response to the subcommittee’s July 29 motion, a recommendation 
to defer approval was the clear choice. 
There was considerable concern that the subcommittee's 
deliberation not be framed so as to discourage Dr. Anderson and 
others from continuing to pursue this important work. However, 
there was also strong support for the view that this first 
clinical trial of gene transfer into humans must be conducted 
under the most stringent conditions. The first hurdle is the 
development of appropriate animal model systems. Most 
participants remained convinced that such efforts had not been 
exhausted. However, the door was left open to reevaluate this 
position at a later date if appropriate animal models are not 
forthcoming. 
In addition, there was consensus that many of the questions 
raised in July had not been resolved, such as the need for more 
quantitative data; more sensitive assays for viral replication 
and reconstruction, and tumorigenesis ; and better assurance that 
marked TIL cells are representative of the relevant cell 
populations . 
Dr. Walters proposed that a short statement outlining the 
subcommittee’s recommendations be prepared for distribution at 
the RAC meeting on Monday. This paper should lay out the grounds 
for deferring approval pending submission of additional data on 
the critical points, and make clear exactly what would constitute 
sufficient data. 
Members of the subcommittee who would be attending the RAC 
meeting agreed to meet Sunday evening to draft this statement. 
The conference call adjourned at 5:00 p.m. 
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Recombinant DNA Research, Volume 13 
