4 
Dr. Anderson did not feel there would be many, if any, initial proposals which 
would contain confidential information. Dr. Walters said Genentech, Inc., the 
only firm known at this time to be involved in research involving human gene 
therapy, does not have a problem with the concept of open session review. 
Dr. Childress thought the language in the introduction dealing with open session 
review was confusing as written; the language both attanpts to state working 
group policy regarding open session review and to encourage open sessions. He 
suggested this section be redrafted. 
Dr. Walters called the attention of the subworking group to Dr. Miller's 
suggestion to substitute the word "composition" for the word "structure" in 
Section I-B-l-b. 
Dr. Anderson said "structure" and "composition" are different concepts. "Compo- 
sition" in the chemical sense is a subclass of structure. He thought the word 
"composition" while it did not contribute a great deal to the data request 
might, however, be added to this section which would then read; "Vhat cure the 
structure and canposition of the material that wall be administered to the 
patient?" 
Dr. Anderson suggested Section I-B-l-b- (1) could also be modified to read; 
"Describe the preparation, structure, and composition of all materials that 
wall be given to the patient or used to treat the patient's cell." 
Dr. Anderson suggested the words "nucleic acid" be substituted for the acronym 
"ENA" in Section I-B-l-b- (l)-(b) of the document. 
Dr. Walters said Dr. Miller had suggested two new sections be added to Section 
I-B-l-b. One section would request the investigator to "describe in detail the 
methods for harvesting, extraction, and purification, and for the removal of 
any toxic chemicals introduced by these procedures." The second new section 
would contain a warning that penicillin and other beta- lactam-containing anti- 
biotics should not be used in the production of materials administered to 
patients . 
Ms. Areen said Dr. Miller's onphasis appears on to be on how the vector is 
prepared or harvested. 
Dr. Anderson said the FDA manual on which Dr. Miller had based his suggestions 
addresses concerns in preparing biological material on an industrial scale. 
Ibis manual would not, however, apply to initial human gene therapy research 
protocols as these procedures wall not use materials produced on the industrial 
scale. Rather, the vectors for human gene therapy will be produced by cultured 
cells in laboratory-scale tissue culture plates as "budding particles." Ihe 
budding particle is self-packaged and does not contain culture medium or toxic 
substances. 
Dr. Anderson said human gene therapy protocols will utilize a biological package 
which excludes contaminants; therefore. Dr. Miller's concerns are not relevant 
to the points to consider document. 
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