
Please contact us for more information about our FDA Advisory Committee Meeting Preparation services.
|
