Rc(X)mbinant DNA Advisory Committee - 
again was the ability to transduce TILs in the mouse model in the same way as with 
humans cells. Dr. Mclvor said that if preclinical data did in fact exist, it was not 
included in the protocol and that it should be. 
Dr. R. Murray brought up a procedural question dealing with the method in which the 
subcommittee had approved the protocol. The subcommittee provided the investigator 
with a detailed list of conditions under which it would approve the protocol in order for 
the RAC to review it at this meeting. What he had before him was the same exact 
protocol as was received at the HGTS meeting, and that the reviewers had in fact been 
asked to review the same protocol without substantive changes. Historically there had 
been a problem when a protocol was forwarded to the RAC for consideration without 
approval of the HGTS, and he concluded that this situation was being repeated in this 
case. 
Dr. McGarrity said that the subcommittee had approved the protocol to go forward to 
the RAC with supplemental data. It was the committee's decision to determine whether 
this supplemental data had in fact been supplied. 
Dr. R. Murray said that his impression was that this data was to have been supplied in 
writing so that the reviewers could view the complete revised protocol, including the 
supplemental data, in order to form a judgement on the merits of the protocol. 
Dr. B. Murray noted that the question was not whether the HGTS and the RAC were 
following its own procedures, but whether the investigators had followed through on their 
promise to supply supplemental data before the protocol was reviewed. She said that 
apparently they may not have complied with the stipulations placed on them by the 
HGTS. 
Dr. Lotze responded that the subcommittee had given the protocol a very fair hearing 
and that most of the changes they requested were really for clarification rather than 
substantive changes. Since he had never received any formal comments from the 
subcommittee and since he had heard that the protocol had been submitted to the full 
RAC, he thought the explanations and clarifications given were sufficient. He had made 
pen and ink changes to his own document, and he was aware that these were not 
generally available to the reviewers and the committee in their copies. He was aware 
that the RAC would have the right, based on what he now understood of the approval 
being granted with stipulations, to table discussion on the protocol and await the data, 
but that he and his group were anxious to push ahead with the protocols. 
Dr. Wivel noted that a portion of the transcript of the meeting of the HGTS was sent to 
Dr. Lotze via FAX detailing the six questions which were the basis for the provisional 
approval of the protocol. Dr. Lotze said he had never seen this document. 
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Recombinant DNA Research, Volume 14 
