By Lisa Peluso

If you logged in for the first product approval-related virtual FDA Advisory Committee meeting on July 14th, you experienced a rough start. Riddled with long silences (people failing to take themselves off mute while speaking), poor audio quality and disappearing slides, the remote Oncologic Drugs Advisory Committee meeting ended before it could properly begin. After only 35 minutes, the meeting was closed, then reopened to another hour of dead air as participants were brought back online. Once everyone had returned, there was a glorious echo while the committee members introduced themselves — again — which made it tough to listen. The presentations were at times garbled, choppy and interrupted. Open Public Hearing speakers’ pre-recorded videos and slide presentations wouldn’t play. Altogether a worrying start to remote Advisory Committee meetings.

What does this experience mean for future Applicants? They need to be prepared for these hiccups and practice overcoming them.

No matter what type of virtual meeting, and regardless of your role, here’s a list of areas for careful attention when preparing to bring your best:

  • As a facilitator or Chair, keep communicating. This means letting participants know what is happening. Don’t allow dead air and poor audio quality to continue. Interject with, “As a reminder, when I say your name, unmute your line and speak. Then mute yourself again.” Better yet, invest in a system that allows you to mute attendees. During Q&A, let people know where you’re going. “Drs Smith, Johnson, and Agarwal are lined up to ask questions next. As you raise your hand I will add you to the list in order.” Nobody likes to be kept in the dark.
  • Hit pause. Don’t just keep going if something is wrong. A meeting is not a singing audition, where you stumble through the song even if you forget the words or the microphone goes out. On a remote meeting, if there are audio issues such as an echo or distortion, tell the attendees  you’re aware of the issues, and what’s happening in the background to fix them. During the Applicant’s introduction, an ODAC member’s unmuted mic created a loud echo. The speaker did the right thing — he paused and waited for the host to mute the offender. When things aren’t going well, take a deep breath and address it.
  • Go ahead and interrupt. Even if you are not the chair, don’t be shy about raising your hand to let people know when they are too quiet, their audio is cutting out, or you can hear their dog in the background. Plan ahead with your team to use the chat window, text directly, or simply jump in. It’s much kinder to let others know than to allow them to continue to talk, oblivious to the distractions.
  • Recap when you regroup. If a meeting needs to be restarted, people join late or there are other interruptions that cause you to begin again, make sure everyone knows where you left off. Newcomers will need a quick “here’s where we are” while those who sat through the first 30 minutes don’t need to hear everything repeated at length.
  • What happens when the slides disappear?  This happened to an FDA presenter, and she handled it well, telling the audience that her tech team was working on getting them back up. However, the slides were available for download, so she could have continued to present, referring to slides by number. The lesson? At the start of the meeting, ensure everyone has a copy of the materials (or knows where to find them) so that even with loss of visuals, the presentation can continue. The FDA presenter, after having her slides disappear a second time, opted to keep going.
  • Assume your audience is distracted. During both the Applicant and the FDA presentations, a committee member could be heard asking his assistant to draft a memo, there were toddler voices on occasion, and people went off mute creating waves of echoes. The onus is on you to re-engage the audience, not cause them to tune out further! Speak slowly, clearly, and vary your tone and pitch.  Stay focused and remember, if you don’t care, they won’t care.
  • Resist the urge to speed up. It’s understandable when pressed for time, or after multiple interruptions, you’ll want to pick up the pace. Be careful not to embrace that feeling and instead, keep a measured stride and respectful tone. This is critical during Q&A, when you must respect the questioner by responding in a manner that is easy to follow. Fast-talking can be hard to comprehend or worse, come off as aggressive and argumentative.
  • Remember to state your name. If you are not on video, remember to say your name before you begin speaking. The transcriptionist for an FDA Advisory Committee meeting needs this for the record. For other regulatory agency meetings, stating your name is imperative, and for any other meeting it’s simply polite.
  • Don’t read scripted answers during Q&A! We can tell you are reading. When your answers are long, run-on compound sentences in passive voice, with little natural inflection and variation in pacing, it’s obvious you are spitting out your talking points. It’s annoying and feels disingenuous.
  • Mute your electronics. It was clear during the ODAC Q&A that the Applicant team was communicating via chat. The constant dinging while they were speaking was distracting for the audience, and disrespectful when others were talking. Everyone understands the need to confer with your team – just turn off the volume. Same goes for phone ringers and email chimes.
  • Use the tools you have to your benefit. Since the Applicant is a “co-presenter” during a remote FDA Adcom and can control the display, leverage it. Show slides to support your answers only if they are helpful. Tell the audience where to look. Use your voice to your advantage. Speak naturally and emphatically with your audience and honor their questions and concerns by listening respectfully and answering briefly and clearly.

There are many considerations in a remote or electronic meeting that complicate an already stressful, high-stakes situation such as an FDA Advisory Committee meeting. These remote hearings require an extra layer of preparation and training to bring your best. In order to win not just the votes, but also the trust of the committee and respect of the FDA, the press and the public, you need to prepare for the worst and bring your best.

Our expert team is continuing to prepare sponsors to present their best case to regulators, whether in person or remotely.

Follow us on Twitter or LinkedIn for additional insights from PharmApprove on the state of virtual FDA advisory committee meetings as well as tips for other high stakes regulatory meetings.

For 20 years we’ve helped innovative life science companies prepare to win at high profile, high stakes meetings such as Advisory CommitteesOral Explanations, expert panels and advisory boards. We’ve coached thousands of professionals and led more than 250 clients through critical junctures to successful outcomes.

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