8 Tips to Set Your Team Up for Success
By Michael Piperno
There is perhaps no regulatory event as intense as an FDA Advisory Committee meeting. The stakes are high, and the applicant team has spent the last six months getting ready to deliver and defend a cohesive and meaningful story grounded in data. The COVID-19 pandemic has made these regulatory meetings even more stressful because they are being conducted virtually. As my colleague Lisa Peluso wrote in a recent post, technological issues combined with remote meeting faux pas have made recent meetings a bit bumpy.
The good news is that there are things you can do to set yourself up for success.
1. Get Comfortable with the Technology
Adobe Connect is the software FDA currently uses for virtual advisory committee meetings. Get to know it, practice with it, and don’t be shy about asking FDA for a dry run so you can ensure everything works as you expect on meeting day.
2. Boost Bandwidth
Every person on your team who will speak or support responses to questions should be certain they have good, stable internet connections. If they can connect directly to their routers with a cable, then do it. If they can’t, ensure they are as close to their wireless base stations as possible. Also, limit other household internet activity during the meeting. Video and music streaming, gaming, and any other online activity within your home or office will affect available bandwidth.
3. Have Understudies Ready to Go On
All it takes is a power outage or bad connection to lose one of your team members during the meeting. If you can’t safely be in the same room together on meeting day, be sure each speaker and Q&A responder has a dedicated backup who is ready to jump in if needed.
4. Practice Q&A Sans Video
Due to bandwidth limitations, FDA does not currently allow live video of panelists or presenters during advisory committee meetings. This means that you must become comfortable answering questions without the benefit of nonverbal feedback. In other words, it will be difficult to know if you’ve answered a question to the questioner’s satisfaction. Also note that the Chairperson tends to call on committee members one at a time, and they ask all of their questions in one shot. This means you need to track bundled questions and be sure to answer all of them. Brush up on those listening skills!
5. Coach Your Speakers
Speakers must be clear and well-rehearsed. Their enunciation, tone, and pacing must be appropriate. After all, their voices and the slides are all you have.
6. Pay Extra Attention to your Slides
Your slides will be viewed on a variety of different screens, many of which are laptops. Ensure the committee members can read them without working too hard. If you must show a complex slide, use highlight boxes to guide the panel’s eyes to the right spot. Ensuring your slides are not too busy and can be quickly understood by the panel is even more critical in the virtual setting.
7. Develop an Internal Communications Plan
Your team is going to need to communicate with each other during the meeting, but you need to do so in a way that is completely behind the scenes. Be sure you have implemented and rehearsed your internal communications and slide retrieval technology to ensure it’s both efficient and silent. The last thing you want is for the panelists to hear loud typing or message notifications coming from your team.
8. Preparation is Paramount
At PharmApprove, we always say that when you’re tired of rehearsing, rehearse again. You can never be too prepared for a high stakes regulatory event like an FDA advisory committee meeting. With virtual meetings, you need to be even more prepared. We can help.
For 20 years we’ve helped innovative life science companies prepare to win at high profile, high stakes meetings such as Advisory Committees, Oral Explanations, expert panels and advisory boards. We’ve coached thousands of professionals and led more than 250 clients through critical junctures to successful outcomes.
