During ECG's more than 35+ years providing communication strategy, development and consulting, we've helped thousands of clients reach their goals - from a productive investigator meeting to a successful FDA Advisory Committee meeting. This is a sampling of how we can help you succeed at your next critical healthcare authority meeting.
Like the Advisory Committee meeting itself, the Briefing Document you will write for the meeting is unique. It's not only unlike other information packages, it's unlike any other piece of writing in the drug development process.
Pharma is a document-intensive industry, but despite innovation throughout the drug development process, document review is often inefficient. Compared to placebo, endless review cycles lack favorable risk-benefit.
At the very least, hostile questions divert attention from your messages; at the worst, they shift it from your program to the individual people involved. Either possibility threatens to undermine your messages and your credibility.
Organized to replicate an actual AdComm meeting in both process and performance, mock meetings are an important component of every Advisory Committee preparation. They provide the team with outside perspectives on company strategy, messages, and data.
Effective speakers and presenters know the value of audience analysis, but for drug, biotech, and device development teams preparing for an Advisory Committee meeting, the incorporation of reliable and thorough profiling of Committee Members takes on special importance.
The realm of interrogative risk lurks behind every meeting with health authorities, ranging from brief teleconferences to longer face-to-face consultations to full day FDA Advisory Committees or the corresponding approval hearings overseas.
Developing a communication strategy for an Advisory Committee meeting is a critical first step toward achieving AdComm success and underlies the rest of the preparation process. A focused and realistic strategy can make the difference between a positive and negative vote.
Failing to make a point is one of the most common problems in scientific and medical presentations and responses to questions. The impact of this failure is amplified when it occurs in critical presentations to audiences such as Advisory Committees and senior management.
Data do not speak for themselves. To succeed at an Advisory Committee meeting, a drug development team must bring its data to life.
