Just like organizations worldwide, the US FDA has been weighing the pros – and cons – of resuming in-person meetings with people outside their organization. For companies seeking agency approval of their drugs, devices, and biologics, this can be quite literally a billion-dollar question – since these meetings can determine their products’ ultimate regulatory fate.
The FDA has said that virtual meetings, while challenging, have shown some advantages over in-person ones, such that remote meetings may remain a significant part of its strategy with sponsors going forward.
But what do sponsors want?
For that, I spoke to my 3D Communications colleagues Jim DiBiasi and Kell Cannon. 3D has been preparing pharmaceutical, biotech, and medical device companies for FDA and EMA regulatory meetings for nearly 20 years. During COVID our work focused on preparing clients for virtual meetings with the agency and its advisors.
Penny: Jim, are sponsors seeing the same advantages that the FDA is seeing from virtual meetings?
Jim: Yes, absolutely – and some of the same disadvantages too. In the last 14 months, people have become much more comfortable with the technology and recognized that remote meetings can save time and money. As a result, you can hold more meetings, which is advantageous to both sponsors and the FDA. Having said that, virtual meetings require more complex preparation for sponsors. You need multiple technology platforms, you can’t see faces, you can’t read body language, and you can’t hear very well. Technical issues can have a negative impact on communication. Sponsors have to “up their game” dramatically to compensate for this added complexity.
Penny: Kell, what impact does the type of meeting have on this issue?
Kell: Most meetings the FDA has with sponsors are private, one-hour meetings held during the course of product development. Normally, the sponsor team flies into the D.C. area to meet in person with the agency. Between the cost of flying people in, and the office time lost, it can be a little over-the-top for a one hour meeting. Sometimes the “out of office” time can be as much as two days. On the other hand, sponsors can sometimes get important information from the agency while walking to and from the meeting room, which they wouldn’t get from a virtual meeting. However, in a virtual meeting, sponsors can privately talk to each other in real time, so that is something to consider as well.
But FDA Advisory Committee meetings are a different story. These large, public meetings can go on for six to eight hours. They are extremely high stakes; the approval – or non-approval – of the sponsor’s product often depends on the outcome. For these meetings, face-to-face interaction is definitely preferable. In a remote situation, it’s just too easy for anyone – on the sponsor or FDA side -– to disengage and miss important content.
Penny: Jim, is it different preparing and coaching people to participate in a virtual meeting than an in person one?
Jim: Yes, definitely. It’s much more difficult to connect with an audience when you can’t see them and they can’t see you. You have to make messages clearer than ever and more consistent across the Briefing Book, Core Presentation and Q&A. Sponsors also have to listen differently in a virtual meeting, as there is a greater risk that questions will be misunderstood. Nothing irritates a panelist more than having to repeat their question because the responder answered something they didn’t ask. We coach people to clarify questions – if necessary – in a respectful, non-confrontational way. Also, sponsors must learn to develop a particularly energetic voice and to vary their pitch, pace, and intonation, so they can keep the audience engaged virtually.
Penny: Kell you suggested the FDA might take a hybrid approach?
Kell: Yes, the FDA may inch back towards in person meetings by first holding “hybrids,” where the sponsor team is in one location and the FDA personnel are at White Oak, while other participants unable or unwilling to travel may participate remotely. In this case, discussions between the sponsor and the agency will still be virtual.
So again, sponsors may have a tougher time making persuasive arguments without being able to fully understand the atmosphere in the room. It’s really important to fully anticipate what scientific issues could create confusion and to ensure that the sponsor’s arguments are as simple, clear, and straightforward – and persuasive – as possible.
Also, with a remote meeting, anything can happen technically, so you have to make sure the people advancing the slides are extremely well trained. It’s basically everything you have to do for an in-person meeting, but with a focus on how to overcome specific challenges of being virtual.
Jim: Let’s not forget that in FDA Advisory Committee meetings, all sponsors deliver their presentations verbatim, so we also have to ensure that every single word is perfect for the presenter – that it’s truly in their voice. Of course, we coach presenters to deliver the script conversationally, as if they were just “talking” and not “reading.”
Penny: Any last thoughts?
Jim: At the end of the day, success is all about planning, preparation and practice, and this is more important than ever when meetings are virtual. For the larger FDA Advisory Committee meetings, where you must make sure the panel doesn’t get confused on the science, and the Q&A time is very short, we hold Mock Advisory Committee meetings with the same technology that the FDA uses, so that by the time the real meeting takes place, the sponsor is ready for anything that can possibly go wrong.
Kell: Right now, the Advisory Committee meetings are starting to be held in hybrid fashion. I do think these large meetings will eventually be face-to-face as they’ve always been. But I also think the FDA – and sponsors for that matter – will see the advantages in continuing to be virtual for many, if not most, of the other smaller meetings with sponsors, long after the pandemic becomes a part of history.