There are few presentations as important as one delivered before an FDA Advisory Committee. This presentation is your company’s primary opportunity to make its case about a drug or device approval to a range of audiences, including the advisory committee, the public, your competition, media, advocacy groups, analysts, and other influential people and groups. Unfortunately, you only have about an hour to summarize years of research and explain complex ideas. With so much at stake and so little time, your presentation needs to fully engage the advisory committee and clearly make your case.
After helping companies write nearly 150 FDA advisory committee presentations, we at 3D Communications are more convinced than ever of our guiding principle: “An FDA Advisory Committee meeting is the wrong time for an original thought!”
The tips below are designed to help you develop a highly effective presentation.
- Know your audience. It’s important to remember that an FDA advisory committee presentation is not a typical scientific presentation. It’s designed to persuade advisory committee members to recommend approval. As a result, you need to know what influences them: how they think, what matters most to them, and what their biases may be – both positive and negative. This requires researching how members voted in the past, what they’ve published, and what they’ve said in other venues from scientific presentations to media interviews.
- Know your goal. Before you write a word, develop a message or even think about a slide, know what it is you’re trying to accomplish with your presentation. Yes, of course, it’s for a positive recommendation for your product. But how? By positioning your product in what way? In one or two sentences, write out your goals. For example: “To position (name of product)as a step-change in (name of indication) therapy because of its high efficacy and manageable safety profile.” Be honest with your goal. You won’t articulate it in your presentation, but it’s important to have a clear goal because all of your messaging should tie back to it.
- Organize your presentation topics. Once you know what’s important to your audience and have identified your goal, it’s time to focus your presentation. With only 60 to 90 minutes to summarize years of complicated research and make a persuasive case for approval, you can’t include everything. You have to prioritize, and that prioritization starts with the topics that HAVE to be addressed for approval. Refer back to your goal. What will be necessary to include to deliver against your goal? And how will you divide the time? For most presentations, efficacy and safety are a must. But frequently one is more important than the other for product approval. Do you need to educate on the unmet need, or will the advisory committee members “get” how important the treatment is? Is there a need to focus on post-marketing commitments, and if so, how much?
- Develop your messages and outline your script. Note that we haven’t said slides yet! Strategy and messages should drive your presentation; slides are your support. Think about your messages as the key takeaways and the foundation of your presentation. They must be credible, positive, and data-driven and must clearly address the FDA’s questions and concerns raised during the ongoing dialogue with the company. To ensure the messages are structured in a way that can be easily processed by the audience, we recommend using the 3D Message Pyramid™. The pyramid is structured to help the speaker immediately engage the audience and clearly state their point of view. The pyramid or message starts with a succinct headline, or the main message point. Then, the speaker outlines the data or facts that support the main point. When appropriate, a relevant example or third-party support may be used to further reinforce the message. Restating the main message at the end – or “bottom-lining” it – reinforces the message and helps the audience remember it. Using the message pyramids as the foundation, you can now create an outline and message flow for your presentation. We recommend using the 3D Message Grid™ to turn your three message pyramids (one for each key message) into a clear, organized narrative.
- Script your presentation. Scripting the presentation helps presenters deliver their message in the strongest, clearest, and most effective way. The precise words presenters choose, how they structure their paragraphs, and the order in which they deliver them all combine to make the difference between a talk that people can easily follow, understand, and buy into versus a rambling, unfocused, unpersuasive “data dump.” Writing a script for the spoken word rather than text for a written publication, especially a scientific publication, is a different skill that requires a different approach. Although the fundamentals of good writing are still important, there are additional rules for writing for the ear instead of the eye. The audience only has one chance to hear, process, and comprehend the words in an oral presentation, so the writing must be even more simple, clear, and concise. Follow the ABCs of effective writing: accuracy, brevity, and clarity.