Recently, the U.S. Food and Drug Administration (FDA) issued formal guidance on how it plans to handle regulatory meetings, including FDA Advisory Committee meetings, as the COVID-19 crisis continues. The agency says that all interactions will now be held virtually, including high-profile FDA advisory committee meetings.
According to the Regulatory Affairs Professionals Society (RAPS), the FDA is “continuing to evaluate the feasibility of conducting advisory committee meetings virtually” and believes it “can host advisory committee meetings virtually with current technology,” but adds that it will discuss the option directly with sponsors and applicants for specific applications.
Before the COVID-19 pandemic, FDA advisory committee meetings were big public events where companies presented their science to a panel of health experts who would then recommend whether the drug should be approved for patients. FDA regulators, company officials, competitors, patient advocates, media and investors would all attend. Now, with the FDA announcing that all advisory committee meetings will be held virtually until further notice, it presents a unique set of challenges for both the FDA and companies.
A new type of meeting
According to Pink Sheet vol. 82 / no. 16, published on April 20, 2020, while the FDA has not decided on all of the logistics of these meetings, they are signaling that companies should expect to have fewer advisory committee members making their recommendation, and will be more focused on a targeted set of issues.
The FDA is also considering a hybrid approach and is deciding whether sponsors will be on-camera live for their main presentation, recorded on-camera, or with just audio. It is also possible that the FDA and advisory committee members will be on-camera from different locations.
Given this new reality, how can companies best prepare for these make-it or break-it meetings? If the last two months of virtual meetings are any indication, speakers will struggle with how to engage and read their audience, run a meeting and handle the technology. In short, companies need to be as effective remotely as they are in-person.
Can you hear me now?
As we prepare companies for virtual advisory committee meetings, it’s clear that people struggle with technology. Full stop. We’ve seen — and heard — it all. It’s a litany of: “Sorry I was on mute;” “My microphone isn’t working;” “I can’t hear you!” Or, “I got disconnected — tried to come off mute and I hung up by mistake;” “Sorry I missed the last five minutes — I had to dial back in and couldn’t find the number.”
That’s in addition to home internets with bandwidth issues or deafening echoes from laptop microphones and phones being on at the same time. Hand-in-hand with the technology issue are basic operational issues. And, it’s often the small things that unravel important meetings.
In virtual meetings, it’s easy for people to talk over one another without realizing it, have problems collaborating during the meeting with team members in multiple locations, and just give up because they can’t “break in” and be heard.
The distraction of distraction
Communicating clearly when the company team, advisory committee members, and the FDA are all in the same room is difficult enough. Company presenters only get about an hour to make their case and there is only 15 minutes scheduled to answer the committee’s questions. Now, add in the very real distractions of the committee members working from home, such as spouses and children working in close quarters, and zoom fatigue from weeks of virtual meetings. It all adds up to a more distracted audience with more pressure on speakers to engage those audiences.
Perfect preparation and practice
What can companies do to get over these barriers and excel? Regulatory teams should focus on three main areas that need attention.
Become proficient with the technology
Since the FDA hasn’t officially announced what technology platform or platforms it will be using, companies need to be familiar with many. Rigorous mock simulations and “dress-rehearsal” practices are essential so that the extended team is able to communicate effectively and support Q&A.
Effective communication includes both with the external audience and team members. That requires more than a Zoom chat box. More sophisticated, private technology is needed to help teams collaborate seamlessly in real-time with all remote team members so that speakers in the “hot seat” can display a command of the data, deliver credible and convincing responses, and call up data and slides instantaneously. It is essential to run full “tech checks” with all participants in advance of the mock rehearsals and actual meetings.
Pay attention to the details
It’s the simple things that can often unravel a meeting — and virtual meetings bring with them an entirely new set of logistical considerations. Make sure all your team members log in and sign in early to make they are in when the meeting starts and have everyone be “camera-ready.” That means every speaker needs to pay attention to their camera position, lighting and background.
A few tweaks can make a big difference on how they come across. For example, backgrounds should be simple so as not to distract. That means no plants or other objects growing out of speaker’s head. Mount the camera at eye level or slightly above eyeline, so that cameras aren’t showing the top of speaker’s heads or their noses or double chins. And make sure the light is positioned in front of faces not coming in from behind. Finally, every participant should have access to a working printer, so they can print the slides and briefing book in advance of the meeting.
Get – and keep – the audience engaged
Now, once the technology and logistics are down, it’s time to concentrate on message and delivery. Focusing a remote audience requires even clearer communications that in-person. That means shorter sentences, simpler slides, and broadcast-professional delivery.
And, there’s one more big communications issue: body language. Body language, especially eye contact, is critical for building trust. And trust is essential for audiences to believe what a speaker is saying. That means speakers need to look into the “eyes” of their audience — so into the camera lens, not the computer screen.
Because technology tends to “flatten” or de-energize how speakers come across, it’s important to ramp up the energy. Standing vs. sitting makes speakers look more confident and commanding. Using hand gestures helps vocal diversity. And speaking clearly, pausing for emphasis, is especially important in a virtual environment.
The bottom line is that these meetings will occur and if teams want outcomes optimized, they need to optimize their performance. That’s the reality of this new reality.
Top image courtesy of Unsplash.