Wow! I am just now recovering from a week in Boston at the 44th Annual DIA Meeting.

It was a great meeting with a record number of attendees (8700+), sessions, and exhibitors. I was fortunate enough to have been on the Program Committee for this meeting as I will be next year and in 2010. It is a 3 year commitment and has been an eye opening experience.

Let me share with you all some thoughts about the meeting, beginning with the Keynote.

It was a two part speech, the first part given by Dr. Dennis Ausiello of Mass General Hospital. I couldn’t really tell you much of what he spoke about, but he was followed up by Ms. Kathy Giusti, from the Multiple Myeloma Research Foundation (MMRF) and Research Consortium (MMRC). Ms. Guisti spoke about these public/private partnerships and the effect they are having on the patient population suffering from MM. It was fascinating to hear a business person talk about a model that has such connection to patients. I enjoyed it very much, not so much because I like the business stuff (I don’t), but the intersection of the topics was refreshing. The talk wasn’t as moving as when Beck Weathers spoke about being stranded on Mt. Everest or Jerry Linenger detailing his very personal brush with death on the Mir Space Station, but it brought home the message about commitment to curing disease, which everyone in the audience could relate to.

I attended a variety of sessions on topics that interest me - the one on Meta-Analyses reminded me once again that instead of wasting my time doing poorly in Calculus in college, I should have been taking Statistics; the one on Due Diligence made me think I should have gone to Law School; and the ones on the FDA Amendment Act made me think I need to go work at the Agency as they have been tasked to do an awful lot in the next 4 years of PDUFA IV. A funny side note: FDAAA has many nicknames that all struck me as funny 1) ‘FDA Ah Ah’ sounds like you are saying it with a speech impediment and 2) ‘FD Triple A’ sounds like some weird merger of food, drugs and car trips. But, I digress.

There was a special plenary session just on FDAAA and Drug Safety and next year’s DIA has already been tagged with a theme “Better Medicines: Securing Safety with Every Step,” so you can tell that the Industry is just as concerned as the Agencies about the public perception of our trade. In fact, if you go out on FDA’s Web site, there is an implementation plan for FDAAA listing section by section what the actionable items are and their status. This session, by the way, made me wish I were a pharmacoepidemiologist, as apparently there are only 6 in the entire US and they are all ready to retire despite the huge demand for them.

Overall, I came away from these sessions excited about what I do for a living, how important providing information in a usable standard format is to the FDA and how I am definitely not ready to retire as the marriage of Regulatory Affairs and technology is about the be blessed!