al., proposal pending receipt of additional data. The motion is 
as follows: 
PAUL E. NEIMAN'S MOTION ON THE ANDERSON PROPOSAL 
HUMAN GENE THERAPY SUBCOMMITTEE 
It was moved that: 
Consideration of the protocol be deferred until animal model 
testing is completed to include: 
1. Transfer of the vector to tumor infiltrating 
lymphocytes (TIL) from a suitable murine tumor system. 
2. Detection of vector marked TIL in recipient mice. 
3. Analysis of retroviral replication, tumorigenesis and 
other undesirable effects in recipient mice. 
In addition, data [should be presented] demonstrating that: 
1. The human TIL that are marked by the vector are 
representative of the relevant cell populations, and 
2. "Dry run" tests with human TIL [should be] completed 
which demonstrate a lack of infectious helper virus by 
the most sensitive assays available. 
After reading the motion. Dr. Walters solicited participants' 
comments on the Anderson material. He asked that comments 
received in writing from Dr. Albert H. Owens, Jr., be read. 
Dr. Owens is the Director of the Johns Hopkins Oncology Center. 
He was asked to review the proposal as an ad hoc consultant in 
order to gain the perspective of an additional oncologist. In 
summary. Dr. Owens expressed support for the proposed experiment 
based on his assessment that concerns raised by the subcommittee 
had been satisfactorily addressed. (It should be noted that 
Dr. Owens had not received all of the preliminary information 
provided to the subcommittee.) 
Responding in alphabetical order. Dr. Erickson noted that data 
resulting from polymerase chain reaction (PCR) tests for presence 
of marker gene DNA in TIL cells were not provided as requested. 
Dr. Parkman suggested that the use of nude mice in testing 
survival of injected marked T cells was not analogous to the same 
test performed in immune competent animals. Dr. Mulligan 
confirmed that normal mice will not accept these cells without 
prior irradiation to ablate the immune system. Moreover, 
Dr. Mulligan stated that issues raised previously by the 
subcommittee concerning an appropriate animal model system had 
not been resolved in the current submission. He stressed the 
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