Building a Case, AdComm Preparation, Part 2

Last week, after a talk I gave on the subject, I put up a posting Building a Case, AdComm Preparation, Part 1, where I talked about some of the reasons why communications is almost as important of a factor in AdComm preparation as the data and science.  There is a sweet spot between good data and good communications that is the place where any sponsor ought to be aiming.  Today, let’s look a little more at some of the mechanics of good prep.

First off with regard to the presentation itself – as with any communications challenge – it is best not to approach it on a piecemeal basis.  Before getting to the individual sections of a presentation – the need for the compound, the safety, the efficacy, etc., it is a good idea to sit down and develop the overall narrative first.  If you were going to write it as a story, what would you have to say?  This master document then is the master messaging document and works to ensure that the individual components hang together to be able to tell a convincing story.  A piecemeal approach can work, but there is also a chance that it can result in a presentation that is halting and at times, even inconsistent.  The overarching narrative provides a master messaging document from which the individual presentations can flow and relate to one another.

But before you even get to the presentation, there is the issue of messaging and organization around the issues one faces.  So prior to developing the narrative around those issues, one must begin to catalog and prioritize the issues.  That work primarily is done in two areas:  research into the history of the committee and the drug class and a good, hard look at the candidate compound itself.

The committee research is comprised of several components.  First look at the history of the committee going back for a few years.  Note that in part 1, I mentioned that I recently databased each committee – the number of meetings, the number of recommendations for approval, etc.  That is a start.  Many people like to track the voting patterns of individual members, and in addition, it is important to go through the transcripts provided on the committee site and assess current sitting members for their hot button issues or recurrent themes or concerns.  Particular attention is paid to compounds that have the same or similar indications.

The other part in looking at the history of the committee is to look at each committee member up close.  What is their expertise and research history that could shed light on the types of questions they may ask?  What professional societies figure in importantly, or third party organizations?  Looking at the committee as a whole, is there expertise that might be missing with regard to the compound and therefore signals a possibility that FDA would bring in a consultant for the meeting?  Who might that consultant be?  In addition, a media analysis of the committee is important.  How have media covered this committee in the past – are there “go-to” spokespeople among the committee members who important members of the media seek out for comment after a meeting?  Who are the likely third parties who will be sought after for comment?

With this outward assessment going on, it is also important to look inward.  Every candidate compound is different and everyone has warts.  A fresh set of eyes – those of someone unburdened by an investment of time and effort in the compound or its success – can be very helpful in cataloging the issues that the particular compound has which may be of concern.  Data, efficacy, design of clinical trials, recruitment of clinical trials, makeup of clinical trials, special populations, outliers… all issues to be assessed.  Here the messaging must be built around each of those issues, taking into account a number of angles for questioning.

A strong master narrative, an environmental research effort and an inward assessment area all key components to get you into the sweet spot.  In Part 3, we will look at a few more issues regarding the meeting itself.

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