|
The original idea for working groups originated in planning for the 2003 Somatic Cell Therapy Symposium meeting, chaired by then ISCT President Stephen Noga. At that meeting, three sessions were held to discuss different working group ideas:
-
release testing (session chairs: Janice Davis, Gary duMoulin & EJ Read)
-
biological licensure application (session chairs: Shelly Heimfeld, Liz Cardwell, Elizabeth Smith)
-
facility sanitization (session chair: Doug Padley)
The consensus at each of these sessions was that there should be a working group set up for each of the areas to draft white papers or guidance for submission to the FDA.
Between September 2003 and May 2004, there was little to no further activity and no defined working groups established. In 2004, the ISCT Executive Committee assigned each of these three working groups topics to an ISCT committee. (see further details below).
Since September 2003, other working groups have been proposed and/or created to deal with isolated issues and generate specific work product. These have been generated out of the Cell Therapy Liaison Meeting and the Executive Committee meetings. The following pages contain a summary of the status of each of these groups.
The current model for working groups is as the Homologous Working Group is designed. The idea is that there a small number of committed people with expertise on the subject who are assigned to the working group. Much thought is given to commitment levels and expertise and little to political affiliation or representation, although balance must be struck between different cell types and types of institutions. A larger and more politically representative advisory group is then struck and used for the purposes of reviewing drafts providing feedback and giving input into the process when requested.
| 
