CHMP Meetings: How to Succeed
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.
To summarize, applicants have exactly one hour to deliver their presentation and answer questions – so messages must be clear and compelling enough to overcome CHMP objections and memorable enough that voting participants retain the information up until the vote.
Importantly, although the CHMP poses tightly focused questions to the panels, we strongly advise our clients to broaden their messages. For example, the agency may focus on a specific safety concern, but we want the panel to consider marketing authorization in the context of overall benefit-risk. In our experience, this strategy yields the most positive results.
A major hurdle is the limited preparation timeline. Often applicants learn there will be a CHMP meeting only one to three months in advance. Within this limited timeframe, applicants must:
- Develop messages based on the data that address the explicit discussion topics posed by the rapporteurs and support overall benefit-risk;
- Craft a very concise 20-minute Core Presentation, including script and slides;
- Write a 40-page (maximum) briefing document;
- Anticipate possible questions; and
- Develop clear, credible answers.
Because of the unique nature of these meetings, applicants should utilize a process and technology specifically tailored to CHMP meeting preparation.
As great speakers well know, the shorter the presentation or speech, the harder it is to write. Preparing for a 20-minute presentation at CHMP meetings takes a lot of work. Every word counts, and applicants need a clear communications goal, key messages, and a script before generating slides.
Ditto for the briefing book. The core messages should be reflected in a clear briefing document. This support document must not only resolve the CHMP questions, it needs to concisely demonstrate a positive benefit-risk.
Message retention at CHMP meetings is essential. And these meetings, by design, give sponsors very little time to address members’ concerns and create a lasting impression. As a result, teams need a system that allows them to rapidly access hundreds of backup slides, to address and resolve every conceivable question. This ability to support each verbal response with a visual is essential to sustain message retention after being dismissed from the room.
There is no question that getting each of these steps right is a lot of work. But the potential rewards – approval of a product you’ve worked on for many years – are immense.
ABOUT THE AUTHORS
Penny Daniels is a strategic communications consultant and coach for pharmaceutical and device companies, academic institutions, government, and non-profits. As an accomplished writer and former national broadcast journalist, Penny uses her expertise to help 3D clients communicate effectively in challenging environments, including FDA Advisory Committee meetings. Penny excels at empowering communicators to optimize their own individual styles to meet audience needs and achieve business and organizational goals. Connect with Penny on LinkedIn.
Kell Cannon brings more than 20 years of U.S. and global lifecycle and pharmaceutical marketing expertise to 3D’s clients. Kell has developed rigorous processes to help clients analyze and prepare their regulatory submissions and FDA Advisory Committee presentations. This assistance enables companies to win approval, expedite product access, and achieve competitive reimbursement. Connect with Kell on LinkedIn.