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FDA Advisory Committee Meeting: synopsis to an advisor panel meeting
You only have one chance to make your presentation to the FDA Advisory Committee for drug or medical device approval:
- Only 1 out of every 5 drugs submitted to the FDA is approved
- Your data must be presented brief, clear, concise and graphically
- Don't be caught unprepared, make your presentation count!
As you know, an FDA Advisory Committee presentation is an incredibly difficult
and tedious process. Developing, organizing and submitting presentations for
FDA approval can be overwhelming. It is easy to lose focus in the face of so
much work, and many sponsor teams simply do not have adequate time to
prepare for and develop an effective presentation.
X2 Media can streamline the entire process for you from start to finish. Our extensive background in preparing presentations for the FDA Advisory
Committee along with meeting planning expertise will get your message through
to the advisory panel. Our presentation format allows you --the sponsor-- to
focus on your message. We'll handle the rest of the details necessary to pull off
a successful advisory panel meeting.
Preparation and rehearsal are the keys to a successful meeting. When it comes
to your data, our system of developing a proper structure for the core
presentation and back-up slides allows incredible flexibility. We can add new
data easily throughout the entire development process, closely managing all information every step of the way. Your data will be presented in a consistent, appealing and easy-to-understand format.
Preparation does not stop at the information level. It is important for the sponsor team to rehearse, rewrite, and rehearse again for the actual meeting. Mock
meetings will prepare your staff, giving them the comfort level necessary for a successful presentation. It is our job to make sure that your consultants and advisors on-site at the mock meetings are adequately prepared as well. In
addition, our team can provide your project manager assistance with all meeting event planning and speaker coaching.
In conjunction with your main presentation, it is important to rehearse our
process of selecting and presenting any back-up material that supports your message to the FDA. This process is important to ensure that all team members involved are able to display any possible slide in a timely and efficient manner.
X2 will remain on-site and at your disposal during the week of your presentation. This will allow us to rehearse the presentations with each of the presenters,
develop additional last minute slides, and handle all of your team's technical
and logistic needs. We will also manage and assemble any information required
by the FDA. This material includes assembling binders for the advisory panel, as well as assembling binders of the core and back-up material for your staff.
Setup of the actual meeting site is another important factor often left to last
minute planning. Our team will ensure the proper setup and use of the main
meeting room, as well as private workrooms for your staff. We also maintain both main and back-up systems, and continually verify that they are fully functional throughout the meeting.
Our team has presented many successful FDA Advisory meetings. We fully understand how to manage a productive and successful meeting, and the many nuances that accompany them. We are also sensitive to the amount of time, effort and the financial commitment you have made for this FDA Advisory meeting,
and we are committed to helping you get the most for your time, investment and getting your drug or medical device to market. Our goal is to provide you with
all the support you need to present your message clearly and concisely to the
FDA Advisory Panel to achieve a favorable response.