The cost of creating a successful new drug is anywhere from $650 million to $2 billion. The price tag is so high because the hit rate is so low: 90 percent of drugs developed don’t make it to market. Few drugs make it through all three phases of clinical trials, and when they do, they still need to get FDA approval. Most drugs are developed after a huge financial investment, years of clinical testing and trials, and a ton of time invested by a team of passionate medical professionals, scientists and even patients with a genuine interest in curing a disease. And after that arduous process, the approval decision hinges on one presentation to an FDA Advisory Committee.
An Advisory Committee, or AdComm, is a panel of experts with special knowledge of the disease the drug is targeted to treat. The AdComm is usually made up of doctors, scientists, patients and industry and consumer representatives. The stakes are high, so naturally, the panel needs the right information about the drug and its trial results to make good decisions. It’s up to the presenter -- the drugmaker -- to give the panel that information during the AdComm review.
We worked with a consultancy called Innovative Science Solutions (ISS) that helps drug and medical device companies get AdComm recommendations for FDA approval. ISS relies on interactive presentations during meetings to do so. All the trial results are compiled into a slide library of more than 1,000 slides. The content tells the entire story of the drug, from its creation in the lab, to its compound structure, its chemical reaction in the human body, as well as the methodology, preparation, execution and results of each clinical trial. The slides include testimonials from patients who participated in the trials. The slide library is like a comprehensive encyclopedic reference for that one drug.
ISS prepares the presentation. It chooses 100 to 200 slides from the library that the Chief Development Officer (CDO) for the drug company will then present to the Advisory Committee.
The AdComm format in and of itself is intense. It is several days with everyone in a hotel conference room or some other neutral location. The CDO presents a formal, linear presentation of results and rationale for approval. That presentation is then followed by several days of questions and answers. Panel members ask about any aspect of the drug, and the CDO is expected to answer in detail. And he can, because he has an interactive slide library at his fingertips. No sooner does the AdComm expert ask a specific question about the chemical composition of the drug than the CDO can search and present the slide with detailed information and a diagram of the compound.
Maybe then another panel expert asks about the methodology of Phase II trials. The presenter can switch and quickly find and project slides about Phase II trials. As Steven Weisman, co-founder of ISS notes, “Speakers are always presenting in high-pressure situations that require them to think on their feet and retrieve content quickly when asked. One misstep can drastically lower the odds of approval – costing companies millions of dollars.” Interactive presentations allow for back and forth, real discussion, between the presenter and the panel experts. The presenter can offer detailed, accurate information showing the AdComm that this drug has been properly developed, tested and is ready for market, while the AdComm gets the information it needs to recommend FDA approval.
The presentation follows the conversation.
Interactivity lets you manage the presentation during the meeting. It is more in line with how people think. Our minds are not linear. Even when we are focused on something, our minds still wander. Adjusting the meeting to your audience’s wandering mindset will help you engage, educate and ultimately convince people to act, which is what presentations are really for -- incenting action.
Interactive meetings are more productive meetings. We learn how to better serve our clients and business partners when they are sharing their knowledge and concerns with us. When the presenter and the audience are both forcing themselves through a linear list of preconceived slides, it severely limits engagement, participation and feedback. Feedback is how we learn more about our clients’ and colleagues’ needs, so we can offer a better solution. The ability to adjust the content on-demand, during the meeting, and provide accurate information about a colleague’s issue will push a sale or an FDA approval further along. The presenter doesn’t have to say, “I’ll get back to you on that,” which will add weeks, even months to a deadline. Interactive presentations empower presenters to cover more, and do more, in the same amount of limited meeting time.
Interactive meetings elevate the presenter. When you answer your customers’ issues on demand, you are perceived as smarter and more sincere. You are showing your customers that you are genuinely concerned with their problems, and you know how to solve them. In so doing, you elevate yourself from salesman to partner. Typically, CEOs and other senior-level executives can answer questions off the cuff. With interactive presentations, you are giving everyone in your company that ability. A junior sales rep looking for a deal can come across like a smart and trusted partner. Clients buy more from smart people whom they trust. Interactive meetings can positively affect your bottom line.