data in a public forum could jeopardize publication in both The 
New England Journal of Medicine and Science. Therefore, he 
suggested a compromise in the form of presenting the a summary of 
the data in slide format, rather than hand-outs, in order to 
avoid jeopardizing future publication. Dr. Anderson said this 
was an issue that NIH should resolve for future reviews of this 
nature . 
Dr. Anderson noted that the Investigational New Drug (IND) 
submission that had been submitted to the Food and Drug 
Administration (FDA) was available for members of the RAC to look 
at the data in "off the record" portions of the meeting such as 
coffee breaks and at lunch on an individual basis. 
Dr. Anderson said the protocol had been under review for six 
months and a great deal of critical evaluation of every aspect 
had been done. The proposal is one in which adults with advanced 
cancer will give their consent to a procedure with minimal risk 
which could provide invaluable information for improved cancer 
treatment. However, before this procedure is used in man, it 
must be shown that: 
1. It is possible to insert a marker gene into human TIL 
and that the inserted gene will be expressed at a 
useful level; 
2. Procedures used to introduce and select for expression 
of the exogenous gene do not significantly alter the 
transduced cell; 
3 . The proposed procedures have a reasonable chance of 
success based on animal feasibility studies; 
4. The proposed protocol does not add a significant new 
threat to the patient; 
5. The gene transfer procedure does not present a risk to 
health care personnel or to the public in general. 
Dr. Anderson said all of these points would be addressed in 
presentations and data addressing each point would be made 
available where possible. Where proprietary data were concerned, 
summary information would be presented. He said the five points 
had been addressed satisfactorily. It was determined that: 
insertion and expression of the marker gene in TIL could be 
accomplished; that the marked TIL are not significantly altered; 
that detection of marked cells in animal models, including murine 
models, showed there was a reasonable chance for success of the 
procedure; and that there is low risk to the patient and no risk 
to the public. 
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