Mad March and the FDA

It has been a busy few weeks for both work and personal reasons. For those who know us, it is lovely to announce that Amanda (AJ) and I got married on the first day of March. Some pictures from a friend can be found here and many thanks from us both to those who have sent kind wishes.

So if that did not make March frantic enough, I find myself sitting on a plane heading to the US for an exciting week of volunteering. The major event of the week is the FDA /PhUSE Computational Science Symposium with the second half of the week being taken up with a CDISC Technical Leadership Committee (TLC) meeting and a CDISC SHARE team face-to-face meeting.

I was surprised and rather honoured – this is English understatement – to be invited to participate in the PhUSE meeting. In the past two years, the DIA have run the event but it has only really manifested as a two day meeting at which people gathered and after two days left. With this event, the FDA is very much driving the idea that the two day gathering is an initial kick off meeting with working groups continuing their work going forward through 2012 and into 2013.

At the current time six working groups have been set up and have undertaken some preliminary work with the real work starting over the next two days:

• Working Group 1 Validation – focusing on collaborating to develop a robust process to rapidly validate and assess data quality as data moves through the product life cycle across both industry and regulatory review.
• Working Group 2 Site Selection – continuing the ongoing work developing standards for the data set used in a risk model designed to improve the quality of clinical inspection site selection for drug trials.
• Working Group 3 Integration – looking at the challenges of analyzing and integrating data from retrospective studies from both an industry and regulatory perspective
• Working Group 4 CDISC Implementation – looking at specific challenges with implementing the CDISC data standards
• Working Group 5 Standard Scripts – focusing on standard scripts for data transformations and analyses across and/or within a therapeutic area and exploratory analysis.
• Working Group 6. Non-Clinical – discussing various approaches to the standardization of nonclinical data and the possible implications to the development and implementation of data standards.

The meeting has sold out with 300 registrations being accepted by PhUSE for the event. It should be an interesting event and it will be exciting to see the work that will emerge from the working groups.

I will endeavour to tweet news over the two days.