Dear Mr. Biedenbach
In the simplest of terms, the presentation you developed for Teva/Lemmon and Hoechst Marion Roussel was unparalleled in my experience. It was extraordinary, and I believe was very much a factor in the Advisory Committee's unanimous recommendation for approval - and ultimate FDA approval decision. I say that from the perspective of having witnessed numerous presentatations while serving as Deputy Director of FDA's Center for Evaluation and Research, and before that as FDA's Associate Commissioner for Management and Operation, as well as during the past five years as a Senior Consultant for the AAC Consulting Group.
The way in which you took the sponsor's data, organized it into reasonable slides, focused each on the issue to be presented, and then organized what must have been literally hundreds of slides was more than impressive by itself. To then have taken those slides during the rehearsals, and organized them so that you could literally have a slide on the screen to assist with the answer to any question - almost as it was being asked - reaffirmed for FDA staff and their Advisory Committee how very much this sponsor was both knowledgeable of their product, and in control of the data obtained from clinical studies. By any standard it was an exceptional contribution, and I am certain the many MS patients who now benefit from this product would be deeply grateful if they were aware of your role.
I am personally pleased that you have become an independent contractor, because I can now refer others to you whose products can also benefit from the skills you and your staff possess. I wish you every success in the future, and please feel free to always use me as a reference.
Sincerely
Gerald F. Meyer