It might seem obvious that one person alone cannot drive successful FDA advisory committee (ADCOM) preparations. What’s less obvious is that one unchallenged thought process could also result in failure. But that’s the unfortunate outcome of company groupthink.
In our last blog, we focused on the non-transparent nature of CHMP meetings – and the challenges sponsors face in making sure that CHMP representatives understand and retain the presenters’ messages.
In this follow up article, we detail how to succeed given an often limited preparation timeline. It requires five key considerations.
The first thing you need to know about CHMP meetings is that they are not public.
Because of this, you can’t research the meeting by watching a video online or reading a transcript. At the same time, these are extremely high-stakes meetings, where companies present their data and answer questions before a panel of individuals who will likely decide – or at least heavily influence – the future of the company’s product.
Have you ever heard that “God gave us one mouth and two ears for a reason, so we ought to listen twice as much as we speak”? The old Irish proverb holds true and is now backed up by science. In Part 1 of this blog series, we talked about how effective speakers set up their presentation to help foster active listening. In this blog, we will discuss how speakers can make sure that THEY are actively listening.
Using both ears is just the beginning.
When we think of being a good communicator or public presenter, we often think it’s about the speaker. But a major component of great communication is whether you and the audience are engaged in “active listening.”
In this, and the next blog, we show you what you as the speaker can do to make active listening an integral part of your presentation style.
All this talk about “fake news,” and “alternative facts” has me reflecting on the difference between relatively harmless untruths versus potentially dangerous ones. For instance, I just read yet another article debunking the “truism” that human beings use only 10% of our brains. So disappointing, since I like to think I could lose 90% of my mind and still be ok.
Seriously, though – believing or not believing this myth probably won’t hurt me. But some myths can be dangerous – to your health, the planet – or your career. In communications, trusting a lie can cause a huge professional blunder – and who needs that?
Preparing a New Drug Application (NDA) or Pre-Market Approval (PMA) is one of the most arduous tasks regulatory teams have to face – and thinking about a possible Advisory Committee (ADCOM) meeting at the same time may seem impossible. But approaching NDA/PMA preparation with the possibility of an Advisory Committee meeting in mind not only improves a Sponsor’s chances at an ADCOM – it could prevent one from ever happening.
Here are five tips on how to approach NDA/PMA preparation with a possible ADCOM in mind.
We couldn’t have scripted a better example for leadership communications than what happened at the Academy Awards Sunday night.
Jordan Horowitz, one of the producers of the film La La Land, had just accepted the award for Best Picture when it was discovered the presenters had been handed the wrong card and announced the wrong winner. Amid the confusion, embarrassment, and apologies that followed, Horowitz held up the right card and declared, “Moonlight, you guys won Best Picture,’” and then, “I’m going to be really proud to hand this to my friends from Moonlight.”
For pharmaceutical or device company teams, there is one common thread for all FDA meetings: the need to tell a clear story and to set the data or issue in context. Just as FDA has a process for determining whether a drug or device should be approved, companies need a proven process to keep their team on track and prepare in the most efficient and effective way. Our process includes these seven steps.
As a former producer for “60 Minutes” and other CBS News magazines, I rarely advise clients to not do high-stakes TV interviews, especially during a crisis. Since reporters interpret silence as a tacit admission of guilt, open communication is the smart approach. But these types of interviews require preparation on an entirely different level. Here is an eleven-step strategy to limit risk and leverage opportunity when engaging with the media in high-stakes or crisis communications situations.